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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 18pt"><b>UNITED
STATES</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 18pt"><b>SECURITIES
AND EXCHANGE COMMISSION</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 12pt"><b>Washington,
D.C. 20549</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 18pt"><b>Form
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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><span id="xdx_900_edei--DocumentRegistrationStatement_c20230101__20231231_zqaXHGWq9k4i"><ix:nonNumeric contextRef="From2023-01-01to2023-12-31" format="ixt:booleanfalse" id="Fact000017" name="dei:DocumentRegistrationStatement">&#9744;</ix:nonNumeric></span>
<b>REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>OR</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><span id="xdx_902_edei--DocumentAnnualReport_c20230101__20231231_zxJGtGG1Bnxi"><ix:nonNumeric contextRef="From2023-01-01to2023-12-31" format="ixt:booleantrue" id="Fact000018" name="dei:DocumentAnnualReport">&#9746;</ix:nonNumeric></span>
<b>ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.2in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>For
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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><span id="xdx_902_edei--DocumentTransitionReport_c20230101__20231231_z7OQQgNFGqCa"><ix:nonNumeric contextRef="From2023-01-01to2023-12-31" format="ixt:booleanfalse" id="Fact000022" name="dei:DocumentTransitionReport">&#9744;</ix:nonNumeric></span>
<b>TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center; background-color: white"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>OR</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><span id="xdx_909_edei--DocumentShellCompanyReport_c20230101__20231231_zpaxO1ZYWNq4"><ix:nonNumeric contextRef="From2023-01-01to2023-12-31" format="ixt:booleanfalse" id="Fact000023" name="dei:DocumentShellCompanyReport">&#9744;</ix:nonNumeric></span>
<b>SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Date
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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>For
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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Commission
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<p style="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 18pt"><b><span id="xdx_902_edei--EntityRegistrantName_c20230101__20231231_zH5wokzfYCb"><ix:nonNumeric contextRef="From2023-01-01to2023-12-31" id="Fact000025" name="dei:EntityRegistrantName">GALMED
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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><i>(Exact
name of Registrant as specified in its charter)</i></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>N/A</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><i>(Translation
of the Registrant&#8217;s name into English)</i></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>State
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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><i>(Jurisdiction
of incorporation or organization)</i></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><span id="xdx_90C_edei--EntityAddressAddressLine1_c20230101__20231231_zDyt0JVxuip1"><ix:nonNumeric contextRef="From2023-01-01to2023-12-31" id="Fact000027" name="dei:EntityAddressAddressLine1">16
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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><i>(Address
of principal executive offices)</i></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><span id="xdx_905_edei--ContactPersonnelName_c20230101__20231231__dei--EntityAddressesAddressTypeAxis__dei--BusinessContactMember_zxtyDrAC6Nkg"><ix:nonNumeric contextRef="From2023-01-012023-12-31_dei_BusinessContactMember" id="Fact000031" name="dei:ContactPersonnelName">Allen
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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>President
and Chief Executive Officer</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><span id="xdx_905_edei--EntityAddressAddressLine1_c20230101__20231231__dei--EntityAddressesAddressTypeAxis__dei--BusinessContactMember_zY5Ldc1YfZyk"><ix:nonNumeric contextRef="From2023-01-012023-12-31_dei_BusinessContactMember" id="Fact000032" name="dei:EntityAddressAddressLine1">16
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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><span id="xdx_903_edei--EntityAddressCityOrTown_c20230101__20231231__dei--EntityAddressesAddressTypeAxis__dei--BusinessContactMember_zprYdpDPp6u1"><ix:nonNumeric contextRef="From2023-01-012023-12-31_dei_BusinessContactMember" id="Fact000033" name="dei:EntityAddressCityOrTown">Ramat Gan</ix:nonNumeric></span>, <span id="xdx_909_edei--EntityAddressCountry_c20230101__20231231__dei--EntityAddressesAddressTypeAxis__dei--BusinessContactMember_zux7AxJqtw58"><ix:nonNumeric contextRef="From2023-01-012023-12-31_dei_BusinessContactMember" format="ixt-sec:countrynameen" id="Fact000034" name="dei:EntityAddressCountry">Israel</ix:nonNumeric></span> <span id="xdx_90B_edei--EntityAddressPostalZipCode_c20230101__20231231__dei--EntityAddressesAddressTypeAxis__dei--BusinessContactMember_zZJSv1idi9ye"><ix:nonNumeric contextRef="From2023-01-012023-12-31_dei_BusinessContactMember" id="Fact000035" name="dei:EntityAddressPostalZipCode">5250608</ix:nonNumeric></span></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>E-mail:
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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Tel:
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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Fax:
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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><i>(Name,
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<p style="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Securities
registered or to be registered pursuant to Section 12(b) of the Act.</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Securities
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<p style="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>N/A</b></span></p>

<!-- Field: Rule-Page --><div style="margin: 0pt auto; width: 100%"><div style="border-top: Black 1.5pt solid; font-size: 1pt">&#160;</div></div><!-- Field: /Rule-Page -->

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><i>(Title
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<p style="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Securities
registered or to be registered pursuant to Section 15(d) of the Act.</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>N/A</b></span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><i>(Title
of each class)</i></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Indicate
the number of outstanding shares of each of the issuer&#8217;s classes of capital or common stock as of the close of the period covered
by the annual report (December 31, 2023): <span id="xdx_90E_edei--EntityCommonStockSharesOutstanding_iI_c20231231_zBIUXXx9T193"><ix:nonFraction name="dei:EntityCommonStockSharesOutstanding" contextRef="AsOf2023-12-31" id="Fact000042" format="ixt:numdotdecimal" decimals="INF" unitRef="Shares">5,045,324</ix:nonFraction></span> ordinary shares are outstanding</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Indicate
by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes </b>&#9744; <b><span id="xdx_909_edei--EntityWellKnownSeasonedIssuer_c20230101__20231231_zzxVqFU2LNZc"><ix:nonNumeric contextRef="From2023-01-01to2023-12-31" id="Fact000043" name="dei:EntityWellKnownSeasonedIssuer">No</ix:nonNumeric></span>
</b>&#9746;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>If
this report is an annual or transition report, indicate by check mark if the registrant is not required to file reports pursuant to Section
13 or 15(d) of the Securities Exchange Act of 1934. Yes </b>&#9744; <b><span id="xdx_907_edei--EntityVoluntaryFilers_c20230101__20231231_zMddxuBtT9"><ix:nonNumeric contextRef="From2023-01-01to2023-12-31" id="Fact000044" name="dei:EntityVoluntaryFilers">No</ix:nonNumeric></span> </b>&#9746;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 16.2pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Note
&#8211; Checking the box above will not relieve any registrant required to file reports pursuant to Section 13 or 15(d) of the Securities
Exchange Act of 1934 from their obligations under those Sections.</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Indicate
by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange
Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2)
has been subject to such filing requirements for the past 90 days. <span id="xdx_906_edei--EntityCurrentReportingStatus_c20230101__20231231_zQehs6Bsjr23"><ix:nonNumeric contextRef="From2023-01-01to2023-12-31" id="Fact000045" name="dei:EntityCurrentReportingStatus">Yes</ix:nonNumeric></span> </b>&#9746; <b>No </b>&#9744;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Indicate
by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule
405 of Regulation S-T (&#167;232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant
was required to submit and post such files). <span id="xdx_90F_edei--EntityInteractiveDataCurrent_c20230101__20231231_zHsffb3iDLD8"><ix:nonNumeric contextRef="From2023-01-01to2023-12-31" id="Fact000046" name="dei:EntityInteractiveDataCurrent">Yes</ix:nonNumeric></span> </b>&#9746; <b>No </b>&#9744;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Indicate
by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer or an emerging growth
company. See definition of &#8220;large accelerated filer,&#8221; &#8220;accelerated filer,&#8221; and &#8220;emerging growth company&#8221;
in Rule 12b-2 of the Exchange Act.</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; width: 30%"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Large
    accelerated filer </b>&#9744;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 35%"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Accelerated
    filer </b>&#9744;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 35%"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><span id="xdx_907_edei--EntityFilerCategory_c20230101__20231231_z9U59qH1nPz1"><ix:nonNumeric contextRef="From2023-01-01to2023-12-31" format="ixt-sec:entityfilercategoryen" id="Fact000047" name="dei:EntityFilerCategory">Non-accelerated
    filer</ix:nonNumeric></span> </b>&#9746;</span></td>
    </tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Emerging
    growth company </b><span id="xdx_90E_edei--EntityEmergingGrowthCompany_c20230101__20231231_zkPVZoW9zFkg"><ix:nonNumeric contextRef="From2023-01-01to2023-12-31" format="ixt:booleanfalse" id="Fact000048" name="dei:EntityEmergingGrowthCompany">&#9744;</ix:nonNumeric></span></span></td>
    </tr>
  </table>
<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>If
an emerging growth company that prepares its financial statements in accordance with U.S. GAAP, indicate by check mark if the registrant
has elected not to use the extended transition period for complying with any new or revised financial accounting standards &#8224; provided
pursuant to Section 13(a) of the Securities Act. &#9744;</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#8224;
<b>The term &#8220;new or revised financial accounting standard&#8221; refers to any update issued by the Financial Accounting Standards
Board to its Accounting Standards Codification after April 5, 2012.</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Indicate
by check mark whether the registrant has filed a report on and attestation to its management&#8217;s assessment of the effectiveness
of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered
public accounting firm that prepared or issued its audit report. </b><span id="xdx_902_edei--IcfrAuditorAttestationFlag_c20230101__20231231_zUkTBsVvA738"><ix:nonNumeric contextRef="From2023-01-01to2023-12-31" format="ixt:booleanfalse" id="Fact000049" name="dei:IcfrAuditorAttestationFlag">&#9744;</ix:nonNumeric></span></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 16.2pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>If
securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant
included in the filing reflect the correction of an error to previously issued financial statements. <span id="xdx_90D_edei--DocumentFinStmtErrorCorrectionFlag_c20230101__20231231_zIRxY9RxW1x5"><ix:nonNumeric contextRef="From2023-01-01to2023-12-31" format="ixt:booleanfalse" id="Fact000050" name="dei:DocumentFinStmtErrorCorrectionFlag">&#9744;</ix:nonNumeric></span></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 16.2pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Indicate
by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation
received by any of the registrant&#8217;s executive officers during the relevant recovery period pursuant to &#167;240.10D-1(b). &#9744;</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Indicate
by check mark which basis of accounting the registrant has used to prepare the financial statements included in this filing:</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; width: 20%"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><span id="xdx_90F_edei--DocumentAccountingStandard_c20230101__20231231_zFpf2RecX99"><ix:nonNumeric contextRef="From2023-01-01to2023-12-31" id="Fact000051" name="dei:DocumentAccountingStandard">U.S. GAAP</ix:nonNumeric></span> </b>&#9746;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 60%"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>International
                                            Financial Reporting Standards</b></span></p>
    <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>as
    issued by the International Accounting Standards Board </b></span></p></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 20%; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Other</b></span></td></tr>
  </table>
<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>If
&#8220;Other&#8221; has been checked in response to the previous question indicate by check mark which financial statement item the Registrant
has elected to follow: Item 17 &#9744; Item 18 </b>&#9744;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>If
this is an annual report, indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange
Act). Yes </b>&#9744; <b>No </b><span id="xdx_90A_edei--EntityShellCompany_dbF_c20230101__20231231_zLlBSb2kxM7h"><ix:nonNumeric contextRef="From2023-01-01to2023-12-31" format="ixt:booleanfalse" id="Fact000052" name="dei:EntityShellCompany">&#9746;</ix:nonNumeric></span></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 16.2pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 16.2pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"></span></p>

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    <div style="break-before: page; margin-top: 6pt"><table cellpadding="0" cellspacing="0" style="border-collapse: collapse; width: 100%; font-size: 10pt"><tr style="vertical-align: top; text-align: left"><td style="width: 100%">&#160;</td></tr></table></div>
    <!-- Field: /Page -->

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>TABLE
OF CONTENTS</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top; background-color: rgb(204,238,255)">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><a href="#p_001">PART I</a> </span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.5in; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">5</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top; background-color: White">
    <td style="font: 10pt Times New Roman, Times, Serif; padding-left: 10pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><a href="#p_002">ITEM 1. Identity of Directors, Senior Management and Advisers.</a> </span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">5</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top; background-color: rgb(204,238,255)">
    <td style="font: 10pt Times New Roman, Times, Serif; padding-left: 10pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><a href="#p_003">ITEM 2. Offer Statistics and Expected Timetable.</a> </span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">5</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top; background-color: White">
    <td style="font: 10pt Times New Roman, Times, Serif; padding-left: 10pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><a href="#p_004">ITEM 3. Key Information.</a> </span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">5</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top; background-color: rgb(204,238,255)">
    <td style="font: 10pt Times New Roman, Times, Serif; padding-left: 10pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><a href="#p_005">ITEM 4. Information on the Company.</a> </span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">55</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top; background-color: White">
    <td style="font: 10pt Times New Roman, Times, Serif; padding-left: 10pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><a href="#am_001">ITEM 4A. Unresolved Staff Comments.</a> </span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">92</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top; background-color: rgb(204,238,255)">
    <td style="font: 10pt Times New Roman, Times, Serif; padding-left: 10pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><a href="#am_002">ITEM 5. Operating and Financial Review and Prospects.</a> </span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">92</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top; background-color: White">
    <td style="font: 10pt Times New Roman, Times, Serif; padding-left: 10pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><a href="#am_003">ITEM 6. Directors, Senior Management and Employees.</a> </span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">99</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top; background-color: rgb(204,238,255)">
    <td style="font: 10pt Times New Roman, Times, Serif; padding-left: 10pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><a href="#am_005">ITEM 7. Major Shareholders and Related Party Transactions.</a> </span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">120</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top; background-color: White">
    <td style="font: 10pt Times New Roman, Times, Serif; padding-left: 10pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><a href="#am_006">ITEM 8. Financial Information.</a> </span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">121</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top; background-color: rgb(204,238,255)">
    <td style="font: 10pt Times New Roman, Times, Serif; padding-left: 10pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><a href="#am_007">ITEM 9. The Offer and Listing.</a> </span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">122</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top; background-color: White">
    <td style="font: 10pt Times New Roman, Times, Serif; padding-left: 10pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><a href="#am_008">ITEM 10. Additional Information.</a> </span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">122</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top; background-color: rgb(204,238,255)">
    <td style="font: 10pt Times New Roman, Times, Serif; padding-left: 10pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><a href="#am_009">ITEM 11. Quantitative and Qualitative Disclosures About Market Risk.</a> </span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">135</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top; background-color: White">
    <td style="font: 10pt Times New Roman, Times, Serif; padding-left: 10pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><a href="#am_010">ITEM 12. Description of Securities Other Than Equity Securities.</a> </span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">136</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top; background-color: rgb(204,238,255)">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top; background-color: White">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><a href="#am_011">PART II</a> </span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">136</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top; background-color: rgb(204,238,255)">
    <td style="font: 10pt Times New Roman, Times, Serif; padding-left: 10pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><a href="#am_012">ITEM 13. Defaults, Dividend Arrearages and Delinquencies.</a> </span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">136</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top; background-color: White">
    <td style="font: 10pt Times New Roman, Times, Serif; padding-left: 10pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><a href="#am_013">ITEM 14. Material Modifications to the Rights of Security Holders and Use of Proceeds.</a> </span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"></span>136</td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top; background-color: rgb(204,238,255)">
    <td style="font: 10pt Times New Roman, Times, Serif; padding-left: 10pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><a href="#am_014">ITEM 15. Controls and Procedures.</a> </span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"></span>136</td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top; background-color: White">
    <td style="font: 10pt Times New Roman, Times, Serif; padding-left: 10pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><a href="#am_015">ITEM 16. [RESERVED]</a> </span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">137</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top; background-color: rgb(204,238,255)">
    <td style="font: 10pt Times New Roman, Times, Serif; padding-left: 10pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><a href="#am_016">ITEM 16A. Audit Committee Financial Expert.</a> </span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"></span>137</td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top; background-color: White">
    <td style="font: 10pt Times New Roman, Times, Serif; padding-left: 10pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><a href="#am_017">ITEM 16B. Code of Ethics.</a> </span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"></span>137</td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top; background-color: rgb(204,238,255)">
    <td style="font: 10pt Times New Roman, Times, Serif; padding-left: 10pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><a href="#am_018">ITEM 16C. Principal Accountant Fees and Services.</a> </span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"></span>138</td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top; background-color: White">
    <td style="font: 10pt Times New Roman, Times, Serif; padding-left: 10pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><a href="#am_019">ITEM 16D. Exemptions from the Listing Standards for Audit Committees.</a> </span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"></span>139</td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top; background-color: rgb(204,238,255)">
    <td style="font: 10pt Times New Roman, Times, Serif; padding-left: 10pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><a href="#am_020">ITEM 16E. Purchases of Equity Securities by the Issuer and Affiliated Purchasers.</a> </span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"></span>139</td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top; background-color: White">
    <td style="font: 10pt Times New Roman, Times, Serif; padding-left: 10pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><a href="#am_021">ITEM 16F. Change in Registrant&#8217;s Certifying Accountant.</a> </span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"></span>139</td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top; background-color: rgb(204,238,255)">
    <td style="font: 10pt Times New Roman, Times, Serif; padding-left: 10pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><a href="#am_022">ITEM 16G. Corporate Governance.</a> </span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"></span>139</td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top; background-color: White">
    <td style="font: 10pt Times New Roman, Times, Serif; padding-left: 10pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><a href="#am_023">ITEM 16H. Mine Safety Disclosure.</a> </span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"></span>141</td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top; background-color: rgb(204,238,255)">
    <td style="font: 10pt Times New Roman, Times, Serif; padding-left: 10pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><a href="#am_024">ITEM 16I. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections.</a> </span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">141</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top; background-color: White">
    <td style="font: 10pt Times New Roman, Times, Serif; padding-left: 10pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><a href="#am_025">ITEM 16J. Insider Trading Policies.</a> </span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"></span>141</td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top; background-color: rgb(204,238,255)">
    <td style="font: 10pt Times New Roman, Times, Serif; padding-left: 10pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><a href="#am_026">ITEM 16K. Cybersecurity.</a> </span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"></span>141</td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top; background-color: White">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top; background-color: rgb(204,238,255)">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><a href="#am_027">PART III</a> </span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: center">141</td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top; background-color: White">
    <td style="font: 10pt Times New Roman, Times, Serif; padding-left: 10pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><a href="#am_028">ITEM 17. Financial Statements.</a> </span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"></span>141</td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top; background-color: rgb(204,238,255)">
    <td style="font: 10pt Times New Roman, Times, Serif; padding-left: 10pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><a href="#am_029">ITEM 18. Financial Statements.</a> </span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">141</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top; background-color: White">
    <td style="font: 10pt Times New Roman, Times, Serif; padding-left: 10pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><a href="#am_030">ITEM 19. Exhibits</a> </span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: center">142</td></tr>
  </table>
<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>


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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>&#160;</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>ABOUT
THIS ANNUAL REPORT</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">All
references to &#8220;we,&#8221; &#8220;us,&#8221; &#8220;our,&#8221; &#8220;the Company&#8221; and &#8220;our Company&#8221;, in this
Annual Report on Form 20-F, or our annual report, are to Galmed Pharmaceuticals Ltd. and its subsidiaries, unless the context otherwise
requires. All references to Aramchol mean Aramchol acid or Aramchol meglumine (salt), unless the context otherwise requires. All references
to &#8220;shares&#8221; or &#8220;ordinary shares&#8221; are to our ordinary shares, NIS 0.15 nominal par value per share. All references
to &#8220;Israel&#8221; are to the State of Israel. &#8220;U.S. GAAP&#8221; means the generally accepted accounting principles of the
United States. Unless otherwise stated, all of our financial information presented in this annual report has been prepared in accordance
with U.S. GAAP. Any discrepancies in any table between totals and sums of the amounts listed are due to rounding. Unless otherwise indicated,
or the context otherwise requires, references in this annual report to financial and operational data for a particular year refer to
the fiscal year of our company ended December 31 of that year.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Our
reporting currency and financial currency is the U.S. dollar. In this annual report, &#8220;NIS&#8221; means New Israeli Shekel, and
&#8220;$,&#8221; &#8220;US$&#8221; and &#8220;U.S. dollars&#8221; mean United States dollars.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">All
information in this Annual Report on Form 20-F relating to shares or price per share reflects the 1-for-15 reverse share split effected
by us on May 15, 2023.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>CAUTIONARY
NOTE REGARDING FORWARD-LOOKING STATEMENTS</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">This
annual report contains forward-looking statements about our expectations, beliefs or intentions regarding, among other things, our product
development efforts, business, financial condition, results of operations, strategies or prospects. In addition, from time to time, we
or our representatives have made or may make forward-looking statements, orally or in writing. Forward-looking statements can be identified
by the use of forward-looking words such as &#8220;believe,&#8221; &#8220;expect,&#8221; &#8220;intend,&#8221; &#8220;plan,&#8221; &#8220;may,&#8221;
&#8220;should,&#8221; &#8220;anticipate,&#8221; &#8220;could,&#8221; &#8220;might,&#8221; &#8220;seek,&#8221; &#8220;target,&#8221; &#8220;will,&#8221;
&#8220;project,&#8221; &#8220;forecast,&#8221; &#8220;continue&#8221; or their negatives or variations of these words or other comparable
words or by the fact that these statements do not relate strictly to historical matters. These forward-looking statements may be included
in, among other things, various filings made by us with the U.S. Securities and Exchange Commission, or the SEC, press releases or oral
statements made by or with the approval of one of our authorized executive officers. Forward-looking statements relate to anticipated
or expected events, activities, trends or results as of the date they are made. Because forward-looking statements relate to matters
that have not yet occurred, these statements are inherently subject to risks and uncertainties that could cause our actual results to
differ materially from any future results expressed or implied by the forward-looking statements. Many factors could cause our actual
activities or results to differ materially from the activities and results anticipated in forward-looking statements, including, but
not limited to, the factors summarized below:</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif">&#160;</td>
    <td style="font: 10pt Times New Roman, Times, Serif">&#9679;</td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify">our ability to pursue, evaluate and complete any strategic alternative
that yields value for our shareholders;</td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif">&#160;</td>
    <td style="font: 10pt Times New Roman, Times, Serif">&#160;</td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify">&#160;</td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; width: 22px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 22px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the
    timing and cost of our planned Primary Sclerosing Cholangitis, or PSC, clinical trial and our pivotal Phase 3 ARMOR trial, or the
    ARMOR Study, if re-initiated, for our product candidates, Aramchol and Amilo-5MER, or for any other pre-clinical or clinical trials;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">completion
    and receiving favorable results of our planned PSC clinical trial and the ARMOR Study (if re-initiated) for Aramchol or any other
    pre-clinical or clinical trial;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">regulatory
    action with respect to Aramchol or any other product candidate by the U.S. Food and Drug Administration, or FDA, the European Medicines
    Authority, or EMA, or the Medicines and Healthcare Products Regulatory Agency, or the MHRA, including but not limited to acceptance
    of an application for marketing authorization, review and approval of such application, and, if approved, the scope of the approved
    indication and labeling;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the
    commercial launch and future sales of Aramchol and any future product candidates;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">our
    ability to comply with all applicable post-market regulatory requirements for Aramchol, Amilo-5MER or any other product candidate
    in the countries in which we seek to market the product;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">our
    ability to achieve favorable pricing for Aramchol, Amilo-5MER or any other product candidate;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">our
    expectations regarding the commercial market for PSC, non-alcoholic steato-hepatitis, or NASH (also known as MASH), in patients or any other targeted
    indication;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">third-party
    payor reimbursement for Aramchol, Amilo-5MER or any other product candidate;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">our
    estimates regarding anticipated capital requirements and our needs for additional financing;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">market
    adoption of Aramchol or any other product candidate by physicians and patients;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the
    timing, cost or other aspects of the commercial launch of Aramchol or any other product candidate;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">our
    ability to obtain and maintain adequate protection of our intellectual property;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the
    possibility that we may face third-party claims of intellectual property infringement;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">our
    ability to manufacture our product candidates in commercial quantities, at an adequate quality or at an acceptable cost;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">our
    ability to establish adequate sales, marketing and distribution channels;</span></td></tr>
  </table>
<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 1in; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>


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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify; width: 22px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify; width: 22px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;
    </span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">intense
    competition in our industry, with competitors having substantially greater financial, technological, research and development, regulatory
    and clinical, manufacturing, marketing and sales, distribution and personnel resources than we do;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the
    development and approval of the use of Aramchol or any other product candidate for additional indications or in combination therapy;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">our
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  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
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    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">current
    or future unfavorable economic and market conditions and adverse developments with respect to financial institutions and associated
    liquidity risk;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">our
    ability to maintain the listing of our ordinary shares on The Nasdaq Capital Market;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">security,
    political and economic instability in the Middle East that could harm our business, including due to the the recent attacks by Hamas
    and other terrorist organizations from the Gaza Strip and elsewhere in the region and Israel&#8217;s war against them and military
    hostilities with Hezbollah on the northern border of Israel</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">those
    factors referred to in &#8220;Item 3.D. Risk Factors,&#8221; &#8220;Item 4. Information on the Company,&#8221; and &#8220;Item 5.
    Operating and Financial Review and Prospects&#8221;, as well as in this annual report on Form 20-F generally.</span></td></tr>
  </table>
<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 1in; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
believe these forward-looking statements are reasonable; however, these statements are only current predictions and are subject to known
and unknown risks, uncertainties and other factors that may cause our or our industry&#8217;s actual results, levels of activity, performance
or achievements to be materially different from those anticipated by the forward-looking statements. We discuss many of these risks in
this annual report in greater detail under the heading &#8220;Risk Factors&#8221; and elsewhere in this annual report. Given these uncertainties,
you should not rely upon forward-looking statements as predictions of future events.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">All
forward-looking statements attributable to us or persons acting on our behalf speak only as of the date hereof and are expressly qualified
in their entirety by the cautionary statements included in this annual report. We undertake no obligations to update or revise forward-looking
statements to reflect events or circumstances that arise after the date made or to reflect the occurrence of unanticipated events. In
evaluating forward-looking statements, you should consider these risks and uncertainties.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>EXPLANATORY
NOTE</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Market
data and certain industry data and forecasts used throughout this annual report were obtained from internal company surveys, market research,
consultant surveys commissioned by the Company, publicly available information, reports of governmental agencies and industry publications
and surveys. Industry surveys, publications, consultant surveys commissioned by the Company and forecasts generally state that the information
contained therein has been obtained from sources believed to be reliable. However, this information may prove to be inaccurate because
of the method by which some of the data for the estimates is obtained or because this information cannot always be verified with complete
certainty due to the limits on the availability and reliability of raw data, the voluntary nature of the data gathering process and other
limitations and uncertainties. As a result, the market and industry data and forecasts included or incorporated by reference in this
annual report, and estimates and beliefs based on that data, may not be reliable. We have relied on certain data from third-party sources,
including internal surveys, industry forecasts and market research, which we believe to be reliable based on our management&#8217;s knowledge
of the industry. However, we have not ascertained the underlying economic assumptions relied upon therein. Forecasts are particularly
likely to be inaccurate, especially over long periods of time. In addition, we do not necessarily know what assumptions regarding general
economic growth were used in preparing the forecasts we cite. Statements as to our market position are based to the best of our knowledge
on the most currently available data. While we are not aware of any misstatements regarding the industry data presented in this annual
report, our estimates involve risks and uncertainties and are subject to change based on various factors, including those discussed under
the heading &#8220;Risk Factors&#8221; in this annual report.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>


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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>&#160;</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><span id="p_001"></span>PART
I</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><span id="p_002"></span>ITEM
1. Identity of Directors, Senior Management and Advisers.</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Not
applicable.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><span id="p_003"></span>ITEM
2. Offer Statistics and Expected Timetable.</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Not
applicable.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><span id="p_004"></span>ITEM
3. Key Information.</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>A.
[Reserved.]</b></span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>B.
Capitalization and Indebtedness.</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Not
applicable.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: -32.6pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>C.
Reasons for the Offer and Use of Proceeds. </b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: -32.6pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Not
applicable.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>&#160;</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>D.
Risk Factors.</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Summary
of Risk Factors</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">An
investment in our ordinary shares is subject to a number of risks. The following summarizes some, but not all, of these risks. Please
carefully consider all of the information discussed in &#8220;Item 3. Key Information&#8212;D. Risk Factors&#8221; in this annual report
for a more thorough description of these and other risks.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Risks
Related to Our Financial Position and Capital Requirements</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
    are a biopharmaceutical company with a history of operating losses. We expect to incur significant additional losses in the future
    and may never be profitable.</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
    have not yet commercialized any products and we may never be able to do so, and even if we do, the products may not gain market acceptance.</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
    will need substantial, additional capital in the future. If additional capital is not available, we will have to delay, reduce or
    cease operations.</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
    are unable to estimate our long-term capital requirements due to uncertainties associated with the development and commercialization
    of Aramchol, Amilo-5MER or any other product candidate. If we fail to obtain necessary funds for our operations, we will be unable
    to develop and commercialize Aramchol, Amilo-5MER or any other product candidate.</span></td></tr>
  </table>
<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Risks
Related to Our Business, Industry and Regulatory Requirements</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Our
    activities to evaluate and pursue strategic alternatives may not be successful.</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
    are substantially dependent on our remaining employees to facilitate the consummation of a strategic transaction. We could lose such
    key employees.</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
    clinical trial process is complex and expensive, and commencement and completion of clinical trials can be delayed or prevented for
    a number of reasons.</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
    have historically developed Aramchol for the treatment of NASH, and there
    is significant uncertainty regarding the regulatory approval process. In addition, during 2022, we discontinued our open label part
    of the ARMOR Study and we do not currently expect to initiate the second part of the ARMOR Study. This makes it difficult to predict
    the timing and costs of the clinical development of Aramchol for the treatment of NASH.</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
    depend largely on the success of our lead product candidate, Aramchol, and we may not obtain regulatory approval of Aramchol.</span></td></tr>
  </table>
<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>


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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify; width: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Commencement
    of our ARMOR Study in jurisdictions outside the United States is subject to acceptance of the foreign equivalent of our IND by regulatory
    authorities.</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
    may be forced to abandon development of Aramchol or any other product candidate which would have a material adverse effect on our
    business and may force us to cease operations.</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
    lack of a reliable non-invasive method for the diagnosis of NASH is likely to present a major challenge to Aramchol&#8217;s market
    penetration, if ever commercialized.</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Our
    Amilo-5MER program is being conducted under a license agreement with Yissum Research Development Company of the Hebrew University
    of Jerusalem, or Yissum.</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">If
    we acquire or in-license additional technologies or product candidates, we may incur significant, incremental expenses, may have
    integration difficulties and may experience other risks that could harm our business and results of operations.</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Changes
    in regulatory requirements and guidance or unanticipated events during our clinical trials may occur, which may result in necessary
    changes to clinical trial protocols, which could result in increased costs to us, delay our development timeline or reduce the likelihood
    of successful completion of our clinical trials.</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
    manage our business through a small number of senior executive officers. We depend on them even more than similarly- situated companies.</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Our
    business is subject to risks arising from epidemic diseases, such as the COVID-19 pandemic, which has impacted and could continue
    to impact our business.</span></td></tr>
  </table>
<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Risks
Related to Our Reliance on Third Parties</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
    have no manufacturing capacity and anticipate reliance on third-party manufacturers for Aramchol, Amilo-5MER or any other product
    candidate.</span></td></tr>
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    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Any
    collaboration arrangements that we may enter into in the future may not be successful, which could adversely affect our ability to
    develop and commercialize our current and potential future product candidates.</span></td></tr>
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    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
    depend on third parties to conduct our clinical trials.</span></td></tr>
  </table>
<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Risks
Related to Our Intellectual Property</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
    failure to obtain or maintain patents, licensing agreements and other intellectual property rights that are sufficiently broad and
    protective could impact our ability to compete effectively.</span></td></tr>
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    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Our
    potential development of Aramchol meglumine may not result in improved bioavailability compared to the existing form of Aramchol.
    Furthermore, although we have pending patent applications and granted patent covering Aramchol meglumine in development, there is
    no assurance that we will receive any patents for them, and even if we receive one or more patents for our Aramchol meglumine in
    development, they may be of little or no commercial value.</span></td></tr>
  </table>
<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Risks
Related to Ownership of Our Ordinary Shares</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Our
    business, operating results and growth rates may be adversely affected by current or future unfavorable economic and market conditions
    and adverse developments with respect to financial institutions and associated liquidity risk.</span></td></tr>
  </table>
<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>


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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

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    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify; width: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify; width: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
    market price of our ordinary shares is volatile and you may sustain a complete loss of your investment.</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">If
    we fail to comply with the continued listing requirements of the Nasdaq Capital Market, our ordinary shares may be delisted and the
    price of our ordinary shares and our ability to access the capital markets could be negatively impacted.</span></td></tr>
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    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Our
    President and Chief Executive Officer beneficially owns approximately 5.6% of our outstanding ordinary shares, as of March 27, 2024.
    Therefore, our principal shareholders will be able to exert significant control over matters submitted to our shareholders for approval.</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Our
    U.S. shareholders may suffer adverse tax consequences due to our classification as a passive foreign investment company.</span></td></tr>
  </table>
<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Risks
Related to Israeli Law and Our Operations in Israel</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Our
    headquarters and other significant operations are located in Israel and, therefore, our results may be adversely affected by political,
    economic and military instability in Israel, such as the recent attacks by Hamas and other terrorist organizations from the Gaza
    Strip and elsewhere in the region and Israel&#8217;s war against them and military hostilities with Hezbollah on the northern border
    of Israel</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Provisions
    of Israeli law and our articles of association, or Articles, may delay, prevent or otherwise impede a merger with, or an acquisition
    of, our company, which could prevent a change of control, even when the terms of such a transaction are favorable to us and our shareholders.</span></td></tr>
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    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Your
    rights, liabilities and responsibilities as a shareholder will be governed by Israeli law and differ in some material respects from
    those under U.S. law.</span></td></tr>
  </table>
<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>RISK
FACTORS</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">An
investment in our ordinary shares involves a high degree of risk. Prior to making a decision about investing in our ordinary shares,
you should carefully consider the risks, uncertainties and assumptions set forth below. Additional risks and uncertainties not presently
known to us, or that we currently see as immaterial, may also harm our business. If any of these risks occur, our business, financial
condition and operating results could be harmed, the trading price of our ordinary shares could decline and you could lose part or all
of your investment.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Risks
Related to Our Financial Position and Capital Requirements</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>We
are a biopharmaceutical company with a history of operating losses. We expect to incur significant additional losses in the future and
may never be profitable.</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
are a biopharmaceutical company with an operating history limited to pre-clinical and clinical drug development and no approved products.
During 2022, we discontinued the open-label part of the ARMOR Study having reached its objectives and initiated a strategic review process.
Following the discontinuation of our open label part of the ARMOR Study, we do not currently expect to initiate the second part of the
ARMOR Study. In addition, we have limited operating experience and have not yet demonstrated an ability to successfully overcome many
of the risks and uncertainties frequently encountered by companies in new and rapidly evolving fields, particularly in the pharmaceutical
industry. We have funded our research and development programs and operations to date primarily through proceeds from private placements
and public offerings. We currently have no products approved for marketing in the United States or any other jurisdiction and have not
generated any revenue from product sales to date, although we have generated revenue from our licensing agreement with Samil Pharm. Co.,
Ltd., or Samil. We have incurred operating losses in each year since the inception of our predecessor in 2000. Our loss attributable
to holders of our ordinary shares for the years ended December 31, 2022, and 2023 was approximately $17.4 million and $7.2 million, respectively.
As of December 31, 2023, we had an accumulated deficit of $193.0 million. Substantially all of our operating losses resulted from costs
incurred in connection with our development program and from general and administrative costs associated with our operations.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>


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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Our
ability to become profitable depends upon our ability to generate revenue in excess of our expenses. To date, we have not generated any
revenue, excluding the licensing revenue we recorded in connection with that certain Samil Agreement (as defined below), as our lead
product candidate, Aramchol and has not been approved by the FDA, nor has any other product candidate. We do not know when, or if, we
will generate any revenue from sales of Aramchol, Amilo-5MER and/or any other product candidate. We do not expect to generate revenue
other than subsequent royalties and/or milestones that can be earned in connection with the Samil Agreement or other potential license
agreements, unless and until we, or an ultimate third-party licensor or acquirer, obtain regulatory and marketing approval of, and commercialize,
Aramchol, Amilo-5MER or any other product candidate. Subject to our strategic review, we will continue to incur significant research
and development and general and administrative expenses related to our operations. We expect to continue to incur losses before we can
consummate any strategic alternatives, which may be significant.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.45in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Based
on our current operating plan, which is subject to change pursuant to our strategic review, we expect to continue to incur significant
expenses and operating losses for the foreseeable future. We anticipate that our expenses will increase substantially if and as we:</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">re-initiate
    the ARMOR Study and/or commence any additional clinical trials for Aramchol and Amilo-5MER, or any other product candidate and initiate
    additional research and development programs;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">seek
    regulatory approvals for Aramchol, Amilo-5MER or any other product candidate;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">seek
    to in-license additional products or technologies to develop;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">expand
    our operational, financial and management systems and personnel, including personnel to support our clinical development, manufacturing
    and commercialization efforts and our operations as a public company;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">hire
    additional management and other personnel; </span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">move
    towards commercialization of Aramchol or any other product candidate;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">explore
    and review a range of strategic alternatives for our company.</span></td></tr>
  </table>
<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
may out-license Aramchol, Amilo-5MER or any other product candidate including through a territorial license, a worldwide license, or
a license for a particular indication, before it is approved by any applicable regulatory agency, commercialized and/or generates revenue,
depending on a number of factors, including, but not limited to, our ability to:</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">demonstrate
    a compelling and/or novel, pre-clinical, unique mechanism of action of Aramchol, Amilo-5MER or any other product candidate;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">obtain
    adequate clinical results from and progress from the clinical development of Aramchol or any other product candidate;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">develop
    and obtain regulatory approvals in the countries and for the uses we intend to pursue for Aramchol, Amilo-5MER or any other product
    candidate;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">contract
    for the manufacture of commercial quantities of Aramchol, Amilo-5MER or any other product candidate by a current good manufacturing
    practice, or cGMP, compliant manufacturing facility at acceptable cost levels if marketing approval is received; and</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">establish
    external, and potentially in the future, internal, sales and marketing capabilities to effectively market and sell Aramchol, Amilo-5MER
    or any other product candidate in the United States and other countries.</span></td></tr>
  </table>
<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>


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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Even
if Aramchol, Amilo-5MER or any other product candidate is approved for commercial sale, it may not gain market acceptance or achieve
commercial success. In addition, we anticipate incurring significant costs associated with seeking regulatory approval and commercialization.
We may not achieve profitability soon after generating product revenue, if ever. If we are unable to generate product revenue, we will
not become profitable and would be unable to continue operations without additional funding.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
expect our research and development expenses to significantly increase if we re-initiate our ARMOR Study and initiate any other pre-clinical
or clinical trials. In addition, if we obtain marketing approval for Aramchol, Amilo-5MER or any other product candidate and opt to commercialize
it ourselves, we will likely initially incur significant expenses associated with outsourcing sales, marketing and manufacturing functions
to third parties, as well as continued research and development expenses. Furthermore, we expect to incur additional costs associated
with operating as a public company. As a result, and subject to our strategic review, we expect to continue to incur significant and
increasing operating losses for the foreseeable future. Because of the numerous risks and uncertainties associated with developing pharmaceutical
products, we are unable to predict the extent of any future losses or when we will become profitable, if at all.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Our
limited operating history makes it difficult to evaluate our business and prospects.</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Our
operating history is limited to pre-clinical and clinical development of two products, and our operations to date have been limited primarily
to research and development, raising capital and recruiting scientific and management personnel and third-party partners. Therefore,
it may be difficult to evaluate our business and prospects. We have not yet demonstrated an ability to commercialize or obtain regulatory
approval for any product candidate. Consequently, any predictions about our future performance may not be accurate, and you may not be
able to fully assess our ability to complete development and/or commercialize our product candidates, obtain regulatory approvals or
achieve market acceptance or favorable pricing for our product candidates.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>We
have not yet commercialized any products and we may never be able to do so, and even if we do, the products may not gain market acceptance.</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
have not yet commercialized any products and we may never be able to do so. During 2022, we discontinued the open-label part of the
ARMOR Study having reached its objectives and initiated a strategic review process. Following the discontinuation of our open label
part of the ARMOR Study, we do not currently expect to initiate the second part of the ARMOR Study and are currently developing Aramchol for PSC. We do not know when or if we
will complete development of Aramchol, Amilo-5MER or any other product candidate, obtain regulatory approval, or successfully
commercialize any approved products. Even if we are successful in developing products that are approved for marketing, we will not
be successful unless these products gain market acceptance for appropriate indications at favorable reimbursement rates. The degree
of market acceptance for these products will depend on a number of factors, including:</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the
    timing and scope of regulatory approvals in the countries we intend to pursue with respect to the commercialization of Aramchol,
    Amilo-5MER or any other product candidate, including the indications for which they are approved;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the
    competitive environment;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the
    ability for Aramchol, Amilo-5MER or any other product candidate to be manufactured, whether by us or third parties, in compliance
    with applicable regulatory requirements, including cGMP;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">our
    ability to effectively promote Aramchol or any other product candidate, whether directly or using third parties, consistent with
    the approved indications and labeling in the countries in which we intend to pursue approval;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the
    acceptance by the medical community of the safety and clinical efficacy of Aramchol, Amilo-5MER or any other product candidate and
    their potential advantages over other therapeutic products;</span></td></tr>
  </table>

<p style="margin-top: 0; margin-bottom: 0">&#160;</p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify; width: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify; width: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the
    development of a non-invasive method for diagnosing NASH as an alternative to the current gold standard of liver biopsy, which we
    view as a rate-limiting factor to complete market uptake because of its expense and its risks and discomfort to patients;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the
    adequacy and success of distribution, sales and marketing efforts, including through strategic agreements with pharmaceutical and
    biotechnology companies; and</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the
    pricing and reimbursement policies of government and third-party payors, such as insurance companies, health maintenance organizations
    and other plan administrators.</span></td></tr>
  </table>
<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Physicians,
patients, third-party payors or the medical community in general may be unwilling to accept, utilize or recommend, and in the case of
third-party payors, reimburse any of our planned future products. As a result, we are unable to predict the extent of future losses or
the time required to achieve profitability, if at all. Even if we successfully develop one or more products, we may not become profitable.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; text-align: justify; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>We
will need substantial, additional capital in the future. If additional capital is not available, we will have to delay, reduce or cease
operations.</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">As
of December 31, 2023, we had a net working capital of $10.5 million, cash and cash equivalents of $2.9 million, restricted cash of $0.1
million, short term deposits of $2.3 million and marketable debt securities of $7.5 million. Based on our current operating plan, which
is subject to change pursuant to our strategic review, we currently estimate that our cash position will support our current operations
as currently conducted for more than 12 months from the date of issuance of this annual report. We will need to raise substantial, additional
capital to fund our operations and to re-initiate the ARMOR Study and develop Aramchol and Amilo-5MER for, and beyond their current development
stage, and ultimately commercialize them, if we opt to do so ourselves. In addition, we may expand our current research and development
focus and clinical operations as well as the development of Aramchol or any other product candidate for other indications or development
of other molecules and/or combination of Aramchol with other molecules for NASH or other liver and inflammatory diseases as well as non-invasive
biomarkers, which we expect will also require additional capital. Our future capital requirements will depend on many factors including:</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the
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  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the
    progress and costs of our pre-clinical studies, clinical trials and other research and development activities;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the
    regulatory pathway of Aramchol, Amilo-5MER or any other product candidate;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the
    scope, prioritization and number of our clinical trials and other collaboration, research and development programs;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the
    amount of revenues and contributions we receive under future licensing, development and commercialization arrangements with respect
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  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the
    costs of the development and expansion of our operational infrastructure;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the
    costs and timing of obtaining regulatory approval for Aramchol, Amilo-5MER or any other product candidate;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the
    ability of us, or our collaborators, to achieve development milestones, marketing approval and other events or developments under
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  </table>
<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; width: 48px; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 48px; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the
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  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the
    costs and timing of securing manufacturing arrangements for clinical or commercial production;</span></td></tr>
  </table>

<p style="margin-top: 0; margin-bottom: 0">&#160;</p>

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    <div style="break-before: page; margin-top: 6pt"><table cellpadding="0" cellspacing="0" style="border-collapse: collapse; width: 100%; font-size: 10pt"><tr style="vertical-align: top; text-align: left"><td style="width: 100%">&#160;</td></tr></table></div>
    <!-- Field: /Page -->

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify; width: 48px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify; width: 48px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the
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  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the
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  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the
    magnitude of our general and administrative expenses;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">any
    cost that we may incur under future in- and out-licensing arrangements relating to Aramchol, Amilo-5MER or any other product candidate;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">market
    conditions; </span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">our
    ability to maintain the listing of our orindary share on The Nasdaq Capital Market; and</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the
    impact of any resurgence of the COVID-19 pandemic and the war between Israel and Hamas, which may exacerbate the magnitude of the factors discussed
    above.</span></td></tr>
  </table>
<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Under
General Instruction I.B.5 to Form F-3, or the Baby Shelf Rule, the amount of funds we can raise through primary public offerings of securities
in any 12-month period using our registration statement on Form F-3 is limited to one-third of the aggregate market value of the ordinary
shares held by non-affiliates of the Company. As of March 27, 2024, our public float was approximately $1.8 million, based on 5,777,351
ordinary shares held by non-affiliates and a price of $0.32 per share, which was the last reported sale price of our ordinary shares
on the Nasdaq Capital Market on March 26, 2024. We therefore are limited by the Baby Shelf Rule as of the filing of this annual report,
until such time as our public float exceeds $75 million. If we are required to file a new registration statement on another form, we
may incur additional costs and be subject to delays due to review by the SEC Staff.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Changing
circumstances may cause us to consume capital significantly faster than we currently anticipate, such as losing our Small and Medium
Enterprise status at the EMA, which entitles us to significant fee reductions. Because there are numerous risks and uncertainties associated
with the development and commercialization of Aramchol, Amilo-5MER or any other product candidate, we are unable to estimate the amount
of increased capital outlays and operating expenditures associated with our anticipated clinical trials. We have no committed external
sources of funds. Additional financing may not be available when we need it or may not be available on terms that are favorable to us
and additional financing may cause significant dilution to our existing shareholders. If adequate funds are not available to us on a
timely basis, or at all, we may be required to terminate or delay planned or ongoing clinical trials or other development activities
for Aramchol, Amilo-5MER or any other product candidate.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; text-align: justify; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Raising
additional capital may be costly or difficult to obtain and will dilute current shareholders&#8217; ownership interests, potentially
substantially.</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Any
debt, equity or structured financing that we may need or desire may not be available on terms favorable to us, or at all. If we obtain
funding through a strategic collaboration or licensing arrangement, we may be required to relinquish our rights to certain of our technologies,
products or marketing territories. If we are unable to obtain required additional capital, we may have to curtail our growth plans or
cut back on existing business, and we may not be able to continue operating if we do not generate sufficient revenues from operations
needed to stay in business.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
may incur substantial costs in pursuing future capital financing, including investment banking fees, legal fees, accounting fees, securities
law compliance fees, printing and distribution expenses and other costs. We may also be required to recognize non-cash expenses in connection
with certain securities we issue, such as convertible notes and warrants, which may adversely impact our capital structure, financial
condition and results of operations.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
addition, our authorized share capital consists of 20,000,000 ordinary shares, par value NIS 0.15 per share. As of March 27, 2024, we
had 6,009,654 ordinary shares issued and outstanding. As of the date of this Annual Report, we also had outstanding pre-funded warrants
to purchase 1,280,000 ordinary shares and warrants to purchase 5,200,000 ordinary shares with an exercise price of $1.25 per share. To
the extent that pre-funded warrants and warrants are exercised, holders of our ordinary shares will experience dilution. </span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>


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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Any
additional capital raised through the sale of equity or equity-linked securities, will dilute our current shareholders&#8217; ownership
in us, potentially substantially, and could also result in a decrease in the market price of our ordinary shares. The terms and conditions
of those securities issued by us in future capital transactions may be more favorable to new investors and may include the issuance of
warrants or other derivative securities, which may have a further dilutive effect.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>We
are unable to estimate our long-term capital requirements due to uncertainties associated with our strategic review and the development
and commercialization of Aramchol, Amilo-5MER or any other product candidate. If we fail to obtain necessary funds for our operations,
we will be unable to develop and commercialize Aramchol, Amilo-5MER or any other product candidate.</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Our
long-term capital requirements are expected to depend on many potential factors, including, among others:</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; width: 48px; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 48px; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the
    outcome of our review of our strategic alternatives; </span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the
    number of product candidates in development;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the
    size, duration and scope of existing and future clinical trials and pre-clinical studies;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the
    regulatory pathway for the approval of Aramchol, Amilo-5MER or any other product candidate;</span></td></tr>
  </table>
<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; width: 48px; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 48px; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the
    results of our clinical trials, which are unpredictable in product candidate development;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">our
    ability to successfully commercialize Aramchol, Amilo-5MER or any other product candidate, including securing commercialization and
    out-licensing agreements with third parties and favorable pricing and market share;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the
    progress, success and cost of our clinical trials and research and development programs, including those associated with milestones
    and royalties;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the
    costs, timing and outcome of regulatory review and obtaining regulatory approval of Aramchol, Amilo-5MER or any other product candidate
    and addressing regulatory and other issues that may arise post-approval;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the
    breadth of the labeling, assuming that Aramchol, Amilo-5MER or any other product candidate are approved for commercialization by
    a relevant regulatory authority, which may not occur;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">our
    need, or decision, to acquire or in-license complementary technologies or new platform technologies or product candidates;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the
    costs of enforcing our issued patents and defending intellectual property-related claims;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the
    costs of investigating patents that might block us from developing potential product candidates;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the
    costs of recruiting and retaining qualified personnel;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the
    costs associated with contracting with third parties to manufacture the product and to perform other necessary services;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">our
    revenue, if any; and</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">our
    consumption of available resources more rapidly than currently anticipated, resulting in the need for additional funding sooner than
    anticipated.</span></td></tr>
  </table>
<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>


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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">If
we are unable to obtain the funds necessary for our operations, we will be unable to develop and commercialize Aramchol, Amilo-5MER or
any other product candidate which would materially and adversely affect our business, liquidity and results of operations.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Risks
Related to Our Business, Industry and Regulatory Requirements</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Our
activities to evaluate and pursue strategic alternatives may not be successful.</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 29.15pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.45in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
May 2022, we announced that we will expand into new anti-fibrotic indications to maximize the potential of Aramchol while at the
same time discontinuing the open label part of the ARMOR Study having reached its objectives. Simultaneously, we initiated a cost
reduction plan and at various times have been evaluating our strategic options alternatives and our structuring to best optimize our
resources to enhance shareholder value and achieve our goals. In June 2023, we announced the closing of a strategic investment in
OnKai, Inc., or OnKai, (see &#8220;Item 4. Information on the Company&#8212; Strategic Collaborations, Research Arrangements and
other Agreements&#8212;Onkai.&#8221;).</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.45in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
also may acquire additional businesses, products or product candidates. Integrating any newly acquired business, product or product candidate
could be expensive and time-consuming. We may not be able to integrate any acquired business, product or product candidate successfully.
If we do acquire any additional business, products, or product candidates, our future financial performance will depend, in part, on
our ability to manage any future growth effectively and our ability to integrate any such acquired businesses, products or product candidates.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Any
strategic transaction may require us to incur non-recurring or other charges, may increase our near- and long-term expenditures and may
pose significant integration challenges or disrupt our management or business, which could adversely affect our operations and financial
results. For example, these transactions may entail numerous operational and financial risks, including:</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 29.15pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; width: 48px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 48px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">exposure
    to unknown liabilities;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">incurrence
    of substantial debt or dilutive issuances of equity securities to pay for acquisitions;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">higher
    than anticipated acquisition and/or integration costs;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">write
    downs of assets or goodwill or impairment charges;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">increased
    amortization expenses;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">difficulty
    and cost in combining the operations and personnel of any acquired businesses with our operations and personnel;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">impairment
    of relationships with key suppliers or customers of any acquired businesses due to changes in management and ownership; and</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the
    inability to retain our key employees or our other service providers or those of any acquired businesses.</span></td></tr>
  </table>
<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Accordingly,
there can be no assurance that we will undertake or successfully complete any strategic transactions of the nature described above and
any transactions that we do complete may be subject to the foregoing or other risks and could have a material adverse effect on our business,
financial condition and prospects.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: white"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>We
are substantially dependent on our remaining employees to facilitate the consummation of a strategic transaction. We could lose such
key employees.</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: white"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Our
cash conservation activities may yield unintended consequences, such as attrition and reduced employee morale, which may cause remaining
employees to seek alternative employment. Our ability to successfully complete a strategic transaction depends in large part on our ability
to retain certain personnel. Despite our efforts to retain these employees, one or more may terminate their employment on short notice.
The loss of the services of any of these employees could potentially harm our ability to evaluate and pursue strategic alternatives,
as well as fulfill our reporting obligations as a public company.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>


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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>&#160;</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>The
clinical trial process is complex and expensive, and commencement and completion of clinical trials can be delayed or prevented for a
number of reasons.</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
may not be able to complete or commence the clinical trials that would support our submission of an NDA to the FDA, a Marketing Authorization
Application or MAA, to the EMA or MHRA or any similar submission to regulatory authorities in other countries. Drug development is a
long, expensive and uncertain process, and delay or failure can occur at any stage of any of our clinical trials. The fact that the FDA,
EMA, MHRA or other regulatory authorities permit a company to conduct human clinical trials is no assurance or guarantee that the trials
will be successful. On the contrary, most candidate drugs that begin clinical trials do not prove to be successful and do not result
in the filing of an NDA, MAA or similar filing. Drug candidates that successfully complete one phase of clinical trials may prove unsuccessful
at a subsequent phase. Human clinical trials are very expensive and difficult to design and implement, in part because they are subject
to rigorous regulatory requirements and in part because the results of clinical trials are inherently uncertain and unpredictable. In
addition, the design of a clinical trial can determine whether its results will support approval of a product, and flaws in the design
of a clinical trial may not become apparent until the clinical trial is well advanced. Regulatory authorities, such as the FDA, may decline
to permit a clinical trial to proceed or may suspend a clinical trial that it has previously permitted to proceed. Additionally, the
clinical trial process is time-consuming, and failure can occur at any stage of the trials. We may encounter problems that cause us to
abandon, delay or repeat clinical trials. The commencement and completion of clinical trials may be delayed by several factors, including:</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; width: 48px; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 48px; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">difficulties
    obtaining regulatory authorization to commence a clinical trial or complying with regulatory requirements for clinical trials or
    with the conditions imposed by a regulatory authority regarding the scope, duration or conduct of a clinical trial;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">delays
    in reaching or failing to reach agreement on acceptable terms with prospective contract research organizations, or CROs, and trial
    sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">insufficient
    or inadequate supply or quality of a product candidate or other materials necessary to conduct our clinical trials;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">difficulties
    in obtaining institutional review board, or IRB, approval to conduct a clinical trial at a prospective site;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">challenges
    in recruiting and enrolling patients to participate in clinical trials for a variety of reasons, including size and nature of patient
    population, proximity of patients to clinical sites, eligibility and exclusion criteria for the trial, nature of trial protocol,
    the availability of approved effective treatments for the relevant disease and competition from other clinical trial programs for
    similar indications;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">challenges
    in identifying or recruiting sufficient study sites or investigators for clinical trials; </span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">limitations
    on employee resources that would otherwise be focused on the conduct of our business including because of military reserve duty call-ups
    in the future that impact our employees and the affect the current war between Israel and Hamas on the productivity of our employees
    and external partners;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">delays
    in necessary interactions with vendors, local regulators, and other important agencies and contractors due to limitations in employee
    resources;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">impacts
    from prolonged remote work arrangements, such as increased cybersecurity risks and strains on our business continuity plans; and</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">lack
    of adequate funding to initiate or continue our clinical trials.</span></td></tr>
  </table>
<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>


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    <div style="break-before: page; margin-top: 6pt"><table cellpadding="0" cellspacing="0" style="border-collapse: collapse; width: 100%; font-size: 10pt"><tr style="vertical-align: top; text-align: left"><td style="width: 100%">&#160;</td></tr></table></div>
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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Even
if we re-initiate the Phase 3 ARMOR Study, the ARMOR Study may still be terminated as a result of, but not limited to, safety signals,
lack of efficacy, uncertainties with regard to the regulatory pathway for the approval of NASH drugs, or commercial considerations based
on the cost-benefit of continuing to run the study. In addition, the ARMOR Study or other clinical trials may be suspended or terminated
by us, the FDA or other regulatory authorities, the principal investigator at a site, the IRBs at the sites where such boards are overseeing
a trial or the data safety monitoring board, or the DSMB, that is overseeing the clinical trial at issue, or other regulatory authorities
due to a number of factors, including:</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; width: 48px; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 48px; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">irregularities
    in conducting a clinical trial, including by way of example, failure to conduct the clinical trial in accordance with regulatory
    requirements, in particular good clinical practice requirements, or GCP, or the FDA-authorized clinical protocols;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">negative
    findings upon inspection of the clinical trial operations or trial sites by the FDA or other regulatory authorities;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">safety
    issues or lack of clinical drug activity or effectiveness; and</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">lack
    of adequate funding to continue the clinical trials.</span></td></tr>
  </table>
<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.45in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">To
date, we have already experienced material delays in both the ARMOR Study largely related to significantly slower than expected recruitment
and the ARREST Study largely related to significantly slower than expected recruitment and the length of time required to obtain regulatory
authorizations to proceed with clinical trials. We may experience further delays in any or all of our clinical trials and there can be
no assurance that we will not experience such risks in the future as we progress with our planned clinical trials.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Furthermore,
positive results in previous clinical studies of our product candidates may not be predictive of similar results in future clinical trials.
Also, interim results, if at all, during a clinical trial do not necessarily predict final results. A number of companies in the pharmaceutical
and biotechnology industries have suffered significant setbacks in late-stage clinical trials even after achieving promising results
in early- and mid-stage development. Accordingly, the results from the completed pre-clinical studies and clinical trials for our product
candidates may not be predictive of the results we may obtain in later stage trials. Our clinical trials may produce negative or inconclusive
results, and we may decide, or regulators may require us, to conduct additional clinical and/or pre-clinical trials, or to even terminate
the development program entirely. Many companies that believed their product candidates performed satisfactorily in pre-clinical and
clinical studies have nonetheless failed to obtain FDA or EMA, or other regulatory agency, approval for their products.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
addition, we or regulatory authorities may suspend our clinical trials at any time if it appears that we are exposing participants to
unacceptable health risks or if the regulatory authorities find deficiencies in our regulatory submissions or the conduct of such trials.
Any suspension of clinical trials will delay possible regulatory approval, if any, and adversely impact our ability to develop products
and generate revenue.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>We
have historically developed Aramchol for the treatment of NASH and there is
significant uncertainty regarding the regulatory approval process. In addition, during 2022, we discontinued our open label part of the
ARMOR Study and we do not currently expect to initiate the second part of the ARMOR Study. This makes it difficult to predict the timing
and costs of the clinical development of Aramchol for the treatment of NASH.</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Pharmaceutical
products generally are subject to rigorous nonclinical testing and clinical studies and other approval procedures mandated by the FDA
and foreign regulatory authorities. We have historically developed Aramchol for the treatment of NASH.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
September 2019, we initiated the ARMOR Study and during 2022 we discontinued the open-label part of the ARMOR Study having reached its
objectives. Following the discontinuation of our open label part of the ARMOR Study, we do not currently expect to initiate the second
part of the ARMOR Study.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Although
there are guidelines issued by the FDA for the development of drugs for the treatment of NASH, it is our current assessment that despite
considerable efforts from the scientific community and regulatory agencies, there are significant uncertainties that remain unresolved
with regards to the conduct of NASH Phase 3 registrational studies. These risks include dependence on biopsies as the primary surrogate
endpoint which are subjective in nature and prone to sampling errors and inadequacy; high screen failure rates which pose a burden to
patients, investigators, and study budget; lack of validated biomarkers and the heterogenous population included under the NASH diagnosis.
Moreover, pathology plays a role in NASH clinical trials with histology being the current reference method to determine inclusion in
trials and change in disease activity and fibrosis stage. Manual histological review is complex, subjective, and prone to inter- and
intra-reader variability and error. Existing pathology scoring systems and practices show only moderate to fair reproducibility, limiting
their utility for clinical research and practice.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
addition, the FDA has indicated that the results of the ARMOR Study must be unequivocal and highly persuasive for a single Phase 3 study
to support approval of an NDA. Therefore, even if the ARMOR Study meets all of its statistical goals and protocol endpoints, the FDA
may not view the results as sufficient to support an NDA.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
expect that the path for regulatory approval for NASH drugs to continue to evolve in the near term as we and other companies in late-stage
development of NASH drugs refine our regulatory approval strategies and interact with the FDA and other regulatory authorities. In particular,
FDA expectations about interpretation of liver biopsy data may evolve especially as more information is published about the inherent
variability in interpretation of liver biopsy data. Certain of our competitors have experienced regulatory setbacks for NASH therapies
following communications from the FDA. See also &#8220;Item 4. Information on the Company&#8212;Competition.&#8221; Even after we receive
and incorporate guidance from the FDA or other regulatory authorities, they could disagree that we have satisfied their requirements,
which may require us to complete additional preclinical studies or clinical trials or impose stricter approval conditions than we currently
expect. Furthermore, as the path for regulatory approval for NASH drugs evolves, it may impact our ARMOR Study in ways that could significantly
increase the development costs and call into question the future viability of continuing to conduct the ARMOR Study. Additionally, we
are considering more robust changes to our development program for NASH. Changes may include focusing on higher risk patients (F3), evaluating
patients with compensated cirrhosis (F4) as well as changes to study design such as two smaller studies instead of one pivotal study
and the addition of a combination arm.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Any
additional delays in the completion of the ARMOR Study or any additional preclinical studies or clinical trials would require us to expend
substantial additional resources and could significantly extend the timeline for clinical development prior to market approval. As a
result of the foregoing, the research and development, preclinical studies and clinical testing of Aramchol and any other product candidate
is expensive and can take many years to complete, and its outcome is inherently uncertain. Failure can occur at any time during the development
process. If we experience delays in the completion of, or if we terminate, any of our clinical trials, this would have a material adverse
effect on our business, liquidity, operating results and financial condition and may force us to cease operations.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>We
depend largely on the success of our lead product candidate, Aramchol, and we may not obtain regulatory approval of Aramchol.</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
have invested almost all of our efforts and financial resources in the research and development (clinical and pre-clinical) of our lead
product candidate, Aramchol. As a result, subject to our strategic review, our business is largely dependent on  our ability to complete the development of, obtain regulatory approval for and successfully commercialize Aramchol in a timely
manner. The process to develop, obtain regulatory approval for and commercialize Aramchol is long, complex, costly and uncertain as to
its outcome and we do not currently expect to initiate the second part of the ARMOR Study.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
research, development, testing, clinical trials, manufacturing, labeling, approval, sale, marketing and distribution of drugs are subject
to extensive regulation by the FDA and other regulatory agencies in other countries. These regulations differ from jurisdiction to jurisdiction.
We have not received marketing approval for Aramchol in any jurisdiction. We are not permitted to market Aramchol, or any other product
candidate, in the United States until we receive approval of a New Drug Application, or NDA, from the FDA, or in any foreign countries
until we receive the requisite approval from the respective regulatory agencies in such countries. The results of clinical trials may
be unsatisfactory, and even if we believe those clinical trials to be successful, the FDA, or other regulatory authorities, may not grant
marketing authorization should we be in a position to request it.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Even
if we re-initiate the ARMOR Study, the requirements and length of time for approval vary in different jurisdictions and could involve
additional studies of Aramchol beyond those we currently anticipate, including potentially post-approval studies. The time required to
obtain approval in other countries might differ from that required to obtain FDA approval in the United States. The marketing approval
process in other countries may include all of the risks detailed above regarding FDA approval as well as other risks. In particular,
in many countries outside the United States, it is required that a product receive pricing and reimbursement approval before the product
can be commercialized. This can result in substantial delays in such countries. In other countries, product approval depends on showing
superiority to an approved therapy. This can result in significant expense to conduct complex clinical trials. Finally, we do not have
any products approved for sale in any jurisdiction, including international markets, and we do not have experience in obtaining regulatory
approval in international markets. If we fail to comply with regulatory requirements in international markets or to obtain and maintain
required approvals or if regulatory approvals in international markets are delayed, our target market will be reduced and our ability
to realize the full market potential of Aramchol or any other product candidate will be harmed.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Marketing
approval in one jurisdiction does not ensure marketing approval in another, but a failure or delay in obtaining marketing approval in
one jurisdiction may have a negative effect on the regulatory process in others. Failure to obtain marketing approval in other countries
or any delay or setback in obtaining such approval would impair our ability to develop foreign markets for Aramchol. This would reduce
our target market and limit the full commercial potential of Aramchol.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Commencement
of our ARMOR Study in jurisdictions outside the United States is subject to acceptance of the foreign equivalent of our IND by regulatory
authorities.</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
the event that the FDA or any other regulatory authority requires us to complete additional preclinical and/or clinical studies or we
are required to satisfy other FDA or other regulatory requests, the start of the ARMOR Study in the applicable jurisdiction or any of
our other programs may be delayed or not started at all. For example, certain regulatory agencies in Europe have required that we conduct
additional clinical studies prior to initiating ARMOR in those jurisdictions. Even after we receive and incorporate guidance from these
regulatory authorities, the FDA or other regulatory authorities could disagree that we have satisfied their requirements to commence
our clinical trial or change their position on the acceptability of our planned trial design or the clinical endpoints selected, which
may require us to complete additional preclinical studies or clinical trials or impose stricter approval conditions than we currently
expect. As a result of the foregoing, the research and development, preclinical studies and clinical testing of any product candidate
is expensive and can take many years to complete, and its outcome is inherently uncertain. Failure can occur at any time during the development
process.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>We
may be forced to abandon development of Aramchol or any other product candidate which would have a material adverse effect on our business
and may force us to cease operations.</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Upon
the completion of any clinical or pre-clinical trial and/or tests, the results might not support the desired indications for use. Further,
success in earlier clinical trials does not ensure that later clinical trials will be successful, and the results of later clinical trials
may not replicate the results of prior clinical trials or pre-clinical testing. In addition, the design of a clinical trial can determine
whether its results will support approval of a product, and flaws in the design of a clinical trial or variability in interpretation
of results may not become apparent until the clinical trial is well advanced. The clinical trial process may fail to demonstrate that
Aramchol or any other product candidate is sufficiently safe and/or effective for the indications we seek to receive FDA or other regulatory
approval. Any such failure may cause us to abandon Aramchol or any other product candidate and may delay development of other potential
product candidates. Any delay in, or termination or suspension of, our clinical trials may delay the requisite filings with the FDA or
other regulatory agencies and, ultimately, our ability to commercialize Aramchol or any other product candidate and generate product
revenues. If the results of the ARMOR Study or any other study, including in any interim readout, are not sufficiently compelling, then
the completion of development of our product candidates may be significantly delayed or abandoned which would have material adverse effect
on our business, liquidity, operating results and financial condition and may force us to cease operations.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>&#160;</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; text-align: justify; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>We
have in the past and may in the future develop Aramchol in combination with other therapies, which exposes us to additional risks.</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
have in the past and, subject to our strategic review, may in the future develop Aramchol in combination with investigational therapies.
We will not be able to market and sell Aramchol or any product candidate we develop in combination with an unapproved therapy for a combination
indication if that unapproved therapy does not ultimately obtain marketing approval either alone or in combination with our product candidate.
In addition, unapproved therapies face the same risks described with respect to Aramchol or any other product candidate currently in
development and clinical trials, including the potential for serious adverse effects, delay in their clinical trials and lack of FDA,
EMA or MHRA approval. If the FDA, EMA, MHRA or comparable foreign regulatory authorities do not approve these other drugs or revoke their
approval of, or if safety, efficacy, quality, manufacturing or supply issues arise with the product candidates we choose to evaluate
in combination with our product candidate we develop, we may be unable to obtain approval of or market such combination therapy.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>The
lack of a reliable non-invasive method for the diagnosis of NASH and fibrosis is likely to present a major challenge to Aramchol&#8217;s
market penetration, if ever commercialized.</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Liver
biopsy is the standard approach for the diagnosis of inflammation and fibrosis associated with NASH. However, the procedure-related morbidity
and, in rare cases, mortality, sample errors, costs, patient discomfort and thus lack of patient interest in undergoing the procedure
limit its use. As such, only patients with a high risk of NASH, which includes patients with metabolic syndrome and an indication of
Non-Alcoholic Fatty Liver Disease, or NAFLD, are generally sent for liver biopsy. Because NASH tends to be asymptomatic until the disease
progresses, many individuals with NASH remain undiagnosed until the disease has reached its late stages, if at all. The lack of a reliable
non-invasive method for the diagnosis of NASH and fibrosis is likely to present a major challenge to Aramchol&#8217;s market penetration,
as many practitioners and patients may not be aware that a patient suffers from NASH and requires treatment. As such, use of Aramchol
might not be as wide-spread as our actual target market and this may limit the commercial potential of Aramchol.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">A
further challenge to Aramchol&#8217;s market penetration is that currently a liver biopsy is the standard approach for measuring improvement
in NASH patients. Because it would be impractical to subject all patients that take Aramchol, when and if it is approved, to regular
and repeated liver biopsies, it will be difficult to demonstrate Aramchol&#8217;s effectiveness to practitioners and patients unless
and until a reliable non-invasive method for the diagnosis and monitoring of NASH becomes available, as to which there can be no assurance.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">While
other companies in the industry are currently working on advancing non-invasive diagnostic approaches, none of these has been clinically
validated, and the timetable for commercial validation, if at all, is uncertain. Moreover, such diagnostics may also be subject to regulation
by FDA or other regulatory authorities as medical devices and may require premarket clearance or approval. See also &#8220;Item 3. Key
Information&#8212;Risk Factors &#8212;Risk Factors&#8212;Risks Related to Our Business, Industry and Regulatory Requirements &#8212;-
We are developing Aramchol for the treatment of NASH, an indication for which there are no approved products, and there is significant
uncertainty regarding the regulatory approval process. This makes it difficult to predict the timing and costs of the clinical development
of Aramchol for the treatment of NASH.&#8221;</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Our
Amilo-5MER program is being conducted under a license agreement with Yissum Research Development Company of the Hebrew University of
Jerusalem, or Yissum.</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Our
Amilo-5MER program is being conducted under a license agreement from Yissum and is subject to various additional obligations, including
obligations with respect to funding, development and commercialization activities, and payment obligations upon entering into the license
agreement and achievement of certain milestones and royalties on product sales. Furthermore, if the license agreement is terminated or
breached, we may:</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.45in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">lose
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  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">not
    be able to secure trade secret protection for Amilo-5MER;</span></td></tr>
  </table>
<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>


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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify; width: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify; width: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">experience
    significant delays in the development or commercialization of Amilo-5MER; or may have to cease development entirely;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">incur
    liability for damages.</span></td></tr>
  </table>
<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.45in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Additionally,
even if not terminated or breached, our intellectual property licenses may be subject to disagreements over contract interpretation which
could narrow the scope of our rights to the relevant intellectual property or technology or increase our financial or other obligations.
If we experience any of the foregoing, it could have a materially adverse effect on our business.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.45in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
January 2022, we announced the completion of our Phase 1 clinical trial of Amilo-5MER. The Phase 1 study was conducted in a single-center,
using a double-blind, randomized, placebo-controlled design. Results demonstrated that all doses of Amilo-5MER were well tolerated with
no clinically significant adverse events and none considered related to the investigational product. Due to its early stage of development,
Amilo-5MER will require significant additional research, development, manufacturing, preclinical and clinical testing, marketing authorization,
and commitment of significant additional resources prior to any commercialization. These activities will require significant cash for
which we will need to raise additional capital. In addition, Amilo-5MER is prone to the risks of failure inherent in pharmaceutical product
development, including the possibility that Amilo-5MER will not be shown to be sufficiently safe and effective for approval by regulatory
authorities.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>If
we acquire or in-license additional technologies or product candidates, we may incur significant, incremental expenses, may have integration
difficulties and may experience other risks that could harm our business and results of operations.</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.45in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
evaluate from time-to-time the acquisition or in-licensing of additional product candidates and technologies. Any product candidate or
technologies we in-license or acquire will likely require additional development efforts prior to commercial sale, including extensive
pre-clinical or clinical testing, or both, and approval by the FDA and applicable foreign regulatory authorities, if any. All product
candidates are prone to risks of failure inherent in pharmaceutical product development, including the possibility that the product candidate,
or product developed based on in-licensed technology, will not be shown to be sufficiently safe and effective for approval by regulatory
authorities. In addition, we cannot assure that any product candidate that we develop based on acquired or in-licensed technology that
is granted regulatory approval will be manufactured or produced economically, successfully commercialized or widely accepted or competitive
in the marketplace. Moreover, integrating any newly acquired or in-licensed product candidates could be expensive and time-consuming.
If we cannot effectively manage these aspects of our business strategy, our business may not succeed.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Obtaining
approval of an NDA, or other regulatory approval, even after clinical trials that are believed to be successful, is an uncertain process.</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.45in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Even
if we complete clinical trials and believe that the clinical data confirms that Aramchol, Amilo-5MER or any other product candidate is
sufficiently safe and effective for its intended use or uses, obtaining approval of an NDA, or other regulatory approval, is an extensive,
lengthy, expensive and uncertain process, and the FDA and other regulatory agencies may delay, limit or deny approval of such product
candidate for many reasons, including, without limitation, the fact that:</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">we
    may not be able to demonstrate to the satisfaction of the applicable regulatory agencies that the product candidate is safe and effective
    for treatment of the targeted indication in patients;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the
    results of clinical trials may not meet the level of statistical significance or clinical significance required by the applicable
    regulatory agencies for approval;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the
    applicable regulatory agencies may disagree with the number, design, size, conduct or implementation of our clinical trials;</span></td></tr>
  </table>

<p style="margin-top: 0; margin-bottom: 0">&#160;</p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the
    applicable regulatory agencies may not find the data from pre-clinical studies and clinical trials sufficient to demonstrate the
    clinical and other benefits outweigh its safety risks;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the
    applicable regulatory agencies may disagree with our interpretation of data from pre-clinical studies or clinical trials;</span></td></tr>
  </table>
<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the
    applicable regulatory agencies may not accept data generated at our clinical trial sites;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the
    data collected from pre-clinical studies and clinical trials may not be sufficient to support the submission of an NDA or similar
    regulatory application;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the
    applicable regulatory agencies may not schedule an advisory committee meeting in a timely manner or the advisory committee may recommend
    against approval of our application or may recommend that the applicable regulatory agencies require, as a condition of approval,
    additional pre-clinical studies or clinical trials, limitations on approved labeling or distribution and use restrictions;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the
    applicable regulatory agencies may require development of a risk evaluation and mitigation strategy, or REMS, as a condition of approval;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the
    applicable regulatory agencies may require simultaneous approval for both adults and children, which would delay required approvals,
    or we may have successful clinical trial results for adults, but not children, or vice versa;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the
    applicable regulatory agencies may change their approval policies or adopt new regulations that may impede consideration or approval
    of our NDA, or similar regulatory application;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the
    applicable regulatory agencies may identify deficiencies in the manufacturing processes or facilities of third-party manufacturers,
    or suppliers of active pharmaceutical ingredients, or APIs, with which we enter into agreements for clinical and commercial supplies;
    and</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the
    applicable regulatory agencies may require post-marketing approval studies, such as Phase 4 clinical trials, in connection with Aramchol
    or any other product candidate.</span></td></tr>
  </table>
<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Before
we can submit an NDA to the FDA or a similar approval application to other regulatory authorities, as applicable, we (or our commercialization
partner, as the case may be) must conduct one or more clinical trials that will be substantially broader than our prior completed trials.
We will also need to agree on a protocol with the FDA or any other regulatory authorities for any clinical trial(s) before commencing
any such trial. Clinical trials frequently produce unsatisfactory results even though prior clinical trials were successful. Therefore,
the results of any prior trial or any future clinical trials that we may conduct may or may not be successful. The applicable regulatory
agencies may suspend all clinical trials or require that we conduct additional clinical, pre-clinical, manufacturing, validation or drug
product quality studies and submit data from these additional studies before considering or reconsidering the NDA or similar regulatory
application. Depending on the extent of these, or any other studies, approval of any applications that we submit may be delayed by several
years, or may require us to expend more resources than we have available. It is also possible that additional studies, if performed and
completed, may not be considered sufficient by the applicable regulatory agencies to provide regulatory approval. If any of these outcomes
occur, we would not receive approval for Aramchol, Amilo-5MER or any other product candidate and may be forced to cease operations.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Even
if we obtain regulatory approval for Aramchol, Amilo-5MER or any other product candidate, the approval might contain significant limitations
related to the indications for use for which the drug is approved, use restrictions including, without limitation, for certain labeled
populations, age groups, warnings, precautions or contraindications, or may be subject to significant post-marketing studies or risk
mitigation requirements. If we are unable to successfully commercialize Aramchol, Amilo-5MER or any other product candidate, we may be
forced to cease operations.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>


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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>&#160;</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Our
product candidates may produce undesirable side effects or have other properties that could delay or prevent its regulatory approval
or result in significant negative consequences following marketing approval, if any, which could substantially increase commercialization
costs or even force us to cease operations.</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Undesirable
side effects caused by Aramchol or any other product candidate could cause us or regulatory authorities to interrupt, delay or halt clinical
trials and could result in a more restrictive label or the delay or denial of regulatory approval by the FDA or applicable foreign regulatory
authorities. To date, we have completed seven clinical trials of Aramchol, and additionally one proof of concept study in patient with
gallstones, and a Phase 2a, investigator initiated clinical trial were completed. Although we have not seen any evidence of reactions
causing a safety concern in our completed clinical trials, it is possible that the FDA may ask for additional data regarding any adverse
events seen in our trials. Results of our future trials could reveal a high and unacceptable severity and prevalence of these or other
side effects. In such an event, our trials could be suspended or terminated and the FDA or applicable foreign regulatory authorities
could order us to cease further development of or deny approval for Aramchol, Amilo-5MER or any other product candidate for any or all
targeted indications. The drug-related side effects could affect patient recruitment or the ability of enrolled patients to complete
future trials or result in potential product liability claims. Any of these occurrences may harm our business, financial condition and
prospects significantly.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Even
if Aramchol or any other product candidate receives marketing approval, we or others may later identify undesirable side effects caused
by the product. In such an event, regulatory authorities may:</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">suspend
    or withdraw their approval of the product;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">require
    the addition of labeling statements, such as warnings, so-called &#8220;black box warnings,&#8221; contraindications or restrictions
    on the product&#8217;s intended use;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">require
    us to issue specific communications to healthcare professionals, such as &#8220;Dear Doctor&#8221; letters;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">issue
    negative publicity regarding the affected product, including safety communications;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">impose
    a risk evaluation and mitigation strategy (REMS), in the case of FDA, or similar risk management strategies in the case of foreign
    regulators;</span></td></tr>
  </table>
<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
addition to these potentially significant negative consequences, we could be required to change the way the product is administered,
conduct additional pre-clinical studies or clinical trials or restrict or cease the distribution or use of the product, and/or be sued
and held liable for harm caused to patients. The foregoing or other events could prevent us from achieving or maintaining market acceptance
of the affected product candidate and could substantially increase commercialization costs or even force us to cease operations.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>If
we encounter difficulties enrolling patients in our clinical trials, our clinical development activities could be delayed or otherwise
adversely affected.</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Patient
enrollment, a significant factor in the timing of clinical trials, is affected by many factors including the size and nature of the patient
population, the proximity of patients to clinical sites, the eligibility criteria for the trial, the design of the clinical trial, patient
willingness to undergo a liver biopsy in our NASH trials, competing clinical trials and clinicians&#8217; and patients&#8217; perceptions
as to the potential advantages and disadvantages of the product candidate being studied in relation to other available therapies, including
any new drugs that may be approved for the indications we are investigating, and actual or threatened public health emergencies and outbreaks
of disease (including, for example, any resurgence of the COVID-19 pandemic). Potential patients for Aramchol, Amilo-5MER or any other
product candidate may not be adequately diagnosed or identified with the diseases which we are targeting or may not meet the entry criteria
for our studies.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
will be required to identify and enroll a sufficient number of patients in the U.S. with NASH for each of our clinical trials of Aramchol
in this indication. We also may encounter difficulties in identifying and enrolling U.S. NASH patients who meet the eligibility criteria
for our planned clinical trials. We may not be able to initiate or continue clinical trials if we are unable to locate a sufficient number
of eligible patients to participate in the clinical trials required by the FDA or other foreign regulatory agencies. In addition, the
process of finding and diagnosing patients may prove costly. To date, we have already experienced significant delays in our clinical
trials largely related to significantly slower than expected recruitment and the length of time required to obtain regulatory authorizations
to proceed with clinical trials. Our inability to enroll a sufficient number of patients for any of our clinical trials could result
in further significant delays, additional expenses, or may require us to abandon one or more clinical trials.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>


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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>&#160;</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Changes
in regulatory requirements and guidance or unanticipated events during our clinical trials may occur, which may result in necessary changes
to clinical trial protocols, which could result in increased costs to us, delay our development timeline or reduce the likelihood of
successful completion of our clinical trials.</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Changes
in regulatory requirements or guidance or unanticipated events during our clinical trials may result in the need for us to amend clinical
trial protocols.  Amendments may require review and approval by regulators and/or IRBs, and re-consent subjects, which
may adversely affect the cost, timing or successful completion of a clinical trial. Even if we re-initiate the ARMOR Study, if we experience
delays in the completion of, or if we terminate, any of the ARMOR Study or any other clinical trials, this could have a material adverse
effect on our business, liquidity, operating results and financial condition and may force us to cease operations. See also &#8220;Item
3. Key Information&#8212;Risk Factors&#8212;Risk Factors&#8212;Risks Related to Our Business, Industry and Regulatory Requirements -
We are developing Aramchol for the treatment of NASH, an indication for which there are currently no approved products, and there is
significant uncertainty regarding the regulatory approval process. This makes it difficult to predict the timing and costs of the clinical
development of Aramchol for the treatment of NASH.&#8221;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Even
if Aramchol, Amilo-5MER or any other product candidate that we develop, receives marketing approval, we will continue to face extensive
regulatory oversight and requirements, and any such product may still face future regulatory risks or new requirements.</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Even
if we receive regulatory approval to market a particular product candidate, any such product will remain subject to extensive regulatory
requirements, including requirements relating to manufacturing, labeling, packaging, adverse event reporting, storage, advertising, promotion,
distribution and recordkeeping. Even if regulatory approval of a product is granted, the approval may be subject to limitations on the
uses for which the product may be marketed or the conditions of approval, or may contain requirements for costly post-marketing testing
and surveillance to monitor the safety or efficacy of the product, which could negatively affect us by reducing revenues or increasing
expenses, and cause the approved product candidate not to be commercially viable. In addition, as clinical experience with a drug expands
after approval, typically because it is used by a greater number and more diverse group of patients after approval than during clinical
trials, side effects and other problems may be observed over time after approval that were not seen or anticipated during pre-approval
studies. Any adverse effects observed after the approval and marketing of a product candidate could result in limitations on the use
of the approved product, withdrawal of FDA approval of the previously approved product, or voluntary withdrawal from the marketplace
of the approved product. Absence of long-term safety data may also limit the approved uses of Aramchol or any other product candidate,
if any. If we fail to comply with the regulatory requirements of the FDA, and other applicable U.S. and foreign regulatory authorities,
or previously unknown problems with any approved commercial products, manufacturers or manufacturing processes are discovered, we could
be subject to administrative or judicially imposed sanctions or other setbacks, including the following:</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">suspension
    or imposition of restrictions on operations, including costly new manufacturing requirements;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">refusal
    to approve pending applications or supplements to applications;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">suspension
    of any ongoing clinical trials;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">suspension
    or withdrawal of marketing approval;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">an
    injunction or imposition of civil or criminal penalties or monetary fines;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">seizure
    or detainment of products;</span></td></tr>
  </table>
<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>


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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">banning
    or restriction of imports and exports;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">issuance
    of warning letters or untitled letters;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">suspension
    or imposition of restrictions on operations, including costly new manufacturing requirements; or</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">refusal
    to approve pending applications or supplements to applications.</span></td></tr>
  </table>
<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
addition, various aspects of our operations are subject to federal, state or local laws, rules and regulations, any of which may change
from time to time. Costs arising out of any regulatory developments could be time-consuming and expensive and could divert management
resources and attention and, consequently, could adversely affect our business operations and financial performance.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Delays
in regulatory approval, limitations in regulatory approval and withdrawals of regulatory approval may have a material adverse effect
on us. If we experience significant delays in testing or receiving approvals or sign-offs to conduct clinical trials, Aramchol or any
other product candidate development costs will increase and our ability to out-license our product candidates may be impeded.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>If
we obtain approval to commercialize any product candidate outside of the United States or out-license a product candidate to additional
territories outside the United States, a variety of risks associated with international operations could materially adversely affect
our business.</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">If
any product candidate is approved for commercialization outside the United States or we out-license a product candidate to additional
territories outside the United States, we will likely enter into agreements with third parties to commercialize a product candidate outside
the United States. We expect that we will be subject to additional risks related to entering into or maintaining international business
relationships, including, without limitation:</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">different
    regulatory requirements for drug approvals in foreign countries;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">differing
    U.S. and foreign drug import and export rules;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">reduced
    protection for intellectual property rights in foreign countries;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">unexpected
    changes in tariffs, trade barriers and regulatory requirements;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">different
    reimbursement systems;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">economic
    weakness, including inflation, or political instability in particular foreign economies and markets;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">compliance
    with tax, employment, immigration and labor laws for employees living or traveling abroad;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">foreign
    currency fluctuations, which could result in increased operating expenses and reduced revenues, and other obligations incident to
    doing business in another country;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">workforce
    uncertainty in countries where labor unrest is more common than in the United States;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">production
    shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">potential
    liability resulting from development work conducted by these distributors;</span></td></tr>
  </table>

<p style="margin-top: 0; margin-bottom: 0">&#160;</p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify; width: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify; width: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">business
    interruptions resulting from geopolitical actions, including war and terrorism, or natural disasters, emergence of a pandemic, or
    other widespread health emergencies (or concerns over the possibility of such an emergency, including for example, the COVID-19 pandemic);
    and</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">risks
    associated with clinical co-development agreements in other jurisdictions prior to or post-regulatory approval.</span></td></tr>
  </table>
<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">A
failure to timely and effectively address the additional risks related to entering into or maintaining international business relationships
could have a material adverse effect on our business, liquidity, operating results and financial condition.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>If
we receive marketing approval for a product candidate, sales will be limited unless the product achieves broad market acceptance.</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
commercial success of a product candidate for which we obtain marketing approval from the FDA, or other regulatory authorities, will
depend on the breadth of its approved labeling and upon the acceptance of the product by the medical community, including physicians,
patients and healthcare payors. The degree of market acceptance of any approved product will depend on a number of factors, including,
without limitation:</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">demonstration
    of clinical safety and efficacy compared to other products;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">ability
    of physicians to accurately diagnose NASH in its early stages;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
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  </table>
<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; width: 48px; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 48px; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the
    prevalence and severity of any adverse side effects;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">limitations,
    warnings or contraindications contained in the product&#8217;s approved labeling;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">distribution
    and use restrictions imposed by the FDA, or other regulatory agencies, or agreed to by us as part of a mandatory or voluntary REMS;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">availability
    of alternative treatments, including, any competitive products already approved or expected to be commercially launched in the near
    future;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">pricing
    and cost effectiveness;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the
    effectiveness of our, or any future collaborators&#8217;, sales and marketing strategies;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">our
    ability to obtain sufficient third-party coverage or reimbursement; and</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the
    willingness of patients to pay for drugs out of pocket in the absence of third-party coverage.</span></td></tr>
  </table>
<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">If
a product candidate is approved, but does not achieve an adequate level of acceptance by physicians, healthcare payors and patients,
we may not generate sufficient revenue from the product, and we may not become profitable. In addition, our efforts to educate the medical
community and third-party payors on the benefits of the product may require significant resources and may never be successful.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>


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    <!-- Field: /Page -->

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>&#160;</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>The
FDA and other regulatory agencies may actively enforce the laws and regulations prohibiting the promotion of off-label uses. If we are
found to have improperly promoted off-label uses, we may become subject to significant liability.</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
FDA and other regulatory agencies strictly regulate the promotional claims that may be made about prescription products. In particular,
a product may not be promoted for uses that are inconsistent with the FDA-approved indications and other conditions or restrictions contained
in the approved labeling, including the prescribing information, for the product. In particular, any labeling approved by FDA or other
foreign regulatory agencies for a product candidate necessarily limits its use for certain conditions in certain patient populations.
Also, regulatory agencies may impose further requirements or restrictions on the distribution or use of Aramchol, Amilo-5MER or any other
product candidate as part of a mandatory plan, such as limiting prescribing to certain physicians or medical centers that have undergone
specialized training, limiting treatment to patients who meet certain safe-use criteria and requiring treated patients to enroll in a
registry. If we receive marketing approval for a product candidate, physicians may nevertheless prescribe the product candidate to their
patients in a manner that is inconsistent with the approved labeling, which is commonly known as &#8220;off label&#8221; use. If we are
found to have promoted any product candidate for such &#8220;off label&#8221; uses, we may become subject to significant liability under
a variety of statutory theories typically alleged by U.S. regulatory authorities. In particular, the U.S. federal government has levied
large civil and criminal fines against companies for alleged improper promotion, has enjoined several companies from engaging in off-label
promotion, and has requested that companies enter into consent decrees or permanent injunctions under which specified promotional conduct
is changed or curtailed.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Our
business and operations may be materially adversely affected in the event of computer system failures or security or breaches due to
cyber-attacks or cyber intrusions, including ransomware, phishing attacks and other malicious intrusions.</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
recent years, cybersecurity threats have become a greater risk and focus for companies. In particular, ransomware attacks, where a hacker
locks and threatens to delete or disclose the victim&#8217;s data unless a ransom is paid, has become a major risk. We and those of our
CROs and other third parties on which we rely are at risk of cyber-attacks or cyber intrusions via the Internet, computer viruses, break-ins,
malware, ransomware, phishing attacks, hacking, denial-of-service attacks or other attacks and similar disruptions from the unauthorized
use of, or access to, computer systems (including from internal and external sources). These types of incidents continue to be prevalent
and pervasive across industries, including in our industry. In addition, we expect information security risks to continue to increase
due to the proliferation of new technologies and the increased sophistication and activities of organized crime, hackers, terrorists
and other external parties, including foreign state actors.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Despite
the implementation of security measures, our internal computer systems, and those of our CROs and other third parties on which we rely,
are vulnerable to damage from computer viruses, unauthorized access, cyber-attacks, cyber intrusions, natural disasters, fire, terrorism,
war, and telecommunication and electrical failures. If such an event were to occur and interrupt our operations, it could result in a
material disruption of our drug development programs and inflict reputational harm upon us that may result in decreased market value
and erode public trust. For example, the loss of clinical trial data from ongoing or planned clinical trials could result in delays in
our regulatory approval efforts and significantly increase our costs to recover or reproduce the data. To the extent that any disruption
or security breach results in a loss of or damage to our data or applications, loss of trade secrets or inappropriate disclosure of confidential
or proprietary information, including protected health information or personal data of employees or former employees, access to our clinical
data, or disruption of the manufacturing process, we could incur liability and the further development of our drug candidates could be
delayed.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>We
may be subject to extensive environmental, health and safety, and other laws and regulations in multiple jurisdictions.</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Our
business involves the controlled use, through our service providers, of hazardous materials, various biological compounds and chemicals,
and as such, we, our agents and our service providers may be subject to various environmental, health and safety laws and regulations,
including those governing air emissions, water and wastewater discharges, noise emissions, the use, management and disposal of hazardous,
radioactive and biological materials and wastes and the cleanup of contaminated sites. The risk of accidental contamination or injury
from these materials cannot be eliminated. If an accident, spill or release of any regulated chemicals or substances occurs, we could
be held liable for resulting damages, including for investigation, remediation and monitoring of the contamination, including natural
resource damages, the costs of which could be substantial. We may incur substantial capital costs and operating expenses and may be required
to obtain consents to comply with any environmental and health laws or regulations and the terms and conditions of any permits required
pursuant to such laws and regulations, including costs incurred by us to install new or updated pollution control equipment for our service
providers, modify our operations or perform other corrective actions at our facilities or the facilities of our service providers. In
addition, fines and penalties may be imposed on us, our agents and/or our service providers for noncompliance with environmental, health
and safety and other laws and regulations or for the failure to have, or comply with the terms and conditions of, required environmental
or other permits or consents.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>


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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>&#160;</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>We
expect the healthcare industry to face increased limitations on coverage of and reimbursement, rebates and other payments as a result
of healthcare reform, which could adversely affect third-party coverage of Aramchol, Amilo-5MER or any other product candidate and how
much or under what circumstances healthcare providers will prescribe or administer Aramchol, Amilo-5MER or any other product candidate.</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
both the United States and other countries, sales of Aramchol Amilo-5MER or any other product candidate will depend in part upon coverage
of the product and the availability of reimbursement from third party payors, including governmental authorities, managed care organizations
and other private health insurers. Third-party payors are increasingly challenging the price and examining the coverage of products based
on cost effectiveness of the medical products and services.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Increasing
expenditures for healthcare have been the subject of considerable public attention in the United States. Both private and government
entities are seeking ways to reduce or contain healthcare costs. Numerous proposals that would effect changes in the U.S. healthcare
system have been introduced or proposed in the U.S. Congress, or Congress, and in some state legislatures, including reducing reimbursement
for prescription products and reducing the levels at which consumers and healthcare providers are reimbursed for purchases of pharmaceutical
products.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
the United States, the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, or the Modernization Act, changed the
way Medicare covers and pays for most pharmaceutical products in a number of ways. Medicare is the single largest third-party payment
program and is administered by the Centers for Medicare &amp; Medicaid Services, or the CMS. Medicare traditionally covered prescription
drugs administered by physicians. The Modernization Act introduced a new reimbursement methodology based on average sales prices for
many of these drugs. The Modernization Act also established a new competitive acquisition program for the purchase of Part B drugs. This
program, when fully implemented, will likely reduce the prices of these drugs. While the Medicare provisions of the Modernization Act
apply only to drug benefits for Medicare beneficiaries, private payors often follow Medicare coverage policy and payment limitations
in setting their own reimbursement rates. Therefore, any reduction in reimbursement that results from federal legislation or regulation
may result in a similar reduction in payments from private payors.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Most
notably, the Modernization Act also expanded coverage through a new Part D to include ordinary self-administered outpatient drugs. Medicare
part D though operates through private insurers, and these insurers negotiate prices with pharmacies and with manufacturers. Intense
negotiations can result in reduced revenues to manufacturers.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Increasing
expenditures for healthcare have been the subject of considerable public attention in the United States. Both private and government
entities are seeking ways to reduce or contain healthcare costs. Numerous proposals that would effect changes in the U.S. healthcare
system have been introduced or proposed in U.S. Congress, and in some state legislatures, including reducing reimbursement for prescription
products and reducing the levels at which consumers and healthcare providers are reimbursed for purchases of pharmaceutical products.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
March 2010, President Barack Obama signed into law the Patient Protection and Affordable Care Act and the Health Care and Education Affordability
Reconciliation Act of 2010, or the Affordable Care Act, a sweeping law intended to broaden access to health insurance, reduce or constrain
the growth of healthcare spending, enhance remedies against fraud and abuse, add new transparency requirements for healthcare and health
insurance industries, impose new taxes and fees on pharmaceutical and medical device manufacturers and impose additional health policy
reforms. The Affordable Care Act expanded manufacturers&#8217; Medicaid rebate liability to include covered drugs dispensed to individuals
who are enrolled in Medicaid managed care organizations, increased the minimum rebate due for innovator drugs from 15.1% of average manufacturer
price, or the AMP, to 23.1% of AMP. The rebate on innovator drugs is the greater of 23.1% of the AMP per unit or the difference between
the AMP and the best price per unit and adjusted by the Consumer Price Index-Urban (CPI-U) based on a launch date and current quarter
AMP. The total rebate amount for innovator drugs is capped at 100.0% of AMP. The Affordable Care Act and subsequent legislation also
narrowed the definition of AMP. Furthermore, the Affordable Care Act imposes a significant annual, nondeductible fee on companies that
manufacture or import certain branded prescription drug products. The Affordable Care Act appears likely to continue to put pressure
on pharmaceutical pricing, especially under the Medicare and Medicaid programs, and may also increase our regulatory burdens and operating
costs.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">There
have been judicial and congressional challenges to the Affordable Care Act. If successful in the challenges, many if not all of the provisions
of the PPACA may no longer apply to prescription drugs. While we are unable to predict what changes may ultimately be enacted, to the
extent that future changes affect how any future products are paid for and reimbursed by government and private payers our business could
be adversely impacted. On December 14, 2018, a federal district court in Texas ruled that the PPACA is unconstitutional as a result of
the Tax Cuts and Jobs Act, the federal income tax reform legislation previously passed by Congress and signed by President Trump on December
22, 2017, that eliminated the individual mandate portion of the PPACA. The case, Texas, et al, v. United States of America, et al., (N.D.
Texas), is an outlier, and the ruling has been stayed by the ruling judge, but in 2019, the Fifth Circuit Court of Appeals subsequently
upheld the lower court decision which was then appealed to the United States Supreme Court. The U.S. Supreme Court declined to hear the
appeal on an expedited basis and so no decision is expected until sometime in 2021 before the end of the next Supreme Court&#8217;s current
term in early 2021. We are not able to state with any certainty what will be the impact of this court decision on our business pending
further court action and possible appeals. In November 2020, Joseph Biden was elected President and, in January 2021, the Democratic
Party obtained control of the Senate. As a result of these electoral developments, it is unlikely that continued legislative efforts
will be pursued to repeal PPACA. Instead, it is possible that executive and regulatory initiatives, as well as legislation will be pursued
to enhance or reform PPACA. We are not able to state with certainty what the impact of potential legislation will be on our business.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
addition, other legislative changes have been proposed and adopted since the Affordable Care Act was enacted. In August 2011, President
Obama signed into law the Budget Control Act of 2011, which, among other things, created the Joint Select Committee on Deficit Reduction
to recommend to Congress proposals in spending reductions. The Joint Select Committee did not achieve a targeted deficit reduction of
an amount greater than $1.2 trillion for the years 2013 through 2021, triggering the legislation&#8217;s automatic reduction to several
government programs. This includes aggregate reductions to Medicare payments to healthcare providers of up to 2.0% per fiscal year, starting
in 2013. These reductions will stay in effect through 2030 unless additional congressional action is taken. However, COVID-19 relief
legislation suspended the 2% Medicare sequester from May 1, 2020 through March 31, 2021. In January 2013, President Obama signed into
law the American Taxpayer Relief Act of 2012, which, among other things, reduced Medicare payments to several categories of healthcare
providers and increased the statute of limitations period for the government to recover overpayments to providers from three to five
years. If we ever obtain regulatory approval and commercialization of Aramchol or any other product candidate, these laws may result
in additional reductions in Medicare and other healthcare funding, which could have a material adverse effect on our customers and accordingly,
our financial operations. Legislative and regulatory proposals have been made to expand post-approval requirements and restrict sales
and promotional activities for pharmaceutical products. We cannot be sure whether additional legislative changes will be enacted, or
whether the FDA regulations, guidance or interpretations will be changed, or what the impact of such changes on the marketing approvals
of Aramchol or any other product candidate may be. Further, the Deficit Reduction Act of 2010, directed CMS to contract a vendor to determine
&#8220;retail survey prices for covered outpatient drugs that represent a nationwide average of consumer purchase prices for such drugs,
net of all discounts and rebates (to the extent any information with respect to such discounts and rebates is available).&#8221; This
survey information can be used to determine the National Average Drug Acquisition Cost, NADAC. Some states have indicated that they will
reimburse based on the NADAC and this can result in further reductions in the prices paid for various outpatient drugs.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Various
states, such as California and Florida, have also taken steps to consider and enact laws or regulations that are intended to increase
the visibility of the pricing of pharmaceutical products with the goal of reducing the prices at which pharmaceutical products are sold.
On August 16, 2022, President Biden signed into law the Inflation Reduction Act of 2022 that contains significant reforms affecting the
pricing of drugs and biologics paid by Medicare. The new requirements establish a timeline for certain drugs to negotiate with the federal
government a &#8220;maximum fair price&#8221; for certain selected drugs beginning in 2026. The numbers of drugs, as well as the selection
criteria, is established for each year. Because these various actual and proposed legislative changes are intended to operate on a state-by-state
level and the new national law, we cannot predict what the full effect of state legislative activities, and the IRA may be on our business
in the future.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Although
we cannot predict the full effect on our business of the implementation of existing legislation or the enactment of additional legislation
pursuant to healthcare and other legislative reform, we believe that legislation or regulations that would reduce reimbursement for,
or restrict coverage of, Aramchol or any other product candidate, could adversely affect how much or under what circumstances healthcare
providers will prescribe or administer our products. This could materially and adversely affect our business by reducing our ability
to generate revenue, raise capital, obtain additional collaborators and market Aramchol or any other product candidate. In addition,
we believe the increasing emphasis on managed care in the United States has and will continue to put pressure on the price and usage
of pharmaceutical products, which may adversely impact any other product sales.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>It
will be difficult for us to profitably sell any product candidate if reimbursement for the product is limited by government authorities
and third-party payor policies.</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
addition to any healthcare reform measures that may affect reimbursement, the market acceptance and sales of any product candidate will
depend on the reimbursement policies of government authorities and third-party payors. It will be difficult for us to profitably sell
a product candidate if reimbursement for the product is limited by government authorities or third-party payors. Government authorities
and third-party payors, such as private health insurers and health maintenance organizations, decide which medications they will pay
for and establish reimbursement levels. A primary trend in the U.S. healthcare industry and elsewhere is cost containment. Government
authorities and these third-party payors have attempted to control costs by limiting coverage and the amount of reimbursement for particular
medications. We cannot be sure that coverage or reimbursement will be available for any product candidate and, if coverage and reimbursement
are available, of the extent of coverage and the level of reimbursement. Reimbursement may affect the demand for, or the price of, any
product for which we obtain marketing approval. In addition, third-party payors are likely to impose strict requirements for reimbursement
in order to limit off-label use of a higher priced drug. Reimbursement by a third-party payor may depend upon a number of factors including
the third-party payor&#8217;s determination that use of a product is:</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">a
    covered benefit under its health plan;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">safe,
    effective and medically necessary;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">appropriate
    for the specific patient;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">cost-effective;
    and</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">neither
    experimental nor investigational.</span></td></tr>
  </table>
<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Obtaining
coverage and reimbursement approval for a product from a government or other third-party payor is a time-consuming and costly process
that could require us to provide supporting scientific, clinical and cost effectiveness data for the use of a product candidate to the
payor. We may not be able to provide data sufficient to gain acceptance with respect to coverage and reimbursement. We cannot be sure
that coverage or adequate reimbursement will be available for any product candidates. Also, we cannot be sure that reimbursement amounts
will not reduce the demand for, or the price of, any product candidates. If reimbursement is not available, or is available only to limited
levels, we may not be able to commercialize any product candidates, profitably, or at all, even if approved. In addition, if physicians,
government agencies and other third-party payors do not accept the use or efficacy of any product candidates, we will not be able to
generate significant revenue, if any.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; text-align: justify; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Governments
outside the United States tend to impose strict price controls, which may adversely affect our revenues, if any.</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
some countries, particularly the countries of the EU, the pricing of prescription pharmaceuticals is subject to governmental control.
In these countries, pricing negotiations with governmental authorities can take considerable time after the receipt of marketing approval
for a product. To obtain reimbursement or pricing approval in some countries, we may be required to conduct a clinical trial that compares
the cost-effectiveness of Aramchol or any other product candidate to other available therapies. If reimbursement of our products is unavailable
or limited in scope or amount, or if pricing is set at unsatisfactory levels, our business could be harmed, possibly materially.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>


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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>&#160;</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>If
we or any of our independent contractors, consultants, collaborators, manufacturers, or service providers fail to comply with healthcare
and data privacy laws and regulations, we or they could be subject to enforcement actions, which could result in penalties and affect
our ability to develop, market and sell Aramchol or any other product candidate and may harm our reputation.</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
are or may in the future be subject to federal, state, and foreign healthcare and data privacy laws and regulations pertaining to, among
other things, fraud and abuse of patients&#8217; rights. These laws and regulations include:</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
    federal Anti-Kickback Statute prohibits, among other things, knowingly and willfully soliciting, offering, receiving, or paying any
    remuneration, directly or indirectly, in cash or in kind, to induce or reward purchasing, ordering or arranging for or recommending
    the purchase or order of any item or service for which payment may be made, in whole or in part, under a federal healthcare program
    such as Medicare and Medicaid. Liability may be established without a person or entity having actual knowledge of the federal Anti-Kickback
    Statute or specific intent to violate it. This statute has been interpreted to apply broadly to arrangements between pharmaceutical
    manufacturers on the one hand and prescribers, patients, purchasers and formulary managers on the other. In addition, the Affordable
    Care Act amended the Social Security Act to provide that the U.S. government may assert that a claim including items or services
    resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the federal
    civil False Claims Act. A conviction for violation of the Anti-kickback Statute requires mandatory exclusion from participation in
    federal health care programs. Although there are a number of statutory exemptions and regulatory safe harbors protecting certain
    common activities from prosecution, the exemptions and safe harbors are drawn narrowly, and those activities may be subject to scrutiny
    or penalty if they do not qualify for an exemption or safe harbor.</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
    federal civil False Claims Act, or FCA, prohibits, among other things, knowingly presenting, or causing to be presented claims for
    payment of government funds that are false or fraudulent, or knowingly making, using or causing to be made or used a false record
    or statement material to such a false or fraudulent claim, or knowingly concealing or knowingly and improperly avoiding, decreasing,
    or concealing an obligation to pay money to the federal government. This statute also permits a private individual acting as a &#8220;whistleblower&#8221;
    to bring actions on behalf of the federal government alleging violations of the FCA and to share in any monetary recovery. The FCA
    prohibits anyone from knowingly presenting, conspiring to present, making a false statement in order to present, or causing to be
    presented, for payment to federal programs (including Medicare and Medicaid) claims for items or services, including drugs, that
    are false or fraudulent, claims for items or services not provided as claimed, or claims for medically unnecessary items or services.
    This law also prohibits anyone from knowingly underpaying an obligation owed to a federal program. Increasingly, U.S. federal agencies
    are requiring nonmonetary remedial measures, such as corporate integrity agreements in FCA settlements. The U.S. Department of Justice
    announced in 2016 its intent to follow the &#8220;Yates Memo,&#8221; taking a far more aggressive approach in pursuing individuals
    as FCA defendants in addition to the corporations. FCA liability is potentially significant in the healthcare industry because the
    statute provides for treble damages and mandatory penalties assessed on a per false claim or statement basis. Government enforcement
    agencies and private whistleblowers have investigated pharmaceutical companies for or asserted liability under the FCA for a variety
    of alleged promotional and marketing activities, such as providing free product to customers with the expectation that the customers
    would bill federal programs for the product; providing consulting fees and other benefits to physicians to induce them to prescribe
    products; engaging in promotion for &#8220;off-label&#8221; uses; and submitting inflated best price information to the Medicaid
    Rebate Program.</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
    federal False Statements Statute prohibits knowingly and willfully falsifying, concealing, or covering up a material fact or making
    any materially false, fictitious or fraudulent statement or representation, or making or using any false writing or document knowing
    the same to contain any materially false, fictitious or fraudulent statement or entry, in connection with the delivery of or payment
    for healthcare benefits, items, or services.</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
    federal Civil Monetary Penalties Law authorizes the imposition of substantial civil monetary penalties against an entity, such as
    a pharmaceutical manufacturer, that engages in activities including, among others (1) knowingly presenting, or causing to be presented,
    a claim for services not provided as claimed or that is otherwise false or fraudulent in any way; (2) arranging for or contracting
    with an individual or entity that is excluded from participation in federal healthcare programs to provide items or services reimbursable
    by a federal healthcare program; (3) violations of the federal Anti-Kickback Statute; or (4) failing to report and return a known
    overpayment.</span></td></tr>
  </table>
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<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify; width: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
    federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, imposes criminal and civil liability for knowingly
    and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program, or knowingly and willfully
    falsifying, concealing or covering up a material fact or making any materially false statement in connection with the delivery of,
    or payment for, healthcare benefits, items or services; similar to the federal Anti-Kickback Statute, a person or entity does not
    need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation.</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">HIPAA,
    as amended by the Health Information Technology for Economic and Clinical Health Act (HITECH), which imposes requirements on certain
    types of people and entities relating to the privacy, security, and transmission of individually identifiable health information,
    requires notification to affected individuals and regulatory authorities of certain breaches of security of individually identifiable
    health information.</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
    federal Physician Payment Sunshine Act, which requires certain manufacturers of drugs, devices, biologics and medical supplies for
    which payment is available under Medicare, Medicaid, or the Children&#8217;s Health Insurance Program, to report annually to the
    Centers for Medicare &amp; Medicaid Services (CMS) information related to payments and other transfers of value to physicians (defined
    to include doctors, dentists, optometrists, podiatrists and chiropractors) and teaching hospitals, and ownership and investment interests
    held by physicians and other healthcare providers and their immediate family members, which is published in a searchable form on
    an annual basis. Effective January 1, 2022, covered manufacturers will also be required to report on payments and other transfers
    of value to physician assistants, nurse practitioners or clinical nurse specialists, anesthesiologist assistants, certified registered
    nurse anesthetists, and certified nurse-midwives during the previous year.</span></td></tr>
  </table>
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<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">State
    laws comparable to each of the above federal laws, such as, for example, anti-kickback and false claims laws that may be broader
    in scope and also apply to commercial insurers and other non-federal.</span></td></tr>
  </table>
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<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Payors
    requirements for mandatory corporate regulatory compliance programs, and laws relating to patient data privacy and security. Other
    state laws require pharmaceutical companies to comply with the pharmaceutical industry&#8217;s voluntary compliance guidelines and
    the relevant compliance guidance promulgated by the federal government; require drug manufacturers to report information related
    to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures; and state and foreign
    laws govern the privacy and security of health information in some circumstances, many of which differ from each other in significant
    ways and often are not preempted by HIPAA, thus complicating compliance efforts.</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
    the European Union, the General Data Protection Regulation, or GDPR,&#8212;Regulation EU 2016/679&#8212;was adopted in May 2016 and
    became applicable on May 25, 2018, or GDPR. The GDPR further harmonizes data protection requirements across the European Union member
    states by establishing new and expanded operational requirements for entities that collect, process or use personal data generated
    in the European Union, including consent requirements for disclosing the way personal information will be used, information retention
    requirements, and notification requirements in the event of a data breach.</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
    the United Kingdom, following the UK&#8217;s exit from the European Union on 31 December 2020, the GDPR continues to form part of
    the law in the UK with some amendments (UK GDPR). There is a risk of divergence in the future, which may increase our overall data
    protection compliance costs.</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
    California Consumer Privacy Act of 2018, or CCPA, effective as of January 1, 2020, gives California residents expanded rights to
    access and require deletion of their personal information, opt out of certain personal information sharing, and receive detailed
    information about how their personal information is used. The CCPA provides for civil penalties for violations, as well as a private
    right of action for data breaches, that is expected to increase data breach litigation.</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
    addition, failure to comply with the Israeli Privacy Protection Law of 1981, and its regulations, as well as the guidelines of the
    Israeli Privacy Protection Authority, may expose us to administrative fines, civil claims (including class actions) and in certain
    cases criminal liability. Current pending legislation may result in a change of the current enforcement measures and sanctions.</span></td></tr>
  </table>
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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">If
our operations are found to be in violation of any such health care laws and regulations, we may be subject to penalties, including significant
administrative, civil and criminal penalties, monetary damages, disgorgement, imprisonment, the curtailment or restructuring of our operations,
loss of eligibility to obtain approvals from the FDA or foreign regulatory authorities, or exclusion from participation in government
contracting, healthcare reimbursement or other government programs, including Medicare and Medicaid, any of which could adversely our
financial results. Any action against us for an alleged or suspected violation could cause us to incur significant legal expenses and
could divert our management&#8217;s attention from the operation of our business, even if our defense is successful. In addition, achieving
and sustaining compliance with applicable laws and regulations may be costly to us in terms of money, time and resources.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Our
employees, principal investigators, consultants, commercial partners or vendors may engage in misconduct or other improper activities,
including non-compliance with regulatory standards.</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
are also exposed to the risk of employees, independent contractors, principal investigators, consultants, commercial partners or vendors
engaging in fraud or other misconduct. Misconduct by employees, independent contractors, principal investigators, consultants, commercial
partners and vendors could include intentional failures to comply with EU or UK regulations, to provide accurate information to the EMA,
MHRA or EU Member States authorities or to comply with manufacturing or quality standards we have or will have established. In particular,
sales, marketing and business arrangements in the healthcare industry are subject to extensive laws and regulations intended to prevent
fraud, misconduct, kickbacks, self-dealing and other abusive practices such as promotion of products by medical practitioners. The EU
Member States in which we operate have different statutory provisions regulating the cooperation of pharmaceutical companies with healthcare
professionals. In addition to these statutory provisions, codes of conduct issued by business associations or other non-statutory standards
may be applicable to our activities. Both statutory provisions and non-statutory codes or standards restrict payments or other benefits
provided to healthcare professionals, and in case of non-compliance, may result in severe sanctions such as bans, administrative fines,
criminal fines or even imprisonment. The advertising of medicinal products for human use in the EU is regulated by Title VIII of European
Directive 2001/83/EC, as amended. These provisions have been implemented into the law of the EU member States. Such laws inter alia restrict
or prohibit a wide range of pricing, discounting, marketing and promotion, sales commission, customer incentive programs and other business
arrangements. Misconduct could also involve the improper use of information obtained in the course of clinical studies, which could result
in regulatory sanctions and serious and irreparable harm to our reputation.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">This
could also apply with respect to data privacy. In the EU (at that time including the United Kingdom), the EU Directive 95/46/EEC was
replaced by the GDPR on May 25, 2018. The GDPR as an EU regulation does not have to be implemented into Member States&#8217; national
law, but applies directly in all Member States since May 25, 2018. It applies to companies with an establishment in the European Economic
Area (EEA) and to certain other companies not in the EEA that offer or provide goods or services to individuals located in the EEA or
monitor individuals located in the EEA. The GDPR implements more stringent operational requirements for controllers of personal data,
including, for example, expanded disclosures about how personal information is to be used, limitations on retention of information, increased
requirements pertaining to health data and pseudonymized (i.e., key-coded) data, increased cyber security requirements, mandatory data
breach notification requirements and higher standards for controllers to demonstrate that they have obtained a valid legal basis for
certain data processing activities. The GDPR provides that EU Member States may continue to make their own further laws and regulations
in relation to the processing of genetic, biometric or health data, which could result in continued or new differences between Member
States, limit our ability to use and share personal data or could cause our costs to increase, and harm our business and financial condition.
The GDPR continues to form part of law in the United Kingdom with some amendments following the United Kingdom&#8217;s exit from the
European Union on 31 December 2020 (UK GDPR) although there is a risk of divergence in the future which may increase our overall data
protection compliance cost. We are also subject to evolving and strict rules on the transfer of personal data out of the European Union
and United Kingdom to the United States. Further prospective revision of the Directive on privacy and electronic communications (Directive
2002/58/EC, as amended), or ePrivacy Directive, and equivalent United Kingdom Legislation may affect our marketing communications.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
have implemented procedures to ensure compliance with the GDPR and UK GDPR and its requirements. Our actual or alleged failure to comply
with this regulation, or to protect personal data, could result in enforcement actions and significant penalties against us, which could
result in negative publicity, increase our operating costs, subject us to claims or other remedies and have a material adverse effect
on our business, financial condition, and results of operations. It is not always possible to identify and deter misconduct by employees
or other parties. The precautions we take to detect and prevent such activity may not protect us from legal or regulatory action resulting
from a failure to comply with applicable laws or regulations. Misconduct by our employees, principal investigators, consultants, commercial
partners or vendors could result in significant financial penalties, criminal sanctions, civil law claims and/or negative media coverage,
and thus have a material adverse effect on our business, including through the imposition of significant fines or other sanctions, and
our reputation. In particular, failure to comply with EU laws, including failure under the GDPR, UK GDPR, ePrivacy Directive and other
laws relating to the security of personal data may result in fines up to &#8364;20,000,000 or up to 4% of the total worldwide annual turnover
of the preceding financial year, if greater, and other administrative penalties including criminal liability, which may be onerous and
adversely affect our business, financial condition, results of operations and prospects. Failure to comply with the GDPR, UK GDPR and
related laws may also give risk to increase risk of private actions, including a new form of class action that is available under the
GDPR and UK GDPR.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>If
we or our manufacturers fail to comply with manufacturing regulations, our financial results and financial condition could be adversely
affected.</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Before
an NDA is approved, and before we begin the commercial manufacture of any product candidate, contract manufacturers must register with
FDA or foreign regulators undergo regulatory inspection of their manufacturing facilities, processes and quality systems. In addition,
pharmaceutical manufacturing facilities are subject to periodic inspection by the FDA and foreign regulatory authorities after product
approval. Due to the complexity of the processes used to manufacture pharmaceutical products and product candidates, any potential third-party
manufacturer may be unable to meet local, federal, or international regulatory requirements either at the outset or on an ongoing basis,
in a cost-effective manner, if at all.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
do not intend to engage in the manufacture of Aramchol or any other product candidate other than for pre-clinical and clinical studies,
but we or our materials suppliers may face manufacturing or quality control problems causing product production and shipment delays or
a situation where we or the supplier may not be able to maintain compliance with the FDA&#8217;s or foreign regulators&#8217; requirements
necessary to continue manufacturing Aramchol or any other product candidate. Drug manufacturers are subject to ongoing periodic unannounced
inspections by the FDA and corresponding foreign regulators to ensure continuing compliance with applicable requirements. Any failure
to comply with FDA or foreign regulatory requirements could adversely affect our clinical research activities and our ability to develop
and market Aramchol or any other product candidate.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">If
a third-party manufacturer with whom we contract is unable to comply with manufacturing requirements, we may be subject to fines, unanticipated
compliance expenses, recall or seizure of Aramchol or any other product candidate, total or partial suspension of production and/or enforcement
actions, including injunctions, and criminal or civil prosecution. These possible sanctions could adversely affect our financial results
and financial condition.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Our
market is subject to intense competition. If we are unable to compete effectively, Aramchol, Amilo-5MER or any other product candidate
that we develop may be rendered suboptimal, noncompetitive or obsolete.</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">There
are a number of products in development for our target indications, many of which are being developed by pharmaceutical companies that
are far larger than us, with significantly greater resources and more experience than us in all aspects of drug development and commercialization.
Further, our industry is highly competitive and subject to rapid and significant technological change. Our potential competitors include
large, fully-integrated pharmaceutical and biotechnology companies, specialty pharmaceutical and generic drug companies, academic institutions,
government agencies and research institutions. All of these competitors currently engage in, have engaged in or may engage in the future
in the development, manufacturing, marketing and commercialization of new pharmaceuticals, some of which may compete with Aramchol, Amilo-5MER
or other product candidates. Smaller or early stage companies may also prove to be significant competitors, particularly through collaborative
arrangements with large, established companies. These companies may have products in development that are superior to any Aramchol or
any other product candidate. Key competitive factors affecting the commercial success of Aramchol or any other product candidate that
we develop are likely to be efficacy, time of onset, safety and tolerability profile, reliability, convenience of dosing, price and reimbursement.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>


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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Many
of our potential competitors have substantially greater financial, technical and human resources than we do and significantly greater
experience in the discovery and development of drug candidates, obtaining FDA and other regulatory approvals of products and the commercialization
of those products. Accordingly, our competitors may be more successful than us in obtaining FDA and other marketing approvals for drugs
and achieving widespread market acceptance. Our competitors&#8217; drugs may be more effective, or more effectively marketed and sold,
than any drug we may commercialize and may render the product candidates that we develop suboptimal, obsolete or non-competitive before
we can recover the expenses of developing and commercializing the product. We anticipate that we will face intense and increasing competition
as new drugs enter the market and advanced technologies become available. Finally, the development of new treatment methods for the diseases
we are targeting could render Aramchol or any other product candidate that we develop, non-competitive or obsolete. If we cannot successfully
compete with new or existing products, our marketing and sales will suffer and we may never be profitable.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Our
competitors in the NASH field currently include companies with marketed
products and/or advanced clinical programs. Our main competitors of Aramchol include, but are not limited to Novo Nordisk, Akero Therapeutics,
Inc., Inc., Madrigal Pharmaceuticals Inc., and Viking Therapeutics among others. <span style="background-color: white">In March 2024,
Madrigal Pharmaceuticals announced FDA approval of Rezdiffra (resmetirom) for the treatment of NASH with moderate to advanced liver fibrosis.&#160;</span>
See also &#8220;Item 4. Information on the Company&#8212;Competition.&#8221; Moreover, several additional companies have reported the
commencement of research projects and proof-of-concept trials related to our target indications, including those mentioned in the preceding
sentence.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
operate in a competitive sector. Several companies are working on technologies, therapeutic targets or drug or biomarker candidates that
aim to treat or diagnose the same diseases or identify the same patient population as our product candidates. While we believe that our
drug candidates and diagnostic solutions, combined with our expertise and know-how, provide us with competitive advantages, we face potential
competition from various sources, including pharmaceutical and biotechnology companies, as well as from academic institutions, governmental
agencies and public and private research institutions. We anticipate that we will face intense and increasing competition as new drugs
and therapies enter the market and advanced technologies become available. In some indications, off-label use of non-approved drugs can
also be considered as competition.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>We
face potential product and other liability exposure, and, if claims are brought against us, we may incur substantial liability.</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Our
product candidates could cause adverse events. These adverse events may not be observed in clinical trials, but may nonetheless occur
in the future. If any of these adverse events occur, they may render Aramchol or any other product candidate ineffective or harmful in
some patients, and our sales would suffer, materially adversely affecting our business, financial conditions and results of operations.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
addition, potential adverse events caused by Aramchol or any other product candidate, could lead to product liability claims. Product
liability claims might be brought against us by consumers, healthcare providers or others coming into contact with Aramchol or any other
product candidate. If we cannot successfully defend ourselves against product liability claims, we could incur substantial liabilities.
In addition, regardless of merit or eventual outcome, product liability claims may result in, among other things:</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">decreased
    demand for our product candidate for which we obtain marketing approval;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">impairment
    of our business reputation and exposure to adverse publicity;</span></td></tr>
  </table>

<p style="margin-top: 0; margin-bottom: 0">&#160;</p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">increased
    warnings on product labels or other regulatory actions;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">withdrawal
    of clinical trial participants;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">costs
    of related litigation;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">distraction
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  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">substantial
    monetary awards to patients or other claimants;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">loss
    of revenue; and</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the
    inability to successfully commercialize any product candidates, for which we obtain marketing approval. </span></td></tr>
  </table>
<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.45in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">If
we are unable to obtain adequate insurance with respect to our clinical trials against and from any losses or claims from third parties,
our financial condition could be adversely affected in the event of uninsured or inadequately insured loss or damage. We may not be able
to obtain insurance policies on terms affordable to us that would adequately cover loss or claims by third parties. To the extent our
business suffers any losses or claims by third parties, which are not covered, or adequately covered, by insurance, our financial condition
may be materially adversely affected.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>If
product liability lawsuits are successfully brought against us, our insurance may be inadequate.</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
have obtained insurance coverage for our clinical trials in accordance with market standards and in compliance with applicable Israeli
law. However, our insurance coverage may not be sufficient to reimburse us for any expenses or losses we may suffer. Moreover, insurance
coverage is becoming increasingly expensive, and, in the future, we may not be able to maintain insurance coverage at a reasonable cost
or in sufficient amounts to protect us against losses due to liability. If and when we obtain marketing approval for any product candidate,
we intend to expand our insurance coverage to include the sale of commercial products; however, we may be unable to obtain this product
liability insurance on commercially reasonable terms. On occasion, large judgments have been awarded in class action lawsuits based on
drugs that had unanticipated side effects. The cost of any product liability litigation or other proceedings, even if resolved in our
favor, could be substantial. A successful product liability claim, or series of claims, brought against us could cause our share price
to decline and, if judgments exceed our insurance coverage, could decrease our cash and adversely affect our business.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
product liability insurance we will need to obtain in connection with the commercial sales of any product candidate, if and when they
receive regulatory approval, may be unavailable in meaningful amounts or at a reasonable cost. If we are the subject of a successful
product liability claim that exceeds the limits of any insurance coverage we obtain, we would incur substantial charges that would adversely
affect our earnings and require the commitment of capital resources that might otherwise be available for the development and commercial
launch of any product candidate&#8217;s programs.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; text-align: justify; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>We
manage our business through a small number of senior executive officers. We depend on them even more than similarly- situated companies.</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Because
of the specialized scientific and managerial nature of our business, we rely heavily on our ability to recruit, attract, retain, manage
and motivate qualified senior executive officers with adequate operational, scientific and technical experience. The loss of the services
of our senior executive officers, including our President, Chief Executive Officer, or the inability to hire or retain experienced management
personnel, could adversely affect our ability to execute our business plan and harm our operating results. In particular, the loss of
one or more of our senior executive officers could be detrimental to us if we cannot recruit suitable replacements in a timely manner.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
do not currently carry &#8220;key person&#8221; insurance on the lives of members of senior management. The competition for qualified
personnel in the pharmaceutical field is intense. Due to this intense competition, we may be unable to attract and retain qualified personnel
necessary for the development of our business or to recruit suitable replacement personnel. Additionally, our ability to effectively
recruit and retain qualified officers and directors could also be adversely affected if we experience difficulty in obtaining adequate
directors&#8217; and officers&#8217; liability insurance. We may be unable to maintain sufficient insurance as a public company to cover
liability claims made against our officers and directors. If we are unable to adequately insure our officers and directors, we may not
be able to retain or recruit qualified officers and directors to manage the Company.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>


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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>&#160;</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Failure
to build our finance infrastructure and improve our accounting systems and controls could impair our ability to comply with the financial
reporting and internal control requirements for publicly traded companies.</i></b></span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">As
a public company, we operate in an increasingly challenging regulatory environment which requires us to comply with the Sarbanes-Oxley
Act of 2002, or the Sarbanes-Oxley Act, and the related rules and regulations of the SEC and securities exchanges, expanded disclosures,
accelerated reporting requirements and more complex accounting rules. Company responsibilities required by the Sarbanes-Oxley Act include
establishing corporate oversight and adequate internal control over financial reporting and disclosure controls and procedures. Effective
internal controls are necessary for us to produce reliable financial reports and are important to help prevent financial fraud.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">We are subject to the requirements of the Sarbanes-Oxley Act. Section 404
of the Sarbanes-Oxley Act requires companies subject to the reporting requirements of the U.S. securities laws to do a comprehensive evaluation
of its and its subsidiaries&#8217; internal control over financial reporting. To comply with this statute, we must document and test our
internal control procedures and our management and issue a report concerning our internal control over financial reporting. In addition,
as long as we do not become an accelerated or large accelerated filer, we are exempt from the auditor attestation requirements of Section
404(b) of the Sarbanes-Oxley Act. Under this exemption, our auditor will not be required to attest to and report on our management&#8217;s
assessment of our internal control over financial reporting until the date we are no longer a non-accelerated filer. We have an ongoing program to perform the
system and process evaluation and testing necessary to continue to comply with these requirements. During the course of our review and
testing, we may identify deficiencies and be unable to remediate them before we must provide the required reports. Furthermore, if we
have a material weakness in our internal controls over financial reporting, we may not detect errors on a timely basis and our financial
statements may be materially misstated. We may not be able to conclude on an ongoing
basis that we have effective internal control over financial reporting, which could harm our operating results, cause investors to lose
confidence in our reported financial information and cause the trading price of our stock to fall.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">To
build our finance infrastructure, we may need to improve our accounting systems, disclosure policies, procedures and controls. If we
are unsuccessful in building an appropriate accounting infrastructure, we may not be able to prepare and disclose, in a timely manner,
our financial statements and other required disclosures, or comply with existing or new reporting requirements. Any failure to report
our financial results on an accurate and timely basis could result in sanctions, lawsuits, delisting of our shares from the Nasdaq Capital
Market or other adverse consequences that would materially harm our business. If we cannot provide reliable financial reports or prevent
fraud, our business and results of operations could be harmed and investors could lose confidence in our reported financial information.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>We
may need to significantly increase the size of our organization, and we may experience difficulties in managing growth.</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Subject
to our strategic review, we may experience rapid and substantial growth in order to achieve our operating plans, which will place a strain
on our human and capital resources. Successful implementation of our business plan will require management of growth, which will result
in an increase in the level of responsibility for management personnel. Any future growth will impose significant added responsibilities
on members of management, including the need to identify, recruit, maintain and integrate additional employees. To that end, we must
be able to, among other things:</span></p>

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<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
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  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
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  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
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    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">hire
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  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
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  </table>
<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>


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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">If
we are unable to establish, scale-up and implement improvements to our control systems in an efficient or timely manner, or if we encounter
deficiencies in existing systems and controls, investors may choose not to invest in us, which could cause our share price to decline
and negatively impact our ability to successfully commercialize Aramchol or any other product candidate.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Failure
to attract and retain sufficient numbers of talented employees will further strain our human resources and could impede our growth or
result in ineffective growth. If we are unable to manage our growth effectively, our losses could materially increase and it will have
a material adverse effect on our business, results of operations and financial condition.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Additional
clinical trials may divert a significant amount of our resources and may ultimately be unsuccessful.</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
are exploring the expansion of Aramchol for the treatment of other indications in order to expand our pipeline, commercial potential
and ultimately de-risk the Company for the success of any one given trial. If we initiate additional clinical trials, this may divert
a significant amount of Company resources and may be unsuccessful. The regulatory pathway may prove simpler than for NASH and as a result
this may shift the priorities for Aramchol in the future.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.45in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: white"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Environmental,
social and corporate governance (ESG) issues, including those related to climate change and sustainability, may have an adverse effect
on our business, financial condition and results of operations and damage our reputation.</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">There
is an increasing focus from certain investors, customers, consumers, employees and other stakeholders concerning ESG matters. Additionally,
public interest and legislative pressure related to public companies&#8217; ESG practices continue to grow. If our ESG practices fail
to meet regulatory requirements or investor, customer, consumer, employee or other shareholders&#8217; evolving expectations and standards
for responsible corporate citizenship in areas including environmental stewardship, support for local communities, Board of Director
and employee diversity, human capital management, employee health and safety practices, product quality, supply chain management, corporate
governance and transparency, our reputation, brand and employee retention may be negatively impacted, and our customers and suppliers
may be unwilling to continue to do business with us.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Customers,
consumers, investors and other shareholders are increasingly focusing on environmental issues, including climate change, energy and water
use, plastic waste and other sustainability concerns. Concern over climate change may result in new or increased legal and regulatory
requirements to reduce or mitigate impacts to the environment. Changing customer and consumer preferences or increased regulatory requirements
may result in increased demands or requirements regarding plastics and packaging materials, including single-use and non-recyclable plastic
products and packaging, other components of our products and their environmental impact on sustainability, or increased customer and
consumer concerns or perceptions (whether accurate or inaccurate) regarding the effects of substances present in certain of our products.
Complying with these demands or requirements could cause us to incur additional manufacturing, operating or product development costs.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">If
we do not adapt to or comply with new regulations, including the SEC&#8217;s newly adopted rules that require companies to provide expanded
climate-related disclosures in their periodic reporting, which may require us to incur significant additional costs to comply and impose
increased oversight obligations on our management and board of directors, or fail to meet evolving investor, industry or stakeholder
expectations and concerns regarding ESG issues, investors may reconsider their capital investment in our Company, we may become subject
to penalties, and customers and consumers may choose to stop purchasing our products, if approved for commercialization, which could
have a material adverse effect on our reputation, business or financial condition.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Our
business is subject to risks arising from epidemic diseases, such as the COVID-19 pandemic, which has impacted and could continue to
impact our business.</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Public
health epidemics or outbreaks could adversely impact our business. In late 2019, a novel strain of COVID-19, also known as coronavirus,
was reported in Wuhan, China. Initially the outbreak was largely concentrated in China, but it rapidly spread to countries across the
globe, including in Israel and the United States. Many countries around the world, including in Israel and the United States, implemented
significant governmental measures to control the spread of the virus, including temporary closure of businesses, severe restrictions
on travel and the movement of people, and other material limitations on the conduct of business. In response, we implemented remote working
and workplace protocols for our employees in accordance with Israeli Ministry of Health requirements to ensure employees safety, experienced
delays in recruitment to our ARMOR Study, and took several cost-reduction measures.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">If
there is a resurgence of COVID-19 its spread may materially affect us economically. While the potential economic impact brought by, and
the duration of, any future resurgence of the COVID-19 pandemic may be difficult to assess or predict, it has already caused, and could
result in further, significant disruption of global financial markets, reducing our ability to access capital, which could in the future
negatively affect our liquidity and financial position. In addition, the trading prices for other companies have been highly volatile
as a result of the COVID-19 pandemic. As a result, we may face difficulties raising capital through sales of our ordinary shares or other
securities and such sales may be on unfavorable terms. To the extent that future waves of COVID-19 disrupt normal business operations,
we may face operational challenges with our services, and we likely will have to adopt remote working and workplace protocols for employees
in accordance with government requirements and other measures to minimize such impact, and we may, subject to our strategic review, experience
disruptions that could impact our business, clinical trials, and supply chains.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
extent to which COVID-19 impacts our operations will depend on future developments, which are highly uncertain and cannot be predicted
with confidence, including the duration and severity of the outbreak, and the actions that may be required to contain COVID-19 or treat
its impact. In particular, the extent to which any resurgence of the COVID-19 pandemic may impact our business and financial performance
will depend on future developments, which are highly uncertain and cannot be predicted with confidence. The impact of any resurgence
of the COVID-19 pandemic may also have the effect of heightening many of the other risks described in the &#8220;Risk Factors&#8221;
section of this Annual Report on Form 20-F.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Risks
Related to Our Reliance on Third Parties</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>We
have no manufacturing capacity and anticipate reliance on third-party manufacturers for Aramchol, Amilo-5MER or any other product candidates.</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
do not currently operate manufacturing facilities for the production of Aramchol, Amilo-5MER or their API. We still have not, and may
never, develop facilities for the manufacture of product candidates or products for clinical trials or commercial purposes. We rely on
third-party manufacturers to produce bulk drug products required for our clinical trials. Our contract manufacturers have not completed
commercial development and validation processes of the Aramchol and Amilo-5Mer API and we have experienced delays in the development
of the Aramchol meglumine formulation. Drug product manufacturing processes may experience further difficulties and delays in production.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Additionally,
if our contract manufacturers and their facilities, as applicable, are not approved by the FDA, or other applicable regulatory authorities,
our commercial supply of the drug substance will be significantly delayed and may result in significant additional costs. We purchase
finished Aramchol from a third-party under a clinical supply agreement. If we will be required to change the finished product manufacturer,
we may encounter significant delay and likely significant additional cost.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">A
failure by our contract manufacturer to achieve and maintain high manufacturing standards, in accordance with applicable good manufacturing
practices and other applicable regulatory requirements could result in patient injury or death, product shortages, product recalls or
withdrawals, delays or failures in product testing or delivery, cost overruns or other problems that could seriously harm our business.
Contract manufacturers often encounter difficulties involving production yields, quality control and quality assurance, as well as shortages
of qualified personnel.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Our
existing manufacturers and any future contract manufacturers may not perform as agreed or may not remain in the contract manufacturing
business. In the event of a natural disaster, business failure, strike or other difficulty, we may be unable to replace a third-party
manufacturer in a timely manner and the production of our product candidates would be interrupted, resulting in delays and additional
costs.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>


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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>&#160;</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>We
intend to rely primarily on third parties to market and sell Aramchol, Amilo-5MER or any other product candidate.</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
have no sales or distribution capabilities. To the extent we rely on third parties to commercialize Aramchol, Amilo-5MER or any other
product candidate, if marketing approval is obtained, we may receive less revenue than if we commercialize them ourselves. In addition,
we would have less control over the sales efforts of any third parties involved in our commercialization efforts. In the event we are
unable to collaborate with a third-party marketing and sales organization to commercialize Aramchol, Amilo-5MER or any other product
candidate, particularly for broader patient populations, our ability to generate revenue will be limited.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Although
we may ultimately develop a marketing and sales force with technical expertise and supporting distribution capabilities in the longer
term, we do not currently intend to do so and, as such, we will be unable to market our product candidates directly in the near future.
To promote any of our potential products through third parties, we will have to locate acceptable third parties for these functions and
enter into agreements with them on acceptable terms, and we may not be able to do so. Any third-party arrangements we are able to enter
into may result in lower revenues than we could achieve by directly marketing and selling our potential products. In addition, to the
extent that we depend on third parties for marketing and distribution, any revenues we receive will depend upon the efforts of such third
parties, as well as the terms of our agreements with such third parties, which cannot be predicted in most cases at this time. As a result,
we might not be able to market and sell our product candidates in the United States or overseas, which would have a material adverse
effect on us.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Any
collaboration arrangements that we may enter into in the future may not be successful, which could adversely affect our ability to develop
and commercialize our current and potential other product candidates.</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
intend to seek collaboration arrangements with pharmaceutical or biotechnology companies for the continued development and commercialization
of our current and potential other product candidates. We will face, to the extent that we decide to enter into collaboration agreements,
significant competition in seeking appropriate collaborators. Moreover, collaboration arrangements are complex and time consuming to
negotiate, document and implement. We may not be successful in our efforts to establish and implement collaborations or other alternative
arrangements. The terms of any collaborations or other arrangements that we may establish may not be favorable to us.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Any
future collaborations that we enter into may not be successful. The success of our collaboration arrangements will depend heavily on
the efforts and activities of our collaborators. Collaborators generally have significant discretion in determining the efforts and resources
that they will apply to these collaborations. Disagreements between parties to a collaboration arrangement regarding clinical development
and commercialization matters can lead to delays in the development process or commercializing the applicable product candidate and,
in some cases, termination of the collaboration arrangement. These disagreements can be difficult to resolve if neither of the parties
has final decision making authority. Moreover, collaborations with pharmaceutical or biotechnology companies and other third parties
are often terminated or allowed to expire by the other party. Any lack of effort or ability by our collaborators or any such disagreement,
termination or expiration could adversely affect us financially and could harm our business reputation.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>We
depend on third parties to conduct our clinical trials.</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
rely on third parties, such as contract research organizations, medical institutions, clinical investigators and contract laboratories
to oversee most of the operations of our clinical trials and to perform data collection and analysis. As a result, we may face additional
delays outside of our control if these parties do not perform their obligations in a timely fashion or in accordance with regulatory
requirements. If these third parties do not successfully carry out their contractual duties or obligations and meet expected deadlines,
if they need to be replaced, or if the quality or accuracy of the clinical data they obtain is compromised due to the failure to adhere
to our clinical protocols or for other reasons, our financial results and the commercial prospects for Aramchol, Amilo-5MER or any other
product candidate could be harmed, our costs could increase and our ability to obtain regulatory approval and commence product sales
could be delayed.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>


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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>&#160;</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Risks
Related to Our Intellectual Property</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>The
failure to obtain or maintain patents, licensing agreements and other intellectual property rights that are sufficiently broad and protective
could impact our ability to compete effectively.</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">To
compete effectively, we must develop and maintain a proprietary position with regard to our own technologies, intellectual property,
licensing agreements, product candidates and business. Legal standards relating to the validity and scope of claims in the biotechnology
and biopharmaceutical fields are still evolving. We cannot predict the scope and extent of patent protection for Aramchol, Amilo-5MER
or any other product candidate because the patent positions of pharmaceutical products are complex and uncertain. Therefore, the degree
of future protection for our proprietary rights in our core technologies and any product candidates or products that might be developed
using these technologies is also uncertain. The risks and uncertainties that we face with respect to our patents and other proprietary
rights include, but are not limited to, the following:</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">while
    the patents we own have been issued, pending patent applications we have filed may not result in issued patents or may take longer
    than we expect to result in issued patents;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">we
    may be subject to interference, reexamination, inter pares review, or post-grant review proceedings in the U.S.;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">we
    may be subject to opposition proceedings in certain foreign countries;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">any
    patents that are issued may not provide meaningful protection for any significant period of time, if at all;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">any
    issued patents may not be broad or strong enough to prevent competition from other products including identical or similar products;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">we
    may not be able to develop additional proprietary technologies that are patentable;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">there
    may be prior art of which we are not aware that may affect the validity or enforceability of a patent claim;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">there
    may be other patents or pending patent applications existing in the patent landscape that will affect our freedom to operate for
    our product candidates;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">other
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  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">a
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  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">other
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  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">other
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  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">if
    we are not awarded patents or if issued patents expire or are declared invalid or not infringed, there may be no protections against
    competitors making generic equivalents;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">enforcement
    of patents is complex, uncertain and expensive, and our patents may be found invalid or enforceable;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">our
    patents could irretrievably lapse due to failure to pay fees or otherwise comply with regulations, or could be subject to compulsory
    licensing; and</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">if
    we encounter delays in our development or clinical trials, the period of time during which we could market our product candidates
    under patent protection would be reduced.</span></td></tr>
  </table>
<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>


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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
cannot be certain that patents will be issued as a result of any of our pending applications, and we cannot be certain that any of our
issued patents, whether issued pursuant to our pending applications or licensed from third parties, will give us adequate protection
from competing products. For example, issued patents may be circumvented or challenged, declared invalid or unenforceable, or narrowed
in scope. In addition, because publication of discoveries in the scientific or patent literature often lags behind actual discoveries,
we cannot be certain that we were the first to make our inventions or to file patent applications covering those inventions. If any of
our composition of matter patents, or pending applications, was subject to a successful challenge or failed to issue, our business and
competitive advantage could be significantly affected. Our current patents will expire or they may otherwise cease to provide meaningful
competitive advantage, and we may be unable to adequately develop new technologies and obtain future patent protection to preserve our
competitive advantage or avoid adverse effects on our business.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Subject
to our strategic review, we plan to transition from Aramchol free acid to Aramchol meglumine (salt) in our double-blind, placebo-controlled
histology-based registrational part of the ARMOR Study and any other clinical trials of Aramchol. As part of our research and development
studies, we have confirmed that several Aramchol salts have improved solubility as compared to the existing form of Aramchol free acid.
We have pending patent applications and have been granted patents directed to composition of matter of Aramchol meglumine as well as
a wide range of other salts.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">There
can be no assurance that the U.S. Patent and Trademark Office, or the USPTO, or any other foreign equivalent will issue any additional
patents based on the patent applications that we submitted to protect our Aramchol salts or Amilo-5MER, nor, should the USPTO or foreign
equivalent issue any patents to us with respect to the Aramchol salts or Amilo-5MER, that we will be provided with adequate protection
against potentially competitive products. Furthermore, if foreign equivalent issues us one or more patents for the Aramchol salts or
Amilo-5MER or with respect to already issued patents for the Aramchol salts or Amilo-5MER, there can be no assurance that the issued
patents will be of any commercial value, or that private parties or competitors will not successfully challenge these patents or circumvent
these patents in the United States or their counterparts abroad. In the absence of adequate patent protection, our business may be adversely
affected by competitors who develop comparable technology or products and our commercial prospects may be materially adversely affected.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Others
may obtain issued patents that could prevent us from commercializing our product candidates or require us to obtain licenses requiring
the payment of significant fees or royalties in order to enable us to conduct our business. As to those patents that we have licensed,
our rights depend on maintaining our obligations to the licensor under the applicable license agreement, and we may be unable to do so.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
addition to patents and patent applications, we depend upon trade secrets and proprietary know-how to protect our proprietary technology.
We require our employees, consultants, advisors and collaborators to enter into confidentiality agreements that prohibit the disclosure
of confidential information to any other parties. We also require our employees and consultants to disclose and assign to us their ideas,
developments, discoveries and inventions. These agreements may not, however, provide adequate protection for our trade secrets, know-how
or other proprietary information in the event of any unauthorized use or disclosure.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Patent
terms may be inadequate to protect our competitive position on our product candidates for an adequate amount of time.</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Patents
have a limited lifespan. In the United States, if all maintenance fees are timely paid, the natural expiration of a patent is generally
20 years from the PCT application. Various extensions may be available, but the life of a patent, and the protection it affords, is limited.
Even if patents covering our product candidates are obtained, once the patent life has expired, we may be open to competition from competitive
products, including generics or biosimilars. Given the amount of time required for the development, testing and regulatory review of
new product candidates, patents protecting such candidates might expire before or shortly after such candidates are commercialized. As
a result, our owned and licensed patent portfolio may not provide us with sufficient rights to exclude others from commercializing products
similar or identical to ours.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>


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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>&#160;</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>We
may not be able to enforce our intellectual property rights throughout the world. This risk is exacerbated for us because we expect Aramchol
or Aramchol meglumine and Amilo-5MER will be manufactured and used in a number of foreign countries.</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
laws of some foreign countries do not protect intellectual property rights to the same extent as the laws of the United States. Many
companies have encountered significant problems in protecting and defending intellectual property rights in certain foreign jurisdictions.
This risk is exacerbated for us because we expect Aramchol or Amilo-5MER will be manufactured and used in a number of foreign countries.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
legal systems of some countries, particularly developing countries, do not favor the enforcement of patents and other intellectual property
protection, especially those relating to life sciences. This could make it difficult for us to stop the infringement of our other intellectual
property rights. For example, several foreign countries have compulsory licensing laws under which a patent owner must grant licenses
to third parties. In addition, some countries limit the enforceability of patents against third parties, including government agencies
or government contractors. In these countries, patents may provide limited or no benefit.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Although
most jurisdictions in which the Company has applied for, intends to apply for, or has been issued patents have patent protection laws
similar to those of the United States, some of them do not. For example, the Company expects to do business in South America, Eurasia,
China and Indochina in the future and the countries in these regions may not provide the same or similar protection as that provided
in the United States.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Proceedings
to enforce our patent rights in foreign jurisdictions could result in substantial costs and divert our efforts and attention from other
aspects of our business. Accordingly, our efforts to protect our intellectual property rights in such countries may be inadequate. In
addition, changes in the law and legal decisions by courts in the United States and foreign countries may affect our ability to obtain
adequate protection for our technology and the enforcement of intellectual property.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>We
may rely on third party patents</i></b><i>.</i></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
may not have rights under some patents or patent applications related to products we may commercialize in the future. Third parties may
own or control these patents and patent applications in the United States and abroad. Therefore, in some cases, to manufacture, sell
or import some of our future products, we or our collaborators may choose to seek, or be required to seek, licenses under third party
patents issued in the United States and abroad or under patents that might be issued from United States and foreign patent applications.
In instances in which we must obtain a license for third party patents, we may be required to pay license fees or royalties or both to
the licensor. If licenses are not available to us on acceptable terms, we or our collaborators may not be able to develop, manufacture,
sell or import these products.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>We
may be unable to protect the intellectual property rights of third parties from whom we may license certain of our intellectual property
or with whom we have entered into other strategic relationships, which could have a material adverse effect on our business, results
of operations and financial condition.</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Certain
of our intellectual property rights may be licensed from third parties, including universities and strategic partners. Such third parties
may determine not to or fail to protect the intellectual property rights that we license from them and we may be unable to defend such
intellectual property rights on our own or we may have to undertake costly litigation to defend the intellectual property rights of such
third parties. There can be no assurances that we will continue to have proprietary rights to any of the intellectual property that we
license from such third parties or otherwise have the right to use through similar strategic relationships. Any loss or limitations on
use with respect to such intellectual property licensed from third parties or otherwise obtained from third parties with whom we have
entered into strategic relationships could have a material adverse effect on our business, results of operations and financial condition.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>


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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>&#160;</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>If
we fail to comply with our obligations in the agreements under which we license intellectual property rights from third parties or otherwise
experience disruptions to our business relationships with our licensors, we could lose intellectual property rights that are important
to our business.</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
may be party to license agreements with third parties and may need to obtain additional licenses from others to advance our research
and development activities or allow the commercialization product candidates we may identify and pursue. License agreements may impose
various development, diligence, commercialization, and other obligations on us. For example, we may be required to use commercially reasonable
efforts to engage in various development and commercialization activities with respect to licensed products, and satisfy specified milestone
and royalty payment obligations. In spite of our efforts, our licensors might conclude that we have materially breached our obligations
under such license agreements and might therefore terminate the license agreements, thereby removing or limiting our ability to develop
and commercialize products and technology covered by these license agreements. If these in-licenses are terminated, or if the underlying
patents fail to provide the intended exclusivity, competitors or other third parties would have the freedom to seek regulatory approval
of, and to market, products identical to ours and we may be required to cease our development and commercialization of product candidates
that we may identify. Any of the foregoing could have a material adverse effect on our competitive position, business, financial conditions,
results of operations, and prospects. Moreover, disputes may arise regarding intellectual property subject to a licensing agreement,
including:</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the
    scope of rights granted under the license agreement and other interpretation-related issues;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the
    extent to which our product candidates, technology and processes infringe on intellectual property of the licensor that is not subject
    to the licensing agreement;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
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    sublicensing of patent and other rights under our collaborative development relationships;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">our
    diligence obligations under the license agreement and what activities satisfy those diligence obligations;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the
    inventorship and ownership of inventions and know-how resulting from the joint creation or use of intellectual property by our licensors
    and us and our partners; and</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the
    priority of invention of patented technology. In addition, the agreements under which we currently or in the future license intellectual
    property or technology from third parties are complex, and certain provisions in such agreements may be susceptible to multiple interpretations.
    The resolution of any contract interpretation disagreement that may arise could narrow what we believe to be the scope of our rights
    to the relevant intellectual property or technology, or increase what we believe to be our financial or other obligations under the
    relevant agreement, either of which could have a material adverse effect on our business, financial condition, results of operations,
    and prospects. Moreover, if disputes over intellectual property that we have licensed prevent or impair our ability to maintain our
    current licensing arrangements on commercially acceptable terms, we may be unable to successfully develop and commercialize the affected
    product candidates, which could have a material adverse effect on our business, financial conditions, results of operations, and
    prospects.</span></td></tr>
  </table>
<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>We
may infringe the intellectual property rights of others, which may prevent or delay our product development efforts and stop us from
commercializing, or increase the costs of commercializing, Aramchol or Amilo-5MER or any other product candidate.</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Our
commercial success depends significantly on our ability to operate without infringing the patents and other intellectual property rights
of third parties. For example, there could be issued patents of which we are not aware that our product candidate infringes. There also
could be patents that we believe we do not infringe, but that we may ultimately be found to infringe. Moreover, patent applications are
in some cases maintained in secrecy until patents are issued. The publication of discoveries in the scientific or patent literature frequently
occurs substantially later than the date on which the underlying discoveries were made and patent applications were filed. Because patents
can take many years to issue, there may be currently pending applications of which we are unaware that may later result in issued patents
that our product candidates infringe. For example, pending applications may exist that provide support or can be amended to provide support
for a claim that results in an issued patent that our product candidates infringes.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>


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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Third
parties may assert that we are employing their proprietary technology without authorization. If a court held that any third-party patents
are valid, enforceable and cover any of our product candidates or their use, the holders of any of these patents may be able to block
our ability to commercialize any such product candidate unless we obtained a license under the applicable patents, or until the patents
expire. In addition to litigation proceedings which may be filed against us, we may not be able to enter into licensing arrangements
or make other arrangements at a reasonable cost or on reasonable terms. Any inability to secure licenses or alternative technology could
result in delays in the introduction of our product candidates or lead to prohibition of the manufacture or sale of products by us.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>We
may become involved in lawsuits to protect or enforce our patents or other intellectual property, which could be expensive, time consuming
and unsuccessful.</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Competitors
may infringe our patents or other intellectual property. Although we are not currently involved in any litigation, if we were to initiate
legal proceedings against a third party to enforce a patent covering our product candidates, the defendant could counterclaim that the
patent covering our product candidate is invalid and/or unenforceable. In patent litigation in the United States, defendant counterclaims
alleging invalidity and/or unenforceability are commonplace. Grounds for a validity challenge could be an alleged failure to meet any
of several statutory requirements, including lack of novelty, obviousness, written description or non-enablement. Grounds for an unenforceability
assertion could be an allegation that someone connected with prosecution of the patent withheld relevant information from the USPTO,
or made a misleading statement, during prosecution. The outcome following legal assertions of invalidity and unenforceability is unpredictable.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Interference
or derivation proceedings provoked by third parties or brought by us or declared by the USPTO may be necessary to determine the priority
of inventions with respect to our patents or patent applications. An unfavorable outcome could require us to cease using the related
technology or to attempt to license rights to it from the prevailing party. Our business could be harmed if the prevailing party does
not offer us a license on commercially reasonable terms or at all, or if a non-exclusive license is offered and our competitors gain
access to the same technology. Our defense of litigation or interference or derivation proceedings may fail and, even if successful,
may result in substantial costs and distract our management and other employees. In addition, the uncertainties associated with litigation
could have a material adverse effect on our ability to raise the funds necessary to continue our clinical trials, continue our research
programs, license necessary technology from third parties, or enter into development partnerships that would help us bring our product
candidates to market.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Furthermore,
because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some
of our confidential information could be compromised by disclosure during this type of litigation. There could also be public announcements
of the results of hearings, motions, or other interim proceedings or developments. If securities analysts or investors perceive these
results to be negative, it could have a material adverse effect on the price of our ordinary shares.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>We
may be unable to adequately prevent disclosure and unauthorized use of trade secrets and other proprietary information by third parties.</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Our
ability to obtain and maintain patent protection and trade secret protection for our intellectual property and proprietary technologies,
our product candidates and their uses is important to our commercial success. We rely on a combination of patent, copyright, trademark
and trade secret laws, non-disclosure and confidentiality agreements, licenses, assignment of inventions agreements and other restrictions
on disclosure and use to protect our intellectual property rights.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
also rely on trade secrets to protect our proprietary know-how and technological advances, especially where we do not believe patent
protection is appropriate or obtainable. However, trade secrets are difficult to protect. We rely in part on confidentiality agreements
with our employees, consultants, outside scientific collaborators, sponsored researchers and other advisors to protect our trade secrets
and other proprietary information. These agreements may not effectively prevent disclosure of confidential information and may not provide
an adequate remedy in the event of unauthorized disclosure of confidential information. In addition, others may independently discover
our trade secrets and proprietary information. Costly and time-consuming litigation could be necessary to enforce and determine the scope
of our proprietary rights. Failure to obtain or maintain trade secret protection could enable competitors to use our proprietary information
to develop products that compete with our product candidates or cause additional material adverse effects upon our competitive business
position.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>


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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
cannot be certain that the steps that we have taken will prevent the misappropriation or other violation of our confidential information
and other intellectual property, particularly in foreign countries in which laws may not protect our proprietary rights as fully as in
the United States and other developed economies. Moreover, if we lose any key personnel, we may not be able to prevent the unauthorized
disclosure or use of our technical knowledge or other trade secrets by those former employees. If we are unable to maintain the security
of our proprietary technology, this could materially adversely affect our competitive advantage, business and results of operations.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Under
applicable U.S. and Israeli law, we may not be able to enforce covenants not to compete and therefore may be unable to prevent our competitors
from benefiting from the expertise of some of our former employees. In addition, employees may be entitled to seek compensation for their
inventions irrespective of their agreements with us, which in turn could impact our future profitability.</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
generally enter into non-competition agreements with our employees and certain key consultants, or our employment and consulting agreements
contain non-competition provisions. These agreements, to the extent they are in place and in effect, prohibit our employees and certain
key consultants, if they cease working for us, from competing directly with us or working for our competitors or clients for a limited
period of time. We may be unable to enforce these agreements under the laws of the jurisdictions in which our employees work and it may
be difficult for us to restrict our competitors from benefitting from the expertise our former employees or consultants developed while
working for us. For example, Israeli courts have required employers seeking to enforce non-compete undertakings of a former employee
to demonstrate that the competitive activities of the former employee will harm one of a limited number of material interests of the
employer which have been recognized by the courts, such as the secrecy of a company&#8217;s confidential commercial information or the
protection of its intellectual property. If we cannot demonstrate that such interests will be harmed, we may be unable to prevent our
competitors from benefiting from the expertise of our former employees or consultants and our ability to remain competitive may be diminished.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
addition, under the Israeli Patent Law, 5727-1967, or the Patent Law, inventions conceived by an employee in the course and as a result
of or arising from his or her employment with a company are regarded as &#8220;service inventions,&#8221; which belong to the employer,
absent a specific agreement between the employee and employer giving the employee service invention rights. The Patent Law also provides
that if there is no such agreement between an employer and an employee, the Israeli Compensation and Royalties Committee, or the Committee,
a body constituted under the Patent Law, shall determine whether the employee is entitled to remuneration for his or her inventions.
Case law clarifies that the right to receive consideration for &#8220;service inventions&#8221; can be waived by the employee and that
in certain circumstances, such waiver does not necessarily have to be explicit. The Committee will examine, on a case-by-case basis,
the general contractual framework between the parties, using interpretation rules of the general Israeli contract laws. Further, the
Committee has not yet determined one specific formula for calculating this remuneration, but rather uses the criteria specified in the
Patent Law. Although we generally enter into assignment-of-invention agreements with our employees pursuant to which such individuals
assign to us all rights to any inventions created in the scope of their employment or engagement with us, we may face claims demanding
remuneration in consideration for assigned inventions. As a consequence of such claims, we could be required to pay additional remuneration
or royalties to our current and/or former employees, or be forced to litigate such claims, which could negatively affect our business.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Any
lawsuits relating to infringement of intellectual property rights necessary to defend ourselves or enforce our rights will be costly
and time consuming.</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
may be required to initiate litigation to enforce our rights or defend our activities in response to alleged infringement of a third-party.
In addition, we may be sued by others who hold intellectual property rights and who claim that their rights are infringed by our product
candidates. These lawsuits can be very time consuming and costly. There is a substantial amount of litigation involving patent and other
intellectual property rights in the biotechnology and pharmaceutical industries generally.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">A
third-party may claim that we are using inventions claimed by their patents and may go to court to stop us from engaging in our normal
operations and activities, such as research, development, and the sale of any future products. Such lawsuits are expensive and would
consume time and other resources. There is a risk that such court will decide that we are infringing the third-party&#8217;s patents
and will order us to stop the activities claimed by the patents, redesign our products or processes to avoid infringement or obtain licenses,
which may not be available on commercially reasonable terms. In addition, there is a risk that a court will order us to pay the other
party damages for infringement.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>


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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Moreover,
there is no guarantee that any prevailing patent owner would offer us a license so that we could continue to engage in activities claimed
by the patent, or that such a license, if made available to us, could be acquired on commercially acceptable terms. In addition, third
parties may, in the future, assert other intellectual property infringement claims against us with respect to other product candidates,
technologies or other matters.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
addition, our patents and patent applications could face challenges. Any of these challenges, if successful, could result in the invalidation
of, or in a narrowing of the scope of, any of our patents and patent applications subject to challenge. Any of these challenges, regardless
of their success, would likely be time consuming and expensive to defend and resolve and would divert our management&#8217;s time and
attention.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Changes
in patent law could diminish the value of patents in general, thereby impairing our ability to protect Aramchol, Amilo-5MER or any other
product candidate.</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">As
is the case with other pharmaceutical companies, our success is heavily dependent on intellectual property, particularly patents. Obtaining
and enforcing patents in the biopharmaceutical industry involve both technological and legal complexity. Therefore, obtaining and enforcing
pharmaceutical patents is costly, time-consuming, and inherently uncertain. In particular, the United States has recently enacted, and
is currently implementing, wide-ranging patent reform legislation. The United States Supreme Court has ruled on several patent cases
in recent years, and could do so again in the future, either narrowing the scope of patent protection available in certain circumstances
or weakening the rights of patent owners in certain situations. In addition to increasing uncertainty regarding our ability to obtain
patents in the future, this combination of events has created uncertainty with respect to the value of patents, once obtained. Depending
on decisions by applicable courts and legislatures in the countries in which we may pursue patent protection, including those of the
U.S. Congress, the federal courts and the USPTO, the laws and regulations governing patents and the interpretations of such laws could
change in unpredictable ways that would weaken our ability to obtain new patents or to enforce our existing patents and patents that
we might obtain in the future.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Obtaining
and maintaining our patent protection depends on compliance with various procedural, documentary, fee payment and other requirements
imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
USPTO and various foreign governmental patent agencies require compliance with a number of procedural, documentary, fee payment and other
provisions during the patent process. There are situations in which noncompliance can result in abandonment or lapse of a patent or patent
application, resulting in partial or complete loss of patent rights in the relevant jurisdiction. In such an event, competitors might
be able to enter the market earlier than would otherwise have been the case.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Risks
Related to Ownership of Our Ordinary Shares</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Our
business, operating results and growth rates may be adversely affected by current or future unfavorable economic and market conditions
and adverse developments with respect to financial institutions and associated liquidity risk. </i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Our
business depends on the economic health of the global economies. If the conditions in the global economies remain uncertain or continue
to be volatile, or if they deteriorate, including as a result of the impact of military conflict, such as the war between Russia and
Ukraine, terrorism or other geopolitical events, our business, operating results and financial condition may be materially adversely
affected.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
addition, increases in inflation raise our costs for commodities, labor, materials and services and other costs required to grow and
operate our business, and failure to secure these on reasonable terms may adversely impact our financial condition. Additionally, increases
in inflation, along with the uncertainties surrounding any resurgence of the COVID-19, geopolitical developments and global supply chain
disruptions, have caused, and may in the future cause, global economic uncertainty and uncertainty about the interest rate environment,
which may make it more difficult, costly or dilutive for us to secure additional financing. A failure to adequately respond to these
risks could have a material adverse impact on our financial condition, results of operations or cash flows.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>


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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">There
can be no assurance that future credit and financial market instability and a deterioration in confidence in economic conditions will
not occur. Our general business strategy may be adversely affected by any such economic downturn, liquidity shortages, volatile business
environment or continued unpredictable and unstable market conditions. If the current equity and credit markets deteriorate, or if adverse
developments are experienced by financial institutions, it may cause short-term liquidity risk and also make any necessary debt or equity
financing more difficult, more costly, more onerous with respect to financial and operating covenants and more dilutive. Failure to secure
any necessary financing in a timely manner and on favorable terms could have a material adverse effect on our growth strategy, financial
performance and stock price and could require us to alter our operating plans. In addition, there is a risk that one or more of our service
providers, financial institutions, manufacturers, suppliers and other partners may be adversely affected by the foregoing risks, which
could directly affect our ability to attain our operating goals on schedule and on budget.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>The
market price of our ordinary shares is volatile and you may sustain a complete loss of your investment</i></b><i>.</i></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Since
our initial public offering, the trading price of our ordinary shares has been volatile and is likely to continue to be volatile. In
addition, the trading volume is and has been volatile and oftentimes relatively illiquid. The following factors, some of which are beyond
our control, in addition to other risk factors described in this section, may have a significant impact on the market price and trading
volume of our ordinary shares:</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the
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  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
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    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">delays
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  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">inability
    to obtain the approvals necessary to commence further clinical trials; </span></td></tr>
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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; width: 48px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 48px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">unsatisfactory
    or inconclusive results of clinical trials;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">termination
    of clinical trials;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
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  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
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  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">announcements
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  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">adverse
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  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
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  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
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  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
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  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
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  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
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  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
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    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
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  </table>
<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>


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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; width: 48px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
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  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
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    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">legislation
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    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
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    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">announcements
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  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
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    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
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  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
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    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
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  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
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  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
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    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
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    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">variations
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  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
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  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">developments
    by our licensees, if any;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">future
    issuances of ordinary shares or other securities; and</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">natural
    disasters and political and economic instability, including wars, terrorism, political unrest, results of certain elections and votes,
    emergence of a pandemic, or other widespread health emergencies (or concerns over the possibility of such an emergency), boycotts,
    adoption or expansion of government trade restrictions, and other business restrictions.</span></td></tr>
  </table>
<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">These
factors and any corresponding price fluctuations may materially and adversely affect the market price and trading volume of our ordinary
shares and result in substantial losses by our investors.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
addition, the stock market in general, and the Nasdaq Capital Market and the market for biotechnology companies in particular, have experienced
extreme price and volume fluctuations that have often been unrelated or disproportionate to the operating performance of our Company
and that of small companies. Broad market and industry factors may negatively affect the market price of our ordinary shares, regardless
of our actual operating performance. Further, a systemic decline in the financial markets and related factors beyond our control may
cause our share price to decline rapidly and unexpectedly. Price volatility of our ordinary shares might be worse if the trading volume
of our ordinary shares is low. Following periods of market volatility or a material decrease in the value of our ordinary shares, shareholders
may institute securities class action litigation. If we were involved in securities litigation, it could have a substantial cost and
divert resources and attention of management from our business, even if we are successful. Future sales of our ordinary shares could
also reduce the market price of such stock. Any adverse determination in litigation could also subject us to significant liabilities.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Moreover,
the liquidity of our ordinary shares has been limited, not only in terms of the number of shares that can be bought and sold at a given
price, but by delays in the timing of transactions and reduction in security analysts&#8217; and the media&#8217;s coverage of us, if
any. These factors may result in lower prices for our ordinary shares than might otherwise be obtained and could also result in a larger
spread between the bid and ask prices for our ordinary shares. In addition, without a large float, our ordinary shares are less liquid
than the stock of companies with broader public ownership and, as a result, the trading prices of our ordinary shares are more volatile.
In the absence of an active public trading market, an investor may be unable to liquidate its investment in our ordinary shares. Trading
of a relatively small volume of our ordinary shares may have a greater impact on the trading price of our stock than would be the case
if our public float were larger. We cannot predict the prices at which our ordinary shares will trade in the future.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>


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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>&#160;</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>If
we fail to comply with the continued listing requirements of the Nasdaq Capital Market, our ordinary shares may be delisted and the price
of our ordinary shares and our ability to access the capital markets could be negatively impacted</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Our
ordinary shares are listed on the Nasdaq Capital Market. As such, we are required to meet the continued listing requirements of the Nasdaq
Capital Market and other Nasdaq rules, including those regarding director independence and independent committee requirements, minimum
shareholders&#8217; equity, minimum share price and certain other corporate governance requirements. In particular, we are required to
maintain a minimum bid price for our listed ordinary shares of $1.00 per share.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">On
September 19, 2023, we were notified by the Nasdaq Stock Market, LLC, or Nasdaq, that we were not in compliance with the minimum bid
price requirements set forth in Nasdaq Listing Rule 5550(a)(2) for continued listing on the Nasdaq Capital Market. Nasdaq Listing Rule
5550(a)(2) requires listed securities to maintain a minimum bid price of $1.00 per share, and Nasdaq Listing Rule 5810(c)(3)(A) provides
that a failure to meet the minimum bid price requirement exists if the deficiency continues for a period of 30 consecutive business days.
The notification provided that we had 180 calendar days, or until March 18, 2024, to regain compliance with Nasdaq Listing Rule 5550(a)(2).
To regain compliance, the bid price of our ordinary shares must have a closing bid price of at least $1.00 per share for a minimum of
10 consecutive business days. Since we did not regain compliance by March 18, 2024, we requested and received from The Nasdaq Capital
Market an additional 180 calendar days or until September 16, 2024 to comply with the minimum bid price. If we fail to regain compliance
during the second compliance period, then Nasdaq will notify us of its determination to delist our ordinary shares, at which point we
will have an opportunity to appeal the delisting determination to a Hearings Panel. No assurance can be given that we will be able to
regain compliance with the Rule. If we do not meet these or other continued listing requirements, our ordinary shares could be delisted.
A delisting of our ordinary shares from Nasdaq could materially reduce the liquidity of our ordinary shares and result in a corresponding
material reduction in the price of our ordinary shares. In addition, delisting could harm our ability to raise capital through alternative
financing sources on terms acceptable to us, or at all, and may result in the potential loss of confidence by investors, employees and
fewer business development opportunities and strategic alternatives. No assurance can be given that we will be able to regain compliance
with the Rule. If we do not meet these or other continued listing requirements, our ordinary shares could be delisted. Delisting of our
ordinary shares from the Nasdaq Capital Market would cause us to pursue eligibility for trading on other markets or exchanges, or on
the pink sheets. In such case, our shareholders&#8217; ability to trade, or obtain quotations of the market value of, our ordinary shares
would be severely limited because of lower trading volumes and transaction delays. These factors could contribute to lower prices and
larger spreads in the bid and ask prices for our securities. There can be no assurance that our ordinary shares, if delisted from the
Nasdaq Capital Market in the future, would be listed on a national securities exchange, a national quotation service, the Over-The-Counter
Markets or the pink sheets. Delisting from the Nasdaq Capital Market, or even the issuance of a notice of potential delisting, would
also result in negative publicity, make it more difficult for us to raise additional capital, adversely affect the market liquidity of
our ordinary shares, reduce security analysts&#8217; coverage of us and diminish investor, supplier and employee confidence. Additionally,
the threat of delisting or a delisting of our ordinary shares from the Nasdaq Capital Market, could reduce the number of investors willing
to hold or acquire our ordinary shares, thereby further restricting our ability to obtain equity financing, and it could reduce our ability
to retain, attract and motivate our directors, officers and employees. In addition, as a consequence of any such delisting, our share
price could be negatively affected and our shareholders would likely find it more difficult to sell, or to obtain accurate quotations
as to the prices of, our ordinary shares.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.45in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Our
President and Chief Executive Officer beneficially owns approximately 5.6% of our outstanding ordinary shares, as of March 27, 2024.
Therefore, our principal shareholders will be able to exert significant control over matters submitted to our shareholders for approval.</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Our
President and Chief Executive Officer currently beneficially owns approximately 5.6% of our outstanding ordinary shares as of March 27,
2024. Therefore, our President and Chief Executive Officer will be able to exert significant control over matters submitted to our shareholders
for approval. As our President and Chief Executive Officer could significantly influence or even unilaterally approve matters requiring
approval by our shareholders, including the election of directors and the approval of mergers or other business combination transactions.
The interests of our President and Chief Executive Officer may not always coincide with our interests or the interests of other shareholders.
This significant concentration of share ownership may adversely affect the trading price for our ordinary shares because investors often
perceive disadvantages in owning stock in companies with controlling shareholders.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>


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    <!-- Field: /Page -->

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Sales
of a substantial number of our ordinary shares in the public market could cause our share price to fall.</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Sales
of a substantial number of our ordinary shares in the public market, or the perception that these sales might occur, could depress the
market price of our ordinary shares and could impair our ability to raise capital through the sale of additional equity securities. We
are unable to predict the effect that sales may have on the prevailing market price of our ordinary shares. Sales of shares by our existing
shareholders would likely result in the supply of our ordinary shares far exceeding the demand for our ordinary shares and could have
a material adverse effect on the trading price of our ordinary shares.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; text-align: justify; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Raising
additional capital would cause dilution to our existing shareholders, and may restrict our operations or require us to relinquish rights.</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Subject
to our strategic review, we will need to raise additional capital and may seek additional capital through a combination of private and
public equity offerings, &#8220;at-the-market&#8221; issuances, equity-linked and structured transactions, debt (straight, convertible,
or otherwise) financings, collaborations and licensing arrangements. To the extent that we raise additional capital through the sale
of equity or convertible debt securities, your ownership interest will be diluted, and the terms may include liquidation or other preferences
that adversely affect your rights as a shareholder. Debt financing, if available, would result in increased fixed payment obligations
and may involve agreements that include covenants limiting or restricting our ability to take specific actions such as incurring debt,
making capital expenditures or declaring dividends. If we raise additional funds through collaboration, strategic alliance and licensing
arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams or product candidates,
or grant licenses on terms that are not favorable to us. Depending upon market liquidity at the time, additional sales of shares registered
at any given time could cause the trading price of our ordinary shares to decline.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; text-align: justify; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Our
U.S. shareholders may suffer adverse tax consequences due to our expected classification as a passive foreign investment company.</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Generally,
if for any taxable year 75% or more of our gross income is passive income, or at least 50% of the average value of our assets is
attributable to assets that are held for the production of, or produce, passive income, we would be characterized as a passive
foreign investment company, or PFIC, for U.S. federal income tax purposes. Based upon our review of our financial data, we believe
that we were a PFIC for our 2023 taxable year and expect to be a PFIC for the 2024 taxable year. Because PFIC status is determined
annually and is based on our income, assets and activities for the entire taxable year, it is not possible to determine with
certainty whether we will be characterized as a PFIC for the 2024 taxable year until after the close of the year, and there can be
no assurance that we will not be classified as a PFIC in any future year. If we were to be characterized as a PFIC for U.S. federal
income tax purposes in any taxable year during which a U.S. Holder (as defined below) owns ordinary shares, such U.S. Holder could
face adverse U.S. federal income tax consequences. For example, such U.S. Holder could be subject to additional taxes and interest
charges upon certain distributions by us and any gain recognized on a sale, exchange or other disposition of our shares, whether or
not we continue to be characterized as a PFIC. Certain adverse consequences of PFIC status can be mitigated if a U.S. Holder makes a
&#8220;mark -to -market&#8221; election or an election to treat us as a qualified electing fund, or QEF. Upon request, we expect to
provide the information necessary for U.S. Holders to make &#8220;qualified electing fund elections&#8221; if we are classified as a
PFIC. There is no assurance, however, that we will have timely knowledge of our status as a PFIC, or that the information that we
provide will be adequate to allow U.S. Holders to make a QEF election Each investor is urged to consult its tax advisor with respect
to the application of the PFIC rules. See also &#8220;Item 10. Additional Information&#8212;E. Taxation&#8212; Certain Material U.S.
Federal Income Tax Considerations.&#8221;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>&#160;</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">If
a United States person is treated as owning at least 10% of our shares, such holder may be subject to adverse U.S. federal income tax
consequences.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"></span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">If
a United States person is treated as owning (directly, indirectly or constructively) at least 10% of the value or voting power of our
shares, such person may be treated as a &#8220;United States shareholder&#8221; with respect to each &#8220;controlled foreign corporation&#8221;
in our group (if any). A United States shareholder of a controlled foreign corporation may be required to annually report and include
in its U.S. taxable income its pro rata share of &#8220;Subpart F income,&#8221; &#8220;global intangible low-taxed income&#8221; and
investments in U.S. property by controlled foreign corporations, whether or not we make any distributions, and may be subject to tax
reporting obligations. An individual that is a United States shareholder with respect to a controlled foreign corporation generally would
not be allowed certain tax deductions or foreign tax credits that would be allowed to a United States shareholder that is a U.S. corporation.
A failure to comply with these reporting obligations may subject you to significant monetary penalties and may prevent the statute of
limitations with respect to your U.S. federal income tax return for the year for which reporting was due from starting. We cannot provide
any assurances that we will assist any shareholder in determining whether such shareholder is treated as a United States shareholder
with respect to any &#8220;controlled foreign corporation&#8221; in our group (if any) or furnish to any United States shareholders information
that may be necessary to comply with the aforementioned reporting and tax paying obligations. A United States investor should consult
its tax advisors regarding the potential application of these rules to its investment in the shares.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>If
the securities analysts that currently cover our stock, or will do so in the future, or industry analysts do not publish or cease publishing
research or reports about us, our business or our market, or if they adversely change their recommendations or publish negative reports
regarding our business or our shares, our share price and trading volume could be negatively impacted.</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
trading market for our ordinary shares is influenced by the research and reports that industry or securities analysts may publish about
us, our business, our market or our competitors. We do not have any control over these analysts and we cannot provide any assurance that
analysts will cover us or provide favorable coverage. If any of the analysts who do cover, or may cover us in the future, adversely change
their recommendation regarding our shares, or provide more favorable relative recommendations about our competitors, our share price
would likely decline. If any analyst who cover us cease coverage of our company or fail to regularly publish reports on us, we could
lose visibility in the financial markets, which in turn could negatively impact our share price or trading volume.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Because
we do not intend to declare cash dividends on our ordinary shares in the foreseeable future, shareholders must rely on appreciation of
the value of our ordinary shares for any return on their investment.</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
have never declared or paid cash dividends on our ordinary shares. We currently anticipate that we will retain future earnings for the
development, operation and expansion of our business and do not anticipate declaring or paying any cash dividends in the foreseeable
future. Moreover, the Israeli Companies Law, 5759-1999, or the Companies Law, imposes certain restrictions on our ability to declare
and pay dividends. See &#8220;Item 8. Financial Information&#8212;Consolidated Financial Statements and Other Financial Information&#8212;Dividend
Policy&#8221; for additional information.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; text-align: justify; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>The
requirements associated with being a public company require significant company resources and management attention.</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
are subject to the reporting requirements of the Securities Exchange Act of 1934, or the Exchange Act, the Sarbanes-Oxley Act, the listing
requirements of the Nasdaq Capital Market, on which our ordinary shares are traded, and other applicable securities rules and regulations.
The Exchange Act requires that we file periodic reports with respect to our business and financial condition and maintain effective disclosure
controls and procedures and internal control over financial reporting. In addition, subsequent rules implemented by the SEC and the Nasdaq
Capital Market may also impose various additional requirements on public companies. As a result, we incurred and will continue to incur
additional legal, accounting and other expenses that we did not incur as a privately-held company, particularly since, as of December
31, 2020, we are no longer considered an &#8220;emerging growth company&#8221; as defined in the JOBS Act. Further, the need to establish
the corporate infrastructure demanded of a public company may divert management&#8217;s attention from implementing our development plans.
We have made and will continue to make changes to our corporate governance standards, compensation policy, disclosure controls and financial
reporting and accounting systems to meet our reporting obligations and applicable law. The measures we take, however, may not be sufficient
to satisfy our obligations as a public company, which could subject us to delisting of our ordinary shares, fines, sanctions and other
regulatory action and potentially civil litigation.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify">&#160;</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>As
a &#8220;foreign private issuer,&#8221; we are permitted to and currently do follow certain home country corporate governance practices
instead of otherwise applicable SEC and Nasdaq Capital Market requirements, which may result in less protection than is accorded to investors
under rules applicable to domestic U.S. issuers.</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">As
a &#8220;foreign private issuer,&#8221; we are permitted to, and currently do, follow certain home country corporate governance practices
instead of those otherwise required under the Listing Rules of the Nasdaq Capital Market, or the Nasdaq Listing Rules, for domestic U.S.
issuers. For instance, we currently follow home country practice in Israel with regard to, among other things, director nomination procedure
and approval of compensation of officers. In addition, we may follow our home country law instead of the Nasdaq Listing Rules that require
that we obtain shareholder approval for certain dilutive events, such as the establishment or amendment of certain equity based compensation
plans, an issuance that will result in a change of control of the company, certain transactions other than a public offering involving
issuances of a 20% or greater interest in the company, and certain acquisitions of the stock or assets of another company. Following
our home country governance practices as opposed to the requirements that would otherwise apply to a U.S. company listed on the Nasdaq
Capital Market may provide less protection to you than what is accorded to investors under the Nasdaq Listing Rules applicable to domestic
U.S. issuers. See &#8220;Item 16G. Corporate Governance.&#8221;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
addition, as a &#8220;foreign private issuer,&#8221; we are exempt from the rules and regulations under the Exchange Act related to the
furnishing and content of proxy statements and certain individual executive compensation information, and our officers, directors and
principal shareholders are exempt from the reporting and short-swing profit recovery provisions contained in Section 16 of the Exchange
Act. Furthermore, foreign private issuers are not required to file their annual report on Form 20-F until 120 days after the end of each
fiscal year, while U.S. domestic issuers that are accelerated filers are required to file their annual report on Form 10-K within 75
days after the end of each fiscal year and U.S. domestic issuers that are large accelerated filers are required to file their annual
report on Form 10-K within 60 days after the end of each fiscal year. Additionally, as a &#8220;foreign private issuer,&#8221; we are
also not subject to the requirements of Regulation FD (Fair Disclosure) promulgated under the Exchange Act. These exemptions and leniencies
reduce the frequency and scope of information and protections to which you are entitled as an investor.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>If
our ordinary shares become a &#8220;penny stock,&#8221; it may be more difficult for investors to sell their ordinary shares, and the
market price of our ordinary shares may be adversely affected.</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Our
ordinary shares could become a &#8220;penny stock&#8221; if, among other things, the share price is below $5.00 per share, we are not
listed on a national securities exchange or we have not met certain net tangible asset or average revenue requirements. Broker-dealers
who sell penny stocks must provide purchasers of these stocks with a standardized risk-disclosure document prepared by the SEC. This
document provides information about penny stocks and the nature and level of risks involved in investing in the penny-stock market. A
broker must also give a purchaser, orally or in writing, bid and offer quotations and information regarding broker and salesperson compensation,
make a written determination that the penny stock is a suitable investment for the purchaser, and obtain the purchaser&#8217;s written
agreement to the purchase. Broker-dealers must also provide customers that hold penny stock in their accounts with such broker-dealer
a monthly statement containing price and market information relating to the penny stock. If a penny stock is sold to an investor in violation
of the penny stock rules, the investor may be able to cancel its purchase and get its money back.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">If
applicable, the penny stock rules may make it difficult for investors to sell their ordinary shares. Because of the rules and restrictions
applicable to a penny stock, there is less trading in penny stocks and the market price of our ordinary shares may be adversely affected.
Also, many brokers choose not to participate in penny stock transactions. Accordingly, investors may not always be able to resell their
ordinary shares publicly at times and prices that they feel are appropriate and the market price of our ordinary shares may be adversely
affected.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.45in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; background-color: white"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Inflation
could adversely affect our business and results of operations.</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; background-color: white"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">While
inflation in the United States and global markets had been relatively low in recent years, during 2021, 2022 and 2023, the economy in
the United States and global markets encountered a material increase in the level of inflation. The impact of COVID-19, geopolitical
developments such as the Russia-Ukraine conflict and global supply chain disruptions continue to increase uncertainty in the outlook
of near-term and long-term economic activity, including whether inflation will continue and how long, and at what rate. Increases in
inflation raise our costs for commodities, labor, materials and services and other costs required to grow and operate our business, and
failure to secure these on reasonable terms may adversely impact our financial condition. Additionally, increases in inflation, along
with the uncertainties surrounding any resurgence of the COVID-19, geopolitical developments and global supply chain disruptions, have
caused, and may in the future cause, global economic uncertainty and uncertainty about the interest rate environment, which may make
it more difficult, costly or dilutive for us to secure additional financing. A failure to adequately respond to these risks could have
a material adverse impact on our financial condition, results of operations or cash flows.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.45in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Risks
Related to Israeli Law and Our Operations in Israel</b></span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Our
headquarters and other significant operations are located in Israel and, therefore, our results may be adversely affected by political,
economic and military instability in Israel.</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Our
executive office is located in Ramat Gan, Israel. In addition, certain of our key employees, officers and directors are residents of Israel.
Accordingly, political, economic and military conditions in the Middle East may affect our business directly. Since the establishment
of the State of Israel in 1948, a number of armed conflicts have occurred between Israel and its neighboring countries and terrorist
organizations active in the region, including Hamas (an Islamist militia and political group in the Gaza Strip) and Hezbollah (an Islamist
militia and political group in Lebanon).</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
October 2023, Hamas terrorists infiltrated Israel&#8217;s southern border from the Gaza Strip and conducted a series of attacks on civilian
and military targets. Hamas also launched extensive rocket attacks on Israeli population and industrial centers located along Israel&#8217;s
border with the Gaza Strip and in other areas within the State of Israel. These attacks resulted in extensive deaths, injuries and kidnapping
of civilians and soldiers. Following the attack, Israel&#8217;s security cabinet declared war against Hamas and a military campaign against
these terrorist organizations commenced in parallel to their continued rocket and terror attacks. In addition, since the commencement
of these events, there have been continued hostilities along Israel&#8217;s northern border with Lebanon (with the Hezbollah terror organization)
and southern border (with the Houthi movement in Yemen, as described below). It is possible that hostilities with Hezbollah in Lebanon
will escalate, and that other terrorist organizations, including Palestinian military organizations in the West Bank as well as other
hostile countries, such as Iran, will join the hostilities. Such clashes may escalate in the future into a greater regional conflict.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
connection with the Israeli security cabinet&#8217;s declaration of war against Hamas and possible hostilities with other organizations,
several hundred thousand Israeli military reservists were drafted to perform immediate military service. Although many of such military
reservists have since been released, they may be called up for additional reserve duty, depending on developments in the war in Gaza
and along Israel&#8217;s other borders. While none of our employees in Israel have been called to active military duty, we rely on service
providers located in Israel and have entered into certain agreements with Israeli counterparties. Employees of such service providers
or contractual counterparties may be called for service in the current or future wars or other armed conflicts with Hamas as well as
the other pending or future armed conflicts in which Israel is or may become engaged, and such persons may be absent for an extended
period of time. As a result, our operations may be disrupted by such absences, which disruption may materially and adversely affect our
business and results of operations.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">While
our executive offices are located in Ramat Gan, Israel, which is not near Israel&#8217;s borders where the main hostilities are currently
taking place and none of our employees have been called into military reserve duty, to help mitigate the effects of Israel&#8217;s war
with Hamas, we have taken several measures, including work-from-home measures and have a business continuity plan. Nevertheless, we experienced
disruptions to our work and over the past few weeks have been returning to full activity together with our local vendors and consultants.
As a result, in November 2023, we determined that the commencement of our Phase 2 PSC study was to be delayed by seven to nine months.
We expect to commence our Phase 2 PSC study following the end of such period.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Further
disruptions that could severely impact our business, clinical trials, and supply chains, include:</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">limitations
    on employee resources that would otherwise be focused on the conduct of our business including because of military reserve duty call-ups
    in the future that impact our employees and the affect the current war between Israel and Hamas on the productivity of our employees
    and external partners;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">delays
    in necessary interactions with vendors, local regulators, and other important agencies and contractors due to limitations in employee
    resources; and</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">impacts
    from prolonged remote work arrangements, such as increased cybersecurity risks and strains on our business continuity plans.</span></td></tr>
  </table>
<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify">&#160;</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
intensity and duration of Israel&#8217;s current war against Hamas is difficult to predict, as are such war&#8217;s economic implications
on the Company&#8217;s business and operations, on Israel&#8217;s economy in general, on the trading price of shares of our ordinary shares
and could impact our ability to raise additional capital on a timely basis or at all. These events may be intertwined with wider macroeconomic
indications of a deterioration of Israel&#8217;s economic standing that may involve a downgrade in Israel&#8217;s credit rating by rating agencies
(such as the recent downgrade by Moody&#8217;s of its credit rating of Israel from A1 to A2, as well as the downgrade of its outlook
rating from &#8220;stable&#8221; to &#8220;negative&#8221;), which may have a material adverse effect on the Company and its ability
to effectively conduct its operations. The impact of the current war between Israel and Hamas may also have the effect of heightening
many of the other risks described in this section and in the &#8220;Risk Factors&#8221; section of our 2022 Annual Report.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
addition, some countries around the world restrict doing business with Israel and Israeli companies, and additional countries may impose
restrictions on doing business with Israel and Israeli companies if hostilities in Israel or political instability in the region continue
or increase. In addition, there have been increased efforts by countries, activists and organizations to cause companies and consumers
to boycott Israeli goods and services. In addition, in January 2024 the International Court of Justice, or ICJ, issued an&#160;interim
ruling&#160;in a case&#160;filed by South Africa against Israel in December 2023, making allegations of genocide amid and in connection
with the war in Gaza, and ordered Israel, among other things, to take measures to prevent genocidal acts, prevent and punish incitement
to genocide, and take steps to provide basic services and humanitarian aid to civilians in Gaza. There are concerns that companies and
businesses will terminate, and may have already terminated, certain commercial relationships with Israeli companies following the ICJ
decision. The foregoing efforts by countries, activists and organizations, particularly if they become more widespread, as well as the
ICJ rulings and future rulings and orders of other tribunals against Israel (if handed), may materially and adversely impact our business,
clinical trials, and supply chains.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Furthermore,
following Hamas&#8217; attack on Israel and Israel&#8217;s security cabinet declaration of war against Hamas, the Houthi movement, which
controls parts of Yemen has launched attacks on Israeli-controlled or owned ships in the Red Sea, resulting in shipping companies rerouting
their cargo ships or ceasing shipments to Israel in the case of the latter. The hostilities with Hamas, Hezbollah, the Houthi movement
and other terrorist organizations, include and may include terror, missile and drone attacks. In the event that our facilities are damaged
as a result of hostile actions, or hostilities otherwise disrupt our ongoing operations, our ability to deliver or provide products and
services in a timely manner to meet our contractual obligations towards customers and vendors could be materially and adversely affected.
Any hostilities involving Israel or the interruption or curtailment of trade between Israel and its present trading partners could have
a material adverse effect on our business and could make it more difficult for us to raise capital. Our insurance policies do not cover
losses that may occur as a result of events associated with war and terrorism. Although the Israeli government currently covers the reinstatement
value of direct damages that are caused by terrorist attacks or acts of war, we cannot assure you that this government coverage will
be maintained or that it will sufficiently cover our potential damages. Any losses or damages incurred by us could have a material adverse
effect on our business. Any armed conflicts or political instability in the region would likely negatively affect business conditions
and could harm our results of operations.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Finally,
political conditions within Israel may affect our operations. Israel has held five general elections between 2019 and 2022, and prior
to October 2023, the Israeli government pursued extensive changes to Israel&#8217;s judicial system, which sparked extensive political
debate and unrest. In response to such initiative, many individuals, organizations and institutions, both within and outside of Israel,
voiced concerns that the proposed changes may negatively impact the business environment in Israel including due to reluctance of foreign
investors to invest or transact business in Israel, as well as to increased currency fluctuations, downgrades in credit rating, increased
interest rates, increased volatility in security markets and other changes in macroeconomic conditions. To date, these initiatives have
been substantially put on hold. If such changes to Israel&#8217;s judicial system are again pursued by the government and approved by
the parliament, this may have an adverse effect on our business, our results of operations and our ability to raise additional funds,
if deemed necessary by our management and board of directors.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i></i></b></span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>&#160;</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; text-align: justify; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Exchange
rate fluctuations between the U.S. dollar and the New Israeli Shekel currencies may negatively affect our earnings.</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Our
functional currency is the U.S. dollar. We incur expenses in U.S. dollars and New Israeli Shekels, or NIS. As a result, we are exposed
to the risks that the NIS may appreciate relative to the U.S. dollar, or, if either the NIS devalues relative to the U.S. dollar, that
the inflation rate in Israel may exceed such rate of devaluation of the NIS, or that the timing of such devaluation may lag behind inflation
in Israel. In any such event, the U.S. dollar cost of our operations in Israel would increase and our U.S. dollar-denominated results
of operations would be adversely affected. The average exchange rate for the year ended December 31, 2023 was $1.00 = NIS 3.62. We cannot
predict any future trends in the rate of inflation in Israel or the rate of devaluation, if any, of the NIS against the U.S. dollar.
As of the date hereof, the inflation rate in Israel has exceeded the rate of devaluation of the NIS, respectively, during the calendar
years 2021, 2022 or 2023.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Provisions
of Israeli law and our articles of association, or Articles, may delay, prevent or otherwise impede a merger with, or an acquisition
of, our company, which could prevent a change of control, even when the terms of such a transaction are favorable to us and our shareholders.</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
Companies Law regulates, among others, mergers, requires tender offers for acquisitions of shares above specified thresholds, requires
special approvals for transactions involving directors, officers or significant shareholders and regulates other matters that may be
relevant to such types of transactions. See &#8220;Item 10. Additional Information&#8212;B. &#8212;Mergers and Acquisitions under Israeli
Law&#8221; for additional information.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Furthermore,
Israeli tax considerations may make potential transactions unappealing to us or to our shareholders whose country of residence does not
have a tax treaty with Israel exempting such shareholders from Israeli tax. See &#8220;Item 10. Additional Information&#8212;E. Taxation&#8212;Certain
Israeli Tax Considerations&#8221; for additional information.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Moreover,
the classification of our Board into three classes with terms of approximately three years each, per our Articles, the requirement of
affirmative vote of at least 75% of the voting rights of the Company represented personally or by proxy and voting thereon at a general
meeting in order to amend or replace our Articles, together with the other provisions of the Articles and Israeli law, could deter or
delay potential future merger, acquisition, tender or takeover offers, proxy contests or changes in control or management of the Company.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>It
may be difficult to enforce a judgment of a United States court against us, our officers, directors and the Israeli experts named in
this annual report in Israel or the United States, to assert United States securities laws claims in Israel or to serve process on our
officers, directors and these experts.</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
were and continue to be organized in Israel. Most of our executive officers and directors reside outside of the United States, and all
of our assets and most of the assets of these persons are located outside of the United States. Therefore, a judgment obtained against
us, or any of these persons, including a judgment based on the civil liability provisions of the U.S. federal securities laws, may not
be collectible in the United States and may not necessarily be enforced by an Israeli court. It also may be difficult to effect service
of process on these persons in the United States or to assert U.S. securities law claims in original actions instituted in Israel. Additionally,
it may be difficult for an investor, or any other person or entity, to initiate an action with respect to United States securities laws
in Israel. Israeli courts may refuse to hear a claim based on an alleged violation of United States securities laws reasoning that Israel
is not the most appropriate forum in which to bring such a claim. In addition, even if an Israeli court agrees to hear a claim, it may
determine that Israeli law and not United States law is applicable to the claim. If United States law is found to be applicable, the
content of applicable United States law must be proven as a fact by expert witnesses, which can be a time consuming and costly process.
Certain matters of procedure will also be governed by Israeli law. There is little binding case law in Israel that addresses the matters
described above. As a result of the difficulty associated with enforcing a judgment against us in Israel, our shareholders may not be
able to collect any damages awarded by either a United States or foreign court.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i></i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>&#160;</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; text-align: justify; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Your
rights, liabilities and responsibilities as a shareholder will be governed by Israeli law and differ in some material respects from those
under U.S. </i>law.</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Because
we are an Israeli company, the rights and responsibilities of our shareholders are governed by our Articles and Israeli law. These rights,
liabilities and responsibilities differ in some material respects from the rights, liabilities and responsibilities of shareholders in
a U.S. corporation. In particular, a shareholder of an Israeli company has a duty to act in good faith towards the company and other
shareholders and to refrain from abusing his, her or its power in the company, including, among other things, when voting at the general
meeting of shareholders on certain matters. Israeli law provides that these duties are applicable to shareholder votes on, among other
things, amendments to a company&#8217;s articles of association, increases in a company&#8217;s authorized share capital, mergers and
interested party transactions requiring shareholder approval. In addition, a controlling shareholder, a shareholder who knows that it
possesses the power to determine the outcome of a shareholders&#8217; vote or a shareholder who has the power to appoint or prevent the
appointment of a director or executive officer in the company, has a duty of fairness towards the company. However, Israeli law does
not define the substance of this duty of fairness. There is little case law available to assist in understanding the implications of
these provisions that govern shareholder behavior. These provisions may be interpreted to impose additional obligations and liabilities
on holders of our ordinary shares that are not typically imposed on shareholders of U.S. corporations. See &#8220;Item 10. Additional
Information&#8212;B Memorandum and Articles of Association&#8212;Shareholder Duties&#8221; for additional information.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Any
of the risk factors referred to above could significantly and negatively affect our business, results of operations or financial condition,
which may reduce our ability to pay dividends and lower the trading price of our ordinary shares. The risks referred to above are not
the only ones that may exist. Additional risks not currently known by us or that we deem immaterial may also impair our business operation</i>s.</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><span id="p_005"></span>ITEM
4. Information on the Company.</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>A.
Historical Background and Corporate Structure</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Galmed
Pharmaceuticals Ltd., was incorporated in Israel on July 31, 2013 as a privately held company and is governed by the Companies Law. However,
our business has been operating since 2000 under a different group of companies established in the same year, or the Group. Originally,
we operated under the parent company, GHI. GHI held all of the equity rights in and to Galmed 2000 Inc., a holdings company incorporated
in the British Virgin Islands, or GTTI. GTTI held all of the equity rights in and to Galmed International Limited, a company incorporated
in Malta, or GIL (other than 0.1% of the share capital held by GHI). GIL held all of the equity rights in and to Galmed Medical Research
Ltd., an Israeli company, or GMR. Our intellectual property was held by GIL. The research and development was conducted by GMR as a service
to GIL on a cost plus basis. GIL was responsible for all product development.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">On
February 2, 2014, we underwent the Reorganization, pursuant to which all of our intangible assets (including our intellectual property)
were transferred from GIL to Galmed Research and Development Ltd., or GRD. The Reorganization was effectuated by share transfers and
asset transfers, resulting in the Company as the parent company and 100% equity-owner of the following companies: (1) GRD, which holds
all the Group&#8217;s intellectual property, including the Company&#8217;s patent portfolio; (2) GIL, which is an inactive company; and
(3) GTTI, which was liquidated in 2017. GIL held GMR, which became an inactive company in 2015 and was liquidated in February 2019. The
Reorganization was conducted in order to simplify our capital structure, reduce our operating cost and to improve our ability to raise
funds. Immediately prior to the Reorganization, all our shareholders collectively held 9,739 ordinary shares of GHI. In connection with
the Reorganization, and in accordance with the Tax Pre-Ruling, we issued to all such shareholders ordinary shares, such that upon the
Reorganization all our shareholders collectively held 7,099,731 of our ordinary shares, in the same proportion among all shareholders,
which reflected a ratio of 729 of our ordinary shares for each ordinary share of GHI. In July 2023, GRD established a new wholly-owned
subsidiary incorporated under the laws of England and Wales called Galmed Therapeutics UK Limited, or Galmed UK.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; text-align: justify; margin: 0pt 0pt 0pt 0; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
following is a diagram of our corporate structure (following GTTI&#8217;s liquidation and the incorporation of Galmed UK):</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><img src="form20-f_001.jpg" alt="" style="height: 272.25pt; width: 468pt"/></span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">On
March 18, 2014, we completed our initial public offering and since then have been listed on the Nasdaq Capital Market under the symbol
&#8220;GLMD&#8221;.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; text-align: justify; margin: 0pt 0pt 0pt 0; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Our
principal executive offices and registered office in Israel is located at 16 Abba Hillel Road, Ramat Gan, Israel 5250608 and our
telephone number is +972-3-693-8448. Our lease at our prior principal executive offices expired on March 21, 2024. We did not extend
the lease and are currently headquartered in Ramat Gan, Israel while we are in the process of searching for a new permanent location
for our principal executive offices. Our website address is http://www.galmedpharma.com. The information contained on, or that can
be accessed through, our website is neither a part of nor incorporated into this annual report. We have included our website address
in this annual report solely as an inactive textual reference. Puglisi &amp; Associates, or Puglisi, serves as our authorized
representative in the United States for certain limited matters. Puglisi&#8217;s address is 850 Library Avenue, Newark, Delaware
19711.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
SEC maintains an internet site that contains reports, proxy and information statements and other information regarding issuers that file
electronically with the SEC at http://sec.gov. We use our website (http://www.galmedpharma.com) as a channel of distribution of Company
information. The information we post through this channel may be deemed material. Accordingly, investors should monitor our website,
in addition to following our press releases, SEC filings and public conference calls and webcasts. The contents of our website are not,
however, a part of this annual report.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Other
than as described in &#8220;Item 5. Operating and Financial Review and Prospects&#8212;Contractual Obligations&#8221;, we have not had
any material commitments for capital expenditures, including any anticipated material acquisition of plant and equipment or interests
in other companies, since January 1, 2014. Additionally, we have not had any material capital divestitures since January 1, 2014.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>B.
Business Overview</b></span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.45in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
are a biopharmaceutical company focused on the development of Aramchol. We have focused almost exclusively on developing Aramchol for
the treatment of liver disease and are currently developing Aramchol for PSC and exploring the feasibility of developing Aramchol for
other fibro-inflammatory indications outside of liver disease. We are also collaborating with the Hebrew University in the development
of Amilo-5MER, a 5 amino acid synthetic peptide.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"></span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
believe that our lead product candidate, Aramchol, has the potential to be a disease modifying treatment for fatty liver disorders, including
NASH, which is a chronic disease that constitutes a large unmet medical need.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Aramchol
is a synthetic conjugate of 3-amino cholic acid, or a type of modified bile acid, and arachidic acid, or a type of saturated fatty acid,
which in its non-synthetic forms, is naturally occurring. The conjugated molecule acts upon important metabolic pathways, reducing fat
accumulation in the liver, improving fatty acid oxidation and regulating the transport of cholesterol. The ability of Aramchol to decrease
liver fat content may also reduce the inflammation and fibrosis in the liver and the risk of cardiovascular complications associated
with NASH. Pre-clinical studies suggest Aramchol&#8217;s effect on fibrosis is also direct via collagen production from human hepatic
stellate cells. We believe that Aramchol&#8217;s ability to reduce liver fat and liver fibrosis and the safety profile observed to date
will enable it to be a treatment for all stages of NASH in patients who are overweight or obese and have pre diabetes or type II diabetes
mellitus and prevent the hepatic complications associated therewith.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.45in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
September 2019, we initiated our Phase 3 ARMOR Study to evaluate the efficacy and safety of Aramchol in subjects with NASH and fibrosis.
The ARMOR Study was originally comprised of two parts, a randomized, double-blind, placebo-controlled histology-based registrational
part and a clinically based part where subjects will continue with the same treatment for approximately five years. In December 2020,
we announced the addition of a 150-patient open label part to the ARMOR Study and suspended randomization of new patients into the double-blind,
placebo-controlled histology-based registrational part of ARMOR as all enrolled patients were transitioned to the open label part.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.45in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
May 2022, we announced our plan to expand into new anti-fibrotic indications to maximize the potential of Aramchol while at the same
time discontinuing the open label part of its ARMOR Study having reached its objectives. Simultaneously, we initiated a cost reduction
plan and initiated a process to evaluate our strategic alternatives. Following the discontinuation of our open label part of the ARMOR
Study, we do not currently expect to initiate the second part of the ARMOR Study in the near term.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; text-align: justify; margin: 0pt 0pt 0pt 0; text-indent: 0.45in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
May 2023, we announced the initiation of a new clinical program to evaluate Aramchol meglumine for the treatment of PSC, a rare disease
for which there is no approved treatment. We initially planned to initiate a Phase 2a study in the last quarter of 2023 however as a
result of Hamas-Israel war, we currently estimate a delay of ~7-9 months in the initiation of the study.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; text-align: justify; margin: 0pt 0pt 0pt 0; text-indent: 0.45in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
randomized, double-blind, proof-of-concept clinical study (NCT06095986) will evaluate the effects of 48 weeks of treatment with Aramchol
meglumine vs. placebo in approximately 24 patients with PSC. The study&#8217;s endpoints will include the conventional relevant laboratory
parameters (alkaline phosphatase and bilirubin), sophisticated imaging including liver stiffness using MR Elastography (MRE), imaging
of the biliary tract using MR cholangiopancreatography, or MRCP, and hepatocyte-specific contrast agents, histological fibrosis and molecular
assessment as well as a range of biomarkers of disease activity and fibrosis. These endpoints are expected to provide a robust assessment
of the underlying disease and the effects of Aramchol.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; text-align: justify; margin: 0pt 0pt 0pt 0; text-indent: 0.45in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">While
PSC is more common in men, especially in Northern European heritage, and is often diagnosed between ages 30-40, we currently estimate
that the number of patients to be around 60,000, or 1 per 10,000, consisting of around 33,5000 patients in the United States and 32,500
patients collectively in France, Germany, Italy, Spain and the United Kingdom. In the preclinical stage, PSC likely involves ulcerative
colitis (UC) leading to biliary inflammation. As biliary fibrosis progresses to cirrhosis, it is coupled with complications and competing
risks, while about 50% of patients with PSC report clinical symptoms. While there are currently no approved drugs for the treatment of
PSC, there is a potential to gain orphan drug status.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; text-align: justify; margin: 0pt 0pt 0pt 0; text-indent: 0.45in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
initially planned to initiate a Phase 2 study in the last quarter of 2023 to evaluate Aramchol meglumine for the treatment of PSC. This study will be followed by a Phase 2b or a phase 2/3 confirmatory adaptive design trial. As a result
of the outbreak of the Hamas-Israel war, in November 2023, we determined that there would be a delay of seven to nine months in the initiation
of the Phase 2 PSC study. We expect to commence our Phase 2 PSC study following the end of such period. As PSC is a fibro-obliterative
cholangiopathy where the disease progression is predominantly determined by biliary fibrosis, Aramchol meglumine has been shown to downregulate
Stearoyl-CoA desaturase 1 (SCD1), a key liver enzyme involved in lipid metabolism, attenuate fibrogenesis by hepatic stellate cells (HSCs).
Aramchol meglumine may have direct effects on cholangiocytes to reduce the production of fibrogenic and inflammatory signals that activate
HSCs suggesting that Aramchol meglumine may be beneficial in treating PSC.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"></span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.45in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
addition, in May 2023, we entered into a definitive agreement, or the OnKai Agreement, for a $1.5 million equity investment in
OnKai, a US-based technology company developing an AI-based platform to advance healthcare for underserved populations across the
United States by facilitating alignment between healthcare stakeholders. The signing of the definitive agreement followed an
announcement that we made in January 2023 that we had entered into a non-binding termsheet for an equity investment in OnKai. The
OnKai Agreement provided that we will invest $1.5 million in exchange for series seed preferred shares of OnKai (which is in
addition to a $1.5 million investment that was made by us in OnKai through a Simple Agreement for Future Equity, or SAFE, and which
converted at a 15% discount into series seed preferred shares upon consummation of the Investment Round (as defined below)). Our
investment in OnKai was part of an approximately $6 million investment round, or the Investment Round, with other investors that was
led by us of which SAFE notes of approximately $3.8 million were converted into preferred shares. On June 19, 2023, the Investment
Round closed. Following the Investment Round, we hold approximately 23.9% of the outstanding share capital of OnKai on an
as-converted and fully diluted basis and our Chief Executive Officer and director, Allen Baharaff serves as a board member of OnKai.
In connection with the OnKai Agreement, our wholly-owned subsidiary, Galmed Research and Development Ltd., or GRD, entered into a
services agreement, or the OnKai Services Agreement, with OnKai. The OnKai Services Agreement provides that GRD shall on a
non-exclusive basis (i) provide support services to OnKai relating to finance, business development, strategic planning, execution
and others; and (ii) lend its experience to OnKai in building a strategy and for the development of treatments for the underserved
and that OnKai shall on a non-exclusive basis (i) take part in plan preparation to serve GDR&#8217;s vision of developing drugs for
the underserved population and (ii) when relevant, design a process on the clinical trial dashboard that could potentially serve
GDR&#8217;s future trial. See &#8220;Item 4. Information on the Company&#8212; Strategic Collaborations, Research Arrangements and
other Agreements&#8212;Onkai.&#8221; In July 2023, we announced that OnKai will apply its artificial intelligence
models for enrollment and execution of clinical trials in underserved communities, starting with our PSC clinical program.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.45in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">While
we previously announced that we were no longer evaluating our strategic alternatives following the initiation of our PSC clinical program
and our investment and collaboration with Onkai, we have recently reinitiated the process of evaluating our strategic options alternatives
and our structuring to best optimize our resources to enhance shareholder value and achieve our goals. See &#8220;Item 3. Key Information&#8212;Risk
Factors&#8212;Risks Related to Our Business, Industry and Regulatory Requirements&#8212;Our activities to evaluate and pursue strategic
alternatives may not be successful&#8221; for additional information.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Non-Alcoholic
Fatty Liver Disease (NAFLD) / Non-Alcoholic Steato-Hepatitis (NASH)</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">It
is estimated that the global prevalence of NAFLD, the precondition to NASH, is approximately 25% in the general population and much higher
in certain high risk groups. This disease is also now recognized as one of the most common liver disorders, and a significant growing
public health problem. In the US alone, 80 - 100 million people are said to be affected by NAFLD, and its prevalence is rapidly growing
in parallel with metabolic syndromes, particularly obesity and diabetes.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">NAFLD
is characterized by the accumulation of fat of 5% or greater in the liver of people who drink alcohol only in moderation, or not at all.
There may be numerous causes of NAFLD, however, the disease is mostly associated with a high fat, fructose-rich diet. Although NAFLD
is generally asymptomatic, it is a major risk factor for liver inflammation (NASH) and scarring (fibrosis and cirrhosis). In addition,
NAFLD is also associated with metabolic syndrome and cardiovascular disease. Currently, NAFLD can only be managed through lifestyle improvements,
such as weight reduction and physical activity.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">NASH
is an emerging world crisis impacting an estimated 3% to 5% of the U.S. population and an estimated 2% to 4% globally, and is associated
with increased risk of liver cirrhosis, liver failure, hepatocellular cancer, as well as metabolic and cardiovascular diseases. The major
characteristics of NASH are elevated liver fat, inflammation, ballooning and fibrosis.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">However,
despite the growing need, there are currently no approved therapeutic treatments for NASH. Modification of risk factors, such as obesity
and hyperlipidemia, and proper diabetic control is generally recommended for the treatment of NASH, and the standard of care includes
lifestyle changes to promote weight loss, including low-calorie, low-fat diets and physical activity. Although weight loss can be potentially
significant in delaying the progression of NASH, studies have shown that, for most individuals, it is generally very difficult to maintain
over the long-term, even following bariatric surgery.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"></span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">There
are currently no drugs approved by regulatory authorities for the treatment of NASH. Even though certain drugs, such as insulin sensitizers
and antihyperlipidemic agents, are prescribed for some NASH patients, they are not approved for the treatment of NASH and their efficacy
has not been proven in adequate and well-controlled clinical studies.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Currently,
it is impossible to predict which of the NAFLD patients will deteriorate to NASH as it is unclear what causes NASH to develop. Researchers
are now focusing on several factors that may contribute to the development of NASH. Therefore, lifestyle changes are recommended for
all patients with NAFLD.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">There
is an exceptionally wide range of estimates regarding the potential commercial market for NASH. This uncertainty stems from (i) the overall
size of the patient population, (ii) the percentage of the addressable market that will be diagnosed and, subsequently, seek treatment,
(iii) the ultimate cost of the therapies, (iv) the number of approved drugs for NASH and their profile, and (v) uncertainty regarding
the regulatory approval process. Some of these factors cannot be known until NASH drugs begin to hit the market or biomarkers replacing
the biopsy diagnosis are validated. Independent estimates generally estimate a commercial multi billion market in developed countries,
though we do not endorse any estimates, which are based on a number of different underlying assumptions.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Aramchol
for NASH</b></span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Overview</i></b></span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Our
product candidate, Aramchol, is a first-in-class synthetic fatty acid-bile acid conjugate molecule, or FABAC, molecule that we are developing
for oral treatment for NASH in patients who are overweight or obese and have prediabetes or type II diabetes mellitus.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Early
in its development, Aramchol&#8217;s ability to modulate hepatic lipid metabolism was observed and validated in numerous pre-clinical
trials with different animal species. Mice fed a high fat diet and treated with Aramchol did not develop fatty liver as compared to non-treated
mice. In these early studies, we also observed that the mechanism of this effect was not a result of malabsorption of fat in the intestines
because the FABAC-treated mice gained weight throughout the test periods to a similar degree to the control mice. This led us to conclude
that FABAC therapy triggers a beneficial modulation of intra-hepatic lipid metabolism and reduces liver fat content.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
<i>in-vitro</i> and in vivo studies, Aramchol down regulates the SCD1 enzyme, an enzyme recognized as playing an important role in the
metabolism of fatty acids. The SCD1 enzyme is essentially the gateway that regulates the use and storage of fat in the body by converting
saturated fatty acids to monounsaturated fatty acids. Experimental animal studies showed that complete inhibition of the SCD1 enzyme
protects against diet-induced obesity, hepatic steatosis, or fatty liver, and insulin resistance by instructing the body to use, rather
than store, all fatty acids. However, various animal studies have indicated that such complete SCD1 enzyme inhibition has mechanism based
serious side effects, such as atherosclerosis, and eye and skin disorders. As observed by us in our pre-clinical and clinical studies
performed to date, and subsequently published in the European Journal of Gastroenterology and Hepatology and Archives of Medical Research
in 2008 and 2010 respectively, one of Aramchol&#8217;s unique characteristics is that it down regulates the SCD1 enzyme but does not
inhibit it completely &#8211; a partial effect. To date, side effects that have been observed in animals with knock out of SCD1 have
not been observed in our toxicology and clinical studies.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">To
better understand the role of Aramchol in NASH, we analyzed the effect of Aramchol in MCD diet model. The aim of this study was to investigate
Aramchol&#8217;s mechanism of action and its effect on fibrosis using the methionine- and choline-deficient (MCD) diet model of NASH.
We collected liver and serum from mice fed a MCD diet containing 0.1% methionine (0.1MCD) for four weeks, which developed steatohepatitis
and fibrosis, as well as mice receiving a control diet; the metabolomes and proteomes were determined. 0.1MCD fed mice were given Aramchol
(5mg/kg/day for the last 2 weeks); liver samples were analyzed histologically. Aramchol administration was found to reduce features of
steatohepatitis and fibrosis in 0.1MCD fed mice. Aramchol downregulated the SCD1 enzyme, a key enzyme involved in triglyceride biosynthesis
whose loss enhances fatty acid &#946;-oxidation. In addition, Aramchol increased the flux through the transsulfuration pathway, leading
to a rise in glutathione (GSH) and GSH/GSSG ratio, the main cellular antioxidant that maintains intracellular redox status. Comparison
of the serum metabolomic pattern between 0.1MCD-fed mice and patients with NAFLD showed a substantial overlap. These findings were published
in Hepatology Communications, Vol. 1, No. 9, 2017.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">As
the effect of Aramchol on fibrosis was first reported we further analyzed the direct effect of Aramchol on collagen production and reported
down regulation of collagen production from the hepatic stellate cells (HSCs) by Aramchol. With that we could conclude that Aramchol
has potential direct effect on collagen production and therefore reduces fibrosis indirectly by down regulation of steatosis by reducing
the sequence of events but also directly affecting collagen producing cells. These findings were published in Hepatology Communications,
Vol. 1, No. 9, 2017.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">These
findings led us to further analyze the effect of Aramchol using the Thiocatemide (TAA) rat model. TAA is the most commonly used toxic
agents to induce liver fibrosis. Repeated IP injections of TAA leads to sever fibrosis / cirrhosis. Among all models for fibrosis, the
TAA model share multiple characteristics with human liver fibrosis and is considered to best predict efficacy in humans. Results demonstrated
that treatment with Aramchol 5mg/kg, significantly prevented TAA induced fibrosis in a dose dependent manner. These findings were presented
at EASL, Amsterdam in April 2017 (The anti Fibrotic effect of Aramchol on liver Fibrosis in TAA animal model).</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Phase
1 Single and Multiple-Dose Study of Aramchol in Healthy Male Volunteers (NCT00776841)</i></b></span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Aramchol
was evaluated in two Phase 1 clinical trials (under a single protocol) to study its safety, tolerability and PK profile in healthy volunteers,
in both single and multiple dose administrations. The first Phase 1 clinical trial was an escalating single-dose trial conducted in 17
healthy subjects testing Aramchol doses ranging from 30 mg to 900 mg, performed in one center in Israel. The subsequent Phase 1 clinical
trial was a repeated-dose trial conducted over four days in 25 healthy subjects testing repeated daily doses of Aramchol of 30 mg and
300 mg, performed in one center in Israel. The profiles for the groups were similar and the maximal plasma concentration of Aramchol
increased with the higher doses. The PK profile demonstrated that Aramchol is suitable at each dose for once-daily administration and
there were neither significant adverse events observed in either Phase 1 trial nor any notable changes in biochemical, hematologic, cardiovascular
or other safety parameters.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Phase
2a Trial: Aramchol Treatment in NAFLD or NASH Patients (NCT01094158)</i></b></span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
January 2012, we completed a 60 patient multi-center, randomized, double-blind, placebo-controlled Phase 2a clinical trial of Aramchol
in patients with NAFLD or NASH between the ages of 18 and 75 in 12 centers in Israel. The Phase 2a study results were published in July
2014 in the peer-reviewed Clinical Gastroenterology and Hepatology Journal. The trial was performed in patients with either NAFLD or
NASH, which design was deemed acceptable by the FDA in 2007 at a pre-IND scientific advisory meeting. The trial&#8217;s primary efficacy
endpoint was a reduction in liver fat content, and did not consider inflammation or fibrosis, which can be diagnosed only by liver biopsy.
We believe that the short study duration of three months of treatment followed by a one-month follow-up period did not warrant repeated
biopsies. The trial evaluated the effects on liver fat content of 100 mg and 300 mg once-daily doses of Aramchol compared to a placebo.
At the end of the three month treatment period, statistically significant reductions in liver fat concentration as measured by MRS were
observed in the 300 mg patient group. Specifically, a 12.57% mean liver fat content reduction was observed in the 300 mg group, as compared
to a mean reduction of 2.89% in the 100 mg group and a mean increase of 6.39% in the placebo-treated patients. These results indicate
that the effects of Aramchol are dose-dependent, as demonstrated in the graph below, which presents the results with respect to the 57
patients who successfully completed the entire treatment period (three patients were excluded from data analysis because of one protocol
violation and two withdrawal consents).</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Relative
Change in MRS from Baseline after Three Months of Treatment</b></span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
table above shows that the primary endpoint of the study was attained. The study demonstrated a statistically significant, dose dependent
reduction in fat content in the livers of patients treated with Aramchol, with a 19% difference between the 300 mg dose group and the
placebo group, while the difference between the 100 mg dose group and the placebo group was not statistically significant. Notably, the
minimal effective dose of Aramchol for fat reduction has been defined.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">There
were no statistically significant differences among the three treatment groups for any of the secondary end points. There was a non-statistically
significant trend of mild weight reduction (P=.1) in the high dose Aramchol group. Serum adiponectin levels increased (0.2 &#177; 1.7
&#956;g/mL) in the high-dose Aramchol group but decreased in the low-dose (-0.3 &#177; 1.5 &#956;g/mL) and placebo groups (-0.7 &#177;_1.3
&#956;gg/mL) (P= 0.88 for trend of dose-response relationship by linear regression). FMD increased non-statistically significantly by 1.28%
&#177; 2.92% in the high-dose group, by 0.34% &#177;3.54% in the low-dose group, and by 0.46% &#177; 2.28% in the placebo group.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
frequency of adverse events was similar in all treatment groups, and none of them were considered to be related to the treatment. All
adverse events in the active treatment arms were mild or moderate and none were serious. None of the patients withdrew as a result of
adverse events. The following table shows the most frequent adverse events (occurring in &#8805; 2 patients in any group) in the study.</span></p>

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<table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 100%">
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    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
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    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
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    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
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    <td style="text-align: left">&#160;</td><td style="text-align: right">&#8212;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"></p>

<!-- Field: Page; Sequence: 61; Value: 2 -->
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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
results of our Phase 2a clinical trial of Aramchol in the peer-reviewed Clinical Gastroenterology and Hepatology Journal were
published in December 2014. The trial manuscript, entitled &#8220;The Fatty Acid-Bile Acid Conjugate Aramchol Reduced Liver Fat
Content in Patients with Nonalcoholic Fatty Liver Disease,&#8221; provides the full report of the Phase 2a trial, which was
completed in January 2012 and presented at the 47<sup>th </sup>Annual Meeting of the European Association for the Study of the Liver
in 2012. Based on this Phase 2a proof-of-concept results, we established a development plan that we believe may confirm: (i) the
good safety profile of Aramchol, (ii) the optimal dose of Aramchol, and (iii) efficacy on steatosis as well as fibrosis in patients
with NASH.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Pharmacokinetics
of Single and Multiple Escalating Doses of Aramchol and Food Effect in Healthy Volunteers (NCT02374437)</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">On
April 28, 2014, we commenced PK and food effect studies of Aramchol. In written correspondence from December 2013 regarding a requested
pre-IND meeting, the FDA recommended that we conduct such studies prior to commencing our Phase 2b ARREST Study.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
conducted the food effect and PK study at the Sourasky Medical Center in Tel Aviv, Israel involving 66 healthy volunteers to evaluate
the PK of Aramchol following single and multiple escalating doses (200 mg, 400 mg and 600 mg), as well as to evaluate the effect of a
high-fat, high-calorie meal on the PK of Aramchol following a single dose in healthy volunteers.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
results showed dose-related, but less than dose-proportional, increases in the mean Aramchol plasma concentrations, or Cmax, area under
the curve, or AUC, (0-t), and AUC (inf) of 200 mg, 400 mg and 600 mg doses administered under fasting conditions or following a light
meal, both at single and repeated dose administration. Cmax and AUC are metrics used to indicate the significance of a drug&#8217;s exposure.
Steady-state was achieved by 144 hours (day seven). Administration of Aramchol after a high-fat, high-calorie meal afforded a 2.6 fold
increase in exposure, as measured by Cmax, AUC(0-t), and AUC(inf) compared to the fasting group.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">No
serious adverse events or deaths occurred during the study. Adverse events were equally distributed between placebo and Aramchol doses,
were mild (with only one moderate adverse event) and the majority defined unrelated to Aramchol. The PK study provides additional safety
data to further support existing safety data from our pre-clinical studies and our Phase 1 and Phase 2a clinical trials of Aramchol.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Pharmacokinetics
of Single and Multiple Escalating Doses of Aramchol Administered under Fed Conditions in Healthy Chinese Volunteers (NCT 02803996)</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
2016, we performed the Chinese PK Study involving Chinese patients who are domiciled in the United States. We enrolled 66 patients in
this study, consisting of two parts. In part A, 32 subjects received a single escalating dose; Part B enrolled 34 subjects which received
a multiple escalating dose. Dr. Evelyn Darius served as the Study Investigator. No safety signal was identified in this study and we
deemed no changes were required in the enrollment of Chinese patients into the ARREST Study.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Phase
2b ARREST Study for Aramchol (NCT 02279524)</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
September 2014, the FDA granted Fast Track designation status to Aramchol for the treatment of NASH. Fast Track designation may accelerate
the development process and may expedite the review of drugs that show promise in treating serious, life-threatening medical conditions
for which no other drug either exists or is as effective.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">On
February 1, 2015, we began our ARREST Study. The ARREST Study was a Phase 2b, multicenter, global, randomized, double-blind, placebo
controlled study to evaluate the efficacy and safety and of two doses of Aramchol for the treatment of NASH in patients who are overweight
or obese and have pre diabetes or type II diabetes mellitus. In order to be eligible to participate in the ARREST Study, patients had
to be affected by NASH, as diagnosed by a biopsy centrally read (steatosis &#8805;1 + inflammation &#8805;1 + ballooning &#8805;1, total activity
NAS score of 4 or more), have a fibrosis stage of 1-3, be overweight or obese as measured by a Body Mass Index between 25 and 40 or waist
circumference between 88cm to 200cm for women, and between 102cm to 200cm for men, and who are pre diabetic or type II diabetic. We targeted
this specific population as it is at the greatest risk of developing NASH and its complications. We have generated data from animal models
that lead us to believe that Aramchol targets all three main pathologies of the disease: steatosis, inflammation and fibrosis.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">A
total of 247 patients (approximately one third in the US, one third in Latin America and one third in Europe and Israel) with liver biopsy-proven
NASH who were overweight or obese and had pre-diabetes or type II diabetes mellitus were randomized. Patients were randomized in a ratio
of 2:2:1 (600mg, 400mg and placebo) taking once-daily oral Aramchol (in the Aramchol treatment arms) or a placebo (in the placebo arm).
The treatment part of the trial was 12 months in duration and patients completing this phase were observed for a three month follow-up
period. In February 2017, we completed randomization of the ARREST Study. Baseline histology of patients enrolled into the ARREST study
demonstrated a population with advanced disease, with 60% having stage 2 and 3 fibrosis and 70% have NAS&gt;5 at baseline.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
primary endpoint of the study was the change from baseline to end of study in liver triglycerides ratio as measured by magnetic resonance
spectroscopy, or MRS (Aramchol 600mg vs. placebo). Secondary endpoints, demonstrated through biopsy, included fibrosis improvement by
at least one stage or more without worsening of NASH (defined by an increase of inflammation and or ballooning) and NASH resolution (defined
by ballooning score 0 and inflammation score 0-1 at termination) without worsening of fibrosis. Other secondary endpoints included improvement
(2 points or more) in NASH activity index, as measured by NAS or SAF, without worsening fibrosis and change in baseline to week 52/termination
in ALT (U/L).</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">On
June 12, 2018, we announced top-line results of the ARREST Study and on November 13, 2018 an oral abstract presentation of one-year results
of the ARREST Study was presented during a Late Breaking Abstract Oral Session at The Liver Meeting&#174; 2018 during the American Association
for the Study of Liver Diseases 2018 Annual Meeting.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Of
the 247 patients, 48 patients were in the placebo arm, 101 patients in the Aramchol 400mg arm and 98 in the Aramchol 600mg treatment
arm. The majority of subjects completed 52 weeks of treatment and 13 weeks of follow up (89.1%, 89.8%, 85.4% in the 400 mg, 600 mg and
placebo arms, respectively). The leading cause of discontinuation was consent withdrawal and early termination due to adverse events;
the incidence of early termination due to AEs was very low and similar across study arms.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Patients
in the ARREST study were planned to undergo MRS, and a liver biopsy at baseline and week 52, which were centrally read, blinded to treatment
allocation. The statistical analysis plan included pre-defined analysis sets: (i) a full analysis set for MRI (FAS -&#8212; MRI): all
intent to treat, or ITT, patients with baseline and at least one second MRS. 214 patients were included in this analysis set (41 in placebo;
90 in Aramchol 400mg; and 83 in Aramchol 600mg); and (ii) a full analysis set for liver biopsy (FAS -&#8212; biopsy): all ITT patients
with baseline and a second biopsy. 198 patients were included in this analysis set (40 in placebo; 80 in Aramchol 400mg; and 78 in Aramchol
600mg).</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Results
from the study showed a statistically significant reduction in liver fat by MRS with Aramchol 400mg vs. placebo (p=0.0450) and not with
600mg (p=0.0655) and thus did not reach the primary endpoint of the study. In a post-hoc analysis, a cutoff of 5% absolute reduction
in liver fat was used as a surrogate for potentially clinically meaningful MRI reduction. In this responder&#8217;s analysis, a dose-response
could be observed; the responder rate was 47.0%, 36.7% and 24.2%, in the Aramchol 600mg, 400mg and placebo arms, respectively. The proportion
of the Aramchol 600mg arm compared to placebo was statistically-significant (p=0.0279).</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Results
for the two biopsy endpoints, which may currently constitute a primary endpoint for a Phase 3 trial to support an FDA marketing application,
demonstrated the following: (i) significantly more patients treated with Aramchol 600mg vs. placebo achieved NASH resolution without
worsening of fibrosis (16.7% vs. 5.0%; p=0.0514); and (ii) a higher proportion of patients showed at least one-point improvement in fibrosis
score without worsening of NASH in Aramchol 600mg vs. placebo (29.5% vs. 17.5%; p=0.2110).</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"></span></p>



<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Statistically
significant reductions in live enzymes alanine transaminase (ALT) and aspartate transaminase (AST) were demonstrated in both Aramchol
arms vs. placebo (p&#8804;0.0002) and (p&lt;0.0001), respectively.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Secondary
endpoints based on NAS and SAF activity score, &#8805;2 points improvement, showed a higher proportion of patients with improvement in the
Aramchol arms (600mg&gt;400mg&gt;placebo; P&gt;0.05).</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Exploratory
endpoints of glycemic parameters showed statistically significant reductions in HbA1c with both Aramchol arms vs. placebo (p&lt;0.007)
implying a potential effect on glycemic control.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">At
52 weeks of treatment, Aramchol continued to show a favorable safety and tolerability profile. Serious adverse events were reported in
12.5%, 8.9% and 9.2% of patients in placebo, Aramchol 400mg and 600mg arms, respectively. No clustering of event type or atypical events
for the studied population was reported in either Aramchol arms. Severe adverse events were reported in 10.4%, 6.9%, and 6.1% of patients
in placebo, Aramchol 400mg, and 600mg arms, respectively. Early terminations due to adverse events occurred in 4.2%, 3.0% and 4.1% in
placebo, Aramchol 400mg and 600mg arms, respectively.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
following table summarizes the most frequent adverse events.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><img src="form20-f_003.jpg" alt="" style="height: 217.5pt; width: 468pt"/></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"></span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
following table summarizes the ARREST results:</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

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    <td style="text-align: left">&#160;</td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">+0.32</span></td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">(0.04</td><td style="text-align: left">)</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">(0.13</td><td style="text-align: left">)</td></tr>
  <tr style="vertical-align: bottom; background-color: White">
    <td>&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">p=0.0061</span></td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">p=0.0008</span></td><td style="text-align: left">&#160;</td></tr>
  </table>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">(1)</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Placebo
    N=41; 400mg N=90, 600mg N=83; Mixed Effect Model Repeat Measurement (MMRM) adjusted mean changes from baseline; p-values for comparison
    of active treatment arm vs. placebo.</span></td></tr>
  </table>
<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">(2)</span></td>
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    N=40, 400mg N=80, 600mg N=78; Baseline adjusted logistic regression; p-values for comparison of active treatment arm vs. placebo.</span></td></tr>
  </table>
<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">(3)</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Placebo
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  </table>
<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">(4)</span></td>
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  </table>
<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"></span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Dose
Splitting Pharmcokinetic Study (NCT03774173)</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">As
a result of the dose response pattern observed in the ARREST Study, we recently conducted a Phase 1, open-label, crossover PK study to
assess whether dose splitting of Aramchol 600mg to twice daily 300mg will significantly increase plasma levels. 16 healthy subjects took
part in two study periods. Eight subjects received each regimen in the first period and the alternate regimen in the second period. A
PK profile was obtained over the dosing interval at steady state on day ten of each period.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Results
of the study showed that the administration of Aramchol 300 mg twice daily resulted in 24-hour plasma concentrations significantly greater
than those observed with the administration of Aramchol 600 mg once daily. (P&lt;0.0001). The average plasma levels (exposure) were 53%
higher and exposure was greater in all 16 subjects with the twice daily dosing. The treatment in both dosing regimens were similar in
terms of safety and were well tolerated.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>First
in Human Aramchol Meglumine Pharmcokinetic Study</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
December 2020, we announced new data from a Phase 1, first in human study that compared Aramchol meglumine to Aramchol acid.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Armachol
acid and Aramchol megluine was administered twice daily to 12 subjects. Below is a summary of the results:</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><img src="form20-f_004.jpg" alt="" style="height: 171.75pt; width: 468pt"/></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">These
initial results demonstrated that the new salt form of Aramchol meglumine has a plasma PK profile that is very similar to Aramchol acid.
It also showed that the administration of both forms resulted in the same form of Aramchol in the blood, regardless of which drug product
is administered and that less Aramchol meglumine is needed for the same exposure of Aramchol acid in the blood.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Phase
3 ARMOR Study for Aramchol</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
September 2019, we initiated the ARMOR Study, a Phase 3 pivotal study of Aramchol for the treatment of NASH, following a successful End-of-Phase
2 meeting with the FDA in April 2019 in which we reached general agreement on key aspects of the Phase 3 development and registration
plan for Aramchol. The ARMOR Study was originally comprised of two parts, a randomized, double-blind, placebo-controlled histology -based
registrational part where 1200 subjects will be treated with Aramchol or matching placebo for 52 weeks and a clinically based part where
subjects will continue with the same treatment for approximately five years, taking into consideration draft guidance issued by the FDA
in December 2018 entitled &#8220;Noncirrhotic Nonalcoholic Steatohepatitis with Liver Fibrosis: Developing Drugs for Treatment&#8221;,
or the &#8220;December Guidance&#8221;. The histology-based data is intended to serve as the basis for the submission of a marketing
authorization application under regulatory provisions of Sub-part H accelerated/conditional approval.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
light of the rapid development of the Aramchol meglumine program and due to the delays resulting from the COVID-19 pandemic, in December
2020, we announced the addition of an open label part to the ARMOR Study and temporarily suspended randomization of new patients into
the double-blind, placebo-controlled histology-based registrational phase of ARMOR as currently enrolled patients are transitioned to
the open label part.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
August 2021, we announced that the FDA agreed with our plan to use Aramchol meglumine (in lieu of Aramchol free acid) in our ARMOR Study
without the need to conduct additional nonclinical and clinical studies other than planned limited pharmacology studies relating to Aramchol
meglumine. In addition, the Medicines and Healthcare products Regulatory Agency, or MHRA, the pharmaceuticals regulator in the UK, also
agreed with our plan to proceed with our proposed clinical studies with Aramchol meglumine in lieu of Aramchol free acid without the
need to repeat nonclinical and clinical studies other than planned limited pharmacology studies relating to Aramchol meglumine.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
November 2021, we announced positive interim data on the open label part of the ARMOR Study showing clinically significant effect on
fibrosis improvement based on histology in the first 16 patients. Subsequently in November 2021, we announced that new analyses of biomarkers
corroborate this effect showing statistically significant reductions in biomarkers associated with liver fibrosis including ALT, AST,
Fib-4 and ProC-3. Reductions of a similar magnitude were seen in a cohort of the first 20 patients for which paired biopsy have been
analyzed and a cohort of 50 patients for which biomarker data was analyzed based on all available data at that time. In addition, we
reported that Aramchol continues to show excellent safety and tolerability profile. Data support that a higher dose of Aramchol could
provide statistically and clinically meaningful effect on fibrosis in the double-blind placebo controlled part for submission of the
ARMOR Study to support an NDA under Sub-part H.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"></span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
April 2022, we announced further positive interim data on the open label part of the ARMOR Study showing robust fibrosis improvement
across multimodality histological assessment. Results of post baseline biopsies performed either at 24 weeks or at 48 weeks from 46 subjects
with NASH and F1-3 that received Aramchol support the anti-fibrotic effect of Aramchol and reinforce the favorable safety profile of
Aramchol.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
May 2022, we announced the discontinuation of the open label part of our ARMOR Study having reached its objectives and in January 2023,
we announced full results from the open label part of the ARMOR Study. Following the discontinuation of our open label part of the ARMOR
Study, we do not currently expect to initiate the second part of the ARMOR Study.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
Phase 3 study is a two-part study, an open-label part and a randomized, double-controlled, placebo part, designed to evaluate the safety
and efficacy of Aramchol and to be conducted in approximately 200 sites in the U.S., Europe and Latin America.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><i>Part
One: Open Label Study</i></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
first part, an open-label study, was originally designed to evaluate treatment response kinetics, pharmacokinetics and safety of twice
daily administration of Aramchol 300mg in approximately 150 subjects with NASH and liver fibrosis stage 1-3 (F1 capped at 30 subjects),
subjects with NASH who may or may not be overweight, and subjects with NASH who may or may not have type 2 diabetes or be pre-diabetic.
Patients were randomized (1:1:1) into three groups with post-baseline liver biopsy being performed at 24 weeks, 48 weeks, or 72 weeks,
respectively. A second post-baseline liver biopsy was conducted after one year for subjects whose post-baseline liver biopsy at week
24, 48 or 72 does not show at least one stage improvement in fibrosis. The open label part was being conducted at approximately 50 selected
sites in the U.S., and around the world which have been less affected by the COVID-19 pandemic.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
open label study enrolled 157 subjects. Fifty-one (51) subjects underwent post-baseline biopsies prior to study discontinuation (28 subjects
at &lt;48 weeks and 23 subjects at &#8805;48 weeks). The study was designed to assess the safety, pharmacokinetics (PK) and efficacy kinetics
as a function of treatment duration. Three independent pathologists and three different histopathology reading methodologies were used
to assess the antifibrotic effect of Aramchol: fibrosis stage based on NASH CRN; ranked assessment (improvement/worsening/stable) of
paired (pre- and post-baseline) biopsies, blinded to sequence; and an automated and continuous score of Fibrosis Composite Severity (FCS),
using FibroNest&#8482;, a quantitative AI digital pathology image analysis method. Noninvasive tests (NITs) included imaging (fibroscan)
and biomarkers (liver enzymes, FIB-4, Pro-C3 and ELF).</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Aramchol
treatment resulted in a high proportion of subjects showing fibrosis improvement based on all three biopsy reading methodologies, with
a larger treatment effect with longer duration of therapy. Following a treatment duration of 48 weeks or more, improvement in fibrosis
was demonstrated in 39% of subjects according to NASH CRN and 61% of subjects according to ranked assessment. At Week 48 AI demonstrated
fibrosis improvement in 100% of subjects when responders were defined by an absolute reduction of the FCS score &gt;0.3, 65% when responders
were defined by a relative reduction of &gt;25%, and a statistically significant reduction from baseline in mean FCS score (p&lt;0.0001).
NASH resolution without worsening of fibrosis was demonstrated in 26.5% of subjects.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Fibroscan,
ALT, AST, and FIB4 were analyzed using MMRM, based on all subjects (N=154). Fibroscan results were consistent, with an improvement in
fibrosis showing a mean absolute reduction from baseline to week 72 of 2.5 kPa (p&lt;0.0001). At Week 72, ALT was reduced by 22 U/L (p&lt;0.0001),
AST was reduced by 18 U/L (p&lt;0.0001), and FIB-4 was reduced by 0.30 (p&lt;0.0001).</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Pro-C3
and ELF were analyzed for 43 subjects at week 24 showing reduction in both Pro-C3 levels (p&lt;0.0001) and ELF (p=0.0038).</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
Open Label part demonstrated the good safety profile of Aramchol 300mg BID including long-term follow up. The incidence of serious adverse
events (SAEs) was consistent with the population (10.4%) and early discontinuation rates due to adverse events (AEs) were low (4.5%).</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><i>Part
Two: Histology-Based and Clinically-Based Study</i></span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
second part of the ARMOR Study is a randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of Aramchol
300 mg BID to support regulatory approval, with both a histology-based phase and a clinically-based phase. As currently designed, a total
of 2000 subjects with NASH and liver fibrosis stage 2 and 3 who are overweight and are either pre-diabetic or have type 2 diabetes would
be randomized 2:1 to receive Aramchol 300mg BID or matching placebo. In the histology-based phase, we intend to treat 1000 subjects with
Aramchol or matching placebo for 72 weeks until the second biopsy. The histology-based data is intended to serve as the basis for the
submission of a Sub-part H marketing authorization application under regulatory provisions of accelerated/conditional approval. The primary
histology-based endpoint is NASH resolution without worsening of fibrosis or fibrosis improvement without NASH worsening. In the clinically-based
phase, all subjects will continue with the same treatment assignment for up to seven years until study completion to confirm clinical
efficacy. We may announce end-of-study at the time when a total of 380 subjects have experienced at least one pre-specified clinical
event or at five years from last subject randomization, whichever comes first. The primary clinically-based endpoint is expected to be
based on clinical events including all-cause mortality, histological progression to cirrhosis, MELD score &gt;15, and hepatic decompensation
events (e.g., hepatic encephalopathy, variceal bleeding, ascites). If the clinical trial results in the histology-based phase are positive,
we plan to submit an NDA for Sub-part H accelerated/conditional approval to the FDA. As discussed elsewhere, we suspended the initiation
of the double-blind placebo-controlled histology-based registrational part of ARMOR and are seeking to initiate the double-blind placebo-controlled
histology-based registrational part of ARMOR in the second half of 2023, subject to, among other things, the results of our open label
part, sufficient funding and clarification of the regulatory approval process for NASH drugs.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
following is a depiction of part two of the ARMOR Study:</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><img src="form20-f_005.jpg" alt="" style="height: 240pt; width: 468pt"/></span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Amilo-5MER</b></span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
August 2020, we announced significant progress in the development of Amilo-5MER, a 5 amino acid synthetic peptide MTADV (Methionine,
Threonine, Alanine, Aspartic acid, Valine). The 5 amino acids sequence of Amilo-5MER is homologue to a specific MTADV sequence in the
human CD44 variant found in synovial fluid cells from joints of rheumatoid arthritis, or RA patients.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Amilo-5MER
is being developed through a research collaboration between us and the Hebrew University of Jerusalem. The molecule originated in the
laboratory of Prof. David Naor, from the Lautenberg Center for Immunology and Cancer Research, Faculty of Medicine, The Hebrew University.
Prof. Naor and his team were the first to publish this specific sequence in the prestigious scientific communication Journal of Clinical
Investigation 1.</span></p>
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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Amilo-5MER
binds to three pro-inflammatory amyloid proteins, Serum Amyloid A, or SAA, Transthyretin and Apolipoprotein B with high affinity. The
first two are known to be active only in their aggregated forms. By binding to SAA, Amilo-5MER interferes with SAA aggregation and therefor
inhibits the destructive autocrine, self-amplifying cytokine loop that causes additional inflammatory reaction.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">SAA
constitutes acute phase reactants, whose concentration in serum rise rapidly in response to acute stimuli such as infection and trauma.
An elevated concentration of SAA was identified in sera of patients with multiple autoimmune diseases and more recently, an outstanding
increase of SAA was also detected in COVID-19 infected patients2-3. SAA in its aggregated form, is a potent and rapid inducer of cytokine
secretion (particularly Interleukin 6 (IL-6). IL-6 plays an important role in chronic inflammation and is implicated in the pathogenesis
of many autoimmune diseases, such as Multiple Sclerosis, or MS, RA, Inflammatory Bowel Disease, or IBD and acute COVID 19. Interference
with SAA polymerization and aggregation is a valid target to prevent chronic inflammatory conditions.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Amilo-5MER
has been shown to significantly reduce chronic inflammation in animal models of RA, IBD and MS (research work supported by a grant to
Prof. Naor from the National Multiple Sclerosis Society (NMSS) of the USA). Amilo-5MER provides a unique mechanism of action to interfere
with this vicious cycle, enabling a specific treatment for chronic inflammatory diseases. Data generated from multiple in-vitro, in-vivo
and human ex-vivo models have shown that Amilo-5MER significantly improves clinical symptoms. Histological improvements and reduction
of pro-inflammatory cytokine secretion were also observed.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Amilo-5MER
is considered a New Chemical Entity. As such, it is eligible for NCE patent protection until July 2034. Patents have been granted and
maintained in the US (US 1061181937), Europe (EP 3169343) and Australia (AU 2015291151) and have been allowed in Japan (JP 6671363).</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
March 2021, we dosed the first subject in our first in human Phase 1 trial of Amilo-5MER for the treatment of chronic inflammatory diseases.
The trial was a three-part, single center, double-blind, randomized, placebo-controlled first in human study of single ascending doses
(Part 1) and multiple doses (Part 2) of Amilo-5MER in young healthy adult male subjects and a single dose cohort in healthy elderly male
and female subjects (Part 3). Overall, 55 healthy male and female subjects were enrolled in the study. Cohorts of 8 subjects were randomized
to receive Amilo-5MER or placebo by subcutaneous injection in a ratio of 6:2. In Part 1, cohorts of young male adults received single
ascending doses of 10, 30, 90, 180 and 360 mg; in Part 2, a single cohort received doses of 180 mg BID for 5 consecutive days and in
Part 3 a single cohort of healthy elderly male and female subjects received a single dose of 180 mg. The primary objectives of the trial
were to evaluate the safety, tolerability, and pharmacokinetics of Amilo-5MER. In January 2022, we announced results in which all doses
of Amilo-5MER were well tolerated with no clinically significant adverse events and none considered related to the investigational product.
All subjects completed the study as per protocol. Overall exposure to Amilo-5MER increased with an increase in dose, with statistically
significant dose proportionality over the 10 mg to 360 mg dose range. We are currently evaluating which indication to pursue further
development of Amilo-5MER.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; text-align: justify; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Additional
Pre-clinical and Clinical Studies Required for Regulatory Submissions</b></span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Toxicology
Studies</i></b></span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Since
the completion of the Phase 2a study, pre-clinical toxicology studies have been conducted to support our ongoing clinical programs and
regulatory submissions. These studies were performed in compliance with the EMA&#8217;s ICH M3 (R2) guidelines. The toxicity program
for Aramchol included repeat dose studies of up to six months in rats and up to nine months in dogs by oral administration, the intended
route of administration in the clinical trials and beyond. The dose level of 1000 mg/kg/day in rats and 1500 mg/kg/day in dogs, which
is the maximal feasible dose in both species showed no side effect and therefore the highest dose of the study was selected as the no-observed-adverse-effect-level,
or NOAEL. There were no observations noted in the rat study. The findings in the dog study were limited to changes in plasma lipids,
including decreases in total blood cholesterol levels, LDL, HDL and phospholipids, and a slight increase in the size of the adrenal glands,
which were considered to be an extension of the primary pharmacology of Aramchol and non-toxic effects, and skin scales from week 13
onwards in all Aramchol-treated groups, with a dose-related incidence. After six months this was not accompanied by any microscopic alteration
of the skin and therefore considered not toxicologically relevant. Results from the study show that after nine months the presence of
scales in all Aramchol-treated groups was accompanied by minor test item-related microscopic findings in the skin: Hyperkeratosis of
the epidermis, correlating to the scales, and keratin plugs in the hair follicles (in males at 750/500 and 1500 mg/kg). After a 12-week
treatment-free recovery period, fewer scales were noted and microscopically there was partial recovery. As these findings were minor
and no clinical symptoms like scratching were noted, these findings were considered not adverse.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Aramchol
was non-mutagenic in vitro in the Ames test and chromosomal aberrations test, each of which is a test to determine whether the subject
chemical can cause mutations in the DNA of an organism. In addition, in bone marrow micronucleus test in male rats at a 2000 mg/kg oral
dose (the maximum recommended dose in accordance with ICH S2 (R1)), Aramchol was not clastogenic, meaning it did not give rise to or
induce disruption or breakages of chromosomes, nor was it aneugenic, meaning it did not cause the number of chromosomes in the nucleus
of a cell to not be an exact multiple of the monoploid number of a particular species.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Embryo-fetal
development toxicity was assessed in rats and rabbits. No maternal or fetal development toxicity was observed in either species. The
NOAEL for maternal and development toxicity was at least 1000 mg/kg in rats and 750 mg/kg in rabbits (the maximum feasible dose in both
species).</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">No
maximum tolerated doses were reached in the studies. Over 50-fold safety margin exposure was achieved in dogs but not in rats. However,
for rats, at least three of the four ICH M3(R2) safety margin criteria were met, and for dogs all four criteria were met. Blood tests
revealed a decrease in total blood cholesterol levels, including LDL, HDL and phospholipids, and there was a slight increase in the size
of the adrenal glands of the dogs, which WIL Research assessed as a physiologic compensatory response to the decrease in blood cholesterol
levels. WIL Research did not consider the decrease in blood cholesterol levels or the physiologic response of the adrenal glands as a
toxic effect, but rather as a pharmacodynamic effect, which is a biochemical and physiological effect of the drug on the body. Based
on the above, it was concluded that the overall safety data for Aramchol is sufficient to support the proposed Phase 2b clinical trial.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">To
support any potential future NDA, we have commenced or are planning to commence several safety studies. Additionally, we plan in the
future to conduct a study of Aramchol in the pediatric population.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
addition, we have conducted carcinogenicity studies to identify whether Aramchol has any tumorigenic potential upon long-term administration
in support of any future NDAs or MAAs. Under FDA guidance, we are required to perform two studies, one in rats and the other in mice.
The carcinogenicity study in rats is a two-year study which was initiated in February 2020 and finalized during 2022. There were no significant
adverse findings reported over the course of the study.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Aramchol
for the Treatment of Other Indications</b></span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">On
February 14, 2018, we announced topline results from the investigator initiated ARRIVE Study for HIV associated lipodystrophy and NAFLD
patients. HIV patients have advanced liver disease which is a major cause for morbidity and mortality. ARRIVE, a Phase 2a, investigator
initiated clinical trial conducted at the University of California</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">San
Diego by Professor Rohit Loomba was a randomized, double-blinded, placebo-controlled, 12 weeks, proof-of-concept study that evaluated
the safety and efficacy of Aramchol at 600mg/day versus placebo in 50 patients with HIV-associated lipodystrophy and NAFLD. The primary
end point of successful therapy was improvement in hepatic steatosis at 12 weeks, as measured by MRI-PDFF. Secondary endpoints were improvement
in total body fat, metabolic profile, and liver biochemistry. Liver biopsies were not included as part of the evaluation in this pilot
trial. The trial showed no difference between HIV patients receiving Aramchol for 12 weeks when compared with HIV patients in the placebo
arm. Aramchol showed a favorable safety and tolerability profile. Although the pathology (fatty liver) is similar to &#8220;garden variety&#8221;
NASH, the pathogenesis involved in the HIV lipodystrophy and NAFLD is different and multi factorial including the effect of the virus
itself and the anti-HIV medications.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">On
November 13, 2014, we announced the first administration of Aramchol in a proof-of-concept Phase 2a clinical trial for the treatment
of newly formed cholesterol gallstones following bariatric surgery. The primary end-point was to prove that Aramchol dissolves newly
formed gallbladder gallstones following bariatric surgery. Patients were to be assigned to one of three treatment arms; 400mg tablets,
600mg tablets and placebo. Only 9 patients were enrolled, and 7 patients completed the study. Due to poor patient recruitment and change
in Company focus, we decided to terminate the study on October 1, 2015. We currently believe that it is unlikely that we will revive
another study in cholesterol gallstones.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
July 2022, we announced results showing significant effects of Aramchol in pre-clinical model of both lung and gastrointestinal (GI)
fibrosis. Fibrosis is a common complication of chronic inflammation and can affect all organs and tissues. To date, only limited anti-fibrotic
drugs are approved or are in development, most of which have restricting side effects. Aramchol is a partial inhibitor of SCD1 with distinctive,
direct, anti-fibrotic activity demonstrated in several pre-clinical models. Treatment with Aramchol resulted in statistically significant
fibrosis improvement in a validated bleomycin model of lung fibrosis (IPF), comparable to Pirfenidone which is the gold standard treatment.
Findings were seen across all important indicators for the severity of fibrosis including hydroxyproline (a marker for collagen deposition
in the fibrotic tissue) P&lt; 0.05, Ashcroft score P &lt; 0.005, % CPA (Percentage Collagen Proportionate Area of the lung) P &lt; 0.001,
and immunohistochemistry (type I collagen and a SMA) P &lt; 0.005 for both staining. Statistically significant improvements were also
demonstrated in a validated DSS model of inflammatory bowel disease (IBD). Dextran sulfate sodium (DSS) induced colitis model is widely
used because of its similarities with human ulcerative colitis. Clinical improvements were statistically significant at least by p value
&lt; 0.05 while in histological score (based on inflammation and colon structural changes) significance was as low as p<span style="text-decoration: underline">&lt;</span>0.01.
Aramchol was found to be the most effective compound tested. Control groups included 5-ASA and local steroids which are the gold standards
for current treatment.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in">In May 2023, we announced the initiation of a new clinical program to evaluate
Aramchol meglumine for the treatment of PSC, a rare disease for which there is no approved treatment. We initially planned to initiate
a Phase 2a study in the last quarter of 2023 however as a result of Hamas-Israel war, we currently estimate a delay of ~7-9 months in
the initiation of the study. While PSC is more common in men, especially in Northern European heritage, and is often diagnosed between
ages 30-40, we currently estimate that the number of patients to be around 60,000, or 1 per 10,000, consisting of around 33,5000 patients
in the United States and 32,500 patients collectively in France, Germany, Italy, Spain and the United Kingdom. In the preclinical stage,
PSC likely involves ulcerative colitis (UC) leading to biliary inflammation. As biliary fibrosis progresses to cirrhosis, it is coupled
with complications and competing risks, while about 50% of patients with PSC report clinical symptoms. While there are currently no approved
drugs for the treatment of PSC, there is a potential to gain orphan drug status.</p>
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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Strategic
Collaborations, Research Arrangements and other Agreements</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Samil
Pharma. Co., Ltd.</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">On
July 28, 2016, we entered into a license agreement, referred to herein as the Samil Agreement, with Samil for the commercialization of
Aramchol (with the option to manufacture) in the Republic of Korea, or the Territory.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Under
the terms of the Samil Agreement, the Company has granted Samil an exclusive licence, or the Samil License, for fatty liver indications
including NASH, or the Field of Use, in the Republic of Korea, or the Territory to such information concerning Aramchol as may be required
to support Samil&#8217;s applications for regulatory approvals, or the Licensed Information, and the patents for the import, marketing,
use, sale, offer for sale, commercialisation and distribution (and, if the option is exercised, manufacture) of Aramchol in tablet form,
or any other physical form as may be produced or manufactured by or on behalf of Galmed or by a third party for Galmed and, if the option
set out below is exercised, any products within the Field of Use, the development, manufacture or sale of which is based, in whole or
in part, on, or involves the use of, the Licensed Information or covered under any patent, or the Product.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
Samil License shall remain in force with respect to each Product (if the Samil Agreement is not early terminated) until the later of:
(i) the date of expiry in the Territory of the last of any patent covering such Product or any formulation, dosing or administration
form thereof; and (ii) the date of expiry of a period of 20 years commencing on the date of first commercial sale by Samil or a sublicensee
of such Product in the Territory.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Upon
the signing of the Samil Agreement, Samil paid the Company a gross upfront fee of approximately $2.1 million and in September 2018, we
received a milestone payment of $1.5 million. Samil has also agreed to pay additional clinical and regulatory-based milestone payments,
which may aggregate to an additional $4.5 million, as well as tiered, double-digit royalties payable on sales (lower if sales of a generic
equivalent commence in the Territory).</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Pursuant
to the terms of the Samil Agreement, following the first achievement of US$25 million of net sales in any calendar year following the
first commercial sale of the Product in the Territory, Samil shall have the option to request that the Licensed Information include methods
for the formulation of Aramchol from its API, to allow for the manufacture of Aramchol by Samil; provided, however, that we shall have
the option, to widen the definition of the Licensed Information as aforesaid at any time.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>


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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
shall be entitled, at our option: (i) to modify the Samil License with respect to any Product so that it is non-exclusive only; or (ii)
to terminate the Samil License hereunder, with respect to any Product if: (a) a first purchasing order from Samil for at least one Product
shall not have been placed by 6 months following the grant of the Korean Ministry of Food and Drug Safety new drug approval; or (b) commercial
sale of such Product having commenced and either (i) there shall be a period of 1 year during which no sales of any Product shall take
place, or (ii) within 1 year of such commencement, aggregate sales of Products shall not have reached a reasonable level, as determined
by the joint development committee, in each case, except as a result of force majeure or other factors beyond the control of Samil. Further,
we shall be entitled to terminate the Samil Agreement if Samil challenges the validity of any of the patents. If any such challenge is
unsuccessful, Samil shall (in addition to our right to terminate) pay us liquidated damages in the amounts of US $8,000,000. Either party
may terminate the Samil Agreement (i) upon the other party&#8217;s material breach if such party fails to cure such breach within 30
days, or, in the case of failure by Samil to pay any amount due from Samil to us pursuant to or in connection with the Samil Agreement
14 days after receiving written notice thereof, or (ii) upon customary events such as the granting of a winding-up order if such order
or act is not cancelled within 60 days.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
the event that we do not achieve the primary endpoint as defined in the study protocol, or Successful Completion, of the ARREST Study,
we shall as soon as practicable notify Samil of the non-achievement of such Successful Completion, and within 60 days thereof, notify
Samil in writing either:</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.4pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">(i)
that we have decided not to develop the Licensed Information further for the Field of Use, or the Cessation Notice, or (ii) that we intend
to continue with such development notwithstanding the non-achievement of such Successful Completion, or the Licensor Continuation Notice.
Also, in the event that we do not achieve the Successful Completion of the potential Phase 3 Study, we shall, as soon as practicable,
notify Samil accordingly, or the Notice of Non-Success. Samil shall thereafter have the option, by notice in writing served to us within
45 days of Samil&#8217;s receipt of either a Cessation Notice, a Licensor Continuation Notice or a Notice of Non-Success, as applicable,
to indicate its intention either: (i) to terminate the Samil License, or (ii) to continue research and development of the Licensed Information
in the Field of Use in the Territory, or the Licensee Continuation Notice. In the event Samil shall serve a Licensee Continuation Notice
following the service of a Cessation Notice or a Notice of Non-Success, any such continuation by Samil shall be subject to the entry
by Samil into a written agreement with us as to the terms and conditions which would govern such continued research and development,
which would be carried out according to Samil&#8217;s own development plan and at its sole expense. In the event Samil serves a Licensee
Continuation Notice following the service of a Licensor Continuation Notice, or Agreed Continuation, the Samil Agreement shall continue
in accordance with its terms. In August 2018, Samil sent a Licensee Continuation Notice to us.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Additionally,
following the Successful Completion of the ARREST Study or Agreed Continuation following non-achievement of Successful Completion of
the ARREST Study, Samil shall, for a period of 90 days following the date of written notification to it by us of such Successful Completion
or following the date of Agreed Continuation following non-achievement of Successful Completion, have the option to require that the
Territory be extended to include Vietnam, or the Extension Option. In the event that Samil exercises its Extension Option, the parties
shall conduct negotiations in good faith for up to 30 days thereafter in order to agree on milestone payments which would replace those
set out in the Samil Agreement. In the event that agreement is not reached in such regard within such period, the Extension Option shall
terminate. Discussions for the extension of the Samil License to Vietnam are ongoing.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Amilo
5-MER</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
have entered into a research and option agreement with Yissum, the tech transfer company of the Hebrew University with respect to our
Amilo-5MER, a 5 amino acid synthetic peptide MTADV (Methionine, Threonine, Alanine, Aspartic acid, Valine). Under this agreement, we
are able to research and initially develop Amilo-5MER, are required to fund the initial research and have been granted an exclusive option
to negotiate and enter into a definitive license agreement with Yissum for Amilo-5MER upon certain pre-agreed upon terms and such other
terms to be agreed upon.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">As
a result of the success in the Phase 1 study, we exercised our option and on June 28, 2021, we entered into a license agreement with
Yissum pursuant to which Yissum granted us a worldwide, exclusive and irrevocable license to develop and commercialize Amilo-5MER. In
November, 2021, the grant of the license took effect when it was approved by the Israel Innovation Authority. Under the license agreement,
we are responsible for carrying out the development and commercialization of Amilo-5MER and the prosecution and maintenance of the licensed
patents under the license agreement. In consideration for the grant of the license, we have agreed to pay to Yissum an upfront license
fee of $100,000, payments of up to $950,000 upon meeting certain regulatory milestones, single digit royalties on any future net sales
and a share of any sublicense fees. Unless earlier terminated, the license will continue in effect on a product-by-product and country-by-country
basis until the later of (i) the expiration of the last to expire patent covering the licensed technology in such country, (ii) the expiration
of any exclusivity on Amilo-5MER granted by a regulatory body in such country, and (iii) 15 years from the first commercial sale in such
country. The license agreement may be terminated early for material breach or bankruptcy. In addition, we may terminate the license agreement
without cause upon 90 days prior written notice to Yissum and Yissum may terminate the license agreement upon written notice to us under
certain limited circumstances.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Onkai</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
May 2023, we entered into the OnKai Agreement for a $1.5 million equity investment in OnKai, a US-based technology company developing
an AI-based platform to advance healthcare for underserved populations across the United States by facilitating alignment between healthcare
stakeholders. The signing of the definitive agreement followed an announcement that we made in January 2023 that we had entered into
a non-binding termsheet for an equity investment in OnKai. The OnKai Agreement provided that we will invest $1.5 million in exchange
for series seed preferred shares of OnKai (which is in addition to a $1.5 million investment that was made by us in OnKai through a SAFE
and which converted at a 15% discount into series seed preferred shares upon consummation of the Investment Round). Our investment in
OnKai was part of an approximately $6.0 million Investment Round with other investors that was led by us of which SAFE notes of approximately
$3.8 million were converted into preferred shares. On June 19, 2023, the Investment Round closed. Following the Investment Round, we
hold approximately 23.9% of the outstanding share capital of OnKai on an as-converted and fully and our Chief Executive Officer and director,
Allen Baharaff serves as a board member of OnKai. In connection with the OnKai Agreement, our wholly-owned subsidiary, GRD entered into
the OnKai Services Agreement with OnKai. The OnKai Services Agreement provides that GRD shall on a non-exclusive basis (i) provide support
services to OnKai relating to finance, business development, strategic planning, execution and others; and (ii) lend its experience to
OnKai in building a strategy and for the development of treatments for the underserved and that OnKai shall on a non-exclusive basis
(i) take part in plan preparation to serve GDR&#8217;s vision of developing drugs for the underserved population and (ii) when relevant,
design a process on the clinical trial dashboard that could potentially serve GDR&#8217;s future trial. In July 2023, we announced that OnKai will apply its artificial intelligence
models for enrollment and execution of clinical trials in underserved communities, starting with our PSC clinical program.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">OnKai
is developing a proprietary technology, a &#8220;smart grid&#8221;, that maps local clinics serving millions of underserved Americans
and streams to these clinics resources, including funding, specialists, training, and access to clinical studies. This is intended to
facilitate faster clinical trial enrollment and provide clinical trials as a healthcare option in these communities by bringing novel
medications, such as access to orphan drugs, to communities in need. We believe that it will potentially benefit in the future from enhanced
access to a pool of clinical trial participants for the advancement of our product candidates.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Competition</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
pharmaceutical industry is characterized by rapidly evolving technology, intense competition and a highly risky, costly and lengthy research
and development process. Adequate protection of intellectual property, successful product development, adequate funding and retention
of skilled, experienced and professional personnel are among the many factors critical to success in the pharmaceutical industry.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
operate in a competitive sector. Several companies are working on technologies, therapeutic targets or drug or biomarker candidates that
aim to treat or diagnose the same diseases or identify the same patient population as our product candidates. While we believe that our
drug candidates and diagnostic solutions, combined with our expertise and know-how, provide us with competitive advantages, we face potential
competition from various sources, including pharmaceutical and biotechnology companies, as well as from academic institutions, governmental
agencies and public and private research institutions. We anticipate that we will face intense and increasing competition as new drugs
and therapies enter the market and advanced technologies become available. In some indications, off-label use of non-approved drugs can
also be considered as competition.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"></span></p>


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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Companies, including Inventiva Pharma,
Cirius Therapeutics and Novo Nordisk A/S, have molecules currently in Phase 3 clinical development. Additionally, there are a host of
other potential competitors in earlier stages of clinical development relative to us for the treatment of NASH. Eli Lilly and Company,
Pfizer, Novartis, Bristol-Myers Squibb, Novo Nordisk A/S, Merck, Viking Therapeutics, Inc., Metacrine, Inc., Poxel SA, Can-Fite BioPharma,
89bio, Inc., Sagimet Biosciences Inc. Terns, Inc., AstraZeneca and Hepanova Inc. and others.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
December 2022, Madrigal announced positive topline results from its pivotal Phase 3 MAESTRO-NASH biopsy clinical trial of resmetirom,
a liver-directed selective thyroid hormone receptor agonist. MAESTRO-NASH, in which Madrigal reported that it achieved both liver histological
improvement endpoints that FDA proposed as reasonably likely to predict clinical benefit to support accelerated approval for the treatment
NASH with liver fibrosis.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
March 2024, Madrigal announced FDA approval of Rezdiffra (resmetirom) for the treatment of NASH with moderate to advanced liver fibrosis.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Notwithstanding
the foregoing, see &#8220;Item 3. Key Information&#8212;Risk Factors&#8212;Risks Related to Our Business, Industry and Regulatory Requirements&#8212;Our
market is subject to intense competition. If we are unable to compete effectively, Aramchol or any other product candidate that we develop
may be rendered noncompetitive or obsolete&#8221; and &#8220;Item 3. Key Information&#8212;Risk Factors&#8212;Risks Related to Our Business,
Industry and Regulatory Requirements&#8212;We are developing Aramchol for the treatment of NASH, an indication for which there are no
approved products, and there is significant uncertainty regarding the regulatory approval process. This makes it difficult to predict
the timing and costs of the clinical development of Aramchol for the treatment of NASH.&#8221;</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Intellectual
Property and Patent Strategy</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
proprietary nature of, and protection for, Aramchol or Amilo-5MER or any other product candidate and our discovery programs for new indications,
processes and know-how are important to our business. We own patent rights to Aramchol and Amilo-5MER in various jurisdictions worldwide,
including within and outside of Israel. We have sought patent protection in the United States and internationally for Aramchol and Amilo-5MER,
our discovery programs, and any other inventions to which we have rights, where available and when appropriate.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
have granted patents and pending patent applications in various jurisdictions relating to (1) the composition of matter of Aramchol meglumine
as well as a wide range of other salts, or the CoM Patent; (2) a method for treating/inhibiting hepatic fibrosis and non-hepatic fibrosis
associated or non-associated with NASH or NAFLD, or the Hepatic Fibrosis Patent; and (3) a method of treating dysbiosis, or the Dysbiosis
Patent. In addition, we have pending patent applications for Aramchol meglumine and other salts, including a granted U.S. patent for
low dose composition of Aramchol (US 10,849,911 B2) and other salts. We have been allowed or granted patents for Aramchol and other salts
which includes claims for the treatment of fatty liver in Europe and certain other countries. The CoM Patent application was granted
in the United States, Brazil and India. The CoM Patent that was granted in the United States and the expected term is December2034,.
The Hepatic Fibrosis Patent has been granted in United States (US 11,197,870 B2), Europe, Japan, Canada and in Israel and has an expected
term in each jurisdiction of 2037. The Dysbiosis Patent was granted in U.S., Israel and Mexico and has an expected term in US of 2038
and of 2037 in Israel and Mexico; and was allowed in Brazil. In addition, patent applications were granted in Israel relating to Aramchol
use in hepatic fibrosis treatment, optionally associated with NAFLD and NASH ; and in Mexico relating to Aramchol use to treat pulmonary
fibrosis. Also, a patent was granted in Mexico and Europe relating to Aramchol use for inhibition of fibrosis in NAFLD patients (having
fibrosis score of zero (0)). We also have granted patentsfor combination therapy for the treatment of liver disease in Canada, Europe,
and Mexico.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
have an exclusive license to a US granted patent directed to Amilo-5MER and anti-inflammatory compositions thereof On 2023 our collaborator,
YISSUM RESEARCH DEVELOPMENT COMPANY OF THE HEBREW UNIVERSITY OF JERUSALEM LTD was granted a new patent (US 11,560, 417 B2, a division
of US 10,611,819 B2) for using the 5MER for the treatment of inflammatory diseases which has an expected term until 2035.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Our
policy is to pursue, maintain and defend patent rights, whether developed internally or licensed from third parties, and to protect the
technology, inventions and improvements that are commercially important to the development of our business. We also rely on trade secrets
that may be important to the development of our business.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Patent
Portfolio for Aramchol and Aramchol Meglumine</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
patent portfolio for Aramchol contains eight patent families including pending patent applications and granted patents directed to composition
of matter, manufacturing methods and methods of use.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">All
patents in this family are expired (term ended).</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">A
patent family directed to topical uses of FABAC compounds (anti-acne) was granted in Europe and maintained in Germany, France, Italy,
the Netherlands and the United Kingdom. Expected term is 2033.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">A
patent family discloses and claims second generation FABAC salt compounds include Aramchol meglumine. This patent family includes Granted
U.S., Brazil, India, Europe (maintained in Albania, Austria, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Greece,
Hungary, Iceland, Italy, Latvia, Lithuania, Macedonia, Malta, Norway, Poland, Portugal, Romania, San Marino, Serbia, Slovakia, Slovenia,
Spain, Sweden, The Netherlands, Turkey, Belgium, France, Germany, Ireland, Luxembourg, Malta, Monaco, Switzerland and United Kingdom),
China, Hong Kong, Macau, Canada, Israel, Korea, Japan, and Australia patents. If the appropriate maintenance, renewal, annuity or other
governmental fees are paid, the expected term for this patent family is December 2034.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">A
patent family having one U.S. patent application, discloses and claims compositions comprising low doses of the second generation FABAC
compounds Aramchol meglumine and other salts which was granted by the USPTO. When the appropriate maintenance, renewal, annuity or other
governmental fees are paid, the expected term for this patent family is December2034.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">A
family is directed to treatment for modulating gut microbiota and/or dysbiosis using Aramchol. This patent family includes a granted
patents in Israel, U.S. and in Mexico; and pending foreign patent applications in Brazil, Canada, China, Europe, Hong Kong and Japan.
Expected term for this patent family is 2037,expect for U.S. where the term is 2038.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">A
patent family and eighth family are directed to uses of Aramchol and Aramchol meglumine for treating and inhibiting fibrosis. The families
have pending patent applications in in Australia, Brazil, Canada, China, Europe, Hong-Kong, Israel, Japan, Korea, Mexico and US. It was
granted in Canada, Europe, Japan and Mexico; and the treatment of pulmonary fibrosis was granted in Mexico and Japan (also dermal fibrosis
in Japan). Expected term of this patent family is 2037. Additionally, a U.S. patent application directed to a method for treating hepatic
fibrosis non-associated with non-alcoholic fatty acid liver disease &#8211; was granted, and the expected term is 2037. In addition,
a US applications have been filed and claims the treatment pulmonary, kidney, dermal, gastro intestinal and heart fibrosis by Aramchol.
The improved bio-availability of Aramchol is supported by the pharmacological model based on the preclinical and the ARREST data. Also,
treatment and inhibition of fibrosis by a regimen of 300 mg of Aramchol twice daily is pending in: Australia and China and granted in
Israel. Expected term of this patent family is 2039.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">A
patent family is directed to a combination therapy of aramchol and MGL3196 for treating fatty liver disease; and has a PCT application
which entered National Phase in: Australia, Brazil, Canada, China, Europe, Hong Kong, Israel, India, Japan, Korea, Mexico and U.S. It
was granted in Canada, Europe and Mexico. Expected term for this patent family is 2039.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Patent
Portfolio for Amilo-5MER</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
patent portfolio for Amilo-5MER contains two patent families including pending patent applications and granted patents directed to composition
of matter and methods of use.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">A
t patent family is directed to Amilo-5MER and anti-inflammatory compositions thereof. Galmed Research and Development Ltd. has an exclusive
license to the U.S. granted patent within this family, and the expected term of this U.S. patent is 2035. Galmed Research and Development
Ltd. has also exclusive licenses to the corresponding granted patents in Europe, Australia, Japan, China and India. The corresponding
applications in Brazil, Korea and Canada are pending. The non-US expected patent term is 2035. A divisional application claiming the
use of Amilo-5MER for the treatment of inflammatory diseases was granted in 2023.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">A
patent family is directed to peptides for treating acute respiratory distress syndrome. This family includes a pending PCT international
patent application. Galmed Research and Development Ltd. is a co-applicant in this PCT application with Yissum. The expected patent term
for this patent family is 2041.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Our
commercial success will depend in part on obtaining and maintaining patent protection and trade secret protection of our current and
other product candidates and the methods used to develop and manufacture them, as well as successfully defending these patents against
third-party challenges. Our ability to stop third parties from making, using, selling, offering to sell or importing our products depends
on the extent to which we have rights under valid and enforceable patents or trade secrets that cover these activities. We believe that
our patents provide broad and comprehensive coverage of Aramchol and the Amilo-5MER and uses thereof. However, the patent positions of
biopharmaceutical companies, such as ourselves, are generally uncertain and involve complex legal and factual questions. Our ability
to maintain and solidify our proprietary position for the technology will depend on our success in obtaining effective claims and enforcing
those claims once granted. There is no certainty that any of the Company&#8217;s pending patent applications will result in the issuance
of any patents. The issued patents and those that may be issued in the future, may be challenged, narrowed, circumvented or found to
be invalid or unenforceable, which could limit our ability to stop competitors from marketing related products or the length of term
of patent protection that we may have for our products. In addition, our competitors may independently develop similar technologies or
duplicate any technology developed by us, and the rights granted under any issued or future patents may not provide us with any meaningful
competitive advantages against these competitors. Furthermore, because of the extensive time required for development, testing and regulatory
review of a potential product, before any of our products can be commercialized, any related patent may expire or remain in force for
only a short period following commercialization, thereby reducing any advantage of such patent. For more risks associated with the protection
of our licensed intellectual property, see &#8220;Item 3. Key Information&#8212; Risk Factors&#8212;Risks Related to Our Intellectual
Property.&#8221;</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Trade
Secrets</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
addition to patents, we rely on trade secrets and know-how to develop and maintain our competitive position. Trade secrets and know-how
can be difficult to protect. We seek to protect our proprietary processes, in part, by confidentiality agreements and invention assignment
agreements with our employees, consultants, scientific advisors, contractors and commercial partners. These agreements are designed to
protect our proprietary information. We also seek to preserve the integrity and confidentiality of our data, trade secrets and know-how
by maintaining physical security of our premises and physical and electronic security of our information technology systems. While we
have confidence in these individuals, organizations and systems, such agreements or security measures may be breached, and we may not
have adequate remedies for any breach. In addition, our trade secrets may otherwise become known or be independently discovered by competitors
or others.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Seasonality</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; text-align: justify; margin: 0pt 0pt 0pt 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Our
business and operations are generally not affected by seasonal fluctuations or factors.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Raw
Materials and Suppliers</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
believe that the raw materials that we require to manufacture Aramchol are readily available commodities commonly used in the pharmaceutical
industry.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Manufacturing</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
do not own or operate manufacturing facilities for the production of Aramchol or any other product candidate, nor do we have plans to
develop our own manufacturing operations in the foreseeable future. We currently rely on third-party contract manufacturers for all of
our required raw materials, API and finished product for our non-clinical research and clinical trials. We do not have long term agreements
with any of these third parties. We also do not have any current contractual relationships for the manufacture of commercial supplies
of Aramchol if it is approved. If Aramchol or any other product candidate are approved by any regulatory agency, we intend to enter into
agreements with a third-party contract manufacturer or collaboration partner and one or more back-up manufacturers for the commercial
production of those products. Development and commercial quantities of any products that we develop will need to be manufactured in facilities,
and by processes, that comply with the requirements of the FDA and the regulatory agencies of other jurisdictions in which we are seeking
approval. We currently employ internal resources to manage our manufacturing contractors. The relevant manufacturers of our drug substance
and drug products for our current pre-clinical and clinical trials have advised us that they are compliant with both cGMP and, cGLP.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">There
can be no assurance that Aramchol, if approved, can be manufactured in sufficient commercial quantities, in compliance with regulatory
requirements and at an acceptable cost. We and our contract manufacturers are, and will be, subject to extensive governmental regulation
in connection with the manufacture of any pharmaceutical products or medical devices. We and our contract manufacturers must ensure that
all of the processes, methods and equipment are compliant with cGMP and cGLP for drugs on an ongoing basis, as mandated by the FDA and
other regulatory authorities, and conduct extensive audits of vendors, contract laboratories and suppliers.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Contract
Research Organizations</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
outsource certain clinical trial activities to CROs. Our clinical CROs comply with guidelines from the International Conference on Harmonisation
of Technical Requirements for Registration of Pharmaceuticals for Human Use, which attempt to harmonize the FDA, the EMA, and the Pharmaceuticals
and Medical Devices Agency of Japan regulations and guidelines. We create and implement the drug development plans and manage the CROs
according to the specific requirements of the drug candidate under development. To the extent clinical research is overseen by the CROs
(or directly by us), compliance with certain federal regulations, including but not limited to 21 C.F.R. parts 50, 54, 56, 58 and 312,
which pertain to, among other things, IRBs, informed consent, financial conflicts of interest by investigators, correct administration
of treatment, follow up of adverse events, good laboratory practices and submitting IND applications, may be required.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Marketing,
Sales and Commercialization</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Given
our stage of development, we do not have any internal sales, marketing or distribution infrastructure or capabilities. In the event we
receive regulatory approval for any product candidate we intend, where appropriate, to pursue commercialization relationships, including
strategic alliances and licensing, with pharmaceutical companies and other strategic partners, which are equipped to market and/or sell
our product candidates through their well-developed sales, marketing and distribution organizations in order to gain access to global
markets. In addition, we may out-license some or all of our worldwide patent rights to more than one party to achieve the fullest development,
marketing and distribution of any products we develop. Over the longer term, we may consider ultimately building an internal marketing,
sales and commercial infrastructure. See &#8220;Item 4. Information on the Company&#8212; Business Overview&#8212;Strategic Collaborations,
Research Arrangements and other Material Agreements&#8212;Samil Pharm Co.&#8221; for information regarding the license agreement we entered
with Samil for the commercialization of Aramchol (with an option to manufacture) for the treatment of fatty liver indications including
NASH, in the Republic of Korea.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Environmental
Matters</b></span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">We,
our agents and our service providers, including our manufacturers, may be subject to various environmental, health and safety laws and
regulations, including those governing air emissions, water and wastewater discharges, noise emissions, the use, management and disposal
of hazardous, radioactive and biological materials and wastes and the cleanup of contaminated sites. We believe that our business, operations
and facilities, including, to our knowledge, those of our agents and service providers, are being operated in compliance in all material
respects with applicable environmental and health and safety laws and regulations. All information with respect to any chemical substance
is filed and stored as a Material Safety Data Sheet, as required by applicable environmental regulations. Based on information currently
available to us, we do not expect environmental costs and contingencies to have a material adverse effect on us. However, significant
expenditures could be required in the future if we, our agents or our service providers are required to comply with new or more stringent
environmental or health and safety laws, regulations or requirements.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Government
Regulation and Product Approval</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Governmental
authorities in the United States and in other countries extensively regulate, among other things, the research, development, testing,
manufacture, labeling, packaging, promotion, storage, advertising, distribution, marketing and export and import of products such as
those we are developing. Aramchol or any other product candidate must be approved by the FDA through the NDA process before they may
be legally marketed in the United States and by the Committee on Human Medicinal Products, or CHMP, via the EMA and European Commission
through the MAA process before they may be legally marketed in Europe, or MHRA through its authorization procedures before they may be
legally marketed in the UK. Aramchol or any other product candidate will be subject to similar requirements in other countries prior
to marketing in those countries. The process of obtaining regulatory approvals and the subsequent compliance with applicable federal,
state, local and foreign statutes and regulations require the expenditure of substantial time and financial resources.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>United
States Government Regulation</i></b></span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><span style="text-decoration: underline">NDA
Approval Processes</span></span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
the United States, the FDA regulates drugs under the Federal Food, Drug, and Cosmetic Act, or the FDCA, and implementing regulations
and guidance documents. Failure to comply with the applicable U.S. requirements at any time during the product development process or
approval process, or after approval, may subject an applicant to administrative or judicial sanctions, any of which could have a material
adverse effect on us. These sanctions could include refusal to approve pending applications, withdrawal of an approval, imposition of
a clinical hold, issuance of warning letters, product seizures, total or partial suspension of production or distribution, injunctions,
fines, disgorgement, and civil or criminal penalties.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; text-align: justify; margin: 0pt 0pt 0pt 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
process required by the FDA before a drug may be marketed in the United States generally involves the following:</span></p>

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<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">completion of pre-clinical
    laboratory tests, animal studies and formulation studies conducted according to GLPs, or other applicable regulations;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">submission to the FDA of
    an IND application, which must become effective before human clinical trials may begin;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">performance of adequate
    and well-controlled human clinical trials according to GCPs, to establish the safety and efficacy of the proposed drug for its intended
    use;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">submission to the FDA of an NDA;</span></td></tr>
  </table>
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<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">satisfactory completion
    of an FDA inspection of the manufacturing facility or facilities at which the product is produced to assess compliance with cGMPs
    to assure that the facilities, methods and controls are adequate to preserve the drug&#8217;s identity, strength, quality and purity;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">satisfactory completion of FDA inspections of clinical
    sites and GLP toxicology studies; and</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">FDA review and approval of the NDA.</span></td></tr>
  </table>
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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
testing and approval process requires substantial time, effort and financial resources, and we cannot be certain that any approvals for
Aramchol, Amilo-5MER or any other product candidate will be granted on a timely basis, if at all.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Once
a product candidate is identified for development, it enters the pre-clinical testing stage. Pre-clinical tests include laboratory evaluations
of product chemistry, toxicity and formulation, as well as animal studies. An IND sponsor must submit the results of the pre-clinical
tests, together with manufacturing information and analytical data, to the FDA as part of the IND. Some pre-clinical testing may continue
after the IND is submitted. In addition to including the results of the pre-clinical studies, the IND will also include a clinical trial
protocol detailing, among other things, the objectives of the clinical trial, the parameters to be used in monitoring safety and, depending
on the phase of the study, the effectiveness criteria to be evaluated. The IND automatically becomes effective 30 days after receipt
by the FDA, unless the FDA, within the 30-day time period, places the IND on clinical hold. In such a case, the IND sponsor and the FDA
must resolve any outstanding concerns before clinical trials can begin. A clinical hold may occur at any time during the life of an IND,
due to safety concerns or non-compliance, and may affect one or more specific studies or all studies conducted under the IND.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">All
clinical trials must be conducted under the supervision of one or more qualified investigators in accordance with the FDA&#8217;s GCP
regulations. These regulations include the requirement that all research subjects provide informed consent. Further, an IRB must review
and approve the plan for any clinical trial, including the informed consent document, before it commences at any institution. An IRB
considers, among other things, whether the risks to individuals participating in the trials are minimized and are reasonable in relation
to anticipated benefits. The IRB also approves the investigator brochure and other information about the trial distributed by the sponsor
and the consent form that must be provided to each trial subject or his or her legal representative and must monitor the study until
completed. All clinical trials must be conducted under protocols detailing the objectives of the trial, dosing procedures, research subject
inclusion and exclusion criteria and the safety and effectiveness criteria to be evaluated. Each protocol must be submitted to the FDA
as part of the IND, and progress reports detailing the status of the clinical trials must be submitted to the FDA annually. Sponsors
must also report within set timeframes to FDA serious and unexpected adverse reactions, any clinically important increase in the rate
of a serious suspected adverse reaction over that listed in the protocol or investigation brochure, or any findings from other studies
or animal or in-vitro testing that suggest a significant risk in humans exposed to the drug. Sponsors must also report to FDA certain
amendments to the protocol and other essential information concerning the IND that does not fall within the scope of other required reports.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; text-align: justify; margin: 0pt 0pt 0pt 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Human
clinical trials are typically conducted in three sequential phases that may overlap or be combined:</span></p>

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<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><i>Phase 1. </i>The drug
    is initially introduced into healthy human subjects and tested for safety, dosage tolerance, absorption, metabolism, distribution
    and elimination. In the case of some products for severe or life-threatening diseases, such as cancer, especially when the product
    may be inherently too toxic to ethically administer to healthy volunteers, the initial human testing is often conducted in patients.</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><i>Phase 2. </i>Clinical
    trials are performed on a limited patient population intended to identify possible adverse effects and risks, to preliminarily evaluate
    the efficacy of the product for specific targeted diseases and to determine dosage tolerance and optimal dosage.</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><i>Phase 3. </i>Clinical
    trials are undertaken to further evaluate dosage, clinical efficacy and safety in an expanded patient population at geographically
    dispersed clinical study sites. Phase 3 clinical trials are conducted to provide sufficient data for the statistically valid evidence
    of safety and efficacy.</span></td></tr>
  </table>
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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"></span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><i>Phase 4. </i>The FDA
    may require that the sponsor conduct additional clinical trials following new drug approval. The purpose of these trials, known as
    Phase 4 studies, is to monitor long-term risks and benefits, study different dosage levels or evaluate safety and effectiveness.
    In recent years, the FDA has increased its reliance on these trials. Phase 4 studies usually involve thousands of participants. Phase
    4 studies also may be initiated by the company sponsoring the new drug to gain broader market value for an approved drug.</span></td></tr>
  </table>
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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Human
clinical trials are inherently uncertain and Phase 1, Phase 2, Phase 3 and Phase 4 testing may not be successfully completed. The FDA
or the sponsor may suspend a clinical trial at any time for a variety of reasons, including a finding that the research subjects or patients
are being exposed to an unacceptable health risk. Similarly, an IRB can suspend or terminate approval of a clinical trial at its institution
if the clinical trial is not being conducted in accordance with the IRB&#8217;s requirements or if the drug has been associated with
unexpected serious harm to patients.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">During
the development of a new drug, sponsors are given opportunities to meet with the FDA at certain points. These points are typically prior
to the submission of an IND, at the end of Phase 2 and before an NDA is submitted. Meetings at other times may also be requested. These
meetings can provide an opportunity for the sponsor to share information about the data gathered to date and for the FDA to provide advice
on the next phase of development. Sponsors typically use the meeting at the end of Phase 2 to discuss their Phase 2 clinical results
and present their plans for the pivotal Phase 3 clinical trial that they believe will support the approval of the NDA.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Concurrent
with clinical trials, sponsors usually complete any remaining animal safety studies and also develop additional information about the
chemistry and physical characteristics of the drug and finalize a process for manufacturing commercial quantities of the product in accordance
with cGMP requirements. The manufacturing process must be capable of consistently producing quality batches of the drug and the manufacturer
must develop methods for testing the quality, purity and potency of the drug. Additionally, appropriate packaging must be selected and
tested and stability studies must be conducted to demonstrate that the drug candidate does not undergo unacceptable deterioration over
its proposed shelf-life.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
results of product development, pre-clinical studies and clinical trials, along with descriptions of the manufacturing process, analytical
tests and other control mechanisms, proposed labeling and other relevant information are submitted to the FDA as part of an NDA requesting
approval to market the product for one or more specified indications. The submission of an NDA is subject to the payment of an application
fee, but a waiver of such fees may be obtained under specified circumstances. We will seek a waiver of these fees as a small business
submitting its first human drug application to the FDA. If the waiver is granted it would not extend to establishment or product fees.
The FDA reviews all NDAs submitted to ensure that they are sufficiently complete for substantive review before it accepts them for filing.
It may request additional information rather than accept an NDA for filing. In this event, the NDA must be resubmitted with the additional
information. The resubmitted application also is subject to review before the FDA accepts it for filing.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Once
the submission is accepted for filing, the FDA begins an in-depth review. The FDA may refuse to approve an NDA if the applicable statutory
and regulatory criteria are not satisfied or may require additional clinical or other data. Even if such data are submitted, the FDA
may ultimately decide that the NDA does not satisfy the criteria for approval. The FDA reviews an NDA to determine, among other things,
whether a product is safe and effective for its intended use and whether its manufacturing is cGMP-compliant. The FDA may refer the NDA
to an advisory committee for review and recommendation as to whether the application should be approved and under what conditions. The
FDA is not bound by the recommendation of an advisory committee, but it generally follows such recommendations. Before approving an NDA,
the FDA will typically inspect the facility or facilities where the product is manufactured and tested. The FDA will also inspect selected
clinical sites that participated in the clinical studies and may inspect the testing facilities that performed the GLP toxicology studies
cited in the NDA.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><span style="text-decoration: underline">Expedited
Review and Approval</span></span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
FDA has various specific programs, including Fast Track, Breakthrough Therapy, Priority Review, and Accelerated Approval, which, in different
ways, are each intended to expedite the process for reviewing and approving drugs. Even if a drug qualifies for one or more of these
programs, the FDA may later decide that the drug no longer meets the conditions for qualification or that the time period for FDA review
or approval will be shortened. Generally, drugs that are eligible for these programs are those for serious or life-threatening conditions,
those with the potential to address unmet medical needs and those that offer meaningful benefits over existing treatments. For example,
Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious or life-threatening
diseases or conditions and fill unmet medical needs, and Breakthrough Therapy designation is designed to expedite the development and
review of drugs that are intended to treat a serious condition where preliminary clinical evidence indicates that the drug may demonstrate
substantial improvement over available therapy on a clinically significant endpoint(s). Priority review is designed to give drugs that
offer major advances in treatment or provide a treatment where no adequate therapy exists an initial review within six months as compared
to a standard review time of ten months. Although Fast Track, Breakthrough Therapy designation and priority review do not affect the
standards for approval, the FDA will attempt to facilitate early and frequent meetings with a sponsor of a Fast Track or Breakthrough
Therapy designated drug and expedite review of the application for a drug designated for priority review. The FDA will also provide Breakthrough
Therapy designated drugs intensive guidance on an efficient drug development program and provide these drug developers with an organizational
commitment from the FDA involving senior managers. Since sponsors can design clinical trials in a number of ways, in providing its guidance
for drugs designated as breakthrough therapies, the FDA will seek to ensure that the sponsor of the product designated as a breakthrough
therapy receives timely advice and interactive communications in order to help the sponsor design and conduct a development program as
efficiently as possible. During these interactions, the FDA may suggest, or a sponsor can propose, alternative clinical trial designs
(e.g., adaptive designs, an enrichment strategy, use of historical controls) that may result in smaller trials or more efficient trials
that require less time to complete. Such trial designs could also help minimize the number of patients exposed to a potentially less
efficacious treatment (i.e., the control group treated with available therapy). On September 23, 2014, the FDA granted Fast Track designation
status to Aramchol for the treatment of patients who are overweight or obese and have pre diabetes or type II diabetes mellitus with
NASH.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Accelerated
Approval, which is described in 21 C.F.R. &#167; 314.500 <i>et seq</i>., provides for approval of a new drug that is intended to treat
a serious or life-threatening disease or condition and that fills an unmet medical need based on a surrogate endpoint. A surrogate endpoint
is a laboratory measurement or physical sign used as an indirect or substitute measurement representing a clinically meaningful outcome.
To be used in accelerated approval, a surrogate endpoint must be &#8220;reasonably likely, based on epidemiologic, therapeutic, pathophysiologic,
or other evidence to predict benefit on irreversible morbidity or mortality.&#8221; The term &#8220;reasonably likely&#8221; implies
that some uncertainty remains about the relationship of the surrogate to the clinical benefit to the patient. Therefore, accelerated
approval is typically contingent on a sponsor&#8217;s agreement to conduct additional post-approval studies to verify and describe the
drug&#8217;s clinical benefit. Accelerated Approval does not change the standards for approval, but by allowing a demonstration of efficacy
based on a surrogate endpoint may expedite the approval process.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><span style="text-decoration: underline">FDA
Guidance</span></span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
December 2018, the FDA issued &#8220;Noncirrhotic Nonalcoholic Steatohepatitis with Liver Fibrosis: Developing Drugs for Treatment&#8221;,
or &#8220;the December Guidance&#8221;. The December Guidance, though nonbinding on the FDA or us, is intended to assist sponsors in
the clinical development of drugs for the treatment of noncirrhotic NASH with liver fibrosis, describes the FDA&#8217;s current thinking
regarding the necessary components of a drug development program for noncirrhotic NASH with liver fibrosis and identifies knowledge gaps
that represent important challenges in the development of drugs for the indication. According to the FDA, the ultimate goal of NASH treatment
is to slow the progress of, halt, or reverse disease progression and improve clinical outcomes (i.e., prevent progression to cirrhosis
and cirrhosis complications, reduce the need for liver transplantation, and improve survival). Because of the slow progression of NASH
and the time required to conduct a trial that would evaluate clinical endpoints such as progression to cirrhosis or survival, the FDA
recommends sponsors consider the following liver histological improvements as endpoints reasonably likely to predict clinical benefit
to support accelerated approval under the regulations:</span></p>

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<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Resolution of steatohepatitis
    on overall histopathological reading and no worsening of liver fibrosis on NASH CRN fibrosis score. Resolution of steatohepatitis
    is defined as absent fatty liver disease or isolated or simple steatosis without steatohepatitis and a NAS score of 0&#8211;1 for
    inflammation, 0 for ballooning, and any value for steatosis; or</span></td></tr>
  </table>
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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Improvement in liver fibrosis
    greater than or equal to one stage (NASH CRN fibrosis score) and no worsening of steatohepatitis (defined as no increase in NAS for
    ballooning, inflammation, or steatosis)</span></td></tr>
  </table>
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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Further,
according to the FDA, for NASH drugs approved on the basis of liver histology under the accelerated approval pathway, randomized, double-blind,
placebo-controlled clinical trials designed to describe and verify the drug&#8217;s clinical benefit should be underway at the time of
submission of the marketing application. Clinical benefit can be verified by demonstrating superiority to placebo in delaying disease
progression measured by a composite endpoint.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
EMA also issued a reflection paper to provide guidance on drug development in the field of NASH. However, the EMA indicated, among other
things, that both resolution of NASH without worsening of fibrosis and improvement in fibrosis without worsening of NASH would both be
required as intermediate endpoints for demonstrating statistical significance for stage 2 and 3 fibrosis.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">See
also &#8220;Item 3. Key Information&#8212;Risk Factors&#8212;Risk Factors&#8212;Risks Related to Our Business, Industry and Regulatory
Requirements - We are developing Aramchol for the treatment of NASH, an indication for which there are no approved products, and there
is significant uncertainty regarding the regulatory approval process. This makes it difficult to predict the timing and costs of the
clinical development of Aramchol for the treatment of NASH.&#8221;</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><span style="text-decoration: underline">Patent
Term Restoration and Marketing Exclusivity</span></span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Depending
upon the timing, duration and specifics of FDA approval of the use of Aramchol or any other product candidate, U.S. patents may be eligible
for limited patent term extension under the Hatch-Waxman Act. The Hatch-Waxman Act permits a patent restoration term of up to five years
as compensation for patent term lost during product development and the FDA regulatory review process. However, patent term restoration
cannot extend the remaining term of a patent beyond a total of 14 years from the product&#8217;s approval date. The patent term restoration
period is generally one-half the time between the effective date of an IND, and the submission date of an NDA, plus the time between
the submission date of an NDA and the approval of that application. Only one patent applicable to an approved drug is eligible for the
extension and the application for extension must be made prior to expiration of the patent. The USPTO, in consultation with the FDA,
reviews and approves the application for any patent term extension or restoration. In the future, we intend to apply for restorations
of patent term for some of our currently owned patents to add patent life beyond their current expiration date, depending on the expected
length of clinical trials and other factors involved in the submission of the relevant NDA.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Market
exclusivity provisions under the FDCA can also delay the submission or the approval of certain applications. The FDCA provides a five-year
period of non-patent marketing exclusivity within the United States to the first applicant to gain approval of an NDA for a new chemical
entity. A drug is a new chemical entity if the FDA has not previously approved any other new drug containing the same active moiety,
which is the molecule or ion responsible for the action of the drug substance. During the exclusivity period, the FDA may not accept
for review an abbreviated new drug application, or ANDA, or a 505(b)(2) NDA submitted by another company for another version of such
drug where the applicant does not own or have a legal right of reference to all the data required for approval. However, an application
may be submitted after four years if it contains a certification of patent invalidity or non-infringement. The FDCA also provides three
years of marketing exclusivity for an NDA, 505(b)(2) NDA or supplement to an approved NDA if new clinical investigations, other than
bioavailability studies, that were conducted or sponsored by the applicant are deemed by the FDA to be essential to the approval of the
application, for example, for new indications, dosages or strengths of an existing drug. This three-year exclusivity covers only the
conditions associated with the new clinical investigations and does not prohibit the FDA from approving ANDAs for drugs containing the
original active agent. Five-year and three-year exclusivity will not delay the submission or approval of a full NDA; however, an applicant
submitting a full NDA would be required to conduct or obtain a right of reference to all of the pre-clinical studies and adequate and
well-controlled clinical trials necessary to demonstrate safety and effectiveness.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><span style="text-decoration: underline">Post-approval
Requirements</span></span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Once
an approval is granted, the FDA, European authorities and other regulatory authorities may withdraw the approval if compliance with regulatory
requirements is not maintained or if problems occur after the product reaches the market. Later discovery of previously unknown problems
with a product may result in restrictions on the product or even complete withdrawal of the product from the market. After approval,
some types of changes to the approved product, such as adding new indications, manufacturing changes and additional labeling claims,
are subject to further regulatory authority review and approval. Some of these modifications, especially adding indications, would likely
require additional clinical studies. In addition, the FDA may require testing and surveillance programs to monitor the effect of approved
products that have been commercialized, and the FDA has the power to prevent or limit further marketing of a product based on the results
of these post-marketing programs.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Any
drug product manufactured or distributed by us pursuant to FDA approvals are subject to continuing regulation by the FDA, including,
among other things record-keeping requirements; cGMPs; reporting of adverse experiences with the drug; providing the FDA with updated
safety and efficacy information; drug sampling and distribution requirements; notifying the FDA and gaining its approval of specified
manufacturing or labeling changes; and complying with FDA promotion and advertising requirements.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Drug
manufacturers and other entities involved in the manufacture and distribution of approved drugs are required to register their establishments
with the FDA and certain state agencies, and are subject to periodic unannounced inspections by the FDA and some state agencies for compliance
with cGMP and other laws.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
rely, and expect to continue to rely, on third parties for the production of clinical and commercial quantities of Aramchol. Future FDA
and state inspections may identify compliance issues at the facilities of our contract manufacturers that may disrupt production or distribution,
or require substantial resources to correct.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">From
time to time, legislation is drafted, introduced and passed in Congress that could significantly change the statutory provisions governing
the approval, manufacturing and marketing of products regulated by the FDA. In addition, FDA regulations and guidance are often revised
or reinterpreted by the agency in ways that may significantly affect our business and our products. It is impossible to predict whether
legislative changes will be enacted, or FDA regulations, guidance or interpretations changed or what the impact of such changes, if any,
may be. In particular, it is unknown whether any of the provisions of the 2016 21<sup>st</sup> Century Cures Act that are intended to
accelerate drug approval will result in any change in the current approval pathway for Aramchol.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Pursuant
to the Affordable Care Act (discussed in greater detail below), the Centers for Medicare &amp; Medicaid Services (CMS) is required to
collect and publish information reported by applicable manufacturers about payments and other transfers of value manufacturers have made
to physicians and teaching hospitals. Such a law, when applicable to our products, could increase the company&#8217;s regulatory liability
through the imposition of additional reporting and regulatory requirements. There are also an increasing number of state laws that require
manufacturers to make similar reports to states on pricing and marketing information.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><span style="text-decoration: underline">Reimbursement</span></span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
face uncertainties over the pricing of pharmaceutical products. Sales of Aramchol or any other product candidate will depend, in part,
on the extent to which the costs of Aramchol or any other product candidate will be covered by third-party payors, such as federal health
programs, commercial insurance and managed care organizations. These third-party payors are increasingly challenging the prices charged
for medical products and services. Additionally, the containment of healthcare costs has become a priority of federal and state governments
and the prices of drugs have been a focus in this effort. The U.S. government, state legislatures, foreign governments and third party
payors have shown significant interest in implementing cost-containment programs, including price controls, pricing transparency disclosure
obligations, restrictions on reimbursement and requirements for substitution of generic products. Adoption of price controls and cost-containment
measures, and adoption of more restrictive policies in jurisdictions with existing controls and measures, could further limit our net
revenue and results. If these third-party payors do not consider Aramchol or any other product candidate to be cost-effective compared
to other therapies, they may not cover Aramchol or any other product candidate after approved as a benefit under their plans or, if they
do, the level of payment may not be sufficient to allow us to sell Aramchol or any other product candidate on a profitable basis.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
Medicare Modernization Act imposed new requirements for the distribution and pricing of prescription drugs for Medicare beneficiaries
under Part D. Under Part D, Medicare beneficiaries may enroll in prescription drug plans offered by private entities that provide coverage
of outpatient prescription drugs. Part D prescription drug plan sponsors are not required to pay for all covered Part D drugs, and each
drug plan can develop its own drug formulary that identifies which drugs it will cover and at what tier or level. However, Part D prescription
drug formularies must include drugs within each therapeutic category and class of covered Part D drugs, though not necessarily all the
drugs in each category or class. The Centers for Medicare &amp; Medicaid Services published a final rule in 2014 implementing the Medicare
Modernization Act. Contrary to the proposed rule, which would have enabled Part D plans to offer fewer drugs, the final rule maintained
the existing six protected classes of drug categories, but stated that some of the proposals not included in the final rule could still
be finalized in the future, which would impact payor formulary and coverage decisions.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
American Recovery and Reinvestment Act of 2009 provides funding for the federal government to compare the effectiveness of different
treatments for the same illness. A plan for the research will be developed by the Department of Health and Human Services, the Agency
for Healthcare Research and Quality and the National Institutes for Health, and periodic reports on the status of the research and related
expenditures will be made to Congress. Although the results of the comparative effectiveness studies are not intended to mandate coverage
policies for public or private payors, it is not clear what effect, if any, the research will have on the sales of any product, if any
such product or the condition that it is intended to treat is the subject of a study. It is also possible that comparative effectiveness
research demonstrating benefits in a competitor&#8217;s product could adversely affect the sales of Aramchol or any other product candidate.
If third-party payors do not consider Aramchol or any other product candidate to be cost-effective compared to other available therapies,
they may not cover Aramchol or any other product candidate as a benefit under their plans or, if they do, the level of payment may not
be sufficient to allow us to sell Aramchol or any other product candidate on a profitable basis.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
Affordable Care Act, enacted in March 2010, has had a significant impact on the health care industry. Some of the key changes made to
date pursuant to the Affordable Care Act include an expansion of coverage for the uninsured, the creation of insurance marketplaces and
increased protection of insureds with new benefits, rights and protections. With regard to pharmaceutical products, among other things,
the Affordable Care Act made major changes to the Medicare prescription drug program, which helped reduce drug costs for seniors and
increased rebates and other costs for the pharmaceutical industry.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">There
have been judicial and congressional challenges to the Affordable Care Act. In December 2017, Congress passed and then the President
Trump signed into law tax reform legislation that made significant changes to the Affordable Care Act including the repeal of the &#8220;individual
mandate&#8221; that was in place to strongly encourage broad participation in the health insurance markets. On December 14, 2018, a federal
district court in Texas ruled that the PPACA is unconstitutional as a result of the Tax Cuts and Jobs Act, the federal income tax reform
legislation previously passed by Congress and signed by President Trump on December 22, 2017, that eliminated the individual mandate
portion of the PPACA. The case, Texas, et al, v. United States of America, et al., (N.D. Texas), is an outlier, but in 2019, the Fifth
Circuit Court of Appeals subsequently upheld the lower court decision which was then appealed to the United States Supreme Court. The
U.S. Supreme Court declined to hear the appeal on an expedited basis and so no decision is expected until sometime in 2021 before the
end of the Supreme Court&#8217;s current term. We are not able to state with any certainty what will be impact of this court decision
on our business pending further court action and possible appeals. Given these changes and other statements of political leaders, we
cannot predict the ultimate impact on the Affordable Care Act and the subsequent effect on the pharmaceutical industry at this time.
In November 2020, Joseph Biden was elected President and, in January 2021, the Democratic Party obtained control of the Senate. As a
result of these electoral developments, it is unlikely that continued legislative efforts will be pursued to repeal PPACA. Instead, it
is possible that executive and regulatory initiatives, as well as legislation, will be pursued to enhance or reform PPACA. We are not
able to state with certainty what the impact of potential legislation will be on our business.</span></p>

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addition, in some non-U.S. jurisdictions, the proposed pricing for a drug must be approved before it may be lawfully marketed. The requirements
governing drug pricing vary widely from country to country. For example, the EU provides options for its member states to restrict the
range of medicinal products for which their national health insurance systems provide reimbursement and to control the prices of medicinal
products for human use. A member state may approve a specific price for the medicinal product or it may instead adopt a system of direct
or indirect controls on the profitability of the company placing the medicinal product on the market. There can be no assurance that
any country that has price controls or reimbursement limitations for pharmaceutical products will allow favorable reimbursement and pricing
arrangements for Aramchol, Amilo-5MER or any other product candidate. Historically, products launched in the EU do not follow price structures
of the United States and generally tend to be significantly lower.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><span style="text-decoration: underline">Healthcare
Fraud and Abuse Laws</span></span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
the U.S., the research, development, testing, manufacturing, handling, storage, distribution, sale and promotion of drug products and
medical devices are potentially subject to regulation by various federal, state and local authorities in addition to the FDA, including
the Centers for Medicare &amp; Medicaid Services, other divisions of the U.S. Department of Health and Human Services (e.g., the Office
of Inspector General), the U.S. Department of Justice, state Attorneys General, and other state and local government agencies. For example,
sales, marketing and scientific/educational grant programs must comply with the fraud and abuse provisions applicable to pharmaceutical
manufacturers, including the federal &#8220;Anti-Kickback Statute&#8221;, the Civil Monetary Penalty Statute, the Stark Law, the federal
False Claims Act, as amended, state and federal &#8220;Physician Payment Sunshine Act&#8221; laws and regulations, the privacy regulations
promulgated under the Health Insurance Portability and Accountability Act, or HIPAA, and similar state laws. Pricing and rebate programs
must comply with the Medicaid Drug Rebate Program requirements of the Omnibus Budget Reconciliation Act of 1990, as amended, and the
Veterans Health Care Act of 1992, as amended. If products are made available to authorized users of the Federal Supply Schedule of the
General Services Administration, additional laws and requirements apply. All of these activities are also potentially subject to federal
and state consumer protection and unfair competition laws. Some of these health care laws include:</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
Anti- Kickback Statute makes it illegal for any person, including a prescription drug manufacturer (or a party acting on its behalf)
to knowingly and willfully solicit, receive, offer, or pay any remuneration that is intended to induce the referral of business, including
the purchase, order, or prescription of a particular drug, for which payment may be made under a federal healthcare program, such as
Medicare or Medicaid.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
federal False Claims Act prohibits anyone from knowingly presenting, conspiring to present, making a false statement in order to present,
or causing to be presented, for payment to federal programs (including Medicare and Medicaid) claims for items or services, including
drugs, that are false or fraudulent, claims for items or services not provided as claimed, or claims for medically unnecessary items
or services. This law also prohibits anyone from knowingly underpaying an obligation owed to a federal program. Increasingly, U.S. federal
agencies are requiring nonmonetary remedial measures, such as corporate integrity agreements in False Claims Act settlements. The U.S.
Department of Justice announced in 2016 its intent to follow the &#8220;Yates Memo,&#8221; taking a far more aggressive approach in pursuing
individuals as False Claims Act defendants in addition to the corporations.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
Physician Payment Sunshine Act, enacted in 2010 as part of the Affordable Care Act, requires certain manufacturers of pharmaceuticals
and medical devices to annually report certain payments and other transfers of value to physicians (defined to include doctors, dentists,
optometrists, podiatrists and chiropractors) and teaching hospitals, as well as investment interests held by physicians and their immediate
family members. Effective January 1, 2022, covered manufacturers will also be required to report on payments and other transfers of value
to physician assistants, nurse practitioners or clinical nurse specialists, anesthesiologist assistants, certified registered nurse anesthetists,
and certified nurse-midwives during the previous year. In recent years, several states in the United States have also enacted legislation
requiring pharmaceutical companies to file periodic reports with the state, make periodic public disclosures on sales, marketing, pricing,
clinical trials and other activities, and/or register their sales representatives, as well as establish marketing compliance programs.
These laws may affect our sales, marketing, and other promotional activities by imposing administrative and compliance burdens on us.
Failure to meet these requirements, to the extent they are applicable to our activities, could also result in a variety of governmental
sanctions that could have a material adverse effect on our business.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">If
our operations are found to be in violation of any of the foregoing or other applicable health care laws and regulations, we may be subject
to penalties, including significant administrative, civil and criminal penalties, monetary damages, disgorgement, imprisonment, the curtailment
or restructuring of our operations, loss of eligibility to obtain approvals from the FDA, or exclusion from participation in government
contracting, healthcare reimbursement or other government programs, including Medicare and Medicaid.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>European
Economic Area</i></b></span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
addition to approval in the United States, we currently intend to seek regulatory approval of Aramchol in the EU. As such, a summary
of the EU regulatory processes follows below.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">A
medicinal product may only be placed on the market in the European Economic Area, or the EEA, composed of the 27 EU member states of
the EU, plus Norway, Iceland and Lichtenstein, when a marketing authorization has been issued by the competent authority of the respective
member state pursuant to member states&#8217; law based on Directive 2001/83/EC, as amended, or an authorization has been granted under
the centralized procedure in accordance with Regulation (EC) No. 726/2004, as amended, or its predecessor, Regulation 2309/93. There
are essentially three community procedures created under prevailing European pharmaceutical legislation that, if successfully completed,
allow an applicant to place a medicinal product on the market in the respective EU or EEA member states.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
withdrawal of the United Kingdom (UK) from the EU took effect on January 1, 2021, and there are 27 member states remaining in the EU.
As of January 1, 2021, the UK is a &#8220;third country&#8221; with regard to the EU (subject to the terms of the EU UK Trade Agreement)
and EU law ceased to apply directly in the UK. However, the UK has retained the EU medicines regulatory regime with certain modifications
as standalone UK legislation. Therefore, the UK regulatory regime is currently similar to EU regulations, but under new legislation,
the Medicines and Medical Devices Act 2021, the UK may adopt changed regulations that may diverge from the EU legislative regime for
medicines and their research, development and commercialization. In order to market a medicinal product in the UK, a license or marketing
authorization must be obtained from the UK Medicines and Healthcare Products Regulatory Agency (MHRA). The UK legislation includes multiple
assessment routes for applications for medicinal products, including a 150-day national assessment or a rolling review application. Further,
and for a transitional period until 31 December 2022, the MHRA may rely on a decision taken by the European Commission on the approval
of a new marketing authorization in the centralized procedure. In addition, the MHRA has the power to have regard to marketing authorizations
approved in EU member states through the decentralized and mutual recognition procedures.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><span style="text-decoration: underline">Centralized
Procedure</span></span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Regulation
726/2004/EC, as amended, governs the centralized procedure when a marketing authorization is granted by the European Commission, acting
in its capacity as the European Licensing Authority on the advice of the EMA. That authorization is valid throughout the entire community
and directly or (as to Norway, Iceland and Liechtenstein) indirectly allows the applicant to place the product on the market in all member
states of the EEA. The EMA is the administrative body responsible for coordinating the existing scientific resources available in the
member states for evaluation, supervision and pharmacovigilance of medicinal products. Certain medicinal products, as described in the
Annex to Regulation 726/2004, must be authorized centrally. These are products that are developed by means of certain biotechnological
processes in accordance with Paragraph 1 to the Annex to the Regulation. Medicinal products for human use containing a new active substance
that, on the date of effectiveness of the Regulation, was not authorized in the European Union, and for which the therapeutic indication
is the treatment of acquired immune deficiency syndrome, or AIDS, cancer, neurodegenerative disorder or diabetes, autoimmune diseases
and other immune dysfunctions and viral diseases must also be authorized centrally. Finally, all medicinal products that are designated
as orphan medicinal products pursuant to Regulation 141/2000 and Advanced Therapy Medicinal Products (ATMP) according to Reg. (EC) No.
1394/2007 and medicinal products for veterinary use that are used primarily as performance enhancers must be authorized under the centralized
procedure. An applicant may also opt for assessment through the centralized procedure if the medicinal product contains a new active
substance which was not authorized in the EU when Reg. (EC) No. 726/2004 entered into force, or if the applicant can show that the medicinal
product constitutes a significant therapeutic, scientific or technical innovation or that the granting of authorization centrally is
in the interests of patients or animal health at the community level. For each application submitted to the EMA for scientific assessment,
the EMA is required to ensure that the opinion of the Committee for Medicinal Products for Human Use, or CHMP, is given within 210 days
after receipt of a valid application. This 210 days period does not include the time that the applicant needs to answer any questions
raised during the application procedure, the so-called &#8216;clock stop&#8217; period. If the opinion is positive, the EMA is required
to send the opinion to the European Commission, which is responsible for preparing the draft decision granting a marketing authorization.
This draft decision may differ from the CHMP opinion, stating reasons for diverging from the CHMP opinion. The draft decision is sent
to the applicant and the member states, after which the European Commission takes a final decision. If the initial opinion of the CHMP
is negative, the applicant is afforded an opportunity to seek a re-examination of the opinion. In that case, the applicant may, within
15 days after receipt of the opinion, give written notice to EMA that he wishes to request a re-examination of the opinion. The applicant
is then required to forward the detailed grounds for request within 60 days after receipt of the opinion. The CHMP is required to re-examine
its opinion within 60 days following receipt of the request by the applicant. All CHMP refusals and the reasons for refusal are made
public on the EMA website. Without a centralized marketing authorization it is prohibited to place a medicinal product that must be authorized
centrally on the market in the EU. Once a centralized marketing authorization has been granted by the European Commission, it is valid
in all EEA States for 5 years on a renewable basis.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><span style="text-decoration: underline">Mutual
Recognition and Decentralized Procedures</span></span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">With
the exception of products that are authorized centrally, the competent authorities of the member states are responsible for granting
marketing authorizations for medicinal products placed on their national markets. If the applicant for a marketing authorization intends
to market the same medicinal product in more than one member state, the applicant may seek an authorization progressively in the community
under the mutual recognition or decentralized procedure. Mutual recognition procedure, or MRP is used if the medicinal product has already
been authorized in a member state. In this case, the holder of this marketing authorization requests the member state where the authorization
has been granted to act as reference member state by preparing an assessment report on the product or, if necessary, to update any existing
assessment report that is then used to facilitate mutual recognition of the existing authorization in the other member states in which
approval is sought (the so-called concerned member state(s)). The reference member state must prepare an updated assessment report within
90 days of receipt of a valid application. This report together with the approved Summary of Product Characteristics, the SmPC (which
sets out the conditions of use of the product), and a labeling and package leaflet are sent to the concerned member states for their
consideration. The concerned member states are required to approve the assessment report, the SmPC and the labeling and package leaflet
within 90 days of receipt of these documents. The reference member state shall record the agreement of all parties, close the procedure
and inform the applicant accordingly. Each member state in which an application has been submitted shall adopt a decision in conformity
with the approved documents, within 30 days after acknowledgement of the agreement. In most cases, the total procedural time of the MRP
is 180 days.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
decentralized procedure, or DCP, is used in cases where the medicinal product has not received a marketing authorization in the EU at
the time of application. The applicant requests a member state of its choice to act as reference member state to prepare an assessment
report that is then used to facilitate agreement with the concerned member states and the grant of a national marketing authorization
in all of these member states. In this procedure, the reference member state must prepare, for consideration by the concerned member
states, the draft assessment report, a draft SmPC and a draft of the labeling and package leaflet within 120 days after receipt of a
valid application. As in the case of mutual recognition, the concerned member states are required to approve these documents within 90
days of their receipt. The reference member state shall record the agreement of all parties, close the procedure and inform the applicant
accordingly. Each member state in which an application has been submitted shall adopt a decision in conformity with the approved documents,
within 30 days after acknowledgement of the agreement. In most cases the total time of the DCP will be 210 days</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">For
both MRP and DCP, if a concerned member state objects to the grant of a marketing authorization on the grounds of a potential serious
risk to public health, it shall give a detailed exposition of the reasons for its position to with the reference member state. The points
of disagreement are in the first instance referred to the Co-ordination Group on MRP and DCP to reach an agreement within 60 days of
the communication of the points of disagreement. If member states fail to reach an agreement, the reference Member State shall record
the agreement, close the procedure and inform the applicant accordingly. If the member states fail to reach an agreement within the 60-day
period, then the matter is referred to the EMA and CHMP for arbitration. The CHMP is required to deliver a reasoned opinion within 60
days of the date on which the matter is referred. The scientific opinion adopted by the CHMP forms the basis for a binding European Commission
decision.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Irrespective
of whether the medicinal product is assessed centrally, de-centrally or through a process of mutual recognition, the medicinal product
must be manufactured in accordance with the principles of GMP for human use as set out in Directive 2001/83/EC and 2017/1572/EU and Delegated
Regulation 2017/1569 that have replaced Directive 2003/94/EC.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>


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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Directive
2017/1572/EU and Volume 4 of the rules governing medicinal products in the European Union govern GMP in the EU. Moreover, EU law requires
the clinical results in support of clinical safety and efficacy based upon clinical trials conducted in the EU to be in compliance with
the requirements of Regulation (EU) 536/2014 on clinical trials with medicinal products for human use and Implementing Regulation 556/2017
on GCP-inspections which implement good clinical practice in the conduct of clinical trials on medicinal products for human use. Clinical
trials conducted outside the European community and used to support applications for marketing within the EU must have been conducted
in a way consistent with the principles set out in Regulation (EU) 536/2017. The conduct of a clinical trial in the EU requires, pursuant
to Regulation (E) 536/2017, authorization by the relevant national competent authority where a trial takes place, and subject to the
relevant national law, an ethics committee to have issued a favorable opinion in relation to the arrangements for the trial. It also
requires that the sponsor of the trial, or a person authorized to act on his behalf in relation to the trial, be established in the community.
In comparison to the former regime, Regulation (EU) 536/2014 further harmonizes EU law on clinical trials and to some extent facilitates
clinical trials conducted in more than one EU Member State. Under Regulation (EU) 536/2014, trial sponsors submit their application for
trial approval via an EU Portal, Clinical Trials Information System (CTIS). The approvals will still have to be granted by the competent
authorities of the EU Member States where a trial takes place, however, the procedure for approval is conducted in a coordinated manner
among the concerned EU Member States as provided under Regulation (EU) 536/2014. While the process for the application and granting of
the approvals was streamlined, it is still a complex process that can significantly delay the start of a multinational clinical trial.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
UK has not adopted Regulation (EU) 536/2014 with respect to clinical trials in the UK. Instead, the Medicines for Human Use (Clinical
Trials) Regulations 2004 applies with respect to clinical trials in the UK. The UK has adopted new legislation, the Medicines and Medical
Devices Act 2021 and has issued a consultation with respect to changes to clinical trial legislation to be made under this Act.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><span style="text-decoration: underline">National
Procedure</span></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">This
procedure is available for medicinal products that do not fall within the scope of mandatory centralized authorization. Specific procedures
and timelines differ between member states, but the duration of the procedure without clock-stop time is generally 210 days and based
on a risk/efficacy assessment by the competent authority of the member state concerned, followed by determination of SmPC, package leaflet
and label text/layout and subsequently grant of the marketing authorization. Marketing authorizations granted on this basis are not mutually
recognized by other member states, but the national marketing authorization can later be used in an MRP to obtain marketing authorizations
in other member states.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; text-align: justify; margin: 0pt 0pt 0pt 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">There
are various types of applications for marketing authorizations:</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><i>Full Applications</i>.
    A full application is one that is made under any of the community procedures described above and that &#8220;stands alone&#8221;
    in the sense that it contains all of the particulars and information required by Article 8(3) of Directive 2001/83 (as amended) to
    allow the competent authority to assess the quality, safety and efficacy of the product and in particular the balance between benefit
    and risk. Article 8(3)(i) in particular refers to the need to present the results of the applicant&#8217;s research on (i) pharmaceutical
    (physical-chemical, biological or microbiological) tests, (ii) pre-clinical (toxicological and pharmacological) studies and (iii)
    clinical trials in humans. The nature of these tests, studies and trials is explained in more detail in Annex I to Directive 2001/83/EC.
    Full applications would be required for products containing new active substances not previously approved by the competent authority,
    but may also be made for other products.</span></td></tr>
  </table>
<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><i>Abridged Applications</i>.
    Article 10 of Directive 2001/83/EC contains exemptions from the requirement that the applicant has to provide the results of its
    own pre-clinical and clinical research. There are three regulatory routes for an applicant to seek an exemption from providing such
    results, namely (i) cross-referral to an innovator&#8217;s results without consent of the innovator, (ii) well established use according
    to published literature and (iii) consent to refer to an existing dossier of research results filed by a previous applicant.</span></td></tr>
  </table>
<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>


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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><span style="text-decoration: underline">Cross-referral
to Innovator&#8217;s Data</span></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Articles
10(1) and 10(2)(b) of Directive 2001/83/EC provide the legal basis for an applicant to seek a marketing authorization on the basis that
its product is a generic medicinal product (a copy) of a reference medicinal product that has already been authorized, in accordance
with community provisions. A reference product is, in principle, an original product granted an authorization on the basis of a full
dossier of particulars and information. This is the main exemption used by generic manufacturers for obtaining a marketing authorization
for a copy product. The generic applicant is not required to provide the results of pre-clinical studies and of clinical trials if its
product meets the definition of a generic medicinal product and the applicable regulatory results protection period for the results submitted
by the innovator has expired. A generic medicinal product is defined as a medicinal product:</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">having the same qualitative
    and quantitative composition in active substance as the reference medicinal product; having the same pharmaceutical form as the reference
    medicinal product; and</span></td></tr>
  </table>
<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">whose bioequivalence with
    the reference medicinal product has been demonstrated by appropriate bioavailability studies.</span></td></tr>
  </table>
<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Applications
in respect of a generic medicinal product cannot be made before the expiry of the protection period. Where the reference product was
granted a national marketing authorization pursuant to an application made before October 30, 2005, the protection period is either six
years or 10 years, depending upon the election of the particular member state concerned. Where the reference product was granted a marketing
authorization centrally, pursuant to an application made before November 20, 2005, the protection period is 10 years. For applications
made after these dates, Regulation 726/2004 and amendments to Directive 2001/83/EC provide for a harmonized protection period regardless
of the approval route utilized. The harmonized protection period is in total 10 years, including eight years of research data protection
and two years of marketing protection. The effect is that the originator&#8217;s results can be the subject of a cross-referral application
after eight years, but any resulting authorization cannot be exploited for a further two years. The rationale of this procedure is that
the relevant particulars can, if the research data protection period has expired, be found on the originator&#8217;s file and used for
assessment of the generic medicinal product. The 10-year protection period can be extended to 11 years where, in the first eight years
post-authorization, the holder of the authorization obtains approval for a new therapeutic indication assessed as offering a significant
clinical benefit in comparison with existing therapies.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">If
the copy product does not meet the definition of a generic medicinal product or if bioequivalence could not be demonstrated through bioavailability
studies or in case of certain types of changes in the active substance(s) or in the therapeutic indications, strength, pharmaceutical
form or route of administration in relation to the reference medicinal product, Article 10(3) of Directive 2001/83/EC provides that the
results of the appropriate pre-clinical studies or clinical trials must be provided by the applicant.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><span style="text-decoration: underline">Well-established
Medicinal Use</span></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Under
Article 10a of Directive 2001/83/EC, an applicant may, in substitution for the results of its own pre-clinical and clinical research,
present detailed references to published literature demonstrating that the active substance(s) of a product have a well- established
medicinal use within the community for at least ten years with recognized efficacy and an acceptable level of safety in terms of the
conditions set out in Annex I of Directive 2001/83/EC. In that event, the test and trial results shall be replaced by appropriate scientific
literature. The applicant is entitled to refer to a variety of different types of literature, including reports of clinical trials with
the same active substance(s) and epidemiological studies that indicate that the constituent or constituents of the product have an acceptable
safety/efficacy profile for a particular indication. However, use of the published literature exemption is restricted by stating that
in no circumstances active substances be treated as having a well- established use if they have been used for less than 10 years from
the first systematic and documented use of the substance as a medicinal product in the EU. Even after 10 years&#8217; systematic use,
the threshold for well-established medicinal use might not be met. European pharmaceutical law requires the competent authorities to
consider among other factors the period over which a substance has been used, the amount of patient use of the substance, the degree
of scientific interest in the use of the substance (as reflected in the scientific literature) and the coherence (consistency) of all
the scientific assessments made in the literature. For this reason, different substances may reach the threshold for well-established
use after different periods, but the minimum period is 10 years. If the applicant seeks approval of an entirely new therapeutic use compared
with that to which the published literature refers, additional pre-clinical and/or clinical results would have to be provided.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>


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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><span style="text-decoration: underline">Authorization
Holder&#8217;s Consent</span></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Under
Article 10c of Directive 2001/83/EC, following the grant of a marketing authorization the holder of such authorization may consent to
a competent authority utilizing the pharmaceutical, pre-clinical and clinical documentation that it submitted to obtain approval for
a medicinal product to assess a subsequent application relating to a medicinal product possessing the same qualitative and quantitative
composition with respect to the active substances and the same pharmaceutical form.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><span style="text-decoration: underline">Law
Relating to Pediatric Research</span></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Regulation
(EC) 1901/2006 (as amended by Regulation (EC) 1902/2006) was adopted on December 12, 2006. This Regulation governs the development of
medicinal products for human use in order to meet the specific therapeutic needs of the pediatric population. It requires any application
for marketing authorization made after July 26, 2008 in respect of a product not authorized in the European Community on January 26,
2007 (the time the Regulation entered into force), to include the results of all studies performed and details of all information collected
in compliance with a pediatric investigation plan agreed by the Pediatric Committee of the EMA, unless the product is subject to an agreed
waiver or deferral or unless the product is excluded from the scope of Regulation 1901/2006 (generics, hybrid medicinal products, biosimilars,
homeopathic and traditional (herbal) medicinal products and medicinal products containing one or more active substances of well-established
medicinal use) according to its Art. 9. Waivers can be granted in certain circumstances where pediatric studies are not required or desirable.
Deferrals can be granted in certain circumstances where the initiation or completion of pediatric studies should be deferred until appropriate
studies in adults have been performed. The EMA does not evaluate an application for market authorization that is not exempt from Regulation
(EC) 1901/2006 if there is no agreed PIP, deferral or waiver. Moreover, this regulation imposes the same obligation from January 26,
2009 on an applicant seeking approval of a new indication, pharmaceutical form or route of administration for a product already authorized
and still protected by a supplementary protection certificate granted under Regulation EC 469/2009 and its precursor Regulation (EEC)
1768/92 or by a patent that qualifies for the granting of such a supplementary protection certificate. The pediatric Regulation (EC)
1901/2006 also provides, subject to certain conditions, a reward for performing such pediatric studies, regardless of whether the pediatric
results provided resulted in the grant of a pediatric indication. This reward comes in the form of an extension of six months to the
supplementary protection certificate granted in respect of the product, unless the product is subject to orphan drug designation, in
which case the 10-year market exclusivity period for such an orphan product is extended to 12 years. If any of the non-centralized procedures
for marketing authorization have been used, the six-month extension of the supplementary protection certificate is only granted if the
medicinal product is authorized in all member states.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><span style="text-decoration: underline">Post-authorization
Obligations</span></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
the pre-authorization phase, the applicant must provide a detailed pharmacovigilance plan that it intends to implement post- authorization.
An authorization to market a medicinal product in the EU carries with it an obligation to comply with many post- authorization organizational
and behavioral regulations relating to the marketing and other activities of authorization holders. These include requirements relating
to post-authorization efficacy studies, post-authorization safety studies, adverse event reporting and other pharmacovigilance requirements,
advertising, packaging and labeling, patient package leaflets, distribution and wholesale dealing. The regulations frequently operate
within a criminal law framework and failure to comply with the requirements may not only affect the authorization, but also can lead
to financial and other sanctions levied on the company in question and responsible officers. EU pharmacovigilance legislation has been
significantly modified by the Pharmacovigilance Directive, Dir. 2010/84/EC which amended the legal framework of pharmacovigilance for
medicines marketed within the EU provided in Regulation (EC) No 726/2004 with respect to EU authorized medicinal products and in Directive
2001/83/EC with respect to nationally authorized medicinal products (including those authorized through the mutual recognition and decentralized
systems). In addition, Commission Implementing Regulation (EU) No 520/2012 outlines the practical details to be respected by marketing
authorization holders, national competent authorities and the EMA, Regulation (EU) No 1027/2012 and Directive 2012/26/EU which further
amended the pharmacovigilance legislation to further strengthen the protection of patient health by allowing prompt notification and
assessment of safety issues and Commission Delegated Regulation (EU) No 357/2014 on post-authorization efficacy studies specifies the
situations in which such studies may be required. Furthermore, EU good pharmacovigilance practice (GVP) rules apply. With these pharmacovigilance
requirements, the financial and organizational burden on market authorization holders is significant, such as the obligation to maintain
a pharmacovigilance system master file that applies to all holders of marketing authorizations granted in accordance with Directive 2001/83/EC,
as amended, or Regulation (EC) No 726/2004, as amended. Marketing authorization holders must furthermore collect data on adverse events
associated with use of the authorized product outside the scope of the authorization. Pharmacovigilance for biological products and medicines
with a new active substance is even stricter, as their authorization is subject to additional monitoring activities.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Any
authorization granted by member state authorities, which within three years of its granting is not followed by the actual placing on
the market of the authorized product in the authorizing member state, ceases to be valid (Art. 24 (4) Directive 2001/83/EC). When an
authorized product previously placed on the market in the authorizing member state is no longer actually present on the market for a
period of three consecutive years, the authorization for that product shall cease to be valid (Art. 24 (5) Directive 2001/83/EC). The
same two three-year periods apply to authorizations granted by the European Commission based on the centralized procedure (Art. 14 (4)
and (5) Regulation (EC) 726/2004).</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Other
Countries</i></b></span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
addition to regulations in the United States, the EU, the UK and Israel, we are subject to a variety of other regulations governing clinical
trials and commercial sales and distribution of drugs in other countries. Whether or not Aramchol or any other product candidate receive
approval from the FDA, approval of such product candidates must be obtained by the comparable regulatory authorities of countries other
than the United States before we can commence clinical trials or marketing of the product in those countries. The approval process varies
from jurisdiction to jurisdiction, and the time may be longer or shorter than that required for FDA approval. The requirements governing
the conduct of clinical trials and product licensing vary greatly from country to country.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
requirements that we and our collaborators must satisfy to obtain regulatory approval by government agencies in other countries prior
to commercialization of Aramchol or any other product candidate in such countries can be rigorous, costly and uncertain. In the European
countries, UK, Canada and Australia, regulatory requirements and approval processes are similar in principle to those in the United States.
Additionally, depending on the type of drug for which approval is sought, there are currently two potential tracks for marketing approval
in the European countries: mutual recognition and the centralized procedure. These review mechanisms may ultimately lead to approval
in all EU countries, but each method grants all participating countries some decision-making authority in product approval. The UK has
a separate review period but for a transitional period until 31 December 2022, may rely on approvals under the EU mutual recognition
and/or centralized procedure. Foreign governments also have stringent post-approval requirements including those relating to manufacture,
labeling, reporting, record keeping and marketing. Failure to substantially comply with these on-going requirements could lead to government
action against the product, us and/or our representatives.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Related
Matters</i></b></span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">From
time to time, legislation is drafted, introduced and passed in governmental bodies that could significantly change the statutory provisions
governing the approval, manufacturing and marketing of products regulated by the FDA, MHRA or EMA and other applicable regulatory bodies
to which we are subject. In addition, regulations and guidance are often revised or reinterpreted by the national agency in ways that
may significantly affect our business and our therapeutic candidates. It is impossible to predict whether such legislative changes will
be enacted, whether FDA, MHRA or EMA regulations, guidance or interpretations will change, or what the impact of such changes, if any,
may be. We may need to adapt our business and therapeutic candidates and products to changes that occur in the future.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>C.
Organizational Structure</b></span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; text-align: justify; margin: 0pt 0pt 0pt 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">See
&#8220;Item 4. Information on the Company&#8212;Historical Background and Corporate Structure&#8221; above.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>D.
Description of Property and Facilities</b></span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; text-align: justify; margin: 0pt 0pt 0pt 0; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Our
principal executive offices and registered office in Israel is located at 16 Abba Hillel Road, Ramat Gan, Israel 5250608 and our telephone
number is +972-3-693-8448. Our lease at our prior principal executive offices expired on March 21, 2024. We did not extend the lease
and are currently headquartered in Ramat Gan, Israel while we are in the process of searching for a new permanent location for our principal
executive offices.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><span id="am_001"></span>ITEM
4A. Unresolved Staff Comments.</b></span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">None.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><span id="am_002"></span>ITEM
5. Operating and Financial Review and Prospects.</b></span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
following discussion and analysis of our financial condition and results of operations should be read in conjunction with our financial
statements and related notes that appear elsewhere in this annual report. In addition to historical financial information, the following
discussion contains forward-looking statements that reflect our plans, estimates and beliefs. Our actual results could differ materially
from those discussed in the forward-looking statements. Factors that could cause or contribute to these differences include those discussed
below and elsewhere in this prospectus, particularly in the sections titled &#8220;Risk Factors&#8221; and &#8220;Cautionary Note Regarding
Forward-Looking Statements.&#8221; Our discussion and analysis for the year ended December 31, 2022 can be found in our Annual Report
on Form 20-F for the fiscal year ended December 31, 2022, filed with the SEC on March 29, 2023 (File No. 001-36345).</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Overview</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.45in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
are a biopharmaceutical company focused on the development of Aramchol. We have focused almost exclusively on developing Aramchol for
the treatment of liver disease and are currently developing Aramchol for PSC and exploring the feasibility of developing Aramchol for
other fibro-inflammatory indications outside of liver disease. We are also collaborating with the Hebrew University in the development
of Amilo-5MER, a 5 amino acid synthetic peptide.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">To
date, we have not generated revenue from the sale of any product, excluding the licensing revenue we recorded in connection with the
Samil Agreement, and we do not expect to generate any significant revenue other than the amortization of the upfront payments under the
license agreement with Samil and of the subsequent royalties and/or milestones that may be earned in connection with the Samil Agreement
or potential other license Agreements, unless and until we commercialize Aramchol, or license the product to additional third parties.
As of December 31, 2023, we had an accumulated deficit of approximately $193.0 million.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Our
financing activities are described below under &#8220;Liquidity and Capital Resources.&#8221; Obtaining approval of an NDA, MMA, or other
similar application is an extensive, lengthy, expensive and uncertain process, and the FDA, EMA, MHRA and other regulatory agencies may
delay, limit or deny approval of Aramchol, Amilo-5MER or any other product candidate.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Financial
Overview</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">To
date, we have funded our operations primarily through proceeds from private placements and public offerings. At December 31, 2023, we
had current assets of $13.2 million, which is mainly comprised of cash and cash equivalents of $2.9 million, restricted cash of $0.1
million, short-term deposits of $2.3 million and short-term marketable securities of $7.5 million. This compares with current assets
of $14.7 million at December 31, 2022, which is mainly comprised of cash and cash equivalents of $2.0 million, restricted cash of $0.1
million and short-term marketable securities of $11.8 million. We believe that such existing funds will be sufficient to continue our
business and operations as currently conducted for more than 12 months from the date of issuance of this annual report. However, significant
additional funding will be necessary to fund our ARMOR Study, our Amilo-5MER program and ongoing research and development work and to
advance our product candidates through regulatory approval and into commercialization, if approved. Subject to our strategic review,
we intend to obtain additional funding through debt or equity financings, governmental grants or through entering into collaborations,
strategic alliances or license agreements to increase the funds available to support our operating and capital needs. Although we have
been successful in raising capital in the past, there is no assurance that we will be successful in obtaining additional financing on
terms acceptable to us. If funds are not available, we may be required to delay, reduce the scope of or eliminate research or development
plans for, or commercialization efforts with respect to Aramchol, Amilo-5MER and/or our other pre-clinical and clinical programs. This
may raise substantial doubts about our ability to continue as a going concern.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Revenues</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
have entered into the Samil Agreement for the commercialization of Aramchol in Korea. Under the terms of the Samil Agreement, we have
received upfront and milestone payments of $3.6 million, and may be eligible to receive up to approximately $4.5 million in additional
payments for development and regulatory milestones for Aramchol in the licensed territories.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
accordance with ASC 606 the Company determined that the Agreement included a combined performance obligation representing the delivery
of the exclusive license and completion of the ARREST study.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">As
of December 31, 2023, management evaluated the remaining clinical and regulatory milestones and determined that the variable consideration
should not be recorded as revenue for the period ended December 31, 2023. The Company will re-evaluate the transaction price in each
reporting period when events whose outcomes are resolved or other changes in circumstances occur that would indicate it is appropriate
to recognize variable consideration as revenue</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Costs
and Operating Expenses</b></span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Our
current costs and operating expenses consist of two components: (i) research and development expenses; and (ii) general and administrative
expenses.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Research
and Development Expenses</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Our
research and development expenses consist primarily of outsourced development expenses, salaries and related personnel expenses and fees
paid to external service providers, patent and regulatory related legal fees, costs of pre-clinical studies and clinical trials and drug
and laboratory supplies. We account for all research and development expenses as they are incurred. Subject to our strategic review,
we expect our research and development expense to remain our primary expense in the near future as we continue to develop Aramchol and
Amilo-5MER. Increases or decreases in research and development expenditures are primarily attributable to the number and/or duration
of the pre-clinical and clinical studies that we conduct.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
expect that a substantial amount of our research and development expense in the future will be incurred in support of our current and
anticipated pre-clinical and clinical development projects. Due to the inherently unpredictable nature of pre-clinical and clinical development
studies, we are unable to estimate with any certainty the costs we will incur in the continued development of Aramchol, Amilo-5MER and
any other potential product candidate. Clinical development timelines, the probability of success and development costs can differ materially
from expectations. We currently expect to continue testing Aramchol and Amilo-5MER in pre-clinical studies for toxicology, safety and
efficacy, and to conduct additional clinical trials for Aramchol and to initiate a first-in-human clinical study for Amilo-5MER.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">While
we are currently focused on advancing Aramchol&#8217;s and Amilo-5MER&#8217;s development, our future research and development expenses
will depend largely on the outcome of our strategic review, the duration of the ARMOR study, the number of enrolled patients, the clinical
success of Aramchol, as well as ongoing assessments of the Aramchol&#8217;s commercial potential. As we obtain results from clinical
trials, we may elect to discontinue or delay clinical trials for our product candidate in certain indications in order to focus our resources
on more promising indications for such product candidate. Completion of clinical trials may take several years or more, but the length
of time generally varies according to the type, complexity, novelty and intended use of a product candidate.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
expect our research and development expenses to increase in the future from current levels as we continue to advance our clinical product
development into a pivotal stage trial and, potentially, the in-licensing of additional product candidates.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
lengthy process of completing clinical trials and seeking regulatory approval for Aramchol and Amilo-5MER or any other product candidate
requires the expenditure of substantial resources. Any failure or delay in completing clinical trials, or in obtaining regulatory approvals,
could cause a delay in generating product revenue and cause our research and development expenses to increase and, in turn, have a material
adverse effect on our operations. Because of the factors set forth above, we are not able to estimate with any certainty when we would
recognize any net cash inflows from our projects.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>General
and Administrative Expenses</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">General
and administrative expenses consist primarily of compensation for employees in executive and operational roles, including finance, /accounting,
legal and other operating positions in connection with our activities. Our other significant general and administrative expenses include
non-cash stock-based compensation costs and facilities costs (including the rental expense for our offices in Tel Aviv, Israel), professional
fees for outside accounting and legal services, travel costs, investors relations, insurance premiums and depreciation.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Financial
Income, Net</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Our
financial income consists mainly of interest income from marketable debt securities, as well as gains from realization of marketable
debt securities, <span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">income from change in fair value of convertible
note</span> and foreign currency gains. Our financial expense consists of fees associated with banking activities and losses from
realization of marketable debt securities and foreign currency losses.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>A.
Results of Operations</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; text-align: justify; margin: 0pt 0pt 0pt 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
table below provides our results of operations for the year ended December 31, 2023 as compared to the year ended December 31, 2022.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

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    <td style="width: 1%; text-align: left">$</td><td style="width: 16%; text-align: right">3,569</td><td style="width: 1%; text-align: left">&#160;</td></tr>
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    <td>&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td></tr>
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  </table>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; text-align: justify; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Research
and Development Expenses</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Our
research and development expenses amounted to approximately $3.6 million during the year ended December 31, 2023, representing a decrease
of approximately $9.4 million, or approximately 72%, compared to approximately $13.0 million for the year ended December 31, 2022. The
decrease primarily resulted from a decrease in clinical trial expenses in the amount of approximately $5.9 million as well as a decrease
in drug development expenses in the amount of approximately $1.8 million.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>General
and Administrative Expenses</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Our
general and administrative expenses amounted to approximately $3.9 million for the year ended December 31, 2023, representing a decrease
of approximately $0.8 million, or 15%, compared to approximately $4.7 million for the year ended December 31, 2022. The decrease primarily
resulted from a decrease in insurance premium expenses of $0.3 million, as well as a decrease in non-cash stock based compensation expenses
of approximately $0.2 million.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>


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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Operating
Loss</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">As
a result of the foregoing research and development and general and administrative expenses, as well as our failure to generate substantial
operating revenues, our operating loss for the year ended December 31, 2023 was approximately $7.5 million, representing a decrease in
our operating loss of approximately $10.2 million, or approximately 58%, compared to approximately $17.7 million for the year ended December
31, 2022.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Financial
Loss (income), Net</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Our
financial income, net, for the year ended December 31, 2023 was approximately $0.6 million, representing an increase of approximately
$0.8 million, compared to a financial loss of approximately $0.2 million for the year ended December 31, 2022. The increase primarily
resulted from a decrease in loss of realization of marketable securities of approximately $0.5 million as compared to such loss
for the comparable period in 2022, as well as from income from change in the fair value of convertible SAFE note of $0.3 million.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Net
Loss</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Our
net loss for the year ended December 31, 2023 was approximately $6.9 million, representing a decrease of approximately $11.0 million,
or approximately 61%, compared to approximately $17.9 million for the year ended December 31, 2022. The decrease primarily resulted from
the above-mentioned decrease in research development expenses and as well from the increase in financial income.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>B.
Liquidity and Capital Resources</b></span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Overview</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">To
date, we have funded our operations primarily through proceeds from private placements and public offerings.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
have incurred substantial losses since our inception. As of December 31, 2023, we had an accumulated deficit of approximately $193.0
million and working capital (current assets less current liabilities) of approximately 10.5 million. Due to our expectation that we will
continue to not generate substantial revenues for the foreseeable future, we expect that losses will continue for the foreseeable future.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; text-align: justify; margin: 0pt 0pt 0pt 0; text-indent: 0.5in; background-color: white"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">As
of December 31, 2023, we had cash and cash equivalents of approximately $2.9 million, restricted cash of $0.1 million, short-term deposits
of $2.3 million and short-term marketable debt securities of approximately $7.5 million invested in accordance with our investment policy,
totaling approximately $12.8 million, as compared to cash and cash equivalents of approximately $2.0 million, restricted cash of $0.1
million and short-term marketable debt securities of approximately $11.8 million, totaling approximately $13.9 million as of December
31, 2022. Our cash requirements from known contractual obligations within the next twelve months include lease obligations of approximately
$0.04 million.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
generally enter into contracts in the ordinary course of business with CROs for clinical trials and clinical supply manufacturing and
with vendors for pre-clinical research studies and other services and products for operating purposes, which generally provide for termination
within 30 to 90 days of notice, and therefore are cancelable contracts and not included in the discussion above. We have included as
purchase obligations our commitments under agreements to the extent they are quantifiable and are not cancelable.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Other
than as described above, we did not have any material commitments for capital expenditures, including any anticipated material acquisition
of plant and equipment or interests in other companies, as of December 31, 2023.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Cash
Flow from Operating Activities</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
had negative cash flow from operating activities of approximately $6.1 million for the year ended December 31, 2023 as compared to a
negative cash flow from operating activities of approximately $18.5 million for the year ended December 31, 2022. The negative cash flow
from operating activities for the year ended December 31, 2023 was mainly attributable to our net loss of approximately $6.9 million,
as well as a decrease in trade payables of approximately $0.7 million, partially offset by non-cash stock based compensation expenses
of approximately $1.0 million.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>


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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Cash
Flow from Investing Activities</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
had positive cash flow from investing activities of approximately $0.8 million for the year ended December 31, 2023 as compared to a
positive cash flow from investing activities of approximately $17.6 million for the year ended December 31, 2022. The positive cash flow
from investing activities for the year ended December 31, 2023 was primarily due to the net sale of marketable debt securities in the
amount of approximately $4.5 million, partially offset by an investment of $1.5 million in an associate and a net investment of $2.2
million in short-term deposits.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Cash
Flow from Financing Activities</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
had positive cash flow from financing activities of approximately $6.2 million for the year ended December 31, 2023 as compared to a
positive cash flow from financing activities of $0.1 million for the year ended December 31, 2022. The positive cash flow from financing
activity for the year ended December 31, 2022 was due to net proceeds from our public offering in July 2023.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">On
March 26, 2021, we entered into a Sales Agreement with Cantor and Canaccord Genuity LLC as sales agents, or the Sale Agents, pursuant
to which we may offer and sell our ordinary shares having an aggregate offering price of up to $50.0 million, from time to time through
the Sales Agents. Under the new Sales Agreement, we may sell, from time to time, up to approximately $50.0 million of additional ordinary
shares subject to limitations under the Baby Shelf Rule. As of December 31, 2023, we sold 7,721 ordinary shares under our ATM program
for total net proceeds of approximately $0.1 million. We did not sell any ordinary shares under our ATM program in 2023.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">On
July 14, 2023, we entered into a definitive securities purchase agreement with investors for the purchase and sale in a public offering
of (i) 380,000 of our ordinary shares, (ii) 5,220,000 pre-funded warrants to purchase 5,220,000 ordinary shares, or the Pre-Funded Warrants,
and (iii) 5,600,000 warrants to purchase 5,600,000 ordinary shares, or the Investor Warrants, at a purchase price of $1.25 per Share
and accompanying Investor Warrant and $1.249 per Pre-Funded Warrant and accompanying Investor Warrant. The net proceeds to the offering
were approximately $6.5 million before deducting estimated offering expenses payable by us. As of the date hereof, 3,940,000 Pre-Funded
Warrants have been exercised into 3,937,312 ordinary shares.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Current
Outlook</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Although
we provide no assurance, we believe that our existing funds will be sufficient to continue our business and operations as currently conducted
for more than 12 months from the date of issuance of this Annual Report on Form 20-F. However, significant additional funding will be
necessary to fund our ARMOR Study, our Amilo-5MER program and ongoing research and development work and to advance our product candidates
through regulatory approval and into commercialization, if approved. Subject to our strategic review, we intend to obtain additional
funding through debt or equity financings, governmental grants or through entering into collaborations, strategic alliances or license
agreements to increase the funds available to support our operating and capital needs. Although we have been successful in raising capital
in the past, there is no assurance that we will be successful in obtaining additional financing on terms acceptable to us. If funds are
not available, we may be required to delay, reduce the scope of or eliminate research or development plans for, or commercialization
efforts with respect to Aramchol, Amilo-5MER and/or our other pre-clinical and clinical programs. This may raise substantial doubts about
our ability to continue as a going concern.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; text-align: justify; margin: 0pt 0pt 0pt 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
extent of our future capital requirements will depend on many other factors, including:</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the outcome of our review
    of our strategic alternatives:</span></td></tr>
  </table>
<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 65pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>


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<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
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    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the progress and costs
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    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the regulatory pathway
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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

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    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the scope, prioritization
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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

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    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the amount of revenues
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    or any other product candidate;</span></td></tr>
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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
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    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
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    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the costs of filing, prosecuting,
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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

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    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the costs and timing of
    securing manufacturing arrangements for clinical or commercial production;</span></td></tr>
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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
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    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
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    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
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    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the magnitude of our general
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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">any cost that we may incur
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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
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    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">market conditions;</span></td></tr>
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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
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    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">our ability to maintain
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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the impact of any resurgence of the COVID-19
    pandemic and the war between Hamas and Israel, which may exacerbate the magnitude of the factors discussed above.</span></td></tr>
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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>C.</b></span> <span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Research and Development, Patents and Licenses</b></span></p>


<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">For
information concerning our research and development policies and a description of the amount spent during each of the last three fiscal
years on company-sponsored research and development activities, see &#8220;Item 5. Operating and Financial Review and Prospects&#8212;Results
of Operations.&#8221;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>D.
Trend Information</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
are a development stage company and it is not possible for us to predict with any degree of accuracy the outcome of our research, development
or commercialization efforts. As such, it is not possible for us to predict with any degree of accuracy any known trends, uncertainties,
demands, commitments or events that are reasonably likely to have a material effect on our net sales or revenues, income from continuing
operations, profitability, liquidity or capital resources, or that would cause reported financial information to not necessarily be indicative
of future operating results or financial conditions. However, to the extent possible, certain trends, uncertainties, demands, commitments
and events are in this &#8220;Operating and Financial Review and Prospects.&#8221;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>


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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>E.
Critical Accounting Policies and Estimates</b></span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
prepare our financial statements in accordance with U.S. GAAP. In doing so, we must make estimates and assumptions that affect our reported
amounts of assets, liabilities and expenses, as well as related disclosure of contingent assets and liabilities. In some cases, we could
reasonably have used different accounting policies and estimates. Changes in the accounting estimates are reasonably likely to occur
from period to period. Accordingly, actual results could differ materially from our estimates. To the extent that there are material
differences between these estimates and actual results, our financial condition or results of operations will be affected.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">While
our significant accounting policies are described in more detail in the notes to our audited consolidated financial statements appearing
elsewhere in this Annual Report on Form 20-F we believe that the following accounting policies are those most critical to the judgments
and estimates used in the preparation of our consolidated financial statements:</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Accounting
for stock-based compensation:</b></span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
grant equity-based awards under share-based compensation plans. We estimate the fair value of share-based payment awards using the Black-Scholes
option valuation model. The Black-Scholes option valuation model requires the input of subjective assumptions, including price volatility
of the underlying stock, risk-free interest rate, dividend yield, and expected life of the option. Share-based compensation expense is
based on awards ultimately expected to vest, and therefore is reduced by expected forfeitures. Changes in assumptions used under the
Black-Scholes option valuation model could materially affect our net loss and net loss per share.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Accounting
for Marketable Debt Securities</b></span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Our
debt securities are classified as available-for-sale and recorded at fair value. We determine the appropriate classification of investments
in debt securities at the acquisition date and re-evaluates the classification at each balance sheet date. Unrealized gains and losses
during the year, net of the related tax effect applicable to available-for-sale are excluded from income and reflected in other comprehensive
income (loss) as a separate component of shareholders&#8217; equity until realized. As the result of the adoption of Accounting Standards
Update (&#8220;ASU&#8221;) 2016-13, Financial Instruments-Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instrument
(&#8220;ASU 2016-13&#8221;) we assess the need at each period end to record an allowance for credit loss. Any portion of the market decline
related to debt securities that is believed to arise from factors other than credit is recorded as a component of other comprehensive
income (loss) rather than against income.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Accounting
for Investment in Associate at Fair Value</b></span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
hold an equity investment of a privately-owned company Onkai, over which  have the ability to exercise significant influence, but
not control. The investment was included as a non-current asset in our balance sheet as of December 31, 2023. We have elected the fair
value option allowed by Accounting Standards Codification 825, Financial Instruments, with respect to this investment because our management
believes this approach will better reflect the economics of our equity interest. Under the fair value option, the investment is remeasured
at fair value (level 3) at each reporting period with changes in fair value, if any, recorded in the statement of operations.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><span id="am_004"></span><span id="am_003"></span>ITEM
6. Directors, Senior Management and Employees.</b></span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>A.
Directors and Senior Management.</b></span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Set
forth below is information concerning the directors, senior management and executive officers of the Company as of March 27, 2024, the
latest practicable date for inclusion in this annual report. The business address for each of our directors, senior management and corporate
officers is c/o Galmed Pharmaceuticals Ltd., 16 Abba Hillel Road, Ramat Gan, Israel 5250608.</span></p>

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    <td style="font: 10pt Times New Roman, Times, Serif; width: 2%"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: center; width: 10%"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 2%"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 52%"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
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    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">59</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">President and Chief Executive Officer, Class II Director</span></td></tr>
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    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
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    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Dr. Liat Hayardeny</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">57</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Chief Scientist Officer</span></td></tr>
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    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
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    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Doron Cohen</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">57</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Chief Financial Officer</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: white">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: #CCEEFF">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Yohai Stenzler</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">41</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Chief Accounting Officer</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: white">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: #CCEEFF">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Guy Nehemya</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">39</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Chief Operating Officer and Data Protection Officer</span></td></tr>
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    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: #CCEEFF">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">David Sidransky, M.D.<sup>(1)(2)(3)(4)(5)</sup></span></td>
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    <td style="font: 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">63</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Lead Independent Director and Chairman of the R&amp;D
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  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: white">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: #CCEEFF">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Shmuel Nir<sup>(2)(3)(4)(5)</sup></span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">62</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Class I Director</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: white">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: #CCEEFF">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Amir Poshinski<sup>(2)(3)(4)(5)</sup></span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">63</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Chairman of our Audit Committee, Class III director</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: white">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: #CCEEFF">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Carol L. Brosgart, M.D. <sup>(1) (2)</sup></span></td>
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    <td style="font: 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">72</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Class I Director</span></td></tr>
  </table>
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<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">(1)</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">A member of our research &amp; development committee.</span></td></tr>
  </table>
<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">(2)</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Independent director under
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  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">(3)</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">A member of our audit committee.</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">(4)</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">A member of our remuneration committee.</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">(5)</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">A member of our nomination committee.</span></td></tr>
  </table>
<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><i>Allen
Baharaff</i>, our President and Chief Executive Officer of our Board, co-founded the Group in 2000, served as the Chief Financial Officer
of GHI from 2000 until January 2015, and has served as our Chief Executive Officer since January 2012 and as our President since March
2015. Previously, he held a senior executive position at Isramex Projects Ltd., an energy project financing company, and Managing Director
of T+M Trusteeship &amp; Management Services (Israel) Ltd., a subsidiary of a Swiss company providing trust and similar services. Since
2005, Mr. Baharaff serves as a Director of the Rubin Museum. Since October 2023, Allen serves as a director of Onkai Inc, a private US-based
technology company Mr. Baharaff holds a Bachelor of Science degree in economics from the London School of Economics, University of London
and LLB and MA degrees from Cambridge University. Since 1993, Mr. Baharaff has been a member of the Israel Bar Association.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><i>Dr.
Liat Hayardeny</i>, our Chief Scientific Officer joined the Company in September 2016 bringing more than 17 years of experience in drug
development at all stages as part of Teva Pharmaceuticals&#8217; global Research and Development Division. Prior to joining Galmed, Dr.
Hayardeny served as Teva&#8217;s Senior Director and Head of Research Scientific Affairs. In that capacity, Dr. Hayardeny established
the scientific positioning of Teva&#8217;s innovative compounds. Additionally, Dr. Hayardeny was responsible for Teva&#8217;s relationship
with institutions of higher education; managing Teva&#8217;s global research collaborations and publications. Dr. Hayardeny holds a Ph.D.
from Sackler School of Medicine and an MBA from Recanati Business School at Tel Aviv University.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><i>Doron
Cohen, </i>our Chief Financial Officer, joined the Company in February 2022, after providing the Company consulting services, including
with respect to management of the Company&#8217;s funds, since 2018. Mr. Cohen brings more than twenty-five years of experience in the
global financial markets, including significant experience on the buy side of life sciences companies. Since 2016, Mr. Cohen has served
as Chief Executive Officer at Tangram Strategic Ltd., a boutique investment firm offering strategic solutions in economic &amp; financial
research, risk and regulation. Before that, between 1992 and 2017, Mr. Cohen served as Research Director at Gems Investments Research
Ltd., an investment research company. During his tenure there, he provided research to hedge funds and managed three teams of analysts,
focusing on investment research, operations research, and risk analysis. Prior to that from 1990 to 1992, Mr. Cohen served as Director
of Public Relations at the World Union of Jewish Students. Since October 2023, Doron serves as the interim CFO of Onkai Inc, a private
US-based technology company Mr. Cohen holds a Master of Science degree in management from Boston University, and a Bachelor&#8217;s degree
in philosophy and political science from the University of New South Wales.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><i>Yohai
Stenzler</i>, our Chief Accounting Officer, has served in such capacity since February 2022. Mr. Stenzler joined the Company in June
2014 as the Company&#8217;s corporate controller, and later on served as the Company&#8217;s Director of Finance. Between February 2017
to February 2022, Mr. Stenzler served as our Chief Financial Officer. Mr. Stenzler has six years of financial management experience as
an accountant at the real estate department at Ernst &amp; Young LLP, where he was involved in financing, taxes, auditing, advising and
accounting of public and private companies, both domestic and international. Mr. Stenzler is a certified CPA and holds a MBA in Finance
from Recanati Business School at Tel Aviv University, and a BA in Economics and Accounting from Ben-Gurion University of the Negev.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><i>Guy
Nehemya</i>, our Chief Operating Officer and Data Protection Officer, has served in each role since January 2019 and March 2021, respectively.
Between March 2017 and January 2019, Mr. Nehemya served as our Vice President, Operations. Mr. Nehemya joined the Company in October
2013 as the Company&#8217;s Director of Operations, after completing his internship at Agmon, Rosenberg, HaCohen &amp; Co. Law Offices.
Mr. Nehemya was a key member of management during the Company&#8217;s initial public offering and execution thereof. Mr. Nehemya holds
a LL.B. from the College of Management and is currently completing his MBA degree at the IDC Herzliya. Mr. Nehemya has been a member
of the Israeli Bar Association since 2012.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><i>David
Sidransky, M.D.</i>, the chairman of our Nomination, Remuneration and R&amp;D Committees, joined our Board in June 2014, originally as
an external director. Dr. Sidransky is a renowned oncologist and research scientist named and profiled by TIME magazine in 2001 as one
of the top physicians and scientists in America, recognized for his work with early detection of cancer. He serves as the Director of
the Head and Neck Cancer Research Program at the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University. He is a Professor
of Oncology, Otolaryngology, Cellular &amp; Molecular Medicine, Urology, Genetics, and Pathology at Johns Hopkins University and Hospital.
Dr. Sidransky has written over 600 peer-reviewed publications and has contributed to more than 60 cancer reviews and chapters. Dr. Sidransky
is a founder of a number of biotechnology companies and holds numerous biotechnology patents. He has been the recipient of many awards
and honors, including the 1997 Sarstedt International prize from the German Society of Clinical Chemistry, 1998 Alton Ochsner Award Relating
Smoking and Health by the American College of Chest Physicians and the 2004 Hinda Rosenthal Award and 2017 Team Award presented by the
American Association of Cancer Research. Dr. Sidransky has served as Vice Chairman of the Board of Directors of ImClone. He is Chairman
of the Board of Ayala Pharma (Nasdaq: AYLA), and is a lead director at Champions Oncology and on the board of directors of Orgenesis
(Nasdaq: ORGS) and Ascentage Pharma. He is serving and has served on scientific advisory boards of corporations and institutions, including
Amgen, MedImmune, Roche and Veridex, LLC (a Johnson &amp; Johnson diagnostic company), among others. In addition, Dr. Sidransky served
as Director of American Association for Cancer Research from 2005 to 2008. Dr. Sidransky received his B.A. from Brandeis University and
his M.D. from the Baylor College of Medicine.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><i>Shmuel
Nir</i>, a director of the Company since 2007, serves as President and Chief Executive Officer of Tushia Consulting Engineers Ltd., an
investment and management services company. From January 2001 to January 2016, Mr. Nir served as Chairman of the board of directors of
Matan Digital Printers Ltd. From March 1998 to January 2008, he served as President and Chief Executive Officer of Macpell Industries
Ltd., a leading industrial group. Between January 1991 and March 1998, Mr. Nir was an Executive Vice President of Operations at Macpell
Industries Ltd. and President and Chief Executive Officer of two of its subsidiaries, New Net Industries Ltd. and New Net Assets Ltd.
Prior to January 1991, Mr. Nir had held various positions with Intel Corporation in Jerusalem, Israel and Tefen Management Consulting.
Between 1999 and 2006, Mr. Nir served as managing partner at Spring Venture Capital Fund. Mr. Nir holds a B.Sc. in Industrial Engineering
and Management from the Technion - Israel Institute of Technology in Haifa, which was awarded in 1989.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><i>Amir
Poshinski</i>, joined our Board in June 2020. Mr. Poshinski is an entrepreneur with over 20 years&#8217; management and leadership experience
across multiple industries, including technology, biotechnology, banking and real estate. Mr. Poshinski is the owner of DAP Holdings,
through which he has acted since 2010 as a management consultant and strategic advisor to global companies. Mr. Poshinski currently serves
as a member of the advisory board of Benson Oak Ventures, a venture focused fund, as well as several other private companies. Prior to
2010, Mr. Poshinski served as Deputy CEO of Primsa Investment House, which at the time was Israel&#8217;s largest investment house, Deputy
CEO of Discount Mortgage Bank, the real estate lending arm of one of Israel&#8217;s largest banks, VP of Marketing at Comverse, a telecommunications
software company that was listed on Nasdaq, VP Marketing, Sales and Advertising of Mifal Hapayis, Israel&#8217;s national lottery, and
VP and Deputy CEO of the Economic Company of the Israeli Local Authorities Association. Mr. Poshinski previously served on the board
of directors of each of TAS-AGT (a TATA joint venture), Excellence Nessuah Mutual Funds, and Therapix Biosciences (Nasdaq: TRPX) as well
as several other private companies. Mr. Poshinski holds a B.A. in Business Administration and Marketing from the New York Institute of
Technology.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><i>Carol
L. Brosgart, M.D. </i>joined our Board on June 7, 2017. Dr. Brosgart served as a member of Tobira Therapeutics&#8217;s Board of Directors
from 2009 until it was acquired by Allergan in 2016 and on the Board of Juvaris, a vaccine company acquired by Bayer. Since January 2018,
she serves on the Board of Directors of Abivax, a biotechnology company, headquartered in Paris, working on HIV Cure and inflammatory
diseases. Since 2022 Dr. Brosgart also seves on the Board of of Eradivir Biotech and Merlin Biotech. Since June 2021, Dr. Brosgart also
serves on the Board of Intrivo Diagnostic. Dr. Brosgart also served on the Board of Mirum Pharmaceuticals Inc. (Nasdaq: MIRM) from 2021
to 2023, and serves since then as a clinical consultant to Mirum. Dr. Brosgart serves as a consultant to Dynavax, Allergan and a number
of biotechnology companies in the areas of liver diseases and infectious diseases and on the Board of Renovaro Inc. (Nasdaq: RENB), focusing
on HIV Cure. Dr. Brosgart also currently serves as a consultant for Dynavax Technologies Corp (Nasdaq: DVAX). Dr. Brosgart currently
serves on the Steering Committee of the National Viral Hepatitis Roundtable, the Executive Committee of the Forum for Collaborative Research,
the Steering Committee of the HBV Cure Group at the Forum, and is on the Board of Directors of the Hepatitis B Foundation and the Northern
California American Liver Foundation and the Board of Berkeley Community Scholars. She is active in the public policy arena for AASLD
and IDSA/HIVMA. Dr. Brosgart served as Senior Advisor on Science and Policy to the Division of Viral Hepatitis at the CDC and to the
Viral Hepatitis Action Coalition at the CDC Foundation from 2011 to 2013. Dr. Brosgart has also served as a member of the clinical faculty
of the School of Medicine at the University of California, San Francisco for the past four decades, where she is a Clinical Professor
of Medicine, Biostatistics and Epidemiology in the Division of Global Health and Infectious Diseases. In 2011, Dr. Brosgart served as
Chief Medical Officer at biotechnology company Alios BioPharma, Inc. Prior to Alios, Dr. Brosgart served as Senior Vice President and
Chief Medical Officer of Children&#8217;s Hospital &amp; Research Center in Oakland, California, from 2009 until February 2011. Previously,
she served for eleven years, from 1998 until 2009, at the biopharmaceutical company Gilead Sciences, Inc., where she held a number of
senior management roles, most recently as Vice President, Public Health and Policy and earlier as Vice President, Clinical Research and
Vice President, Medical Affairs. Prior to Gilead, Dr. Brosgart was the Medical Director of the East Bay AIDS Center in Berkeley, California
(1987-1998) and the Medical Director of the Central Health Center for the Alameda County Public Health Department (1978-1987). Dr. Brosgart
received a B.S. in Community Medicine from the University of California, Berkeley and received an M.D. from the University of California,
San Francisco. Her residency training was in pediatrics, public health and preventive medicine at UCSF and UC Berkeley School of Public
Health. She has published extensively in the areas of HIV, HBV, CMV, and liver disease.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">There
are no family relationships between any director or executive officer. There are no arrangements or understandings with major shareholders,
customers, suppliers or others, pursuant to which any director or executive officer was selected as a director or member of senior management,
as the case may be.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center; background-color: white"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Board
Diversity Matrix (As of March 27, 2024)</b></span></p>

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<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; width: 49%"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Country of Principal Executive Offices</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 2%; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 49%"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Israel</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Foreign Private Issuer</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Yes</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Disclosure Prohibited under Home Country Law</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">No</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Total Number of Directors</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">5</span></td></tr>
  </table>
<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>


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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom">
    <td style="font: 10pt Times New Roman, Times, Serif; width: 51%"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Part I:
    Gender Identity</b></span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 2%; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="border-bottom: black 1.5pt solid; font: 10pt Times New Roman, Times, Serif; width: 8%; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Female</b></span></td>
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    <td style="font: 10pt Times New Roman, Times, Serif; width: 2%; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="border-bottom: black 1.5pt solid; font: 10pt Times New Roman, Times, Serif; width: 10%; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Non-Binary</b></span></td>
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    Not Disclose&#8194;</b></span></p>
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  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Directors</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">1</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">4</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">0</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">0</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Part II: Demographic Background</b></span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif">
    <td style="font: 10pt Times New Roman, Times, Serif; vertical-align: top"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Underrepresented Individual
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    <td style="font: 10pt Times New Roman, Times, Serif; vertical-align: top; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">0</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">LGBTQ+</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">0</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Did Not Disclose Demographic Background</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">0</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  </table>
<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Scientific
Advisory Board</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
seek advice from our Scientific Advisory Board generally on scientific and medical matters. Our Scientific Advisory Board includes the
following: Professor Vlad Ratziu from the University Pierre et Marie Curie in Paris, France and coordinator of the EU FP7 FLIP consortium;
Professor Scott Friedman from the Icahn School of Medicine at Mount Sinai in New York, United States; Professor Arun Sanyal, from the
Virginia Commonwealth University in Richmond, Virginia; Professor Jose Mato, from CIC bioGUNE Spain; and Professor Shomron Ben-Horin,
Chief of the Gastroenterology Department at Sheba Medical Center.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>B.
Compensation.</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; text-align: justify; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Certain
Approvals Required for Office Holders&#8217; Compensation of the Companies Law</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Pursuant
to the Companies Law, the Company is required to adopt a compensation policy regarding the terms of office and employment of its Office
Holders (as such terms are defined below), which includes exemption and release of the Office Holders from liability for breach of his
or her duty of care to the Company, an undertaking to indemnify the Office Holder, post factum indemnification or insurance; any grant,
payment, remuneration, compensation, or other benefit provided in connection with termination of service; and any benefit, other payment
or undertaking to provide any payment as aforesaid, or the Terms of Office and Employment.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
Company&#8217;s current amended and restated compensation policy with respect to the terms of office and employment of the Company&#8217;s
Office Holders, or the Compensation Policy, was adopted by the Board on May 30, 2023, and will remain in effect for a period of three
years according to the Companies Law, unless replaced prior. The Compensation Policy was approved in accordance with the mechanism set
forth in the Companies Law, which allows the Board to approve the Compensation Policy, notwithstanding the resolution of the general
meeting on May 11, 2023, provided that the remuneration committee and thereafter the Board have concluded, following further and detailed
discussion of the matter and for specified reasons, that such approval is in the Company&#8217;s best interests. To that end, the remuneration
committee and our Bord considered the results of the general meeting vote, details of the Compensation Policy and its alignment with
the Company&#8217;s compensation philosophy and other relevant considerations and thereafter determined that the approval of the Compensation
Policy is in the best interest of the Company.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
term &#8216;Office Holder&#8217; as defined in the Companies Law includes a general manager, chief business manager, deputy general manager,
vice general manager, any other person fulfilling or assuming the responsibilities of any of the foregoing positions without regard to
such person&#8217;s title, as well as a director, or a manager directly subordinate to the general manager or the chief executive officer.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Pursuant
to the Companies Law, arrangements between the Company and its Office Holders must generally be approved by the remuneration committee
and the Board and be consistent with the Compensation Policy. However, under certain circumstances, the Company may approve an arrangement
that is not consistent with the Compensation Policy, if such arrangement is approved by a majority of the Company&#8217;s shareholders,
provided that (i) such majority includes a majority of the votes cast by shareholders who are not controlling shareholders and who do
not have a personal interest in the matter, present and voting (abstentions are disregarded), or (ii) the votes cast by shareholders
who are not controlling shareholders and who do not have a personal interest in the matter who were present and voted against the arrangement
constitute two percent or less of the voting power of the company, or the Special Majority.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>


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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
terms of office and employment of directors (including an officer who is a director but is not a controlling shareholder) further require
the approval of the shareholders by a simple majority in addition to the approval of the Remuneration Committee and the Board, in that
order, and under certain circumstances, a Special Majority; with respect to a chief executive officer who is not also a director or an
officer who is a controlling shareholder, the approval of the shareholders must be made by the Special Majority. In addition, under certain
circumstances, a company may be temporarily exempt from receiving the shareholders&#8217; approval with respect to the terms of office
and employment of a non-affiliated candidate for chief executive officer.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Under
certain circumstances, if the terms of office and employment of Office Holders (who are not directors or controlling shareholders) are
not approved by the shareholders, where such approval is required, the remuneration committee and the Board may subsequently override
the resolution of the shareholders following a new discussion of the matter and for specified reasons. In addition, amendment of terms
of office and employment of Office Holders (who are not directors or controlling shareholders) requires the approval of the remuneration
committee only, if the remuneration committee determines that the amendment is not material.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Aggregate
Executive Compensation</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
aggregate compensation, including share-based compensation, paid by us to all of our Office Holders as a group, with respect to the year
ended December 31, 2023, was approximately $2.76 million. This amount includes approximately $0.3 million set aside or accrued to provide
pension, severance, retirement, vacation or similar benefits or expenses, but does not include business travel, relocation, professional
and business association dues and expenses reimbursed to Office Holders, and other benefits commonly reimbursed or paid by companies
in our industry. In addition to the five current members of the Board (including the Company&#8217;s President and Chief Executive Officer),
the Company considers four other individuals, namely, the Chief Scientist Officer, Chief Financial Officer, Chief Accounting Officer
and the Chief Operating Officer, to have been Office Holders in 2023.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">As
of December 31, 2023, options to purchase 217,273 of our ordinary shares granted to our Office Holders as a group were outstanding, of
which options to purchase 165,955 of our ordinary shares have vested, with a weighted average exercise price of $49.61 per ordinary share
and 1,315,000 restricted share units, or RSUs granted to our Office Holders were outstanding, of which none were settled.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">For
outstanding equity-based awards granted to our Office Holders, see below under &#8220;Item 6. Directors, Senior Management and Employees&#8212;E.
Share Ownership&#8212;Certain Information Concerning Equity Awards to Office Holders.&#8221;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Individual
Compensation of Covered Executives</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
following table sets forth the compensation granted to the five most highly compensated Office Holders during or with respect to the
year ended December 31, 2023. All amounts reported in the table reflect the cost to the Company, as recognized in its financial statements
for the year ended December 31, 2023. The five individuals for whom disclosure is provided are referred to herein as &#8220;Covered Executives.&#8221;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"></span></p>

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    <td style="border-bottom: Black 1.5pt solid; font: bold 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Information
    Regarding the Covered Executives</span></td><td style="font: bold 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td colspan="22" style="border-bottom: Black 1.5pt solid; font: bold 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Compensation
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  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td><td style="font: bold 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td colspan="2" style="font: bold 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Base</span></td><td style="font: bold 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td><td style="font: bold 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
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    <td colspan="2" style="font: bold 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Equity-Based</span></td><td style="font: bold 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td><td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td colspan="2" style="font: 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td><td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td><td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td colspan="2" style="font: 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td><td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td><td style="font: bold 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td colspan="2" style="font: bold 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Salary</span></td><td style="font: bold 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td><td style="font: bold 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td colspan="2" style="font: bold 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Perquisites</span></td><td style="font: bold 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td><td style="font: bold 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
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    <td colspan="2" style="font: bold 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Compensation</span></td><td style="font: bold 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td><td style="font: bold 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td colspan="2" style="font: bold 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Other</span></td><td style="font: bold 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td><td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td colspan="2" style="font: 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td><td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom">
    <td style="border-bottom: Black 1.5pt solid; font: bold 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Name
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    <td colspan="2" style="border-bottom: Black 1.5pt solid; font: bold 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">($)</span></td><td style="font: bold 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td><td style="font: bold 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td colspan="2" style="border-bottom: Black 1.5pt solid; font: bold 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>($)<sup>(2)</sup></b></span></td><td style="font: bold 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td><td style="font: bold 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td colspan="2" style="border-bottom: Black 1.5pt solid; font: bold 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>($)<sup>(3)</sup></b></span></td><td style="font: bold 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td><td style="font: bold 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td colspan="2" style="border-bottom: Black 1.5pt solid; font: bold 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>($)<sup>(4)</sup></b></span></td><td style="font: bold 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td><td style="font: bold 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td colspan="2" style="border-bottom: Black 1.5pt solid; font: bold 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>($)<sup>(5)</sup></b></span></td><td style="font: bold 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td><td style="font: bold 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td colspan="2" style="border-bottom: Black 1.5pt solid; font: bold 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Total
    ($)</span></td><td style="font: bold 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="font: 10pt Times New Roman, Times, Serif; width: 40%; text-align: left"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Allen
    Baharaff (President and Chief Executive Officer)</span></td><td style="font: 10pt Times New Roman, Times, Serif; width: 2%"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 1%; text-align: left"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td><td style="font: 10pt Times New Roman, Times, Serif; width: 6%; text-align: right"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">550,874</span></td><td style="font: 10pt Times New Roman, Times, Serif; width: 1%; text-align: left"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td><td style="font: 10pt Times New Roman, Times, Serif; width: 2%"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
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    <td style="font: 10pt Times New Roman, Times, Serif; width: 1%; text-align: left"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td><td style="font: 10pt Times New Roman, Times, Serif; width: 6%; text-align: right"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">384,026</span></td><td style="font: 10pt Times New Roman, Times, Serif; width: 1%; text-align: left"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td><td style="font: 10pt Times New Roman, Times, Serif; width: 2%"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 1%; text-align: left"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td><td style="font: 10pt Times New Roman, Times, Serif; width: 6%; text-align: right"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">40,000</span></td><td style="font: 10pt Times New Roman, Times, Serif; width: 1%; text-align: left"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td><td style="font: 10pt Times New Roman, Times, Serif; width: 2%"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 1%; text-align: left"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td><td style="font: 10pt Times New Roman, Times, Serif; width: 6%; text-align: right"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">1,356,183</span></td><td style="font: 10pt Times New Roman, Times, Serif; width: 1%; text-align: left"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td><td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: left"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td><td style="font: 10pt Times New Roman, Times, Serif; text-align: right"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td><td style="font: 10pt Times New Roman, Times, Serif; text-align: left"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td><td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: left"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td><td style="font: 10pt Times New Roman, Times, Serif; text-align: right"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td><td style="font: 10pt Times New Roman, Times, Serif; text-align: left"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td><td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: left"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td><td style="font: 10pt Times New Roman, Times, Serif; text-align: right"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td><td style="font: 10pt Times New Roman, Times, Serif; text-align: left"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td><td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: left"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td><td style="font: 10pt Times New Roman, Times, Serif; text-align: right"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td><td style="font: 10pt Times New Roman, Times, Serif; text-align: left"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td><td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: left"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td><td style="font: 10pt Times New Roman, Times, Serif; text-align: right"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td><td style="font: 10pt Times New Roman, Times, Serif; text-align: left"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td><td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: left"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td><td style="font: 10pt Times New Roman, Times, Serif; text-align: right"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td><td style="font: 10pt Times New Roman, Times, Serif; text-align: left"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: left"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Yohai
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    <td style="font: 10pt Times New Roman, Times, Serif; text-align: left"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td><td style="font: 10pt Times New Roman, Times, Serif; text-align: right"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">167,855</span></td><td style="font: 10pt Times New Roman, Times, Serif; text-align: left"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td><td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: left"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td><td style="font: 10pt Times New Roman, Times, Serif; text-align: right"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">50,733</span></td><td style="font: 10pt Times New Roman, Times, Serif; text-align: left"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td><td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
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    <td style="font: 10pt Times New Roman, Times, Serif; text-align: left"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td><td style="font: 10pt Times New Roman, Times, Serif; text-align: right"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">87,751</span></td><td style="font: 10pt Times New Roman, Times, Serif; text-align: left"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td><td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
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  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White">
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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

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    into Dollars at an exchange rate of NIS 3.62 = $1.00, which reflects the average conversion rate for fiscal year ended December 31,
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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>


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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
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    the extent applicable to the Covered Executives, payments, contributions and/or allocations for savings funds, pension, severance,
    vacation, car allowance, risk insurance (e.g., life, disability, accident), telephone, convalescence pay, payments for social security
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<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
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    to equity-based compensation. Assumptions and key variables used in the calculation of such amounts are discussed in Note 10 to the
    Financial Statements. For outstanding equity-based awards granted to Covered Executives see below under &#8220;Item 6. Directors,
    Senior Management and Employees&#8212;E. Share Ownership&#8212;Certain Information Concerning Equity Awards to Office Holders.&#8221;</span></td></tr>
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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
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    Company&#8217;s financial statements for the&#160;year ended December&#160;31, 2023 (including if such bonuses were paid in 2024).
    They exclude bonuses paid in 2023 which were provided for in the Company&#8217;s financial statements for previous&#160;years. Cash
    bonuses are paid in accordance with the Company&#8217;s 2023 Annual Cash Bonus Plan and are intended to promote the Company&#8217;s
    work plan and business strategy by rewarding officers for achievement of the Company&#8217;s business and financial goals through
    teamwork and collaboration. Key performance indicators which are factored into cash bonus determinations are based both on personal</span></td></tr>
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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
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    2023 relating to directors&#8217; fees.</span></td></tr>
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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>&#160;</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Compensation
of Directors</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">As
approved by our shareholders at our 2020 annual meeting of shareholders, in connection with their services as directors of the Company,
each of our directors from time to time, is entitled to an annual payment of $40,000, plus value-added tax, or VAT, if applicable, and
with respect to an expert external director (if applicable), $50,000 plus VAT, payable quarterly at the end of each quarter, and, upon
first becoming a member of the Board. As approved by our shareholders at our 2023 special meeting of shareholders, (i) each of our non-management
directors, except Dr. Carol L. Brosgart, received a grant of RSU&#8217;s to purchase 75,000 ordinary shares, or the Director RSUs. The
Director RSUs were granted under the 2013 Plan and (ii) our director, Dr. Carol L. Brosgart, received a grant of options to purchase
75,000 ordinary shares, or the Director Options. The Director Options were granted under the 2013 Plan at an exercise price equal to
$0.92, the closing price of our Ordinary Shares on the Nasdaq Stock Market on August 6, 2023, the day prior to the meeting of the Board
approving such grant. The Director RSUs and the Director Options vest over a period of three years, such that Director RSUs and the Director
Options will vest with respect to 1/3 of the underlying Ordinary Shares on the first anniversary of the grant (i.e., the date of the
Board&#8217;s approval on August 7, 2023), and thereafter, Director RSUs and the Director Options will vest with respect to the additional
2/3 of the underlying ordinary shares on an equally quarterly basis, provided that each non-management director continues to serve as
a director of us or our affiliates throughout each such vesting date. All unvested options held by a non-management director in office
will automatically vest and become exercisable upon the consummation of a Transaction, as such term is defined in the 2013 Plan. The
grant is subject to the execution by each director of an option agreement with us confirming the terms and conditions applying to the
grant.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Our
Board has determined that each of Mr. Nir, Mr. Poshinski, and Dr. Sidransky are entitled to receive compensation equivalent to what an
&#8216;expert external director&#8217; would have received. See also &#8220;Item 6. Directors, Senior Management and Employees&#8212;C.
Board Practices&#8212;External Directors&#8221; and &#8220;Item 7. Major Shareholders and Related Party Transactions&#8212;C. Related
Party Transactions&#8221; below.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">For
the outstanding equity-based awards granted to our directors, see below under &#8220;Item 6. Directors, Senior Management and Employees&#8212;E.
Share Ownership&#8212;Certain Information Concerning Equity Awards to Office Holders.&#8221;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>


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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Employment
Agreements and Arrangements with Directors and Related Parties</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
entered into written employment agreements with each of our executive officers. These agreements provide for notice periods of varying
duration for termination of the agreement by us or by the relevant executive officer, during which time the executive officer will continue
to receive base salary and benefits. These agreements also contain customary provisions regarding non-competition, confidentiality of
information and assignment of inventions. However, the enforceability of the non-competition and assignment of inventions provisions
may be limited under applicable law. See &#8220;Item 3. Key Information&#8212;Risk Factors&#8212;Risks Related to Our Business, Industry
and Regulatory Requirements.&#8221;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Employment
Agreement with Our President and Chief Executive Officer</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">On
December 30, 2013, we entered into a personal employment agreement with our controlling shareholder, Mr. Allen Baharaff who serves as
our president and chief executive officer and as the chairman of our Board, as amended on March 15, 2016, July 20, 2017, August 1, 2019,
and August 30, 2021 which provides that Mr. Baharaff&#8217;s terms of office and employment are for an undefined term, subject to re-approval
under the Companies Law and termination in accordance with the terms of the employment agreement.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Under
the current terms of his employment agreement, Mr. Baharaff is entitled to a gross monthly salary of NIS 170,000, following shareholder
approval which was obtained at our 2021 annual meeting of shareholders. In addition, Mr. Baharaff will be entitled to an annual cash
bonus based on achievement of qualitative and quantitative performance goals and objectives. As approved at our 2021 annual meeting of
shareholders the annual cash bonus amount may be of up to six times Mr. Baharaff&#8217;s monthly base salary, and the actual bonus paid
in a given year shall be determined based on the achievement of certain qualitative and quantitative performance goals and objectives
set by our remuneration committee and Board, which effective as of January 1, 2022, does not require further shareholder approval.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Mr.
Baharaff is also entitled to receive the following bonuses (i) upon execution of a Strategic Agreement (as defined below), and subject
to the discretion of the Board, a cash bonus in an amount of up to twelve times his monthly base salary. A &#8220;Strategic Agreement&#8221;
means: a license agreement or any other strategic agreement (i.e. research and development, manufacture, distribution, etc.) for the
U.S., Europe, Japan or China; (ii) upon consummation of a fund raising (excluding funds received from a Strategic Agreement), and, subject
to the discretion of the Board, a cash bonus in an amount of up to ten times his monthly base salary if the funds received by the Company
are between $8 Million to $10 million and up to twelve times his monthly base salary if the funds received by the Company are $10 million
or more; (iv) upon a Change of Control Event (as defined below), and, subject to the discretion of the Board, a cash bonus in an amount
of up to twelve times his monthly base salary, a &#8220;Change of Control Event&#8221; means: (a) the acquisition of the Company by another
entity or individual or group of individuals by means of any transaction or series of related transactions (including, without limitation,
any reorganization, merger, share purchase or consolidation), unless the Company&#8217;s shareholders of record as constituted immediately
prior to any such transaction will, immediately after such transaction (by virtue of securities issued as consideration for the Company&#8217;s
share capital, assets or otherwise) hold more than 50% of the voting power of the surviving or acquiring entity; or (b) a sale of all
or substantially all of the assets of the Company.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Mr.
Baharaff will also be entitled to the following equity based compensation: (i) in the event that our options are cashed-out upon a Change
of Control Event, all unvested options granted to Mr. Baharaff will vest immediately prior to the consummation of the Change of Control
Event; (ii) if upon a Change of Control Event (a) Mr. Baharaff&#8217;s employment as chief executive officer of the Company or the surviving
entity is terminated within twelve months as of the Change of Control Event, and (b) unvested options are replaced for new options of
the surviving entity as part of the Change of Control Event with a vesting schedule and terms identical to the replaced options, or the
Replacement Options, then (x) all unvested Replacement Options granted to Mr. Baharaff will vest immediately prior to the termination
of Mr. Baharaff&#8217;s employment, and (y) Mr. Baharaff&#8217;s Replacement Options will be exercisable until the earlier of (a) two
years from termination, and (b) expiration of the Replacement Options.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>


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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Mr.
Baharaff will also receive other benefits required under Israeli law or that are customary for senior executives in Israel such as confidentiality,
reimbursement of expenses, payment for absence days, sick leave, pension and/or a manager&#8217;s insurance policy and study fund.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Mr.
Baharaff is also entitled to accumulate vacation days for no more than two years. As approved at our 2021 annual meeting of shareholders,
unused accumulated vacation days that exceed the number of vacation days that may be accumulated over a two-year period (currently, 48
vacation days) shall be redeemed once a year, on March 1, provided that the redemption will not result in the number of accumulated vacation
days following the redemption being less than 48 days, or as otherwise required by law. Accumulated vacation days shall also be redeemed
in the event of termination of employment of Mr. Baharaff.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Mr.
Baharaff&#8217;s employment agreement is terminable by either party upon six months prior written notice, or Prior Notice Period, and
contains customary provisions regarding noncompetition, confidentiality of information and assignment of inventions. Upon termination,
provided such termination was not for cause, Mr. Baharaff shall be entitled, in addition to the Prior Notice Period, to a payment in
an amount of up to twelve times his monthly base salary, to be paid in twelve equal monthly installments, in exchange for Mr. Baharaff&#8217;s
undertaking not to compete with the Company for a period of twelve months, or Non-Compete Grant. Other than in case of resignation by
Mr. Baharaff, excluding resignation for a Good Reason Event (as defined below), or termination for cause: (i) all Mr. Baharaff&#8217;s
unvested options will vest upon termination; and (ii) unexercised options granted to Mr. Baharaff may be exercised until the earlier
of (a) two years from his termination, and (b) expiration of his options. A &#8220;Good Reason Event&#8221; means: any of the following
events, provided that the event is effected by the Company without the written consent of Mr. Baharaff: (i) a material reduction or adverse
change in Mr. Baharaff&#8217;s authority, duties or responsibilities; (ii) a reduction in Mr. Baharaff&#8217;s monthly base salary, other
than a reduction of no more than 10% of his then current monthly base salary as part of an across the board reduction in all salaries
for employees of the Company; (iii) a material breach by the Company of Mr. Baharaff&#8217;s employment agreement or any other agreements
pertaining directly to Mr. Baharaff&#8217;s compensation or employment or (iv) death, disability or severe illness. Upon termination
for cause by the Company, Mr. Baharaff shall not be entitled to any Prior Notice Period, Non-Compete Grant or any other payment, and
any unvested outstanding equity awards shall terminate immediately upon the date of such termination for cause.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">For
cash bonuses granted to Mr. Baharaff see &#8220;Item 6. Directors, Senior Management and Employees&#8212; B. Compensation&#8212;Individual
Compensation of Covered Executives.&#8221; For outstanding equity-based awards granted to Mr. Baharaff see below under &#8220;Item 6.
Directors, Senior Management and Employees&#8212;E. Share Ownership&#8212;Certain Information Concerning Equity Awards to Office Holders.&#8221;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>C.
Board Practices.</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
are incorporated in Israel, and, therefore, we are subject to various corporate governance practices under Israeli law relating to such
matters as external directors (if required), independent directors, audit committees, remuneration committees and internal auditors.
These Israeli law requirements are in addition to the requirements of the Nasdaq Listing Rules and other relevant provisions of U.S.
securities laws. Under such Nasdaq Listing Rules, a foreign private issuer may generally follow its home country practices for corporate
governance in lieu of such comparable listing rules&#8217; requirements, except for certain matters such as composition and responsibilities
of the audit committee and the SEC-mandated standards for the independence of its members. See below under &#8220;Item 16G. Corporate
Governance&#8221; for further information.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Membership
of the Board</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Our
Articles provide that the minimum number of members of the Board is three and the maximum number of members is eleven. The Board is presently
comprised of five members. Pursuant to regulations <span style="background-color: white">promulgated under the Companies Law,</span>
or the Relief Regulations,, companies with no controlling shareholder whose shares are listed for trading on specified exchanges outside
of Israel, including the Nasdaq Capital Market, may adopt exemptions from various corporate governance requirements of the Companies
Law so long as the company satisfies the applicable foreign country laws and regulations, including applicable stock exchange rules,
that apply to companies organized in that country relating to the appointment of independent directors and the composition of audit and
remuneration committees. Such exemptions include an exemption from the requirement to appoint external directors and the requirement
that an external director be a member of the audit and remuneration committees.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
March 2020, our Board adopted this exemption , and our directors then in office who were elected and classified as an external director,
were no longer classified as such under the Companies Law.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
minimum and maximum number of directors may be changed, at any time and from time to time, by a majority vote of our directors then in
office, provided that no decrease in the number of directors shall shorten the term of any incumbent director. Under our Articles, the
Board consists of three classes of directors which are appointed for fixed terms of office in accordance with the Companies Law and our
Articles, with one class being elected each year for a term of approximately three years by our shareholders at our annual general meeting.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Directors
so elected cannot be removed from office by the shareholders until the expiration of their term of office. The directors do not receive
any benefits upon the expiration of their term of office.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
three classes of directors are Class I Directors, Class II Directors and Class III Directors. Shmuel Nir and Dr. Carol Brosgart serve
as our Class I Directors until the close of the annual general meeting to be held in 2024; Allen Baharaff serves as our Class II Director
until the close of the annual general meeting to be held in 2025; and Dr. David Sidransky and Amir Poshinski serve as our Class III Directors
until the close of the annual general meeting to be held in 2026.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
accordance with the Articles, any vacancies on the Board of, including unfilled positions, may be filled by a vote of a majority of the
directors then in office, and each director chosen in this manner would hold office until the next annual general meeting of the Company
(or until the earlier termination of his or her appointment as provided for in the Companies Law or the Articles).</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Any
amendment of our Articles regarding the election of directors, as described above, requires the affirmative vote of at least 75% of the
voting rights in the Company, represented personally or by proxy and voting thereon at a general meeting. See &#8220;Item 6. Directors,
Senior Management and Employees&#8212;C. Board Practices&#8212;External Directors&#8221; for a description of the procedure for the election
of external directors.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; text-align: justify; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">A
nominee for service as a director in a public company may not be elected without submitting a declaration to the company, prior to election,
specifying that he or she has the requisite qualifications to serve as a director, independent director or external director (if required),
as applicable, and the ability to devote the appropriate time to performing his or her duties as such.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">A
director, who ceases to meet the statutory requirements to serve as a director, external director or independent director, as applicable,
must notify the company to that effect immediately and his or her service as a director will expire upon submission of such notice.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Alternate
Directors</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Our
Articles provide, as allowed by the Companies Law, that any director may, subject to the conditions set thereto, appoint a person as
an alternate to act in his place, to remove the alternate and appoint another in his place and to appoint an alternate in place of an
alternate whose office is vacated for any reason whatsoever. Under the Companies Law, a person who is not qualified to be appointed as
a director, a person who is already serving as a director or a person who is already serving as an alternate director for another director,
may not be appointed as an alternate director. Nevertheless, a director who is already serving as a director may be appointed as an alternate
director for a member of a committee of the board of directors so long as he or she is not already serving as a member of such committee.
A person who is not qualified to be appointed as an independent director, pursuant to the Companies Law, may not be appointed as an alternate
director of an independent director qualified as such under the Companies Law. Unless the appointing director limits the time or scope
of the appointment, the appointment is effective for all purposes until the appointing director ceases to be a director or terminates
the appointment.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>External
Directors</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Generally,
unless a regulatory relief is available, under the Companies Law and the regulations promulgated pursuant thereto, Israeli companies
whose shares have been offered to the public, or that are publicly traded outside of Israel, which we refer to as a public company, are
required to appoint at least two natural persons as &#8220;external directors.&#8221;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Pursuant
the Relief Regulations, companies with shares traded on certain U.S. stock exchanges, including Nasdaq, which do not have a &#8220;controlling
shareholder,&#8221; may, subject to certain conditions, &#8220;opt out&#8221; from the Companies Law requirements to appoint external
directors and related Companies Law rules concerning the composition of the audit committee and remuneration committee of the board of
directors. In accordance with these regulations, in March 2020, our Board elected to &#8220;opt out&#8221; from the Companies Law requirement
to appoint external directors and related Companies Law rules concerning the composition of the audit committee and remuneration committee
of our Board.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>&#160;</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Director
Independence</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Following
our &#8220;opt-out&#8221; of the requirement to have external directors serving on our Board, we comply with the director independence
requirements and the audit committee and the remuneration committee composition requirements under U.S. laws (including applicable Nasdaq
Capital Market rules) applicable to U.S. domestic issuers. Our Board has undertaken a review of the independence of each director. Based
on information provided by each director concerning their background, employment and affiliations, our Board has determined that Mr.
Nir, Mr. Poshinski, Dr. Sidransky, and Dr. Brosgart do not have a relationship that would interfere with the exercise of independent
judgment in carrying out the responsibilities of a director and that each of these directors is &#8220;independent&#8221; as that term
is defined under the listing standards of the Nasdaq. In making these determinations, our Board considered the current and prior relationships
that each non-employee director has with our company and all other facts and circumstances our Board deemed relevant in determining their
independence, including the beneficial ownership of our capital shares by each non-employee director.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Committees
of the Board</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Our
Articles also provide that the Board may delegate any, or all, of its powers to one or more committees of the Board, and may entrust
to and confer upon a &#8220;managing director&#8221; such of its powers as it deems appropriate. However, the Companies Law provides
that certain powers and authorities (for example, the power to approve the financial statements) may not be delegated and may be exercised
only by the Board. Notwithstanding the foregoing, we currently do, and intend to continue to, comply with the corporate governance requirements
of the Nasdaq Capital Market, except to the extent indicated elsewhere in this annual report, including as set forth under &#8220;Item
16G. Corporate Governance&#8221; below. The Companies Law requires public companies such as the Company to appoint an audit committee
and a remuneration committee.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Audit
Committee</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
Companies Law requires public companies to appoint an audit committee comprised of at least three directors, including all of the external
directors, if any the majority of whom must be independent directors under the Companies Law. The Companies Law further stipulates that
the following may not be members of the audit committee: (i) the chairman of the board of directors; (ii) any director employed by or
providing services on an ongoing basis to the company, to a controlling shareholder of the company or an entity controlled by a controlling
shareholder of the company; (iii) a director whose livelihood mainly depends on a controlling shareholder; and (iv) a controlling shareholder
or any relative of a controlling shareholder.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
Companies Law further requires that: (i) the chairperson of the audit committee must be an external director; (ii) generally, any person
who is not entitled to be a member of the audit committee may not attend the audit committee&#8217;s meetings and voting sessions, unless
such person was invited by the chairperson of the committee for the purpose of presenting a specific subject matter thereof; and (iii)
the quorum required for the convening of meetings of the audit committee and for adopting resolutions by the audit committee is a majority
of the members of the audit committee, provided that the majority of the members present are independent directors and at least one of
them is an external director. As noted, under the Relief Regulation, companies with no controlling shareholder whose shares are listed
for trading on specified exchanges outside of Israel, including the Nasdaq Capital Market, may adopt exemptions from various corporate
governance requirements of the Companies Law so long as the company satisfies the applicable foreign country laws and regulations, including
applicable stock exchange rules, that apply to companies organized in that country relating to the appointment of independent directors
and the composition of audit and remuneration committees. Such exemptions include an exemption from the requirement to appoint external
directors and the requirement that an external director be a member of certain committees. In accordance with these Regulations, we elected
to &#8220;opt out&#8221; from such requirements of the Companies Law.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>


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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
responsibilities of the audit committee under the Companies Law include: (i) identifying flaws in the management of a company&#8217;s
business and making recommendations to the board of directors as to how to correct them; (ii) with respect to certain actions involving
conflicts of interest and with respect to certain related party transactions, deciding whether such actions are material actions and
whether such transactions are extraordinary transactions, respectively, all for the purpose of approving such actions or transactions;
(iii) reviewing and deciding whether to approve certain related party transactions and certain actions involving conflicts of interest;
(iv) reviewing the internal auditor&#8217;s work program; (v) examining the company&#8217;s internal control structure and processes,
the performance of the internal auditor and whether the internal auditor has at his or her disposal the tools and resources required
to perform his or her duties, considering, inter alia, the special needs of the company and its size; (vi) examining the independent
auditor&#8217;s scope of work as well as the independent auditor&#8217;s fees and providing its recommendations to the appropriate corporate
organ; (vii) providing for arrangements as to the manner in which the company will deal with employee complaints with respect to deficiencies
in the management of the company&#8217;s business and the protection to be provided to such employees; and (viii) with respect to related
party transactions with a controlling shareholder, regardless of whether such transactions are extraordinary transactions, that prior
to entering into such transaction, to establish the requirement of having a competitive process under the supervision of the audit committee
or any individual, committee or body on its behalf and according to criteria established by the audit committee and to determine procedures
for approving certain related party transactions with a controlling shareholder, which were determined by the audit committee to be non-extraordinary
transactions, but which are not negligible transactions.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Our
Board has adopted an audit committee charter setting forth the responsibilities of the audit committee consistent with the rules of the
SEC and the Nasdaq Listing Rules, as well as the requirements for such committee under the Companies Law, as described below.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Our
audit committee oversees the accounting and financial reporting processes of the Company. It also provides assistance to the Board in
fulfilling its legal and fiduciary obligations with respect to matters involving the accounting, auditing, financial reporting and internal
control functions of the Company. In carrying out its duties, our audit committee meets with management at least once a quarter, at which
time, among other things, it reviews, and either approves or disapproves, the financial results of the Company for the immediately preceding
calendar quarter and conveys its conclusions in this regard to the Board. Our audit committee also monitors generally the services provided
by the Company&#8217;s independent auditors to ensure their independence and reviews all audit and non-audit services provided by them.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Our
Board has resolved to delegate to the audit committee the power to pre-approve non-auditing services rendered by the Company&#8217;s
independent auditors without the need for further approval by our Board. As such, on March 15, 2016, our audit committee approved the
adoption of a pre-approval policy, such that the Chairman of the audit committee is authorized to pre-approve any engagement of our independent
auditors during a period of twelve months from the date of such approval, for the provision of non-auditing services, for fees not to
exceed $20,000, and any such engagement which exceeds $20,000 shall require a pre-approval by the entire audit committee. Once services
have been pre-approved, our management must then report to the audit committee on a periodic basis regarding the extent of services actually
provided in accordance with the pre-approval policy, and regarding the fees for the services performed.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
Company&#8217;s independent and internal auditors also report regularly to our audit committee, and our audit committee discusses with
the Company&#8217;s independent auditors the quality, not just the acceptability, of the accounting principles, the reasonableness of
significant judgments and the clarity of disclosures in the Company&#8217;s financial statements, as and when it deems it appropriate
to do so.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Under
the provisions of the Sarbanes-Oxley Act, the audit committee is directly responsible for the appointment, compensation and oversight
of the work of the company&#8217;s independent auditors. However, under Israeli law, the appointment of independent auditors and their
compensation require the approval of the shareholders of a public company. Pursuant to Israeli law, the shareholders may delegate the
authority to determine the compensation of the independent auditors to the board of directors. In addition, pursuant to the Companies
Law, the audit committee is required to examine the independent auditors&#8217; fees and to provide its recommendations with respect
thereto to the appropriate corporate body. Accordingly, the appointment of our independent auditors is required to be approved and recommended
to the shareholders by our audit committee and Board and approved by the shareholders. The compensation of the independent auditors for
audit services is required to be approved and recommended to the Board by our audit committee and approved by the Board. The Board has
delegated its authority to approve the compensation of independent auditors for non-auditing services to the audit committee.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>


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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Mr.
Nir, Mr. Poshinski and Dr. Sidransky are the current members of our audit committee, with Mr. Poshinski serving as chairperson. Each
of our audit committee members are &#8220;independent directors&#8221; in accordance with the Nasdaq Capital Market corporate governance
requirements, as affirmatively determined by our Board. In addition, our Board has affirmatively determined that Mr. Poshinski also qualifies
as an audit committee financial expert pursuant to the applicable SEC rules, and accordingly has the necessary financial sophistication
as required by the Nasdaq Capital Market rules.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Remuneration
Committee</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
Companies Law requires public companies to appoint a remuneration committee comprised of at least three directors, including all of the
external directors, who must generally also constitute a majority of the members. All other members of the committee, who are not external
directors, must be directors who receive compensation consistent with that of external directors and that is in compliance with the compensation
related regulations promulgated under the Companies Law. In addition, the chairperson of the remuneration committee must be an external
director. As noted, under the Relief Regulations, we elected to &#8220;opt out&#8221; from such requirements of the Companies Law.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
Companies Law further stipulates that directors who are not qualified to serve on the audit committee, as described above, may not serve
on the remuneration committee either and that similar to the audit committee, generally, any person who is not entitled to be a member
of the remuneration committee may not attend the remuneration committee&#8217;s meetings. Our Board has adopted a remuneration committee
charter setting forth the responsibilities of our remuneration committee, as described below.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
responsibilities of the remuneration committee under the Companies Law include: (i) making recommendations to the board of directors
with respect to the approval of the compensation policy and any extensions thereto; (ii) periodically reviewing the implementation of
the compensation policy and providing the board of directors with recommendations with respect to any amendments or updates thereto;
(iii) reviewing and resolving whether or not to approve transactions with respect to the terms of office and employment of Office Holders;
and (iv) resolving, under certain circumstances prescribed under the Companies Law, whether or not to exempt a transaction with a candidate
for chief executive officer who meets non-affiliation criteria from shareholder approval.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Our
remuneration committee also oversees the administration of the Company&#8217;s various compensation plans and arrangements, in particular,
the incentive compensation, deferred compensation and equity based plans of the Company (and to the extent appropriate, of the subsidiaries
of the Company) and assists the Board in fulfilling its responsibilities relating to the compensation of directors, the Chief Executive
Officer and other Office Holders of the Company. In carrying out these duties, our remuneration committee meets on an ad hoc basis. Under
the Companies Law, our remuneration committee may need to seek the approval of the Board and the shareholders for certain compensation
decisions as described above. Each member of our remuneration committee is an &#8220;independent director&#8221; in accordance with the
Nasdaq Capital Market corporate governance requirements, as affirmatively determined by our Board. Mr. Nir, Mr. Poshinksi and Dr. Sidransky
are the current members of our remuneration committee, with Dr. Sidransky serving as chairperson.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Compensation
Policy</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">As
approved by our shareholders, and as required by the Companies Law, we have adopted a Compensation Policy regarding the terms of office
and employment of our &#8220;office holders&#8221; (as defined under the Companies Law, which includes directors, the CEO, other executive
officers and any other managers directly subordinate to the CEO), including cash compensation, equity-based awards, releases from liability,
indemnification and insurance, severance and other benefits. Each of the named executive officers is an &#8220;office holder&#8221; within
the meaning of the Companies Law. The Compensation Policy is reviewed from time to time by our remuneration committee and our Board to
ensure its appropriateness, and is required to be brought at least once every three years to our shareholders for approval. See &#8220;Item
6. Directors, Senior Management and Employees &#8212; B. Compensation &#8212; Certain Approvals Required for Office Holders&#8217; Compensation
of the Companies Law&#8221;.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Our
current Compensation Policy was approved and adopted on May 30, 2023 and will be in effect for a period of three years until May 29,
2026, unless replaced in accordance with the Companies Law prior. The Compensation Policy links pay to performance and aligns our executive
officers&#8217; interests with those of the Company and of our shareholders. It allows us to provide meaningful incentives that reflect
both our short and long-term goals and performance, as well as the executive officers&#8217; individual performance and impact on shareholder
value, while providing compensation that is competitive in the global marketplace in which we recruit talent and is designed to reduce
incentives for our executive officers to take excessive risks.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; text-align: justify; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
Compensation Policy emphasizes each executive officer&#8217;s individual characteristics (such as his or her respective position, education,
scope of responsibilities and contribution to the attainment of our goals) as the basis for compensation variation among executive officers,
taking into account the internal ratios between compensation of our executive officers and directors and other employees of the Company.
Pursuant to the Compensation Policy, the compensation that may be granted to an executive officer may include: base salary and benefits,
annual cash bonuses and other cash bonuses (such as retention and special bonuses), as well as equity-based compensation, retirement
and termination of employment benefits, change of control provisions and other benefits. The cash bonuses that may be granted under the
Compensation Policy are limited to a maximum amount linked to the executive officer&#8217;s base salary.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Under
the Compensation Policy, an annual cash bonus that will be awarded to executive officers (other than the CEO) will be based on performance
objectives and a discretionary evaluation of the executive officer&#8217;s overall performance by the CEO and may be subject to minimum
thresholds. The remuneration committee and the Board will determine any applicable minimum thresholds that must be met for entitlement
to the annual cash bonus (all or any portion thereof) and the formula for calculating any annual cash bonus payout on the basis of, but
not limited to, company and individual objectives. Notwithstanding the above, we may determine that, with respect to any executive officer
subordinated to the CEO, which does not serve as a director, a portion or all of his or her annual cash bonus will be based on the evaluation
of the CEO.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
Compensation Policy provides that the annual bonus awarded to the Company&#8217;s CEO will be mainly based on measurable objectives of
the Company, subject to a minimum threshold on the basis of, but not limited to, company and personal objectives. 30% or less of the
annual cash bonus granted to the Company&#8217;s CEO may be based on a discretionary evaluation of the CEO&#8217;s overall performance
by the remuneration committee and the Board. The measurable objectives will be determined annually by the remuneration committee and
the Board at the commencement of each calendar year, or upon engagement, in case of newly hired CEO, or in other special circumstances
as set forth in the Compensation Policy.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
equity-based compensation under the Compensation Policy for our executive officers is designed in a manner intended to attract and retain
officers and align their interests with shareholders&#8217; interests to maximize creation of long-term economic value for the Company,
and to strengthen the retention and the motivation of executive officers in the long term. Equity-based awards may be granted from time
to time in the form of options and/or other equity- based awards, such as RSUs in accordance with our 2013 Plan as may be updated from
time to time.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
Compensation Policy contains compensation recovery provisions in the event of accounting restatement, which would allow us, under certain
conditions, to recover bonuses or performance-based equity paid in excess of what would have been paid under the financial statements,
as restated. The Compensation Policy also contains provisions that allow us to exculpate, indemnify and insure our executive officers
and directors subject to certain updated limitations set forth in the Compensation Policy.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>


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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
Compensation Policy also governs the compensation of our non-management Board members and provides that our directors will be entitled
to an annual cash fee retainer, which shall not exceed US$100,000 plus VAT, or the Maximum Amount, and with respect to an Expert External
Director, as defined in the compensation related regulations promulgated under the Companies Law, plus 33% to the Maximum Amount. Our
non-management Board members may also receive equity awards up to the limits set forth in the Compensation Policy.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>&#160;</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Nominating
Committee</i></b></span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
Nasdaq Capital Market corporate governance requires each company adopting a nominating committee to certify that it has adopted a formal
written charter or board resolution, as applicable, addressing the nominations process and such related matters as may be required under
U.S. federal securities laws. Although not required as a foreign private issuer to adopt a nominating committee, we have decided to follow
such requirement.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Our
Board has adopted a nominating committee charter setting forth the responsibilities of the nominating committee consistent with the Nasdaq
Listing Rules.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
nominating committee is responsible for identifying individuals qualified to be appointed as board members, and recommending to the Board
appropriate director nominees for election at the general meeting of shareholders.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Independent
director oversight of nominations enhances investor confidence in the selection of well-qualified director nominees, as well as independent
nominees as required by the rules. The Nasdaq Capital Market listing rule is also intended to provide flexibility for a company to choose
an appropriate board structure and reduce resource burdens, while ensuring that independent directors approve all nominations.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Mr.
Nir, Mr. Poshinski, and Dr. Sidransky are the current members of our nominating committee, with Dr. Sidransky serving as chairperson.
Nasdaq Capital Market Listing Rule 5605(e) requires that our nominating committee be comprised solely of independent directors unless
the nominating committee is comprised of at least three members and the Board determines that such non-independent director&#8217;s membership,
which shall not be longer than two years, is required by the best interests of the Company and our shareholders.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>R&amp;D
Committee</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Our
R&amp;D Committee, which was established by the Board on May 2014, advises and assists the Board in its oversight of our research and
development programs, including the rationale and timeline of clinical trials and other studies, as well as market surveys in connection
therewith. The R&amp;D Committee operates in accordance with the purposes and objectives determined by the Board from time to time. Dr.
Sidransky, Dr. Brosgart and Mr. Baharaff are the current members of our R&amp;D Committee, with Dr. Sidransky serving as chairperson.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Internal
Auditor</i></b></span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Under
the Companies Law, the board of directors of an Israeli public company must appoint an internal auditor recommended by the audit committee
and nominated by the board of directors. The role of the internal auditor is to examine, among other things, our compliance with applicable
law and orderly business procedures. An internal auditor should comply with the requirements of the Companies Law and the Internal Audit
Law, 5752-1992, and may not be:</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">(a)</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">a person (or a relative
    of a person) who holds more than 5% of the Company&#8217;s outstanding shares or voting rights;</span></td></tr>
  </table>
<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
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    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">(b)</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">a person (or a relative
    of a person) who has the power to appoint a director or the general manager of the Company;</span></td></tr>
  </table>
<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">(c)</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">an Office Holder, including
    a director, of the Company (or a relative thereof); or</span></td></tr>
  </table>
<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">(d)</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">a member of the Company&#8217;s
    independent accounting firm, or anyone on his or her behalf.</span></td></tr>
  </table>
<p style="font: 10pt Times New Roman, Times, Serif; text-align: justify; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Pursuant
to Israeli law, an internal auditor&#8217;s tenure cannot be terminated without his or her consent, nor can he or she be suspended from
such position unless the board of directors of the company has so resolved following the recommendations of the company&#8217;s audit
committee and, after providing the internal auditor with the opportunity to present his or her position to the board of directors of
the company and to the audit committee.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>


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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">On
January 12, 2021, our Board appointed Zach Refaeli, CPA, from Ernst &amp; Young Israel - Kost Forer Gabbay &amp; Kasierer, Tel Aviv,
Israel, as the Company&#8217;s internal auditor for a period of three years, effective as of January 12, 2021.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Exculpation
and Indemnification of Directors and Officers</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Under
the Companies Law, a company may not exculpate an Office Holder from liability for a breach of the duty of loyalty. An Israeli company
may exculpate an Office Holder in advance from liability to the company, in whole or in part, for damages caused to the company as a
result of a breach of the duty of care but only if a provision authorizing such exculpation is included in its articles of association.
Our Articles include such a provision. The Company may not exculpate in advance a director from liability arising out of a prohibited
dividend or distribution to shareholders.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Under
the Companies Law, and the Israeli Securities Law, 5738&#8212;1968, or the Securities Law, a company may indemnify, or undertake in advance
to indemnify, an Office Holder for the following liabilities and expenses, imposed on Office Holder or incurred by Office Holder due
to acts performed by him or her as an Office Holder, provided its articles of association include a provision authorizing such indemnification:</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">a monetary liability incurred
    by or imposed on him or her in favor of another person pursuant to a judgment, including a settlement or arbitrator&#8217;s award
    approved by a court. However, if an undertaking to indemnify an Office Holder with respect to such liability is provided in advance,
    then such an undertaking must be limited to events which, in the opinion of the board of directors, can be foreseen based on the
    company&#8217;s activities when the undertaking to indemnify is given, and to an amount or according to criteria determined by the
    board of directors as reasonable under the circumstances, and such undertaking shall detail the abovementioned foreseen events and
    amount or criteria;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">reasonable litigation expenses,
    including attorneys&#8217; fees, incurred by the Office Holder as a result of an investigation or proceeding instituted against him
    or her by an authority authorized to conduct such investigation or proceeding, provided that (i) no indictment was filed against
    such Office Holder as a result of such investigation or proceeding; and (ii) no financial liability was imposed upon him or her as
    a substitute for the criminal proceeding as a result of such investigation or proceeding or, if such financial liability was imposed,
    it was imposed with respect to an offense that does not require proof of criminal intent or as a monetary sanction;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">a monetary liability imposed
    on him or her in favor of an injured party at an Administrative Procedure (as defined below) pursuant to Section 52(54)(a)(1)(a)
    of the Securities Law;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">expenses incurred by an
    office holder or certain compensation payments made to an injured party that were instituted against an office holder in connection
    with an Administrative Procedure under the Securities Law, including reasonable litigation expenses and reasonable attorneys&#8217;
    fees; and</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">reasonable litigation expenses,
    including attorneys&#8217; fees, incurred by the Office Holder or imposed by a court in proceedings instituted against him or her
    by the company, on its behalf, or by a third-party, or in connection with criminal proceedings in which the Office Holder was acquitted,
    or as a result of a conviction for an offense that does not require proof of criminal intent.</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">An
    &#8220;Administrative Procedure&#8221; is defined as a procedure pursuant to chapters H3 (Monetary Sanction by the Israeli Securities
    Authority), H4 (Administrative Enforcement Procedures of the Administrative Enforcement Committee) or I1 (Arrangement to prevent
    Procedures or Interruption of procedures subject to conditions) to the Securities Law.</span></td></tr>
  </table>
<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>


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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Under
the Companies Law and the Securities Law, a company may insure an Office Holder against the following liabilities incurred for acts performed
by him or her as an Office Holder if and to the extent provided in the company&#8217;s articles of association:</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">a breach of the duty of
    loyalty to the company, provided that the Office Holder acted in good faith and had a reasonable basis to believe that such act would
    not prejudice the company;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">a breach of the duty of care to the company or to a
    third-party;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">a monetary liability imposed on the Office Holder in
    favor of a third-party;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">a monetary liability imposed
    on the office holder in favor of an injured party at an Administrative Procedure pursuant to Section 52(54) (a)(1)(a) of the Securities
    Law; and</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">expenses incurred by an
    office holder in connection with an Administrative Procedure instituted against him or her, including reasonable litigation expenses
    and reasonable attorneys&#8217; fees.</span></td></tr>
  </table>
<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Nevertheless,
under the Companies Law, a company may not indemnify, exculpate or insure an Office Holder against any of the following:</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">a breach of the duty of
    loyalty, except for indemnification and insurance for a breach of the duty of loyalty to the company in the event Office Holder acted
    in good faith and had a reasonable basis to believe that the act would not prejudice the company;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">a breach of the duty of
    care committed intentionally or recklessly, excluding a breach arising out of the negligent conduct of the Office Holder;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">an act or omission committed
    with intent to derive unlawful personal benefit; or</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">a fine, monetary sanction,
    penalty or forfeit levied against the Office Holder.</span></td></tr>
  </table>
<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Under
the Companies Law, exculpation, indemnification and insurance of Office Holders require the approval of the remuneration committee, board
of directors and, in certain circumstances, the shareholders, as described above under &#8220;Item 6<b>&#8212;</b>Directors, Senior Management
and Employees&#8212;B. Compensation.&#8221;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Our
Articles permit us to exculpate, indemnify and insure our Office Holders to the fullest extent permitted by the Companies Law. Each of
our Office Holders have entered into an indemnification agreement with us, exculpating them, to the fullest extent permitted by Israeli
law, from liability to us for damages caused to us as a result of a breach of the duty of care and undertaking to indemnify them to the
fullest extent permitted by Israeli law, including with respect to liabilities resulting from certain acts performed by such Office Holders
in their capacity as an Office Holder of the Company, our subsidiaries or our affiliates.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
the opinion of the SEC, indemnification of directors and Office Holders for liabilities arising under the Securities Act, however, is
against public policy and therefore unenforceable.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Agreements
with Directors</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Other
than a written agreement with our President, Chief Executive Officer and Chairman, as detailed in &#8220;Item 6. Directors, Senior Management
and Employees&#8212;B. Compensation&#8212;Employment Agreements and Arrangements with Directors and Related Parties&#8212;Employment
Agreement with Our President, Chief Executive Officer and Chairman of the Board,&#8221; we do not have written agreements with any director
providing for benefits upon the termination of his or her services with our Company.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>


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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>D.
Employees.</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">As
of December 31, 2023, we had eight employees, of which three were full-time employees and five were part-time employees. Four of our
employees were involved in our clinical and product development operations and 4 served in general and administrative capacities.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">While
none of our employees are party to any collective bargaining agreements or represented by any labor unions, certain provisions of the
Israeli labor laws and certain collective bargaining agreements between the Histadrut (General Federation of Labor in Israel) and the
Coordination Bureau of Economic Organizations (including the Industrialists&#8217; Associations) are applicable to our employees by order
of the Israel Ministry of Economics. These provisions primarily concern the length of the workday, minimum daily wages for professional
workers, pension fund benefits for all employees, insurance for work-related accidents, procedures for dismissing employees, determination
of severance pay and other conditions of employment. We generally provide our employees with benefits and working conditions beyond the
required minimums. We have never experienced any employment-related work stoppages and believe our relationship with our employees is
favorable.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>E.
Share Ownership.</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
following table sets forth information regarding beneficial ownership of our ordinary shares as of March 27, 2024, the latest practicable
date for inclusion in this annual report, held by our directors and executive officers, individually and as a group and beneficial owners
of more than 5% of our outstanding shares.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Beneficial
ownership is determined in accordance with the rules of the SEC and includes voting or investment power with respect to ordinary shares.
Ordinary shares issuable under share options, warrants or other conversion rights currently exercisable or that are exercisable within
60 days after March 27, 2024 are deemed outstanding for the purpose of computing the percentage ownership of the person holding the options,
or other conversion rights, but are not deemed outstanding for the purpose of computing the percentage ownership of any other person.
Percentage of shares beneficially owned is based on 6,009,654 ordinary shares outstanding on March 27, 2024.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Except
as otherwise indicated, and subject to applicable community property laws, the persons named in the table have sole voting and investment
power and the right to receive the economic benefit of ownership with respect to all ordinary shares held by that person.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Unless
otherwise stated, the address for our directors and senior management is c/o Galmed Pharmaceuticals Ltd., 16 Abba Hillel Road, Ramat Gan, Israel 5250608.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 100%">
  <tr style="vertical-align: bottom">
    <td>&#160;</td>
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    <td>&#160;</td><td style="font-weight: bold">&#160;</td>
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    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Dr. Liat Hayardeny<sup>(7)</sup></span></td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">12,997</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">*</span></td><td style="text-align: left">&#160;</td></tr>
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    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Yohai Stenzler<sup>(8)</sup></span></td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">12,206</td><td style="text-align: left">&#160;</td><td>&#160;</td>
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    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Guy Nehemya<sup>(9)</sup></span></td><td>&#160;</td>
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    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Amir Poshinski<sup>(10)</sup></span></td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">3,165</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">*</span></td><td style="text-align: left">&#160;</td></tr>
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    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Doron Cohen<sup>(11)</sup></span></td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">1,333</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">*</span></td><td style="text-align: left">&#160;</td></tr>
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  </table>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">*Less
than 1%.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">(1)
All options included are either currently exercisable or will be exercisable within 60 days of March 27, 2023.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>


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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">(2)
Based upon information contained in a Schedule 13G/A filed by the shareholder on February 14, 2024. Shares beneficially owned consist
of (i) 269,238 ordinary shares and (ii) 145,589 ordinary shares issuable upon the exercise of warrants. The warrants are subject to a
beneficial ownership limitation of 9.99%, which such limitation restricts the holder from exercising that portion of the warrants that
would result in the holder and its affiliates owning, after exercise, a number of ordinary share in excess of the beneficial ownership
limitation. Heights Capital Management, Inc., the authorized agent of CVI Investments, Inc. (&#8220;CVI&#8221;), has discretionary authority
to vote and dispose of the shares held by CVI and may be deemed to be the beneficial owner of these shares. Martin Kobinger, in his capacity
as Investment Manager of Heights Capital Management, Inc., may also be deemed to have investment discretion and voting power over the
shares held by CVI. Mr. Kobinger disclaims any such beneficial ownership of the shares. The principal business address of CVI is c/o
Heights Capital Management, Inc., 101 California Street, Suite 3250, San Francisco, California 94111.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">(3)
Consists of (i) 227,790 ordinary shares are held through G. Yarom Medical Research Ltd., a company incorporated under the laws of the
State of Israel, of which Mr. Baharaff is the controlling shareholder and the chairman of its board of directors; and (ii) options to
purchase 112,305 ordinary shares that are currently exercisable within 60 days as of March 27, 2024. Of the 340,095 ordinary shares,
Mr. Baharaff exercises sole voting and dispositive power over 112,305 shares beneficially owned and shared voting and dispositive power
with G. Yarom Medical Research Ltd. over 227,790 shares.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">(4)
Consists of (i) 500 ordinary shares held by Mr. Nir; and (ii) 2,762 ordinary shares
are held through Tushia Consulting Engineers Ltd., of which Shmuel Nir is its controlling shareholder and (iii) 5,831 ordinary shares
issuable upon the exercise of options that are currently exercisable or will be exercisable within 60 days as of March 27, 2024.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">(5)
Consists of (i) 500 ordinary shares held by Dr. Sidransky; and (ii) 5,831 ordinary shares issuable upon the exercise of options that
are currently exercisable or will be exercisable within 60 days as of March 27, 2024.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">(6)
Consists of 4,498 ordinary shares issuable upon the exercise of options that are currently exercisable or will be exercisable within
60 days as of March 27, 2024.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">(7)
Consists of 12,997 ordinary shares issuable upon the exercise of options that are currently exercisable or will be exercisable within
60 days as of March 27, 2024.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">(8)
Consists of (i) 375 ordinary shares held by Mr. Stenzler; and (ii) 11,831 ordinary shares issuable upon the exercise of options that
are currently exercisable or will be exercisable within 60 days as of March 27, 2024.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">(9)
Consists of (i) 375 ordinary shares held by Mr. Nehemya; and (ii) 11,831 ordinary shares issuable upon the exercise of options that are
currently exercisable or will be exercisable within 60 days as of March 27, 2024.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">(10)
Consists of 3,165 ordinary shares issuable upon the exercise of options that are currently exercisable or will be exercisable within
60 days as of March 27, 2024.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">(11)
Consists of 1,133 ordinary shares issuable upon the exercise of options that are currently exercisable or will be exercisable within
60 days as of March 27, 2024.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Change
in Control</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">To
our knowledge, (i) we are not directly or indirectly owned or controlled by another corporation, by any foreign government or by any
other natural or legal person severally or jointly, except as disclosed in the above table regarding our major shareholders, and (ii)
there are no arrangements which would result in our change in control at a subsequent date.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>


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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Significant
Changes in the Ownership of Major Shareholders</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">To
our knowledge, other than as disclosed in the table above, our other filings with the SEC and this annual report, there has been no significant
change in the percentage ownership held by any major shareholder since January 1, 2020.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Major
Shareholders Voting Rights</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; text-align: justify; margin: 0pt 0pt 0pt 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Our
major shareholders do not have different voting rights.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Record
Holders</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">To
our knowledge, as of March 27, 2024, we had one holder of record of our ordinary shares with a U.S. address, Cede &amp; Co., the nominee
of The Depository Trust Company. This holder held in the aggregate 5,779,871 ordinary shares, or 96.2% of our outstanding ordinary shares
as of March 27, 2024. The number of record holders in the United States is not representative of the number of beneficial holders of
our ordinary shares nor is it representative of where such beneficial holders are resident since many of these ordinary shares were held
by brokers or other nominees.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>2013
Incentive Share Option Plan</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
maintain one equity-based incentive plan, our 2013 Plan. As of March 27, 2024, the latest practicable date for inclusion in this annual
report, a total of 2,000,000 shares were reserved for issuance under our 2013 Plan, of which (1) options to purchase 240,970 ordinary
were issued and outstanding thereunder (i.e., were granted but not canceled, expired or exercised); (2) RSU&#8217;s to purchase 1,315,000
ordinary shares were issued and outstanding; (3) options to purchase 72,737 ordinary shares were exercised and 4,267 ordinary shares
were issued upon vesting of RSUs; and (3) 367,026 shares remain unallocated for future equity awards pursuant to our 2013 Plan.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Our
2013 Plan, which was adopted by our Board on September 2, 2013, and approved by our shareholders in December 30, 2013 (as amended on
March 30, 2015, May 11, 2015, August 30, 2018 and August 7, 2023), will be in effect until October 4, 2026 and provides for the grant
of options to purchase our ordinary shares and the issuance of RSUs to our officers, directors, employees, service providers and consultants.
Our 2013 Plan provides for such equity-based compensation under various and different tax regimes, including those detailed below.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
2013 Plan is administered by our Board, which, on its own or upon the recommendation of our remuneration committee or any other similar
committee of the Board, shall determine, subject to applicable law, the identity of grantees of awards and various terms of the grant.
Consistent with our Compensation Policy, the 2013 Plan provides for granting options to purchase our ordinary shares pursuant to Section
102 of the Israeli Income Tax Ordinance, or the Ordinance, under the capital gains route, to directors, officers and employees who are
Israeli residents holding (or have a right to hold or to purchase) less than 10% of our total share capital and do not have a right to
receive 10% or more of the Company&#8217;s profits.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Section
102 of the Ordinance allows Israeli employees, directors and officers, who are not controlling shareholders to receive favorable tax
treatment for compensation in the form of shares or options. However, under this route we are not allowed to deduct any expense with
respect to the issuance of the options or shares. Israeli non-employee service providers, consultants and shareholders who hold 10% or
more of our total share capital or are otherwise controlling shareholders, may be granted options pursuant to Section 3(i) of the Ordinance,
which does not provide for similar tax benefits. In order to comply with the terms of the capital gains route pursuant to Section 102
of the Ordinance, the granted options as well as the ordinary shares issued upon exercise of these options and other shares received
subsequently following any realization of rights with respect to such options (such as share dividends and share splits), must be granted
to a trustee for the benefit of the relevant grantee and should be held by the trustee for at least two years after the date of the grant.
If such options or shares are sold by the trustee or are transferred to the grantee before the end of the two-year period, then the grantee
would be taxed at top marginal rates upon selling the shares.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>


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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">For
residents, or deemed residents, of the United States, the 2013 Plan provides grants, which are pursuant to Section 422 of the Internal
Revenue Code of 1986, as amended, or the Code, as incentive stock options, or ISOs, and any other participants which do not qualify for
ISOs, as non-statutory stock options, or NSOs, pursuant to the Code.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Section
422 of the Code allows employees, directors and officers, who are non-controlling shareholders (e.g., less than 10% shareholders) and
are considered residents of the United States or those who are deemed to be residents of the United States for purposes of the payment
of tax, or are otherwise subject to taxation in the United States with respect to the grant of awards, to receive favorable tax treatment
for compensation in the form of shares or ISOs. 10% shareholders or persons which are not service providers will receive NSOs, which
do not entitle them to receive similar tax benefits. Section 422(b) of the Code provides for the ISO track such that the individual does
not have to pay ordinary income tax (nor employment taxes) on the difference between the exercise price and the fair market value of
the shares issued (however, the holder may have to pay U.S. alternative minimum tax instead). However, if the shares are held for one
year from the date of exercise and two years from the date of grant, then the profit (if any) made on sale of the shares is taxed as
long-term capital gain. Section 422 of the Code requires that any grant of awards shall not be made at a price which is less than 100%
of the fair market value of such awards on the date of the grant, all pursuant to the terms of Section 409A of the Code. However, under
this ISO track, we are not allowed to deduct any expense with respect to the issuance of the options or shares. In order to comply with
the terms of the ISO track, the option granted thereunder must meet the requirements of Section 422 of the Code when granted and at all
times until the exercise thereof.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Options
and RSUs granted under the 2013 Plan will vest in accordance with the vesting dates as determined by the Board following the recommendation
of the remuneration committee or any other similar committee of the Board with respect to each grant. Generally, options that are not
exercised within ten years from the grant date expire, unless otherwise determined by the Board and the remuneration committee, as applicable,
provided, however, that, pursuant to our Compensation Policy, any equity-based awards to Office Holders must include both a gradual vesting
period of at least three years from the date of grant, and an exercise period of no more than ten years from the date of grant.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Upon
such date or dates designated in the applicable award agreement, unless earlier forfeited, subject to the receipt of any approvals required
from any relevant tax authority, we shall settle each RSU upon vesting by delivering one ordinary share.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
case of termination for reasons of disability or death, the grantee or his legal successor may exercise options that have vested prior
to termination within a period of twelve months from the date of disability or death. If we terminate a grantee&#8217;s employment or
service for cause, all of the grantee&#8217;s vested and unvested unexercised options will expire and terminate on the date of termination.
If a grantee&#8217;s employment or service is terminated for any other reason, the grantee may exercise his or her vested options within
90 days of the date of termination or within a longer period under specified circumstances determined by our Board. Any expired or unvested
options shall return to the option pool reserved under the 2013 Plan for reissuance.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
the event of grantee&#8217;s termination prior to a vesting date by reason of such grantee&#8217;s death or disability, all of such grantee&#8217;s
RSUs shall immediately become vested as of the date of such termination. In the event of a grantee&#8217;s termination for cause prior
to settlement, all of such grantee&#8217;s RSUs shall immediately be forfeited for no consideration as of the date of such termination.
If a grantee&#8217;s employment or service is terminated for any other reason, (1) all vesting with respect to such grantee&#8217;s RSUs
shall cease, (2) all of such grantee&#8217;s unvested RSUs shall immediately be forfeited for no consideration as of the date of such
termination, and (3) to the extent not already settled, all of such grantee&#8217;s vested RSUs shall be settled in accordance with the
settlement schedule set forth in the applicable award agreement.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
the event of a merger or consolidation of our company subsequent to which we would no longer exist as a legal entity, or a sale of all,
or substantially all, of our ordinary shares or assets or other transaction having a similar effect on us, or a Transaction, any unexercised
options then outstanding will be cancelled. Notwithstanding the foregoing, the Board, or the relevant committee of the Board, may determine
that the options will not be cancelled but will be assumed or substituted for an appropriate number of the same type of shares or other
securities of the successor company as were distributed to the Company or the shareholders in connection with the Transaction. In addition,
the Board, or the relevant committee of the Board, may determine to include in certain option agreements either a clause that provides
for acceleration of vesting of all or part of the unvested options in the event of a Transaction or the occurrence of another event or
a clause which provides that if the optionee&#8217;s employment with the successor company is terminated by the successor company without
cause within a certain period, not to exceed two years from the closing of such Transaction, all or part of the unvested options shall
be accelerated.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>


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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; text-align: justify; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Certain
Information Concerning Equity Awards to Office Holders</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
following tables set forth information, as of March 27, 2024 concerning all outstanding equity awards to Office Holders as of such date.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Options</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 100%">
  <tr style="vertical-align: bottom">
    <td style="border-bottom: Black 1.5pt solid; vertical-align: bottom; font-weight: bold; text-align: center">Name of Office Holder</td><td style="text-align: center; font-weight: bold; padding-bottom: 1.5pt; vertical-align: bottom">&#160;</td>
    <td style="border-bottom: Black 1.5pt solid; vertical-align: bottom; font-weight: bold; text-align: center">Date of grant</td><td style="text-align: center; padding-bottom: 1.5pt; font-weight: bold; vertical-align: bottom">&#160;</td><td style="text-align: center; font-weight: bold; padding-bottom: 1.5pt; vertical-align: bottom">&#160;</td>
    <td colspan="2" style="border-bottom: Black 1.5pt solid; vertical-align: bottom; font-weight: bold; text-align: center"><p style="margin-top: 0; margin-bottom: 0">Exercise price per</p>
                                                                                <p style="margin-top: 0; margin-bottom: 0">share ($)*</p></td><td style="text-align: center; padding-bottom: 1.5pt; font-weight: bold; vertical-align: bottom">&#160;</td><td style="text-align: center; font-weight: bold; padding-bottom: 1.5pt; vertical-align: bottom">&#160;</td>
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                                                                                                    <p style="margin-top: 0; margin-bottom: 0">to the option</p></td><td style="text-align: center; padding-bottom: 1.5pt; font-weight: bold; vertical-align: bottom">&#160;</td><td style="text-align: center; font-weight: bold; padding-bottom: 1.5pt; vertical-align: bottom">&#160;</td>
    <td colspan="2" style="border-bottom: Black 1.5pt solid; vertical-align: bottom; font-weight: bold; text-align: center"><p style="margin-top: 0; margin-bottom: 0">Shares vested and</p>
                                                                                <p style="margin-top: 0; margin-bottom: 0">unexercised</p></td><td style="text-align: center; padding-bottom: 1.5pt; font-weight: bold; vertical-align: bottom">&#160;</td>
    <td style="text-align: center; padding-bottom: 1.5pt; font-weight: bold; vertical-align: bottom">&#160;</td>
    <td colspan="2" style="border-bottom: Black 1.5pt solid; vertical-align: bottom; font-weight: bold; text-align: center"><p style="margin-top: 0; margin-bottom: 0">Shares</p>
                                                                                <p style="margin-top: 0; margin-bottom: 0">unvested</p></td><td style="text-align: center; padding-bottom: 1.5pt; font-weight: bold; vertical-align: bottom">&#160;</td><td style="text-align: center; font-weight: bold; padding-bottom: 1.5pt; vertical-align: bottom">&#160;</td>
    <td style="border-bottom: Black 1.5pt solid; vertical-align: bottom; font-weight: bold; text-align: center">Schedule date of expiration</td><td style="text-align: center; padding-bottom: 1.5pt; font-weight: bold; vertical-align: bottom">&#160;</td></tr>
  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="width: 28%; text-align: left">Allen Baharaff</td><td style="width: 2%">&#160;</td>
    <td style="width: 11%; text-align: right"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">December 30, 2013</span></td><td style="width: 1%; text-align: left">&#160;</td><td style="width: 1%">&#160;</td>
    <td style="width: 1%; text-align: left">&#160;</td><td style="width: 8%; text-align: right"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">NIS 0.15</span></td><td style="width: 1%; text-align: left">&#160;</td><td style="width: 1%">&#160;</td>
    <td style="width: 1%; text-align: left">&#160;</td><td style="width: 8%; text-align: right">16,069</td><td style="width: 1%; text-align: left">&#160;</td><td style="width: 1%">&#160;</td>
    <td style="width: 1%; text-align: left">&#160;</td><td style="width: 8%; text-align: right">16,069</td><td style="width: 2%; text-align: left">(**)</td>
    <td style="width: 1%; text-align: left">&#160;</td>
    <td style="width: 1%; text-align: left">&#160;</td><td style="width: 8%; text-align: right">0</td><td style="width: 1%; text-align: left">&#160;</td><td style="width: 1%">&#160;</td>
    <td style="width: 11%; text-align: right"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Dec-12-2028</span></td><td style="width: 1%; text-align: left">&#160;</td></tr>
  <tr style="vertical-align: bottom; background-color: White">
    <td>&#160;</td><td>&#160;</td>
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    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td>
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    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
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    <td style="text-align: left">&#160;</td><td style="text-align: right">2,666</td><td style="text-align: left">&#160;</td>
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    <td style="text-align: left">&#160;</td><td style="text-align: right">0</td><td style="text-align: left">&#160;</td><td>&#160;</td>
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    <td style="text-align: left">&#160;</td><td style="text-align: right">2,666</td><td style="text-align: left">&#160;</td>
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    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td>
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    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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    <td style="text-align: left">&#160;</td><td style="text-align: right">1,500</td><td style="text-align: left">&#160;</td>
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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    <td style="text-align: left">&#160;</td><td style="text-align: right">2,666</td><td style="text-align: left">&#160;</td>
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    <td style="text-align: left">&#160;</td><td style="text-align: right">2,666</td><td style="text-align: left">&#160;</td>
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    <td style="text-align: left">&#160;</td><td style="text-align: right">0</td><td style="text-align: left">&#160;</td><td>&#160;</td>
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    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td>
    <td style="text-align: left">&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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    <td style="text-align: left">&#160;</td><td style="text-align: right">1,333</td><td style="text-align: left">&#160;</td>
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    <td style="text-align: left">&#160;</td><td style="text-align: right">0</td><td style="text-align: left">&#160;</td><td>&#160;</td>
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    <td style="text-align: left">&#160;</td><td style="text-align: right">2,000</td><td style="text-align: left">&#160;</td>
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    <td style="text-align: left">&#160;</td><td style="text-align: right">0</td><td style="text-align: left">&#160;</td><td>&#160;</td>
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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    <td style="text-align: left">&#160;</td><td style="text-align: right">1,333</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">998</td><td style="text-align: left">&#160;</td>
    <td style="text-align: left">&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">335</td><td style="text-align: left">&#160;</td><td>&#160;</td>
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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">(*)
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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

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On May 11, 2023, we repriced outstanding options to purchase an aggregate of 35,598 ordinary shares held by several Office Holders to
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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>


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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"></span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>F.
Disclosure of a registrant&#8217;s action to recover erroneously awarded compensation.</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; text-align: justify; margin: 0pt 0pt 0pt 0; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Not
applicable.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><span id="am_005"></span>ITEM
7. Major Shareholders and Related Party Transactions.</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>A.
Major Shareholders.</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Except
as set forth in &#8220;Item 6. Directors, Senior Management and Employees&#8212;E. Share Ownership,&#8221; to the best of our knowledge,
no other person who we know beneficially owns 5% or more of the Company&#8217;s ordinary shares outstanding as of March 27, 2024, the
latest practicable date for inclusion in this annual report. None of our shareholders has different voting rights from other shareholders.
Other than as described herein, to the best of our knowledge, we are not owned or controlled, directly or indirectly, by another corporation,
by any foreign government or by any natural person or legal persons, severally or jointly, and we are not aware of any arrangement that
may, at a subsequent date, result in a change of control of our company.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>B.
Related Party Transactions.</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
following is a summary description of the material terms of those transactions with related parties to which we, or our subsidiaries,
are party and which were in effect since January 1, 2023.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Financing
Agreement with GRD</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
have provided financing to GRD from time to time, pursuant to which the Company and GRD have executed several capital notes for an aggregate
outstanding principal amount of approximately $147.0 million. The par value of such notes is in NIS, and they bear no interest nor repayment
date; provided, however, that no repayment shall be made before the fifth anniversary from the issuance date of each note.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>


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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Agreements
with Directors and Officers</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><i>Employment
and Consulting Agreements</i>. We have entered into written employment or consulting agreements with certain of our Office Holders. These
agreements provide for notice periods of varying duration for termination of the agreement by us or by the relevant Office Holder, during
which time the Office Holder will continue to receive base salary and benefits. We have also entered into customary non-competition,
confidentiality of information and ownership of inventions arrangements with these Office Holders. However, the enforceability of the
noncompetition provisions may be limited under applicable law.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><i>Options.
</i>Since our inception, we have granted options to purchase our ordinary shares to certain of our Office Holders. Such option agreements
may contain acceleration provisions upon certain merger, acquisition, or change of control transactions. During November 2022, we effected
a repricing of certain options. See also &#8220;Item 6. Directors, Senior Management and Employees&#8212;E. Share Ownership&#8221;. We
describe our 2013 Plan under &#8220;Item 6. Directors, Senior Management and Employees&#8212;B. Compensation&#8212; 2013 Incentive Share
Option Plan.&#8221; If the relationship between us and an Office Holder is terminated except for &#8220;cause&#8221; (as defined in the
2013 Plan and/or the applicable option award agreement), options that are vested will generally remain exercisable for 90 days after
such termination; provided, however, that prior to the date of such termination, our remuneration committee may authorize an extension
of the terms of all or part of the vested options beyond the date of such termination for a period not to exceed the period during which
the options by their terms would otherwise have been exercisable, and provided further that the vested options may lose their status
as incentive stock options and/or approved 102 options if such extension extends beyond the maximum extension authorized by the Ordinance
or the Code, as applicable<i>.</i></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; text-align: justify; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><i>RSUs.
</i>We have granted RSUs to certain of our Office Holders. Such award agreements may contain acceleration provisions upon certain merger,
acquisition, or change of control transactions. See also &#8220;Item 6. Directors, Senior Management and Employees&#8212;E. Share Ownership.&#8221;
We describe our 2013 Plan under &#8220;Item 6. Directors, Senior Management and Employees&#8212;B. Compensation&#8212;2013 Incentive
Share Option Plan.&#8221; If the relationship between us and an Office Holder is terminated, RSUs that are vested shall be settled in
accordance with the settlement schedule set forth in the applicable award agreement.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>OnKai</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.45in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.45in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
May 2023, we entered into the OnKai Agreement for a $1.5 million equity investment in OnKai, a US-based technology company developing
an AI-based platform to advance healthcare for underserved populations across the United States by facilitating alignment between healthcare
stakeholders. The signing of the definitive agreement followed an announcement that we made in January 2023 that we had entered into
a non-binding termsheet for an equity investment in OnKai. The OnKai Agreement provided that we will invest $1.5 million in exchange
for series seed preferred shares of OnKai (which is in addition to a $1.5 million investment that was made by us in OnKai through a SAFE
and which converted at a 15% discount into series seed preferred shares upon consummation of the Investment Round). Our investment in
OnKai was part of an approximately $6 million Investment Round with other investors that was led by us of which SAFE notes of approximately
$3.8 million were converted into preferred shares. On June 19, 2023, the Investment Round closed. Following the Investment Round, we
hold approximately 23.9% of the outstanding share capital of OnKai on an as-converted and fully and our Chief Executive Officer and director,
Allen Baharaff serves as a board member of OnKai. In connection with the OnKai Agreement, our wholly-owned subsidiary, GRD entered into
the OnKai Services Agreement with OnKai. The OnKai Services Agreement provides that GRD shall on a non-exclusive basis (i) provide support
services to OnKai relating to finance, business development, strategic planning, execution and others; and (ii) lend its experience to
OnKai in building a strategy and for the development of treatments for the underserved and that OnKai shall on a non-exclusive basis
(i) take part in plan preparation to serve GDR&#8217;s vision of developing drugs for the underserved population and (ii) when relevant,
design a process on the clinical trial dashboard that could potentially serve GDR&#8217;s future trial.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>C.
Interests of Experts and Counsel.</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; text-align: justify; margin: 0pt 0pt 0pt 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Not
applicable.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><span id="am_006"></span>ITEM
8. Financial Information.</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>A.
Consolidated Financial Statements and Other Financial Information.</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; text-align: justify; margin: 0pt 0pt 0pt 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">See
&#8220;Item 18. Financial Statements&#8221; for a list of all financial statements filed as part of this annual report.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>


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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Legal
Matters</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
are neither party to any legal or arbitration proceedings, including those relating to bankruptcy, receivership or similar proceedings
and those involving any third-party, nor any governmental proceedings pending or known to be contemplated, which may have, or have had
in the recent past, significant effects on the Company&#8217;s financial position or profitability.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Dividend
Policy</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
have never declared or paid any cash dividends on our ordinary shares and do not anticipate paying any cash dividends in the foreseeable
future. Payment of cash dividends, if any, in the future will be at the discretion of our Board and will depend on then-existing conditions,
including our financial condition, operating results, contractual restrictions, capital requirements, business prospects and other factors
our Board may deem relevant.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Payment
of dividends may also be subject to Israeli withholding taxes. See &#8220;Item 10. Additional Information&#8212;E. Taxation&#8212;Certain
Israeli Tax Considerations&#8221; for additional information.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>B.
Significant Changes.</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Other
than as otherwise described in this Annual Report on Form 20-F and as set forth below, no significant change has occurred in our operations
since the date of our consolidated financial statements included in this Annual Report on Form 20-F.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><span id="am_007"></span>ITEM
9. The Offer and Listing.</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>A.
Offer and Listing Details</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Our
ordinary shares have been listed on the Nasdaq Capital Market under the symbol &#8220;GLMD&#8221; since March 13, 2014. Prior to that
date, there was no public trading market for our ordinary shares.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>B.
Plan of Distribution</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Not
applicable.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>C.
Market for Ordinary Shares</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Our
ordinary shares have been quoted on the NASDAQ Capital Market since March 18, 2014 under the symbol &#8220;GLMD.&#8221;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>D.
Selling Shareholders</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; text-align: justify; margin: 0pt 0pt 0pt 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Not
applicable.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>E.
Dilution</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; text-align: justify; margin: 0pt 0pt 0pt 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Not
applicable.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>F.
Expenses of the issue</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; text-align: justify; margin: 0pt 0pt 0pt 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Not
applicable.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><span id="am_008"></span>ITEM
10. Additional Information.</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>A.
Share Capital.</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; text-align: justify; margin: 0pt 0pt 0pt 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Not
applicable.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>


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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>B.
Memorandum and Articles of Association.</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Our
registration number is 51-495351-2. At the 2014 annual general meeting of shareholders, our shareholders adopted our Articles, which
became effective on the consummation of our initial public offering in the United States in March 2014. Under Section 2 of our Articles,
the purpose of the Company is to engage in any lawful activity.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
information set forth in Exhibit 2.1 of this Annual Report is incorporated herein by reference.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>C.
Material Contracts</b></span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">For
a description of our material agreements relating to our strategic collaborations and research arrangements and other material agreements,
please refer to &#8220;Item 4.B. Information on the Company&#8212;Business Overview&#8212;Strategic Collaborations, Research Arrangements
and other Material Agreements.&#8221; &#8220;and &#8220;Item 7.B &#8220;Related Party Transactions&#8221;.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Employment
Agreements</i></b></span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; text-align: justify; margin: 0pt 0pt 0pt 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">See
&#8220;Item 6. Directors, Senior Management and Employees&#8212;B. Compensation&#8221;.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>D.
Exchange Controls.</b></span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">There
are no Israeli government laws, decrees, regulations or other legislation that restrict or that affect our export or import of capital,
including the availability of cash and cash equivalents for use by us and our wholly-owned subsidiaries, or the remittance of dividends,
interest or other payments to non-resident holders of our securities, except for ownership by nationals of certain countries that are,
or have been, declared as enemies of Israel or otherwise as set forth under &#8220;Item 10. Additional Information&#8212;E. Taxation.&#8221;</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>E.
Taxation.</b></span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
following description is not intended to constitute a complete analysis of all tax consequences relating to the ownership or disposition
of our ordinary shares. You should consult your own tax advisor concerning the tax consequences of your particular situation, as well
as any tax consequences that may arise under the laws of any state, local, foreign, including Israel, or other taxing jurisdiction.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Certain
Israeli Tax Considerations</i></b></span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
following is a brief summary of the material Israeli income tax laws applicable to us. This section also contains a discussion of material
Israeli tax consequences concerning the ownership and disposition of our ordinary shares. This summary does not discuss all the aspects
of Israeli tax law that may be relevant to a particular investor in light of his or her personal investment circumstances or to some
types of investors subject to special treatment under Israeli law. Examples of this kind of investor include residents of Israel or investors
in securities who are subject to special tax regimes not covered in this discussion. To the extent that the discussion is based on new
tax legislation that has not yet been subject to judicial or administrative interpretation, we cannot assure you that the appropriate
tax authorities or the courts will accept the views expressed in this discussion. This summary is based on laws and regulations in effect
as of the date hereof and does not take into account possible future amendments which may be under consideration.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>General
Corporate Tax Structure in Israel</i></b></span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Israeli
resident companies (as defined below), such as the Company, are generally subject to corporate tax at the rate of 23% on their taxable
income, as of January 1, 2018 (23% in 2023). However, the effective tax rate payable by a company that derives income from a Preferred
Enterprise or a Technology Enterprise, as discussed below, may be considerably less.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Capital
gains derived by an Israeli resident company are generally subject to tax at the same rate as the corporate tax rate. Under Israeli tax
legislation, a corporation will be considered an &#8220;Israeli resident&#8221; if it meets one of the following: (i) it was incorporated
in Israel; or (ii) the control and management of its business are exercised in Israel.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Law
for the Encouragement of Industry (Taxes), 5729-1969</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
Law for the Encouragement of Industry (Taxes), 5729-1969, which we refer to as the Industry Encouragement Law, provides several tax benefits
for &#8220;Industrial Companies,&#8221; which are defined as Israeli resident-companies which were incorporated in Israel, of which 90%
or more of their income in any tax year, other than income from certain government loans, is derived from an &#8220;Industrial Enterprise&#8221;
that it owns and located in Israel or in the &#8220;Area&#8221;, in accordance with the definition under Section 3A of the Israeli Tax
Ordinance. An &#8220;Industrial Enterprise&#8221; is defined as an enterprise whose principal activity in a given tax year is industrial
production. Eligibility for benefits under the Industry Encouragement Law is not contingent upon approval of any governmental authority.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; text-align: justify; margin: 0pt 0pt 0pt 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
following tax benefits, among others, are available to Industrial Companies:</span></p>

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<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">amortization
    over an eight year period of the cost of purchasing a patent, rights to use a patent and rights to know-how, which are used for the
    development or advancement of the company, commencing in the year in which such rights were first exercised;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">under limited conditions,
    an election to file consolidated tax returns with related Industrial Companies controlled by it; and</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">deductions
    of expenses related to a public offering in equal amounts over a three year period commencing on the year of the offering.</span></td></tr>
  </table>
<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
believe that we qualify as an &#8220;Industrial Company&#8221; within the meaning of the Industry Encouragement Law. There can be no
assurance that we will continue to qualify as an Industrial Company in the future or that the benefits described above will be available
to us at all.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Law
for the Encouragement of Capital Investments, 5719-1959</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
Law for the Encouragement of Capital Investments, 5719-1959, which we refer to as the Investment Law, provides certain incentives for
capital investments in production facilities (or other eligible assets) by &#8220;Industrial Enterprises&#8221; (as defined under the
Investment Law). Generally, an investment program that is implemented in accordance with the provisions of the Investment Law, is entitled
to benefits. These benefits may include cash grants from the Israeli government and tax benefits, based upon, among other things, the
geographic location in Israel of the facility in which the investment is made. In order to qualify for these incentives, an Approved
Enterprise, a Beneficiary Enterprise or a Preferred Enterprise is required to comply with the requirements of the Investment Law.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
Investment Law was significantly amended effective April 1, 2005, further amended as of January 1, 2011, or the 2011 Amendment, and as
of January 1, 2017, or the 2017 Amendment. The 2011 Amendment introduced new benefits to replace those granted in accordance with the
provisions of the Investment Law in effect prior to the 2011 Amendment. However, companies entitled to benefits under the Investment
Law as in effect up to January 1, 2011 were entitled to choose to continue to enjoy such benefits, provided that certain conditions are
met, or elect instead, irrevocably, to forego such benefits and elect the benefits of the 2011 Amendment. The 2017 Amendment introduces
new benefits for Technological Enterprises, alongside the existing tax benefits.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; text-align: justify; margin: 0pt 0pt 0pt 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
following discussion is a summary of the Investment Law following its most recent amendments:</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Tax
Benefits Under the 2011 Amendment</i></b></span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
2011 Amendment canceled the availability of the benefits granted to Industrial Companies under the Investment Law prior to 2011 and,
instead, introduced new benefits for income generated by a &#8220;Preferred Company&#8221; through its &#8220;Preferred Enterprise&#8221;
(as such terms are defined in the Investment Law) as of January 1, 2011.</span></p>
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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
definition of a Preferred Company includes a company incorporated in Israel that is not fully owned by a governmental entity, and that
has, among other things, a Preferred Enterprise and is controlled and managed from Israel. Pursuant to the 2011 Amendment, beginning
in 2014 and in each year thereafter until 2016, a Preferred Company may only be entitled to a reduced corporate tax rate of 16% with
respect to its preferred income derived by its Preferred Enterprise, unless the Preferred Enterprise is located in a specified development
zone, in which case the rate will be 9%. Pursuant to the 2017 Amendment, in 2017 and thereafter, the corporate tax rate for Preferred
Enterprise which is located in a specified development zone was reduced to 7.5%, while the reduced corporate tax rate for other development
zones remains 16%. Income derived by a Preferred Company from a &#8220;Special Preferred Enterprise&#8221; (as such term is defined in
the Investment Law) would be entitled, during a benefit period of ten years, to further reduced tax rates of 8%, or 5% if the Special
Preferred Enterprise is located in a certain development zone. As of January 1, 2017, the definition for &#8216;Special Preferred Enterprise&#8217;
includes less stringent conditions.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">As
of January 1, 2014, dividends paid to Israeli shareholders out of income attributed to a Preferred Enterprise or to a Special Preferred
Enterprise are generally subject to withholding tax at source at the rate of 20% (in the case of non-Israeli shareholders - subject to
the receipt in advance of a valid certificate from the ITA allowing for a reduced tax rate, 20%, or such a lower tax rate as may be provided
under an applicable tax treaty). However, if such dividends are paid to an Israeli company, no tax is required to be withheld (although,
if such dividends are subsequently distributed to individuals or a non-Israeli company, the aforesaid will apply).</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>New
Tax benefits under the 2017 Amendment</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
2017 Amendment was enacted as part of the Economic Efficiency Law that was published on December 29, 2016, and is effective as of January
1, 2017. The 2017 Amendment provides new tax benefits for two types of &#8220;Technology Enterprises&#8221;, as described below, and
is in addition to the other existing tax beneficial programs under the Investment Law.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
2017 Amendment provides that a technology company satisfying certain conditions will qualify as a &#8220;Preferred Technology Enterprise&#8221;
and will thereby enjoy a reduced corporate tax rate of 12% on income that qualifies as &#8220;Preferred Technology Income&#8221;, as
defined in the Investment Law. The tax rate is further reduced to 7.5% for a Preferred Technology Enterprise located in development zone
A. In addition, a Preferred Technology Company will enjoy a reduced corporate tax rate of 12% on capital gain derived from the sale of
certain &#8220;Benefitted Intangible Assets&#8221; (as defined in the Investment Law) to a related foreign company if the Benefitted
Intangible Assets were acquired from a foreign company on or after January 1, 2017 for at least NIS 200 million (approximately $56 million),
and the sale receives prior approval from the National Authority for Technological Innovation (previously known as the Israeli Office
of the Chief Scientist), to which we refer as IIA.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
2017 Amendment further provides that a technology company satisfying certain conditions will qualify as a &#8220;Special Preferred Technology
Enterprise&#8221; and will thereby enjoy a reduced corporate tax rate of 6% on &#8220;Preferred Technology Income&#8221; regardless of
the company&#8217;s geographic location within Israel. In addition, a Special Preferred Technology Enterprise will enjoy a reduced corporate
tax rate of 6% on capital gain derived from the sale of certain &#8220;Benefitted Intangible Assets&#8221; to a related foreign company
if the Benefitted Intangible Assets were either developed by the Special Preferred Technology Enterprise or acquired from a foreign company
on or after January 1, 2017, and the sale received prior approval from IIA. A Special Preferred Technology Enterprise that acquires Benefitted
Intangible Assets from a foreign company for more than NIS 500 million will be eligible for these benefits for at least ten years, subject
to certain approvals as specified in the Investment Law.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Dividends
distributed by a Preferred Technology Enterprise or a Special Preferred Technology Enterprise to Israeli shareholders, paid out of Preferred
Technology Income, are subject to withholding tax at source at the rate of 20% (in the case of non-Israeli shareholders - subject to
the receipt in advance of a valid certificate from the ITA allowing for a reduced tax rate, 20%, or such lower rate as may be provided
in an applicable tax treaty). However, if such dividends are paid to an Israeli company, no tax is required to be withheld (although,
if such dividends are subsequently distributed to individuals or a non-Israeli company, the aforesaid will apply). If such dividends
are distributed to a foreign parent company holding, alone or together with other foreign companies, at least 90% of the shares of the
distributing company and other conditions are met, the withholding tax rate will be 4% (or a lower rate under a tax treaty, if applicable,
subject to the receipt in advance of a valid certificate from the ITA allowing for a reduced tax rate).</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">After
examining the impact of the 2017 Amendment, we submitted a request to receive a tax ruling from the Israel Tax Authority to be recognized
as a Preferred Technology Enterprise and we received a tax ruling from the Israel Tax Authority granting GRD a Preferred Technology Enterprise
status, subject to terms and conditions determined in the tax ruling.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Taxation
of Our Israeli Individual Shareholders on Receipt of Dividends</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Israeli
residents who are individuals are generally subject to Israeli income tax for dividends paid on our ordinary shares (other than bonus
shares or share dividends) at a rate of 25%, or 30% if the recipient of such dividend is a Substantial Shareholder (as defined below)
at the time of distribution or at any time during the preceding 12-month period. However, dividends distributed from taxable income accrued
from Preferred Enterprise or Preferred Technology Enterprise to Israeli individuals are subject to withholding tax at the rate of 20%.
However, if such dividends are distributed to an Israeli company, no tax is imposed (although, if such dividends are subsequently distributed
to individuals or a non-Israeli company, withholding tax at a rate of 20% or such lower rate as may be provided in an applicable tax
treaty (subject to the receipt in advance of a valid certificate from the Israel Tax Authority (&#8220;ITA&#8221;) allowing for a reduced
tax rate will apply). An average rate will be set in case the dividend is distributed from mixed types of income (regular and preferred
income).</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">A
&#8220;Substantial Shareholder&#8221; is generally a person who alone, or together with his or her relative or another person who collaborates
with him or her on a regular basis, holds, directly or indirectly, at least 10% of any of the &#8220;means of control&#8221; of a corporation.
&#8220;Means of control&#8221; generally include the right to vote, receive profits, nominate a director or an officer, receive assets
upon liquidation or instruct someone who holds any of the aforesaid rights regarding the manner in which he or she is to exercise such
right(s), all regardless of the source of such right.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">With
respect to individuals, the term &#8220;Israeli resident&#8221; is generally defined under Israeli tax legislation as a person whose
center of life is in Israel. The Israeli Tax Ordinance (as amended by Amendment Law No. 132 of 2002), states that in order to determine
the center of life of an individual, consideration will be given to the individual&#8217;s family, economic and social connections, including:
(i) place of permanent residence; (ii) place of residential dwelling of the individual and the individual&#8217;s immediate family; (iii)
place of the individual&#8217;s regular or permanent occupation or the place of his or her permanent employment; (iv) place of the individual&#8217;s
active and substantial economic interests; (v) place of the individual&#8217;s activities in organizations, associations and other institutions.
The center of life of an individual will be presumed to be in Israel if: (i) the individual was present in Israel for 183 days or more
in the tax year; or (ii) the individual was present in Israel for 30 days or more in the tax year, and the total period of the individual&#8217;s
presence in Israel in that tax year and the two previous tax years is 425 days or more. Such presumption may be rebutted either by the
individual or by the assessing officer.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Payers
of dividends on our ordinary shares, including the Israeli stockbroker effectuating the transaction, or the financial institution through
which the securities are held, are generally required, subject to any of the foregoing exemptions, reduced tax rates and the demonstration
of a shareholder regarding his, her or its foreign residency, to withhold tax upon the distribution of dividend at the rate of 25% (whether
the recipient is a Substantial Shareholder or not), so long as the shares are registered with a nominee company.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Taxation
of Israeli Resident Corporations on Payment of Dividends</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Israeli
resident corporations are generally exempt from Israeli corporate income tax with respect to dividends paid on ordinary shares of Israeli
resident corporations as long as the profits out of which the dividends were paid were derived in Israel.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Capital
Gains Taxes Applicable to Israeli Resident Shareholders</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
income tax rate applicable to real capital gains derived by an Israeli individual resident from the sale of shares that were purchased
after January 1, 2012, whether listed on a stock exchange or not, is 25%. However, if such shareholder is considered a Substantial Shareholder
at the time of sale or at any time during the preceding 12 month period and/or claims a deduction for interest and linkage differences
expenses in connection with the purchase and holding of such shares, such gain will be taxed at the rate of 30%.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Moreover,
capital gains derived by an individual shareholder who is a dealer or trader in securities, or to whom such income is otherwise taxable
as ordinary business income, are taxed in Israel at their marginal rates applicable to business income (up to 50% in 2022 and 2023, including
Excess Tax as detailed below).</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">At
the sale of securities traded on a stock exchange, a detailed return, including a computation of the tax due, must be filed and an advanced
payment must be paid on January 31 and July 31 of every tax year in respect of sales of securities made within the previous six months.
However, if all tax due was withheld at source according to applicable provisions of the Israeli Tax Ordinance and regulations promulgated
thereunder, the aforementioned return is not required to be filed and no advance payment must be paid. Capital gain is also reportable
on the annual income tax return.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Taxation
of Non-Israeli Shareholders on Receipt of Dividends</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Non-Israeli
residents are generally subject to Israeli income tax on the receipt of dividends paid on our ordinary shares at the rate of 25% (or
30% for individuals, if such person is a Substantial Shareholder at the time he or she receives the dividend or on any date in the 12
months preceding such date), or 20% if the dividend is distributed from income attributed to Preferred Enterprise unless a lower rate
is provided under an applicable tax treaty between Israel and the shareholder&#8217;s country of residence and provided that a certificate
from the Israel Tax Authority allowing for a reduced withholding tax rate is obtained in advance.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">A
non-Israeli resident who has dividend income derived from or accrued in Israel, from which the full amount of tax was withheld at source,
is generally exempt from the duty to file tax returns in Israel in respect of such income; provided that (i) such income was not derived
from a business conducted in Israel by the taxpayer, (ii) the taxpayer has no other taxable sources of income in Israel with respect
to which a tax return is required to be filed, and (iii) the taxpayer is not obligated to pay excess tax (as further explained below).</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">For
example, under the Convention Between the Government of the United States of America and the Government of Israel with Respect to Taxes
on Income, as amended, or the U.S.-Israel Tax Treaty, Israeli withholding tax on dividends paid to a U.S. resident for treaty purposes
may not, in general, exceed 25%, subject to certain conditions. Where the recipient is a U.S. corporation owning 10% or more of the voting
shares of the paying corporation during the part of the paying corporation&#8217;s taxable year which precedes the date of payment of
the dividend and during the entirety of its prior taxable year (if any), the Israeli tax withheld may not exceed 12.5%, subject to certain
conditions.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Payers
of dividends on our ordinary shares, including the Israeli stockbroker effectuating the transaction, or the financial institution through
which the securities are held, are generally required, subject to any of the foregoing exemptions, reduced tax rates and the demonstration
of a shareholder regarding his, her or its foreign residency, to withhold tax upon the distribution of dividend at the rate of 25% (whether
the recipient is a Substantial Shareholder or not), so long as the shares are registered with a nominee company.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Capital
Gains Income Taxes Applicable to Non-Israeli Shareholders</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Non-Israeli
resident shareholders are generally exempt from Israeli capital gains tax on any gains derived from the sale, exchange or disposition
of our ordinary shares, provided that such shareholders did not acquire their shares prior to January 1, 2009 or acquired their shares
after the Company was listed for trading on NASDAQ and such gains were not derived from a permanent business or business activity of
such shareholders in Israel. These provisions dealing with capital gain are not applicable to a person whose gains from selling or otherwise
disposing of the shares are deemed to be business income. However, non-Israeli corporations will not be entitled to the foregoing exemptions
if an Israeli resident (i) has a controlling interest of more than 25% in such non-Israeli corporation or (ii) is the beneficiary of
or is entitled to 25% or more of the revenues or profits of such non-Israeli corporation, whether directly or indirectly.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
addition, a sale of securities by a non-Israeli resident may be exempt from Israeli capital gains tax under the provisions of an applicable
tax treaty. For example, under the U.S.-Israel Tax Treaty, the sale, exchange or disposition of our ordinary shares by a shareholder
who is a U.S. resident (for purposes of the U.S.-Israel Tax Treaty) holding the ordinary shares as a capital asset and is entitled to
claim the benefits afforded to such a resident by the U.S.-Israel Tax Treaty, or a Treaty U.S. Resident, is generally exempt from Israeli
capital gains tax unless: (i) such Treaty U.S. Resident is an individual and was present in Israel for 183 days or more in the aggregate
during the relevant taxable year; (ii) such Treaty U.S. Resident holds, directly or indirectly, shares representing 10% or more of our
voting power of the Company during any part of the 12 month period preceding such sale, exchange or disposition, subject to certain conditions;
(iii) the capital gains arising from such sale, exchange or disposition are attributable to a permanent establishment of the Treaty U.S.
Resident maintained in Israel, subject to certain conditions; (iv) the capital gains arising from such sale, exchange or disposition
is attributed to real estate located in Israel; or (v) the capital gains arising from such sale, exchange or disposition is attributed
to royalties. In any such case, the sale, exchange or disposition of our ordinary shares would be subject to Israeli tax, to the extent
applicable. However, under the U.S.-Israel Tax Treaty, such Treaty U.S. Resident would be permitted to claim a credit for such taxes
against U.S. federal income tax imposed on any gain from such sale, exchange or disposition, under the circumstances and subject to the
limitations specified in the U.S.-Israel Income Tax Treaty.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Regardless
of whether shareholders may be liable for Israeli income tax on the sale of our ordinary shares, the payment of the consideration may
be subject to withholding of Israeli tax at the source. Accordingly, shareholders may be required to demonstrate that they are exempt
from tax on their capital gains in order to avoid withholding at source at the time of sale. Specifically, in transactions involving
a sale of all of the shares of an Israeli resident company, in the form of a merger or otherwise, the Israel Tax Authority may require
from shareholders who are not liable for Israeli tax to sign declarations in forms specified by this authority or obtain a specific exemption
from the Israel Tax Authority to confirm their status as non-Israeli resident, and, in the absence of such declarations or exemptions,
may require the purchaser of the shares to withhold taxes at source.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Excess
Tax</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Individuals
who are subject to tax in Israel are also subject to an additional tax at a rate of 3% on annual income exceeding a certain threshold
(NIS 698,280 for 2023, which amount is linked to the annual change in the Israeli consumer price index), including, but not limited to,
dividends, interest and capital gains.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Estate
and Gift Tax</i></b></span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; text-align: justify; margin: 0pt 0pt 0pt 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Israeli
law presently does not impose estate or gift taxes.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Certain
Material U.S. Federal Income Tax Considerations</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
following is a general summary of certain material U.S. federal income tax consequences relating to the purchase, ownership and disposition
of our ordinary shares by U.S. Holders (as defined below). This summary is based on the Code, the regulations of the U.S. Department
of the Treasury issued pursuant to the Code, or the Treasury Regulations, the income tax treaty between the United States and Israel,
or the U.S.-Israel Tax Treaty, and administrative and judicial interpretations thereof, all as in effect on the date hereof and all of
which are subject to change, possibly with retroactive effect, or to different interpretation. No ruling has been sought from the Internal
Revenue Service, or the IRS, with respect to any U.S. federal income tax consequences described below, and there can be no assurance
that the IRS or a court will not take a contrary position. This summary is no substitute for consultation by prospective investors with
their own tax advisors and does not constitute tax advice. This summary applies only to U.S. Holders that hold our ordinary shares as
capital assets for U.S. federal income tax purposes (generally, property held for investment) and does not address all of the tax considerations
that may be relevant to specific U.S. Holders in light of their particular circumstances or to U.S. Holders subject to special treatment
under U.S. federal income tax law (including, without limitation, banks, insurance companies, tax-exempt entities, retirement plans,
regulated investment companies, partnerships, dealers in securities, brokers, real estate investment trusts, grantor trusts, certain
former citizens or residents of the United States, persons who acquire our ordinary shares as part of a straddle, hedge, conversion transaction
or other integrated investment, persons who acquire our ordinary shares through the exercise or cancellation of employee stock options
or otherwise as compensation for their services, persons that have a &#8220;functional currency&#8221; other than the U.S. dollar, persons
that own (or are deemed to own, indirectly, or by attribution) 10% or more of our shares (by vote or value), or persons that mark their
securities to market for U.S. federal income tax purposes). This summary does not address any U.S. state or local or non-U.S. tax considerations,
any U.S. federal estate, gift or alternative minimum tax considerations, or any U.S. federal tax consequences other than U.S. federal
income tax consequences.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">As
used in this summary, the term &#8220;U.S. Holder&#8221; means a beneficial owner of our ordinary shares that is, for U.S. federal income
tax purposes, (i) an individual citizen or resident of the United States, (ii) a corporation, or other entity taxable as a corporation
for U.S. federal income tax purposes, created or organized in or under the laws of the United States, any state thereof, or the District
of Columbia, (iii) an estate the income of which is subject to U.S. federal income tax regardless of its source, or (iv) a trust with
respect to which a court within the United States is able to exercise primary supervision over its administration and one or more U.S.
persons have the authority to control all of its substantial decisions, or that has a valid election in effect under applicable Treasury
Regulations to be treated as a &#8220;United States person.&#8221;</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">If
an entity or arrangement treated as a partnership for U.S. federal income tax purposes holds our ordinary shares, the tax treatment of
such entity or arrangement treated as a partnership and each person treated as a partner thereof generally will depend upon the status
and activities of the entity and such person. A holder that is treated as a partnership for U.S. federal income tax purposes should consult
its own tax advisor regarding the U.S. federal income tax considerations applicable to it and its partners of the purchase, ownership
and disposition of our ordinary shares.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Prospective
investors should be aware that this summary does not address the tax consequences to investors who are not U.S. Holders. Prospective
investors should consult their own tax advisors as to the particular tax considerations applicable to them relating to the purchase,
ownership and disposition of our ordinary shares, including the applicability of U.S. federal, state and local tax laws and non-U.S.
tax laws.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Taxation
of U.S. Holders</i></b></span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><i>Distributions</i>.
Subject to the discussion below under &#8220;Passive Foreign Investment Company,&#8221; a U.S. Holder that receives a distribution with
respect to an ordinary share generally will be required to include the amount of such distribution in gross income as a dividend (without
reduction for any Israeli tax withheld from such distribution) when actually or constructively received to the extent of the U.S. Holder&#8217;s
pro rata share of our current and/or accumulated earnings and profits (as determined under U.S. federal income tax principles). Any distributions
in excess of our earnings and profits will be applied against and will reduce (but not below zero) the U.S. Holder&#8217;s tax basis
in its ordinary shares, and, to the extent they exceed that tax basis, will be treated as gain from the sale or exchange of our ordinary
shares. We do not intend to calculate our earnings and profits under U.S. federal income tax principles. Therefore, a U.S. Holder should
expect that a distribution will be reported as a dividend even if that distribution would otherwise be treated as a non-taxable return
of capital or as capital gain under the rules described above.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">As
noted above, we do not anticipate paying any cash dividends in the foreseeable future. If we were to pay dividends, we expect to pay
such dividends in NIS. A dividend paid in NIS, including the amount of any Israeli taxes withheld, will be includible in a U.S. Holder&#8217;s
income at a U.S. dollar amount calculated by reference to the exchange rate in effect on the date such dividend is received, regardless
of whether the payment is in fact converted into U.S. dollars. If the dividend is converted to U.S. dollars on the date of receipt, a
U.S. Holder generally will not recognize a foreign currency gain or loss. However, if the U.S. Holder converts the NIS into U.S. dollars
on a later date, the U.S. Holder must include, in computing its income, any gain or loss resulting from any exchange rate fluctuations.
The gain or loss will be equal to the difference between (i) the U.S. dollar value of the amount included in income when the dividend
was received and (ii) the amount received on the conversion of the NIS into U.S. dollars. Such gain or loss generally will be ordinary
income or loss and will be U.S. source income or loss for U.S. foreign tax credit purposes. U.S. Holders should consult their own tax
advisors regarding the tax consequences to them if we pay dividends in NIS or any other non-U.S. currency.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Subject
to certain significant conditions and limitations, any Israeli taxes paid on or withheld from distributions from us and not refundable
to a U.S. Holder may be credited against the U.S. Holder&#8217;s U.S. federal income tax liability or, alternatively, may be deducted
from the U.S. Holder&#8217;s taxable income. However, as a result of recent changes to the U.S. foreign tax credit rules, a withholding
tax may need to satisfy certain additional requirements in order to be considered a creditable tax for a U.S. Holder. We have
not determined whether these requirements have been met and, accordingly, no assurance can be given that any withholding tax on dividends
paid by us will be creditable. The election to deduct, rather than credit, foreign taxes, is made on a year-by-year basis and applies
to all foreign taxes paid by a U.S. Holder or withheld from a U.S. Holder that year. Dividends paid on our ordinary shares generally
will constitute income from sources outside the United States and be categorized as &#8220;passive category income&#8221; or, in the
case of some U.S. Holders, as &#8220;general category income&#8221; for U.S. foreign tax credit purposes. Because the rules governing
foreign tax credits are complex, U.S. Holders should consult their own tax advisors regarding the availability of foreign tax credits
in their particular circumstances.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Dividends
paid on our ordinary shares will not be eligible for the &#8220;dividends-received&#8221; deduction generally allowed to corporate U.S.
Holders with respect to dividends received from U.S. corporations.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Certain
distributions treated as dividends that are received by an individual U.S. Holder from a &#8220;qualified foreign corporation&#8221;
may be classified as &#8220;qualified dividend income,&#8221;<b><span style="text-decoration: line-through">&#8201;&#8212;&#8201;</span></b>&#8201;which is
generally taxed at the lower applicable long term capital gains rates provided certain holding period and other requirements are
satisfied. A non-U.S. corporation (other than a PFIC for the taxable year in which the dividend is paid or the preceding taxable
year) generally will be considered to be a qualified foreign corporation (i) if it is eligible for the benefits of a comprehensive
tax treaty with the United States which the Secretary of Treasury of the United States determines is satisfactory for purposes of
this provision and which includes an exchange of information program, or (ii) with respect to any dividend it pays on stock which is
readily tradable on an established securities market in the United States. We will not be a qualified foreign corporation if we are
a passive foreign investment company, or PFIC, for the taxable year in which we pay a dividend or for the preceding taxable year. As
discussed below under &#8220;Passive Foreign Investment Company,&#8221; we believe that we were a PFIC for our 2023 taxable year and
expect to be a PFIC for the 2024 taxable year. Because the PFIC determination is highly fact intensive, there can be no assurance
that we will not be a PFIC in 2024 or for any other taxable year. Our ordinary shares will generally be considered to be readily
tradable on an established securities market in the United States if they are listed on the Nasdaq Capital Market, as we intend our
ordinary shares will be. U.S. Holders should consult their own tax advisors regarding the availability of the lower rate for
dividends paid with respect to our ordinary shares.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
additional 3.8% &#8220;net investment income tax&#8221; (described below) may apply to dividends received by certain U.S. Holders who
meet certain modified adjusted gross income thresholds.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><i>Sale,
Exchange or Other Taxable Disposition of Ordinary Shares</i>. Subject to the discussion under &#8220;Passive Foreign Investment Company&#8221;
below, a U.S. Holder generally will recognize capital gain or loss upon the sale, exchange, or other taxable disposition of our ordinary
shares in an amount equal to the difference between the amount realized on the sale, exchange, or other taxable disposition and the U.S.
Holder&#8217;s adjusted tax basis (determined under U.S. federal income tax rules) in such ordinary shares. This capital gain or loss
will be long-term capital gain or loss if the U.S. Holder&#8217;s holding period in our ordinary shares exceeds one year. Preferential
tax rates for long-term capital gain (currently, with a maximum rate of 20%) will apply to individual U.S. Holders. The deductibility
of capital losses is subject to limitations. The gain or loss generally will be income or loss from sources within the United States
for U.S. foreign tax credit purposes, subject to certain possible exceptions under the U.S.-Israel Tax Treaty. The additional 3.8% &#8220;net
investment income tax&#8221; (described below) may apply to gains recognized upon the sale, exchange, or other taxable disposition of
our ordinary shares by certain U.S. Holders who meet certain modified adjusted gross income thresholds.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">U.S.
Holders should consult their own tax advisors regarding the U.S. federal income tax consequences of receiving currency other than U.S.
dollars upon the disposition of their ordinary shares.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><i>Passive
Foreign Investment Company. </i>In general, a non-U.S. corporation will be treated as a PFIC for U.S. federal income tax purposes in
any taxable year in which either (i) at least 75% of its gross income is &#8220;passive income,&#8221; or (ii) on average at least 50%
of its assets by value produce passive income or are held for the production of passive income. Passive income for this purpose generally
includes, among other things, certain dividends, interest, royalties, rents and gains from commodities and securities transactions and
from the sale or exchange of property that gives rise to passive income. Passive income also includes amounts derived by reason of the
temporary investment of funds, including those raised in a public offering. Assets that produce or are held for the production of passive
income may include cash, even if held as working capital or raised in a public offering, as well as marketable debt securities and other
assets that may produce passive income. In determining whether a non-U.S. corporation is a PFIC, a proportionate share of the income
and assets of each corporation in which it owns, directly or indirectly, at least a 25% interest (by value) is taken into account.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">A
foreign corporation&#8217;s PFIC status is an annual determination that is based on tests that are factual in nature, and our status
for any year will depend on our income, assets, and activities for such year. Based upon our review of our financial data, we believe
that we were a PFIC for our 2023 taxable year and expect to be a PFIC for the 2024 taxable year. Because PFIC status is determined annually
and is based on our income, assets and activities for the entire taxable year, it is not possible to determine with certainty whether
we will be characterized as a PFIC for the 2024 taxable year until after the close of the year, and there can be no assurance that we
will not be classified as a PFIC in any future year.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><i>Default
PFIC Rules</i>. If we are a PFIC for any tax year, a U.S. Holder who does not make a timely &#8220;qualified electing fund&#8221; election,
or &#8220;QEF election&#8221; or a mark-to-market election (as described below), referred to in this summary as a &#8220;Non-Electing
U.S. Holder,&#8221; will be subject to special rules with respect to (i) any &#8220;excess distribution&#8221; (generally, the portion
of any distributions received by the Non-Electing U.S. Holder on the ordinary shares in a taxable year in excess of 125% of the average
annual distributions received by the Non-Electing U.S. Holder in the three preceding taxable years, or, if shorter, the Non-Electing
U.S. Holder&#8217;s holding period for the ordinary shares), and (ii) any gain realized on the sale or other disposition of such ordinary
shares. Under these rules:</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the excess distribution
    or gain would be allocated ratably over the Non-Electing U.S. Holder&#8217;s holding period for such ordinary shares;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the amount allocated to the current taxable year and
    any year prior to us becoming a PFIC would be taxed as ordinary income; and</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the amount allocated to
    each of the other taxable years would be subject to tax at the highest rate of tax in effect for the applicable class of taxpayer
    for that year, and an interest charge for the deemed deferral benefit would be imposed with respect to the resulting tax attributable
    to each such other taxable year.</span></td></tr>
  </table>
<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">If
a Non-Electing U.S. Holder who is an individual dies while owning our ordinary shares, the Non-Electing U.S. Holder&#8217;s successor
would be ineligible to receive a step-up in tax basis of such ordinary shares. Non-Electing U.S. Holders should consult their tax advisors
regarding the application of the &#8220;net investment income tax&#8221; (described below) to their specific situation.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">To
the extent a distribution on our ordinary shares does not constitute an excess distribution to a Non-Electing U.S. Holder, such Non-Electing
U.S. Holder generally will be required to include the amount of such distribution in gross income as a dividend to the extent of our
current and/or accumulated earnings and profits (as determined for U.S. federal income tax purposes) that are not allocated to excess
distributions. The tax consequences of such distributions are discussed above under &#8220;Taxation of U.S. Holders&#8212;Distributions.&#8221;
Each U.S. Holder is encouraged to consult its own tax advisor with respect to the appropriate U.S. federal income tax treatment of any
distribution on our ordinary shares.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">If
we are treated as a PFIC for any taxable year during the holding period of a Non-Electing U.S. Holder, we will continue to be treated
as a PFIC for all succeeding years during which the Non-Electing U.S. Holder is treated as a direct or indirect Non-Electing U.S. Holder
even if we are not a PFIC for such years. A U.S. Holder is encouraged to consult its tax advisor with respect to any available elections
that may be applicable in such a situation, including the &#8220;deemed sale&#8221; election of Section 1298(b)(1) of the Code (which
will be taxed under the adverse tax rules described above).</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
may invest in the equity of foreign corporations that are PFICs or may own subsidiaries that are PFICs (any such entity, a &#8220;lower-tier
PFIC&#8221;). If we are classified as a PFIC, under attribution rules, U.S. Holders will be subject to the PFIC rules with respect to
their indirect ownership interests in such lower-tier PFICs, such that a disposition by us of the shares of the lower-tier PFIC or receipt
by us of a distribution from the lower-tier PFIC generally will be treated as a deemed disposition of such shares or the deemed receipt
of such distribution by the U.S. Holder, subject to taxation under the PFIC rules even though the U.S. Holder does not receive any proceeds
from those dispositions or distributions. There can be no assurance that a U.S. Holder will be able to make a QEF election with respect
to any lower-tier PFICs in which we invest. Each U.S. Holder is encouraged to consult its own tax advisor with respect to tax consequences
of an investment by us in a lower-tier PFIC.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><i>QEF
Election</i>. Certain adverse consequences of PFIC status can be mitigated for holders of our ordinary shares if a U.S. Holder makes
a QEF election. A U.S. Holder who makes a timely QEF election, referred to in this disclosure as an &#8220;Electing U.S. Holder,&#8221;
with respect to us must report for U.S. federal income tax purposes its pro rata share of our ordinary earnings and net capital gain,
if any, for our taxable year that ends with or within the taxable year of the Electing U.S. Holder. The &#8220;net capital gain&#8221;
of a PFIC is the excess, if any, of the PFIC&#8217;s net long-term capital gains over its net short-term capital losses. The amount so
included in income generally will be treated as ordinary income to the extent of such Electing U.S. Holder&#8217;s allocable share of
the PFIC&#8217;s ordinary earnings and as long-term capital gain to the extent of such Electing U.S. Holder&#8217;s allocable share of
the PFIC&#8217;s net capital gains. Such Electing U.S. Holder generally will be required to translate such income into U.S. dollars based
on the average exchange rate for the PFIC&#8217;s taxable year with respect to the PFIC&#8217;s functional currency. Such income generally
will be treated as income from sources outside the United States for U.S. foreign tax credit purposes. Amounts previously included in
income by such Electing U.S. Holder under the QEF rules generally will not be subject to tax when they are distributed to such Electing
U.S. Holder. The Electing U.S. Holder&#8217;s tax basis in our ordinary shares generally will increase by any amounts so included under
the QEF rules and decrease by any amounts not included in income when distributed.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">An
Electing U.S. Holder will be subject to U.S. federal income tax on such amounts for each taxable year in which we are a PFIC, regardless
of whether such amounts are actually distributed to such Electing U.S. Holder. However, an Electing U.S. Holder may, subject to certain
limitations, elect to defer payment of current U.S. federal income tax on such amounts, subject to an interest charge. If an Electing
U.S. Holder is an individual, any such interest will be treated as non-deductible &#8220;personal interest.&#8221;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Any
net operating losses or net capital losses of a PFIC will not pass through to the Electing U.S. Holder and will not offset any ordinary
earnings or net capital gain of a PFIC recognized by Electing U.S. Holder in subsequent years.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">So
long as an Electing U.S. Holder&#8217;s QEF election with respect to us is in effect with respect to the entire holding period for our
ordinary shares, any gain or loss recognized by such Electing U.S. Holder on the sale, exchange or other disposition of such shares generally
will be long-term capital gain or loss if such Electing U.S. Holder has held such shares for more than one year at the time of such sale,
exchange or other disposition. Preferential tax rates for long-term capital gain (currently, a maximum rate of 20%) will apply to individual
U.S. Holders. The deductibility of capital losses is subject to limitations.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
general, a U.S. Holder must make a QEF election on or before the due date for filing its income tax return for the first year to which
the QEF election is to apply. A U.S. Holder makes a QEF election by completing the relevant portions of and filing IRS Form 8621 in accordance
with the instructions thereto. Upon request, we expect to provide U.S. Holders with the information needed to complete IRS Form 8621
(which form would be required to be filed with the IRS on an annual basis by the U.S. Holder) and to make and maintain a valid QEF election
for any year in which we are a PFIC. There is no assurance, however, that we will have timely
knowledge of our status as a PFIC or the status of a lower-tier PFIC, or that the information that we provide will be adequate to allow
U.S. Holders to make a QEF election. A QEF election will not apply to any taxable year during which we are not a PFIC, but will remain
in effect with respect to any subsequent taxable year in which we become a PFIC.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Each
U.S. Holder should consult its own tax advisor with respect to the advisability of, the tax consequences of, and the procedures for making
a QEF election with respect to us.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><i>Mark-to-Market
Election</i>. Alternatively, if our ordinary shares are treated as &#8220;marketable stock,&#8221; a U.S. Holder would be allowed to
make a &#8220;mark-to-market&#8221; election with respect to our ordinary shares, provided the U.S. Holder completes and files IRS Form
8621 in accordance with the relevant instructions and related Treasury Regulations. If that election is made, the U.S. Holder generally
would include as ordinary income in each taxable year the excess, if any, of the fair market value of our ordinary shares at the end
of the taxable year over such holder&#8217;s adjusted tax basis in such ordinary shares. The U.S. Holder would also be permitted an ordinary
loss in respect of the excess, if any, of the U.S. Holder&#8217;s adjusted tax basis in our ordinary shares over their fair market value
at the end of the taxable year, but only to the extent of the net amount previously included in income as a result of the mark-to- market
election. A U.S. Holder&#8217;s tax basis in our ordinary shares would be adjusted to reflect any such income or loss amount. Gain realized
on the sale, exchange or other disposition of our ordinary shares would be treated as ordinary income, and any loss realized on the sale,
exchange or other disposition of our ordinary shares would be treated as ordinary loss to the extent that such loss does not exceed the
net mark-to-market gains previously included in income by the U.S. Holder, and any loss in excess of such amount will be treated as capital
loss. Amounts treated as ordinary income will not be eligible for the favorable tax rates applicable to qualified dividend income or
long-term capital gains.</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Generally,
stock will be considered marketable stock if it is &#8220;regularly traded&#8221; on a &#8220;qualified exchange&#8221; within the meaning
of applicable Treasury Regulations. A class of stock is regularly traded on an exchange during any calendar year during which such class
of stock is traded, other than in de minimis quantities, on at least 15 days during each calendar quarter. To be marketable stock, our
ordinary shares must be regularly traded on a qualifying exchange (i) in the United States that is registered with the SEC or a national
market system established pursuant to the Exchange Act or (ii) outside the United States that is properly regulated and meets certain
trading, listing, financial disclosure and other requirements. Our ordinary shares are expected to constitute &#8220;marketable stock&#8221;
as long as they remain listed on the Nasdaq Capital Market and are regularly traded.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">A
mark-to-market election will not apply to our ordinary shares held by a U.S. Holder for any taxable year during which we are not a PFIC,
but will remain in effect with respect to any subsequent taxable year in which we become a PFIC. Such election will not apply to any
lower-tier PFIC that we own. Each U.S. Holder is encouraged to consult its own tax advisor with respect to the availability and tax consequences
of a mark-to-market election with respect to our ordinary shares.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Each
U.S. Holder should consult its own tax adviser with respect to the applicability of the &#8220;net investment income tax&#8221; (discussed
below) where a mark-to-market election is in effect.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
addition, U.S. Holders should consult their tax advisors regarding the IRS information reporting and filing obligations that may arise
as a result of the ownership of ordinary shares in a PFIC, including IRS Form 8621, Information Return by a Shareholder of a Passive
Foreign Investment Company or Qualified Electing Fund.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>The
U.S. federal income tax rules relating to PFICs, QEF elections, and mark-to market elections are complex. U.S. Holders are urged to consult
their own tax advisors with respect to the purchase, ownership and disposition of our ordinary shares, any elections available with respect
to such ordinary shares and the IRS information reporting obligations with respect to the purchase, ownership and disposition of our
ordinary shares.</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Certain
Reporting Requirements</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Certain
U.S. Holders may be required to file IRS Form 926, Return by U.S. Transferor of Property to a Foreign Corporation and IRS Form 5471,
Information Return of U.S. Persons With Respect to Certain Foreign Corporations, reporting transfers of cash or other property to us
and information relating to the U.S. Holder and us. Substantial penalties may be imposed upon a U.S. Holder that fails to comply. See
also the discussion regarding Form 8621, Information Return by a Shareholder of a Passive Foreign Investment Company or Qualified Electing
Fund, above.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
addition, certain U.S. Holders must report information on IRS Form 8938, Statement of Specified Foreign Financial Assets, with respect
to their investments in certain &#8220;specified foreign financial assets,&#8221; which would include an investment in our ordinary shares,
if the aggregate value of all of those assets exceeds $50,000 on the last day of the taxable year (and in some circumstances, a higher
threshold). This reporting requirement applies to individuals and certain U.S. entities.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">U.S.
Holders who fail to report required information could become subject to substantial penalties. U.S. Holders should consult their tax
advisors regarding the possible implications of these reporting requirements arising from their investment in our ordinary shares.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>


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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Backup
Withholding Tax and Information Reporting Requirements</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Generally,
information reporting requirements will apply to distributions on our ordinary shares or proceeds on the disposition of our ordinary
shares paid within the United States (and, in certain cases, outside the United States) to U.S. Holders other than certain exempt recipients,
such as corporations. Furthermore, backup withholding (currently at 24%) may apply to such amounts if the U.S. Holder fails to (i) provide
a correct taxpayer identification number, (ii) report interest and dividends required to be shown on its U.S. federal income tax return,
or (iii) make other appropriate certifications in the required manner. U.S. Holders who are required to establish their exempt status
generally must provide such certification on IRS Form W-9.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Backup
withholding is not an additional tax. Amounts withheld as backup withholding from a payment may be credited against a U.S. Holder&#8217;s
U.S. federal income tax liability and such U.S. Holder may obtain a refund of any excess amounts withheld by filing the appropriate claim
for refund with the IRS and furnishing any required information in a timely manner.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Medicare
Tax on Investment Income</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Certain
U.S. persons, including individuals, estates and trusts, will be subject to an additional 3.8% Medicare tax, or &#8220;net investment
income tax,&#8221; on unearned income. For individuals, the additional net investment income tax applies to the lesser of (i) &#8220;net
investment income&#8221; or (ii) the excess of &#8220;modified adjusted gross income&#8221; over $200,000 ($250,000 if married and filing
jointly or $125,000 if married and filing separately). &#8220;Net investment income&#8221; generally equals the taxpayer&#8217;s gross
investment income reduced by the deductions that are allocable to such income. Investment income generally includes, among other things,
passive income such as interest, dividends, annuities, royalties, rents, and capital gains. U.S. Holders are urged to consult their own
tax advisors regarding the implications of the additional net investment income tax resulting from their ownership and disposition of
our ordinary shares.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>THE
DISCUSSION ABOVE IS A GENERAL SUMMARY. IT DOES NOT COVER ALL TAX MATTERS THAT MAY BE OF IMPORTANCE TO A PROSPECTIVE INVESTOR. EACH PROSPECTIVE
INVESTOR IS URGED TO CONSULT ITS OWN TAX ADVISOR ABOUT THE TAX CONSEQUENCES RELATING TO THE PURCHASE, OWNERSHIP AND DISPOSITION OF OUR
ORDINARY SHARES IN LIGHT OF THE INVESTOR&#8217;S OWN CIRCUMSTANCES, INCLUDING THE CONSEQUENCES OF ANY PROPOSED CHANGE IN APPLICABLE LAWS.</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>F.
Dividends and Paying Agents.</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; text-align: justify; margin: 0pt 0pt 0pt 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Not
applicable.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>G.
Statements by Experts.</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; text-align: justify; margin: 0pt 0pt 0pt 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Not
applicable.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>H.
Documents on Display.</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
SEC maintains an Internet website that contains reports and other information regarding issuers that file electronically with the SEC.
You may read and copy this annual report, including the related exhibits and schedules, and any document we file with the SEC at http://www.sec.gov.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">As
a &#8220;foreign private issuer,&#8221; we are subject to the information reporting requirements of the Exchange Act that are applicable
to foreign private issuers, and under those requirements file reports with the SEC. Those other reports or other information may be inspected
without charge at the locations described above. As a &#8220;foreign private issuer,&#8221; we are exempt from the rules under the Exchange
Act related to the furnishing and content of proxy statements, and our officers, directors and principal shareholders will be exempt
from the reporting and &#8220;short-swing&#8221; profit recovery provisions contained in Section 16 of the Exchange Act with respect
to their purchases and sales of ordinary shares. Furthermore, as a &#8220;foreign private issuer,&#8221; we are also not subject to the
requirements of Regulation FD (Fair Disclosure) promulgated under the Exchange Act.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>


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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
maintain a corporate website at http://www.galmedpharma.com. Information contained on, or that can be accessed through, our website is
not incorporated by reference into this annual report and does not constitute a part of this annual report. We have included our website
address in this annual report solely as an inactive textual reference.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>I.
Subsidiary Information.</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Not
applicable.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>J.
Annual Report to Security Holders</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Not
applicable.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><span id="am_009"></span>ITEM
11. Quantitative and Qualitative Disclosures About Market Risk.</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Quantitative
and Qualitative Disclosure About Market Risk</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
are exposed to market risks in the ordinary course of our business. Market risk represents the risk of loss that may impact our financial
position, results of operations or cash flows due to adverse changes in financial market prices and rates, including interest rates and
foreign exchange rates, of financial instruments.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Foreign
Currency Exchange Risk</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Our
foreign currency exposures give rise to market risk associated with exchange rate movements of the Euro and NIS mainly against the U.S.
dollar because a large portion of our expenses are denominated in Euros and NIS. Our Euro expenses consist principally of payments made
to sub-contractors and consultants for pre-clinical studies, clinical trials and other research and development activities. Our NIS expenses
consist principally of payments made to employees, subcontractors and consultants for pre-clinical studies, clinical trials, professional
services, other research and development activities and general and administrative activities. We anticipate that a large portion of
our expenses will continue to be denominated in currencies other than the U.S. dollar. Our financial position, results of operations
and cash flow are subject to fluctuations due to changes in foreign currency exchange rates. Our results of operations and cash flow
are, therefore, subject to fluctuations due to changes in foreign currency exchange rates and may be adversely affected in the future
due to changes in foreign exchange rates. Approximately 35% of our expected expenses are denominated in NIS. Changes of 5% and 10% in
the U.S. dollar to NIS exchange rate will increase/decrease our operation expenses by 1.75% and 3.5%, respectively. Approximately 10%
of our expected expenses are denominated in Euros. Changes of 5% and 10% in the U.S. dollar to Euro exchange rate, will increase/decrease
our operation expenses by 0.5% and 1.0%, respectively. To date, fluctuations in the exchange rates have not materially affected our results
of operations or financial condition for the periods under review.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">To
date, we have not engaged in hedging our foreign currency exchange risk. In the future, we may enter into formal currency hedging transactions
to decrease the risk of financial exposure from fluctuations in the exchange rates of our principal operating currencies. These measures,
however, may not adequately protect us from the material adverse effects of such fluctuations.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Interest
Rate Risk</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Our
primary exposure to market risk is interest income sensitivity, which is affected by changes in the general level of U.S. interest rates.
We currently do not hedge interest rate exposure. Because of the short-term maturities of our cash equivalents and investment securities,
we do not believe that an increase in market rates would have any significant impact on the realized value of our investment securities.
If a 10% change in interest rates were to have occurred on December 31, 2023, this change would not have had a material effect on the
fair value of our investment portfolio as of that date.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>


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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Liquidity</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
do not believe that our cash and cash equivalents and available for sale investments have significant risk of default or illiquidity.
While we believe our cash, cash equivalents and available for sale investments do not contain excessive risk, we cannot provide absolute
assurance that in the future our investments will not be subject to adverse changes in market value. In addition, we maintain significant
amounts of cash and cash equivalents at one or more financial institutions that are in excess of federally insured limits.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><span id="am_010"></span>ITEM
12. Description of Securities Other Than Equity Securities.</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>A.
Debt Securities.</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Not
applicable.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>B.
Warrants and Rights.</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Not
applicable.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>C.
Other Securities.</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Not
applicable.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>D.
American Depositary Shares.</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Not
applicable.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><span id="am_011"></span>PART
II</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><span id="am_012"></span>ITEM
13. Defaults, Dividend Arrearages and Delinquencies.</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; text-align: justify; margin: 0pt 0pt 0pt 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Not
applicable.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><span id="am_013"></span>ITEM
14. Material Modifications to the Rights of Security Holders and Use of Proceeds.</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; text-align: justify; margin: 0pt 0pt 0pt 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Not
applicable.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><span id="am_014"></span>ITEM
15. Controls and Procedures.</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Disclosure
Controls and Procedures</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
performed an evaluation of the effectiveness of our disclosure controls and procedures that are designed to ensure that information required
to be disclosed in this annual report and filed with the SEC is recorded, processed, summarized and reported timely within the time period
specified in the SEC&#8217;s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures
designed to ensure that information required to be disclosed by an issuer in the reports that it files or submits under the Exchange
Act, is accumulated and communicated to the issuer&#8217;s management, including its principal executive and principal financial officers,
or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure. There can be no assurance
that our disclosure controls and procedures will detect or uncover all failures of persons within our Company to disclose information
otherwise required to be set forth in our reports. Nevertheless, our disclosure controls and procedures are designed to provide reasonable
assurance of achieving the desired control objectives. Based on our evaluation, our management, including our President, Chief Executive
Officer and Chairman and Chief Accounting Officer, have concluded that our disclosure controls and procedures (as defined in Rules 13a-15(e)
and 15(d)-15(e) of the Exchange Act) as of the end of the period covered by this annual report are effective at such reasonable assurance
level.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>


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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Management&#8217;s
Annual Report on Internal Control over Financial Reporting</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Our
management is responsible for establishing and maintaining adequate internal control over our financial reporting. Internal control over
financial reporting is defined in Rule 13a-15(f) or 15d-15(f) promulgated under the Exchange Act as a process designed by, or under the
supervision of, the company&#8217;s principal executive and principal financial officers and effected by the company&#8217;s board of
directors, management and other personnel, to provide reasonable assurance regarding the reliability of financial reporting and the preparation
of financial statements for external purposes in accordance with generally accepted accounting principles and includes those policies
and procedures that:</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">pertain to the maintenance of records that in reasonable
    detail accurately and fairly reflect the transaction and dispositions of the assets of the company;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">provide reasonable assurance
    that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting
    principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management
    and directors of the company; and</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">provide reasonable assurance regarding prevention or
    timely detection of unauthorized acquisition, use or disposition of the company&#8217;s assets that could have a material effect
    on the financial statements.</span></td></tr>
  </table>
<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Because
of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Projections of any evaluation
of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that
the degree of compliance with the policies or procedures may deteriorate.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Our
management assessed the effectiveness of our internal control over financial reporting as of December 31, 2023. In making this assessment,
our management used the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission (COSO) in Internal
Control-Integrated Framework (2013). Based on that assessment, our management concluded that as of December 31, 2023, our internal control
over financial reporting was effective.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; text-align: justify; margin: 0pt 0pt 0pt 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Changes
in Internal Controls Over Financial Reporting</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">There
were no changes in our internal control over financial reporting that occurred during the year ended December 31, 2023 that have materially
affected, or are reasonably likely to materially affect, our internal control over financial reporting.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><span id="am_015"></span>ITEM
16. [RESERVED]</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><span id="am_016"></span>ITEM
16A. Audit Committee Financial Expert.</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Our
Board has determined that Mr. Poshinski qualifies as an audit committee financial expert pursuant to the applicable SEC rules and that
Mr. Poshinski is &#8220;independent&#8221; in accordance with the Nasdaq Capital Market corporate governance requirements. For information
relating to Mr. Poshinski&#8217;s qualifications and experience, see &#8220;Item 6. Directors, Senior Management and Employees&#8212;A.
Directors and Senior Management.&#8221;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><span id="am_017"></span>ITEM
16B. Code of Ethics.</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
have adopted a Code of Business Conduct and Ethics applicable to all of our directors and employees, including our President, Chief Executive
Officer and Chairman, Chief Financial Officer, controller or principal accounting officer or other persons performing similar functions,
which is a &#8220;code of ethics&#8221; as defined in Item 16B of Form 20-F promulgated by the SEC and as required by the Nasdaq Listing
Rules, which refers to Section 406(c) of the Sarbanes-Oxley Act. Section 406(c) of the Sarbanes-Oxley Act provides that a &#8220;code
of ethics&#8221; means such standards as are reasonably necessary to promote (i) honest and ethical conduct, including the ethical handling
of actual or apparent conflicts of interest between personal and professional relationships; (ii) full, fair, accurate, timely and understandable
disclosure in the periodic reports required to be filed by the issuer; and (iii) compliance with applicable governmental rules and regulation.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>


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    <div style="break-before: page; margin-top: 6pt"><p style="margin: 0pt">&#160;</p></div>
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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
full text of the Code of Business Conduct and Ethics is posted on our website at www.galmedpharma.com. Information contained on, or that
can be accessed through, our website does not constitute a part of this prospectus and is not incorporated by reference herein. We will
provide a copy of such code of ethics without charge upon request by mail or by telephone. If we make any amendment to the Code of Business
Conduct and Ethics or grant any waivers, including any implicit waiver, from a provision of the Code of Business Conduct and Ethics,
we will disclose the nature of such amendment or waiver on our website to the extent required by the rules and regulations of the SEC.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><span id="am_018"></span>ITEM
16C. Principal Accountant Fees and Services.</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Brightman
Almagor Zohar &amp; Co., a Firm in the Deloitte Global Network, an independent registered public accounting firm, served as our independent
public accountants for the fiscal years ended December 31, 2023 and 2022, for which audited financial statements appear in this annual
report.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; text-align: justify; margin: 0pt 0pt 0pt 0; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
following table presents the aggregate fees for professional services rendered by such accountants to us during their respective term
as our principal accountants in 2023 and 2022.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 100%">
  <tr style="vertical-align: bottom">
    <td style="text-align: center">&#160;</td><td style="font-weight: bold; padding-bottom: 1.5pt">&#160;</td>
    <td colspan="2" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">2023</td><td style="padding-bottom: 1.5pt; font-weight: bold">&#160;</td><td style="font-weight: bold; padding-bottom: 1.5pt">&#160;</td>
    <td colspan="2" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">2022</td><td style="padding-bottom: 1.5pt; font-weight: bold">&#160;</td></tr>
  <tr style="vertical-align: bottom; background-color: White">
    <td style="text-align: center">&#160;</td><td style="font-weight: bold">&#160;</td>
    <td style="font-weight: bold; text-align: left">&#160;</td><td style="font-weight: bold; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>(US$ in thousands)</b></span></td><td style="font-weight: bold; text-align: left">&#160;</td><td style="font-weight: bold">&#160;</td>
    <td style="font-weight: bold; text-align: left">&#160;</td><td style="font-weight: bold; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>(US$ in thousands)</b></span></td><td style="font-weight: bold; text-align: left">&#160;</td></tr>
  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="width: 60%; text-align: left">Audit Fees (1)</td><td style="width: 2%">&#160;</td>
    <td style="width: 1%; text-align: left">&#160;</td><td style="width: 16%; text-align: right">120</td><td style="width: 1%; text-align: left">&#160;</td><td style="width: 2%">&#160;</td>
    <td style="width: 1%; text-align: left">&#160;</td><td style="width: 16%; text-align: right">120</td><td style="width: 1%; text-align: left">&#160;</td></tr>
  <tr style="vertical-align: bottom; background-color: White">
    <td style="text-align: left">Audit-Related fees (2)</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">40</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">20</td><td style="text-align: left">&#160;</td></tr>
  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="text-align: left">Tax and incentives Fees (3)</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">0</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">27</td><td style="text-align: left">&#160;</td></tr>
  <tr style="vertical-align: bottom; background-color: White">
    <td style="font-weight: bold">Total</td><td style="font-weight: bold">&#160;</td>
    <td style="font-weight: bold; text-align: left">&#160;</td><td style="font-weight: bold; text-align: right">160</td><td style="font-weight: bold; text-align: left">&#160;</td><td style="font-weight: bold">&#160;</td>
    <td style="font-weight: bold; text-align: left">&#160;</td><td style="font-weight: bold; text-align: right">167</td><td style="font-weight: bold; text-align: left">&#160;</td></tr>
  </table>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">(1)</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Includes professional services
    rendered in connection with the audit of our annual financial statements and the review of our interim financial statements.</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">(2)</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Audit related services
    consist of services that were reasonably related to the performance of the audit or reviews of our financial statements and not included
    under &#8220;Audit Fees&#8221; above, including, principally, providing consents for registration statement filings.</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">(3)</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Tax fees consist of services related to obtaining a
    tax rulings t.</span></td></tr>
  </table>
<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Audit
Committee Pre-Approval Policies and Procedures</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">One
of our audit committee&#8217;s main roles is to assist the board of directors in fulfilling its responsibility for oversight of the quality
and integrity of the accounting, auditing and reporting practices of the Company. The audit committee oversees the appointment, compensation,
and oversight of the public accounting firm engaged to prepare or issue an audit report on the financial statements of the Company. Our
Board has delegated to the audit committee the power to pre-approve non-auditing services rendered by the Company&#8217;s independent
auditors without the need for further approval by the board of directors. As such, our audit committee has adopted a pre-approval policy
for the engagement of our independent registered public accounting firm to perform certain audit and non-audit services. Pursuant to
this policy, which is designed to assure that such engagements do not impair the independence of our auditors, the audit committee pre-approves
annually a list of specific audit and non-audit services in the categories of audit services, audit-related services, tax services and
other services that may be performed by our independent registered public accounting firm. The last pre-approval policy was adopted by
our audit committee on April 2, 2024 for a period of twelve months. Since its establishment in May 2014, the audit committee has approved
all of the audit-related fees, tax fees and all other fees. If a type of service that is to be provided by our auditors has not received
such general pre-approval, it will require specific pre-approval by our audit committee. The policy prohibits retention of the independent
registered public accounting firm to perform the prohibited non-audit functions defined in applicable SEC rules.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>


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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><span id="am_019"></span>ITEM
16D. Exemptions from the Listing Standards for Audit Committees.</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Not
applicable.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><span id="am_020"></span>ITEM
16E. Purchases of Equity Securities by the Issuer and Affiliated Purchasers.</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Not
applicable.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><span id="am_021"></span>ITEM
16F. Change in Registrant&#8217;s Certifying Accountant.</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Not
applicable.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><span id="am_022"></span>ITEM
16G. Corporate Governance.</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Our
shares are listed on the Nasdaq Capital Market under the symbol &#8220;GLMD.&#8221; In addition to the corporate governance requirements
of the Sarbanes-Oxley Act and the related rules implemented by the SEC, we must comply with the Nasdaq Listing Rules. Under those Nasdaq
Listing Rules, we may elect to follow certain corporate governance practices permitted under the Companies Law in lieu of compliance
with corresponding corporate governance requirements otherwise imposed by the Nasdaq Listing Rules for U.S. domestic issuers.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
accordance with Israeli law and practice, and subject to the exemption set forth in Rule 5615 of the Nasdaq Listing Rules, we follow
the provisions of the Companies Law, rather than the Nasdaq Listing Rules, with respect to the following requirements:</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><i>Distribution of certain
    reports to shareholders</i>. As opposed to the Nasdaq Listing Rules, which require listed issuers to make certain reports, such as
    annual reports, interim reports and quarterly reports, available to shareholders in one of a number of specific manners, Israeli
    law does not require us to distribute periodic reports directly to shareholders, and the generally accepted business practice in
    Israel is not to distribute such reports to shareholders, but to make such reports available through a public website. In addition
    to making such reports available on a public website, we plan to make our audited financial statements available to our shareholders
    at our offices and will only mail such reports to shareholders upon request. As a foreign private issuer, we are generally exempt
    from the SEC&#8217;s proxy solicitation rules. See &#8220;Item 10. Additional Information&#8212;Documents on Display&#8221; for a
    description of our Exchange Act reporting obligations.</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><i>Quorum</i>. While the
    Nasdaq Listing Rules require that the quorum for purposes of any meeting of the holders of a listed company&#8217;s common voting
    stock be no less than 33.33% of the company&#8217;s outstanding common voting stock, under Israeli law, a company is entitled to
    determine in its articles of association the number of shareholders and percentage of holdings required for a quorum at a shareholders
    meeting. Our articles of association provide that a quorum of two or more shareholders holding at least 33.33% of the voting rights
    in person or by proxy is required for commencement of business at a general meeting. However, the quorum set forth in our articles
    of association with respect to an adjourned meeting consists of any two shareholders present in person or by proxy even if, between
    them, they represent shares conferring 33.33% or less of the voting rights of the Company.</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><i>Nomination of directors</i>.
    With the exception of directors elected by our Board due to vacancy, our directors are elected by an annual meeting of our shareholders
    to hold office until the next annual meeting following three years from his or her election. See &#8220;Item 6. Directors, Senior
    Management and Employees&#8212;C. Board Practices.&#8221; The nominations for directors, which are presented to our shareholders
    by our Board, are made by the nominating committee itself, in accordance with the provisions of Nasdaq Capital Market Listing Rule
    5605(e), our Articles and the Companies Law.</span></td></tr>
  </table>
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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="width: 0.5in">&#160;</td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><i>Compensation
    of officers</i>. We follow the provisions of the Companies Law with respect to matters in connection with the composition and responsibilities
    of our remuneration committee, Office Holder compensation and any required approval by the shareholders of such compensation. Israeli
    law and our Articles do not require that the independent members of our Board, or a remuneration committee composed solely of independent
    members of our Board, determine an executive officer&#8217;s compensation, as is generally required under the Nasdaq Listing Rules
    with respect to the Chief Executive Officer and all other executive officers of a company. Instead, remuneration of Office Holders
    is determined and approved by our remuneration committee, and in general, by our Board as well, and in certain circumstances, by
    our shareholders, as detailed above. The requirements for shareholder approval of any Office Holder compensation, and the relevant
    majority or Special Majority for such approval, are all as set forth in the Companies Law. Thus, we seek shareholder approval for
    all corporate actions with respect to Office Holder compensation requiring such approval under the requirements of the Companies
    Law, including for our Compensation Policy and for certain Office Holder Compensation, rather than seeking approval for such corporate
    actions in accordance with Nasdaq Listing Rules. All members of our remuneration committee are independent directors under applicable
    Nasdaq Capital Market and SEC rules, as affirmatively determined by our Board. See &#8220;Item 6. Directors, Senior Management and
    Employees&#8212;B. Compensation.&#8221;</span></td></tr>
  </table>
<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="width: 0.5in">&#160;</td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><i>Independent
    directors</i>. Although Israeli law does not require that a majority of the directors serving on our Board be &#8220;independent,&#8221;
    as defined under Nasdaq Capital Market Listing Rule 5605(a)(2), but rather requires we have at least two external directors who meet
    the requirements of the Companies Law, as described above under &#8220;Item 6. Directors, Senior Management and Employees&#8212;C.
    Board Practices&#8212;External Directors.&#8221;, following our &#8220;opt-out&#8221; of the requirement to appoint external directors,
    a majority of our Board is independent based on the Nasdaq Capital Market rules. We are required, however, to ensure that all members
    of our audit committee are &#8220;independent&#8221; under the applicable Nasdaq Capital Market and SEC criteria for independence
    (as we cannot exempt ourselves from compliance with that SEC independence requirement, despite our status as a foreign private issuer).
    Our independent directors&#8217; conduct regularly scheduled meetings at which only such independent directors are present, as required
    by the Nasdaq Listing Rules. Our Board has affirmatively determined that each of Mr. Nir, Mr. Poshinski, Dr. Sidransky and Dr. Brosgart
    qualifies as &#8220;independent&#8221; under the Nasdaq Capital Market independence standards.</span></td></tr>
  </table>
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<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="width: 0.5in">&#160;</td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><i>Shareholder
    approval</i>. We will seek shareholder approval for all corporate actions requiring such approval under requirements of the Companies
    Law, rather than seeking approval for corporate actions in accordance with Nasdaq Capital Market Listing Rule 5635. In particular,
    under this Nasdaq Capital Market rule, shareholder approval is generally required for: (i) an acquisition of shares or assets of
    another company that involves the issuance of 20% or more of the acquirer&#8217;s shares or voting rights or if a director, officer
    or 5% shareholder has greater than a 5% interest in the target company or the consideration to be received; (ii) the issuance of
    shares leading to a change of control; (iii) adoption or amendment of equity compensation arrangements; and (iv) issuances of 20%
    or more of the shares or voting rights (including securities convertible into, or exercisable for, equity) of a listed company via
    a private placement (or via sales by directors, officers or 5% shareholders) if such equity is issued (or sold) at below the greater
    of the book or market value of shares. By contrast, under the Companies Law, shareholder approval is required for, among other things:
    (i) transactions with directors concerning the terms of their service or indemnification, exemption and insurance for their service
    (or for any other position that they may hold at a company), for which approvals of the remuneration committee, board of directors
    and shareholders are all required, (ii) Extraordinary Transactions with controlling shareholders of publicly held companies, which
    require the special approval described under &#8220;Item 6. Directors, Senior Management and Employees&#8212;C. Board Practices&#8212;Approval
    of Related Party Transactions under Israeli Law&#8212; Transactions with Controlling Shareholders,&#8221; and (iii) terms of office
    and employment or other engagement of the controlling shareholder of the Company or such controlling shareholder&#8217;s relative,
    which require the special approval described under &#8220;Item 6. Directors, Senior Management and Employees&#8212;B. Compensation&#8221;
    and &#8220;Item 6. Directors, Senior Management and Employees&#8212;C. Board Practices&#8212; Approval of Related Party Transactions
    under Israeli Law.&#8221; In addition, under the Companies Law, a merger requires approval of the shareholders of each of the merging
    companies. See also &#8220;Compensation of officers&#8221; above.</span></td></tr>
  </table>
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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><span id="am_023"></span>ITEM
16H. Mine Safety Disclosure.</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; text-align: justify; margin: 0pt 0pt 0pt 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Not
applicable.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><span id="am_024"></span>ITEM
16I. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections.</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; text-align: justify; margin: 0pt 0pt 0pt 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Not
applicable.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><span id="am_025"></span>ITEM
16J. Insider Trading Policies.</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-indent: 27.75pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Pursuant
to applicable SEC transition guidance, the disclosure required by Item 16J will only be applicable to the Company from the fiscal year
ending on December 31, 2024.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>&#160;</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><span id="am_026"></span>ITEM
16K. Cybersecurity.</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
have developed and maintain a cybersecurity risk management program, consisting of cybersecurity policies, procedures, compliance
and awareness programs to mitigate risk and to ensure compliance with security, availability and confidentiality trust principles.
The cybersecurity process has been integrated into our overall risk management system and process, and is solely internally managed.
Management is responsible for identifying risks that threaten achievement of the control activities stated in the management&#8217;s
description of the services organizations systems. Management has implemented a process for identifying relevant risks that could
affect the organization&#8217;s ability to provide secure and reliable service to its users. In addition, we maintain cybersecurity
insurance. The risk assessment occurs as business needs change, and covers identification of risks that could act
against the company&#8217;s objectives as well as specific risks related to a compromise to the security of data. See &#8220;Item
3.D Risk Factors&#8212; Risks Related to Information Technology, Intellectual Property and Data Security and Privacy&#8212;If we or
our third-party service providers experience a security breach, data loss or other compromise, including if unauthorized parties
obtain access to our customers&#8217; data, our reputation may be harmed, demand for our products and services may be reduced, and
we may incur significant liabilities.&#8221;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center; background-color: white"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; background-color: white"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
oversight of cybersecurity threats is undertaken by our IT external provider, who holds over 25 years of experience, and is supported
by management. Our audit committee is responsible for cybersecurity oversight and monitoring risk. Management informs the audit and remuneration
committee of such risk at committee meetings.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center; background-color: white"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">As
of the date of this report, we are not aware of any material risks from cybersecurity threats that have materially affected or are reasonably
likely to materially affect us, including our business strategy, results of operations or financial condition.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><span id="am_027"></span>PART
III</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; text-align: left; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><span id="am_028"></span>ITEM
17. Financial Statements.</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; text-align: justify; margin: 0pt 0pt 0pt 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
have responded to Item 18 in lieu of responding to this item.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; text-align: left; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><span id="am_029"></span>ITEM
18. Financial Statements.</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Please
refer to the financial statements beginning on page F-1. The following financial statements, financial statement schedules and related
notes are filed as part of this annual report, together with the report of the independent registered public accounting firm.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="font: 10pt Times New Roman, Times, Serif">
    <td style="font: 10pt Times New Roman, Times, Serif; vertical-align: top; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="border-bottom: black 1.5pt solid; font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; width: 0.5in; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Page</b></span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; background-color: #CCEEFF">
    <td style="font: 10pt Times New Roman, Times, Serif; vertical-align: top"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><a href="#f_001">Report of Independent Registered Public Accounting Firm</a> (PCAOB ID: <span id="xdx_900_edei--AuditorFirmId_c20230101__20231231_zI2ArnK1mSU"><ix:nonNumeric contextRef="From2023-01-01to2023-12-31" id="Fact000053" name="dei:AuditorFirmId">1197</ix:nonNumeric></span>)</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">F-1</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top; background-color: white">
    <td style="font: 10pt Times New Roman, Times, Serif"><a href="#f_002"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Consolidated Balance Sheets</span></a></td>
    <td style="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">F-3</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top; background-color: #CCEEFF">
    <td style="font: 10pt Times New Roman, Times, Serif"><a href="#f_003"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Consolidated Statements of Operations</span></a></td>
    <td style="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">F-4</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top; background-color: white">
    <td style="font: 10pt Times New Roman, Times, Serif"><a href="#f_004"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Consolidated Statements of Comprehensive Loss</span></a></td>
    <td style="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">F-5</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top; background-color: #CCEEFF">
    <td style="font: 10pt Times New Roman, Times, Serif"><a href="#f_005"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Consolidated Statements of Changes in Shareholders&#8217; Equity</span></a></td>
    <td style="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">F-6</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top; background-color: white">
    <td style="font: 10pt Times New Roman, Times, Serif"><a href="#f_006"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Consolidated Statements of Cash Flows</span></a></td>
    <td style="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">F-7</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top; background-color: #CCEEFF">
    <td style="font: 10pt Times New Roman, Times, Serif"><a href="#f_007"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Notes to Consolidated Financial Statements</span></a></td>
    <td style="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">F-8</span></td></tr>
  </table>
<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"></span></p>


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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><span id="f_001"></span><b>REPORT
OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">To
the shareholders and the Board of Directors of Galmed Pharmaceuticals Ltd.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Opinion
on the Financial Statements</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
have audited the accompanying consolidated balance sheets of Galmed Pharmaceuticals Ltd. and subsidiaries (the
&#8220;Company&#8221;) as of December 31, 2023 and 2022, the related consolidated statements of operations, comprehensive loss,
changes in stockholders&#8217; equity and cash flows, for each of the three years in the period ended December 31, 2023, and the
related notes (collectively referred to as the &#8220;consolidated financial statements&#8221;). In our opinion, the consolidated
financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2023 and
2022, and the results of its operations and its cash flows for each of the three years in the period ended December 31, 2023, in
conformity with accounting principles generally accepted in the United States of America.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Basis
for Opinion</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">These
consolidated financial statements are the responsibility of the Company&#8217;s management. Our responsibility is to express an opinion
on the Company&#8217;s consolidated financial statements based on our audits. We are a public accounting firm registered with the Public
Company Accounting Oversight Board (United States) (&#8220;PCAOB&#8221;) and are required to be independent with respect to the Company
in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission
and the PCAOB.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain
reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud.
Our audits included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether
due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence
regarding the amounts and disclosures in the consolidated financial statements. Our audits also included evaluating the accounting principles
used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements.
We believe that our audits provide a reasonable basis for our opinion.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Critical
Audit Matter</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
critical audit matter communicated below is a matter arising from the current-period audit of the financial statements that was communicated
or required to be communicated to the audit committee and that (1) relates to accounts or disclosures that are material to the financial
statements and (2) involved our especially challenging, subjective, or complex judgments. The communication of critical audit matters
does not alter in any way our opinion on the financial statements, taken as a whole, and we are not, by communicating the critical audit
matter below, providing a separate opinion on the critical audit matter or on the accounts or disclosures to which it relates.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Marketable
Debt Securities Classified as Available-for-Sale&#8211; Refer to Note 3 to the consolidated financial statements</i></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Critical
Audit Matter Description</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
Company invests its excess cash primarily in available-for-sale marketable debt securities. Investments in marketable debt securities
classified as available-for-sale are reported at fair value in the financial statements. The investments totaled approximately $7.5 million
as of December 31, 2023.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>


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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
identified the investments in marketable debt securities classified as available-for-sale as a critical audit matter because of the magnitude
of these investments and due to the increased extent of audit effort in relation to our audit as a whole.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><i>How
the Critical Audit Matter Was Addressed in the Audit</i></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Our
audit procedures related to the Company&#8217;s investments in marketable debt securities classified as available-for-sale included the
following, among others:</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
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    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
    assessed the accuracy and completeness of the quantities of marketable debt securities held by the Company as of December 31, 2023
    by comparing the Company&#8217;s investment report to the custodians&#8217; balance confirmations.</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
    obtained independent estimates of the fair value of the investments in marketable debt securities classified as available-for-sale
    held by the Company as of December 31, 2023 and compared our estimates to the Company&#8217;s estimates.</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
    agreed the recorded values of investments in marketable debt securities classified as available-for-sale to the fair values indicated
    in the custodians&#8217; balance confirmations.</span></td></tr>
  </table>
<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>/s/
Brightman Almagor Zohar &amp; Co.</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><span id="xdx_90B_edei--AuditorName_c20230101__20231231_z3aFNVLbLB18"><ix:nonNumeric contextRef="From2023-01-01to2023-12-31" id="Fact000054" name="dei:AuditorName">Brightman
Almagor Zohar &amp; Co.</ix:nonNumeric></span></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Certified
Public Accountants</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>A
Firm in the Deloitte Global Network</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><span id="xdx_90F_edei--AuditorLocation_c20230101__20231231_z7cbQ0twFuT9"><ix:nonNumeric contextRef="From2023-01-01to2023-12-31" id="Fact000055" name="dei:AuditorLocation">Tel
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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">April
4, 2024</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
have served as the Company&#8217;s auditor since 2013.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>


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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>&#160;</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><span id="f_002"></span>GALMED
PHARMACEUTICALS LTD.</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Consolidated
Balance Sheet</b>s</span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: bold 10pt Times New Roman, Times, Serif; text-align: left; margin-top: 0pt; margin-bottom: 0pt"><span style="font-family: Times New Roman, Times, Serif">U.S.
Dollars in thousands, except share data and per share data</span></p>



<p style="margin: 0"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></p>

<table cellpadding="0" cellspacing="0" id="xdx_305_111_pn3n3_zdSt6zGQOv8k" summary="xdx: Statement - Consolidated Balance Sheets" style="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 100%">
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<tr style="vertical-align: bottom">
    <td style="text-align: center"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: center"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
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  <tr id="xdx_404_eus-gaap--DepositsAssetsCurrent_i02I_maACzrxv_zrdp1KOfMdL8" style="vertical-align: bottom; background-color: rgb(204,238,255)">
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    <td style="text-align: center"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif"><ix:nonFraction name="us-gaap:DepositsAssetsCurrent" contextRef="AsOf2023-12-31" id="Fact000069" format="ixt:numdotdecimal" decimals="-3" scale="3" unitRef="USD">2,253</ix:nonFraction></span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
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  <tr id="xdx_40B_eus-gaap--MarketableSecuritiesCurrent_i02I_maACzrxv_zmVJn3Hqu5G4" style="vertical-align: bottom; background-color: White">
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    <td style="text-align: center"><span style="font-family: Times New Roman, Times, Serif">3</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif"><ix:nonFraction name="us-gaap:MarketableSecuritiesCurrent" contextRef="AsOf2023-12-31" id="Fact000072" format="ixt:numdotdecimal" decimals="-3" scale="3" unitRef="USD">7,528</ix:nonFraction></span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
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  <tr id="xdx_40D_eus-gaap--OtherReceivablesNetCurrent_i02I_maACzrxv_zvJEjBg8dnA9" style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="padding-bottom: 1.5pt; text-align: left"><span style="font-family: Times New Roman, Times, Serif">Other receivables</span></td><td style="padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
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    <td style="border-bottom: Black 1.5pt solid; text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="border-bottom: Black 1.5pt solid; text-align: right"><span style="font-family: Times New Roman, Times, Serif"><ix:nonFraction name="us-gaap:OtherReceivablesNetCurrent" contextRef="AsOf2022-12-31" id="Fact000076" format="ixt:numdotdecimal" decimals="-3" scale="3" unitRef="USD">825</ix:nonFraction></span></td><td style="padding-bottom: 1.5pt; text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td></tr>
  <tr id="xdx_40A_eus-gaap--AssetsCurrent_i02TI_maAz1Kh_mtACzrxv_z930G7Q5vpgd" style="vertical-align: bottom; background-color: White">
    <td style="padding-left: 10pt; font-weight: bold; text-align: left"><span style="font-family: Times New Roman, Times, Serif">Total
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    <td style="text-align: center"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif"><ix:nonFraction name="us-gaap:AssetsCurrent" contextRef="AsOf2023-12-31" id="Fact000078" format="ixt:numdotdecimal" decimals="-3" scale="3" unitRef="USD">13,239</ix:nonFraction></span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: center"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td></tr>
  <tr id="xdx_401_eus-gaap--OperatingLeaseRightOfUseAsset_i01I_maANzeLV_zpJBZMdoZMR6" style="vertical-align: bottom; background-color: White">
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">Operating lease right-of-use assets</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: center"><span style="font-family: Times New Roman, Times, Serif">5</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif"><ix:nonFraction name="us-gaap:OperatingLeaseRightOfUseAsset" contextRef="AsOf2023-12-31" id="Fact000081" format="ixt:numdotdecimal" decimals="-3" scale="3" unitRef="USD">42</ix:nonFraction></span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif"><ix:nonFraction name="us-gaap:OperatingLeaseRightOfUseAsset" contextRef="AsOf2022-12-31" id="Fact000082" format="ixt:numdotdecimal" decimals="-3" scale="3" unitRef="USD">223</ix:nonFraction></span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td></tr>
  <tr id="xdx_405_eus-gaap--PropertyPlantAndEquipmentNet_i01I_pn3n3_maANzeLV_ztagMdbrQCo9" style="vertical-align: bottom; background-color: rgb(204,238,255)">
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    <td style="text-align: center"><span style="font-family: Times New Roman, Times, Serif">6</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif"><ix:nonFraction name="us-gaap:PropertyPlantAndEquipmentNet" contextRef="AsOf2023-12-31" id="Fact000084" format="ixt:numdotdecimal" decimals="-3" scale="3" unitRef="USD">83</ix:nonFraction></span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif"><ix:nonFraction name="us-gaap:PropertyPlantAndEquipmentNet" contextRef="AsOf2022-12-31" id="Fact000085" format="ixt:numdotdecimal" decimals="-3" scale="3" unitRef="USD">114</ix:nonFraction></span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td></tr>
  <tr id="xdx_409_eus-gaap--InvestmentsInAffiliatesSubsidiariesAssociatesAndJointVentures_i01I_maANzeLV_zTz8cO0cdv55" style="vertical-align: bottom; background-color: White">
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">Investment in associate at fair value</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: center"><span style="font-family: Times New Roman, Times, Serif">7</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif"><ix:nonFraction name="us-gaap:InvestmentsInAffiliatesSubsidiariesAssociatesAndJointVentures" contextRef="AsOf2023-12-31" id="Fact000087" format="ixt:numdotdecimal" decimals="-3" scale="3" unitRef="USD">3,265</ix:nonFraction></span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif"><span style="-sec-ix-hidden: xdx2ixbrl0088">-</span></span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td></tr>
  <tr id="xdx_409_eus-gaap--LongTermInvestments_i01I_maANzeLV_zyEbumUHqpC1" style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="padding-bottom: 1.5pt; text-align: left"><span style="font-family: Times New Roman, Times, Serif">Investment in convertible
    note</span></td><td style="padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="padding-bottom: 1.5pt; text-align: center"><span style="font-family: Times New Roman, Times, Serif">7</span></td><td style="padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="border-bottom: Black 1.5pt solid; text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="border-bottom: Black 1.5pt solid; text-align: right"><span style="font-family: Times New Roman, Times, Serif"><span style="-sec-ix-hidden: xdx2ixbrl0090">-</span></span></td><td style="padding-bottom: 1.5pt; text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="border-bottom: Black 1.5pt solid; text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="border-bottom: Black 1.5pt solid; text-align: right"><span style="font-family: Times New Roman, Times, Serif"><ix:nonFraction name="us-gaap:LongTermInvestments" contextRef="AsOf2022-12-31" id="Fact000091" format="ixt:numdotdecimal" decimals="-3" scale="3" unitRef="USD">1,500</ix:nonFraction></span></td><td style="padding-bottom: 1.5pt; text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td></tr>
  <tr id="xdx_406_eus-gaap--AssetsNoncurrent_i01TI_mtANzeLV_maAz1Kh_znXUtmQtq41a" style="vertical-align: bottom; background-color: White">
    <td style="padding-bottom: 1.5pt; font-weight: bold; text-align: left"><span style="font-family: Times New Roman, Times, Serif">Total
    non-current assets</span></td><td style="padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="padding-bottom: 1.5pt; text-align: center"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="border-bottom: Black 1.5pt solid; text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="border-bottom: Black 1.5pt solid; text-align: right"><span style="font-family: Times New Roman, Times, Serif"><ix:nonFraction name="us-gaap:AssetsNoncurrent" contextRef="AsOf2023-12-31" id="Fact000093" format="ixt:numdotdecimal" decimals="-3" scale="3" unitRef="USD">3,390</ix:nonFraction></span></td><td style="padding-bottom: 1.5pt; text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="border-bottom: Black 1.5pt solid; text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="border-bottom: Black 1.5pt solid; text-align: right"><span style="font-family: Times New Roman, Times, Serif"><ix:nonFraction name="us-gaap:AssetsNoncurrent" contextRef="AsOf2022-12-31" id="Fact000094" format="ixt:numdotdecimal" decimals="-3" scale="3" unitRef="USD">1,837</ix:nonFraction></span></td><td style="padding-bottom: 1.5pt; text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td></tr>
  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: center"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td></tr>
  <tr id="xdx_40D_eus-gaap--Assets_i01TI_mtAz1Kh_z2vCmntvpzfe" style="vertical-align: bottom; background-color: White">
    <td style="padding-bottom: 1.5pt; font-weight: bold; text-align: left"><span style="font-family: Times New Roman, Times, Serif">Total
    assets</span></td><td style="padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="padding-bottom: 1.5pt; text-align: center"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
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    <td style="border-bottom: Black 1.5pt solid; text-align: left"><span style="font-family: Times New Roman, Times, Serif">$</span></td><td style="border-bottom: Black 1.5pt solid; text-align: right"><span style="font-family: Times New Roman, Times, Serif"><ix:nonFraction name="us-gaap:Assets" contextRef="AsOf2022-12-31" id="Fact000097" format="ixt:numdotdecimal" decimals="-3" scale="3" unitRef="USD">16,561</ix:nonFraction></span></td><td style="padding-bottom: 1.5pt; text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td></tr>
  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: center"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td></tr>
  <tr id="xdx_400_eus-gaap--LiabilitiesAndStockholdersEquityAbstract_iB_zss7AQRpIqP4" style="vertical-align: bottom; background-color: White">
    <td style="font-weight: bold; text-align: left"><span style="font-family: Times New Roman, Times, Serif">Liabilities and stockholders&#8217;
    equity</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: center"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td></tr>
  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: center"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td></tr>
  <tr id="xdx_40B_eus-gaap--LiabilitiesCurrentAbstract_i01B_zGlGTRMBe1Jj" style="vertical-align: bottom; background-color: White">
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    <td style="text-align: center"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td></tr>
  <tr id="xdx_40E_eus-gaap--AccountsPayableCurrent_i02I_maCzBey_znnLnkkuWFjh" style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">Trade payables</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: center"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
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  <tr id="xdx_401_eus-gaap--OtherLoansPayableCurrent_i02I_maCzBey_zobpSi2IHyY" style="vertical-align: bottom; background-color: White">
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  <tr id="xdx_409_eus-gaap--LiabilitiesCurrent_i02TI_mtCzBey_maLASEzugD_z1tcvXFFFrq" style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="padding-left: 10pt; padding-bottom: 1.5pt; font-weight: bold; text-align: left"><span style="font-family: Times New Roman, Times, Serif">Total
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    <td style="padding-bottom: 1.5pt; text-align: center"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="border-bottom: Black 1.5pt solid; text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="border-bottom: Black 1.5pt solid; text-align: right"><span style="font-family: Times New Roman, Times, Serif"><ix:nonFraction name="us-gaap:LiabilitiesCurrent" contextRef="AsOf2023-12-31" id="Fact000111" format="ixt:numdotdecimal" decimals="-3" scale="3" unitRef="USD">2,750</ix:nonFraction></span></td><td style="padding-bottom: 1.5pt; text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="border-bottom: Black 1.5pt solid; text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="border-bottom: Black 1.5pt solid; text-align: right"><span style="font-family: Times New Roman, Times, Serif"><ix:nonFraction name="us-gaap:LiabilitiesCurrent" contextRef="AsOf2022-12-31" id="Fact000112" format="ixt:numdotdecimal" decimals="-3" scale="3" unitRef="USD">3,094</ix:nonFraction></span></td><td style="padding-bottom: 1.5pt; text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td></tr>
  <tr style="vertical-align: bottom; background-color: White">
    <td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: center"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td></tr>
  <tr id="xdx_405_eus-gaap--LiabilitiesNoncurrentAbstract_i01B_zKNsWKwfxUL7" style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="text-align: justify"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Non-current
                                    liabilities</b></span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"></p></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: center"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td></tr>
  <tr id="xdx_403_eus-gaap--OperatingLeaseLiabilityNoncurrent_i02I_maCz06r_zPteT7oZ8XIk" style="vertical-align: bottom; background-color: White">
    <td style="padding-bottom: 1.5pt; text-align: justify"><span style="font-family: Times New Roman, Times, Serif">Operating lease liabilities,
    net of current portion <br/></span></td><td style="padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="padding-bottom: 1.5pt; text-align: center"><span style="font-family: Times New Roman, Times, Serif">5</span></td><td style="padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="border-bottom: Black 1.5pt solid; text-align: left"><span style="font-family: Times New Roman, Times, Serif">$</span></td><td style="border-bottom: Black 1.5pt solid; text-align: right"><span style="font-family: Times New Roman, Times, Serif"><span style="-sec-ix-hidden: xdx2ixbrl0117">-</span></span></td><td style="padding-bottom: 1.5pt; text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="border-bottom: Black 1.5pt solid; text-align: left"><span style="font-family: Times New Roman, Times, Serif">$</span></td><td style="border-bottom: Black 1.5pt solid; text-align: right"><span style="font-family: Times New Roman, Times, Serif"><ix:nonFraction name="us-gaap:OperatingLeaseLiabilityNoncurrent" contextRef="AsOf2022-12-31" id="Fact000118" format="ixt:numdotdecimal" decimals="-3" scale="3" unitRef="USD">44</ix:nonFraction></span></td><td style="padding-bottom: 1.5pt; text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td></tr>
  <tr id="xdx_406_eus-gaap--LiabilitiesNoncurrent_i02TI_mtCz06r_maLASEzugD_zlgQmsqHkTe" style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="text-align: justify"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Total
                                    non-current liabilities</b></span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: center"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif"><span style="-sec-ix-hidden: xdx2ixbrl0120">-</span></span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif"><ix:nonFraction name="us-gaap:LiabilitiesNoncurrent" contextRef="AsOf2022-12-31" id="Fact000121" format="ixt:numdotdecimal" decimals="-3" scale="3" unitRef="USD">44</ix:nonFraction></span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td></tr>
  <tr id="xdx_402_eus-gaap--StockholdersEquityAbstract_iB_z599rGsycEx" style="vertical-align: bottom; background-color: White">
    <td style="text-align: justify"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Stockholders&#8217;
                                    equity</b></span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"></p></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: center"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td></tr>
  <tr id="xdx_402_eus-gaap--CommonStockValue_i01I_maSEzsbJ_ziyxK7UdpbY6" style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif">Ordinary shares, par value NIS <span id="xdx_90F_eus-gaap--CommonStockParOrStatedValuePerShare_iI_pid_uILSPShares_c20231231_zLM9AKKK4I5c"><span id="xdx_90A_eus-gaap--CommonStockParOrStatedValuePerShare_iI_pid_uILSPShares_c20221231_z8bL9NUR9nj5" title="Ordinary shares, par value"><ix:nonFraction name="us-gaap:CommonStockParOrStatedValuePerShare" contextRef="AsOf2023-12-31" id="Fact000128" format="ixt:numdotdecimal" decimals="INF" unitRef="ILSPShares"><ix:nonFraction name="us-gaap:CommonStockParOrStatedValuePerShare" contextRef="AsOf2022-12-31" id="Fact000130" format="ixt:numdotdecimal" decimals="INF" unitRef="ILSPShares">0.15</ix:nonFraction></ix:nonFraction></span>
    </span></span><span style="font-family: Times New Roman, Times, Serif">per share; Authorized <span id="xdx_90A_eus-gaap--CommonStockSharesAuthorized_iI_pid_c20231231_zmVz4SeNkx2"><span id="xdx_90D_eus-gaap--CommonStockSharesAuthorized_iI_pid_c20221231_zGkSW5NoTwq1" title="Ordinary shares, authorized"><ix:nonFraction name="us-gaap:CommonStockSharesAuthorized" contextRef="AsOf2023-12-31" id="Fact000131" format="ixt:numdotdecimal" decimals="INF" unitRef="Shares"><ix:nonFraction name="us-gaap:CommonStockSharesAuthorized" contextRef="AsOf2022-12-31" id="Fact000133" format="ixt:numdotdecimal" decimals="INF" unitRef="Shares">20,000,000</ix:nonFraction></ix:nonFraction></span>
    </span></span><span style="font-family: Times New Roman, Times, Serif">shares; Issued and outstanding: <span id="xdx_900_eus-gaap--CommonStockSharesIssued_iI_pid_c20231231_zJMRDsoUmP7" title="Ordinary shares, issued"><span id="xdx_905_eus-gaap--CommonStockSharesOutstanding_iI_pid_c20231231_znUPrUVhHuJg" title="Ordinary shares, outstanding"><ix:nonFraction name="us-gaap:CommonStockSharesIssued" contextRef="AsOf2023-12-31" id="Fact000135" format="ixt:numdotdecimal" decimals="INF" unitRef="Shares"><ix:nonFraction name="us-gaap:CommonStockSharesOutstanding" contextRef="AsOf2023-12-31" id="Fact000137" format="ixt:numdotdecimal" decimals="INF" unitRef="Shares">5,045,324</ix:nonFraction></ix:nonFraction></span>
    </span></span><span style="font-family: Times New Roman, Times, Serif">shares as of December 31, 2023; <span id="xdx_90C_eus-gaap--CommonStockSharesIssued_iI_pid_c20221231_zHD0WMhBxnOl" title="Ordinary shares, issued"><span id="xdx_903_eus-gaap--CommonStockSharesOutstanding_iI_pid_c20221231_z3uNNyZIl1Wj" title="Ordinary shares, outstanding"><ix:nonFraction name="us-gaap:CommonStockSharesIssued" contextRef="AsOf2022-12-31" id="Fact000139" format="ixt:numdotdecimal" decimals="INF" unitRef="Shares"><ix:nonFraction name="us-gaap:CommonStockSharesOutstanding" contextRef="AsOf2022-12-31" id="Fact000141" format="ixt:numdotdecimal" decimals="INF" unitRef="Shares">1,692,342</ix:nonFraction></ix:nonFraction></span>
    </span></span><span style="font-family: Times New Roman, Times, Serif">shares as of December 31, 2022 <span id="xdx_F46_zIlRsalL6o61">(*)</span></span><span style="font-family: Times New Roman, Times, Serif"><br/></span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: center"><span style="font-family: Times New Roman, Times, Serif">11</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif"><ix:nonFraction name="us-gaap:CommonStockValue" contextRef="AsOf2023-12-31" id="Fact000126" format="ixt:numdotdecimal" decimals="-3" scale="3" unitRef="USD">209</ix:nonFraction></span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif"><ix:nonFraction name="us-gaap:CommonStockValue" contextRef="AsOf2022-12-31" id="Fact000127" format="ixt:numdotdecimal" decimals="-3" scale="3" unitRef="USD">70</ix:nonFraction></span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td></tr>
  <tr id="xdx_40A_eus-gaap--AdditionalPaidInCapital_i01I_maSEzsbJ_zeVNvyda5Wrf" style="vertical-align: bottom; background-color: White">
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif">Additional paid-in capital <br/></span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: center"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif"><ix:nonFraction name="us-gaap:AdditionalPaidInCapital" contextRef="AsOf2023-12-31" id="Fact000143" format="ixt:numdotdecimal" decimals="-3" scale="3" unitRef="USD">207,076</ix:nonFraction></span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif"><ix:nonFraction name="us-gaap:AdditionalPaidInCapital" contextRef="AsOf2022-12-31" id="Fact000144" format="ixt:numdotdecimal" decimals="-3" scale="3" unitRef="USD">200,138</ix:nonFraction></span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td></tr>
  <tr id="xdx_404_eus-gaap--AccumulatedOtherComprehensiveIncomeLossNetOfTax_i01I_maSEzsbJ_zwM7eZHCz1d5" style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif">Accumulated other comprehensive loss <br/></span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: center"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif">(<ix:nonFraction name="us-gaap:AccumulatedOtherComprehensiveIncomeLossNetOfTax" contextRef="AsOf2023-12-31" id="Fact000146" format="ixt:numdotdecimal" decimals="-3" scale="3" sign="-" unitRef="USD">454</ix:nonFraction></span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">)</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif">(<ix:nonFraction name="us-gaap:AccumulatedOtherComprehensiveIncomeLossNetOfTax" contextRef="AsOf2022-12-31" id="Fact000147" format="ixt:numdotdecimal" decimals="-3" scale="3" sign="-" unitRef="USD">745</ix:nonFraction></span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">)</span></td></tr>
  <tr id="xdx_40E_eus-gaap--RetainedEarningsAccumulatedDeficit_i01I_maSEzsbJ_zPqWzKjTAvF2" style="vertical-align: bottom; background-color: White">
    <td style="padding-bottom: 1.5pt; text-align: justify"><span style="font-family: Times New Roman, Times, Serif">Accumulated deficit
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    <td style="padding-bottom: 1.5pt; text-align: center"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
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  <tr style="vertical-align: bottom; background-color: White">
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    <td style="text-align: center"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
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  <tr id="xdx_408_eus-gaap--LiabilitiesAndStockholdersEquity_iTI_mtLASEzugD_zPa4qAds3pv" style="vertical-align: bottom; background-color: rgb(204,238,255)">
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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td id="xdx_F00_zSV41JLFwRr6" style="font: 10pt Times New Roman, Times, Serif; width: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">(*)</span></td>
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                                                         share and per share data has been retroactively adjusted to reflect the <span id="xdx_90A_eus-gaap--StockholdersEquityReverseStockSplit_c20230101__20231231_z3kP0gQLHsE7" title="Reverse stock split"><ix:nonNumeric contextRef="From2023-01-01to2023-12-31" id="Fact000159" name="us-gaap:StockholdersEquityReverseStockSplit">1 for 15 reverse share split</ix:nonNumeric></span> effected on May 15, 2023 for all periods prior to the date of the reverse share split. See Note
                                                         11A4.</ix:footnote></span></p>
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  </table>
<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Accompanying
notes are an integral part of the consolidated financial statements.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>


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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><span id="f_003"></span>GALMED
PHARMACEUTICALS LTD.</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Consolidated
Statements of Operations</b></span></p>

<!-- Field: Rule-Page --><div style="margin-left: auto; margin-right: auto; width: 100%"><div style="border-top: Black 1.5pt solid; font-size: 1pt"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></div></div><!-- Field: /Rule-Page -->

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: bold 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"><span style="font-family: Times New Roman, Times, Serif">U.S.
Dollars in thousands, except share data and per share data</span></p>



<p style="margin: 0"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></p>

<table cellpadding="0" cellspacing="0" id="xdx_305_113_pn3n3_zTdcyV24y8ph" summary="xdx: Statement - Consolidated Statements of Operations" style="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 100%">
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    <td style="text-align: center"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: center; padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: center"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: center; font-weight: bold; padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
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    <td style="text-align: center"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: center; padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: center"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: center; font-weight: bold; padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
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    <td style="width: 38%; text-align: left"><span style="font-family: Times New Roman, Times, Serif">Research and development expenses</span></td><td style="width: 2%"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
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  <tr style="vertical-align: bottom; background-color: White">
    <td style="padding-bottom: 2.5pt; text-align: left"><span style="font-family: Times New Roman, Times, Serif">Weighted-average number
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    <td style="padding-bottom: 2.5pt; text-align: center"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="padding-bottom: 2.5pt"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="border-bottom: Black 2.5pt double; text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="border-bottom: Black 2.5pt double; text-align: right"><span style="font-family: Times New Roman, Times, Serif"><span id="xdx_909_eus-gaap--WeightedAverageNumberOfSharesOutstandingBasic_pid_c20230101__20231231_fKCop_zv5zhErD9Dn3" title="Weighted average number of shares outstanding used in computing net loss per share, basic" class="xdx_phnt_U3RhdGVtZW50IC0gQ29uc29saWRhdGVkIFN0YXRlbWVudHMgb2YgT3BlcmF0aW9ucwA_"><span id="xdx_90C_eus-gaap--WeightedAverageNumberOfDilutedSharesOutstanding_pid_c20230101__20231231_fKCop_znTkbccuPVqc" title="Weighted average number of shares outstanding used in computing net loss per share, diluted" class="xdx_phnt_U3RhdGVtZW50IC0gQ29uc29saWRhdGVkIFN0YXRlbWVudHMgb2YgT3BlcmF0aW9ucwA_"><ix:nonFraction name="us-gaap:WeightedAverageNumberOfSharesOutstandingBasic" contextRef="From2023-01-01to2023-12-31" id="Fact000193" format="ixt:numdotdecimal" decimals="INF" unitRef="Shares"><ix:nonFraction name="us-gaap:WeightedAverageNumberOfDilutedSharesOutstanding" contextRef="From2023-01-01to2023-12-31" id="Fact000195" format="ixt:numdotdecimal" decimals="INF" unitRef="Shares">2,769,539</ix:nonFraction></ix:nonFraction></span></span></span></td><td style="padding-bottom: 2.5pt; text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="padding-bottom: 2.5pt"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="border-bottom: Black 2.5pt double; text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="border-bottom: Black 2.5pt double; text-align: right"><span style="font-family: Times New Roman, Times, Serif"><span id="xdx_904_eus-gaap--WeightedAverageNumberOfSharesOutstandingBasic_pid_c20220101__20221231_fKCop_zSOJvImuILJf" title="Weighted average number of shares outstanding used in computing net loss per share, basic" class="xdx_phnt_U3RhdGVtZW50IC0gQ29uc29saWRhdGVkIFN0YXRlbWVudHMgb2YgT3BlcmF0aW9ucwA_"><span id="xdx_903_eus-gaap--WeightedAverageNumberOfDilutedSharesOutstanding_pid_c20220101__20221231_fKCop_zdmkDwBooZ1a" title="Weighted average number of shares outstanding used in computing net loss per share, diluted" class="xdx_phnt_U3RhdGVtZW50IC0gQ29uc29saWRhdGVkIFN0YXRlbWVudHMgb2YgT3BlcmF0aW9ucwA_"><ix:nonFraction name="us-gaap:WeightedAverageNumberOfSharesOutstandingBasic" contextRef="From2022-01-012022-12-31" id="Fact000197" format="ixt:numdotdecimal" decimals="INF" unitRef="Shares"><ix:nonFraction name="us-gaap:WeightedAverageNumberOfDilutedSharesOutstanding" contextRef="From2022-01-012022-12-31" id="Fact000199" format="ixt:numdotdecimal" decimals="INF" unitRef="Shares">1,676,183</ix:nonFraction></ix:nonFraction></span></span></span></td><td style="padding-bottom: 2.5pt; text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="padding-bottom: 2.5pt"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="border-bottom: Black 2.5pt double; text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="border-bottom: Black 2.5pt double; text-align: right"><span style="font-family: Times New Roman, Times, Serif"><span id="xdx_900_eus-gaap--WeightedAverageNumberOfSharesOutstandingBasic_pid_c20210101__20211231_fKCop_zkGVsJBzSZGj" title="Weighted average number of shares outstanding used in computing net loss per share, basic" class="xdx_phnt_U3RhdGVtZW50IC0gQ29uc29saWRhdGVkIFN0YXRlbWVudHMgb2YgT3BlcmF0aW9ucwA_"><span id="xdx_900_eus-gaap--WeightedAverageNumberOfDilutedSharesOutstanding_pid_c20210101__20211231_fKCop_z7iLMkRG9PCf" title="Weighted average number of shares outstanding used in computing net loss per share, diluted" class="xdx_phnt_U3RhdGVtZW50IC0gQ29uc29saWRhdGVkIFN0YXRlbWVudHMgb2YgT3BlcmF0aW9ucwA_"><ix:nonFraction name="us-gaap:WeightedAverageNumberOfSharesOutstandingBasic" contextRef="From2021-01-012021-12-31" id="Fact000201" format="ixt:numdotdecimal" decimals="INF" unitRef="Shares"><ix:nonFraction name="us-gaap:WeightedAverageNumberOfDilutedSharesOutstanding" contextRef="From2021-01-012021-12-31" id="Fact000203" format="ixt:numdotdecimal" decimals="INF" unitRef="Shares">1,639,843</ix:nonFraction></ix:nonFraction></span></span></span></td><td style="padding-bottom: 2.5pt; text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td></tr>
  </table>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; width: 48px"><span id="xdx_F09_zzUKiWTfzq72" style="font-family: Times New Roman, Times, Serif; font-size: 10pt">(*)</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span id="xdx_F10_zWdU0tgpgM05" style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><ix:footnote id="Footnote000204" xml:lang="en-US">All
                                                         share and per share data has been retroactively adjusted to reflect the <span id="xdx_90A_eus-gaap--StockholdersEquityReverseStockSplit_c20230101__20231231_zYaqXopNooea" title="Reverse stock split"><ix:nonNumeric contextRef="From2023-01-01to2023-12-31" id="Fact000206" name="us-gaap:StockholdersEquityReverseStockSplit">1 for 15 reverse share split</ix:nonNumeric></span> effected on May 15, 2023 for all periods prior to the date of the reverse share split. See Note
                                                         11A4.</ix:footnote></span></p>
    <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"></p></td>
    </tr>
  </table>
<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Accompanying
notes are an integral part of the consolidated financial statements.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>


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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><span id="f_004"></span>GALMED
PHARMACEUTICALS LTD.</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Consolidated
Statements of Comprehensive Loss</b></span></p>

<!-- Field: Rule-Page --><div style="margin-left: auto; margin-right: auto; width: 100%"><div style="border-top: Black 1.5pt solid; font-size: 1pt">&#160;</div></div><!-- Field: /Rule-Page -->

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>U.S.
Dollars in thousands, except share data and per share data</b></span></p>



<p style="margin: 0"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></p>

<table cellpadding="0" cellspacing="0" id="xdx_303_113_pn3n3_zMzmVUi44Ygk" summary="xdx: Statement - Consolidated Statements of Comprehensive Loss" style="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 100%">
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<tr style="vertical-align: bottom">
    <td style="padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
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  <tr style="vertical-align: bottom">
    <td style="text-align: center"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: center; font-weight: bold; padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
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  <tr id="xdx_402_eus-gaap--NetIncomeLoss_iN_di_maCzhrw_zIqqx7fY6Cv2" style="vertical-align: bottom; background-color: rgb(204,238,255)">
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  <tr id="xdx_40F_eus-gaap--OtherComprehensiveIncomeLossTaxAbstract_iB_zgpEPKxq7zv9" style="vertical-align: bottom; background-color: White">
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    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
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  <tr id="xdx_408_eus-gaap--ComprehensiveIncomeNetOfTaxIncludingPortionAttributableToNoncontrollingInterest_i01NT_di_mtCzhrw_zMyTdgy4paYc" style="vertical-align: bottom; background-color: White">
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  </table>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Accompanying
notes are an integral part of the consolidated financial statements.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>


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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><span id="f_005"></span><b>GALMED
PHARMACEUTICALS LTD.</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Statements
of Changes in Stockholders&#8217; Equity</b></span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0"><span style="font-family: Times New Roman, Times, Serif"><b>U.S. Dollars
in thousands, except share data and per share data</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></p>

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<table cellpadding="0" cellspacing="0" id="xdx_309_114_pn3n3_zvsMDmyxFwn3" summary="xdx: Statement - Statements of Changes in Stockholders' Equity" style="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 100%">
  <tr style="vertical-align: bottom">
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  <tr style="vertical-align: bottom">
    <td style="text-align: center"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: center"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
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  <tr style="vertical-align: bottom">
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  <tr style="vertical-align: bottom">
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    <td colspan="2"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
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    <td colspan="2"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
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  <tr id="xdx_430_c20210101__20211231_eus-gaap--StockholdersEquity_iS_zYrAeKaYua5l" style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="width: 40%; font-weight: bold"><span style="font-family: Times New Roman, Times, Serif">Balance - January 1, 2021</span></td><td style="width: 2%"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
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    <td style="width: 1%; text-align: left"><span style="font-family: Times New Roman, Times, Serif">$</span></td><td style="width: 6%; text-align: right"><span style="font-family: Times New Roman, Times, Serif"><ix:nonFraction name="us-gaap:StockholdersEquity" contextRef="AsOf2020-12-31" id="Fact000228" format="ixt:numdotdecimal" decimals="-3" scale="3" unitRef="USD">44,153</ix:nonFraction></span></td><td style="width: 1%; text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td></tr>
  <tr style="vertical-align: bottom; background-color: White">
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    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td></tr>
  <tr id="xdx_401_eus-gaap--AdjustmentsToAdditionalPaidInCapitalSharebasedCompensationAndExerciseOfStockOptions_i_pn3n3" style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">Stock-based compensation</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif">&#8212;</span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif"><span style="-sec-ix-hidden: xdx2ixbrl0232">&#8212;</span></span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
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    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif"><span style="-sec-ix-hidden: xdx2ixbrl0235">&#8212;</span></span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
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  <tr style="vertical-align: bottom; background-color: White">
    <td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td></tr>
  <tr id="xdx_40B_eus-gaap--StockIssuedDuringPeriodValueStockOptionsExercised_zprVqHBxo9og" style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">Exercise of options and vesting of restricted
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    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><span style="display: none; font-family: Times New Roman, Times, Serif; font-size: 10pt"><span style="-sec-ix-hidden: xdx2ixbrl0238">-</span></span><span id="xdx_F22_zgK4WEqz2Jn">(*)</span></span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
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    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif"><span style="-sec-ix-hidden: xdx2ixbrl0241">&#8212;</span></span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">                                           <span id="xdx_F25_zzY6NCxTzQtc">(*)</span></span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td></tr>
  <tr style="vertical-align: bottom; background-color: White">
    <td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td></tr>
  <tr id="xdx_40D_ecustom--IssuanceOfOrdinarySharesInAtTheMarketAtOfferingNetOfIssuanceCosts_zNzI5QaLJXL1" style="vertical-align: bottom; background-color: rgb(204,238,255)">
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    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">Issuance of ordinary shares under Underwritten
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  <tr id="xdx_400_eus-gaap--NetIncomeLoss_zALMTD6oeBK5" style="vertical-align: bottom; background-color: rgb(204,238,255)">
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  <tr style="vertical-align: bottom; background-color: White">
    <td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
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    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
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    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">Stock-based compensation</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
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    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
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  <tr id="xdx_400_eus-gaap--StockIssuedDuringPeriodValueNewIssues_zA5elzOlwWO7" style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">Issuance of ordinary shares in ATM offering
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    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
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    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
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  <tr id="xdx_408_eus-gaap--OtherComprehensiveIncomeUnrealizedHoldingGainLossOnSecuritiesArisingDuringPeriodNetOfTax_zwgC4fS4K5vd" style="vertical-align: bottom; background-color: rgb(204,238,255)">
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  <tr id="xdx_400_eus-gaap--NetIncomeLoss_zKqCNE4fra83" style="vertical-align: bottom; background-color: rgb(204,238,255)">
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  <tr id="xdx_43B_c20230101__20231231_eus-gaap--StockholdersEquity_iS_zwKkLaFi2y54" style="vertical-align: bottom; background-color: rgb(204,238,255)">
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  <tr id="xdx_43F_c20230101__20231231_eus-gaap--StockholdersEquity_iS_zZY0WdxFSIB5" style="display: none; vertical-align: bottom; background-color: rgb(204,238,255)">
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    <td style="border-bottom: Black 2.5pt double; text-align: left"><span style="font-family: Times New Roman, Times, Serif">$</span></td><td style="border-bottom: Black 2.5pt double; text-align: right"><span style="font-family: Times New Roman, Times, Serif">(<ix:nonFraction name="us-gaap:StockholdersEquity" contextRef="AsOf2022-12-31_us-gaap_RetainedEarningsMember" id="Fact000325" format="ixt:numdotdecimal" decimals="-3" scale="3" sign="-" unitRef="USD">186,040</ix:nonFraction></span></td><td style="padding-bottom: 2.5pt; text-align: left"><span style="font-family: Times New Roman, Times, Serif">)</span></td><td style="padding-bottom: 2.5pt"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
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<tr style="vertical-align: bottom; background-color: White">
    <td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
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    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
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  <tr id="xdx_409_ecustom--StockIssuedDuringPeriodValueOrdinarySharesPrefundedWarrantsAndWarrantsNetOfIssuanceCosts_z0R5XOLgktTl" style="vertical-align: bottom; background-color: rgb(204,238,255)">
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  <tr style="vertical-align: bottom; background-color: White">
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  <tr id="xdx_404_ecustom--ExerciseOfPrefundedWarrants_zixFq0aTymi4" style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td><span style="font-family: Times New Roman, Times, Serif">Exercise of Pre-funded warrants <span id="xdx_F47_zqlh0eAOhs91">(***)</span></span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
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  <tr style="vertical-align: bottom; background-color: White">
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  <tr id="xdx_40F_eus-gaap--AdjustmentsToAdditionalPaidInCapitalSharebasedCompensationAndExerciseOfStockOptions_zcaO2ZLk7Vmk" style="vertical-align: bottom; background-color: rgb(204,238,255)">
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  <tr style="vertical-align: bottom; background-color: White">
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    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
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  <tr style="vertical-align: bottom; background-color: White">
    <td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
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    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td></tr>
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</table>

<p style="font: 11pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></p>
<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"></p>

<table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-bottom: 6pt; width: 100%"><tr style="vertical-align: top; text-align: justify">
<td style="width: 15pt; text-align: right"><span id="xdx_F0F_z29ed1BFfj1f" style="font-family: Times New Roman, Times, Serif; font-size: 10pt">(*)</span></td><td style="width: 5pt"/><td style="text-align: justify"><span id="xdx_F17_z6r320EdEka3" style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><ix:footnote id="Footnote000381" xml:lang="en-US">Represents amount
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</tr></table>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-bottom: 6pt; width: 100%"><tr style="vertical-align: top; text-align: justify">
<td style="width: 15pt; text-align: right"><span id="xdx_F08_zTt6yoHGdRKd" style="font-family: Times New Roman, Times, Serif; font-size: 10pt">(**)</span></td><td style="width: 5pt"/><td style="text-align: justify"><span id="xdx_F12_zzOUvCx1FASf" style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><ix:footnote id="Footnote000382" xml:lang="en-US">All share and per
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</tr></table>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-bottom: 6pt; width: 100%"><tr style="vertical-align: top; text-align: justify">
<td style="width: 15pt; text-align: right"><span id="xdx_F03_zCqqwppSvr15" style="font-family: Times New Roman, Times, Serif; font-size: 10pt">(***)</span></td><td style="width: 5pt"/><td style="text-align: justify"><span id="xdx_F1F_z9Gbwjnf4lsf" style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><ix:footnote id="Footnote000385" xml:lang="en-US">See also Note 11A.5</ix:footnote></span></td>
</tr></table>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Accompanying
notes are an integral part of the consolidated financial statements.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"></p>


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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><span id="f_006"></span><b>GALMED
PHARMACEUTICALS LTD.</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Consolidated
Statements of Cash Flows</b></span></p>

<!-- Field: Rule-Page --><div style="margin-left: auto; margin-right: auto; width: 100%"><div style="border-top: Black 1.5pt solid; font-size: 1pt"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></div></div><!-- Field: /Rule-Page -->

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>U.S.
Dollars in thousands, except share data and per share data</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<table cellpadding="0" cellspacing="0" id="xdx_309_112_pn3n3_zqbR2o1ODLTd" summary="xdx: Statement - Consolidated Statements of Cash Flows" style="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 100%">
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<tr style="vertical-align: bottom">
    <td style="padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td colspan="10" style="border-bottom: Black 1.5pt solid; text-align: center"><span style="font-family: Times New Roman, Times, Serif"><b>Year
    ended December 31,</b></span></td><td style="padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td></tr>
  <tr style="vertical-align: bottom">
    <td style="text-align: center"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: center; font-weight: bold; padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
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    <td colspan="2" style="border-bottom: Black 1.5pt solid; text-align: center; font-weight: bold"><span style="font-family: Times New Roman, Times, Serif">2022</span></td><td style="text-align: center; padding-bottom: 1.5pt; font-weight: bold"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: center; font-weight: bold; padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
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  <tr id="xdx_405_eus-gaap--NetCashProvidedByUsedInOperatingActivitiesAbstract_iB_zp9G7y8MDf7" style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="font-weight: bold; text-align: left"><span style="font-family: Times New Roman, Times, Serif">Cash flow from operating
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    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td></tr>
  <tr style="vertical-align: bottom; background-color: White">
    <td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td></tr>
  <tr id="xdx_40D_eus-gaap--NetIncomeLoss_i01_maNCPBUze3g_z02jZy2Xukol" style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="width: 46%; text-align: left"><span style="font-family: Times New Roman, Times, Serif">Net loss for the year</span></td><td style="width: 2%"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
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    <td style="width: 1%; text-align: left"><span style="font-family: Times New Roman, Times, Serif">$</span></td><td style="width: 14%; text-align: right"><span style="font-family: Times New Roman, Times, Serif">(<ix:nonFraction name="us-gaap:NetIncomeLoss" contextRef="From2022-01-012022-12-31" id="Fact000392" format="ixt:numdotdecimal" decimals="-3" scale="3" sign="-" unitRef="USD">17,866</ix:nonFraction></span></td><td style="width: 1%; text-align: left"><span style="font-family: Times New Roman, Times, Serif">)</span></td><td style="width: 2%"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="width: 1%; text-align: left"><span style="font-family: Times New Roman, Times, Serif">$</span></td><td style="width: 14%; text-align: right"><span style="font-family: Times New Roman, Times, Serif">(<ix:nonFraction name="us-gaap:NetIncomeLoss" contextRef="From2021-01-012021-12-31" id="Fact000393" format="ixt:numdotdecimal" decimals="-3" scale="3" sign="-" unitRef="USD">32,467</ix:nonFraction></span></td><td style="width: 1%; text-align: left"><span style="font-family: Times New Roman, Times, Serif">)</span></td></tr>
  <tr id="xdx_407_eus-gaap--AdjustmentsToReconcileNetIncomeLossToCashProvidedByUsedInOperatingActivitiesAbstract_i01B_zjdUGEhrjgE4" style="vertical-align: bottom; background-color: White">
    <td style="font-weight: bold; text-align: left"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Adjustments
    required to reconcile net loss to net cash used in</span> <span style="font-family: Times New Roman, Times, Serif">operating activities:</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td></tr>
  <tr id="xdx_40D_eus-gaap--DepreciationAndAmortization_i02_maNCPBUze3g_zHfaGCVUaqC9" style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td><span style="font-family: Times New Roman, Times, Serif">Depreciation</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif"><ix:nonFraction name="us-gaap:DepreciationAndAmortization" contextRef="From2023-01-01to2023-12-31" id="Fact000399" format="ixt:numdotdecimal" decimals="-3" scale="3" unitRef="USD">31</ix:nonFraction></span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif"><ix:nonFraction name="us-gaap:DepreciationAndAmortization" contextRef="From2022-01-012022-12-31" id="Fact000400" format="ixt:numdotdecimal" decimals="-3" scale="3" unitRef="USD">35</ix:nonFraction></span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif"><ix:nonFraction name="us-gaap:DepreciationAndAmortization" contextRef="From2021-01-012021-12-31" id="Fact000401" format="ixt:numdotdecimal" decimals="-3" scale="3" unitRef="USD">42</ix:nonFraction></span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td></tr>
  <tr id="xdx_403_eus-gaap--AmortizationOfDebtDiscountPremium_i02_maNCPBUze3g_zI9W0VeVYz71" style="vertical-align: bottom; background-color: White">
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">Amortization of discount (premium) on marketable
    debt securities</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif"><ix:nonFraction name="us-gaap:AmortizationOfDebtDiscountPremium" contextRef="From2023-01-01to2023-12-31" id="Fact000403" format="ixt:numdotdecimal" decimals="-3" scale="3" unitRef="USD">19</ix:nonFraction></span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif">(<ix:nonFraction name="us-gaap:AmortizationOfDebtDiscountPremium" contextRef="From2022-01-012022-12-31" id="Fact000404" format="ixt:numdotdecimal" decimals="-3" scale="3" sign="-" unitRef="USD">2</ix:nonFraction></span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">)</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif"><ix:nonFraction name="us-gaap:AmortizationOfDebtDiscountPremium" contextRef="From2021-01-012021-12-31" id="Fact000405" format="ixt:numdotdecimal" decimals="-3" scale="3" unitRef="USD">121</ix:nonFraction></span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td></tr>
  <tr id="xdx_40A_eus-gaap--GainLossOnSaleOfInvestments_i02N_di_msNCPBUze3g_zibcRSXb24w2" style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">Gain (loss) on sale of marketable debt securities</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif"><ix:nonFraction name="us-gaap:GainLossOnSaleOfInvestments" contextRef="From2023-01-01to2023-12-31" id="Fact000407" format="ixt:numdotdecimal" decimals="-3" scale="3" sign="-" unitRef="USD">13</ix:nonFraction></span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif"><ix:nonFraction name="us-gaap:GainLossOnSaleOfInvestments" contextRef="From2022-01-012022-12-31" id="Fact000408" format="ixt:numdotdecimal" decimals="-3" scale="3" sign="-" unitRef="USD">523</ix:nonFraction></span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif">(<ix:nonFraction name="us-gaap:GainLossOnSaleOfInvestments" contextRef="From2021-01-012021-12-31" id="Fact000409" format="ixt:numdotdecimal" decimals="-3" scale="3" unitRef="USD">37</ix:nonFraction></span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">)</span></td></tr>
  <tr id="xdx_404_ecustom--ProceedsFinanceLeaseInterestExpenseIncome_i02_maNCPBUze3g_zirr89qQoRVc" style="vertical-align: bottom; background-color: White">
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">Finance expenses (income)</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif"><ix:nonFraction name="GLMD:ProceedsFinanceLeaseInterestExpenseIncome" contextRef="From2023-01-01to2023-12-31" id="Fact000411" format="ixt:numdotdecimal" decimals="-3" scale="3" unitRef="USD">6</ix:nonFraction></span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif">(<ix:nonFraction name="GLMD:ProceedsFinanceLeaseInterestExpenseIncome" contextRef="From2022-01-012022-12-31" id="Fact000412" format="ixt:numdotdecimal" decimals="-3" scale="3" sign="-" unitRef="USD">36</ix:nonFraction></span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">)</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif"><ix:nonFraction name="GLMD:ProceedsFinanceLeaseInterestExpenseIncome" contextRef="From2021-01-012021-12-31" id="Fact000413" format="ixt:numdotdecimal" decimals="-3" scale="3" unitRef="USD">6</ix:nonFraction></span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td></tr>
  <tr id="xdx_402_ecustom--InterestIncomeFromShorttermDeposits_i02N_di_msNCPBUze3g_zFwkdyA8MOFj" style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">Interest income from short-term deposits</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right">(<ix:nonFraction name="GLMD:InterestIncomeFromShorttermDeposits" contextRef="From2023-01-01to2023-12-31" id="Fact000415" format="ixt:numdotdecimal" decimals="-3" scale="3" unitRef="USD">53</ix:nonFraction><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">)</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif"><span style="-sec-ix-hidden: xdx2ixbrl0416">-</span></span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif"><ix:nonFraction name="GLMD:InterestIncomeFromShorttermDeposits" contextRef="From2021-01-012021-12-31" id="Fact000417" format="ixt:numdotdecimal" decimals="-3" scale="3" sign="-" unitRef="USD">7</ix:nonFraction></span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td></tr>
  <tr id="xdx_406_eus-gaap--ShareBasedCompensation_i02_maNCPBUze3g_zBpFtTjDB9Og" style="vertical-align: bottom; background-color: White">
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">Stock-based compensation expense</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif"><ix:nonFraction name="us-gaap:ShareBasedCompensation" contextRef="From2023-01-01to2023-12-31" id="Fact000419" format="ixt:numdotdecimal" decimals="-3" scale="3" unitRef="USD">892</ix:nonFraction></span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif"><ix:nonFraction name="us-gaap:ShareBasedCompensation" contextRef="From2022-01-012022-12-31" id="Fact000420" format="ixt:numdotdecimal" decimals="-3" scale="3" unitRef="USD">1,296</ix:nonFraction></span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif"><ix:nonFraction name="us-gaap:ShareBasedCompensation" contextRef="From2021-01-012021-12-31" id="Fact000421" format="ixt:numdotdecimal" decimals="-3" scale="3" unitRef="USD">1,886</ix:nonFraction></span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td></tr>
  <tr id="xdx_401_ecustom--ChangeInFairValueConvertibleNote_i02N_di_msNCPBUze3g_zYlMbco8ni92" style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">Change in fair value convertible note</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif">(<ix:nonFraction name="GLMD:ChangeInFairValueConvertibleNote" contextRef="From2023-01-01to2023-12-31" id="Fact000423" format="ixt:numdotdecimal" decimals="-3" scale="3" unitRef="USD">265</ix:nonFraction></span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">)</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif"><span style="-sec-ix-hidden: xdx2ixbrl0424">-</span></span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif"><span style="-sec-ix-hidden: xdx2ixbrl0425">-</span></span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td></tr>
  <tr id="xdx_402_eus-gaap--IncreaseDecreaseInOperatingCapitalAbstract_i02B_zPHVKbdSmlwg" style="vertical-align: bottom; background-color: White">
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    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
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    <td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
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  <tr id="xdx_408_eus-gaap--IncreaseDecreaseInAccountsAndOtherReceivables_i03N_di_msNCPBUze3g_zY1ShxqQAtLg" style="vertical-align: bottom; background-color: White">
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">Decrease (increase) in other receivables</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
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    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif"><ix:nonFraction name="us-gaap:IncreaseDecreaseInAccountsAndOtherReceivables" contextRef="From2022-01-012022-12-31" id="Fact000432" format="ixt:numdotdecimal" decimals="-3" scale="3" sign="-" unitRef="USD">300</ix:nonFraction></span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
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  <tr id="xdx_402_eus-gaap--IncreaseDecreaseInAccountsPayableTrade_i03_maNCPBUze3g_zt9a2RY0fa2l" style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">Decrease in trade payables</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
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  <tr id="xdx_40C_eus-gaap--IncreaseDecreaseInOtherAccountsPayable_i03_maNCPBUze3g_zDABHkRCrJLe" style="vertical-align: bottom; background-color: White">
    <td style="text-align: left; padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif">Increase (decrease)
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    <td style="border-bottom: Black 1.5pt solid; text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="border-bottom: Black 1.5pt solid; text-align: right"><span style="font-family: Times New Roman, Times, Serif">(<ix:nonFraction name="us-gaap:IncreaseDecreaseInOtherAccountsPayable" contextRef="From2022-01-012022-12-31" id="Fact000440" format="ixt:numdotdecimal" decimals="-3" scale="3" sign="-" unitRef="USD">440</ix:nonFraction></span></td><td style="padding-bottom: 1.5pt; text-align: left"><span style="font-family: Times New Roman, Times, Serif">)</span></td><td style="padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="border-bottom: Black 1.5pt solid; text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="border-bottom: Black 1.5pt solid; text-align: right"><span style="font-family: Times New Roman, Times, Serif"><ix:nonFraction name="us-gaap:IncreaseDecreaseInOtherAccountsPayable" contextRef="From2021-01-012021-12-31" id="Fact000441" format="ixt:numdotdecimal" decimals="-3" scale="3" unitRef="USD">38</ix:nonFraction></span></td><td style="padding-bottom: 1.5pt; text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td></tr>
  <tr id="xdx_400_eus-gaap--NetCashProvidedByUsedInOperatingActivities_i02T_mtNCPBUze3g_maCCERCzRBC_zXtAe5XK1sM5" style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="padding-left: 10pt; font-weight: bold; text-align: left; padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif">Net
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    <td style="border-bottom: Black 1.5pt solid; text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="border-bottom: Black 1.5pt solid; text-align: right"><span style="font-family: Times New Roman, Times, Serif">(<ix:nonFraction name="us-gaap:NetCashProvidedByUsedInOperatingActivities" contextRef="From2023-01-01to2023-12-31" id="Fact000443" format="ixt:numdotdecimal" decimals="-3" scale="3" sign="-" unitRef="USD">6,137</ix:nonFraction></span></td><td style="padding-bottom: 1.5pt; text-align: left"><span style="font-family: Times New Roman, Times, Serif">)</span></td><td style="padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="border-bottom: Black 1.5pt solid; text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="border-bottom: Black 1.5pt solid; text-align: right"><span style="font-family: Times New Roman, Times, Serif">(<ix:nonFraction name="us-gaap:NetCashProvidedByUsedInOperatingActivities" contextRef="From2022-01-012022-12-31" id="Fact000444" format="ixt:numdotdecimal" decimals="-3" scale="3" sign="-" unitRef="USD">18,501</ix:nonFraction></span></td><td style="padding-bottom: 1.5pt; text-align: left"><span style="font-family: Times New Roman, Times, Serif">)</span></td><td style="padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="border-bottom: Black 1.5pt solid; text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="border-bottom: Black 1.5pt solid; text-align: right"><span style="font-family: Times New Roman, Times, Serif">(<ix:nonFraction name="us-gaap:NetCashProvidedByUsedInOperatingActivities" contextRef="From2021-01-012021-12-31" id="Fact000445" format="ixt:numdotdecimal" decimals="-3" scale="3" sign="-" unitRef="USD">32,892</ix:nonFraction></span></td><td style="padding-bottom: 1.5pt; text-align: left"><span style="font-family: Times New Roman, Times, Serif">)</span></td></tr>
  <tr style="vertical-align: bottom; background-color: White">
    <td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td></tr>
  <tr id="xdx_409_eus-gaap--NetCashProvidedByUsedInInvestingActivitiesAbstract_iB_zsu7j0Qo7Ut9" style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="font-weight: bold; text-align: left"><span style="font-family: Times New Roman, Times, Serif">Cash flow from investing
    activities</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td></tr>
  <tr id="xdx_402_eus-gaap--PaymentsToAcquirePropertyPlantAndEquipment_i01N_di_msNCPBUzIK2_zvMHXHP8HfH1" style="vertical-align: bottom; background-color: White">
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">Purchase of property and equipment</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif"><span style="-sec-ix-hidden: xdx2ixbrl0451">-</span></span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif">(<ix:nonFraction name="us-gaap:PaymentsToAcquirePropertyPlantAndEquipment" contextRef="From2022-01-012022-12-31" id="Fact000452" format="ixt:numdotdecimal" decimals="-3" scale="3" unitRef="USD">4</ix:nonFraction></span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">)</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif">(<ix:nonFraction name="us-gaap:PaymentsToAcquirePropertyPlantAndEquipment" contextRef="From2021-01-012021-12-31" id="Fact000453" format="ixt:numdotdecimal" decimals="-3" scale="3" unitRef="USD">11</ix:nonFraction></span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">)</span></td></tr>
  <tr id="xdx_406_ecustom--IncreaseDecreaseInRestrictedDeposits_i01N_di_msNCPBUzIK2_zoZkhEIFcdh" style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">Increase in restricted deposit</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif"><span style="-sec-ix-hidden: xdx2ixbrl0455">-</span></span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif"><span style="-sec-ix-hidden: xdx2ixbrl0456">-</span></span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif">(<ix:nonFraction name="GLMD:IncreaseDecreaseInRestrictedDeposits" contextRef="From2021-01-012021-12-31" id="Fact000457" format="ixt:numdotdecimal" decimals="-3" scale="3" unitRef="USD">1</ix:nonFraction></span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">)</span></td></tr>
  <tr id="xdx_40D_ecustom--PaymentsForInvestmentInAvailableForSaleSecurities_i01N_di_msNCPBUzIK2_zj44AhQehDOk" style="vertical-align: bottom; background-color: White">
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">Investment in available for sale securities,</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif">(<ix:nonFraction name="GLMD:PaymentsForInvestmentInAvailableForSaleSecurities" contextRef="From2023-01-01to2023-12-31" id="Fact000459" format="ixt:numdotdecimal" decimals="-3" scale="3" unitRef="USD">4,133</ix:nonFraction></span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">)</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif">(<ix:nonFraction name="GLMD:PaymentsForInvestmentInAvailableForSaleSecurities" contextRef="From2022-01-012022-12-31" id="Fact000460" format="ixt:numdotdecimal" decimals="-3" scale="3" unitRef="USD">2,373</ix:nonFraction></span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">)</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif">(<ix:nonFraction name="GLMD:PaymentsForInvestmentInAvailableForSaleSecurities" contextRef="From2021-01-012021-12-31" id="Fact000461" format="ixt:numdotdecimal" decimals="-3" scale="3" unitRef="USD">13,569</ix:nonFraction></span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">)</span></td></tr>
  <tr id="xdx_40F_ecustom--PaymentsForProceedsFromInvestmentInConvertibleNote_i01N_di_msNCPBUzIK2_z13vTcBzgqag" style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">Investment in Convertible note <span id="xdx_F4A_zbth8wO5pIv4">(**)</span></span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif"><span style="-sec-ix-hidden: xdx2ixbrl0463">-</span></span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif">(<ix:nonFraction name="GLMD:PaymentsForProceedsFromInvestmentInConvertibleNote" contextRef="From2022-01-012022-12-31" id="Fact000464" format="ixt:numdotdecimal" decimals="-3" scale="3" unitRef="USD">1,500</ix:nonFraction></span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">)</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif"><span style="-sec-ix-hidden: xdx2ixbrl0465">-</span></span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td></tr>
  <tr id="xdx_40D_ecustom--PaymentsForProceedsFromInvestmentInAssociate_i01N_di_msNCPBUzIK2_zeYmMl1zuGvc" style="vertical-align: bottom; background-color: White">
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">Investment in Associate <span id="xdx_F4B_zVMO7RBYlCf4">(**)</span></span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
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  <tr id="xdx_408_eus-gaap--PaymentsForProceedsFromOtherDeposits_i01N_di_msNCPBUzIK2_zH4Zpz7tHhh6" style="vertical-align: bottom; background-color: White">
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  <tr id="xdx_40E_eus-gaap--NetCashProvidedByUsedInInvestingActivities_i01T_mtNCPBUzIK2_maCCERCzRBC_zDiFArYRxhvl" style="vertical-align: bottom; background-color: rgb(204,238,255)">
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  <tr id="xdx_40A_eus-gaap--NetCashProvidedByUsedInFinancingActivitiesAbstract_iB_zNd0VQ6Mwif2" style="vertical-align: bottom; background-color: rgb(204,238,255)">
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    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
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  <tr id="xdx_40E_eus-gaap--ProceedsFromIssuanceInitialPublicOffering_maNCPBUzrcP_z0KciVA9d0x" style="vertical-align: bottom; background-color: White">
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  <tr id="xdx_40F_ecustom--IssuanceOfOrdinarySharesPrefundedWarrantsAndWarrantsNetOfIssuanceCosts_iN_di_msNCPBUzrcP_zTSXSsSB5JGa" style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Issuance of ordinary shares,
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    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td></tr>
  <tr id="xdx_40B_eus-gaap--ProceedsFromIssuanceOfCommonStock_maNCPBUzrcP_z0JzsUvg1Sc" style="vertical-align: bottom; background-color: White">
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">Issuance of ordinary shares net of issuance
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    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif"><span style="-sec-ix-hidden: xdx2ixbrl0495">-</span></span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
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  <tr id="xdx_40F_eus-gaap--ProceedsFromStockOptionsExercised_maNCPBUzrcP_zU1pSPEb6f98" style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="text-align: left; padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif">Proceeds from exercise
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    <td style="border-bottom: Black 1.5pt solid; text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="border-bottom: Black 1.5pt solid; text-align: right"><span style="font-family: Times New Roman, Times, Serif"><span style="-sec-ix-hidden: xdx2ixbrl0500">-</span></span></td><td style="padding-bottom: 1.5pt; text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
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  <tr id="xdx_40C_eus-gaap--NetCashProvidedByUsedInFinancingActivities_iT_mtNCPBUzrcP_maCCERCzRBC_z8fu3reX8zEe" style="vertical-align: bottom; background-color: White">
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  <tr id="xdx_401_eus-gaap--CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalentsPeriodIncreaseDecreaseIncludingExchangeRateEffect_mtCCERCzRBC_z1y49sgrPRHf" style="vertical-align: bottom; background-color: rgb(204,238,255)">
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    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
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  <tr id="xdx_40C_eus-gaap--RightOfUseAssetObtainedInExchangeForOperatingLeaseLiability_i02_zBYoLC9HNoQj" style="vertical-align: bottom; background-color: rgb(204,238,255)">
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    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">$</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif"><span style="-sec-ix-hidden: xdx2ixbrl0532">-</span></span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
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  <tr id="xdx_40C_ecustom--ConversionOfConvertibleNoteIntoInvestmentInAssociate_i02_z5NAPEloxI61" style="vertical-align: bottom; background-color: White">
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    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif"><span style="-sec-ix-hidden: xdx2ixbrl0537">-</span></span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td></tr>
  </table>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt">&#160;</p>

<table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-bottom: 6pt; width: 100%"><tr style="vertical-align: top; text-align: justify">
<td style="width: 15pt; text-align: right"><span id="xdx_F01_zP9F60fYxvij" style="font-family: Times New Roman, Times, Serif; font-size: 10pt">(*)</span></td><td style="width: 5pt"/><td style="text-align: justify"><span id="xdx_F1F_zEcOZ7QTbYlf" style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><ix:footnote id="Footnote000538" xml:lang="en-US">Represents amount
less than $1</ix:footnote></span></td>
</tr></table>


<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-bottom: 6pt; width: 100%"><tr style="vertical-align: top; text-align: justify">
<td style="width: 15pt; text-align: right"><span id="xdx_F02_zC5axU8YdLCj" style="font-family: Times New Roman, Times, Serif; font-size: 10pt">(**)</span></td><td style="width: 5pt"/><td style="text-align: justify"><span id="xdx_F15_z4sLxonJVdBf" style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><ix:footnote id="Footnote000539" xml:lang="en-US">See also Note 7</ix:footnote></span></td>
</tr></table>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-bottom: 6pt; width: 100%"><tr style="vertical-align: top; text-align: justify">
<td style="width: 15pt; text-align: right"><span id="xdx_F01_z3xvD5wabzC1" style="font-family: Times New Roman, Times, Serif; font-size: 10pt">(***)</span></td><td style="width: 5pt"/><td style="text-align: justify"><span id="xdx_F1C_z9aALsHQxxa3" style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><ix:footnote id="Footnote000540" xml:lang="en-US">See also Note 11.</ix:footnote></span></td>
</tr></table>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
accompanying notes are an integral part of the consolidated financial statements.</span></p>
<!-- Field: Split-Segment; Name: 001 -->
<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>


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    <div style="break-before: page; margin-top: 6pt"><p style="margin: 0pt">&#160;</p></div>
    <!-- Field: /Page -->

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><span id="f_007"></span>GALMED
PHARMACEUTICALS LTD.</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Notes
to Consolidated Financial Statements</b></span></p>

<!-- Field: Rule-Page --><div style="margin-left: auto; margin-right: auto; width: 100%"><div style="border-top: Black 1.5pt solid; font-size: 1pt"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></div></div><!-- Field: /Rule-Page -->

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<ix:nonNumeric contextRef="From2023-01-01to2023-12-31" escape="true" id="Fact000542" name="us-gaap:OrganizationConsolidationAndPresentationOfFinancialStatementsDisclosureTextBlock"><p id="xdx_80A_eus-gaap--OrganizationConsolidationAndPresentationOfFinancialStatementsDisclosureTextBlock_zvNUCKfVJZJ6" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Note
1 &#8211; <span id="xdx_823_z2tVRVjB7iZ">General</span></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.25in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Galmed
Pharmaceuticals Ltd. (the &#8220;Company&#8221;) was incorporated in Israel on <span id="xdx_90A_edei--EntityIncorporationDateOfIncorporation_c20230101__20231231_zwmbNnpA41We" title="Date of incorporation"><ix:nonNumeric contextRef="From2023-01-01to2023-12-31" format="ixt:datemonthdayyearen" id="Fact000544" name="dei:EntityIncorporationDateOfIncorporation">July 31, 2013</ix:nonNumeric></span> and commenced operations on <span id="xdx_908_eus-gaap--OperationsCommencedDate1_c20230101__20231231_zY8SrbNENws8" title="Date of commenced operations"><ix:nonNumeric contextRef="From2023-01-01to2023-12-31" format="ixt:datemonthdayyearen" id="Fact000546" name="us-gaap:OperationsCommencedDate1">February 2,
2014</ix:nonNumeric></span>.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.25in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
Company holds three wholly-owned subsidiaries, Galmed International Ltd., which is incorporated in Malta, and Galmed Research and Development
Ltd. (&#8220;GRD&#8221;) and Galtopa Therapeutics Ltd., both of which are incorporated in Israel. In July 2023, GRD established a new
wholly-owned subsidiary incorporated under the laws of England and Wales called Galmed Therapeutics UK Limited.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.25in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
Company is a biopharmaceutical company focused on the development of Aramchol. The Company has focused almost exclusively on developing
Aramchol for the treatment of liver disease and is currently developing Aramchol for Primary Sclerosing Cholangitis, or PSC, and exploring
the feasibility of developing Aramchol for other fibro-inflammatory indications outside of liver disease. The Company is also collaborating
with the Hebrew University in the development of Amilo-5MER. The Company has an operating history limited to pre-clinical and clinical
drug development.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.25in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.25in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
Company funded its research and development programs and operations to date primarily through proceeds from private placements and public
offerings. The Company currently has no products approved for marketing and has not generated any revenue from product sales to date.
As of December 31, 2023, the Company had cash and cash equivalents of $<span id="xdx_90A_eus-gaap--CashAndCashEquivalentsAtCarryingValue_iI_pn5n6_c20231231_zQoST9epMkNf" title="Cash and cash equivalents"><ix:nonFraction name="us-gaap:CashAndCashEquivalentsAtCarryingValue" contextRef="AsOf2023-12-31" id="Fact000548" format="ixt:numdotdecimal" decimals="-5" scale="6" unitRef="USD">2.9</ix:nonFraction></span> million, restricted cash of $<span id="xdx_900_eus-gaap--RestrictedCashCurrent_iI_pn5n6_c20231231_z5ziAPnP07Ra" title="Restricted cash"><ix:nonFraction name="us-gaap:RestrictedCashCurrent" contextRef="AsOf2023-12-31" id="Fact000550" format="ixt:numdotdecimal" decimals="-5" scale="6" unitRef="USD">0.1</ix:nonFraction></span> million, short-term deposits
of $<span id="xdx_90F_eus-gaap--DepositsAssetsCurrent_iI_pn5n6_c20231231_zgqYlRcNvnvk" title="Short-term deposits"><ix:nonFraction name="us-gaap:DepositsAssetsCurrent" contextRef="AsOf2023-12-31" id="Fact000552" format="ixt:numdotdecimal" decimals="-5" scale="6" unitRef="USD">2.3</ix:nonFraction></span> million and marketable debt securities of $<span id="xdx_904_eus-gaap--ShortTermInvestments_iI_pn5n6_c20231231_z9JJhc6tw7j" title="Marketable securities debt"><ix:nonFraction name="us-gaap:ShortTermInvestments" contextRef="AsOf2023-12-31" id="Fact000554" format="ixt:numdotdecimal" decimals="-5" scale="6" unitRef="USD">7.5</ix:nonFraction></span> million.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.25in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
Company has incurred operating losses in each year since inception. The Company&#8217;s loss attributable to holders of its ordinary
shares for the years ended December 31, 2021, 2022, and 2023 was approximately $<span id="xdx_905_eus-gaap--ProfitLoss_pn5n6_c20210101__20211231_zOA2jxhwl5Dh" title="Profit loss"><ix:nonFraction name="us-gaap:ProfitLoss" contextRef="From2021-01-012021-12-31" id="Fact000556" format="ixt:numdotdecimal" decimals="-5" scale="6" unitRef="USD">32.4</ix:nonFraction></span> million, $<span id="xdx_90F_eus-gaap--ProfitLoss_pn5n6_c20220101__20221231_zmg00Xsn7hpj" title="Profit loss"><ix:nonFraction name="us-gaap:ProfitLoss" contextRef="From2022-01-012022-12-31" id="Fact000558" format="ixt:numdotdecimal" decimals="-5" scale="6" unitRef="USD">17.9</ix:nonFraction></span> million, and $<span id="xdx_909_eus-gaap--ProfitLoss_pn5n6_c20230101__20231231_zlmOF2UC069f" title="Profit loss"><ix:nonFraction name="us-gaap:ProfitLoss" contextRef="From2023-01-01to2023-12-31" id="Fact000560" format="ixt:numdotdecimal" decimals="-5" scale="6" unitRef="USD">6.9</ix:nonFraction></span> million, respectively.
As of December 31, 2023, the Company had an accumulated deficit of $<span id="xdx_90D_eus-gaap--RetainedEarningsAccumulatedDeficit_iNI_pn5n6_di_c20231231_zHJw8lUXTSva" title="Retained earnings accumulated deficit"><ix:nonFraction name="us-gaap:RetainedEarningsAccumulatedDeficit" contextRef="AsOf2023-12-31" id="Fact000562" format="ixt:numdotdecimal" decimals="-5" scale="6" sign="-" unitRef="USD">193.0</ix:nonFraction></span> million. Substantially all of its operating losses resulted
from costs incurred in connection with the Company&#8217;s development program and from general and administrative costs associated with
its operations.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.25in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
Company will need to raise substantial, additional capital to fund its operations and to develop Aramchol and Amilo-5MER for, and beyond
its current development stage and any future commercialization, as well as any additional indications.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.25in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Based
on the Company&#8217;s current operating plan, the Company&#8217;s management currently estimates that its cash position will support
its current operations as currently conducted for more than 12 months from the date of issuance of these financial statements.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

</ix:nonNumeric><ix:nonNumeric contextRef="From2023-01-01to2023-12-31" escape="true" id="Fact000564" name="us-gaap:SignificantAccountingPoliciesTextBlock"><p id="xdx_805_eus-gaap--SignificantAccountingPoliciesTextBlock_z1loxzdLW6Jc" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Note
2 &#8211; <span id="xdx_821_zgM91LBCTM3g">Significant Accounting Policies</span></b></span></p>

<ix:nonNumeric contextRef="From2023-01-01to2023-12-31" escape="true" id="Fact000566" name="us-gaap:BasisOfAccountingPolicyPolicyTextBlock"><p id="xdx_848_eus-gaap--BasisOfAccountingPolicyPolicyTextBlock_zUCannj2Erag" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>A.</b></span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><span id="xdx_86F_zHsfrhUZWaa">Basis
    of presentation</span></b></span></td></tr>
  </table>
<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>&#160;</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
consolidated financial statements have been prepared in accordance with United States Generally Accepted Accounting Principles (&#8220;U.S.
GAAP&#8221;).</span></p>

</ix:nonNumeric><ix:nonNumeric contextRef="From2023-01-01to2023-12-31" escape="true" id="Fact000568" name="us-gaap:UseOfEstimates"><p id="xdx_841_eus-gaap--UseOfEstimates_zzqlevzFSGd" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>&#160;</b></span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>B.</b></span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><span id="xdx_86D_zLy9zFeMBtW3">Use
    of estimates</span></b></span></td></tr>
  </table>
<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
preparation of consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that
affect the reported amounts of assets and liabilities as of the date of the financial statements, and the reported amounts of expenses
during the reporting period. Actual results could differ from those estimates.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>


<ix:exclude><!-- Field: Page; Sequence: 149; Value: 1 -->
    <div style="border-bottom: Black 1.5pt solid; margin-bottom: 6pt"><table cellpadding="0" cellspacing="0" style="border-collapse: collapse; width: 100%; font-size: 10pt"><tr style="vertical-align: top; text-align: left"><td style="text-align: center; width: 100%">F-<!-- Field: Sequence; Type: Arabic; Name: PageNo -->8<!-- Field: /Sequence --></td></tr></table></div>
    <div style="break-before: page; margin-top: 6pt"><p style="margin: 0pt">&#160;</p></div>
    <!-- Field: /Page --></ix:exclude>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>GALMED
PHARMACEUTICALS LTD.</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Notes
to Consolidated Financial Statements</b></span></p>

<!-- Field: Rule-Page --><div style="margin-left: auto; margin-right: auto; width: 100%"><div style="border-top: Black 1.5pt solid; font-size: 1pt"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></div></div><!-- Field: /Rule-Page -->

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Note
2 &#8211; Significant Accounting Policies (Cont.)</b></span></p>

</ix:nonNumeric><ix:nonNumeric contextRef="From2023-01-01to2023-12-31" escape="true" id="Fact000570" name="us-gaap:ForeignCurrencyTransactionsAndTranslationsPolicyTextBlock"><p id="xdx_841_eus-gaap--ForeignCurrencyTransactionsAndTranslationsPolicyTextBlock_z5YVOnsFnxJ4" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>C.</b></span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><span id="xdx_86F_zAler2UCapCa">Financial
    statement in U.S. dollars</span></b></span></td></tr>
  </table>
<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>&#160;</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
functional currency of the Company and its subsidiaries is the U.S dollar (the &#8220;dollar&#8221;), because the dollar is the currency
of the primary economic environment in which the Company and its subsidiaries operate, and expect to continue operating in the foreseeable
future. Transactions and balances denominated in dollars are presented in their original amounts. Non-dollar denominated transactions
and balances have been re-measured to dollars in accordance with the provisions of ASC 830, &#8220;Foreign Currency Matters.&#8221; All
transaction gains and losses from re-measurement of monetary balance sheet items denominated in non-dollar currencies are reflected in
the statement of operations as financial income or expenses, as appropriate.</span></p>

</ix:nonNumeric><ix:nonNumeric contextRef="From2023-01-01to2023-12-31" escape="true" id="Fact000572" name="us-gaap:ConsolidationPolicyTextBlock"><p id="xdx_843_eus-gaap--ConsolidationPolicyTextBlock_zcSBJQqpBNIi" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>&#160;</b></span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>D.</b></span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><span id="xdx_860_zGL2OOh20xLa">Principles
    of consolidation</span></b></span></td></tr>
  </table>
<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>&#160;</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries: Galmed Research and Development
Ltd., Galmed International Ltd., Galtopa Therapeutics Ltd and Galmed Therapeutics UK Limited. All intercompany balances and transactions
have been eliminated upon consolidation.</span></p>

</ix:nonNumeric><ix:nonNumeric contextRef="From2023-01-01to2023-12-31" escape="true" id="Fact000574" name="us-gaap:CashAndCashEquivalentsPolicyTextBlock"><p id="xdx_84C_eus-gaap--CashAndCashEquivalentsPolicyTextBlock_zxOGj0RBswvk" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>&#160;</b></span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>E.</b></span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><span id="xdx_860_zHoCgk4kiKte">Cash
    and cash equivalents</span></b></span></td></tr>
  </table>
<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>&#160;</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Cash
equivalents are short-term, highly liquid investments that are readily convertible into cash with maturities of three months or less
as of the date acquired.</span></p>

</ix:nonNumeric><ix:nonNumeric contextRef="From2023-01-01to2023-12-31" escape="true" id="Fact000576" name="us-gaap:CashAndCashEquivalentsRestrictedCashAndCashEquivalentsPolicy"><p id="xdx_84A_eus-gaap--CashAndCashEquivalentsRestrictedCashAndCashEquivalentsPolicy_z9ce13sMa1ra" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>&#160;</b></span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>F.</b></span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><span id="xdx_869_zFkoru0oFg4i">Restricted
    Cash</span></b></span></td></tr>
  </table>
<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>&#160;</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Cash
that is held for a specific purpose and is not available for immediate or general business use due to external restrictions is classified
in the Company&#8217;s consolidated balance sheets as restricted cash.</span></p>

</ix:nonNumeric><ix:nonNumeric contextRef="From2023-01-01to2023-12-31" escape="true" id="Fact000578" name="GLMD:ShortTermDepositsPolicyTextBlock"><p id="xdx_841_ecustom--ShortTermDepositsPolicyTextBlock_zUoEybqMVPM2" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>G.</b></span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><span id="xdx_864_zl8zHazHnRPc">Short-term
    deposits</span></b></span></td></tr>
  </table>
<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>&#160;</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Bank
deposits with maturities of more than three months but less than one year are included in short-term bank deposits. Such short-term deposits
are stated at cost which approximates fair market value. Interest rates on the Company&#8217;s short-term deposits were between <span id="xdx_908_eus-gaap--InvestmentInterestRate_iI_dp_c20231231__srt--RangeAxis__srt--MinimumMember_zCBESGF9Ufzf" title="Short-Term deposits interest rate"><ix:nonFraction name="us-gaap:InvestmentInterestRate" contextRef="AsOf2023-12-31_srt_MinimumMember" id="Fact000580" format="ixt:numdotdecimal" decimals="INF" scale="-2" unitRef="Pure">5.04</ix:nonFraction>%</span>-<span id="xdx_900_eus-gaap--InvestmentInterestRate_iI_dp_c20231231__srt--RangeAxis__srt--MaximumMember_zAAuAXnqQcGb" title="Short-Term deposits interest rate"><ix:nonFraction name="us-gaap:InvestmentInterestRate" contextRef="AsOf2023-12-31_srt_MaximumMember" id="Fact000582" format="ixt:numdotdecimal" decimals="INF" scale="-2" unitRef="Pure">6.64</ix:nonFraction>%</span>
during the year ended December 31, 2023.</span></p>

</ix:nonNumeric><ix:nonNumeric contextRef="From2023-01-01to2023-12-31" escape="true" id="Fact000584" name="us-gaap:MarketableSecuritiesPolicy"><p id="xdx_84D_eus-gaap--MarketableSecuritiesPolicy_zxQCxufwfGMk" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>&#160;</b></span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>H.</b></span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><span id="xdx_86D_zq2GLxws3mQ8">Marketable
    debt securities</span></b></span></td></tr>
  </table>
<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>&#160;</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
Company invests most of its excess cash primarily in debt securities.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>&#160;</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
Company accounts for its investments in investment grade debt securities in accordance with ASC 320 &#8220;Investments - Debt and Equity
Securities&#8221;. Management determines the appropriate classification of its investments in debt securities at the time of purchase
and re-evaluates such determinations at each balance sheet date.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>&#160;</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Marketable
debt securities are considered to be available for sale and are carried at fair value on the consolidated balance sheet. Unrealized gains
and losses net of tax, if any, are reported in a separate component of stockholders&#8217; equity in accumulated other comprehensive
income (&#8220;OCI&#8221;). Gains and losses are recognized when realized, on a specific identification basis, in the Company&#8217;s
consolidated statements of operations.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>&#160;</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Following
the adoption of ASC 326, current expected credit losses on the Company&#8217;s marketable grade debt securities are recorded, if expected,
through an allowance for current expected credit losses. The amount of allowance for current expected credit losses is limited to the
amount that the fair value is less than the amortized cost basis. Any remaining unrealized losses are included in accumulated other comprehensive
loss in stockholders&#8217; equity.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>&#160;</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">If
the Company intends to sell the debt security (that is, it has decided to sell the security), or more likely than not will be required
to sell the security before recovery of its amortized cost basis, any allowance for current expected credit losses is written off and
the amortized cost basis shall be written down to the debt security&#8217;s fair value at the reporting date with any incremental impairment
reported in earnings. Based on management&#8217;s assessment, the Company does not intend to sell its securities for less than amortized
cost; therefore, an allowance for current expected credit losses has not been recorded as of December 31, 2023 and 2022.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>


<ix:exclude><!-- Field: Page; Sequence: 150; Value: 1 -->
    <div style="border-bottom: Black 1.5pt solid; margin-bottom: 6pt"><table cellpadding="0" cellspacing="0" style="border-collapse: collapse; width: 100%; font-size: 10pt"><tr style="vertical-align: top; text-align: left"><td style="text-align: center; width: 100%">F-<!-- Field: Sequence; Type: Arabic; Name: PageNo -->9<!-- Field: /Sequence --></td></tr></table></div>
    <div style="break-before: page; margin-top: 6pt"><p style="margin: 0pt">&#160;</p></div>
    <!-- Field: /Page --></ix:exclude>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>GALMED
PHARMACEUTICALS LTD.</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Notes
to Consolidated Financial Statements</b></span></p>

<!-- Field: Rule-Page --><div style="margin-left: auto; margin-right: auto; width: 100%"><div style="border-top: Black 1.5pt solid; font-size: 1pt"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></div></div><!-- Field: /Rule-Page -->

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Note
2 &#8211; Significant Accounting Policies (Cont.)</b></span></p>

</ix:nonNumeric><ix:nonNumeric contextRef="From2023-01-01to2023-12-31" escape="true" id="Fact000586" name="us-gaap:ConcentrationRiskCreditRisk"><p id="xdx_848_eus-gaap--ConcentrationRiskCreditRisk_zOK8xoVNiqCj" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>H.</b></span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span id="xdx_869_zavLyP0HdQY5" style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Concentrations
    of credit risk (Cont.)</b></span></td></tr>
  </table>
<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>&#160;</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Financial
instruments which potentially subject the Company to credit risk consist primarily of cash, cash equivalents, marketable debt securities
and short-term deposits. The Company hold these investments in highly-rated financial institutions, and, by policy, limit the amounts
of credit exposure to any one financial institution. These amounts at times may exceed federally insured limits. The Company has not
experienced any credit losses in such accounts and does not believe we are exposed to any significant credit risk on these funds. The
Company has no off-balance sheet concentrations of credit risk, such as foreign currency exchange contracts, option contracts, or other
hedging arrangements.</span></p>

</ix:nonNumeric><ix:nonNumeric contextRef="From2023-01-01to2023-12-31" escape="true" id="Fact000588" name="us-gaap:PropertyPlantAndEquipmentPolicyTextBlock"><p id="xdx_84A_eus-gaap--PropertyPlantAndEquipmentPolicyTextBlock_zNAy99S16Axe" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>&#160;</b></span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>I.</b></span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><span id="xdx_86A_zspSqBwaLKCg">Property
    and equipment</span></b></span></td></tr>
  </table>
<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>&#160;</b></span></p>

<ix:nonNumeric contextRef="From2023-01-01to2023-12-31" escape="true" id="Fact000590" name="GLMD:ScheduleOfDepreciationRatesForPropertyPlantAndEquipmentTableTextBlock"><p id="xdx_899_ecustom--ScheduleOfDepreciationRatesForPropertyPlantAndEquipmentTableTextBlock_zel2fJBf88Ia" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Property
and equipment are stated at cost, less accumulated depreciation. Depreciation is calculated using the straight-line method over the estimated
useful lives of the assets. The annual depreciation rates are as follows:</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="display: none; font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;<span id="xdx_8BD_zemGWpAcW8K9">Schedule of Depreciation Rates for Property, Plant and Equipment</span></span></p>

<table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 93%; margin-left: 0.5in">
  <tr style="vertical-align: bottom; background-color: White">
    <td style="padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="padding-bottom: 1.5pt; font-weight: bold"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="border-bottom: Black 1.5pt solid; padding-bottom: 1.5pt; text-align: center; font-weight: bold"><span style="font-family: Times New Roman, Times, Serif">%</span></td></tr>
  <tr style="vertical-align: bottom; background-color: White">
    <td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: center"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td></tr>
  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="width: 49%; text-align: left"><span style="font-family: Times New Roman, Times, Serif">Office furniture and equipment</span></td><td style="width: 2%"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: center; width: 49%"><span style="font-family: Times New Roman, Times, Serif"><span id="xdx_90D_eus-gaap--PropertyPlantAndEquipmentSalvageValuePercentage_iI_pid_dp_uPure_c20231231__srt--RangeAxis__srt--MinimumMember__us-gaap--PropertyPlantAndEquipmentByTypeAxis__custom--OfficeFurnitureAndEquipmentMember_zVid8B3YBnAj" title="Property and equipment, depreciation, percentage"><ix:nonFraction name="us-gaap:PropertyPlantAndEquipmentSalvageValuePercentage" contextRef="AsOf2023-12-31_srt_MinimumMember_custom_OfficeFurnitureAndEquipmentMember" id="Fact000592" format="ixt:numdotdecimal" decimals="INF" scale="-2" unitRef="Pure">7</ix:nonFraction></span>&#8211;<span id="xdx_906_eus-gaap--PropertyPlantAndEquipmentSalvageValuePercentage_iI_pid_dp_uPure_c20231231__srt--RangeAxis__srt--MaximumMember__us-gaap--PropertyPlantAndEquipmentByTypeAxis__custom--OfficeFurnitureAndEquipmentMember_zmd2uQNlZdl5" title="Property and equipment, depreciation, percentage"><ix:nonFraction name="us-gaap:PropertyPlantAndEquipmentSalvageValuePercentage" contextRef="AsOf2023-12-31_srt_MaximumMember_custom_OfficeFurnitureAndEquipmentMember" id="Fact000594" format="ixt:numdotdecimal" decimals="INF" scale="-2" unitRef="Pure">16</ix:nonFraction></span></span></td></tr>
  <tr style="vertical-align: bottom; background-color: White">
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">Computer software and electronic equipment</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: center"><span style="font-family: Times New Roman, Times, Serif"><span id="xdx_90A_eus-gaap--PropertyPlantAndEquipmentSalvageValuePercentage_iI_pid_dp_uPure_c20231231__srt--RangeAxis__srt--MinimumMember__us-gaap--PropertyPlantAndEquipmentByTypeAxis__custom--ComputerSoftwareElectronicEquipmentMember_z4CHfcN8J0N7" title="Property and equipment, depreciation, percentage"><ix:nonFraction name="us-gaap:PropertyPlantAndEquipmentSalvageValuePercentage" contextRef="AsOf2023-12-31_srt_MinimumMember_custom_ComputerSoftwareElectronicEquipmentMember" id="Fact000596" format="ixt:numdotdecimal" decimals="INF" scale="-2" unitRef="Pure">15</ix:nonFraction></span>&#8211;<span id="xdx_908_eus-gaap--PropertyPlantAndEquipmentSalvageValuePercentage_iI_pid_dp_uPure_c20231231__srt--RangeAxis__srt--MaximumMember__us-gaap--PropertyPlantAndEquipmentByTypeAxis__custom--ComputerSoftwareElectronicEquipmentMember_z8jgwDlismHg" title="Property and equipment, depreciation, percentage"><ix:nonFraction name="us-gaap:PropertyPlantAndEquipmentSalvageValuePercentage" contextRef="AsOf2023-12-31_srt_MaximumMember_custom_ComputerSoftwareElectronicEquipmentMember" id="Fact000598" format="ixt:numdotdecimal" decimals="INF" scale="-2" unitRef="Pure">33</ix:nonFraction></span></span></td></tr>
  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">Leasehold improvements</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: center"><span style="font-family: Times New Roman, Times, Serif"><span id="xdx_904_eus-gaap--PropertyPlantAndEquipmentDepreciationMethodExtensibleEnumeration_iI_dxL_c20231231__us-gaap--PropertyPlantAndEquipmentByTypeAxis__us-gaap--LeaseholdImprovementsMember_z6Jg8zem00n9" title="::XDX::http%3A%2F%2Ffasb.org%2Fus-gaap%2F2023%23UsefulLifeShorterOfTermOfLeaseOrAssetUtilityMember"><span style="-sec-ix-hidden: xdx2ixbrl0599">Shorter of the remaining lease term or useful
    life</span></span></span></td></tr>
  </table>

</ix:nonNumeric><p id="xdx_8A9_zfWPFxxzmCPd" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>&#160;</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
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</ix:nonNumeric><ix:nonNumeric contextRef="From2023-01-01to2023-12-31" escape="true" id="Fact000603" name="us-gaap:CompensationRelatedCostsPolicyTextBlock"><p id="xdx_842_eus-gaap--CompensationRelatedCostsPolicyTextBlock_zG3dl4bJDMn2" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>&#160;</b></span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>J.</b></span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><span id="xdx_86C_zoc1tPhkKcxi">Severance
    pay</span></b></span></td></tr>
  </table>
<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>&#160;</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
Company employees are included under section 14 of the Severance Compensation Act, 1963 (&#8220;Section 14&#8221;) in Israel for a portion
of their salaries. According to Section 14, these employees are entitled to monthly deposits at a rate of <span id="xdx_90D_ecustom--MonthlyDepositsOfEmployeesPercentageOnMonthlySalary_pid_dp_uPure_c20230101__20231231_zHlXtpusW0d7" title="Monthly deposits percentage"><ix:nonFraction name="GLMD:MonthlyDepositsOfEmployeesPercentageOnMonthlySalary" contextRef="From2023-01-01to2023-12-31" id="Fact000605" format="ixt:numdotdecimal" decimals="INF" scale="-2" unitRef="Pure">8.33</ix:nonFraction>%</span> of their monthly salary,
contributed on their behalf with insurance companies. Under the Severance Compensation Act, 1963, payments in accordance with Section
14 release the Company from any future severance payments to those employees. Therefore, the Company does not recognize a liability for
severance pay due to these employees and the deposits under Section 14 are not recorded as an asset in the Company&#8217;s consolidated
balance sheets. The Company&#8217;s contributions to the defined contribution plans are charged to the consolidated statements of operations
as and when the services are received from the Company&#8217;s employees.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>


<ix:exclude><!-- Field: Page; Sequence: 151; Value: 1 -->
    <div style="border-bottom: Black 1.5pt solid; margin-bottom: 6pt"><table cellpadding="0" cellspacing="0" style="border-collapse: collapse; width: 100%; font-size: 10pt"><tr style="vertical-align: top; text-align: left"><td style="text-align: center; width: 100%">F-<!-- Field: Sequence; Type: Arabic; Name: PageNo -->10<!-- Field: /Sequence --></td></tr></table></div>
    <div style="break-before: page; margin-top: 6pt"><p style="margin: 0pt">&#160;</p></div>
    <!-- Field: /Page --></ix:exclude>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>GALMED
PHARMACEUTICALS LTD.</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Notes
to Consolidated Financial Statements</b></span></p>

<!-- Field: Rule-Page --><div style="margin-left: auto; margin-right: auto; width: 100%"><div style="border-top: Black 1.5pt solid; font-size: 1pt"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></div></div><!-- Field: /Rule-Page -->

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Note
2 &#8211; Significant Accounting Policies (Cont.)</b></span></p>

</ix:nonNumeric><ix:nonNumeric contextRef="From2023-01-01to2023-12-31" escape="true" id="Fact000607" name="us-gaap:FairValueOfFinancialInstrumentsPolicy"><p id="xdx_844_eus-gaap--FairValueOfFinancialInstrumentsPolicy_zxNXU27jTvZf" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>K.</b></span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><span id="xdx_861_zMOZu0ifOyb6">Fair
    value of financial instruments</span></b></span></td></tr>
  </table>
<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>&#160;</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
estimated fair value of financial instruments was determined by the Company using available market information and valuation methodologies.
Considerable judgment is required in estimating fair values. Accordingly, the estimates may not be indicative of the amounts the Company
could realize in a current market exchange.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>&#160;</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
following methods and assumptions were used by the Company in estimating its fair value disclosures for financial instruments:</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>&#160;</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
carrying amounts of cash and cash equivalents, short-term deposits, other accounts receivables, trade payables and other trade payables
approximate their fair value due to the short-term maturity of such instruments.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>&#160;</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Fair
value is an exit price representing the amount that would be received upon selling an asset or that would be paid to transfer a liability
in an orderly transaction between market participants. As such, fair value is a market-based measurement that should be determined based
on assumptions used by market participants in pricing an asset or a liability.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>&#160;</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">A
three-tier fair-value hierarchy was established as a basis for considering such assumptions and for inputs used in the valuation methodologies
in measuring fair value:</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>&#160;</b></span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.75in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Level
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  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Level
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    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
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    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Level
    3 - Unobservable inputs that are supported by little or no market activity</span></td></tr>
  </table>
<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
fair value hierarchy also requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when
measuring fair value.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<ix:nonNumeric contextRef="From2023-01-01to2023-12-31" escape="true" id="Fact000609" name="us-gaap:ScheduleOfFairValueAssetsAndLiabilitiesMeasuredOnRecurringBasisTableTextBlock"><p id="xdx_898_eus-gaap--ScheduleOfFairValueAssetsAndLiabilitiesMeasuredOnRecurringBasisTableTextBlock_zDTgebMOSDrb" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
fair value of the Company&#8217;s assets measured at fair value on a recurring basis by level within the fair value hierarchy are as
follows (in thousands):</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span><span id="xdx_8BE_z87p2a86zpD2" style="display: none">Schedule of Assets Measured at Fair Value on Recurring Basis</span></p>

<table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 93%; margin-left: 0.5in">
  <tr style="display: none; vertical-align: bottom">
    <td style="text-align: center">&#160;</td><td style="text-align: center; font-weight: bold; padding-bottom: 1.5pt">&#160;</td>
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<tr style="vertical-align: bottom">
    <td style="text-align: center"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: center; padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
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    <td colspan="2" style="text-align: center; font-weight: bold"><span style="font-family: Times New Roman, Times, Serif">Fair</span></td><td style="text-align: center; font-weight: bold"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td></tr>
  <tr style="vertical-align: bottom">
    <td style="text-align: center"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: center; font-weight: bold; padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
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    <td colspan="2" style="border-bottom: Black 1.5pt solid; text-align: center; font-weight: bold"><span style="font-family: Times New Roman, Times, Serif">Value</span></td><td style="text-align: center; padding-bottom: 1.5pt; font-weight: bold"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td></tr>
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    <td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td colspan="2"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td colspan="2"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
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  <tr id="xdx_404_eus-gaap--AssetsFairValueDisclosure_iI_pn3n3_hus-gaap--FinancialInstrumentAxis__us-gaap--CorporateDebtSecuritiesMember_zXFz9bvUXTsl" style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="width: 40%; text-align: left"><span style="font-family: Times New Roman, Times, Serif">Corporate bonds</span></td><td style="width: 3%"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="width: 1%; text-align: left"><span style="font-family: Times New Roman, Times, Serif">$</span></td><td style="width: 10%; text-align: right"><span style="font-family: Times New Roman, Times, Serif"><span style="-sec-ix-hidden: xdx2ixbrl0611">-</span></span></td><td style="width: 1%; text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="width: 3%"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
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    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">Treasury bills</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
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    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">Mutual funds</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
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  </table>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 93%; margin-left: 0.5in">
  <tr style="display: none; vertical-align: bottom">
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    <td style="text-align: center"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: center; padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
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    <td style="text-align: center"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: center"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
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    <td colspan="2" style="text-align: center"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: center"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: center; font-weight: bold"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
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    <td style="text-align: center"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: center; font-weight: bold; padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
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    <td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td colspan="2"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td colspan="2"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td colspan="2"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td colspan="2"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td></tr>
  <tr id="xdx_404_eus-gaap--AssetsFairValueDisclosure_iI_pn3n3_hus-gaap--FinancialInstrumentAxis__us-gaap--CorporateDebtSecuritiesMember_zZmfT0DnqdT2" style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="width: 40%; text-align: left"><span style="font-family: Times New Roman, Times, Serif">Corporate bonds</span></td><td style="width: 3%"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="width: 1%; text-align: left"><span style="font-family: Times New Roman, Times, Serif">$</span></td><td style="width: 10%; text-align: right"><span style="font-family: Times New Roman, Times, Serif"><span style="-sec-ix-hidden: xdx2ixbrl0636">-</span></span></td><td style="width: 1%; text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="width: 3%"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
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    <td style="width: 1%; text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="width: 10%; text-align: right"><span style="font-family: Times New Roman, Times, Serif"><span style="-sec-ix-hidden: xdx2ixbrl0638">&#8212;</span></span></td><td style="width: 1%; text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="width: 3%"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
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  <tr id="xdx_40B_eus-gaap--AssetsFairValueDisclosure_iI_pn3n3_hus-gaap--FinancialInstrumentAxis__us-gaap--MutualFundMember_zM8fdslrEqVa" style="vertical-align: bottom; background-color: White">
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    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif"><span style="-sec-ix-hidden: xdx2ixbrl0643">&#8212;</span></span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
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  <tr id="xdx_409_eus-gaap--AssetsFairValueDisclosure_iI_pn3n3_hus-gaap--FinancialInstrumentAxis__us-gaap--ConvertibleDebtSecuritiesMember_zMaIUJpPNMlc" style="vertical-align: bottom; background-color: rgb(204,238,255)">
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    <td style="border-bottom: Black 1.5pt solid; text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="border-bottom: Black 1.5pt solid; text-align: right"><span style="font-family: Times New Roman, Times, Serif"><span style="-sec-ix-hidden: xdx2ixbrl0648">&#8212;</span></span></td><td style="padding-bottom: 1.5pt; text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="border-bottom: Black 1.5pt solid; text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="border-bottom: Black 1.5pt solid; text-align: right"><span style="font-family: Times New Roman, Times, Serif"><ix:nonFraction name="us-gaap:AssetsFairValueDisclosure" contextRef="AsOf2022-12-31_us-gaap_FairValueMeasurementsRecurringMember_us-gaap_ConvertibleDebtSecuritiesMember" id="Fact000649" format="ixt:numdotdecimal" decimals="-3" scale="3" unitRef="USD">1,500</ix:nonFraction></span></td><td style="padding-bottom: 1.5pt; text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td></tr>
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    <td style="font-weight: bold; text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="font-weight: bold; text-align: right"><span style="font-family: Times New Roman, Times, Serif"><ix:nonFraction name="us-gaap:AssetsFairValueDisclosure" contextRef="AsOf2022-12-31_us-gaap_FairValueMeasurementsRecurringMember_us-gaap_FairValueInputsLevel2Member" id="Fact000652" format="ixt:numdotdecimal" decimals="-3" scale="3" unitRef="USD">2,640</ix:nonFraction></span></td><td style="font-weight: bold; text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif"><span style="-sec-ix-hidden: xdx2ixbrl0653">&#8212;</span></span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="font-weight: bold"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="font-weight: bold; text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="font-weight: bold; text-align: right"><span style="font-family: Times New Roman, Times, Serif"><ix:nonFraction name="us-gaap:AssetsFairValueDisclosure" contextRef="AsOf2022-12-31_us-gaap_FairValueMeasurementsRecurringMember" id="Fact000654" format="ixt:numdotdecimal" decimals="-3" scale="3" unitRef="USD">13,269</ix:nonFraction></span></td><td style="font-weight: bold; text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td></tr>
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</ix:nonNumeric><p id="xdx_8AC_zkFn4Ybsl245" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

</ix:nonNumeric><ix:nonNumeric contextRef="From2023-01-01to2023-12-31" escape="true" id="Fact000656" name="us-gaap:ShareBasedCompensationOptionAndIncentivePlansPolicy"><p id="xdx_84D_eus-gaap--ShareBasedCompensationOptionAndIncentivePlansPolicy_zMiLoRGjB4xi" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>L.</b></span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><span id="xdx_866_z9uKRI8JcAx">Accounting
    for stock-based compensation</span></b></span></td></tr>
  </table>
<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>&#160;</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
Company accounts for share-based compensation under ASC 718, Compensation - Stock Compensation (&#8220;ASC 718&#8221;), which requires
the measurement and recognition of compensation expense based on estimated fair values for all share-based payment awards made to employees,
non-employee consultants and directors, including options and restricted share units (&#8220;RSUs&#8221;) based on the fair value of
the awards on the date of grant. ASC 718 requires companies to estimate the fair value of equity-based payment awards on the date of
grant using an option-pricing model. The expense for share-based compensation cost is recognized over the requisite service period of
each individual grant using the straight-line method for  service-based awards. Forfeitures are accounted for
as they occur.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>


<ix:exclude><!-- Field: Page; Sequence: 152; Value: 1 -->
    <div style="border-bottom: Black 1.5pt solid; margin-bottom: 6pt"><table cellpadding="0" cellspacing="0" style="border-collapse: collapse; width: 100%; font-size: 10pt"><tr style="vertical-align: top; text-align: left"><td style="text-align: center; width: 100%">F-<!-- Field: Sequence; Type: Arabic; Name: PageNo -->11<!-- Field: /Sequence --></td></tr></table></div>
    <div style="break-before: page; margin-top: 6pt"><p style="margin: 0pt">&#160;</p></div>
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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>GALMED
PHARMACEUTICALS LTD.</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Notes
to Consolidated Financial Statements</b></span></p>

<!-- Field: Rule-Page --><div style="margin-left: auto; margin-right: auto; width: 100%"><div style="border-top: Black 1.5pt solid; font-size: 1pt"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></div></div><!-- Field: /Rule-Page -->

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Note
2 &#8211; Significant Accounting Policies (Cont.)</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>L.</b></span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Accounting
    for stock-based compensation (Cont.)</b></span></td></tr>
  </table>
<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>&#160;</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
Company calculates the fair value of RSUs based on the fair value on the closing trading price of the underlying shares at the date of
grant and estimates the fair value of stock options granted using a <span id="xdx_90E_ecustom--ShareBasedCompensationArrangementByShareBasedPaymentAwardFairValueAssumptionsDescription_c20230101__20231231__us-gaap--AwardTypeAxis__us-gaap--RestrictedStockMember_zaeiwAcgwdFb" title="Black scholes option pricing model"><ix:nonNumeric contextRef="From2023-01-012023-12-31_us-gaap_RestrictedStockMember" id="Fact000658" name="GLMD:ShareBasedCompensationArrangementByShareBasedPaymentAwardFairValueAssumptionsDescription">Black-Scholes option-pricing model</ix:nonNumeric></span>. The option-pricing model requires
a number of assumptions, the most significant of which are the expected stock-price volatility and the expected option term (the time
from the grant date until the options are exercised or expire).</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>&#160;</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
Company&#8217;s calculations of the expected volatility were based upon actual historical stock-price movements over the period, which
was equal to the expected option term. The expected option term was calculated for options granted to employees and directors in accordance
with ASC-718-10-S99, using the &#8220;simplified&#8221; method, and grants to non-employees were based on the contractual term. Historically,
the Company has not paid dividends, and has no foreseeable plans to do so. The risk-free interest rate is based on the yield from U.S.
Treasury zero-coupon bonds with an equivalent term.</span></p>

</ix:nonNumeric><ix:nonNumeric contextRef="From2023-01-01to2023-12-31" escape="true" id="Fact000660" name="us-gaap:RevenueFromContractWithCustomerPolicyTextBlock"><p id="xdx_842_eus-gaap--RevenueFromContractWithCustomerPolicyTextBlock_zUBBUo8xFXCh" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>&#160;</b></span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>M.</b></span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><span id="xdx_86F_zktMLN1R6RLa">Revenue
    Recognition</span></b></span></td></tr>
  </table>
<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>&#160;</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
Company only has one license agreement for which it has recognized revenues to date, from a license agreement with Samil Pharm. Co.,
Ltd. (&#8220;Samil&#8221; or the &#8220;Samil Agreement&#8221;). The Samil Agreement was signed on July 28, 2016, for an exclusive, royalty-bearing
license for the commercialization of Aramchol (with an option to manufacture) for the treatment of fatty liver indications including
NASH in the Republic of Korea. Additionally, following the ARREST Study, Samil has an option to extend the license to Vietnam, which,
if exercised, would increase the clinical- and regulatory-based milestone payments.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>&#160;</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Under
the terms of the Samil Agreement, the Company received an up-front payment of approximately $<span id="xdx_907_ecustom--RevenueRecognitionMilestoneMethodRevenuesRecognized_pn5n6_c20160101__20161231__dei--LegalEntityAxis__custom--SamilPharmCoLtdMember_zonfNe0L6Z85" title="Milestone method revenue payment"><ix:nonFraction name="GLMD:RevenueRecognitionMilestoneMethodRevenuesRecognized" contextRef="From2016-01-012016-12-31_custom_SamilPharmCoLtdMember" id="Fact000662" format="ixt:numdotdecimal" decimals="-5" scale="6" unitRef="USD">2.1</ix:nonFraction></span> million in 2016 and a milestone payment
of $<span id="xdx_900_ecustom--RevenueRecognitionMilestoneMethodRevenuesRecognized_pn5n6_c20180101__20181231__dei--LegalEntityAxis__custom--SamilPharmCoLtdMember_zqJzMNxyWgE6" title="Milestone method revenue payment"><ix:nonFraction name="GLMD:RevenueRecognitionMilestoneMethodRevenuesRecognized" contextRef="From2018-01-012018-12-31_custom_SamilPharmCoLtdMember" id="Fact000664" format="ixt:numdotdecimal" decimals="-5" scale="6" unitRef="USD">1.5</ix:nonFraction></span> million from Samil in connection with the completion of its ARREST study in 2018. Samil has also agreed to pay additional clinical
and regulatory-based milestone payments, which may aggregate up to $<span id="xdx_90C_eus-gaap--AccruedRoyaltiesCurrentAndNoncurrent_iI_pn5n6_c20231231__dei--LegalEntityAxis__custom--SamilPharmCoLtdMember_zLyV6jrdTTf2" title="Accrued royalties"><ix:nonFraction name="us-gaap:AccruedRoyaltiesCurrentAndNoncurrent" contextRef="AsOf2023-12-31_custom_SamilPharmCoLtdMember" id="Fact000666" format="ixt:numdotdecimal" decimals="-5" scale="6" unitRef="USD">4.5</ix:nonFraction></span> million, as well as tiered, double-digit royalties payable on
sales (under certain limitations).</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>&#160;</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">As
of December 31, 2023, management evaluated the remaining clinical and regulatory milestones and determined that the variable consideration
should not be recorded as revenue for the period ended December 31, 2023. The Company will re-evaluate the transaction price in each
reporting period when events whose outcomes are resolved or other changes in circumstances occur that would indicate it is appropriate
to recognize variable consideration as revenue.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>


<ix:exclude><!-- Field: Page; Sequence: 153; Value: 1 -->
    <div style="border-bottom: Black 1.5pt solid; margin-bottom: 6pt"><table cellpadding="0" cellspacing="0" style="border-collapse: collapse; width: 100%; font-size: 10pt"><tr style="vertical-align: top; text-align: left"><td style="text-align: center; width: 100%">F-<!-- Field: Sequence; Type: Arabic; Name: PageNo -->12<!-- Field: /Sequence --></td></tr></table></div>
    <div style="break-before: page; margin-top: 6pt"><p style="margin: 0pt">&#160;</p></div>
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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>GALMED
PHARMACEUTICALS LTD.</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Notes
to Consolidated Financial Statements</b></span></p>

<!-- Field: Rule-Page --><div style="margin-left: auto; margin-right: auto; width: 100%"><div style="border-top: Black 1.5pt solid; font-size: 1pt"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></div></div><!-- Field: /Rule-Page -->

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Note
2 &#8211; Significant Accounting Policies (Cont.)</b></span></p>

</ix:nonNumeric><ix:nonNumeric contextRef="From2023-01-01to2023-12-31" escape="true" id="Fact000668" name="us-gaap:ResearchAndDevelopmentExpensePolicy"><p id="xdx_84D_eus-gaap--ResearchAndDevelopmentExpensePolicy_z71Tu7z8myv9" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
<tr style="vertical-align: top">
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
  <td style="text-align: justify; width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>N.</b></span></td>
  <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><span id="xdx_86B_zshPYZoSGDr3">Research and development
  expenses</span></b></span></td></tr>
</table>


<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>&#160;</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Research
and development expenses are charged to the statements of operations as incurred.</span></p>

</ix:nonNumeric><ix:nonNumeric contextRef="From2023-01-01to2023-12-31" escape="true" id="Fact000670" name="us-gaap:IncomeTaxPolicyTextBlock"><p id="xdx_84B_eus-gaap--IncomeTaxPolicyTextBlock_za2kYNU7Ydwg" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>&#160;</b></span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
<tr style="vertical-align: top">
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
  <td style="text-align: justify; width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>O.</b></span></td>
  <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><span id="xdx_86D_zVLtx3wkJ3W9">Income taxes</span></b></span></td></tr>
</table>


<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
Company accounts for income taxes in accordance with ASC 740, Income Taxes (&#8220;ASC 740&#8221;), using the liability method whereby
deferred tax assets and liability account balances are determined based on the differences between financial reporting and the tax basis
for assets and liabilities and are measured using the enacted tax rates and laws that will be in effect when the differences are expected
to reverse. The Company provides a valuation allowance, if necessary, to reduce deferred tax assets to the amounts that are more likely-than-not
to be realized. As of December 31, 2023 and 2022, the Company recorded a full valuation allowance against its deferred tax assets.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
Company applies a more-likely-than-not recognition threshold to uncertain tax positions based on the technical merits of the income tax
positions taken. The Company does not recognize a tax benefit unless it is more likely than not that the tax position will be sustained
upon examination, including resolution of any related appeals or litigation processes, based on the technical merits of the position.
The tax benefit that is recorded for these positions is measured at the largest amount of benefit that is greater than 50% likely of
being realized upon ultimate settlement. As of December 31, 2023 and 2022, no liability for unrecognized tax benefits was recorded due
to immateriality.</span></p>

</ix:nonNumeric><ix:nonNumeric contextRef="From2023-01-01to2023-12-31" escape="true" id="Fact000672" name="us-gaap:EarningsPerSharePolicyTextBlock"><p id="xdx_848_eus-gaap--EarningsPerSharePolicyTextBlock_ztWO9VZLHtW8" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>&#160;</b></span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
<tr style="vertical-align: top">
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
  <td style="text-align: justify; width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>P.</b></span></td>
  <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><span id="xdx_860_zLebM71ZwAlg">Basic and diluted net
  loss per share</span></b></span></td></tr>
</table>


<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>&#160;</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Basic
net loss per share is computed based on the weighted-average number of shares outstanding during each year. Diluted net loss per share
is computed based on the weighted-average number of shares outstanding during each year, plus the dilutive potential of the ordinary
shares considered outstanding during the year, in accordance with ASC 260-10, &#8220;Earnings Per Share.&#8221;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">All
outstanding stock options, RSU&#8217;s, prefunded-warrants and warrants were excluded from the calculation of the diluted loss per share
for the years ended December 31, 2023, 2022 and 2021, because all such securities have an anti-dilutive effect.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>


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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>GALMED
PHARMACEUTICALS LTD.</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Notes
to Consolidated Financial Statements</b></span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Note
2 &#8211; Significant Accounting Policies (Cont.)</b></span></p>

</ix:nonNumeric><ix:nonNumeric contextRef="From2023-01-01to2023-12-31" escape="true" id="Fact000674" name="us-gaap:SegmentReportingPolicyPolicyTextBlock"><p id="xdx_84D_eus-gaap--SegmentReportingPolicyPolicyTextBlock_zeHMAJPsgHEc" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Q.</b></span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><span id="xdx_861_zvkUD5TORCo8">Segment
    Reporting</span></b></span></td></tr>
  </table>
<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>&#160;</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
chief operating decision maker for the Company is the Chief Executive Officer. The Chief Executive Officer reviews financial information
presented on a consolidated basis for purposes of allocating resources and evaluating financial performance. Accordingly, management
has determined that the Company operates in one operating and reportable segment.</span></p>

</ix:nonNumeric><ix:nonNumeric contextRef="From2023-01-01to2023-12-31" escape="true" id="Fact000676" name="us-gaap:LesseeLeasesPolicyTextBlock"><p id="xdx_84C_eus-gaap--LesseeLeasesPolicyTextBlock_zDhTH4NEvJVi" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>&#160;</b></span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>R.</b></span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><span id="xdx_860_zpBFT2JG9yq1">Leases</span></b></span></td></tr>
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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>&#160;</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
Company accounts for leases in accordance with ASC 842 &#8220;Leases.&#8221; Arrangements that are determined to be operating leases
at inception are recognized as right-of-use operating lease assets and lease liabilities in the balance sheets at lease commencement.
The Company recognizes a lease liability at the present value of the lease payments to be made over the lease term, and concurrently
recognizes a right-of-use asset at the same amount of the liability, adjusted for any prepaid or accrued lease payments, plus initial
direct costs incurred in respect of the lease. The Company uses its incremental borrowing rate based on the information available at
the commencement date to determine the present value of the lease payments. The subsequent measurement depends on whether the lease is
classified as a finance lease or an operating lease. During the reporting periods, the Company has only operating leases. Lease terms
include options to extend the lease when it is reasonably certain that the Company will exercise that option. Lease expenses for operating
leases are recognized on a straight-line basis over the lease term.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>&#160;</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
Company has made a policy election not to capitalize leases with a term of 12 months or less,.the Company made has also made a policy
election to include lease and non-lease components as a single lease component.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Payments
for variable lease costs are expensed as incurred and are not included in the operating lease right-of-use assets and lease liabilities.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>&#160;</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
accordance with ASC 360-10, management reviews operating lease assets for impairment whenever events or changes in circumstances indicate
that the carrying amount of an asset may not be recoverable based on estimated future undiscounted cash flows. If so indicated, an impairment
loss would be recognized for the difference between the carrying amount of the asset and its fair value.</span></p>

</ix:nonNumeric><ix:nonNumeric contextRef="From2023-01-01to2023-12-31" escape="true" id="Fact000678" name="us-gaap:InvestmentPolicyTextBlock"><p id="xdx_840_eus-gaap--InvestmentPolicyTextBlock_zC44r2KEp8C9" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>S.</b></span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><span id="xdx_869_zfGjOut5gZ3k">Investment
    in Associate at Fair Value</span></b></span></td></tr>
  </table>
<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
Company holds an equity investment of a privately-owned company, Onkai Inc. (&#8220;Onkai&#8221;), over which it has the ability to exercise
significant influence, but not control. The investment was included as a non-current asset in the balance sheet as of December 31, 2023.
The Company has elected the fair value option allowed by ASC 825, Financial Instruments, with respect to this investment because management
believes this approach will better reflect the economics of its equity interest. Under the fair value option, the investment is remeasured
at fair value (level 3) at each reporting period with changes in fair value, if any, recorded in the statement of operations.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Management
determined the fair value of its investment in Onkai based on the acquisition price of the equity investment made during 2023. Management,
together with its fair valuation expert, assessed the qualitative aspects of the equity investment and macroeconomic factors as of December
31, 2023 and determined that there was no material change in the investment as of December 31, 2023</span></p>
</ix:nonNumeric><ix:nonNumeric contextRef="From2023-01-01to2023-12-31" escape="true" id="Fact000680" name="us-gaap:NewAccountingPronouncementsPolicyPolicyTextBlock"><p id="xdx_843_eus-gaap--NewAccountingPronouncementsPolicyPolicyTextBlock_zKPMvzbc1eea" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>T.</b></span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><span id="xdx_86A_zbtAydZE0jQ9">Recently
    adopted accounting pronouncements</span></b></span></td></tr>
  </table>
<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">From
time to time, new accounting pronouncements are issued by FASB, or other standard setting bodies and adopted by the Company as of the
specified effective date. Unless otherwise discussed, the impact of recently issued standards that are not yet effective will not have
a material impact on our financial position or results of operations upon adoption.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures. The ASU expands
public entities&#8217; segment disclosures by requiring disclosure of significant segment expenses that are regularly reviewed by the
chief operating decision maker (&#8220;CODM&#8221;) and included within each reported measure of segment profit or loss, an amount and
description of its composition for other segment items, and interim disclosures of a reportable segment&#8217;s profit or loss and assets.
The ASU also allows, in addition to the measure that is most consistent with U.S. GAAP, the disclosure of additional measures of segment
profit or loss that are used by the CODM in assessing segment performance and deciding how to allocate resources. The ASU is effective
for the Company&#8217;s Annual Report on Form 20-F for the fiscal year ended December 31, 2024, and subsequent interim periods, with
early adoption permitted. The Company is currently evaluating the impact of adopting this ASU on its consolidated financial statements
and disclosures.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 49.5pt; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
December 2023, the FASB issued ASU No. 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures. This ASU requires disclosure
of specific categories in the rate reconciliation and additional information for reconciling items that meet a quantitative threshold.
The amendment also includes other changes to improve the effectiveness of income tax disclosures, including further disaggregation of
income taxes paid for individually significant jurisdictions. This ASU is effective for annual periods beginning after December 15, 2024.
Adoption of this ASU should be applied on a prospective basis. Early adoption is permitted. The Company is currently evaluating the impact
of adopting this ASU on its consolidated financial statements and disclosures.</span></p>

</ix:nonNumeric><p id="xdx_85B_zXMf9HkKcgHc" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>&#160;</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"></p>


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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>&#160;</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>GALMED
PHARMACEUTICALS LTD.</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Notes
to Consolidated Financial Statements</b></span></p>

<!-- Field: Rule-Page --><div style="margin-left: auto; margin-right: auto; width: 100%"><div style="border-top: Black 1.5pt solid; font-size: 1pt"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></div></div><!-- Field: /Rule-Page -->

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"></p>



<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

</ix:nonNumeric><ix:nonNumeric contextRef="From2023-01-01to2023-12-31" escape="true" id="Fact000682" name="us-gaap:CashCashEquivalentsAndMarketableSecuritiesTextBlock"><p id="xdx_80B_eus-gaap--CashCashEquivalentsAndMarketableSecuritiesTextBlock_zJEJ9PNVqdqk" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Note
3 &#8211; <span id="xdx_82E_zdnPIK2Iqxyh">Marketable debt securities</span></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<ix:nonNumeric contextRef="From2023-01-01to2023-12-31" escape="true" id="Fact000684" name="us-gaap:MarketableSecuritiesTextBlock"><p id="xdx_891_eus-gaap--MarketableSecuritiesTextBlock_zv9LnpBAI2Lh" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
following table summarizes the Company&#8217;s marketable debt securities as of December 31, 2023 and 2022.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="display: none; font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;<span id="xdx_8B2_zh3fUwfCrc2b">Schedule of Marketable Debt Securities</span></span></p>

<table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 100%">
<tr style="vertical-align: bottom">
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    <td colspan="14" style="border-bottom: Black 1.5pt solid; text-align: center"><span style="font-family: Times New Roman, Times, Serif"><b>As
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  <tr style="vertical-align: bottom">
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  <tr style="vertical-align: bottom">
    <td style="text-align: center"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="font-weight: bold"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
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  <tr style="vertical-align: bottom">
    <td style="text-align: center"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="font-weight: bold; padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
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  <tr style="vertical-align: bottom">
    <td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="width: 36%; text-align: left"><span style="font-family: Times New Roman, Times, Serif">Corporate bonds</span></td><td style="width: 2%"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
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    <td style="width: 1%; text-align: left"><span style="font-family: Times New Roman, Times, Serif">$</span></td><td id="xdx_98C_eus-gaap--AvailableForSaleSecuritiesDebtSecurities_iI_pn3n3_c20231231__us-gaap--FinancialInstrumentAxis__us-gaap--CorporateDebtSecuritiesMember_zYtk4ITtcZ2l" title="Estimated Fair Value" style="width: 12%; text-align: right"><span style="font-family: Times New Roman, Times, Serif"><ix:nonFraction name="us-gaap:AvailableForSaleSecuritiesDebtSecurities" contextRef="AsOf2023-12-31_us-gaap_CorporateDebtSecuritiesMember" id="Fact000692" format="ixt:numdotdecimal" decimals="-3" scale="3" unitRef="USD">1,969</ix:nonFraction></span></td><td style="width: 1%; text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td></tr>
  <tr style="vertical-align: bottom; background-color: White">
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    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td id="xdx_983_eus-gaap--AvailableForSaleDebtSecuritiesAmortizedCostBasis_iI_pn3n3_c20231231__us-gaap--FinancialInstrumentAxis__us-gaap--USTreasurySecuritiesMember_zxn0zYd4mAc1" title="Amortized Cost" style="text-align: right"><span style="font-family: Times New Roman, Times, Serif"><ix:nonFraction name="us-gaap:AvailableForSaleDebtSecuritiesAmortizedCostBasis" contextRef="AsOf2023-12-31_us-gaap_USTreasurySecuritiesMember" id="Fact000694" format="ixt:numdotdecimal" decimals="-3" scale="3" unitRef="USD">400</ix:nonFraction></span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td id="xdx_98F_eus-gaap--AvailableForSaleDebtSecuritiesGrossUnrealizedGain_pn3n3_c20230101__20231231__us-gaap--FinancialInstrumentAxis__us-gaap--USTreasurySecuritiesMember_zBq79RsaNUf" title="Gross Unrealized Gains" style="text-align: right"><span style="font-family: Times New Roman, Times, Serif"><ix:nonFraction name="us-gaap:AvailableForSaleDebtSecuritiesGrossUnrealizedGain" contextRef="From2023-01-012023-12-31_us-gaap_USTreasurySecuritiesMember" id="Fact000696" format="ixt:numdotdecimal" decimals="-3" scale="3" unitRef="USD">9</ix:nonFraction></span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td id="xdx_982_eus-gaap--AvailableForSaleDebtSecuritiesGrossUnrealizedLoss_iN_pn3n3_di_c20230101__20231231__us-gaap--FinancialInstrumentAxis__us-gaap--USTreasurySecuritiesMember_zOn3w3AJg2c5" title="Gross Unrealized Losses" style="text-align: right"><span style="font-family: Times New Roman, Times, Serif"><span style="-sec-ix-hidden: xdx2ixbrl0698">-</span></span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td id="xdx_986_eus-gaap--AvailableForSaleSecuritiesDebtSecurities_iI_pn3n3_c20231231__us-gaap--FinancialInstrumentAxis__us-gaap--USTreasurySecuritiesMember_zrIIoNpC30gc" title="Estimated Fair Value" style="text-align: right"><span style="font-family: Times New Roman, Times, Serif"><ix:nonFraction name="us-gaap:AvailableForSaleSecuritiesDebtSecurities" contextRef="AsOf2023-12-31_us-gaap_USTreasurySecuritiesMember" id="Fact000700" format="ixt:numdotdecimal" decimals="-3" scale="3" unitRef="USD">409</ix:nonFraction></span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td></tr>
  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="text-align: left; padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif">Mutual funds</span></td><td style="padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="border-bottom: Black 1.5pt solid; text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td id="xdx_98C_eus-gaap--AvailableForSaleDebtSecuritiesAmortizedCostBasis_iI_pn3n3_c20231231__us-gaap--FinancialInstrumentAxis__us-gaap--MutualFundMember_z2iDx8uFr39j" title="Amortized Cost" style="border-bottom: Black 1.5pt solid; text-align: right"><span style="font-family: Times New Roman, Times, Serif"><ix:nonFraction name="us-gaap:AvailableForSaleDebtSecuritiesAmortizedCostBasis" contextRef="AsOf2023-12-31_us-gaap_MutualFundMember" id="Fact000702" format="ixt:numdotdecimal" decimals="-3" scale="3" unitRef="USD">5,459</ix:nonFraction></span></td><td style="padding-bottom: 1.5pt; text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="border-bottom: Black 1.5pt solid; text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td id="xdx_981_eus-gaap--AvailableForSaleDebtSecuritiesGrossUnrealizedGain_pn3n3_c20230101__20231231__us-gaap--FinancialInstrumentAxis__us-gaap--MutualFundMember_ziMw999sLPp1" title="Gross Unrealized Gains" style="border-bottom: Black 1.5pt solid; text-align: right"><span style="font-family: Times New Roman, Times, Serif"><ix:nonFraction name="us-gaap:AvailableForSaleDebtSecuritiesGrossUnrealizedGain" contextRef="From2023-01-012023-12-31_us-gaap_MutualFundMember" id="Fact000704" format="ixt:numdotdecimal" decimals="-3" scale="3" unitRef="USD">1</ix:nonFraction></span></td><td style="padding-bottom: 1.5pt; text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="border-bottom: Black 1.5pt solid; text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td id="xdx_980_eus-gaap--AvailableForSaleDebtSecuritiesGrossUnrealizedLoss_iN_pn3n3_di_c20230101__20231231__us-gaap--FinancialInstrumentAxis__us-gaap--MutualFundMember_zrQeG84OzZCk" title="Gross Unrealized Losses" style="border-bottom: Black 1.5pt solid; text-align: right"><span style="font-family: Times New Roman, Times, Serif">(<ix:nonFraction name="us-gaap:AvailableForSaleDebtSecuritiesGrossUnrealizedLoss" contextRef="From2023-01-012023-12-31_us-gaap_MutualFundMember" id="Fact000706" format="ixt:numdotdecimal" decimals="-3" scale="3" unitRef="USD">310</ix:nonFraction></span></td><td style="padding-bottom: 1.5pt; text-align: left"><span style="font-family: Times New Roman, Times, Serif">)</span></td><td style="padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="border-bottom: Black 1.5pt solid; text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td id="xdx_985_eus-gaap--AvailableForSaleSecuritiesDebtSecurities_iI_pn3n3_c20231231__us-gaap--FinancialInstrumentAxis__us-gaap--MutualFundMember_znunLoe99k18" title="Estimated Fair Value" style="border-bottom: Black 1.5pt solid; text-align: right"><span style="font-family: Times New Roman, Times, Serif"><ix:nonFraction name="us-gaap:AvailableForSaleSecuritiesDebtSecurities" contextRef="AsOf2023-12-31_us-gaap_MutualFundMember" id="Fact000708" format="ixt:numdotdecimal" decimals="-3" scale="3" unitRef="USD">5,150</ix:nonFraction></span></td><td style="padding-bottom: 1.5pt; text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td></tr>
  <tr style="vertical-align: bottom; background-color: White">
    <td style="text-align: left; padding-bottom: 2.5pt"><span style="font-family: Times New Roman, Times, Serif">Total short-term investments</span></td><td style="padding-bottom: 2.5pt"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
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    <td style="border-bottom: Black 2.5pt double; text-align: left"><span style="font-family: Times New Roman, Times, Serif">$</span></td><td id="xdx_987_eus-gaap--AvailableForSaleDebtSecuritiesGrossUnrealizedGain_pn3n3_c20230101__20231231_z43q0P2VIwd9" title="Gross Unrealized Gains" style="border-bottom: Black 2.5pt double; text-align: right"><span style="font-family: Times New Roman, Times, Serif"><ix:nonFraction name="us-gaap:AvailableForSaleDebtSecuritiesGrossUnrealizedGain" contextRef="From2023-01-01to2023-12-31" id="Fact000712" format="ixt:numdotdecimal" decimals="-3" scale="3" unitRef="USD">16</ix:nonFraction></span></td><td style="padding-bottom: 2.5pt; text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="padding-bottom: 2.5pt"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="border-bottom: Black 2.5pt double; text-align: left"><span style="font-family: Times New Roman, Times, Serif">$</span></td><td id="xdx_98A_eus-gaap--AvailableForSaleDebtSecuritiesGrossUnrealizedLoss_iN_pn3n3_di_c20230101__20231231_zjTCX3G5B26b" title="Gross Unrealized Losses" style="border-bottom: Black 2.5pt double; text-align: right"><span style="font-family: Times New Roman, Times, Serif">(<ix:nonFraction name="us-gaap:AvailableForSaleDebtSecuritiesGrossUnrealizedLoss" contextRef="From2023-01-01to2023-12-31" id="Fact000714" format="ixt:numdotdecimal" decimals="-3" scale="3" unitRef="USD">470</ix:nonFraction></span></td><td style="padding-bottom: 2.5pt; text-align: left"><span style="font-family: Times New Roman, Times, Serif">)</span></td><td style="padding-bottom: 2.5pt"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="border-bottom: Black 2.5pt double; text-align: left"><span style="font-family: Times New Roman, Times, Serif">$</span></td><td id="xdx_98E_eus-gaap--AvailableForSaleSecuritiesDebtSecurities_iI_pn3n3_c20231231_zxGyg6bec8gc" title="Estimated Fair Value" style="border-bottom: Black 2.5pt double; text-align: right"><span style="font-family: Times New Roman, Times, Serif"><ix:nonFraction name="us-gaap:AvailableForSaleSecuritiesDebtSecurities" contextRef="AsOf2023-12-31" id="Fact000716" format="ixt:numdotdecimal" decimals="-3" scale="3" unitRef="USD">7,528</ix:nonFraction></span></td><td style="padding-bottom: 2.5pt; text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td></tr>
  </table>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 100%">
<tr style="vertical-align: bottom">
    <td style="padding-bottom: 1.5pt; text-align: center"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="padding-bottom: 1.5pt; text-align: center; font-weight: bold"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
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  <tr style="vertical-align: bottom">
    <td style="text-align: center"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: center"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td colspan="2" style="text-align: center"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: center"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: center; font-weight: bold"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
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    <td colspan="2" style="text-align: center"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: center"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td></tr>
  <tr style="vertical-align: bottom">
    <td style="text-align: center"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: center; font-weight: bold"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
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  <tr style="vertical-align: bottom">
    <td style="padding-bottom: 1.5pt; text-align: center"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="padding-bottom: 1.5pt; text-align: center; font-weight: bold"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
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    Value</span></td><td style="padding-bottom: 1.5pt; text-align: center; font-weight: bold"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td></tr>
  <tr style="vertical-align: bottom">
    <td style="text-align: center"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: center"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td colspan="14" style="text-align: center"><span style="font-family: Times New Roman, Times, Serif">(in thousands)</span></td><td style="text-align: center"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td></tr>
  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="width: 36%; text-align: left"><span style="font-family: Times New Roman, Times, Serif">Corporate bonds</span></td><td style="width: 2%"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="width: 1%; text-align: left"><span style="font-family: Times New Roman, Times, Serif">$</span></td><td id="xdx_98D_eus-gaap--AvailableForSaleDebtSecuritiesAmortizedCostBasis_iI_pn3n3_c20221231__us-gaap--FinancialInstrumentAxis__us-gaap--CorporateDebtSecuritiesMember_zkUBTVZWXfg9" title="Amortized Cost" style="width: 12%; text-align: right"><span style="font-family: Times New Roman, Times, Serif"><ix:nonFraction name="us-gaap:AvailableForSaleDebtSecuritiesAmortizedCostBasis" contextRef="AsOf2022-12-31_us-gaap_CorporateDebtSecuritiesMember" id="Fact000718" format="ixt:numdotdecimal" decimals="-3" scale="3" unitRef="USD">1,327</ix:nonFraction></span></td><td style="width: 1%; text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="width: 2%"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="width: 1%; text-align: left"><span style="font-family: Times New Roman, Times, Serif">$</span></td><td id="xdx_986_eus-gaap--AvailableForSaleDebtSecuritiesGrossUnrealizedGain_pn3n3_c20220101__20221231__us-gaap--FinancialInstrumentAxis__us-gaap--CorporateDebtSecuritiesMember_zp3rLwqR5lIl" title="Gross Unrealized Gains" style="width: 12%; text-align: right"><span style="font-family: Times New Roman, Times, Serif"><span style="-sec-ix-hidden: xdx2ixbrl0720">-</span></span></td><td style="width: 1%; text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="width: 2%"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
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  <tr style="vertical-align: bottom; background-color: White">
    <td style="padding-bottom: 1.5pt; text-align: left"><span style="font-family: Times New Roman, Times, Serif">Mutual funds</span></td><td style="padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="border-bottom: Black 1.5pt solid; text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td id="xdx_983_eus-gaap--AvailableForSaleDebtSecuritiesAmortizedCostBasis_iI_pn3n3_c20221231__us-gaap--FinancialInstrumentAxis__us-gaap--MutualFundMember_z9zYWBuleQX8" title="Amortized Cost" style="border-bottom: Black 1.5pt solid; text-align: right"><span style="font-family: Times New Roman, Times, Serif"><ix:nonFraction name="us-gaap:AvailableForSaleDebtSecuritiesAmortizedCostBasis" contextRef="AsOf2022-12-31_us-gaap_MutualFundMember" id="Fact000726" format="ixt:numdotdecimal" decimals="-3" scale="3" unitRef="USD">11,187</ix:nonFraction></span></td><td style="padding-bottom: 1.5pt; text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="border-bottom: Black 1.5pt solid; text-align: left"><span style="font-family: Times New Roman, Times, Serif">$</span></td><td id="xdx_986_eus-gaap--AvailableForSaleDebtSecuritiesGrossUnrealizedGain_pn3n3_c20220101__20221231__us-gaap--FinancialInstrumentAxis__us-gaap--MutualFundMember_zuMzeh7yyeQ5" title="Gross Unrealized Gains" style="border-bottom: Black 1.5pt solid; text-align: right"><span style="font-family: Times New Roman, Times, Serif"><ix:nonFraction name="us-gaap:AvailableForSaleDebtSecuritiesGrossUnrealizedGain" contextRef="From2022-01-012022-12-31_us-gaap_MutualFundMember" id="Fact000728" format="ixt:numdotdecimal" decimals="-3" scale="3" unitRef="USD">30</ix:nonFraction></span></td><td style="padding-bottom: 1.5pt; text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="border-bottom: Black 1.5pt solid; text-align: left"><span style="font-family: Times New Roman, Times, Serif">$</span></td><td id="xdx_987_eus-gaap--AvailableForSaleDebtSecuritiesGrossUnrealizedLoss_iN_pn3n3_di_c20220101__20221231__us-gaap--FinancialInstrumentAxis__us-gaap--MutualFundMember_zFCyzx94CBV7" title="Gross Unrealized Losses" style="border-bottom: Black 1.5pt solid; text-align: right"><span style="font-family: Times New Roman, Times, Serif">(<ix:nonFraction name="us-gaap:AvailableForSaleDebtSecuritiesGrossUnrealizedLoss" contextRef="From2022-01-012022-12-31_us-gaap_MutualFundMember" id="Fact000730" format="ixt:numdotdecimal" decimals="-3" scale="3" unitRef="USD">588</ix:nonFraction></span></td><td style="padding-bottom: 1.5pt; text-align: left"><span style="font-family: Times New Roman, Times, Serif">)</span></td><td style="padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="border-bottom: Black 1.5pt solid; text-align: left"><span style="font-family: Times New Roman, Times, Serif">$</span></td><td id="xdx_980_eus-gaap--AvailableForSaleSecuritiesDebtSecurities_iI_pn3n3_c20221231__us-gaap--FinancialInstrumentAxis__us-gaap--MutualFundMember_zUWwz9tE2rA8" title="Estimated Fair Value" style="border-bottom: Black 1.5pt solid; text-align: right"><span style="font-family: Times New Roman, Times, Serif"><ix:nonFraction name="us-gaap:AvailableForSaleSecuritiesDebtSecurities" contextRef="AsOf2022-12-31_us-gaap_MutualFundMember" id="Fact000732" format="ixt:numdotdecimal" decimals="-3" scale="3" unitRef="USD">10,629</ix:nonFraction></span></td><td style="padding-bottom: 1.5pt; text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td></tr>
  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="padding-bottom: 2.5pt; font-weight: bold; text-align: left"><span style="font-family: Times New Roman, Times, Serif">Total
    short-term investments</span></td><td style="padding-bottom: 2.5pt"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="border-bottom: Black 2.5pt double; text-align: left"><span style="font-family: Times New Roman, Times, Serif">$</span></td><td id="xdx_987_eus-gaap--AvailableForSaleDebtSecuritiesAmortizedCostBasis_iI_pn3n3_c20221231_ztBF15r0Lg0a" title="Amortized Cost" style="border-bottom: Black 2.5pt double; text-align: right"><span style="font-family: Times New Roman, Times, Serif"><ix:nonFraction name="us-gaap:AvailableForSaleDebtSecuritiesAmortizedCostBasis" contextRef="AsOf2022-12-31" id="Fact000734" format="ixt:numdotdecimal" decimals="-3" scale="3" unitRef="USD">12,514</ix:nonFraction></span></td><td style="padding-bottom: 2.5pt; text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="padding-bottom: 2.5pt"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="border-bottom: Black 2.5pt double; text-align: left"><span style="font-family: Times New Roman, Times, Serif">$</span></td><td id="xdx_98E_eus-gaap--AvailableForSaleDebtSecuritiesGrossUnrealizedGain_pn3n3_c20220101__20221231_zzqPFaLOMASa" title="Gross Unrealized Gains" style="border-bottom: Black 2.5pt double; text-align: right"><span style="font-family: Times New Roman, Times, Serif"><ix:nonFraction name="us-gaap:AvailableForSaleDebtSecuritiesGrossUnrealizedGain" contextRef="From2022-01-012022-12-31" id="Fact000736" format="ixt:numdotdecimal" decimals="-3" scale="3" unitRef="USD">30</ix:nonFraction></span></td><td style="padding-bottom: 2.5pt; text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="padding-bottom: 2.5pt"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="border-bottom: Black 2.5pt double; text-align: left"><span style="font-family: Times New Roman, Times, Serif">$</span></td><td id="xdx_98E_eus-gaap--AvailableForSaleDebtSecuritiesGrossUnrealizedLoss_iN_pn3n3_di_c20220101__20221231_z9FZreFn8mo8" title="Gross Unrealized Losses" style="border-bottom: Black 2.5pt double; text-align: right"><span style="font-family: Times New Roman, Times, Serif">(<ix:nonFraction name="us-gaap:AvailableForSaleDebtSecuritiesGrossUnrealizedLoss" contextRef="From2022-01-012022-12-31" id="Fact000738" format="ixt:numdotdecimal" decimals="-3" scale="3" unitRef="USD">775</ix:nonFraction></span></td><td style="padding-bottom: 2.5pt; text-align: left"><span style="font-family: Times New Roman, Times, Serif">)</span></td><td style="padding-bottom: 2.5pt"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="border-bottom: Black 2.5pt double; text-align: left"><span style="font-family: Times New Roman, Times, Serif">$</span></td><td id="xdx_98B_eus-gaap--AvailableForSaleSecuritiesDebtSecurities_iI_pn3n3_c20221231_zsrA7HagHPmh" title="Estimated Fair Value" style="border-bottom: Black 2.5pt double; text-align: right"><span style="font-family: Times New Roman, Times, Serif"><ix:nonFraction name="us-gaap:AvailableForSaleSecuritiesDebtSecurities" contextRef="AsOf2022-12-31" id="Fact000740" format="ixt:numdotdecimal" decimals="-3" scale="3" unitRef="USD">11,769</ix:nonFraction></span></td><td style="padding-bottom: 2.5pt; text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td></tr>
  </table>

</ix:nonNumeric><p id="xdx_8AB_zT3pHZv5hbl1" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
contractual maturities of the aforementioned corporate bonds and treasury bills are less than one year for the year ended December 31,
2023 and one year and a half of the aforementioned corporate bonds for the year ended December 31, 2022.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

</ix:nonNumeric><ix:nonNumeric contextRef="From2023-01-01to2023-12-31" escape="true" id="Fact000742" name="us-gaap:LoansNotesTradeAndOtherReceivablesDisclosureTextBlock"><p id="xdx_806_eus-gaap--LoansNotesTradeAndOtherReceivablesDisclosureTextBlock_zD6SjC9oQJck" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Note
4&#8211; <span id="xdx_822_z13mOgf82eX7">Other Receivables</span></b></span></p>

<ix:nonNumeric contextRef="From2023-01-01to2023-12-31" escape="true" id="Fact000744" name="us-gaap:ScheduleOfAccountsNotesLoansAndFinancingReceivableTextBlock"><p id="xdx_896_eus-gaap--ScheduleOfAccountsNotesLoansAndFinancingReceivableTextBlock_z0hbDWjXrqC1" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="display: none; font-family: Times New Roman, Times, Serif; font-size: 10pt"><span id="xdx_8B4_z0s0wKGgllZ7">Schedule
of Other  Receivables</span></span></p>

<table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 90%; margin-left: 0.25in">
  <tr style="display: none; vertical-align: bottom">
    <td style="padding-bottom: 1.5pt; text-align: center"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="padding-bottom: 1.5pt; text-align: center"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td colspan="2" id="xdx_492_20231231_zFUy29KaTwy8" style="border-bottom: Black 1.5pt solid; text-align: center"><span style="font-family: Times New Roman, Times, Serif"><b>2023</b></span></td><td style="padding-bottom: 1.5pt; text-align: center"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="padding-bottom: 1.5pt; text-align: center; font-weight: bold"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td colspan="2" id="xdx_491_20221231_zdrqBLe32FBg" style="border-bottom: Black 1.5pt solid; text-align: center; font-weight: bold"><span style="font-family: Times New Roman, Times, Serif">2022</span></td><td style="padding-bottom: 1.5pt; text-align: center; font-weight: bold"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td></tr>
<tr style="vertical-align: bottom">
    <td style="padding-bottom: 1.5pt; text-align: center"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="padding-bottom: 1.5pt; text-align: center; font-weight: bold"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td colspan="6" style="border-bottom: Black 1.5pt solid; text-align: center; font-weight: bold"><span style="font-family: Times New Roman, Times, Serif">As
    of December 31,</span></td><td style="padding-bottom: 1.5pt; text-align: center; font-weight: bold"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td></tr>
  <tr style="vertical-align: bottom">
    <td style="padding-bottom: 1.5pt; text-align: center"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="padding-bottom: 1.5pt; text-align: center"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td colspan="2" style="border-bottom: Black 1.5pt solid; text-align: center"><span style="font-family: Times New Roman, Times, Serif"><b>2023</b></span></td><td style="padding-bottom: 1.5pt; text-align: center"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="padding-bottom: 1.5pt; text-align: center; font-weight: bold"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td colspan="2" style="border-bottom: Black 1.5pt solid; text-align: center; font-weight: bold"><span style="font-family: Times New Roman, Times, Serif">2022</span></td><td style="padding-bottom: 1.5pt; text-align: center; font-weight: bold"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td></tr>
  <tr style="vertical-align: bottom">
    <td style="text-align: center"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: center; font-weight: bold"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
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  <tr id="xdx_405_eus-gaap--PrepaidExpenseCurrent_iI_pn3n3_maRNCz4tF_z8sntfi70RZi" style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="width: 60%; text-align: left"><span style="font-family: Times New Roman, Times, Serif">Prepaid expenses</span></td><td style="width: 2%"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="width: 1%; text-align: left"><span style="font-family: Times New Roman, Times, Serif">$</span></td><td style="width: 16%; text-align: right"><span style="font-family: Times New Roman, Times, Serif"><ix:nonFraction name="us-gaap:PrepaidExpenseCurrent" contextRef="AsOf2023-12-31" id="Fact000746" format="ixt:numdotdecimal" decimals="-3" scale="3" unitRef="USD">315</ix:nonFraction></span></td><td style="width: 1%; text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="width: 2%"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="width: 1%; text-align: left"><span style="font-family: Times New Roman, Times, Serif">$</span></td><td style="width: 16%; text-align: right"><span style="font-family: Times New Roman, Times, Serif"><ix:nonFraction name="us-gaap:PrepaidExpenseCurrent" contextRef="AsOf2022-12-31" id="Fact000747" format="ixt:numdotdecimal" decimals="-3" scale="3" unitRef="USD">668</ix:nonFraction></span></td><td style="width: 1%; text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td></tr>
  <tr id="xdx_408_eus-gaap--GrantsReceivable_iI_pn3n3_maRNCz4tF_zVFM3stcZWtc" style="vertical-align: bottom; background-color: White">
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">Government institutions</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif"><ix:nonFraction name="us-gaap:GrantsReceivable" contextRef="AsOf2023-12-31" id="Fact000749" format="ixt:numdotdecimal" decimals="-3" scale="3" unitRef="USD">47</ix:nonFraction></span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif"><ix:nonFraction name="us-gaap:GrantsReceivable" contextRef="AsOf2022-12-31" id="Fact000750" format="ixt:numdotdecimal" decimals="-3" scale="3" unitRef="USD">124</ix:nonFraction></span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td></tr>
  <tr id="xdx_407_eus-gaap--OtherReceivables_iI_pn3n3_maRNCz4tF_zKt94icHNGy" style="vertical-align: bottom; background-color: rgb(204,238,255)">
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    <td style="border-bottom: Black 1.5pt solid; text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="border-bottom: Black 1.5pt solid; text-align: right"><span style="font-family: Times New Roman, Times, Serif"><ix:nonFraction name="us-gaap:OtherReceivables" contextRef="AsOf2023-12-31" id="Fact000752" format="ixt:numdotdecimal" decimals="-3" scale="3" unitRef="USD">118</ix:nonFraction></span></td><td style="padding-bottom: 1.5pt; text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="border-bottom: Black 1.5pt solid; text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="border-bottom: Black 1.5pt solid; text-align: right"><span style="font-family: Times New Roman, Times, Serif"><ix:nonFraction name="us-gaap:OtherReceivables" contextRef="AsOf2022-12-31" id="Fact000753" format="ixt:numdotdecimal" decimals="-3" scale="3" unitRef="USD">33</ix:nonFraction></span></td><td style="padding-bottom: 1.5pt; text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td></tr>
  <tr id="xdx_406_eus-gaap--ReceivablesNetCurrent_iTI_pn3n3_mtRNCz4tF_znYJEyZi9ENc" style="vertical-align: bottom; background-color: White">
    <td style="padding-bottom: 2.5pt"><span style="display: none; font-family: Times New Roman, Times, Serif; font-size: 10pt">Total</span></td><td style="padding-bottom: 2.5pt"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="border-bottom: Black 2.5pt double; text-align: left"><span style="font-family: Times New Roman, Times, Serif">$</span></td><td style="border-bottom: Black 2.5pt double; text-align: right"><span style="font-family: Times New Roman, Times, Serif"><ix:nonFraction name="us-gaap:ReceivablesNetCurrent" contextRef="AsOf2023-12-31" id="Fact000755" format="ixt:numdotdecimal" decimals="-3" scale="3" unitRef="USD">480</ix:nonFraction></span></td><td style="padding-bottom: 2.5pt; text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="padding-bottom: 2.5pt"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="border-bottom: Black 2.5pt double; text-align: left"><span style="font-family: Times New Roman, Times, Serif">$</span></td><td style="border-bottom: Black 2.5pt double; text-align: right"><span style="font-family: Times New Roman, Times, Serif"><ix:nonFraction name="us-gaap:ReceivablesNetCurrent" contextRef="AsOf2022-12-31" id="Fact000756" format="ixt:numdotdecimal" decimals="-3" scale="3" unitRef="USD">825</ix:nonFraction></span></td><td style="padding-bottom: 2.5pt; text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td></tr>
  </table>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

</ix:nonNumeric></ix:nonNumeric><ix:nonNumeric contextRef="From2023-01-01to2023-12-31" escape="true" id="Fact000758" name="us-gaap:LesseeOperatingLeasesTextBlock"><p id="xdx_808_eus-gaap--LesseeOperatingLeasesTextBlock_zqbrsoRuT8Ae" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Note
5&#8211; <span id="xdx_82A_ziJFgLzaOVg7">Leases</span></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">During
the year ended December 31, 2023, the Company leased, approximately <span id="xdx_902_eus-gaap--AreaOfLand_iI_uSqft_c20231231_zucCN20pc288" title="Area of land under operating lease agreement"><ix:nonFraction name="us-gaap:AreaOfLand" contextRef="AsOf2023-12-31" id="Fact000760" format="ixt:numdotdecimal" decimals="INF" unitRef="Sqft">590</ix:nonFraction></span> square meters at a facility located in Tel-Aviv, Israel. The
lease expired on <span id="xdx_909_eus-gaap--LeaseExpirationDate1_dd_c20230101__20231231_z8i4kTS3oc7h" title="Lease expiry date"><ix:nonNumeric contextRef="From2023-01-01to2023-12-31" format="ixt:datemonthdayyearen" id="Fact000762" name="us-gaap:LeaseExpirationDate1">March 21, 2024</ix:nonNumeric></span>. The Company does not plan to extend the lease and the Company&#8217;s employees are currently working
remotely while management is in the process of searching for a new permanent location for its principal executive offices. In addition,
the Company leases vehicles under various operating lease agreements.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 33pt; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">During
2023, 2022 and 2021, the Company recorded lease expenses in its statement of operations in the amount of $<span id="xdx_90D_eus-gaap--OperatingLeaseExpense_pn5n6_c20230101__20231231_zOg1MKmWQ6V8" title="Lease expense"><ix:nonFraction name="us-gaap:OperatingLeaseExpense" contextRef="From2023-01-01to2023-12-31" id="Fact000764" format="ixt:numdotdecimal" decimals="-5" scale="6" unitRef="USD">0.2</ix:nonFraction></span> million, $<span id="xdx_904_eus-gaap--OperatingLeaseExpense_pn5n6_c20220101__20221231_z4hmOmnZAD73" title="Lease expense"><ix:nonFraction name="us-gaap:OperatingLeaseExpense" contextRef="From2022-01-012022-12-31" id="Fact000766" format="ixt:numdotdecimal" decimals="-5" scale="6" unitRef="USD">0.2</ix:nonFraction></span> million,
and $<span id="xdx_900_eus-gaap--OperatingLeaseExpense_pn5n6_c20210101__20211231_zcroULfNUrUe" title="Lease expense"><ix:nonFraction name="us-gaap:OperatingLeaseExpense" contextRef="From2021-01-012021-12-31" id="Fact000768" format="ixt:numdotdecimal" decimals="-5" scale="6" unitRef="USD">0.2</ix:nonFraction></span> million respectively. During 2023, the Company subleased a portion of its facility for a total of $<span id="xdx_903_eus-gaap--SubleaseIncome_pn3n3_c20230101__20231231_zGV5T4ridNxl" title="Sublease income"><ix:nonFraction name="us-gaap:SubleaseIncome" contextRef="From2023-01-01to2023-12-31" id="Fact000770" format="ixt:numdotdecimal" decimals="-3" scale="3" unitRef="USD">44</ix:nonFraction></span> thousand that were recorded
in its statement of operations.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 33pt; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"></p>


<ix:exclude><!-- Field: Page; Sequence: 156; Value: 1 -->
    <div style="border-bottom: Black 1.5pt solid; margin-bottom: 6pt"><table cellpadding="0" cellspacing="0" style="border-collapse: collapse; width: 100%; font-size: 10pt"><tr style="vertical-align: top; text-align: left"><td style="text-align: center; width: 100%">F-<!-- Field: Sequence; Type: Arabic; Name: PageNo -->15<!-- Field: /Sequence --></td></tr></table></div>
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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>GALMED
PHARMACEUTICALS LTD.</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Notes
to Consolidated Financial Statements</b></span></p>

<!-- Field: Rule-Page --><div style="margin-left: auto; margin-right: auto; width: 100%"><div style="border-top: Black 1.5pt solid; font-size: 1pt"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></div></div><!-- Field: /Rule-Page -->

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Note
5 &#8211; Leases (Cont.)</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">At
December 31, 2023, the Company&#8217;s operating lease right-of-use assets and current lease liabilities for operating leases totaled
$<span id="xdx_906_eus-gaap--OperatingLeaseRightOfUseAsset_iI_pn3n3_c20231231_zwvKXsDon118" title="Operating lease assets"><ix:nonFraction name="us-gaap:OperatingLeaseRightOfUseAsset" contextRef="AsOf2023-12-31" id="Fact000772" format="ixt:numdotdecimal" decimals="-3" scale="3" unitRef="USD">42</ix:nonFraction></span> thousand and $<span id="xdx_90A_eus-gaap--OperatingLeaseLiability_iI_pn3n3_c20231231_zct4A1RvkiAg" title="Operating lease liability"><ix:nonFraction name="us-gaap:OperatingLeaseLiability" contextRef="AsOf2023-12-31" id="Fact000774" format="ixt:numdotdecimal" decimals="-3" scale="3" unitRef="USD">41</ix:nonFraction></span> thousand, respectively, while at December 31, 2022, the Company&#8217;s operating lease assets and lease liabilities
(both the current and non-current portion) for operating leases totaled $<span id="xdx_90F_eus-gaap--OperatingLeaseRightOfUseAsset_iI_pn3n3_c20221231_zGJ44KFJUdvg" title="Operating lease assets"><ix:nonFraction name="us-gaap:OperatingLeaseRightOfUseAsset" contextRef="AsOf2022-12-31" id="Fact000776" format="ixt:numdotdecimal" decimals="-3" scale="3" unitRef="USD">223</ix:nonFraction></span> thousand and $<span id="xdx_90C_eus-gaap--OperatingLeaseLiability_iI_pn3n3_c20221231_zsPV5atG08u5" title="Operating lease liability"><ix:nonFraction name="us-gaap:OperatingLeaseLiability" contextRef="AsOf2022-12-31" id="Fact000778" format="ixt:numdotdecimal" decimals="-3" scale="3" unitRef="USD">216</ix:nonFraction></span> thousand, respectively.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
Company uses its incremental borrowing rate as the discount rate for its leases, as the implicit rate in the lease is not readily determinable.
As of December 31, 2023, the Company&#8217;s operating leases had a weighted average remaining lease term of <span id="xdx_90C_eus-gaap--OperatingLeaseWeightedAverageRemainingLeaseTerm1_iI_dtY_c20231231_zNUkw2lxc3Jk" title="Operating leases, weighted average remaining lease term (in years)"><ix:nonNumeric contextRef="AsOf2023-12-31" format="ixt-sec:duryear" id="Fact000780" name="us-gaap:OperatingLeaseWeightedAverageRemainingLeaseTerm1">0.25</ix:nonNumeric></span> years and a weighted
average borrowing rate of <span id="xdx_90D_eus-gaap--OperatingLeaseWeightedAverageDiscountRatePercent_iI_pid_dp_uPure_c20231231_zdGEe8l6fVzk" title="Operating leases, weighted average borrowing rate"><ix:nonFraction name="us-gaap:OperatingLeaseWeightedAverageDiscountRatePercent" contextRef="AsOf2023-12-31" id="Fact000782" format="ixt:numdotdecimal" decimals="INF" scale="-2" unitRef="Pure">2.3</ix:nonFraction>%</span>.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 33pt; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<ix:nonNumeric contextRef="From2023-01-01to2023-12-31" escape="true" id="Fact000784" name="us-gaap:LesseeOperatingLeaseLiabilityMaturityTableTextBlock"><p id="xdx_897_eus-gaap--LesseeOperatingLeaseLiabilityMaturityTableTextBlock_z7d1cRelGc43" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
following table summarizes the maturities of lease liabilities as of December 31, 2023:</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 33pt"><span style="display: none; font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;<span id="xdx_8B0_zo1rhGZ3wFq4">Schedule of Maturities of Lease Liabilities</span></span></p>

<table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 70%; margin-left: 0.5in">
  <tr style="display: none; vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td id="xdx_492_20231231_zE6FfaEWj9j1" style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td></tr>
  <tr id="xdx_40A_eus-gaap--LesseeOperatingLeaseLiabilityPaymentsDueNextTwelveMonths_iI_pn3n3_maOLLz9xP_zzRdqDEqltUk" style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="width: 80%; text-align: left"><span style="font-family: Times New Roman, Times, Serif">2024</span></td><td style="width: 2%"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="width: 1%; text-align: left"><span style="font-family: Times New Roman, Times, Serif">$</span></td><td style="width: 16%; text-align: right"><span style="font-family: Times New Roman, Times, Serif"><ix:nonFraction name="us-gaap:LesseeOperatingLeaseLiabilityPaymentsDueNextTwelveMonths" contextRef="AsOf2023-12-31" id="Fact000786" format="ixt:numdotdecimal" decimals="-3" scale="3" unitRef="USD">42</ix:nonFraction></span></td><td style="width: 1%; text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td></tr>
  <tr id="xdx_402_eus-gaap--LesseeOperatingLeaseLiabilityUndiscountedExcessAmount_iI_pn3n3_maOLLz9xP_z0eScGz48auc" style="vertical-align: bottom; background-color: White">
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">Imputed interest</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif"><ix:nonFraction name="us-gaap:LesseeOperatingLeaseLiabilityUndiscountedExcessAmount" contextRef="AsOf2023-12-31" id="Fact000788" format="ixt:numdotdecimal" decimals="-3" scale="3" unitRef="USD">1</ix:nonFraction></span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td></tr>
  <tr id="xdx_408_eus-gaap--OperatingLeaseLiability_iTI_pn3n3_mtOLLz9xP_zSXlsZUdKkz5" style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="padding-bottom: 2.5pt"><span style="font-family: Times New Roman, Times, Serif">Present value of lease liabilities</span></td><td style="padding-bottom: 2.5pt"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="border-bottom: Black 2.5pt double; text-align: left"><span style="font-family: Times New Roman, Times, Serif">$</span></td><td style="border-bottom: Black 2.5pt double; text-align: right"><span style="font-family: Times New Roman, Times, Serif"><ix:nonFraction name="us-gaap:OperatingLeaseLiability" contextRef="AsOf2023-12-31" id="Fact000790" format="ixt:numdotdecimal" decimals="-3" scale="3" unitRef="USD">41</ix:nonFraction></span></td><td style="padding-bottom: 2.5pt; text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td></tr>
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</ix:nonNumeric><p id="xdx_8A0_zYrOScX7u2fc" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

</ix:nonNumeric><ix:nonNumeric contextRef="From2023-01-01to2023-12-31" escape="true" id="Fact000792" name="us-gaap:PropertyPlantAndEquipmentDisclosureTextBlock"><p id="xdx_803_eus-gaap--PropertyPlantAndEquipmentDisclosureTextBlock_z0i4K8X7bMie" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Note
6 &#8211; <span id="xdx_823_zGDXykbUos3l">Property and equipment, net</span></b></span></p>

<ix:nonNumeric contextRef="From2023-01-01to2023-12-31" escape="true" id="Fact000794" name="us-gaap:PropertyPlantAndEquipmentTextBlock"><p id="xdx_89B_eus-gaap--PropertyPlantAndEquipmentTextBlock_ztSAfJJFRSQe" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="display: none; font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;<span id="xdx_8B0_zbNFSB8gMeU3">Schedule of Property and Equipment</span></span></p>

<table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 90%; margin-left: 0.5in">
  <tr style="display: none; vertical-align: bottom">
    <td style="padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="padding-bottom: 1.5pt; font-weight: bold"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
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<tr style="vertical-align: bottom">
    <td style="padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="padding-bottom: 1.5pt; font-weight: bold"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td colspan="6" style="border-bottom: Black 1.5pt solid; text-align: center; font-weight: bold"><span style="font-family: Times New Roman, Times, Serif">As
    of December 31,</span></td><td style="padding-bottom: 1.5pt; font-weight: bold"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td></tr>
  <tr style="vertical-align: bottom">
    <td style="padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="padding-bottom: 1.5pt; font-weight: bold"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
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  <tr style="vertical-align: bottom">
    <td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td colspan="6" style="text-align: center"><span style="font-family: Times New Roman, Times, Serif">(in thousands)</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td></tr>
  <tr id="xdx_40E_eus-gaap--MachineryAndEquipmentGross_iI_pn3n3_maPPAEGzWKA_zxqIdKo2lqih" style="vertical-align: bottom; background-color: rgb(204,238,255)">
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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>GALMED
PHARMACEUTICALS LTD.</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Notes
to Consolidated Financial Statements</b></span></p>

<!-- Field: Rule-Page --><div style="margin-left: auto; margin-right: auto; width: 100%"><div style="border-top: Black 1.5pt solid; font-size: 1pt"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></div></div><!-- Field: /Rule-Page -->

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

</ix:nonNumeric><ix:nonNumeric contextRef="From2023-01-01to2023-12-31" escape="true" id="Fact000817" name="us-gaap:InvestmentTextBlock"><p id="xdx_806_eus-gaap--InvestmentTextBlock_zFVTWbvx0yr1" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Note
</b>7 &#8211; <b><span id="xdx_82F_zuU3L57tp1U2">Investment in an Associate</span></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">On
May 4, 2023, the Company entered into a definitive agreement (the &#8220;Agreement&#8221;) for a $<span id="xdx_902_eus-gaap--StockIssuedDuringPeriodValueConversionOfConvertibleSecurities_pn5n6_c20230504__20230504__srt--TitleOfIndividualAxis__custom--OnkaiIncMember_zryBHcmKr12b" title="Additional investment on convertible safe notes"><ix:nonFraction name="us-gaap:StockIssuedDuringPeriodValueConversionOfConvertibleSecurities" contextRef="From2023-05-042023-05-04_custom_OnkaiIncMember" id="Fact000819" format="ixt:numdotdecimal" decimals="-5" scale="6" unitRef="USD">1.5</ix:nonFraction></span> million equity investment in OnKai,
a US-based technology company developing an AI-based platform to advance healthcare for underserved populations across the United States
by facilitating alignment between healthcare stakeholders.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Previously,
in November, 2022 the Company invested $<span id="xdx_90F_eus-gaap--StockIssuedDuringPeriodValueConversionOfConvertibleSecurities_pn5n6_c20221130__20221130__srt--TitleOfIndividualAxis__custom--OnkaiIncMember_zFQlddv0t0P4"><ix:nonFraction name="us-gaap:StockIssuedDuringPeriodValueConversionOfConvertibleSecurities" contextRef="From2022-11-302022-11-30_custom_OnkaiIncMember" id="Fact000820" format="ixt:numdotdecimal" decimals="-5" scale="6" unitRef="USD">1.5</ix:nonFraction>
</span></span><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">million in OnKai through a Simple Agreement for
Future Equity (&#8220;SAFE&#8221;) which converted at a <span id="xdx_90C_ecustom--CapitalStockDiscountRate_pid_dp_uPure_c20221130__20221130__srt--TitleOfIndividualAxis__custom--OnkaiIncMember_zitJk1oxE2qd"><ix:nonFraction name="GLMD:CapitalStockDiscountRate" contextRef="From2022-11-302022-11-30_custom_OnkaiIncMember" id="Fact000821" format="ixt:numdotdecimal" decimals="INF" scale="-2" unitRef="Pure">15</ix:nonFraction>%
</span></span><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">discount into series seed preferred shares upon
closing of the Investment Round (as defined below). The Company recorded in its statement of operations a change in the fair value of
the convertible note (the SAFE) which totaled $<span id="xdx_906_eus-gaap--GainLossOnInvestments_pn5n6_c20220101__20221231__srt--TitleOfIndividualAxis__custom--OnkaiIncMember_zF50C5pLipM5"><ix:nonFraction name="us-gaap:GainLossOnInvestments" contextRef="From2022-01-012022-12-31_custom_OnkaiIncMember" id="Fact000822" format="ixt:numdotdecimal" decimals="-5" scale="6" unitRef="USD">0.3</ix:nonFraction>
</span></span><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">million for the year ended December 31, 2023.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
Company&#8217;s investment in OnKai was part of an approximately $<span id="xdx_905_eus-gaap--PaymentsToAcquireInvestments_pn6n6_c20230101__20231231_z7I0ldOdlJsd" title="Investment"><ix:nonFraction name="us-gaap:PaymentsToAcquireInvestments" contextRef="From2023-01-01to2023-12-31" id="Fact000824" format="ixt:numdotdecimal" decimals="-6" scale="6" unitRef="USD">60</ix:nonFraction></span>. million investment round (the &#8220;Investment Round&#8221;) with
other investors that was led by the Company of which SAFEs of approximately $<span id="xdx_909_eus-gaap--StockIssuedDuringPeriodValueConversionOfConvertibleSecurities_pn5n6_c20230101__20231231__srt--TitleOfIndividualAxis__custom--OnkaiIncMember_zirdyCmpghBd" title="Value conversion"><ix:nonFraction name="us-gaap:StockIssuedDuringPeriodValueConversionOfConvertibleSecurities" contextRef="From2023-01-012023-12-31_custom_OnkaiIncMember" id="Fact000826" format="ixt:numdotdecimal" decimals="-5" scale="6" unitRef="USD">3.8</ix:nonFraction></span> were converted into preferred shares of Onkai upon the
consummation of the Investment Round.. On June 19, 2023, the Investment Round closed. Following the closing of the Investment Round,
the Company holds <span id="xdx_903_eus-gaap--InvestmentOwnedBalanceShares_iI_pid_c20230619__srt--TitleOfIndividualAxis__custom--OnkaiIncMember_zKiNFg3FQIh2" title="Shares owned"><ix:nonFraction name="us-gaap:InvestmentOwnedBalanceShares" contextRef="AsOf2023-06-19_custom_OnkaiIncMember" id="Fact000828" format="ixt:numdotdecimal" decimals="INF" unitRef="Shares">1,223,535</ix:nonFraction></span> preferred shares which comprised approximately <span id="xdx_906_eus-gaap--InvestmentOwnedPercentOfNetAssets_iI_pid_dp_uPure_c20230619__srt--TitleOfIndividualAxis__custom--OnkaiIncMember_ze7BZDtZ5sB3" title="Shares owned percentage"><ix:nonFraction name="us-gaap:InvestmentOwnedPercentOfNetAssets" contextRef="AsOf2023-06-19_custom_OnkaiIncMember" id="Fact000830" format="ixt:numdotdecimal" decimals="INF" scale="-2" unitRef="Pure">24</ix:nonFraction>%</span> of the outstanding share capital of OnKai on an as-converted
basis as of December 31, 2023. The Company&#8217;s Chief Executive Officer and director, Allen Baharaff, serves as one of three board
member of OnKai.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 3pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Under
the terms of the Agreement, during the three-year period following the closing of the Investment Round the Company will have the right
to merge with OnKai subject to the approval of the boards of directors of each of the Company and OnKai. The Company was granted certain
customary pre-emptive rights as well as registration rights, first refusal rights, co-sale, a board seat, and certain customary protective
provisions.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
connection with the Agreement, the Company&#8217;s wholly-owned subsidiary, (&#8220;GRD&#8221;), entered into a services agreement (the
&#8220;Services Agreement&#8221;) with OnKai. The Services Agreement provides that GRD will on a non-exclusive basis (i) provide support
services to OnKai relating to finance, business development, strategic planning, execution and others; and (ii) lend its experience to
OnKai in building a strategy and for the development of treatments for the underserved and that OnKai shall on a non-exclusive basis
(i) take part in plan preparation to serve GRD&#8217;s vision of developing drugs for the underserved population and (ii) when relevant,
design a process on the clinical trial dashboard that could potentially serve GDR&#8217;s future trial.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
connection with the above mentioned service agreement, the Company recorded management fee income of $<span id="xdx_90D_eus-gaap--GeneralAndAdministrativeExpense_pn3n3_c20230101__20231231__srt--ProductOrServiceAxis__us-gaap--AdministrativeServiceMember_zjtq4qNy1w7d" title="Management fee income"><ix:nonFraction name="us-gaap:GeneralAndAdministrativeExpense" contextRef="From2023-01-012023-12-31_us-gaap_AdministrativeServiceMember" id="Fact000832" format="ixt:numdotdecimal" decimals="-3" scale="3" unitRef="USD">12</ix:nonFraction></span> thousand in general and administrative
expenses in its statement of operations for the year ended December 31, 2023.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Attached
is a summarized un-audited financial information of OnkaI:</span></p>

<ix:nonNumeric contextRef="From2023-01-01to2023-12-31" escape="true" id="Fact000834" name="GLMD:ScheduleOfBalanceSheetsTableTextBlock"><p id="xdx_898_ecustom--ScheduleOfBalanceSheetsTableTextBlock_zHeizPDe0QC5" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>&#160;</b></span><span id="xdx_8BD_zh1bjYqUX2We" style="display: none">Schedule
of Balance Sheets</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><span style="text-decoration: underline">Balance
sheet as of December 31, 2023</span></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 65%; margin-left: 0.75in">
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    <td style="text-align: center"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: center; font-weight: bold"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
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  <tr style="vertical-align: bottom">
    <td style="text-align: center"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: center; font-weight: bold; padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
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  <tr style="vertical-align: bottom">
    <td style="text-align: center"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: center; font-weight: bold"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
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  <tr id="xdx_405_eus-gaap--AssetsCurrent_iI_pn3n3_msSEzDrf_zJRV6fjxFQO3" style="vertical-align: bottom; background-color: rgb(204,238,255)">
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</ix:nonNumeric><p id="xdx_8AD_zswVdjaqDGY6" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><span style="text-decoration: underline">Statement
of operations for the period from June 19, 2023 to December 31, 2023:</span></b></span></p>

<ix:nonNumeric contextRef="From2023-01-01to2023-12-31" escape="true" id="Fact000846" name="GLMD:ScheduleOfStatementOfOperationsTableTextBlock"><p id="xdx_896_ecustom--ScheduleOfStatementOfOperationsTableTextBlock_z6qGMOiu2De3" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span><span id="xdx_8BC_zG737Z1cjaD7" style="display: none">Schedule of Statement of Operations</span></p>

<table cellpadding="0" cellspacing="0" summary="xdx: Disclosure - Schedule of Unaudited Operation Statement Information (Details)" style="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 90%; margin-left: 0.5in">
  <tr style="vertical-align: bottom">
    <td style="padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="padding-bottom: 1.5pt; font-weight: bold"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td colspan="2" id="xdx_490_20230101__20231231__srt--TitleOfIndividualAxis__custom--OnkaiIncMember_z4pSlDq2EUsk" style="border-bottom: Black 1.5pt solid; text-align: center; font-weight: bold"><span style="font-family: Times New Roman, Times, Serif">(in
    thousands)</span></td><td style="padding-bottom: 1.5pt; font-weight: bold"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td></tr>
  <tr style="vertical-align: bottom">
    <td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td colspan="2"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td></tr>
  <tr id="xdx_40D_eus-gaap--OperatingExpenses_pn3n3_msNILzGpU_zW4x0XfeIPW1" style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="width: 80%; text-align: left"><span style="font-family: Times New Roman, Times, Serif">Total operating loss</span></td><td style="width: 2%"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
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  <tr id="xdx_40C_eus-gaap--NonoperatingIncomeExpense_pn3n3_maNILzGpU_zLWtDT49mqcf" style="vertical-align: bottom; background-color: White">
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">Financial income, net</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif"><ix:nonFraction name="us-gaap:NonoperatingIncomeExpense" contextRef="From2023-01-012023-12-31_custom_OnkaiIncMember" id="Fact000850" format="ixt:numdotdecimal" decimals="-3" scale="3" unitRef="USD">23</ix:nonFraction></span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td></tr>
  <tr id="xdx_40C_eus-gaap--IncomeTaxExpenseBenefit_pn3n3_msNILzGpU_zpL4Fml0T5V4" style="vertical-align: bottom; background-color: rgb(204,238,255)">
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    <td style="border-bottom: Black 1.5pt solid; text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="border-bottom: Black 1.5pt solid; text-align: right"><span style="font-family: Times New Roman, Times, Serif"><ix:nonFraction name="us-gaap:IncomeTaxExpenseBenefit" contextRef="From2023-01-012023-12-31_custom_OnkaiIncMember" id="Fact000852" format="ixt:numdotdecimal" decimals="-3" scale="3" unitRef="USD">16</ix:nonFraction></span></td><td style="padding-bottom: 1.5pt; text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td></tr>
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</ix:nonNumeric><p id="xdx_8AD_zI2bsgtSgrRg" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>


<ix:exclude><!-- Field: Page; Sequence: 158; Value: 1 -->
    <div style="border-bottom: Black 1.5pt solid; margin-bottom: 6pt"><table cellpadding="0" cellspacing="0" style="border-collapse: collapse; width: 100%; font-size: 10pt"><tr style="vertical-align: top; text-align: left"><td style="text-align: center; width: 100%">F-<!-- Field: Sequence; Type: Arabic; Name: PageNo -->17<!-- Field: /Sequence --></td></tr></table></div>
    <div style="break-before: page; margin-top: 6pt"><p style="margin: 0pt">&#160;</p></div>
    <!-- Field: /Page --></ix:exclude>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>GALMED
                                            PHARMACEUTICALS LTD.</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Notes
to Consolidated Financial Statements</b></span></p>

<!-- Field: Rule-Page --><div style="margin-left: auto; margin-right: auto; width: 100%"><div style="border-top: Black 1.5pt solid; font-size: 1pt"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></div></div><!-- Field: /Rule-Page -->

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"></p>


<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

</ix:nonNumeric><ix:nonNumeric contextRef="From2023-01-01to2023-12-31" escape="true" id="Fact000856" name="us-gaap:OtherLiabilitiesDisclosureTextBlock"><p id="xdx_800_eus-gaap--OtherLiabilitiesDisclosureTextBlock_z05p8pSz2c48" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Note
8 &#8211; <span id="xdx_82E_z7p0HO6Zc1yg">Other Payables</span></b></span></p>


<ix:nonNumeric contextRef="From2023-01-01to2023-12-31" escape="true" id="Fact000858" name="us-gaap:OtherLiabilitiesTableTextBlock"><p id="xdx_89B_eus-gaap--OtherLiabilitiesTableTextBlock_zV96Po8cuHQg" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="display: none; font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;<span id="xdx_8BE_zZPyVRTCkqB6">Schedule
of Other Payables</span></span></p>

<table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 90%; margin-left: 0.5in">
  <tr style="display: none; vertical-align: bottom">
    <td style="padding-bottom: 1.5pt; text-align: center"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="padding-bottom: 1.5pt; text-align: center; font-weight: bold"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
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<tr style="vertical-align: bottom">
    <td style="padding-bottom: 1.5pt; text-align: center"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="padding-bottom: 1.5pt; text-align: center; font-weight: bold"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
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  <tr style="vertical-align: bottom">
    <td style="padding-bottom: 1.5pt; text-align: center"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="padding-bottom: 1.5pt; text-align: center; font-weight: bold"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
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  <tr style="vertical-align: bottom">
    <td style="text-align: center"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: center; font-weight: bold"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
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    <td style="width: 60%; text-align: left"><span style="font-family: Times New Roman, Times, Serif">Employees and related</span></td><td style="width: 2%"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
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    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">Short-term lease obligation</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif"><ix:nonFraction name="GLMD:ShorttermLeaseObligation" contextRef="AsOf2023-12-31" id="Fact000863" format="ixt:numdotdecimal" decimals="-3" scale="3" unitRef="USD">41</ix:nonFraction></span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif"><ix:nonFraction name="GLMD:ShorttermLeaseObligation" contextRef="AsOf2022-12-31" id="Fact000864" format="ixt:numdotdecimal" decimals="-3" scale="3" unitRef="USD">171</ix:nonFraction></span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td></tr>
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    <td style="text-align: left">Other Payables</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><span style="-sec-ix-hidden: xdx2ixbrl0866">-</span></td><td style="text-align: left">&#160;</td><td>&#160;</td>
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</ix:nonNumeric><p id="xdx_8AE_zjrUJVGUbQt6" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

</ix:nonNumeric><ix:nonNumeric contextRef="From2023-01-01to2023-12-31" escape="true" id="Fact000875" name="us-gaap:RelatedPartyTransactionsDisclosureTextBlock"><p id="xdx_808_eus-gaap--RelatedPartyTransactionsDisclosureTextBlock_zXdX1corb449" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 3pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Note
9 &#8211; <span id="xdx_828_zK94XaRlY1Ji">Related Parties</span></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">1.</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">As
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  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
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    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">2.</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">As
    of December 31, 2023, the Company had a receivable balance of $<span id="xdx_901_eus-gaap--RelatedPartyTransactionAmountsOfTransaction_pn3n3_c20230101__20231231__us-gaap--TypeOfArrangementAxis__custom--ServiceAgreementMember_zBko0ldhD5U2" title="Related party services, balance amount"><ix:nonFraction name="us-gaap:RelatedPartyTransactionAmountsOfTransaction" contextRef="From2023-01-012023-12-31_custom_ServiceAgreementMember" id="Fact000881" format="ixt:numdotdecimal" decimals="-3" scale="3" unitRef="USD">4</ix:nonFraction></span>
    thousand, pursuant to a service agreement with OnKai.</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
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  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">4.</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">During
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  </table>
<!-- Field: Split-Segment; Name: 002 -->
<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

</ix:nonNumeric><ix:nonNumeric contextRef="From2023-01-01to2023-12-31" escape="true" id="Fact000889" name="us-gaap:CommitmentsAndContingenciesDisclosureTextBlock"><p id="xdx_800_eus-gaap--CommitmentsAndContingenciesDisclosureTextBlock_zAcs8SAVGzx6" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Note
10 </b>&#8211; <b><span id="xdx_829_zxa16YZm2En7">Commitments and Contingencies</span></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">1.</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">As
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  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">2.</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
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    supply manufacturing and with vendors for non-clinical research studies and other services and products for operating purposes, which
    generally provide for termination upon 30 to 90 days&#8217; notice or less, and therefore are cancelable contracts and not considered
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  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">3.</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">For
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  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">4.</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">On
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    develop and commercialize Amilo-5Mer. Under the license agreement, the Company is responsible for carrying out the development and
    commercialization of Amilo-5Mer and the prosecution and maintenance of the licensed patents under the license agreement. In consideration
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  </table>
<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify; text-indent: -16.2pt"></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>


<ix:exclude><!-- Field: Page; Sequence: 159; Value: 1 -->
    <div style="border-bottom: Black 1.5pt solid; margin-bottom: 6pt"><table cellpadding="0" cellspacing="0" style="border-collapse: collapse; width: 100%; font-size: 10pt"><tr style="vertical-align: top; text-align: left"><td style="text-align: center; width: 100%">F-<!-- Field: Sequence; Type: Arabic; Name: PageNo -->18<!-- Field: /Sequence --></td></tr></table></div>
    <div style="break-before: page; margin-top: 6pt"><p style="margin: 0pt">&#160;</p></div>
    <!-- Field: /Page --></ix:exclude>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>GALMED
PHARMACEUTICALS LTD.</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Notes
to Consolidated Financial Statements</b></span></p>

<!-- Field: Rule-Page --><div style="margin-left: auto; margin-right: auto; width: 100%"><div style="border-top: Black 1.5pt solid; font-size: 1pt"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></div></div><!-- Field: /Rule-Page -->

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

</ix:nonNumeric><ix:nonNumeric contextRef="From2023-01-01to2023-12-31" escape="true" id="Fact000899" name="us-gaap:ShareholdersEquityAndShareBasedPaymentsTextBlock"><p id="xdx_803_eus-gaap--ShareholdersEquityAndShareBasedPaymentsTextBlock_zaXt106vRgkj" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Note
11 &#8211; <span id="xdx_822_zALpJjUcyvt2">Stockholders&#8217; equity</span></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>A.</b></span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Ordinary
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  </table>
<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>&#160;</b></span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="width: 0.5in"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">1.</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Ordinary
    shares confer upon the holders the right to receive notice to participate and vote in general meetings of the Company and the right
    to receive dividends, if declared.</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">2.</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">During
    February 2021, the Company entered into an underwriting agreement (the &#8220;Underwriting Agreement&#8221;) with Cantor Fitzgerald
    &amp; Co. (the &#8220;Underwriter&#8221;) in connection with an underwritten public offering (the &#8220;Underwritten Public Offering&#8221;)
    of <span id="xdx_903_eus-gaap--StockIssuedDuringPeriodSharesNewIssues_pid_c20210201__20210228__us-gaap--StatementEquityComponentsAxis__us-gaap--CommonStockMember__us-gaap--SubsidiarySaleOfStockAxis__custom--UnderwrittenPublicOfferingMember_z1xaaWOCjXC8" title="Shares issued, shares"><ix:nonFraction name="us-gaap:StockIssuedDuringPeriodSharesNewIssues" contextRef="From2021-02-012021-02-28_us-gaap_CommonStockMember_custom_UnderwrittenPublicOfferingMember" id="Fact000901" format="ixt:numdotdecimal" decimals="INF" unitRef="Shares">147,577</ix:nonFraction></span> ordinary shares (the &#8220;Firm Shares&#8221;) of the Company (the &#8220;Ordinary Shares&#8221;). The Underwriter agreed
    to purchase the Firm Shares from the Company at a price of $<span id="xdx_90B_eus-gaap--SharesIssuedPricePerShare_iI_pid_c20210228__us-gaap--StatementEquityComponentsAxis__us-gaap--CommonStockMember__us-gaap--SubsidiarySaleOfStockAxis__custom--UnderwrittenPublicOfferingMember_zXZDTQaC2ivl" title="Share price"><ix:nonFraction name="us-gaap:SharesIssuedPricePerShare" contextRef="AsOf2021-02-28_us-gaap_CommonStockMember_custom_UnderwrittenPublicOfferingMember" id="Fact000903" format="ixt:numdotdecimal" decimals="INF" unitRef="USDPShares">64.81</ix:nonFraction></span> per share. The net proceeds to the Company were approximately $<span id="xdx_901_eus-gaap--ProceedsFromIssuanceOfCommonStock_pn5n6_c20210201__20210228__us-gaap--StatementEquityComponentsAxis__us-gaap--CommonStockMember__us-gaap--SubsidiarySaleOfStockAxis__custom--UnderwrittenPublicOfferingMember_zze8u1hLjUX6" title="Proceeds from sale of ordinary shares"><ix:nonFraction name="us-gaap:ProceedsFromIssuanceOfCommonStock" contextRef="From2021-02-012021-02-28_us-gaap_CommonStockMember_custom_UnderwrittenPublicOfferingMember" id="Fact000905" format="ixt:numdotdecimal" decimals="-5" scale="6" unitRef="USD">9.2</ix:nonFraction></span>
    million.</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">3.</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">On
    March 26, 2021, the Company entered into a Sales Agreement with Cantor Fitzgerald &amp; Co. and Canaccord Genuity LLC, as sales agents,
    pursuant to which the Company may offer and sell ordinary shares &#8220;at the market&#8221; having an aggregate offering price of
    up to $<span id="xdx_90A_ecustom--MaximumAmountOfSharesToBeIssued_iI_pn5n6_c20210326__us-gaap--TypeOfArrangementAxis__custom--NewSalesAgreementMember_zzdljcxqFgqh" title="Aggregate offering price"><ix:nonFraction name="GLMD:MaximumAmountOfSharesToBeIssued" contextRef="AsOf2021-03-26_custom_NewSalesAgreementMember" id="Fact000907" format="ixt:numdotdecimal" decimals="-5" scale="6" unitRef="USD">50.0</ix:nonFraction></span> million from time to time through the sales agents. As of December 31, 2023, the Company sold <span id="xdx_90E_eus-gaap--StockIssuedDuringPeriodSharesNewIssues_pid_c20230101__20231231__us-gaap--TypeOfArrangementAxis__custom--NewSalesAgreementMember_zWKZq4QDf7dc" title="Additional ordinary shares"><ix:nonFraction name="us-gaap:StockIssuedDuringPeriodSharesNewIssues" contextRef="From2023-01-012023-12-31_custom_NewSalesAgreementMember" id="Fact000909" format="ixt:numdotdecimal" decimals="INF" unitRef="Shares">7,721</ix:nonFraction></span> ordinary shares under
    its ATM program for total net proceeds of approximately $<span id="xdx_904_eus-gaap--ProceedsFromIssuanceOfCommonStock_pn5n6_c20230101__20231231__us-gaap--TypeOfArrangementAxis__custom--NewSalesAgreementMember_zxR4GZoYsJRj" title="Proceeds from sale of ordinary shares"><ix:nonFraction name="us-gaap:ProceedsFromIssuanceOfCommonStock" contextRef="From2023-01-012023-12-31_custom_NewSalesAgreementMember" id="Fact000911" format="ixt:numdotdecimal" decimals="-5" scale="6" unitRef="USD">0.1</ix:nonFraction></span> million.</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">4.</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">On
    May 15, 2023, the Company effected a reverse share split of the Company&#8217;s ordinary shares at the ratio of <span id="xdx_905_eus-gaap--StockholdersEquityReverseStockSplit_c20230515__20230515__us-gaap--StatementEquityComponentsAxis__us-gaap--CommonStockMember_zHWc0aoxeMC6" title="Reverse stock split"><ix:nonNumeric contextRef="From2023-05-152023-05-15_us-gaap_CommonStockMember" id="Fact000913" name="us-gaap:StockholdersEquityReverseStockSplit">1-for-15</ix:nonNumeric></span>, such that
    each fifteen (15) ordinary shares, par value NIS <span id="xdx_902_eus-gaap--CommonStockNoParValue_iI_pid_uILSPShares_c20230515__us-gaap--StatementEquityComponentsAxis__us-gaap--CommonStockMember_zJigc9I2N7sd" title="Common stock, par value"><ix:nonFraction name="us-gaap:CommonStockNoParValue" contextRef="AsOf2023-05-15_us-gaap_CommonStockMember" id="Fact000915" format="ixt:numdotdecimal" decimals="INF" unitRef="ILSPShares">0.01</ix:nonFraction></span> per share, were consolidated into one (1) ordinary share, par value NIS <span id="xdx_90D_eus-gaap--SaleOfStockPricePerShare_iI_pid_uILSPShares_c20230515__us-gaap--StatementEquityComponentsAxis__us-gaap--CommonStockMember_zcV43sjAWDA7" title="Share price"><ix:nonFraction name="us-gaap:SaleOfStockPricePerShare" contextRef="AsOf2023-05-15_us-gaap_CommonStockMember" id="Fact000917" format="ixt:numdotdecimal" decimals="INF" unitRef="ILSPShares">0.15</ix:nonFraction></span>.
    As a result, all share and per share amounts prior to the reverse share split were adjusted retroactively for all periods presented
    in these consolidated financial statements.</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">5.</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">On
    July 18, 2023, the Company sold to investors in a public offering (i) <span id="xdx_90B_eus-gaap--StockIssuedDuringPeriodSharesNewIssues_c20230718__20230718_zrpR0fwoEQc5"><ix:nonFraction name="us-gaap:StockIssuedDuringPeriodSharesNewIssues" contextRef="From2023-07-182023-07-18" id="Fact000918" format="ixt:numdotdecimal" decimals="-3" scale="3" unitRef="Shares">380,000</ix:nonFraction></span> ordinary shares, (ii) <span id="xdx_908_eus-gaap--ClassOfWarrantOrRightNumberOfSecuritiesCalledByEachWarrantOrRight_iI_c20230718__us-gaap--SubsidiarySaleOfStockAxis__custom--PrefundedWarrantsMember_zJNr9Jxew4Pl" title="Stock and warrants issued during period shares"><ix:nonFraction name="us-gaap:ClassOfWarrantOrRightNumberOfSecuritiesCalledByEachWarrantOrRight" contextRef="AsOf2023-07-18_custom_PrefundedWarrantsMember" id="Fact000920" format="ixt:numdotdecimal" decimals="-3" scale="3" unitRef="Shares">5,220,000</ix:nonFraction></span> pre-funded warrants
    to purchase <span id="xdx_90B_eus-gaap--ConversionOfStockSharesIssued1_c20230718__20230718__us-gaap--SubsidiarySaleOfStockAxis__custom--PrefundedWarrantsMember__us-gaap--StatementEquityComponentsAxis__us-gaap--CommonStockMember_z1nDrD87bdUc" title="Class of Warrant or Right, Number of Securities Called by Warrants or Rights"><ix:nonFraction name="us-gaap:ConversionOfStockSharesIssued1" contextRef="From2023-07-182023-07-18_custom_PrefundedWarrantsMember_us-gaap_CommonStockMember" id="Fact000922" format="ixt:numdotdecimal" decimals="-3" scale="3" unitRef="Shares">5,220,000</ix:nonFraction></span> ordinary shares (the &#8220;Pre-Funded Warrants&#8221;), and (iii) <span id="xdx_906_eus-gaap--ClassOfWarrantOrRightNumberOfSecuritiesCalledByEachWarrantOrRight_iI_c20230718__us-gaap--SubsidiarySaleOfStockAxis__custom--InvestorWarrantsMember_zoIi5VdYces6" title="Stock and warrants issued during period shares"><ix:nonFraction name="us-gaap:ClassOfWarrantOrRightNumberOfSecuritiesCalledByEachWarrantOrRight" contextRef="AsOf2023-07-18_custom_InvestorWarrantsMember" id="Fact000924" format="ixt:numdotdecimal" decimals="-3" scale="3" unitRef="Shares">5,600,000</ix:nonFraction></span> warrants to purchase <span id="xdx_904_eus-gaap--ConversionOfStockSharesIssued1_c20230718__20230718__us-gaap--SubsidiarySaleOfStockAxis__custom--InvestorWarrantsMember__us-gaap--StatementEquityComponentsAxis__us-gaap--CommonStockMember_zd24ZdyqSBEe" title="Class of Warrant or Right, Number of Securities Called by Warrants or Rights"><ix:nonFraction name="us-gaap:ConversionOfStockSharesIssued1" contextRef="From2023-07-182023-07-18_custom_InvestorWarrantsMember_us-gaap_CommonStockMember" id="Fact000926" format="ixt:numdotdecimal" decimals="-3" scale="3" unitRef="Shares">5,600,000</ix:nonFraction></span>
    ordinary shares (the &#8220;Investor Warrants&#8221;), at a purchase price of $<span id="xdx_90A_eus-gaap--SharePrice_iI_pid_c20230718__us-gaap--SubsidiarySaleOfStockAxis__custom--InvestorWarrantsMember__us-gaap--StatementEquityComponentsAxis__us-gaap--CommonStockMember_zAhJvbwAN5J4" title="Share price"><ix:nonFraction name="us-gaap:SharePrice" contextRef="AsOf2023-07-18_custom_InvestorWarrantsMember_us-gaap_CommonStockMember" id="Fact000928" format="ixt:numdotdecimal" decimals="INF" unitRef="USDPShares">1.25</ix:nonFraction></span> per ordinary share and accompanying Investor
    Warrant and $<span id="xdx_908_eus-gaap--ClassOfWarrantOrRightExercisePriceOfWarrantsOrRights1_iI_pid_c20230718__us-gaap--SubsidiarySaleOfStockAxis__custom--InvestorWarrantsMember_zmTpmeEcgY32" title="Exercise price of warrants"><ix:nonFraction name="us-gaap:ClassOfWarrantOrRightExercisePriceOfWarrantsOrRights1" contextRef="AsOf2023-07-18_custom_InvestorWarrantsMember" id="Fact000930" format="ixt:numdotdecimal" decimals="INF" unitRef="USDPShares">1.249</ix:nonFraction></span> per Pre-Funded Warrant and accompanying Investor Warrant. </span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
    Pre-Funded Warrants are immediately exercisable at an exercise price of $<span id="xdx_904_eus-gaap--ClassOfWarrantOrRightExercisePriceOfWarrantsOrRights1_iI_pid_c20230718__us-gaap--SubsidiarySaleOfStockAxis__custom--PrefundedWarrantsMember__us-gaap--StatementEquityComponentsAxis__us-gaap--CommonStockMember_zRtnCxn5j2Qa" title="Exercise price of warrants"><ix:nonFraction name="us-gaap:ClassOfWarrantOrRightExercisePriceOfWarrantsOrRights1" contextRef="AsOf2023-07-18_custom_PrefundedWarrantsMember_us-gaap_CommonStockMember" id="Fact000932" format="ixt:numdotdecimal" decimals="INF" unitRef="USDPShares">0.001</ix:nonFraction></span> per ordinary share and will not expire until exercised
    in full. The Investor Warrants have an exercise price of $<span id="xdx_903_eus-gaap--ClassOfWarrantOrRightExercisePriceOfWarrantsOrRights1_iI_pid_c20230718__us-gaap--SubsidiarySaleOfStockAxis__custom--InvestorWarrantsMember__us-gaap--StatementEquityComponentsAxis__us-gaap--CommonStockMember_zzwOj6p3nBDh" title="Exercise price of warrants"><ix:nonFraction name="us-gaap:ClassOfWarrantOrRightExercisePriceOfWarrantsOrRights1" contextRef="AsOf2023-07-18_custom_InvestorWarrantsMember_us-gaap_CommonStockMember" id="Fact000934" format="ixt:numdotdecimal" decimals="INF" unitRef="USDPShares">1.25</ix:nonFraction></span> per ordinary share, are immediately exercisable, and may be exercised
    until July 18, 2028. The net proceeds to the Company were approximately $<span id="xdx_905_eus-gaap--ProceedsFromIssuanceOfCommonStock_pn5n6_c20230718__20230718_zZepxZhikpvd" title="Proceeds from sale of ordinary shares"><ix:nonFraction name="us-gaap:ProceedsFromIssuanceOfCommonStock" contextRef="From2023-07-182023-07-18" id="Fact000936" format="ixt:numdotdecimal" decimals="-5" scale="6" unitRef="USD">6.2</ix:nonFraction></span> million.</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">6.</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><p style="margin: 0"><span style="font-family: Times New Roman, Times, Serif">As
                                            of December 31, 2023, a total of <span id="xdx_904_eus-gaap--ClassOfWarrantOrRightNumberOfSecuritiesCalledByEachWarrantOrRight_iI_c20231231__us-gaap--SubsidiarySaleOfStockAxis__custom--PrefundedWarrantsMember_zuvjIFzumYG5" title="Stock and warrants issued during period shares"><ix:nonFraction name="us-gaap:ClassOfWarrantOrRightNumberOfSecuritiesCalledByEachWarrantOrRight" contextRef="AsOf2023-12-31_custom_PrefundedWarrantsMember" id="Fact000938" format="ixt:numdotdecimal" decimals="-3" scale="3" unitRef="Shares">2,975,000</ix:nonFraction></span> Pre-Funded Warrants were exercised into <span id="xdx_90B_eus-gaap--ConversionOfStockSharesIssued1_c20230101__20231231__us-gaap--SubsidiarySaleOfStockAxis__custom--PrefundedWarrantsMember__us-gaap--StatementEquityComponentsAxis__us-gaap--CommonStockMember_z6emRSMJJzXl" title="Class of Warrant or Right, Number of Securities Called by Warrants or Rights"><ix:nonFraction name="us-gaap:ConversionOfStockSharesIssued1" contextRef="From2023-01-012023-12-31_custom_PrefundedWarrantsMember_us-gaap_CommonStockMember" id="Fact000940" format="ixt:numdotdecimal" decimals="-3" scale="3" unitRef="Shares">2,972,982</ix:nonFraction></span>
                                            ordinary shares, out of <span style="font-size: 10pt">which a total of <span id="xdx_907_eus-gaap--ClassOfWarrantOrRightNumberOfSecuritiesCalledByWarrantsOrRights_iI_c20231231__us-gaap--SubsidiarySaleOfStockAxis__custom--PrefundedWarrantsMember_zj32d1t4yzL" title="Stock and warrants issued during period shares"><ix:nonFraction name="us-gaap:ClassOfWarrantOrRightNumberOfSecuritiesCalledByWarrantsOrRights" contextRef="AsOf2023-12-31_custom_PrefundedWarrantsMember" id="Fact000942" format="ixt:numdotdecimal" decimals="-3" scale="3" unitRef="Shares">1,090,000</ix:nonFraction></span> Pre-funded
                                            warrants were exercised on a cashless basis (as permitted under the terms of the Pre-Funded
                                            Warrants) into <span id="xdx_90B_eus-gaap--ConversionOfStockSharesConverted1_pid_c20230101__20231231__us-gaap--SubsidiarySaleOfStockAxis__custom--PrefundedWarrantsMember__us-gaap--StatementEquityComponentsAxis__us-gaap--CommonStockMember_zbGSZdwXaf0e" title="Stock and warrants issued during period shares"><ix:nonFraction name="us-gaap:ConversionOfStockSharesConverted1" contextRef="From2023-01-012023-12-31_custom_PrefundedWarrantsMember_us-gaap_CommonStockMember" id="Fact000944" format="ixt:numdotdecimal" decimals="INF" unitRef="Shares">1,087,982</ix:nonFraction></span> ordinary shares. Subsequent to the balance sheet date, as April
                                            3, 2024 a total of <span id="xdx_902_eus-gaap--ClassOfWarrantOrRightNumberOfSecuritiesCalledByEachWarrantOrRight_iI_pid_c20240403__us-gaap--SubsequentEventTypeAxis__us-gaap--SubsequentEventMember__us-gaap--SubsidiarySaleOfStockAxis__custom--PrefundedWarrantsMember_zBeLysOwkEWj" title="Stock and warrants issued during period shares"><span><ix:nonFraction name="us-gaap:ClassOfWarrantOrRightNumberOfSecuritiesCalledByEachWarrantOrRight" contextRef="AsOf2024-04-03_us-gaap_SubsequentEventMember_custom_PrefundedWarrantsMember" id="Fact000946" format="ixt:numdotdecimal" decimals="INF" unitRef="Shares">965,000</ix:nonFraction></span></span> Pre-Funded Warrants were exercised into <span id="xdx_90B_eus-gaap--ConversionOfStockSharesIssued1_pid_c20240403__20240403__us-gaap--SubsequentEventTypeAxis__us-gaap--SubsequentEventMember__us-gaap--SubsidiarySaleOfStockAxis__custom--PrefundedWarrantsMember__us-gaap--StatementEquityComponentsAxis__us-gaap--CommonStockMember_zhIoG3jtt7L5" title="Class of Warrant or Right, Number of Securities Called by Warrants or Rights"><ix:nonFraction name="us-gaap:ConversionOfStockSharesIssued1" contextRef="From2024-04-032024-04-03_us-gaap_SubsequentEventMember_custom_PrefundedWarrantsMember_us-gaap_CommonStockMember" id="Fact000948" format="ixt:numdotdecimal" decimals="INF" unitRef="Shares">964,330</ix:nonFraction></span> ordinary shares,
                                            out of which, a total of <span id="xdx_90F_eus-gaap--ClassOfWarrantOrRightNumberOfSecuritiesCalledByWarrantsOrRights_iI_pid_c20240403__us-gaap--SubsequentEventTypeAxis__us-gaap--SubsequentEventMember__us-gaap--SubsidiarySaleOfStockAxis__custom--PrefundedWarrantsMember_zZLGns2RrZY7" title="Stock and warrants issued during period shares"><ix:nonFraction name="us-gaap:ClassOfWarrantOrRightNumberOfSecuritiesCalledByWarrantsOrRights" contextRef="AsOf2024-04-03_us-gaap_SubsequentEventMember_custom_PrefundedWarrantsMember" id="Fact000950" format="ixt:numdotdecimal" decimals="INF" unitRef="Shares">240,000</ix:nonFraction></span> Pre-funded Warrants were exercised on a cashless basis (as
                                            permitted under the terms of the Pre-Funded Warrants)into <span id="xdx_907_eus-gaap--ConversionOfStockSharesConverted1_pid_c20240403__20240403__us-gaap--SubsequentEventTypeAxis__us-gaap--SubsequentEventMember__us-gaap--SubsidiarySaleOfStockAxis__custom--PrefundedWarrantsMember__us-gaap--StatementEquityComponentsAxis__us-gaap--CommonStockMember_zikb311Wtmyl" title="Stock and warrants issued during period shares"><ix:nonFraction name="us-gaap:ConversionOfStockSharesConverted1" contextRef="From2024-04-032024-04-03_us-gaap_SubsequentEventMember_custom_PrefundedWarrantsMember_us-gaap_CommonStockMember" id="Fact000952" format="ixt:numdotdecimal" decimals="INF" unitRef="Shares">239,330</ix:nonFraction></span> ordinary shares.</span></span></p></td></tr>
  </table>
<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 1in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>


<ix:exclude><!-- Field: Page; Sequence: 160; Value: 1 -->
    <div style="border-bottom: Black 1.5pt solid; margin-bottom: 6pt"><table cellpadding="0" cellspacing="0" style="border-collapse: collapse; width: 100%; font-size: 10pt"><tr style="vertical-align: top; text-align: left"><td style="text-align: center; width: 100%">F-<!-- Field: Sequence; Type: Arabic; Name: PageNo -->19<!-- Field: /Sequence --></td></tr></table></div>
    <div style="break-before: page; margin-top: 6pt"><p style="margin: 0pt">&#160;</p></div>
    <!-- Field: /Page --></ix:exclude>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>GALMED
PHARMACEUTICALS LTD.</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Notes
to Consolidated Financial Statements</b></span></p>

<!-- Field: Rule-Page --><div style="margin-left: auto; margin-right: auto; width: 100%"><div style="border-top: Black 1.5pt solid; font-size: 1pt"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></div></div><!-- Field: /Rule-Page -->

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Note
11 &#8211; Stockholders&#8217; equity (Cont.)</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>B.</b></span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Stock-based
    compensation</b></span></td></tr>
  </table>
<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">1.</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
    Company has an equity-based incentive plan, the 2013 Incentive Share Option Plan (the &#8220;2013 Plan&#8221;). As of December 31,
    2023, based on the latest amendment to the plan from August 7, 2023, a total of <span id="xdx_90D_eus-gaap--CommonStockCapitalSharesReservedForFutureIssuance_iI_pid_c20231231__us-gaap--PlanNameAxis__custom--IncentiveShareOptionPlan2013Member_z3lITfLf8IY4" title="Shares reserved for future issuance"><ix:nonFraction name="us-gaap:CommonStockCapitalSharesReservedForFutureIssuance" contextRef="AsOf2023-12-31_custom_IncentiveShareOptionPlan2013Member" id="Fact000954" format="ixt:numdotdecimal" decimals="INF" unitRef="Shares">2,000,000</ix:nonFraction></span> ordinary shares were reserved for issuance
    under the 2013 Plan, of which a total of <span id="xdx_900_ecustom--CommonStockCapitalSharesReservedForFutureIssuanceUnallocated_iI_pid_c20231231__us-gaap--PlanNameAxis__custom--IncentiveShareOptionPlan2013Member_zIDSBi1OXax9" title="Shares reserved for future issuance"><ix:nonFraction name="GLMD:CommonStockCapitalSharesReservedForFutureIssuanceUnallocated" contextRef="AsOf2023-12-31_custom_IncentiveShareOptionPlan2013Member" id="Fact000956" format="ixt:numdotdecimal" decimals="INF" unitRef="Shares">367,026</ix:nonFraction></span> ordinary shares remain reserved, but unallocated for future equity awards. The 2013
    Plan, which was adopted by the Board on September 2, 2013, and approved by the Company&#8217;s shareholders on December 30, 2013
    (as was amended by the Board and the Company&#8217;s shareholders on March 30, 2015, May 11, 2015, August 30, 2018 and August 7,
    2023 respectively), provides for the grant of options to purchase the ordinary shares and the issuance of RSUs to the Company&#8217;s
    officers, directors, employees, service providers and consultants. The 2013 Plan provides for such equity-based compensation under
    various and different tax regimes.</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">2.</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">During
    February 2021, certain office holders exercised options into <span id="xdx_906_eus-gaap--StockIssuedDuringPeriodSharesStockOptionsExercised_pid_c20210201__20210228_zZEdtpH3hRa" title="Exercised options ordinary shares"><ix:nonFraction name="us-gaap:StockIssuedDuringPeriodSharesStockOptionsExercised" contextRef="From2021-02-012021-02-28" id="Fact000958" format="ixt:numdotdecimal" decimals="INF" unitRef="Shares">1,249</ix:nonFraction></span> ordinary shares of the Company for a total amount of less than
    $<span id="xdx_904_eus-gaap--StockIssuedDuringPeriodValueStockOptionsExercised_pn3n3_c20210201__20210228_z54viHuSSnwk" title="Stock option exercised amount"><ix:nonFraction name="us-gaap:StockIssuedDuringPeriodValueStockOptionsExercised" contextRef="From2021-02-012021-02-28" id="Fact000960" format="ixt:numdotdecimal" decimals="-3" scale="3" unitRef="USD">1</ix:nonFraction></span> thousand.</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">3.</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
    March 2021, the Company granted options to purchase <span id="xdx_908_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsGrantsInPeriodGross_pid_c20210301__20210331_zUk6F1t12y3h" title="Options granted"><ix:nonFraction name="us-gaap:ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsGrantsInPeriodGross" contextRef="From2021-03-012021-03-31" id="Fact000962" format="ixt:numdotdecimal" decimals="INF" unitRef="Shares">3,000</ix:nonFraction></span> ordinary shares of the Company to an employee and a consultant. The options
    are exercisable at $<span id="xdx_906_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsExercisableWeightedAverageExercisePrice_iI_pid_c20210331_zvf4s59zcQg" title="Options exercisable per share"><ix:nonFraction name="us-gaap:ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsExercisableWeightedAverageExercisePrice" contextRef="AsOf2021-03-31" id="Fact000964" format="ixt:numdotdecimal" decimals="INF" unitRef="USDPShares">62.4</ix:nonFraction></span> per share, have a <span id="xdx_901_eus-gaap--SharebasedCompensationArrangementBySharebasedPaymentAwardOptionsOutstandingWeightedAverageRemainingContractualTerm2_dtY_c20210301__20210331_z8gmsc1Etvx5" title="Contractual term"><ix:nonNumeric contextRef="From2021-03-012021-03-31" format="ixt-sec:duryear" id="Fact000966" name="us-gaap:SharebasedCompensationArrangementBySharebasedPaymentAwardOptionsOutstandingWeightedAverageRemainingContractualTerm2">10</ix:nonNumeric></span>-year term and vest over a period of four years. The aggregate grant date fair value
    of such options was approximately $<span id="xdx_903_eus-gaap--SharebasedCompensationArrangementBySharebasedPaymentAwardEquityInstrumentsOtherThanOptionsAggregateIntrinsicValueVested_pn5n6_c20210301__20210331_zzpfFk55D7vk" title="Aggregate grant fair value"><ix:nonFraction name="us-gaap:SharebasedCompensationArrangementBySharebasedPaymentAwardEquityInstrumentsOtherThanOptionsAggregateIntrinsicValueVested" contextRef="From2021-03-012021-03-31" id="Fact000968" format="ixt:numdotdecimal" decimals="-5" scale="6" unitRef="USD">0.1</ix:nonFraction></span> million.</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">4.</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
    July, 2021, the Company granted options to purchase <span id="xdx_90D_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsGrantsInPeriodGross_pid_c20210701__20210731_zwS4Z5sDfg85" title="Options granted"><ix:nonFraction name="us-gaap:ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsGrantsInPeriodGross" contextRef="From2021-07-012021-07-31" id="Fact000970" format="ixt:numdotdecimal" decimals="INF" unitRef="Shares">6,667</ix:nonFraction></span> ordinary shares of the Company to its non-management directors subject
    to shareholders&#8217; approval (which was obtained in August 2021). The options are exercisable at $<span id="xdx_900_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsExercisableWeightedAverageExercisePrice_iI_pid_c20210731_zLWv5qdAKaIh" title="Options exercisable per share"><ix:nonFraction name="us-gaap:ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsExercisableWeightedAverageExercisePrice" contextRef="AsOf2021-07-31" id="Fact000972" format="ixt:numdotdecimal" decimals="INF" unitRef="USDPShares">46.5</ix:nonFraction></span> per share, have a <span id="xdx_906_eus-gaap--SharebasedCompensationArrangementBySharebasedPaymentAwardOptionsOutstandingWeightedAverageRemainingContractualTerm2_dtY_c20210701__20210731_zEfC3wdrhZ77" title="Contractual term"><ix:nonNumeric contextRef="From2021-07-012021-07-31" format="ixt-sec:duryear" id="Fact000974" name="us-gaap:SharebasedCompensationArrangementBySharebasedPaymentAwardOptionsOutstandingWeightedAverageRemainingContractualTerm2">10</ix:nonNumeric></span>-year
    term and vest over a period of <span id="xdx_902_eus-gaap--SharebasedCompensationArrangementBySharebasedPaymentAwardOptionsVestedAndExpectedToVestOutstandingWeightedAverageRemainingContractualTerm1_dt_c20210701__20210731_z9U8KDsUzcA5" title="Vest period"><ix:nonNumeric contextRef="From2021-07-012021-07-31" format="ixt-sec:durwordsen" id="Fact000976" name="us-gaap:SharebasedCompensationArrangementBySharebasedPaymentAwardOptionsVestedAndExpectedToVestOutstandingWeightedAverageRemainingContractualTerm1">three years</ix:nonNumeric></span>. The aggregate grant date fair value of such options was approximately $<span id="xdx_907_eus-gaap--SharebasedCompensationArrangementBySharebasedPaymentAwardEquityInstrumentsOtherThanOptionsAggregateIntrinsicValueVested_pn5n6_c20210701__20210731_zfPJrVwo7dge" title="Aggregate grant fair value"><ix:nonFraction name="us-gaap:SharebasedCompensationArrangementBySharebasedPaymentAwardEquityInstrumentsOtherThanOptionsAggregateIntrinsicValueVested" contextRef="From2021-07-012021-07-31" id="Fact000978" format="ixt:numdotdecimal" decimals="-5" scale="6" unitRef="USD">0.2</ix:nonFraction></span> million.</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">5.</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
    August, 2021, the Company granted options to purchase <span id="xdx_90A_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsGrantsInPeriodGross_pid_c20210801__20210831_z1bl8rAsQE3d" title="Options granted"><ix:nonFraction name="us-gaap:ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsGrantsInPeriodGross" contextRef="From2021-08-012021-08-31" id="Fact000980" format="ixt:numdotdecimal" decimals="INF" unitRef="Shares">2,500</ix:nonFraction></span> ordinary shares of the Company to certain service providers. The options
    are exercisable at $<span id="xdx_909_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsExercisableWeightedAverageExercisePrice_iI_pid_c20210831_z7N94YbKDvbe" title="Options exercisable per share"><ix:nonFraction name="us-gaap:ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsExercisableWeightedAverageExercisePrice" contextRef="AsOf2021-08-31" id="Fact000982" format="ixt:numdotdecimal" decimals="INF" unitRef="USDPShares">42.45</ix:nonFraction></span> per share, have a <span id="xdx_90E_eus-gaap--SharebasedCompensationArrangementBySharebasedPaymentAwardOptionsOutstandingWeightedAverageRemainingContractualTerm2_dtY_c20210801__20210831_z9FVQxjMGwoe" title="Contractual term"><ix:nonNumeric contextRef="From2021-08-012021-08-31" format="ixt-sec:duryear" id="Fact000984" name="us-gaap:SharebasedCompensationArrangementBySharebasedPaymentAwardOptionsOutstandingWeightedAverageRemainingContractualTerm2">10</ix:nonNumeric></span>-year term and vest over a period of <span id="xdx_909_eus-gaap--SharebasedCompensationArrangementBySharebasedPaymentAwardOptionsVestedAndExpectedToVestOutstandingWeightedAverageRemainingContractualTerm1_dt_c20210801__20210831_zayjFkOhOFeh" title="Vest period"><ix:nonNumeric contextRef="From2021-08-012021-08-31" format="ixt-sec:durwordsen" id="Fact000986" name="us-gaap:SharebasedCompensationArrangementBySharebasedPaymentAwardOptionsVestedAndExpectedToVestOutstandingWeightedAverageRemainingContractualTerm1">three years</ix:nonNumeric></span>. The aggregate grant date fair value
    of such options was approximately $<span id="xdx_90B_eus-gaap--SharebasedCompensationArrangementBySharebasedPaymentAwardEquityInstrumentsOtherThanOptionsAggregateIntrinsicValueVested_pn4n6_c20210801__20210831_zL2vLu1vI5X5" title="Aggregate grant fair value"><ix:nonFraction name="us-gaap:SharebasedCompensationArrangementBySharebasedPaymentAwardEquityInstrumentsOtherThanOptionsAggregateIntrinsicValueVested" contextRef="From2021-08-012021-08-31" id="Fact000988" format="ixt:numdotdecimal" decimals="-4" scale="6" unitRef="USD">0.01</ix:nonFraction></span> million.</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">6.</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
    February 2022, the Company granted options to purchase <span id="xdx_903_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsGrantsInPeriodGross_pid_c20220201__20220228_zJq8KjLIzrK7" title="Options granted"><ix:nonFraction name="us-gaap:ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsGrantsInPeriodGross" contextRef="From2022-02-012022-02-28" id="Fact000990" format="ixt:numdotdecimal" decimals="INF" unitRef="Shares">2,667</ix:nonFraction></span> ordinary shares of the Company to one of its officers. The options are
    exercisable at $<span id="xdx_90B_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsExercisableWeightedAverageExercisePrice_iI_pid_c20220228_zFC6vbEIcMV8" title="Options exercisable per share"><ix:nonFraction name="us-gaap:ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsExercisableWeightedAverageExercisePrice" contextRef="AsOf2022-02-28" id="Fact000992" format="ixt:numdotdecimal" decimals="INF" unitRef="USDPShares">24.15</ix:nonFraction></span> per share, have a <span id="xdx_909_eus-gaap--SharebasedCompensationArrangementBySharebasedPaymentAwardOptionsOutstandingWeightedAverageRemainingContractualTerm2_dtY_c20220201__20220228_zTFZuQ8ugYD4" title="Contractual term"><ix:nonNumeric contextRef="From2022-02-012022-02-28" format="ixt-sec:duryear" id="Fact000994" name="us-gaap:SharebasedCompensationArrangementBySharebasedPaymentAwardOptionsOutstandingWeightedAverageRemainingContractualTerm2">10</ix:nonNumeric></span>-year term and vest over a period of <span id="xdx_90E_eus-gaap--SharebasedCompensationArrangementBySharebasedPaymentAwardOptionsVestedAndExpectedToVestOutstandingWeightedAverageRemainingContractualTerm1_dt_c20220201__20220228_zh0hjl07nNdd" title="Vest period"><ix:nonNumeric contextRef="From2022-02-012022-02-28" format="ixt-sec:durwordsen" id="Fact000996" name="us-gaap:SharebasedCompensationArrangementBySharebasedPaymentAwardOptionsVestedAndExpectedToVestOutstandingWeightedAverageRemainingContractualTerm1">four years</ix:nonNumeric></span>.</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">7.</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">On
    March 23, 2023, the Company received a ruling from the Israel Tax Authority (&#8220;ITA&#8221;) confirming the repricing of certain
    stock options. This repricing was accounted for as a modification of a share-based payment award. The incremental compensation expense
    recognized as a result of the modification during the year ended December 31, 2023 was approximately $<span id="xdx_908_eus-gaap--OtherExpenses_pn5n6_c20230101__20231231_zm6TVv8sHref" title="Compensation expense"><ix:nonFraction name="us-gaap:OtherExpenses" contextRef="From2023-01-01to2023-12-31" id="Fact000998" format="ixt:numdotdecimal" decimals="-5" scale="6" unitRef="USD">0.1</ix:nonFraction></span> million.</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">8.</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
    August 2023, the Company granted <span id="xdx_905_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsGrantsInPeriodGross_pid_c20230801__20230831__us-gaap--AwardTypeAxis__us-gaap--RestrictedStockUnitsRSUMember_z0X9Vjh2lgv5" title="Options granted"><ix:nonFraction name="us-gaap:ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsGrantsInPeriodGross" contextRef="From2023-08-012023-08-31_us-gaap_RestrictedStockUnitsRSUMember" id="Fact001000" format="ixt:numdotdecimal" decimals="INF" unitRef="Shares">1,315,000</ix:nonFraction></span> (RSUs) and <span id="xdx_90F_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsGrantsInPeriodGross_pid_c20230801__20230831_zQxrGQg9FOhg" title="Options granted"><ix:nonFraction name="us-gaap:ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsGrantsInPeriodGross" contextRef="From2023-08-012023-08-31" id="Fact001002" format="ixt:numdotdecimal" decimals="INF" unitRef="Shares">75,000</ix:nonFraction></span> options to purchase <span id="xdx_90F_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsGrantsInPeriodGross_pid_c20230801__20230831_zNx4uzJtnX95" title="Options granted"><ix:nonFraction name="us-gaap:ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsGrantsInPeriodGross" contextRef="From2023-08-012023-08-31" id="Fact001004" format="ixt:numdotdecimal" decimals="INF" unitRef="Shares">75,000</ix:nonFraction></span> ordinary shares of the Company to its officers
    and directors. The options are exercisable at $<span id="xdx_90A_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsExercisableWeightedAverageExercisePrice_iI_pid_c20230831_zQzSX6Ucpchj" title="Options exercisable per share"><ix:nonFraction name="us-gaap:ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsExercisableWeightedAverageExercisePrice" contextRef="AsOf2023-08-31" id="Fact001006" format="ixt:numdotdecimal" decimals="INF" unitRef="USDPShares">1.05</ix:nonFraction></span> per share and have a <span id="xdx_907_eus-gaap--SharebasedCompensationArrangementBySharebasedPaymentAwardOptionsOutstandingWeightedAverageRemainingContractualTerm2_dtY_c20230801__20230831_z2zISTWQo67l" title="Contractual term"><ix:nonNumeric contextRef="From2023-08-012023-08-31" format="ixt-sec:duryear" id="Fact001008" name="us-gaap:SharebasedCompensationArrangementBySharebasedPaymentAwardOptionsOutstandingWeightedAverageRemainingContractualTerm2">10</ix:nonNumeric></span>-year term. The options and RSUs vest over a period of
    three years. The aggregate grant date fair value of such RSUs and options was approximately $<span id="xdx_907_eus-gaap--SharebasedCompensationArrangementBySharebasedPaymentAwardEquityInstrumentsOtherThanOptionsAggregateIntrinsicValueVested_pn5n6_c20230801__20230831_z8YReEF47SBc" title="Aggregate grant fair value"><ix:nonFraction name="us-gaap:SharebasedCompensationArrangementBySharebasedPaymentAwardEquityInstrumentsOtherThanOptionsAggregateIntrinsicValueVested" contextRef="From2023-08-012023-08-31" id="Fact001010" format="ixt:numdotdecimal" decimals="-5" scale="6" unitRef="USD">0.9</ix:nonFraction></span> million.</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">9.</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
    September 2023, the Company extended the exercise period of <span id="xdx_90F_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsGrantsInPeriodGross_pid_c20230901__20230930__srt--TitleOfIndividualAxis__srt--ChiefExecutiveOfficerMember_z2dLveWHXd22" title="Options granted"><ix:nonFraction name="us-gaap:ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsGrantsInPeriodGross" contextRef="From2023-09-012023-09-30_srt_ChiefExecutiveOfficerMember" id="Fact001012" format="ixt:numdotdecimal" decimals="INF" unitRef="Shares">21,654</ix:nonFraction></span> options with an exercise price of <span id="xdx_906_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsExercisableWeightedAverageExercisePrice_iI_pid_uILSPShares_c20230930__srt--TitleOfIndividualAxis__srt--ChiefExecutiveOfficerMember_zkHG3sDmFKil" title="Options granted"><ix:nonFraction name="us-gaap:ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsExercisableWeightedAverageExercisePrice" contextRef="AsOf2023-09-30_srt_ChiefExecutiveOfficerMember" id="Fact001014" format="ixt:numdotdecimal" decimals="INF" unitRef="ILSPShares">0.15</ix:nonFraction></span> NIS previously granted
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    represented a modification in accordance with ASC 718. The Incremental compensation expense on the modification date was less than
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  </table>
<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 65pt; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"></p>


<ix:exclude><!-- Field: Page; Sequence: 161; Value: 1 -->
    <div style="border-bottom: Black 1.5pt solid; margin-bottom: 6pt"><table cellpadding="0" cellspacing="0" style="border-collapse: collapse; width: 100%; font-size: 10pt"><tr style="vertical-align: top; text-align: left"><td style="text-align: center; width: 100%">F-<!-- Field: Sequence; Type: Arabic; Name: PageNo -->20<!-- Field: /Sequence --></td></tr></table></div>
    <div style="break-before: page; margin-top: 6pt"><p style="margin: 0pt">&#160;</p></div>
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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>GALMED
PHARMACEUTICALS LTD.</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Notes
to Consolidated Financial Statements</b></span></p>

<!-- Field: Rule-Page --><div style="margin-left: auto; margin-right: auto; width: 100%"><div style="border-top: Black 1.5pt solid; font-size: 1pt"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></div></div><!-- Field: /Rule-Page -->

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Note
11 &#8211; Stockholders&#8217; equity (Cont.)</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>B.</b></span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Stock-based
    compensation (Cont.)</b></span></td></tr>
  </table>
<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
<tr style="vertical-align: top">
    <td style="width: 0.5in"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
  <td style="text-align: justify; width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">7.</span></td>
  <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">A summary of the status of
  the Company&#8217;s outstanding options as of December 31, 2023 and 2022 and changes during the years then ended are presented below:</span></td></tr>
</table>


<ix:nonNumeric contextRef="From2023-01-01to2023-12-31" escape="true" id="Fact001020" name="us-gaap:ScheduleOfShareBasedCompensationStockOptionsActivityTableTextBlock"><p id="xdx_89E_eus-gaap--ScheduleOfShareBasedCompensationStockOptionsActivityTableTextBlock_zAjcPadpktPh" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><span id="xdx_8B2_zPuAckMaAnSj" style="display: none">Summary
of Status of Company's Option Plans and Changes</span></span></p>

<table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 97%; margin-left: 0.25in">
  <tr style="vertical-align: bottom">
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  <tr style="vertical-align: bottom">
    <td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
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  <tr style="vertical-align: bottom">
    <td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="font-weight: bold"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
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  <tr style="vertical-align: bottom">
    <td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="font-weight: bold"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td colspan="2" style="font-weight: bold; text-align: center"><span style="font-family: Times New Roman, Times, Serif">share</span></td><td style="font-weight: bold"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="font-weight: bold"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td colspan="2" style="font-weight: bold; text-align: center"><span style="font-family: Times New Roman, Times, Serif">exercise</span></td><td style="font-weight: bold"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="font-weight: bold"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
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    <td colspan="2" style="font-weight: bold; text-align: center"><span style="font-family: Times New Roman, Times, Serif">exercise</span></td><td style="font-weight: bold"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td></tr>
  <tr style="vertical-align: bottom">
    <td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="font-weight: bold; padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td colspan="2" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center"><span style="font-family: Times New Roman, Times, Serif">options</span></td><td style="padding-bottom: 1.5pt; font-weight: bold"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="font-weight: bold; padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
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    <td colspan="2" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center"><span style="font-family: Times New Roman, Times, Serif">price</span></td><td style="padding-bottom: 1.5pt; font-weight: bold"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td></tr>
  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="width: 36%; font-weight: bold; text-align: left"><span style="font-family: Times New Roman, Times, Serif">Options outstanding
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  <tr style="vertical-align: bottom; background-color: White">
    <td style="font-weight: bold"><span style="font-family: Times New Roman, Times, Serif">Granted</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td id="xdx_987_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsGrantsInPeriodGross_pid_c20230101__20231231__us-gaap--OptionIndexedToIssuersEquityEquityAxis__us-gaap--EmployeeStockOptionMember_z6oYRZbHSide" title="Number of share options, Granted" style="text-align: right"><span style="font-family: Times New Roman, Times, Serif"><ix:nonFraction name="us-gaap:ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsGrantsInPeriodGross" contextRef="From2023-01-012023-12-31_us-gaap_EmployeeStockOptionMember241848234" id="Fact001030" format="ixt:numdotdecimal" decimals="INF" unitRef="Shares">75,000</ix:nonFraction></span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">$</span></td><td id="xdx_985_eus-gaap--ShareBasedCompensationArrangementsByShareBasedPaymentAwardOptionsGrantsInPeriodWeightedAverageExercisePrice_pid_c20230101__20231231__us-gaap--OptionIndexedToIssuersEquityEquityAxis__us-gaap--EmployeeStockOptionMember_zFymRhRSYNVh" title="Weighted average exercise price, Granted" style="text-align: right"><span style="font-family: Times New Roman, Times, Serif"><ix:nonFraction name="us-gaap:ShareBasedCompensationArrangementsByShareBasedPaymentAwardOptionsGrantsInPeriodWeightedAverageExercisePrice" contextRef="From2023-01-012023-12-31_us-gaap_EmployeeStockOptionMember241848234" id="Fact001032" format="ixt:numdotdecimal" decimals="INF" unitRef="USDPShares">1.05</ix:nonFraction></span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td id="xdx_983_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsGrantsInPeriodGross_pid_c20220101__20221231__us-gaap--OptionIndexedToIssuersEquityEquityAxis__us-gaap--EmployeeStockOptionMember_zGTWPd0gnrL6" title="Number of share options, Granted" style="text-align: right"><span style="font-family: Times New Roman, Times, Serif"><ix:nonFraction name="us-gaap:ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsGrantsInPeriodGross" contextRef="From2022-01-012022-12-31_us-gaap_EmployeeStockOptionMember241848250" id="Fact001034" format="ixt:numdotdecimal" decimals="INF" unitRef="Shares">2,666</ix:nonFraction></span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">$</span></td><td id="xdx_989_eus-gaap--ShareBasedCompensationArrangementsByShareBasedPaymentAwardOptionsGrantsInPeriodWeightedAverageExercisePrice_pid_c20220101__20221231__us-gaap--OptionIndexedToIssuersEquityEquityAxis__us-gaap--EmployeeStockOptionMember_zdqS00MhNsI1" title="Weighted average exercise price, Granted" style="text-align: right"><span style="font-family: Times New Roman, Times, Serif"><ix:nonFraction name="us-gaap:ShareBasedCompensationArrangementsByShareBasedPaymentAwardOptionsGrantsInPeriodWeightedAverageExercisePrice" contextRef="From2022-01-012022-12-31_us-gaap_EmployeeStockOptionMember241848250" id="Fact001036" format="ixt:numdotdecimal" decimals="INF" unitRef="USDPShares">5.7</ix:nonFraction></span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td></tr>
  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="font-weight: bold; padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif">Forfeited</span></td><td style="padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="border-bottom: Black 1.5pt solid; text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td id="xdx_98D_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsForfeituresInPeriod_iN_pid_di_c20230101__20231231__us-gaap--OptionIndexedToIssuersEquityEquityAxis__us-gaap--EmployeeStockOptionMember_zWscTzSuaDU2" title="Number of share options, Forfeited" style="border-bottom: Black 1.5pt solid; text-align: right"><span style="font-family: Times New Roman, Times, Serif">(<ix:nonFraction name="us-gaap:ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsForfeituresInPeriod" contextRef="From2023-01-012023-12-31_us-gaap_EmployeeStockOptionMember241848234" id="Fact001038" format="ixt:numdotdecimal" decimals="INF" unitRef="Shares">11,351</ix:nonFraction></span></td><td style="padding-bottom: 1.5pt; text-align: left"><span style="font-family: Times New Roman, Times, Serif">)</span></td><td style="padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="border-bottom: Black 1.5pt solid; text-align: left"><span style="font-family: Times New Roman, Times, Serif">$</span></td><td id="xdx_988_eus-gaap--ShareBasedCompensationArrangementsByShareBasedPaymentAwardOptionsForfeituresInPeriodWeightedAverageExercisePrice_pid_c20230101__20231231__us-gaap--OptionIndexedToIssuersEquityEquityAxis__us-gaap--EmployeeStockOptionMember_zQZKISvx6am" title="Weighted average exercise price, Forfeited" style="border-bottom: Black 1.5pt solid; text-align: right"><span style="font-family: Times New Roman, Times, Serif"><ix:nonFraction name="us-gaap:ShareBasedCompensationArrangementsByShareBasedPaymentAwardOptionsForfeituresInPeriodWeightedAverageExercisePrice" contextRef="From2023-01-012023-12-31_us-gaap_EmployeeStockOptionMember241848234" id="Fact001040" format="ixt:numdotdecimal" decimals="INF" unitRef="USDPShares">36.8</ix:nonFraction></span></td><td style="padding-bottom: 1.5pt; text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="border-bottom: Black 1.5pt solid; text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td id="xdx_989_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsForfeituresInPeriod_iN_pid_di_c20220101__20221231__us-gaap--OptionIndexedToIssuersEquityEquityAxis__us-gaap--EmployeeStockOptionMember_zqY8c4jdIYjk" title="Number of share options, Forfeited" style="border-bottom: Black 1.5pt solid; text-align: right"><span style="font-family: Times New Roman, Times, Serif">(<ix:nonFraction name="us-gaap:ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsForfeituresInPeriod" contextRef="From2022-01-012022-12-31_us-gaap_EmployeeStockOptionMember241848250" id="Fact001042" format="ixt:numdotdecimal" decimals="INF" unitRef="Shares">14,961</ix:nonFraction></span></td><td style="padding-bottom: 1.5pt; text-align: left"><span style="font-family: Times New Roman, Times, Serif">)</span></td><td style="padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="border-bottom: Black 1.5pt solid; text-align: left"><span style="font-family: Times New Roman, Times, Serif">$</span></td><td id="xdx_98B_eus-gaap--ShareBasedCompensationArrangementsByShareBasedPaymentAwardOptionsForfeituresInPeriodWeightedAverageExercisePrice_pid_c20220101__20221231__us-gaap--OptionIndexedToIssuersEquityEquityAxis__us-gaap--EmployeeStockOptionMember_zCzwoNLveB76" title="Weighted average exercise price, Forfeited" style="border-bottom: Black 1.5pt solid; text-align: right"><span style="font-family: Times New Roman, Times, Serif"><ix:nonFraction name="us-gaap:ShareBasedCompensationArrangementsByShareBasedPaymentAwardOptionsForfeituresInPeriodWeightedAverageExercisePrice" contextRef="From2022-01-012022-12-31_us-gaap_EmployeeStockOptionMember241848250" id="Fact001044" format="ixt:numdotdecimal" decimals="INF" unitRef="USDPShares">49.61</ix:nonFraction></span></td><td style="padding-bottom: 1.5pt; text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td></tr>
  <tr style="vertical-align: bottom; background-color: White">
    <td style="font-weight: bold; text-align: left; padding-bottom: 2.5pt"><span style="font-family: Times New Roman, Times, Serif">Outstanding
    at end of year</span></td><td style="padding-bottom: 2.5pt"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="border-bottom: Black 2.5pt double; text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td id="xdx_98D_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsOutstandingNumber_iE_pid_c20230101__20231231__us-gaap--OptionIndexedToIssuersEquityEquityAxis__us-gaap--EmployeeStockOptionMember_zTRFV9axdMPb" title="Number of share options, Ending" style="border-bottom: Black 2.5pt double; text-align: right"><span style="font-family: Times New Roman, Times, Serif"><ix:nonFraction name="us-gaap:ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsOutstandingNumber" contextRef="AsOf2023-12-31_us-gaap_EmployeeStockOptionMember241848281" id="Fact001046" format="ixt:numdotdecimal" decimals="INF" unitRef="Shares">240,744</ix:nonFraction></span></td><td style="padding-bottom: 2.5pt; text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="padding-bottom: 2.5pt"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="border-bottom: Black 2.5pt double; text-align: left"><span style="font-family: Times New Roman, Times, Serif">$</span></td><td id="xdx_980_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsOutstandingWeightedAverageExercisePrice_iE_pid_c20230101__20231231__us-gaap--OptionIndexedToIssuersEquityEquityAxis__us-gaap--EmployeeStockOptionMember_zVxpkQtZVsg1" title="Weighted average exercise price, Ending" style="border-bottom: Black 2.5pt double; text-align: right"><span style="font-family: Times New Roman, Times, Serif"><ix:nonFraction name="us-gaap:ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsOutstandingWeightedAverageExercisePrice" contextRef="AsOf2023-12-31_us-gaap_EmployeeStockOptionMember241848281" id="Fact001048" format="ixt:numdotdecimal" decimals="INF" unitRef="USDPShares">38.32</ix:nonFraction></span></td><td style="padding-bottom: 2.5pt; text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="padding-bottom: 2.5pt"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="padding-bottom: 2.5pt; text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td id="xdx_983_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsOutstandingNumber_iE_pid_c20220101__20221231__us-gaap--OptionIndexedToIssuersEquityEquityAxis__us-gaap--EmployeeStockOptionMember_zjPvqbcYE9ik" title="Number of share options, Ending" style="border-bottom: Black 2.5pt double; text-align: right"><span style="font-family: Times New Roman, Times, Serif"><ix:nonFraction name="us-gaap:ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsOutstandingNumber" contextRef="AsOf2022-12-31_us-gaap_EmployeeStockOptionMember241848203" id="Fact001050" format="ixt:numdotdecimal" decimals="INF" unitRef="Shares">177,095</ix:nonFraction></span></td><td style="padding-bottom: 2.5pt; text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="padding-bottom: 2.5pt"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="border-bottom: Black 2.5pt double; text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td id="xdx_985_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsOutstandingWeightedAverageExercisePrice_iE_pid_c20220101__20221231__us-gaap--OptionIndexedToIssuersEquityEquityAxis__us-gaap--EmployeeStockOptionMember_zmgnihaKlT54" title="Weighted average exercise price, Ending" style="border-bottom: Black 2.5pt double; text-align: right"><span style="font-family: Times New Roman, Times, Serif"><ix:nonFraction name="us-gaap:ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsOutstandingWeightedAverageExercisePrice" contextRef="AsOf2022-12-31_us-gaap_EmployeeStockOptionMember241848203" id="Fact001052" format="ixt:numdotdecimal" decimals="INF" unitRef="USDPShares">54.51</ix:nonFraction></span></td><td style="padding-bottom: 2.5pt; text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td></tr>
  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="font-weight: bold; text-align: left; padding-bottom: 2.5pt"><span style="font-family: Times New Roman, Times, Serif">Options
    exercisable at year end</span></td><td style="padding-bottom: 2.5pt"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="border-bottom: Black 2.5pt double; text-align: left"><span style="font-family: Times New Roman, Times, Serif">$</span></td><td id="xdx_98F_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsExercisableNumber_iE_pid_c20230101__20231231__us-gaap--OptionIndexedToIssuersEquityEquityAxis__us-gaap--EmployeeStockOptionMember_zphoQULN7tZe" title="Number of share options exercisable, Ending" style="border-bottom: Black 2.5pt double; text-align: right"><span style="font-family: Times New Roman, Times, Serif"><ix:nonFraction name="us-gaap:ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsExercisableNumber" contextRef="AsOf2023-12-31_us-gaap_EmployeeStockOptionMember241848281" id="Fact001054" format="ixt:numdotdecimal" decimals="INF" unitRef="Shares">159,229</ix:nonFraction></span></td><td style="padding-bottom: 2.5pt; text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="padding-bottom: 2.5pt"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="border-bottom: Black 2.5pt double; text-align: left"><span style="font-family: Times New Roman, Times, Serif">$</span></td><td id="xdx_985_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsExercisableWeightedAverageExercisePrice_iE_pid_c20230101__20231231__us-gaap--OptionIndexedToIssuersEquityEquityAxis__us-gaap--EmployeeStockOptionMember_zmRsuuKqZ8ik" title="Weighted average exercise price, Options exercisable, Ending" style="border-bottom: Black 2.5pt double; text-align: right"><span style="font-family: Times New Roman, Times, Serif"><ix:nonFraction name="us-gaap:ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsExercisableWeightedAverageExercisePrice" contextRef="AsOf2023-12-31_us-gaap_EmployeeStockOptionMember241848281" id="Fact001056" format="ixt:numdotdecimal" decimals="INF" unitRef="USDPShares">55.88</ix:nonFraction></span></td><td style="padding-bottom: 2.5pt; text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="padding-bottom: 2.5pt"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="padding-bottom: 2.5pt; text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td id="xdx_989_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsExercisableNumber_iE_pid_c20220101__20221231__us-gaap--OptionIndexedToIssuersEquityEquityAxis__us-gaap--EmployeeStockOptionMember_zjx5Rj3XZ8J7" title="Number of share options exercisable, Ending" style="border-bottom: Black 2.5pt double; text-align: right"><span style="font-family: Times New Roman, Times, Serif"><ix:nonFraction name="us-gaap:ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsExercisableNumber" contextRef="AsOf2022-12-31_us-gaap_EmployeeStockOptionMember241848203" id="Fact001058" format="ixt:numdotdecimal" decimals="INF" unitRef="Shares">152,469</ix:nonFraction></span></td><td style="padding-bottom: 2.5pt; text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="padding-bottom: 2.5pt"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="border-bottom: Black 2.5pt double; text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td id="xdx_98C_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsExercisableWeightedAverageExercisePrice_iE_pid_c20220101__20221231__us-gaap--OptionIndexedToIssuersEquityEquityAxis__us-gaap--EmployeeStockOptionMember_z6CM0r9xgXxe" title="Weighted average exercise price, Options exercisable, Ending" style="border-bottom: Black 2.5pt double; text-align: right"><span style="font-family: Times New Roman, Times, Serif"><ix:nonFraction name="us-gaap:ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsExercisableWeightedAverageExercisePrice" contextRef="AsOf2022-12-31_us-gaap_EmployeeStockOptionMember241848203" id="Fact001060" format="ixt:numdotdecimal" decimals="INF" unitRef="USDPShares">56.9</ix:nonFraction></span></td><td style="padding-bottom: 2.5pt; text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td></tr>
  </table>

</ix:nonNumeric><p id="xdx_8AD_z2c1mnHmKqCa" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
following assumptions were used for the fiscal year 2023, 2022 and 2021 grants:</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">-</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">dividend
    yield of <span id="xdx_90D_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardFairValueAssumptionsExpectedDividendRate_pid_dp_c20230101__20231231__us-gaap--AwardTypeAxis__us-gaap--EmployeeStockOptionMember_z15WUeBRg5s3" title="Dividend yield"><span id="xdx_901_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardFairValueAssumptionsExpectedDividendRate_pid_dp_c20220101__20221231__us-gaap--AwardTypeAxis__us-gaap--EmployeeStockOptionMember_zASzgdek5Mt4" title="Dividend yield"><span id="xdx_904_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardFairValueAssumptionsExpectedDividendRate_pid_dp_c20210101__20211231__us-gaap--AwardTypeAxis__us-gaap--EmployeeStockOptionMember_zV4xwfoeuz4j" title="Dividend yield"><ix:nonFraction name="us-gaap:ShareBasedCompensationArrangementByShareBasedPaymentAwardFairValueAssumptionsExpectedDividendRate" contextRef="From2023-01-012023-12-31_us-gaap_EmployeeStockOptionMember" id="Fact001062" format="ixt:numdotdecimal" decimals="INF" scale="-2" unitRef="Pure"><ix:nonFraction name="us-gaap:ShareBasedCompensationArrangementByShareBasedPaymentAwardFairValueAssumptionsExpectedDividendRate" contextRef="From2022-01-012022-12-31_us-gaap_EmployeeStockOptionMember" id="Fact001064" format="ixt:numdotdecimal" decimals="INF" scale="-2" unitRef="Pure"><ix:nonFraction name="us-gaap:ShareBasedCompensationArrangementByShareBasedPaymentAwardFairValueAssumptionsExpectedDividendRate" contextRef="From2021-01-012021-12-31_us-gaap_EmployeeStockOptionMember" id="Fact001066" format="ixt:numdotdecimal" decimals="INF" scale="-2" unitRef="Pure">0.00</ix:nonFraction></ix:nonFraction></ix:nonFraction></span></span></span>% for all periods.</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">-</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">risk-free
    interest rate between <span id="xdx_906_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardFairValueAssumptionsRiskFreeInterestRateMinimum_pid_dp_c20210101__20211231__us-gaap--AwardTypeAxis__us-gaap--EmployeeStockOptionMember_zd1Qf0ZJnNZk" title="Risk-free interest rate, minimum"><ix:nonFraction name="us-gaap:ShareBasedCompensationArrangementByShareBasedPaymentAwardFairValueAssumptionsRiskFreeInterestRateMinimum" contextRef="From2021-01-012021-12-31_us-gaap_EmployeeStockOptionMember" id="Fact001068" format="ixt:numdotdecimal" decimals="INF" scale="-2" unitRef="Pure">0.80</ix:nonFraction></span>% and <span id="xdx_904_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardFairValueAssumptionsRiskFreeInterestRateMaximum_pid_dp_c20210101__20211231__us-gaap--AwardTypeAxis__us-gaap--EmployeeStockOptionMember_z9wSoTGx6AG" title="Risk-free interest rate, maximum"><ix:nonFraction name="us-gaap:ShareBasedCompensationArrangementByShareBasedPaymentAwardFairValueAssumptionsRiskFreeInterestRateMaximum" contextRef="From2021-01-012021-12-31_us-gaap_EmployeeStockOptionMember" id="Fact001070" format="ixt:numdotdecimal" decimals="INF" scale="-2" unitRef="Pure">1.34</ix:nonFraction></span>% for the fiscal year 2021, <span id="xdx_907_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardFairValueAssumptionsRiskFreeInterestRate_pid_dp_c20220101__20221231__us-gaap--AwardTypeAxis__us-gaap--EmployeeStockOptionMember_z3LdPxOVIDp4" title="Risk-free interest rate"><ix:nonFraction name="us-gaap:ShareBasedCompensationArrangementByShareBasedPaymentAwardFairValueAssumptionsRiskFreeInterestRate" contextRef="From2022-01-012022-12-31_us-gaap_EmployeeStockOptionMember" id="Fact001072" format="ixt:numdotdecimal" decimals="INF" scale="-2" unitRef="Pure">1.94</ix:nonFraction></span>% for the fiscal year 2022 and <span id="xdx_907_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardFairValueAssumptionsRiskFreeInterestRate_pid_dp_c20230101__20231231__us-gaap--AwardTypeAxis__us-gaap--EmployeeStockOptionMember_za5hHmg0Utf1" title="Risk-free interest rate"><ix:nonFraction name="us-gaap:ShareBasedCompensationArrangementByShareBasedPaymentAwardFairValueAssumptionsRiskFreeInterestRate" contextRef="From2023-01-012023-12-31_us-gaap_EmployeeStockOptionMember" id="Fact001074" format="ixt:numdotdecimal" decimals="INF" scale="-2" unitRef="Pure">4.16</ix:nonFraction></span>% for the fiscal year 2023.</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">-</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">an
    expected life between <span id="xdx_90B_eus-gaap--SharebasedCompensationArrangementBySharebasedPaymentAwardFairValueAssumptionsExpectedTerm1_dtY_c20230101__20231231__srt--RangeAxis__srt--MinimumMember__us-gaap--AwardTypeAxis__us-gaap--EmployeeStockOptionMember_zFrsM3R5NJa6" title="Expected life, term"><span id="xdx_906_eus-gaap--SharebasedCompensationArrangementBySharebasedPaymentAwardFairValueAssumptionsExpectedTerm1_dtY_c20220101__20221231__srt--RangeAxis__srt--MinimumMember__us-gaap--AwardTypeAxis__us-gaap--EmployeeStockOptionMember_zWzdVNbblkGi" title="Expected life, term"><span id="xdx_908_eus-gaap--SharebasedCompensationArrangementBySharebasedPaymentAwardFairValueAssumptionsExpectedTerm1_dtY_c20210101__20211231__srt--RangeAxis__srt--MinimumMember__us-gaap--AwardTypeAxis__us-gaap--EmployeeStockOptionMember_zTkXT6LJ7Oyg" title="Expected life, term"><ix:nonNumeric contextRef="From2023-01-012023-12-31_srt_MinimumMember_us-gaap_EmployeeStockOptionMember" format="ixt-sec:duryear" id="Fact001076" name="us-gaap:SharebasedCompensationArrangementBySharebasedPaymentAwardFairValueAssumptionsExpectedTerm1"><ix:nonNumeric contextRef="From2022-01-012022-12-31_srt_MinimumMember_us-gaap_EmployeeStockOptionMember" format="ixt-sec:duryear" id="Fact001078" name="us-gaap:SharebasedCompensationArrangementBySharebasedPaymentAwardFairValueAssumptionsExpectedTerm1"><ix:nonNumeric contextRef="From2021-01-012021-12-31_srt_MinimumMember_us-gaap_EmployeeStockOptionMember" format="ixt-sec:duryear" id="Fact001080" name="us-gaap:SharebasedCompensationArrangementBySharebasedPaymentAwardFairValueAssumptionsExpectedTerm1">5</ix:nonNumeric></ix:nonNumeric></ix:nonNumeric></span></span></span> and <span id="xdx_908_eus-gaap--SharebasedCompensationArrangementBySharebasedPaymentAwardFairValueAssumptionsExpectedTerm1_dtY_c20230101__20231231__srt--RangeAxis__srt--MaximumMember__us-gaap--AwardTypeAxis__us-gaap--EmployeeStockOptionMember_zNreIJYB4QAg" title="Expected life, term"><span id="xdx_90E_eus-gaap--SharebasedCompensationArrangementBySharebasedPaymentAwardFairValueAssumptionsExpectedTerm1_dtY_c20220101__20221231__srt--RangeAxis__srt--MaximumMember__us-gaap--AwardTypeAxis__us-gaap--EmployeeStockOptionMember_z6LRJ5WnUx1f" title="Expected life, term"><span id="xdx_90C_eus-gaap--SharebasedCompensationArrangementBySharebasedPaymentAwardFairValueAssumptionsExpectedTerm1_dtY_c20210101__20211231__srt--RangeAxis__srt--MaximumMember__us-gaap--AwardTypeAxis__us-gaap--EmployeeStockOptionMember_zEurssFOpHah" title="Expected life, term"><ix:nonNumeric contextRef="From2023-01-012023-12-31_srt_MaximumMember_us-gaap_EmployeeStockOptionMember" format="ixt-sec:duryear" id="Fact001082" name="us-gaap:SharebasedCompensationArrangementBySharebasedPaymentAwardFairValueAssumptionsExpectedTerm1"><ix:nonNumeric contextRef="From2022-01-012022-12-31_srt_MaximumMember_us-gaap_EmployeeStockOptionMember" format="ixt-sec:duryear" id="Fact001084" name="us-gaap:SharebasedCompensationArrangementBySharebasedPaymentAwardFairValueAssumptionsExpectedTerm1"><ix:nonNumeric contextRef="From2021-01-012021-12-31_srt_MaximumMember_us-gaap_EmployeeStockOptionMember" format="ixt-sec:duryear" id="Fact001086" name="us-gaap:SharebasedCompensationArrangementBySharebasedPaymentAwardFairValueAssumptionsExpectedTerm1">6.25</ix:nonNumeric></ix:nonNumeric></ix:nonNumeric></span></span></span> years for all periods.</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">-</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">and
    a volatility rate ranging between <span id="xdx_906_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardFairValueAssumptionsExpectedVolatilityRateMinimum_pid_dp_c20210101__20211231__us-gaap--AwardTypeAxis__us-gaap--EmployeeStockOptionMember_zm68xj9ZWYWb" title="Volatility rate, minimum"><ix:nonFraction name="us-gaap:ShareBasedCompensationArrangementByShareBasedPaymentAwardFairValueAssumptionsExpectedVolatilityRateMinimum" contextRef="From2021-01-012021-12-31_us-gaap_EmployeeStockOptionMember" id="Fact001088" format="ixt:numdotdecimal" decimals="INF" scale="-2" unitRef="Pure">64</ix:nonFraction></span>% and <span id="xdx_908_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardFairValueAssumptionsExpectedVolatilityRateMaximum_pid_dp_c20210101__20211231__us-gaap--AwardTypeAxis__us-gaap--EmployeeStockOptionMember_z8UqgGVrFFgl" title="Volatility rate, maximum"><ix:nonFraction name="us-gaap:ShareBasedCompensationArrangementByShareBasedPaymentAwardFairValueAssumptionsExpectedVolatilityRateMaximum" contextRef="From2021-01-012021-12-31_us-gaap_EmployeeStockOptionMember" id="Fact001090" format="ixt:numdotdecimal" decimals="INF" scale="-2" unitRef="Pure">81</ix:nonFraction></span>% for the fiscal year 2021, <span id="xdx_905_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardFairValueAssumptionsExpectedVolatilityRate_pid_dp_c20220101__20221231__us-gaap--AwardTypeAxis__us-gaap--EmployeeStockOptionMember_zOJxAIXloKTb" title="Volatility rate"><ix:nonFraction name="us-gaap:ShareBasedCompensationArrangementByShareBasedPaymentAwardFairValueAssumptionsExpectedVolatilityRate" contextRef="From2022-01-012022-12-31_us-gaap_EmployeeStockOptionMember" id="Fact001092" format="ixt:numdotdecimal" decimals="INF" scale="-2" unitRef="Pure">65</ix:nonFraction></span>% for the fiscal year 2022 and<span id="xdx_903_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardFairValueAssumptionsExpectedVolatilityRate_pid_dp_c20230101__20231231__us-gaap--AwardTypeAxis__us-gaap--EmployeeStockOptionMember_zn9pi094yKL4" title="Volatility rate"> <ix:nonFraction name="us-gaap:ShareBasedCompensationArrangementByShareBasedPaymentAwardFairValueAssumptionsExpectedVolatilityRate" contextRef="From2023-01-012023-12-31_us-gaap_EmployeeStockOptionMember" id="Fact001094" format="ixt:numdotdecimal" decimals="INF" scale="-2" unitRef="Pure">108</ix:nonFraction></span>% for the fiscal year
    2023.</span></td></tr>
  </table>
<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">As
of December 31, 2023, and 2022, the weighted-average remaining contractual term of the outstanding options, excluding the <span id="xdx_90D_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsGrantsInPeriodGross_pid_c20230101__20231231__us-gaap--AwardTypeAxis__us-gaap--EmployeeStockOptionMember_znMHgDeHAjHd" title="Options, granted"><span id="xdx_90A_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsGrantsInPeriodGross_pid_c20220101__20221231__us-gaap--AwardTypeAxis__us-gaap--EmployeeStockOptionMember_zsVXJNEwxBg6" title="Options, granted"><ix:nonFraction name="us-gaap:ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsGrantsInPeriodGross" contextRef="From2023-01-012023-12-31_us-gaap_EmployeeStockOptionMember" id="Fact001096" format="ixt:numdotdecimal" decimals="INF" unitRef="Shares"><ix:nonFraction name="us-gaap:ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsGrantsInPeriodGross" contextRef="From2022-01-012022-12-31_us-gaap_EmployeeStockOptionMember" id="Fact001098" format="ixt:numdotdecimal" decimals="INF" unitRef="Shares">2,575</ix:nonFraction></ix:nonFraction></span></span> options
granted in 2002 that have no expiration date, is <span id="xdx_902_eus-gaap--SharebasedCompensationArrangementBySharebasedPaymentAwardOptionsOutstandingWeightedAverageRemainingContractualTerm2_dtY_c20230101__20231231__us-gaap--AwardTypeAxis__us-gaap--EmployeeStockOptionMember_zTygjO7V5Yul" title="Contractual term"><ix:nonNumeric contextRef="From2023-01-012023-12-31_us-gaap_EmployeeStockOptionMember" format="ixt-sec:duryear" id="Fact001100" name="us-gaap:SharebasedCompensationArrangementBySharebasedPaymentAwardOptionsOutstandingWeightedAverageRemainingContractualTerm2">6.24</ix:nonNumeric></span> and <span id="xdx_900_eus-gaap--SharebasedCompensationArrangementBySharebasedPaymentAwardOptionsOutstandingWeightedAverageRemainingContractualTerm2_dtY_c20220101__20221231__us-gaap--AwardTypeAxis__us-gaap--EmployeeStockOptionMember_zugQt2ESdX82" title="Contractual term"><ix:nonNumeric contextRef="From2022-01-012022-12-31_us-gaap_EmployeeStockOptionMember" format="ixt-sec:duryear" id="Fact001102" name="us-gaap:SharebasedCompensationArrangementBySharebasedPaymentAwardOptionsOutstandingWeightedAverageRemainingContractualTerm2">4.84</ix:nonNumeric></span> years, respectively.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
weighted average grant date fair value of the options granted during the years ended December 31, 2023, 2022 and 2021 is $<span id="xdx_902_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsGrantsInPeriodWeightedAverageGrantDateFairValue_pid_c20230101__20231231__us-gaap--AwardTypeAxis__us-gaap--EmployeeStockOptionMember_zpSwhnh3Gtth" title="Weighted average grant date fair value"><ix:nonFraction name="us-gaap:ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsGrantsInPeriodWeightedAverageGrantDateFairValue" contextRef="From2023-01-012023-12-31_us-gaap_EmployeeStockOptionMember" id="Fact001104" format="ixt:numdotdecimal" decimals="INF" unitRef="USDPShares">0.63</ix:nonFraction></span>, $<span id="xdx_90C_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsGrantsInPeriodWeightedAverageGrantDateFairValue_pid_c20220101__20221231__us-gaap--AwardTypeAxis__us-gaap--EmployeeStockOptionMember_zHhmyZnGjeu4" title="Weighted average grant date fair value"><ix:nonFraction name="us-gaap:ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsGrantsInPeriodWeightedAverageGrantDateFairValue" contextRef="From2022-01-012022-12-31_us-gaap_EmployeeStockOptionMember" id="Fact001106" format="ixt:numdotdecimal" decimals="INF" unitRef="USDPShares">0.68</ix:nonFraction></span>,
and $<span id="xdx_90F_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsGrantsInPeriodWeightedAverageGrantDateFairValue_pid_c20210101__20211231__us-gaap--AwardTypeAxis__us-gaap--EmployeeStockOptionMember_zyRGDJvtmcri" title="Weighted average grant date fair value"><ix:nonFraction name="us-gaap:ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsGrantsInPeriodWeightedAverageGrantDateFairValue" contextRef="From2021-01-012021-12-31_us-gaap_EmployeeStockOptionMember" id="Fact001108" format="ixt:numdotdecimal" decimals="INF" unitRef="USDPShares">2.19</ix:nonFraction></span> respectively.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">As
of December 31, 2023, a total of <span id="xdx_903_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsExercisableNumber_iI_pid_c20231231_zw3SFJZmgdGg" title="Options, exercisable"><ix:nonFraction name="us-gaap:ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsExercisableNumber" contextRef="AsOf2023-12-31" id="Fact001110" format="ixt:numdotdecimal" decimals="INF" unitRef="Shares">21,654</ix:nonFraction></span> outstanding and exercisable options are &#8220;in the money&#8221; with aggregate intrinsic value
of $<span id="xdx_903_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsOutstandingIntrinsicValue_iI_pn3n6_c20231231_zZuaeCQ5V4C4" title="Options, intrinsic value"><ix:nonFraction name="us-gaap:ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsOutstandingIntrinsicValue" contextRef="AsOf2023-12-31" id="Fact001112" format="ixt:numdotdecimal" decimals="-3" scale="6" unitRef="USD">0.001</ix:nonFraction></span> million; while as of December 31, 2022 a total of <span id="xdx_906_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsExercisableNumber_iI_pid_c20221231_z71PoCMOinP1" title="Options, exercisable"><ix:nonFraction name="us-gaap:ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsExercisableNumber" contextRef="AsOf2022-12-31" id="Fact001114" format="ixt:numdotdecimal" decimals="INF" unitRef="Shares">21,654</ix:nonFraction></span> outstanding and exercisable options were &#8220;in the money&#8221;
with aggregate intrinsic value of $<span id="xdx_907_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsOutstandingIntrinsicValue_iI_pn5n6_c20221231_zEHEEX4LOeR" title="Options, intrinsic value"><ix:nonFraction name="us-gaap:ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsOutstandingIntrinsicValue" contextRef="AsOf2022-12-31" id="Fact001116" format="ixt:numdotdecimal" decimals="-5" scale="6" unitRef="USD">0.2</ix:nonFraction></span> million.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
unrecognized compensation expense calculated under the fair-value method for stock options expected to vest as of December 31, 2023,
2022 and 2021 is approximately $<span id="xdx_907_eus-gaap--EmployeeServiceShareBasedCompensationNonvestedAwardsTotalCompensationCostNotYetRecognized_iI_pn5n6_c20231231__us-gaap--AwardTypeAxis__us-gaap--EmployeeStockOptionMember_zvAEn5uIfhUj" title="Unrecognized share based compensation"><ix:nonFraction name="us-gaap:EmployeeServiceShareBasedCompensationNonvestedAwardsTotalCompensationCostNotYetRecognized" contextRef="AsOf2023-12-31_us-gaap_EmployeeStockOptionMember" id="Fact001118" format="ixt:numdotdecimal" decimals="-5" scale="6" unitRef="USD">0.3</ix:nonFraction></span> million, $<span id="xdx_900_eus-gaap--EmployeeServiceShareBasedCompensationNonvestedAwardsTotalCompensationCostNotYetRecognized_iI_pn5n6_c20221231__us-gaap--AwardTypeAxis__us-gaap--EmployeeStockOptionMember_zZAZOzIjaaqd" title="Unrecognized share based compensation"><ix:nonFraction name="us-gaap:EmployeeServiceShareBasedCompensationNonvestedAwardsTotalCompensationCostNotYetRecognized" contextRef="AsOf2022-12-31_us-gaap_EmployeeStockOptionMember" id="Fact001120" format="ixt:numdotdecimal" decimals="-5" scale="6" unitRef="USD">0.9</ix:nonFraction></span> million, and $<span id="xdx_90C_eus-gaap--EmployeeServiceShareBasedCompensationNonvestedAwardsTotalCompensationCostNotYetRecognized_iI_pn5n6_c20211231__us-gaap--AwardTypeAxis__us-gaap--EmployeeStockOptionMember_zQ5V8N6f2gU1" title="Unrecognized share based compensation"><ix:nonFraction name="us-gaap:EmployeeServiceShareBasedCompensationNonvestedAwardsTotalCompensationCostNotYetRecognized" contextRef="AsOf2021-12-31_us-gaap_EmployeeStockOptionMember" id="Fact001122" format="ixt:numdotdecimal" decimals="-5" scale="6" unitRef="USD">3.4</ix:nonFraction> </span>million, respectively, and is expected to be recognized over a weighted-average
period of <span id="xdx_90B_eus-gaap--EmployeeServiceShareBasedCompensationNonvestedAwardsTotalCompensationCostNotYetRecognizedPeriodForRecognition1_dtY_c20230101__20231231__us-gaap--AwardTypeAxis__us-gaap--EmployeeStockOptionMember_zb77LtOIJnT4" title="Unrecognized compensation, term"><ix:nonNumeric contextRef="From2023-01-012023-12-31_us-gaap_EmployeeStockOptionMember" format="ixt-sec:duryear" id="Fact001124" name="us-gaap:EmployeeServiceShareBasedCompensationNonvestedAwardsTotalCompensationCostNotYetRecognizedPeriodForRecognition1">0.3</ix:nonNumeric></span> years, <span id="xdx_90E_eus-gaap--EmployeeServiceShareBasedCompensationNonvestedAwardsTotalCompensationCostNotYetRecognizedPeriodForRecognition1_dtY_c20220101__20221231__us-gaap--AwardTypeAxis__us-gaap--EmployeeStockOptionMember_zt2SA1tssuSc" title="Unrecognized compensation, term"><ix:nonNumeric contextRef="From2022-01-012022-12-31_us-gaap_EmployeeStockOptionMember" format="ixt-sec:duryear" id="Fact001126" name="us-gaap:EmployeeServiceShareBasedCompensationNonvestedAwardsTotalCompensationCostNotYetRecognizedPeriodForRecognition1">1.41</ix:nonNumeric></span> years and <span id="xdx_909_eus-gaap--EmployeeServiceShareBasedCompensationNonvestedAwardsTotalCompensationCostNotYetRecognizedPeriodForRecognition1_dtY_c20210101__20211231__us-gaap--AwardTypeAxis__us-gaap--EmployeeStockOptionMember_zwmKOsTBO8Oi" title="Unrecognized compensation, term"><ix:nonNumeric contextRef="From2021-01-012021-12-31_us-gaap_EmployeeStockOptionMember" format="ixt-sec:duryear" id="Fact001128" name="us-gaap:EmployeeServiceShareBasedCompensationNonvestedAwardsTotalCompensationCostNotYetRecognizedPeriodForRecognition1">1.75</ix:nonNumeric></span> years, respectively.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">For
the years ended 2023, 2022 and 2021, the Company recorded a total of $<span id="xdx_90D_eus-gaap--AllocatedShareBasedCompensationExpense_pn5n6_c20230101__20231231__us-gaap--AwardTypeAxis__us-gaap--EmployeeStockOptionMember_zPlePz4D7EFa" title="Allocated stock based compensation"><ix:nonFraction name="us-gaap:AllocatedShareBasedCompensationExpense" contextRef="From2023-01-012023-12-31_us-gaap_EmployeeStockOptionMember" id="Fact001130" format="ixt:numdotdecimal" decimals="-5" scale="6" unitRef="USD">0.8</ix:nonFraction></span> million, $<span id="xdx_906_eus-gaap--AllocatedShareBasedCompensationExpense_pn5n6_c20220101__20221231__us-gaap--AwardTypeAxis__us-gaap--EmployeeStockOptionMember_zIFCBnvsGLkk" title="Allocated stock based compensation"><ix:nonFraction name="us-gaap:AllocatedShareBasedCompensationExpense" contextRef="From2022-01-012022-12-31_us-gaap_EmployeeStockOptionMember" id="Fact001132" format="ixt:numdotdecimal" decimals="-5" scale="6" unitRef="USD">1.3</ix:nonFraction></span> million, and $<span id="xdx_90D_eus-gaap--AllocatedShareBasedCompensationExpense_pn5n6_c20210101__20211231__us-gaap--AwardTypeAxis__us-gaap--EmployeeStockOptionMember_zJygUmBhrhwl" title="Allocated stock based compensation"><ix:nonFraction name="us-gaap:AllocatedShareBasedCompensationExpense" contextRef="From2021-01-012021-12-31_us-gaap_EmployeeStockOptionMember" id="Fact001134" format="ixt:numdotdecimal" decimals="-5" scale="6" unitRef="USD">1.9</ix:nonFraction></span> milliion of stock-based compensation
expenses, in connection with the above-mentioned options.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>


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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>GALMED
PHARMACEUTICALS LTD.</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Notes
to Consolidated Financial Statements</b></span></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Note
11 &#8211; Stockholders&#8217; equity (Cont.)</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>B.</b></span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Stock-based
    compensation (Cont.)</b></span></td></tr>
  </table>
<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">On
August 7, 2023, the Company issued a total of <span id="xdx_90F_eus-gaap--StockIssuedDuringPeriodSharesNewIssues_c20230807__20230807__us-gaap--AwardTypeAxis__us-gaap--RestrictedStockUnitsRSUMember_zBD5chOlDiZj"><ix:nonFraction name="us-gaap:StockIssuedDuringPeriodSharesNewIssues" contextRef="From2023-08-072023-08-07_us-gaap_RestrictedStockUnitsRSUMember" id="Fact001135" format="ixt:numdotdecimal" decimals="INF" unitRef="Shares">1,315,000</ix:nonFraction></span> RSU&#8221;s. Upon vesting, each RSU will settle by the issuance of one ordinary
share. The RSUs vest over <span id="xdx_903_eus-gaap--SharebasedCompensationArrangementBySharebasedPaymentAwardOptionsVestedAndExpectedToVestOutstandingWeightedAverageRemainingContractualTerm1_dt_c20230807__20230807__us-gaap--AwardTypeAxis__us-gaap--RestrictedStockUnitsRSUMember_zaJDQ7iyUPTi"><ix:nonNumeric contextRef="From2023-08-072023-08-07_us-gaap_RestrictedStockUnitsRSUMember" format="ixt-sec:durwordsen" id="Fact001136" name="us-gaap:SharebasedCompensationArrangementBySharebasedPaymentAwardOptionsVestedAndExpectedToVestOutstandingWeightedAverageRemainingContractualTerm1">three years</ix:nonNumeric></span>. As of December 31, 2023, none of the RSU&#8217;s were vested. with respect to the above-mentioned
RSU&#8217;s, the Company recorded stock-based compensation expenses in the amount of $<span id="xdx_902_eus-gaap--EmployeeServiceShareBasedCompensationNonvestedAwardsTotalCompensationCostNotYetRecognized_iI_pn5n6_c20231231__us-gaap--AwardTypeAxis__us-gaap--RestrictedStockUnitsRSUMember_z5ZKUhHrXBI6" title="Unrecognized compensation expense"><ix:nonFraction name="us-gaap:EmployeeServiceShareBasedCompensationNonvestedAwardsTotalCompensationCostNotYetRecognized" contextRef="AsOf2023-12-31_us-gaap_RestrictedStockUnitsRSUMember" id="Fact001138" format="ixt:numdotdecimal" decimals="-5" scale="6" unitRef="USD">0.1</ix:nonFraction></span> million for the year ended December 31, 2023.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
weighted average grant date fair value of the RSU&#8217;s granted during the year ended December 31, 2023 was $<span id="xdx_90D_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsGrantsInPeriodWeightedAverageGrantDateFairValue_pid_c20230101__20231231__us-gaap--AwardTypeAxis__us-gaap--RestrictedStockUnitsRSUMember_zJTaNXqOidu4" title="Weighted average grant date fair value"><ix:nonFraction name="us-gaap:ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsGrantsInPeriodWeightedAverageGrantDateFairValue" contextRef="From2023-01-012023-12-31_us-gaap_RestrictedStockUnitsRSUMember" id="Fact001140" format="ixt:numdotdecimal" decimals="INF" unitRef="USDPShares">0.63</ix:nonFraction></span>.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
unrecognized compensation expense calculated for RSU&#8217;s expected to vest as of December 31, 2023, is
approximately $<span id="xdx_909_eus-gaap--EmployeeServiceShareBasedCompensationNonvestedAwardsTotalCompensationCostNotYetRecognizedStockOptions_iI_pn5n6_c20231231__us-gaap--AwardTypeAxis__us-gaap--RestrictedStockUnitsRSUMember_zplfasNgXMK" title="Unrecognized share based compensation"><ix:nonFraction name="us-gaap:EmployeeServiceShareBasedCompensationNonvestedAwardsTotalCompensationCostNotYetRecognizedStockOptions" contextRef="AsOf2023-12-31_us-gaap_RestrictedStockUnitsRSUMember" id="Fact001142" format="ixt:numdotdecimal" decimals="-5" scale="6" unitRef="USD">0.7</ix:nonFraction></span> million and is expected to be recognized over a weighted-average period of <span id="xdx_90D_eus-gaap--EmployeeServiceShareBasedCompensationNonvestedAwardsTotalCompensationCostNotYetRecognizedPeriodForRecognition1_dtY_c20230101__20231231__us-gaap--AwardTypeAxis__us-gaap--RestrictedStockUnitsRSUMember_zNyVSEExgnXg" title="Unrecognized compensation, term"><ix:nonNumeric contextRef="From2023-01-012023-12-31_us-gaap_RestrictedStockUnitsRSUMember" format="ixt-sec:duryear" id="Fact001144" name="us-gaap:EmployeeServiceShareBasedCompensationNonvestedAwardsTotalCompensationCostNotYetRecognizedPeriodForRecognition1">2.5</ix:nonNumeric></span> years.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

</ix:nonNumeric><ix:nonNumeric contextRef="From2023-01-01to2023-12-31" escape="true" id="Fact001146" name="us-gaap:ResearchDevelopmentAndComputerSoftwareDisclosureTextBlock"><p id="xdx_800_eus-gaap--ResearchDevelopmentAndComputerSoftwareDisclosureTextBlock_zyxdZJuYdGda" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Note
12 &#8211; <span id="xdx_82C_zNUbToou00F">Research and Development Expenses</span></b></span></p>

<ix:nonNumeric contextRef="From2023-01-01to2023-12-31" escape="true" id="Fact001148" name="us-gaap:ResearchAndDevelopmentArrangementContractToPerformForOthersTextBlock"><p id="xdx_897_eus-gaap--ResearchAndDevelopmentArrangementContractToPerformForOthersTextBlock_zDgWgaR6hbv4" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><span id="xdx_8BC_zV0VXbTFQ8b8" style="display: none">Schedule of Research and Development Expenses</span><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"></p><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 93%; margin-left: 0.5in">
<tr style="vertical-align: bottom">
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    <td colspan="10" style="border-bottom: Black 1.5pt solid; text-align: center; font-weight: bold"><span style="font-family: Times New Roman, Times, Serif">Year
    ended December 31,</span></td><td style="padding-bottom: 1.5pt; text-align: center; font-weight: bold"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td></tr>

<tr style="vertical-align: bottom">
    <td style="padding-bottom: 1.5pt; text-align: center"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="padding-bottom: 1.5pt; text-align: center; font-weight: bold"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
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  <tr style="vertical-align: bottom; background-color: White">
    <td><span style="font-family: Times New Roman, Times, Serif">Salaries</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td id="xdx_983_eus-gaap--ResearchAndDevelopmentExpense_pn3n3_c20230101__20231231__us-gaap--IncomeStatementLocationAxis__custom--SalariesMember_zPsPt3Ayvzye" title="Research and development expense" style="text-align: right"><span style="font-family: Times New Roman, Times, Serif"><ix:nonFraction name="us-gaap:ResearchAndDevelopmentExpense" contextRef="From2023-01-012023-12-31_custom_SalariesMember" id="Fact001156" format="ixt:numdotdecimal" decimals="-3" scale="3" unitRef="USD">676</ix:nonFraction></span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td id="xdx_988_eus-gaap--ResearchAndDevelopmentExpense_pn3n3_c20220101__20221231__us-gaap--IncomeStatementLocationAxis__custom--SalariesMember_zXRSo6Pm4KV5" title="Research and development expense" style="text-align: right"><span style="font-family: Times New Roman, Times, Serif"><ix:nonFraction name="us-gaap:ResearchAndDevelopmentExpense" contextRef="From2022-01-012022-12-31_custom_SalariesMember" id="Fact001158" format="ixt:numdotdecimal" decimals="-3" scale="3" unitRef="USD">1,692</ix:nonFraction></span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">Stock-based compensation</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td id="xdx_98A_eus-gaap--ResearchAndDevelopmentExpense_pn3n3_c20230101__20231231__us-gaap--IncomeStatementLocationAxis__custom--StockBasedCompensationMember_zGyRyWHvzUr3" title="Research and development expense" style="text-align: right"><span style="font-family: Times New Roman, Times, Serif"><ix:nonFraction name="us-gaap:ResearchAndDevelopmentExpense" contextRef="From2023-01-012023-12-31_custom_StockBasedCompensationMember" id="Fact001162" format="ixt:numdotdecimal" decimals="-3" scale="3" unitRef="USD">243</ix:nonFraction></span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td id="xdx_98A_eus-gaap--ResearchAndDevelopmentExpense_pn3n3_c20220101__20221231__us-gaap--IncomeStatementLocationAxis__custom--StockBasedCompensationMember_zo2NUVaa33Yc" title="Research and development expense" style="text-align: right"><span style="font-family: Times New Roman, Times, Serif"><ix:nonFraction name="us-gaap:ResearchAndDevelopmentExpense" contextRef="From2022-01-012022-12-31_custom_StockBasedCompensationMember" id="Fact001164" format="ixt:numdotdecimal" decimals="-3" scale="3" unitRef="USD">383</ix:nonFraction></span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
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  <tr style="vertical-align: bottom; background-color: White">
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    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td id="xdx_98E_eus-gaap--ResearchAndDevelopmentExpense_pn3n3_c20220101__20221231__us-gaap--IncomeStatementLocationAxis__custom--ResearchAndPreclinicalStudiesMember_zbQRao1gJe81" title="Research and development expense" style="text-align: right"><span style="font-family: Times New Roman, Times, Serif"><ix:nonFraction name="us-gaap:ResearchAndDevelopmentExpense" contextRef="From2022-01-012022-12-31_custom_ResearchAndPreclinicalStudiesMember" id="Fact001170" format="ixt:numdotdecimal" decimals="-3" scale="3" unitRef="USD">1,346</ix:nonFraction></span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
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    <td style="border-bottom: Black 1.5pt solid; text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td id="xdx_98E_eus-gaap--ResearchAndDevelopmentExpense_pn3n3_c20220101__20221231__us-gaap--IncomeStatementLocationAxis__custom--RegulatoryAndOtherExpensesMember_zRnVc2oHQtGc" title="Research and development expense" style="border-bottom: Black 1.5pt solid; text-align: right"><span style="font-family: Times New Roman, Times, Serif"><ix:nonFraction name="us-gaap:ResearchAndDevelopmentExpense" contextRef="From2022-01-012022-12-31_custom_RegulatoryAndOtherExpensesMember" id="Fact001182" format="ixt:numdotdecimal" decimals="-3" scale="3" unitRef="USD">594</ix:nonFraction></span></td><td style="padding-bottom: 1.5pt; text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
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    <td style="border-bottom: Black 2.5pt double; text-align: left"><span style="font-family: Times New Roman, Times, Serif">$</span></td><td id="xdx_986_eus-gaap--ResearchAndDevelopmentExpense_pn3n3_c20210101__20211231_zLzE5xORNELg" title="Research and development expense" style="border-bottom: Black 2.5pt double; text-align: right"><span style="font-family: Times New Roman, Times, Serif"><ix:nonFraction name="us-gaap:ResearchAndDevelopmentExpense" contextRef="From2021-01-012021-12-31" id="Fact001190" format="ixt:numdotdecimal" decimals="-3" scale="3" unitRef="USD">27,220</ix:nonFraction></span></td><td style="padding-bottom: 2.5pt; text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td></tr>
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</ix:nonNumeric><p id="xdx_8AF_zjFDmY52oMe1" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"></span></p>


</ix:nonNumeric><ix:nonNumeric contextRef="From2023-01-01to2023-12-31" escape="true" id="Fact001192" name="GLMD:GeneralAndAdministrativeExpensesDisclosureTextBlock"><p id="xdx_809_ecustom--GeneralAndAdministrativeExpensesDisclosureTextBlock_znoTDBtTB344" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Note
13 &#8211; <span id="xdx_823_zC8APCqPY8Oe">General and Administrative Expenses</span></b></span></p>


<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"></span></p>


<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"></span></p>

<ix:nonNumeric contextRef="From2023-01-01to2023-12-31" escape="true" id="Fact001194" name="GLMD:GeneralAndAdministrativeExpensesTableTextBlock"><p id="xdx_890_ecustom--GeneralAndAdministrativeExpensesTableTextBlock_zHGBkYpL2dm2" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><span id="xdx_8B0_z5mVaRcbKtEi" style="display: none">Schedule of General and Administrative Expenses</span><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></span></p>

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    <td colspan="10" style="border-bottom: Black 1.5pt solid; text-align: center; font-weight: bold"><span style="font-family: Times New Roman, Times, Serif">Year
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<tr style="vertical-align: bottom">
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    <td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td colspan="2"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="font-weight: bold"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td colspan="2" style="font-weight: bold"><span style="font-family: Times New Roman, Times, Serif">(in thousands)</span></td><td style="font-weight: bold"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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    <td style="width: 1%; text-align: left"><span style="font-family: Times New Roman, Times, Serif">$</span></td><td id="xdx_98A_eus-gaap--GeneralAndAdministrativeExpense_pn3n3_c20220101__20221231__us-gaap--IncomeStatementLocationAxis__custom--StockBasedCompensationMember_zB4yAUP6KNre" title="General and administrative expenses" style="width: 14%; text-align: right"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> <ix:nonFraction name="us-gaap:GeneralAndAdministrativeExpense" contextRef="From2022-01-012022-12-31_custom_StockBasedCompensationMember" id="Fact001198" format="ixt:numdotdecimal" decimals="-3" scale="3" unitRef="USD">913</ix:nonFraction></span></td><td style="width: 1%; text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="width: 2%"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left; width: 1%"><span style="font-family: Times New Roman, Times, Serif">$</span></td><td id="xdx_982_eus-gaap--GeneralAndAdministrativeExpense_pn3n3_c20210101__20211231__us-gaap--IncomeStatementLocationAxis__custom--StockBasedCompensationMember_z5M8s8UUu2O" title="General and administrative expenses" style="text-align: right; width: 14%"><span style="font-family: Times New Roman, Times, Serif"><ix:nonFraction name="us-gaap:GeneralAndAdministrativeExpense" contextRef="From2021-01-012021-12-31_custom_StockBasedCompensationMember" id="Fact001200" format="ixt:numdotdecimal" decimals="-3" scale="3" unitRef="USD">1,225</ix:nonFraction></span></td><td style="text-align: left; width: 1%"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td></tr>
  <tr style="vertical-align: bottom; background-color: White">
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    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td id="xdx_982_eus-gaap--GeneralAndAdministrativeExpense_pn3n3_c20230101__20231231__us-gaap--IncomeStatementLocationAxis__custom--ProfessionalFeeMember_zMiAguNa2cVj" title="General and administrative expenses" style="text-align: right"><span style="font-family: Times New Roman, Times, Serif"><ix:nonFraction name="us-gaap:GeneralAndAdministrativeExpense" contextRef="From2023-01-012023-12-31_custom_ProfessionalFeeMember" id="Fact001202" format="ixt:numdotdecimal" decimals="-3" scale="3" unitRef="USD">908</ix:nonFraction></span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td id="xdx_989_eus-gaap--GeneralAndAdministrativeExpense_pn3n3_c20220101__20221231__us-gaap--IncomeStatementLocationAxis__custom--ProfessionalFeeMember_z3o7sCNOXOk4" title="General and administrative expenses" style="text-align: right"><span style="font-family: Times New Roman, Times, Serif"><ix:nonFraction name="us-gaap:GeneralAndAdministrativeExpense" contextRef="From2022-01-012022-12-31_custom_ProfessionalFeeMember" id="Fact001204" format="ixt:numdotdecimal" decimals="-3" scale="3" unitRef="USD">1,084</ix:nonFraction></span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td id="xdx_982_eus-gaap--GeneralAndAdministrativeExpense_pn3n3_c20210101__20211231__us-gaap--IncomeStatementLocationAxis__custom--ProfessionalFeeMember_zGJFADRd2bz2" title="General and administrative expenses" style="text-align: right"><span style="font-family: Times New Roman, Times, Serif"><ix:nonFraction name="us-gaap:GeneralAndAdministrativeExpense" contextRef="From2021-01-012021-12-31_custom_ProfessionalFeeMember" id="Fact001206" format="ixt:numdotdecimal" decimals="-3" scale="3" unitRef="USD">897</ix:nonFraction></span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td></tr>
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    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td id="xdx_98E_eus-gaap--GeneralAndAdministrativeExpense_pn3n3_c20230101__20231231__us-gaap--IncomeStatementLocationAxis__custom--SalariesAndBenefitsMember_zhD8BZYmkCfg" title="General and administrative expenses" style="text-align: right"><span style="font-family: Times New Roman, Times, Serif"><ix:nonFraction name="us-gaap:GeneralAndAdministrativeExpense" contextRef="From2023-01-012023-12-31_custom_SalariesAndBenefitsMember" id="Fact001208" format="ixt:numdotdecimal" decimals="-3" scale="3" unitRef="USD">1,428</ix:nonFraction></span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
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    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td id="xdx_980_eus-gaap--GeneralAndAdministrativeExpense_pn3n3_c20210101__20211231__us-gaap--IncomeStatementLocationAxis__custom--SalariesAndBenefitsMember_zZ84mvaekoAa" title="General and administrative expenses" style="text-align: right"><span style="font-family: Times New Roman, Times, Serif"><ix:nonFraction name="us-gaap:GeneralAndAdministrativeExpense" contextRef="From2021-01-012021-12-31_custom_SalariesAndBenefitsMember" id="Fact001212" format="ixt:numdotdecimal" decimals="-3" scale="3" unitRef="USD">1,617</ix:nonFraction></span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td></tr>
  <tr style="vertical-align: bottom; background-color: White">
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</ix:nonNumeric><p id="xdx_8AD_zW1PnJgxZbMd" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"></p>


<ix:exclude><!-- Field: Page; Sequence: 163; Value: 1 -->
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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>GALMED
PHARMACEUTICALS LTD.</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Notes
to Consolidated Financial Statements</b></span></p>

<!-- Field: Rule-Page --><div style="margin-left: auto; margin-right: auto; width: 100%"><div style="border-top: Black 1.5pt solid; font-size: 1pt"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></div></div><!-- Field: /Rule-Page -->

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"></p>

</ix:nonNumeric><ix:nonNumeric contextRef="From2023-01-01to2023-12-31" escape="true" id="Fact001238" name="us-gaap:RevenueFromContractWithCustomerTextBlock"><p id="xdx_80D_eus-gaap--RevenueFromContractWithCustomerTextBlock_zG5R8x2bKQH7" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Note
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    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif"><ix:nonFraction name="us-gaap:DebtSecuritiesAvailableForSaleGainLoss" contextRef="From2022-01-012022-12-31" id="Fact001251" format="ixt:numdotdecimal" decimals="-3" scale="3" unitRef="USD">526</ix:nonFraction></span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif"><ix:nonFraction name="us-gaap:DebtSecuritiesAvailableForSaleGainLoss" contextRef="From2021-01-012021-12-31" id="Fact001252" format="ixt:numdotdecimal" decimals="-3" scale="3" unitRef="USD">80</ix:nonFraction></span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td></tr>
  <tr id="xdx_405_ecustom--ChangeInFairValueOfConvertibleNote_pn3n3_maONIEzWxF_zoq1Nukb7RXi" style="vertical-align: bottom; background-color: White">
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">Change in fair value of convertible note</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
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    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif"><span style="-sec-ix-hidden: xdx2ixbrl1255">-</span></span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif"><span style="-sec-ix-hidden: xdx2ixbrl1256">-</span></span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td></tr>
  <tr id="xdx_401_eus-gaap--ForeignCurrencyTransactionGainLossBeforeTax_pn3n3_maONIEzWxF_zBOem3wEHRNk" style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="text-align: left; padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif">Foreign currency (gains)
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    <td style="border-bottom: Black 1.5pt solid; text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="border-bottom: Black 1.5pt solid; text-align: right"><span style="font-family: Times New Roman, Times, Serif">(<ix:nonFraction name="us-gaap:ForeignCurrencyTransactionGainLossBeforeTax" contextRef="From2022-01-012022-12-31" id="Fact001259" format="ixt:numdotdecimal" decimals="-3" scale="3" sign="-" unitRef="USD">36</ix:nonFraction></span></td><td style="padding-bottom: 1.5pt; text-align: left"><span style="font-family: Times New Roman, Times, Serif">)</span></td><td style="padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
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    <td style="padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif"><span style="display: none; font-family: Times New Roman, Times, Serif; font-size: 10pt">Financial
    income net</span></span></td><td style="padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="border-bottom: Black 1.5pt solid; text-align: left"><span style="font-family: Times New Roman, Times, Serif">$</span></td><td style="border-bottom: Black 1.5pt solid; text-align: right"><span style="font-family: Times New Roman, Times, Serif">(<ix:nonFraction name="us-gaap:OtherNonoperatingIncomeExpense" contextRef="From2023-01-01to2023-12-31" id="Fact001262" format="ixt:numdotdecimal" decimals="-3" scale="3" unitRef="USD">580</ix:nonFraction></span></td><td style="padding-bottom: 1.5pt; text-align: left"><span style="font-family: Times New Roman, Times, Serif">)</span></td><td style="font-weight: bold; padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="border-bottom: Black 1.5pt solid; font-style: normal; font-weight: normal; text-align: left"><span style="font-family: Times New Roman, Times, Serif">$</span></td><td style="border-bottom: Black 1.5pt solid; font-style: normal; font-weight: normal; text-align: right"><span style="font-family: Times New Roman, Times, Serif"><ix:nonFraction name="us-gaap:OtherNonoperatingIncomeExpense" contextRef="From2022-01-012022-12-31" id="Fact001263" format="ixt:numdotdecimal" decimals="-3" scale="3" sign="-" unitRef="USD">215</ix:nonFraction></span></td><td style="padding-bottom: 1.5pt; font-weight: bold; text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="padding-bottom: 1.5pt"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="border-bottom: Black 1.5pt solid; text-align: left"><span style="font-family: Times New Roman, Times, Serif">$</span></td><td style="border-bottom: Black 1.5pt solid; text-align: right"><span style="font-family: Times New Roman, Times, Serif">(<ix:nonFraction name="us-gaap:OtherNonoperatingIncomeExpense" contextRef="From2021-01-012021-12-31" id="Fact001264" format="ixt:numdotdecimal" decimals="-3" scale="3" unitRef="USD">414</ix:nonFraction></span></td><td style="padding-bottom: 1.5pt; text-align: left"><span style="font-family: Times New Roman, Times, Serif">)</span></td></tr>
  </table>

</ix:nonNumeric><p id="xdx_8AF_zKZzjojltt8d" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

</ix:nonNumeric><ix:nonNumeric contextRef="From2023-01-01to2023-12-31" escape="true" id="Fact001266" name="us-gaap:IncomeTaxDisclosureTextBlock"><p id="xdx_803_eus-gaap--IncomeTaxDisclosureTextBlock_zLvMXg27WfU6" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Note
15 &#8211; <span id="xdx_820_zbggtorJbBD6">Income Taxes</span></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>A.</b></span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>General</b></span></td></tr>
  </table>
<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>&#160;</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
Company is assessed for tax purposes on an unconsolidated basis. Each of the Company&#8217;s subsidiaries is subject to the tax rules
prevailing in its country of incorporation.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>&#160;</b></span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>B.</b></span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Corporate
    Taxation</b></span></td></tr>
  </table>
<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Israeli
Companies:</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
Israeli corporate income tax rate is <span id="xdx_909_eus-gaap--EffectiveIncomeTaxRateReconciliationAtFederalStatutoryIncomeTaxRate_pid_dp_c20230101__20231231__us-gaap--IncomeTaxAuthorityNameAxis__us-gaap--IsraelTaxAuthorityMember_zcTE1Jls5ep4" title="Effective income tax rate reconciliation, at federal statutory income tax rate, percent"><span id="xdx_90F_eus-gaap--EffectiveIncomeTaxRateReconciliationAtFederalStatutoryIncomeTaxRate_pid_dp_c20220101__20221231__us-gaap--IncomeTaxAuthorityNameAxis__us-gaap--IsraelTaxAuthorityMember_z6HmSRQqnp82" title="Effective income tax rate reconciliation, at federal statutory income tax rate, percent"><span id="xdx_900_eus-gaap--EffectiveIncomeTaxRateReconciliationAtFederalStatutoryIncomeTaxRate_pid_dp_c20210101__20211231__us-gaap--IncomeTaxAuthorityNameAxis__us-gaap--IsraelTaxAuthorityMember_zVjege2pCoqb" title="Effective income tax rate reconciliation, at federal statutory income tax rate, percent"><ix:nonFraction name="us-gaap:EffectiveIncomeTaxRateReconciliationAtFederalStatutoryIncomeTaxRate" contextRef="From2023-01-012023-12-31_us-gaap_IsraelTaxAuthorityMember" id="Fact001268" format="ixt:numdotdecimal" decimals="INF" scale="-2" unitRef="Pure"><ix:nonFraction name="us-gaap:EffectiveIncomeTaxRateReconciliationAtFederalStatutoryIncomeTaxRate" contextRef="From2022-01-012022-12-31_us-gaap_IsraelTaxAuthorityMember" id="Fact001270" format="ixt:numdotdecimal" decimals="INF" scale="-2" unitRef="Pure"><ix:nonFraction name="us-gaap:EffectiveIncomeTaxRateReconciliationAtFederalStatutoryIncomeTaxRate" contextRef="From2021-01-012021-12-31_us-gaap_IsraelTaxAuthorityMember" id="Fact001272" format="ixt:numdotdecimal" decimals="INF" scale="-2" unitRef="Pure">23</ix:nonFraction></ix:nonFraction></ix:nonFraction></span></span></span>% for the years 2021, 2022 and 2023.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">On
February 7, 2018, the Israeli Tax Authority issued a ruling granting the Company&#8217;s Israeli subsidiary, Galmed Research and Development
Ltd, a &#8220;Preferred Technological Enterprise&#8221; status as defined under the Encouragement of Capital Investment Law -1959 (the
&#8220;Approval&#8221;). The grant of the status means that the Company&#8217;s Israeli subsidiary will be subject to a reduced Israeli
corporate tax rate that will range between 6%-12% on any future taxable &#8220;technological income&#8221; which includes sales, licenses
and royalties from its IP protected products. The tax ruling applies for five years until the end of 2022 and may be extended for further
periods subject to meeting certain requirements.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>&#160;</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Maltese
subsidiary:</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>&#160;</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Taxable
income of Maltese companies was subject to tax at the rate of <span id="xdx_906_eus-gaap--EffectiveIncomeTaxRateReconciliationAtFederalStatutoryIncomeTaxRate_pid_dp_c20210101__20211231__us-gaap--IncomeTaxAuthorityNameAxis__custom--MalteseSubsidiaryMember_ziS6DOTWjKE8" title="Effective income tax rate reconciliation, at federal statutory income tax rate, percent"><span id="xdx_907_eus-gaap--EffectiveIncomeTaxRateReconciliationAtFederalStatutoryIncomeTaxRate_pid_dp_c20220101__20221231__us-gaap--IncomeTaxAuthorityNameAxis__custom--MalteseSubsidiaryMember_zn8SmCqmAsgi" title="Effective income tax rate reconciliation, at federal statutory income tax rate, percent"><span id="xdx_902_eus-gaap--EffectiveIncomeTaxRateReconciliationAtFederalStatutoryIncomeTaxRate_pid_dp_c20230101__20231231__us-gaap--IncomeTaxAuthorityNameAxis__custom--MalteseSubsidiaryMember_zYl1IQZkaq3i" title="Effective income tax rate reconciliation, at federal statutory income tax rate, percent"><ix:nonFraction name="us-gaap:EffectiveIncomeTaxRateReconciliationAtFederalStatutoryIncomeTaxRate" contextRef="From2021-01-012021-12-31_custom_MalteseSubsidiaryMember" id="Fact001274" format="ixt:numdotdecimal" decimals="INF" scale="-2" unitRef="Pure"><ix:nonFraction name="us-gaap:EffectiveIncomeTaxRateReconciliationAtFederalStatutoryIncomeTaxRate" contextRef="From2022-01-012022-12-31_custom_MalteseSubsidiaryMember" id="Fact001276" format="ixt:numdotdecimal" decimals="INF" scale="-2" unitRef="Pure"><ix:nonFraction name="us-gaap:EffectiveIncomeTaxRateReconciliationAtFederalStatutoryIncomeTaxRate" contextRef="From2023-01-012023-12-31_custom_MalteseSubsidiaryMember" id="Fact001278" format="ixt:numdotdecimal" decimals="INF" scale="-2" unitRef="Pure">35</ix:nonFraction></ix:nonFraction></ix:nonFraction></span></span></span>% for the years 2021, 2022, and 2023.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>&#160;</b></span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>C.</b></span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Net
    Operating Loss Carry forward</b></span></td></tr>
  </table>
<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>&#160;</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">As
of December 31, 2023, the Company had approximately $<span id="xdx_904_eus-gaap--OperatingLossCarryforwards_iI_pn5n6_c20231231_zIrrwlxJPVLj" title="Operating loss carry forwards"><ix:nonFraction name="us-gaap:OperatingLossCarryforwards" contextRef="AsOf2023-12-31" id="Fact001280" format="ixt:numdotdecimal" decimals="-5" scale="6" unitRef="USD">165.1</ix:nonFraction></span> million net-operating-loss carry forwards, consisting of approximately $<span id="xdx_90B_eus-gaap--OperatingLossCarryforwards_iI_pn5n6_c20231231__us-gaap--RelatedPartyTransactionsByRelatedPartyAxis__custom--MalteseSubsidiaryMember_zQY92IpCZpGl" title="Operating loss carry forwards"><ix:nonFraction name="us-gaap:OperatingLossCarryforwards" contextRef="AsOf2023-12-31_custom_MalteseSubsidiaryMember" id="Fact001282" format="ixt:numdotdecimal" decimals="-5" scale="6" unitRef="USD">11.7</ix:nonFraction></span>
million of Maltese net-operating-loss carry forwards and approximately $<span id="xdx_90A_eus-gaap--OperatingLossCarryforwards_iI_pn5n6_c20231231__us-gaap--RelatedPartyTransactionsByRelatedPartyAxis__custom--IsraeliSubsidiaryMember_zpcKXFW59KD3" title="Operating loss carry forwards"><ix:nonFraction name="us-gaap:OperatingLossCarryforwards" contextRef="AsOf2023-12-31_custom_IsraeliSubsidiaryMember" id="Fact001284" format="ixt:numdotdecimal" decimals="-5" scale="6" unitRef="USD">153.4</ix:nonFraction></span> million Israeli net-operating-loss carry forward. Additionally,
the Company had approximately $<span id="xdx_904_eus-gaap--DeferredTaxAssetsCapitalLossCarryforwards_iI_pn5n6_c20231231__us-gaap--RelatedPartyTransactionsByRelatedPartyAxis__custom--IsraeliSubsidiaryMember_zkOCvjiWqtD6" title="Deferred tax assets, capital loss carry forwards"><ix:nonFraction name="us-gaap:DeferredTaxAssetsCapitalLossCarryforwards" contextRef="AsOf2023-12-31_custom_IsraeliSubsidiaryMember" id="Fact001286" format="ixt:numdotdecimal" decimals="-5" scale="6" unitRef="USD">3.1</ix:nonFraction></span> million of capital loss carry forward from the sale of marketable debt securities in Israel. The Maltese
and the Israeli loss carry forwards have no expiration date.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>


<ix:exclude><!-- Field: Page; Sequence: 164; Value: 1 -->
    <div style="border-bottom: Black 1.5pt solid; margin-bottom: 6pt"><table cellpadding="0" cellspacing="0" style="border-collapse: collapse; width: 100%; font-size: 10pt"><tr style="vertical-align: top; text-align: left"><td style="text-align: center; width: 100%">F-<!-- Field: Sequence; Type: Arabic; Name: PageNo -->23<!-- Field: /Sequence --></td></tr></table></div>
    <div style="break-before: page; margin-top: 6pt"><p style="margin: 0pt">&#160;</p></div>
    <!-- Field: /Page --></ix:exclude>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>GALMED
PHARMACEUTICALS LTD.</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Notes
to Consolidated Financial Statements</b></span></p>

<!-- Field: Rule-Page --><div style="margin-left: auto; margin-right: auto; width: 100%"><div style="border-top: Black 1.5pt solid; font-size: 1pt"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></div></div><!-- Field: /Rule-Page -->

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Note
15 &#8211; Income Taxes (Cont.)</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>D.</b></span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Deferred
    income taxes</b></span></td></tr>
  </table>
<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>&#160;</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">As
of December 31, 2023, the significant components of the Company&#8217;s deferred tax assets are net operating loss carryforward in the
amount of $<span id="xdx_905_eus-gaap--DeferredTaxAssetsCapitalLossCarryforwards_iI_pn5n6_c20231231_zzlE95Xpy1Pl" title="Deferred tax assets, capital loss carry forwards"><ix:nonFraction name="us-gaap:DeferredTaxAssetsCapitalLossCarryforwards" contextRef="AsOf2023-12-31" id="Fact001288" format="ixt:numdotdecimal" decimals="-5" scale="6" unitRef="USD">165.1</ix:nonFraction> </span>million and research and development expenses in the amount of $<span id="xdx_907_eus-gaap--ResearchAndDevelopmentExpense_pn5n6_c20230101__20231231__us-gaap--RegulatoryAssetAxis__us-gaap--DeferredIncomeTaxChargesMember_zau3NqjkwtU5" title="Research and development expenses"><ix:nonFraction name="us-gaap:ResearchAndDevelopmentExpense" contextRef="From2023-01-012023-12-31_us-gaap_DeferredIncomeTaxChargesMember" id="Fact001290" format="ixt:numdotdecimal" decimals="-5" scale="6" unitRef="USD">6.4</ix:nonFraction></span> million. The Company has evaluated the positive
and negative evidence bearing upon its ability to realize the deferred tax assets. Management has considered the Company&#8217;s history
of cumulative net losses incurred since inception and its lack of commercialization of any products or generation of any revenue from
product sales since inception and has concluded that it is more likely than not that the Company will not realize the benefits of the
deferred tax assets. Accordingly, a full valuation allowance has been established against the deferred tax assets as of December 31,
2023. Management reevaluates the positive and negative evidence at each reporting period.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>&#160;</b></span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>E.</b></span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Tax
    assessment</b>s</span></td></tr>
  </table>
<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>&#160;</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
Israeli subsidiaries received final tax assessments through the year ended December 31, 2019.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>&#160;</b></span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>F.</b></span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Effective
    tax expense</b></span></td></tr>
  </table>
<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>&#160;</b></span></p>

<ix:nonNumeric contextRef="From2023-01-01to2023-12-31" escape="true" id="Fact001292" name="us-gaap:ScheduleOfEffectiveIncomeTaxRateReconciliationTableTextBlock"><p id="xdx_893_eus-gaap--ScheduleOfEffectiveIncomeTaxRateReconciliationTableTextBlock_zQ2tjXonIgrj" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">A
reconciliation of the Company&#8217;s effective tax expense to the Company&#8217;s theoretical statutory tax benefit is as follows:</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><span id="xdx_8B9_z0EVgRorPuHe" style="display: none">Schedule of Effective Income Tax Rate Reconciliation</span><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></span></p>

<table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 93%; margin-left: 0.5in">
  <tr style="display: none; vertical-align: bottom">
    <td style="padding-bottom: 1.5pt; text-align: center"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="padding-bottom: 1.5pt; text-align: center; font-weight: bold"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
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<tr style="vertical-align: bottom">
    <td style="padding-bottom: 1.5pt; text-align: center"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="padding-bottom: 1.5pt; text-align: center; font-weight: bold"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
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  <tr style="vertical-align: bottom">
    <td style="padding-bottom: 1.5pt; text-align: center"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="padding-bottom: 1.5pt; text-align: center; font-weight: bold"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
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  <tr style="vertical-align: bottom">
    <td style="text-align: center"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: center"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
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    <td colspan="2" style="text-align: center"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: center"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td></tr>
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    <td style="border-bottom: Black 2.5pt double"><span style="font-family: Times New Roman, Times, Serif">$</span></td>
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    <td style="border-bottom: Black 2.5pt double"><span style="font-family: Times New Roman, Times, Serif">$</span></td>
    <td style="border-bottom: Black 2.5pt double; text-align: right"><span style="font-family: Times New Roman, Times, Serif"><ix:nonFraction name="us-gaap:IncomeLossFromContinuingOperationsBeforeIncomeTaxesExtraordinaryItemsNoncontrollingInterest" contextRef="From2021-01-012021-12-31" id="Fact001296" format="ixt:numdotdecimal" decimals="-3" scale="3" sign="-" unitRef="USD">32,467</ix:nonFraction></span></td><td style="padding-bottom: 2.5pt"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td></tr>
  <tr style="vertical-align: bottom; background-color: White">
    <td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td></tr>
  <tr id="xdx_40D_eus-gaap--EffectiveIncomeTaxRateReconciliationAtFederalStatutoryIncomeTaxRate_pid_dp_uPure_zb19t7I2hrTc" style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="padding-bottom: 2.5pt; width: 46%; text-align: left"><span style="font-family: Times New Roman, Times, Serif">Statutory
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    <td style="border-bottom: Black 2.5pt double; width: 1%; text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="border-bottom: Black 2.5pt double; width: 14%; text-align: right"><span style="font-family: Times New Roman, Times, Serif"><ix:nonFraction name="us-gaap:EffectiveIncomeTaxRateReconciliationAtFederalStatutoryIncomeTaxRate" contextRef="From2023-01-01to2023-12-31" id="Fact001298" format="ixt:numdotdecimal" decimals="INF" scale="-2" unitRef="Pure">23</ix:nonFraction></span></td><td style="padding-bottom: 2.5pt; width: 1%; text-align: left"><span style="font-family: Times New Roman, Times, Serif">%</span></td><td style="padding-bottom: 2.5pt; width: 2%"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
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  <tr style="vertical-align: bottom; background-color: White">
    <td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td></tr>
  <tr id="xdx_409_eus-gaap--IncomeTaxReconciliationIncomeTaxExpenseBenefitAtFederalStatutoryIncomeTaxRate_pn3n3_maITEBzSAa_zmziIWpVvFIg" style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">Theoretical tax benefit</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif"><ix:nonFraction name="us-gaap:IncomeTaxReconciliationIncomeTaxExpenseBenefitAtFederalStatutoryIncomeTaxRate" contextRef="From2023-01-01to2023-12-31" id="Fact001302" format="ixt:numdotdecimal" decimals="-3" scale="3" unitRef="USD">1,590</ix:nonFraction></span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
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  <tr style="vertical-align: bottom; background-color: White">
    <td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td></tr>
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    <td style="border-bottom: Black 1.5pt solid; text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="border-bottom: Black 1.5pt solid; text-align: right"><span style="font-family: Times New Roman, Times, Serif">(<ix:nonFraction name="us-gaap:IncomeTaxReconciliationChangeInDeferredTaxAssetsValuationAllowance" contextRef="From2021-01-012021-12-31" id="Fact001308" format="ixt:numdotdecimal" decimals="-3" scale="3" sign="-" unitRef="USD">3,896</ix:nonFraction></span></td><td style="padding-bottom: 1.5pt; text-align: left"><span style="font-family: Times New Roman, Times, Serif">)</span></td></tr>
  <tr style="vertical-align: bottom; background-color: White">
    <td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td></tr>
  <tr id="xdx_403_eus-gaap--IncomeTaxExpenseBenefit_iT_pn3n3_mtITEBzSAa_zc5Y4ailP1xh" style="vertical-align: bottom; background-color: rgb(204,238,255)">
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    <td style="border-bottom: Black 2.5pt double; text-align: left"><span style="font-family: Times New Roman, Times, Serif">$</span></td><td style="border-bottom: Black 2.5pt double; text-align: right"><span style="font-family: Times New Roman, Times, Serif"><span style="-sec-ix-hidden: xdx2ixbrl1311">&#8212;</span></span></td><td style="padding-bottom: 2.5pt; text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td><td style="padding-bottom: 2.5pt"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="border-bottom: Black 2.5pt double; text-align: left"><span style="font-family: Times New Roman, Times, Serif">$</span></td><td style="border-bottom: Black 2.5pt double; text-align: right"><span style="font-family: Times New Roman, Times, Serif"><span style="-sec-ix-hidden: xdx2ixbrl1312">&#8212;</span></span></td><td style="padding-bottom: 2.5pt; text-align: left"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td></tr>
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</ix:nonNumeric><p id="xdx_8A0_zE20oBnbOsH3" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

</ix:nonNumeric><ix:nonNumeric contextRef="From2023-01-01to2023-12-31" escape="true" id="Fact001314" name="us-gaap:SubsequentEventsTextBlock"><p id="xdx_807_eus-gaap--SubsequentEventsTextBlock_z0JUA0tDWVnl" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Note
16 &#8211; <span id="xdx_82C_zCn1g0Cq1eFg">Subsequent event</span></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>&#160;</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Subsequent
to the balance sheet date, as of April 3, 2024, a total of <span id="xdx_90B_eus-gaap--ClassOfWarrantOrRightNumberOfSecuritiesCalledByEachWarrantOrRight_iI_pid_c20240403__us-gaap--SubsequentEventTypeAxis__us-gaap--SubsequentEventMember__us-gaap--SubsidiarySaleOfStockAxis__custom--PrefundedWarrantsMember_z468NaGCQIR4" title="Stock and warrants issued during period shares"><ix:nonFraction name="us-gaap:ClassOfWarrantOrRightNumberOfSecuritiesCalledByEachWarrantOrRight" contextRef="AsOf2024-04-03_us-gaap_SubsequentEventMember_custom_PrefundedWarrantsMember" id="Fact001316" format="ixt:numdotdecimal" decimals="INF" unitRef="Shares">965,000</ix:nonFraction></span>
Pre-Funded Warrants were exercised into <span id="xdx_906_eus-gaap--ConversionOfStockSharesIssued1_pid_c20240403__20240403__us-gaap--SubsequentEventTypeAxis__us-gaap--SubsequentEventMember__us-gaap--SubsidiarySaleOfStockAxis__custom--PrefundedWarrantsMember__us-gaap--StatementEquityComponentsAxis__us-gaap--CommonStockMember_zxTBlv8d8sh5" title="Class of Warrant or Right, Number of Securities Called by Warrants or Rights"><ix:nonFraction name="us-gaap:ConversionOfStockSharesIssued1" contextRef="From2024-04-032024-04-03_us-gaap_SubsequentEventMember_custom_PrefundedWarrantsMember_us-gaap_CommonStockMember" id="Fact001318" format="ixt:numdotdecimal" decimals="INF" unitRef="Shares">964,330</ix:nonFraction></span>
ordinary shares, out of which, a total of <span id="xdx_90E_eus-gaap--ClassOfWarrantOrRightNumberOfSecuritiesCalledByWarrantsOrRights_iI_pid_c20240403__us-gaap--SubsequentEventTypeAxis__us-gaap--SubsequentEventMember__us-gaap--SubsidiarySaleOfStockAxis__custom--PrefundedWarrantsMember_zQ6izbsZ1zyk" title="Stock and warrants issued during period shares"><ix:nonFraction name="us-gaap:ClassOfWarrantOrRightNumberOfSecuritiesCalledByWarrantsOrRights" contextRef="AsOf2024-04-03_us-gaap_SubsequentEventMember_custom_PrefundedWarrantsMember" id="Fact001320" format="ixt:numdotdecimal" decimals="INF" unitRef="Shares">240,000</ix:nonFraction></span>
Pre-funded Warrants were exercised on a cashless basis (as permitted under the terms of the Pre-Funded Warrants) into <span id="xdx_90D_eus-gaap--ConversionOfStockSharesConverted1_pid_c20240403__20240403__us-gaap--SubsequentEventTypeAxis__us-gaap--SubsequentEventMember__us-gaap--SubsidiarySaleOfStockAxis__custom--PrefundedWarrantsMember__us-gaap--StatementEquityComponentsAxis__us-gaap--CommonStockMember_z9Fzmqvh29h9" title="Stock and warrants issued during period shares"><ix:nonFraction name="us-gaap:ConversionOfStockSharesConverted1" contextRef="From2024-04-032024-04-03_us-gaap_SubsequentEventMember_custom_PrefundedWarrantsMember_us-gaap_CommonStockMember" id="Fact001322" format="ixt:numdotdecimal" decimals="INF" unitRef="Shares">239,330</ix:nonFraction></span>
ordinary shares.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"></p>

</ix:nonNumeric><p id="xdx_81E_z6S54wfo8y02" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>


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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify">&#160;</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; text-align: left; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><span id="am_030"></span>ITEM
19. Exhibits.</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"></span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom">
    <td style="border-bottom: black 1.5pt solid; font: 10pt Times New Roman, Times, Serif; width: 0.75in; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Exhibit
    No.</b></span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.1in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="border-bottom: black 1.5pt solid; font: 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Description</b></span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif">
    <td style="font: 10pt Times New Roman, Times, Serif; vertical-align: top; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">1.1</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><a href="https://www.sec.gov/Archives/edgar/data/1595353/000149315223021672/ex3-1.htm" style="-sec-extract: exhibit">Amended and Restated Articles of Association of Galmed Pharmaceuticals Ltd. (19)</a></span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom">
    <td colspan="3" style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif">
    <td style="font: 10pt Times New Roman, Times, Serif; vertical-align: top; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">2.1</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; text-align: justify"><a href="ex2-1.htm"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Description of Securities Registered under Section 12 of the Exchange Act*</span></a></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom">
    <td colspan="3" style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif">
    <td style="font: 10pt Times New Roman, Times, Serif; vertical-align: top; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">4.1</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><a href="https://www.sec.gov/Archives/edgar/data/1595353/000114420414012612/v367917_ex10-2.htm" style="-sec-extract: exhibit">Form of Indemnification Agreement (1)</a></span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom">
    <td colspan="3" style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif">
    <td style="font: 10pt Times New Roman, Times, Serif; vertical-align: top; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">4.2</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; text-align: justify"><a href="https://www.sec.gov/Archives/edgar/data/1595353/000114420415020787/v406342_ex99-1.htm" style="-sec-extract: exhibit"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Galmed Pharmaceuticals Ltd. 2013 Incentive Share Option Plan as anemded on October 4, 2023 (4)</span></a></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom">
    <td colspan="3" style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif">
    <td style="font: 10pt Times New Roman, Times, Serif; vertical-align: top; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">4.3</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><a href="https://www.sec.gov/Archives/edgar/data/1595353/000114420414006610/v367324_ex10-1.htm" style="-sec-extract: exhibit">Registration and Information Rights Agreement, dated December 2013, by and among Galmed Pharmaceuticals Ltd., Shirat HaChaim Ltd., David &amp; Debora Goldfarb, Medgal S.A. and G. Yarom Medical Research Ltd. (2)</a></span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom">
    <td colspan="3" style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif">
    <td style="font: 10pt Times New Roman, Times, Serif; vertical-align: top; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">4.4</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><a href="https://www.sec.gov/Archives/edgar/data/1595353/000114420414006610/v367324_ex10-8.htm" style="-sec-extract: exhibit">Personal Employment Agreement, dated December 23, 2013, by and between Galmed Medical Research Ltd. and Allen Baharaff (2)</a></span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom">
    <td colspan="3" style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif">
    <td style="font: 10pt Times New Roman, Times, Serif; vertical-align: top; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">4.5</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><a href="https://www.sec.gov/Archives/edgar/data/1595353/000114420418014234/tv487506_ex4-6.htm" style="-sec-extract: exhibit">Amendment No.1 to Employment Agreement by and between Galmed Research and Development Ltd. and Allen Baharaff (10)</a></span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom">
    <td colspan="3" style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif">
    <td style="font: 10pt Times New Roman, Times, Serif; vertical-align: top; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">4.6</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><a href="https://www.sec.gov/ix?doc=/Archives/edgar/data/1595353/000110465921038205/tmb-20201231x20f.htm" style="-sec-extract: exhibit">Amendment No.2 to Employment Agreement by and between Galmed Research and Development Ltd. and Allen Baharaff(12)</a></span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom">
    <td colspan="3" style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif">
    <td style="font: 10pt Times New Roman, Times, Serif; vertical-align: top; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">4.7</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><a href="https://www.sec.gov/Archives/edgar/data/1595353/000149315222011729/ex4-7.htm" style="-sec-extract: exhibit">Amendment No.3 to Employment Agreement by and between Galmed Research and Development Ltd. And Allen Baharaff(13)</a></span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom">
    <td colspan="3" style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif">
    <td style="font: 10pt Times New Roman, Times, Serif; vertical-align: top; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">4.8</span></td>
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    <td style="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><a href="https://www.sec.gov/Archives/edgar/data/1595353/000149315223021672/ex10-8.htm" style="-sec-extract: exhibit">Compensation Policy of Galmed Pharmaceuticals Ltd.(5)</a></span></td></tr>
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    <td colspan="3" style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif">
    <td style="font: 10pt Times New Roman, Times, Serif; vertical-align: top; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">4.9</span></td>
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    <td style="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><a href="https://www.sec.gov/Archives/edgar/data/1595353/000114420417016148/v462263_ex4-8.htm" style="-sec-extract: exhibit">Lease, dated March 22, 2015, between Galmed Research and Development Ltd. and Mintz K. Construction Company Ltd.(8)</a></span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom">
    <td colspan="3" style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif">
    <td style="font: 10pt Times New Roman, Times, Serif; vertical-align: top; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">4.10</span></td>
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    <td style="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><a href="https://www.sec.gov/Archives/edgar/data/1595353/000114420417016148/v462263_ex4-9.htm" style="-sec-extract: exhibit">Addendum to Lease, dated February 27, 2017, between Galmed Research and Development Ltd. and Mintz K. Construction Company Ltd. (8)</a></span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom">
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  <tr style="font: 10pt Times New Roman, Times, Serif">
    <td style="font: 10pt Times New Roman, Times, Serif; vertical-align: top; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">4.11</span></td>
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  <tr style="font: 10pt Times New Roman, Times, Serif">
    <td style="font: 10pt Times New Roman, Times, Serif; vertical-align: top; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">4.12</span></td>
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    <td style="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><a href="https://www.sec.gov/ix?doc=/Archives/edgar/data/1595353/000110465921038205/tmb-20201231x20f.htm" style="-sec-extract: exhibit">Addendum to Lease, dated March 11, 2021, between Galmed Research and Development Ltd. and Mintz K. Construction Company Ltd.(12)</a></span></td></tr>
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  <tr style="font: 10pt Times New Roman, Times, Serif">
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    <td style="font: 10pt Times New Roman, Times, Serif; vertical-align: top; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif">
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    <td style="font: 10pt Times New Roman, Times, Serif; vertical-align: top; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif">
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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

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<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
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  <tr style="font: 10pt Times New Roman, Times, Serif">
    <td style="font: 10pt Times New Roman, Times, Serif; vertical-align: top; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif">
    <td style="font: 10pt Times New Roman, Times, Serif; vertical-align: top; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">4.17</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
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    <td style="font: 10pt Times New Roman, Times, Serif; vertical-align: top; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
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  <tr style="font: 10pt Times New Roman, Times, Serif">
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    <td style="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><a href="ex8-1.htm">List of subsidiaries of Galmed Pharmaceuticals Ltd.*</a></span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom">
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  <tr style="font: 10pt Times New Roman, Times, Serif">
    <td style="font: 10pt Times New Roman, Times, Serif; vertical-align: top; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">11.1</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
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  <tr style="font: 10pt Times New Roman, Times, Serif">
    <td style="font: 10pt Times New Roman, Times, Serif; vertical-align: top; text-align: center">&#160;</td>
    <td style="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom">&#160;</td>
    <td style="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; text-align: justify">&#160;</td></tr>
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  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom">
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  <tr style="font: 10pt Times New Roman, Times, Serif">
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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="font: 10pt Times New Roman, Times, Serif">
    <td style="font: 10pt Times New Roman, Times, Serif; vertical-align: top; text-align: center; width: 0.75in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">13.1</span></td>
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  <tr style="font: 10pt Times New Roman, Times, Serif">
    <td style="font: 10pt Times New Roman, Times, Serif; vertical-align: top; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td>&#160;</td>
    <td style="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif">
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    <td>&#160;</td>
    <td style="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><a href="ex15-1.htm">Consent of Brightman Almagor Zohar &amp; Co.*</a></span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif">
    <td style="font: 10pt Times New Roman, Times, Serif; vertical-align: top; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td>&#160;</td>
    <td style="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif">
    <td style="font: 10pt Times New Roman, Times, Serif; vertical-align: top; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">97.1</span></td>
    <td>&#160;</td>
    <td style="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; text-align: justify"><a href="ex97-1.htm"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Executive Officer Clawback Policy*</span></a></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif">
    <td style="font: 10pt Times New Roman, Times, Serif; vertical-align: top; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td>&#160;</td>
    <td style="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom">
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    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Inline XBRL Instance Document*</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td>&#160;</td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">101.SCH</span></td>
    <td>&#160;</td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Inline XBRL Taxonomy Extension Schema Document*</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td>&#160;</td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">101.CAL</span></td>
    <td>&#160;</td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Inline XBRL Taxonomy Extension Calculation Linkbase
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  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td>&#160;</td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">101.DEF</span></td>
    <td>&#160;</td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Inline XBRL Taxonomy Extension Definition Linkbase
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  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom">
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td>&#160;</td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom">
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    <td style="font: 10pt Times New Roman, Times, Serif; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td>&#160;</td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom">
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    <td>&#160;</td>
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    <td>&#160;</td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
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    <td>&#160;</td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Cover Page Interactive Data File (embedded within the
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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.3in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.3in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">(1)</span></td>
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    reference to Amendment No. 1 to the Registration Statement on Form F-1, filed with the SEC on February 28, 2014.</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
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    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Incorporated herein by
    reference to the Registration Statement on Form F-1, filed with the SEC on February 6, 2014.</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
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    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Incorporated herein by
    reference to the Company&#8217;s Report on Form 6-K filed with the SEC on June 1, 2016.</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">(4)</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Incorporated herein by
    reference to Exhibit A to the Company&#8217;s Report on Form 6-K filed with the SEC on April 2, 2015.</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">(5)</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Incorporated herein by
    reference to Exhibit 10.8 to the Company&#8217;s Registration Statement on Form F-1 filed with the SEC on June 16, 2023.</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">(6)</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Incorporated herein by
    reference to the Company&#8217;s Annual Report on Form 20-F filed with the SEC on March 31, 2015.</span></td></tr>
  </table>

<p style="margin-top: 0; margin-bottom: 0">&#160;</p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.3in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 0.3in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">(7)</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Incorporated herein by
    reference to the Company&#8217;s Annual Report on Form 20-F filed with the SEC on March 22, 2016.</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">(8)</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Incorporated herein by
    reference to the Company&#8217;s Annual Report on Form 20-F filed with the SEC on March 23, 2017.</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">(9)</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Incorporated herein by
    reference to Exhibit 1.1 to the Company&#8217;s Report on Form 6-K filed with the SEC on March 26, 2021.</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">(10)</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Incorporated herein by
    reference to the Company&#8217;s Annual Report on Form 20-F filed with the SEC on March 13, 2018.</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">(11)</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Incorporated herein by
    reference to the Company&#8217;s Annual Report on Form 20-F filed with the SEC on March 13, 2019.</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">(12)</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Incorporated herein by
    reference to the Company&#8217;s Annual Report on Form 20-F filed with the SEC on March 18, 2021.</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">(13)</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Incorporated herein by
    reference to the Company&#8217;s Annual Report on Form 20-F filed with the SEC on May 2, 2022.</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">(14)</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Incorporated herein by
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  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">(15)</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Incorporated herein by
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  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
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    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Incorporated herein by
    reference to Exhibit 10.3 to the Company&#8217;s Report on Form 6-K filed with the SEC on July 18, 2023.</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
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    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Incorporated herein by
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  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
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    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Incorporated herein by
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    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
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    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">(19)</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Incorporated herein by
    reference to Exhibit 3.1 to the Company&#8217;s Registration Statement on Form F-1 filed with the SEC on June 16, 2023.</span></td></tr>
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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">*Filed
herewith.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>


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<p style="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>SIGNATURES</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
registrant hereby certifies that it meets all of the requirements for filing on Form 20-F and that it has duly caused and authorized
the undersigned to sign this annual report on its behalf.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

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    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td colspan="2" style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>GALMED PHARMACEUTICALS LTD.</b></span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
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    <td style="font: 10pt Times New Roman, Times, Serif; width: 50%"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 3%"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><i>By:</i></span></td>
    <td style="border-bottom: black 1.5pt solid; font: 10pt Times New Roman, Times, Serif; width: 47%"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><i>/s/
    Allen Baharaff</i></span></td></tr>
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    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Allen Baharaff</span></td></tr>
  <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">President, Chief Executive Officer and Chairman</span></td></tr>
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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Date:
April 4, 2024</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p>


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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
Form
20-F
☐
REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934
OR
☒
ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the fiscal year ended
December 31
,
2023
☐
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
OR
☐
SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
Date
of event requiring this shell company report ________________
For
the transition period from _______________________________
to
_______________________________
Commission
File No.
001-36345
GALMED
PHARMACEUTICALS LTD.
(Exact
name of Registrant as specified in its charter)
N/A
(Translation
of the Registrant's name into English)
State
of
Israel
(Jurisdiction
of incorporation or organization)
16
Abba Hillel Road
,
Ramat Gan
,
Israel
5250608
(Address
of principal executive offices)
Allen
Baharaff
President
and Chief Executive Officer
16
Abba Hillel Road
Ramat Gan
,
Israel
5250608
E-mail:
ab@galmedpharma.com
Tel:
+972.3
.
693.8448
Fax:
+972.3.693.8447
(Name,
Telephone, E-mail and/or Facsimile number and Address of Company Contact Person)
Securities
registered or to be registered pursuant to Section 12(b) of the Act.
Title
    of each class
Trading
    Symbol(s)
Name
    of each exchange on which registered
Ordinary
    shares, par value NIS 0.15 per share
GLMD
Nasdaq
Capital Market
Securities
registered or to be registered pursuant to Section 12(g) of the Act.
N/A
(Title
of each class)
Securities
registered or to be registered pursuant to Section 15(d) of the Act.
N/A
(Title
of each class)
Indicate
the number of outstanding shares of each of the issuer's classes of capital or common stock as of the close of the period covered
by the annual report (December 31, 2023):
5,045,324
ordinary shares are outstanding
Indicate
by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes
☐
No
☒
If
this report is an annual or transition report, indicate by check mark if the registrant is not required to file reports pursuant to Section
13 or 15(d) of the Securities Exchange Act of 1934. Yes
☐
No
☒
Note
– Checking the box above will not relieve any registrant required to file reports pursuant to Section 13 or 15(d) of the Securities
Exchange Act of 1934 from their obligations under those Sections.
Indicate
by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange
Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2)
has been subject to such filing requirements for the past 90 days.
Yes
☒
No
☐
Indicate
by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule
405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant
was required to submit and post such files).
Yes
☒
No
☐
Indicate
by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer or an emerging growth
company. See definition of "large accelerated filer," "accelerated filer," and "emerging growth company"
in Rule 12b-2 of the Exchange Act.
Large
    accelerated filer
☐
Accelerated
    filer
☐
Non-accelerated
    filer
☒
Emerging
    growth company
☐
If
an emerging growth company that prepares its financial statements in accordance with U.S. GAAP, indicate by check mark if the registrant
has elected not to use the extended transition period for complying with any new or revised financial accounting standards † provided
pursuant to Section 13(a) of the Securities Act. ☐
†
The term "new or revised financial accounting standard" refers to any update issued by the Financial Accounting Standards
Board to its Accounting Standards Codification after April 5, 2012.
Indicate
by check mark whether the registrant has filed a report on and attestation to its management's assessment of the effectiveness
of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered
public accounting firm that prepared or issued its audit report.
☐
If
securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant
included in the filing reflect the correction of an error to previously issued financial statements.
☐
Indicate
by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation
received by any of the registrant's executive officers during the relevant recovery period pursuant to §240.10D-1(b). ☐
Indicate
by check mark which basis of accounting the registrant has used to prepare the financial statements included in this filing:
U.S. GAAP
☒
International
                                            Financial Reporting Standards
as
    issued by the International Accounting Standards Board
Other
If
"Other" has been checked in response to the previous question indicate by check mark which financial statement item the Registrant
has elected to follow: Item 17 ☐ Item 18
☐
If
this is an annual report, indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange
Act). Yes
☐
No
☒
TABLE
OF CONTENTS
PART I
5
ITEM 1. Identity of Directors, Senior Management and Advisers.
5
ITEM 2. Offer Statistics and Expected Timetable.
5
ITEM 3. Key Information.
5
ITEM 4. Information on the Company.
55
ITEM 4A. Unresolved Staff Comments.
92
ITEM 5. Operating and Financial Review and Prospects.
92
ITEM 6. Directors, Senior Management and Employees.
99
ITEM 7. Major Shareholders and Related Party Transactions.
120
ITEM 8. Financial Information.
121
ITEM 9. The Offer and Listing.
122
ITEM 10. Additional Information.
122
ITEM 11. Quantitative and Qualitative Disclosures About Market Risk.
135
ITEM 12. Description of Securities Other Than Equity Securities.
136
PART II
136
ITEM 13. Defaults, Dividend Arrearages and Delinquencies.
136
ITEM 14. Material Modifications to the Rights of Security Holders and Use of Proceeds.
136
ITEM 15. Controls and Procedures.
136
ITEM 16. [RESERVED]
137
ITEM 16A. Audit Committee Financial Expert.
137
ITEM 16B. Code of Ethics.
137
ITEM 16C. Principal Accountant Fees and Services.
138
ITEM 16D. Exemptions from the Listing Standards for Audit Committees.
139
ITEM 16E. Purchases of Equity Securities by the Issuer and Affiliated Purchasers.
139
ITEM 16F. Change in Registrant's Certifying Accountant.
139
ITEM 16G. Corporate Governance.
139
ITEM 16H. Mine Safety Disclosure.
141
ITEM 16I. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections.
141
ITEM 16J. Insider Trading Policies.
141
ITEM 16K. Cybersecurity.
141
PART III
141
ITEM 17. Financial Statements.
141
ITEM 18. Financial Statements.
141
ITEM 19. Exhibits
142
2
ABOUT
THIS ANNUAL REPORT
All
references to "we," "us," "our," "the Company" and "our Company", in this
Annual Report on Form 20-F, or our annual report, are to Galmed Pharmaceuticals Ltd. and its subsidiaries, unless the context otherwise
requires. All references to Aramchol mean Aramchol acid or Aramchol meglumine (salt), unless the context otherwise requires. All references
to "shares" or "ordinary shares" are to our ordinary shares, NIS 0.15 nominal par value per share. All references
to "Israel" are to the State of Israel. "U.S. GAAP" means the generally accepted accounting principles of the
United States. Unless otherwise stated, all of our financial information presented in this annual report has been prepared in accordance
with U.S. GAAP. Any discrepancies in any table between totals and sums of the amounts listed are due to rounding. Unless otherwise indicated,
or the context otherwise requires, references in this annual report to financial and operational data for a particular year refer to
the fiscal year of our company ended December 31 of that year.
Our
reporting currency and financial currency is the U.S. dollar. In this annual report, "NIS" means New Israeli Shekel, and
"$," "US$" and "U.S. dollars" mean United States dollars.
All
information in this Annual Report on Form 20-F relating to shares or price per share reflects the 1-for-15 reverse share split effected
by us on May 15, 2023.
CAUTIONARY
NOTE REGARDING FORWARD-LOOKING STATEMENTS
This
annual report contains forward-looking statements about our expectations, beliefs or intentions regarding, among other things, our product
development efforts, business, financial condition, results of operations, strategies or prospects. In addition, from time to time, we
or our representatives have made or may make forward-looking statements, orally or in writing. Forward-looking statements can be identified
by the use of forward-looking words such as "believe," "expect," "intend," "plan," "may,"
"should," "anticipate," "could," "might," "seek," "target," "will,"
"project," "forecast," "continue" or their negatives or variations of these words or other comparable
words or by the fact that these statements do not relate strictly to historical matters. These forward-looking statements may be included
in, among other things, various filings made by us with the U.S. Securities and Exchange Commission, or the SEC, press releases or oral
statements made by or with the approval of one of our authorized executive officers. Forward-looking statements relate to anticipated
or expected events, activities, trends or results as of the date they are made. Because forward-looking statements relate to matters
that have not yet occurred, these statements are inherently subject to risks and uncertainties that could cause our actual results to
differ materially from any future results expressed or implied by the forward-looking statements. Many factors could cause our actual
activities or results to differ materially from the activities and results anticipated in forward-looking statements, including, but
not limited to, the factors summarized below:
●
our ability to pursue, evaluate and complete any strategic alternative
that yields value for our shareholders;
●
the
    timing and cost of our planned Primary Sclerosing Cholangitis, or PSC, clinical trial and our pivotal Phase 3 ARMOR trial, or the
    ARMOR Study, if re-initiated, for our product candidates, Aramchol and Amilo-5MER, or for any other pre-clinical or clinical trials;
●
completion
    and receiving favorable results of our planned PSC clinical trial and the ARMOR Study (if re-initiated) for Aramchol or any other
    pre-clinical or clinical trial;
●
regulatory
    action with respect to Aramchol or any other product candidate by the U.S. Food and Drug Administration, or FDA, the European Medicines
    Authority, or EMA, or the Medicines and Healthcare Products Regulatory Agency, or the MHRA, including but not limited to acceptance
    of an application for marketing authorization, review and approval of such application, and, if approved, the scope of the approved
    indication and labeling;
●
the
    commercial launch and future sales of Aramchol and any future product candidates;
●
our
    ability to comply with all applicable post-market regulatory requirements for Aramchol, Amilo-5MER or any other product candidate
    in the countries in which we seek to market the product;
●
our
    ability to achieve favorable pricing for Aramchol, Amilo-5MER or any other product candidate;
●
our
    expectations regarding the commercial market for PSC, non-alcoholic steato-hepatitis, or NASH (also known as MASH), in patients or any other targeted
    indication;
●
third-party
    payor reimbursement for Aramchol, Amilo-5MER or any other product candidate;
●
our
    estimates regarding anticipated capital requirements and our needs for additional financing;
●
market
    adoption of Aramchol or any other product candidate by physicians and patients;
●
the
    timing, cost or other aspects of the commercial launch of Aramchol or any other product candidate;
●
our
    ability to obtain and maintain adequate protection of our intellectual property;
●
the
    possibility that we may face third-party claims of intellectual property infringement;
●
our
    ability to manufacture our product candidates in commercial quantities, at an adequate quality or at an acceptable cost;
●
our
    ability to establish adequate sales, marketing and distribution channels;
3
●
intense
    competition in our industry, with competitors having substantially greater financial, technological, research and development, regulatory
    and clinical, manufacturing, marketing and sales, distribution and personnel resources than we do;
●
the
    development and approval of the use of Aramchol or any other product candidate for additional indications or in combination therapy;
●
our
    expectations regarding licensing, acquisitions and strategic operations;
●
current
    or future unfavorable economic and market conditions and adverse developments with respect to financial institutions and associated
    liquidity risk;
●
our
    ability to maintain the listing of our ordinary shares on The Nasdaq Capital Market;
●
security,
    political and economic instability in the Middle East that could harm our business, including due to the the recent attacks by Hamas
    and other terrorist organizations from the Gaza Strip and elsewhere in the region and Israel's war against them and military
    hostilities with Hezbollah on the northern border of Israel
●
those
    factors referred to in "Item 3.D. Risk Factors," "Item 4. Information on the Company," and "Item 5.
    Operating and Financial Review and Prospects", as well as in this annual report on Form 20-F generally.
We
believe these forward-looking statements are reasonable; however, these statements are only current predictions and are subject to known
and unknown risks, uncertainties and other factors that may cause our or our industry's actual results, levels of activity, performance
or achievements to be materially different from those anticipated by the forward-looking statements. We discuss many of these risks in
this annual report in greater detail under the heading "Risk Factors" and elsewhere in this annual report. Given these uncertainties,
you should not rely upon forward-looking statements as predictions of future events.
All
forward-looking statements attributable to us or persons acting on our behalf speak only as of the date hereof and are expressly qualified
in their entirety by the cautionary statements included in this annual report. We undertake no obligations to update or revise forward-looking
statements to reflect events or circumstances that arise after the date made or to reflect the occurrence of unanticipated events. In
evaluating forward-looking statements, you should consider these risks and uncertainties.
EXPLANATORY
NOTE
Market
data and certain industry data and forecasts used throughout this annual report were obtained from internal company surveys, market research,
consultant surveys commissioned by the Company, publicly available information, reports of governmental agencies and industry publications
and surveys. Industry surveys, publications, consultant surveys commissioned by the Company and forecasts generally state that the information
contained therein has been obtained from sources believed to be reliable. However, this information may prove to be inaccurate because
of the method by which some of the data for the estimates is obtained or because this information cannot always be verified with complete
certainty due to the limits on the availability and reliability of raw data, the voluntary nature of the data gathering process and other
limitations and uncertainties. As a result, the market and industry data and forecasts included or incorporated by reference in this
annual report, and estimates and beliefs based on that data, may not be reliable. We have relied on certain data from third-party sources,
including internal surveys, industry forecasts and market research, which we believe to be reliable based on our management's knowledge
of the industry. However, we have not ascertained the underlying economic assumptions relied upon therein. Forecasts are particularly
likely to be inaccurate, especially over long periods of time. In addition, we do not necessarily know what assumptions regarding general
economic growth were used in preparing the forecasts we cite. Statements as to our market position are based to the best of our knowledge
on the most currently available data. While we are not aware of any misstatements regarding the industry data presented in this annual
report, our estimates involve risks and uncertainties and are subject to change based on various factors, including those discussed under
the heading "Risk Factors" in this annual report.
4
PART
I
ITEM
1. Identity of Directors, Senior Management and Advisers.
Not
applicable.
ITEM
2. Offer Statistics and Expected Timetable.
Not
applicable.
ITEM
3. Key Information.
A.
[Reserved.]
B.
Capitalization and Indebtedness.
Not
applicable.
C.
Reasons for the Offer and Use of Proceeds.
Not
applicable.
D.
Risk Factors.
Summary
of Risk Factors
An
investment in our ordinary shares is subject to a number of risks. The following summarizes some, but not all, of these risks. Please
carefully consider all of the information discussed in "Item 3. Key Information—D. Risk Factors" in this annual report
for a more thorough description of these and other risks.
Risks
Related to Our Financial Position and Capital Requirements
●
We
    are a biopharmaceutical company with a history of operating losses. We expect to incur significant additional losses in the future
    and may never be profitable.
●
We
    have not yet commercialized any products and we may never be able to do so, and even if we do, the products may not gain market acceptance.
●
We
    will need substantial, additional capital in the future. If additional capital is not available, we will have to delay, reduce or
    cease operations.
●
We
    are unable to estimate our long-term capital requirements due to uncertainties associated with the development and commercialization
    of Aramchol, Amilo-5MER or any other product candidate. If we fail to obtain necessary funds for our operations, we will be unable
    to develop and commercialize Aramchol, Amilo-5MER or any other product candidate.
Risks
Related to Our Business, Industry and Regulatory Requirements
●
Our
    activities to evaluate and pursue strategic alternatives may not be successful.
●
We
    are substantially dependent on our remaining employees to facilitate the consummation of a strategic transaction. We could lose such
    key employees.
●
The
    clinical trial process is complex and expensive, and commencement and completion of clinical trials can be delayed or prevented for
    a number of reasons.
●
We
    have historically developed Aramchol for the treatment of NASH, and there
    is significant uncertainty regarding the regulatory approval process. In addition, during 2022, we discontinued our open label part
    of the ARMOR Study and we do not currently expect to initiate the second part of the ARMOR Study. This makes it difficult to predict
    the timing and costs of the clinical development of Aramchol for the treatment of NASH.
●
We
    depend largely on the success of our lead product candidate, Aramchol, and we may not obtain regulatory approval of Aramchol.
5
●
Commencement
    of our ARMOR Study in jurisdictions outside the United States is subject to acceptance of the foreign equivalent of our IND by regulatory
    authorities.
●
We
    may be forced to abandon development of Aramchol or any other product candidate which would have a material adverse effect on our
    business and may force us to cease operations.
●
The
    lack of a reliable non-invasive method for the diagnosis of NASH is likely to present a major challenge to Aramchol's market
    penetration, if ever commercialized.
●
Our
    Amilo-5MER program is being conducted under a license agreement with Yissum Research Development Company of the Hebrew University
    of Jerusalem, or Yissum.
●
If
    we acquire or in-license additional technologies or product candidates, we may incur significant, incremental expenses, may have
    integration difficulties and may experience other risks that could harm our business and results of operations.
●
Changes
    in regulatory requirements and guidance or unanticipated events during our clinical trials may occur, which may result in necessary
    changes to clinical trial protocols, which could result in increased costs to us, delay our development timeline or reduce the likelihood
    of successful completion of our clinical trials.
●
We
    manage our business through a small number of senior executive officers. We depend on them even more than similarly- situated companies.
●
Our
    business is subject to risks arising from epidemic diseases, such as the COVID-19 pandemic, which has impacted and could continue
    to impact our business.
Risks
Related to Our Reliance on Third Parties
●
We
    have no manufacturing capacity and anticipate reliance on third-party manufacturers for Aramchol, Amilo-5MER or any other product
    candidate.
●
Any
    collaboration arrangements that we may enter into in the future may not be successful, which could adversely affect our ability to
    develop and commercialize our current and potential future product candidates.
●
We
    depend on third parties to conduct our clinical trials.
Risks
Related to Our Intellectual Property
●
The
    failure to obtain or maintain patents, licensing agreements and other intellectual property rights that are sufficiently broad and
    protective could impact our ability to compete effectively.
●
Our
    potential development of Aramchol meglumine may not result in improved bioavailability compared to the existing form of Aramchol.
    Furthermore, although we have pending patent applications and granted patent covering Aramchol meglumine in development, there is
    no assurance that we will receive any patents for them, and even if we receive one or more patents for our Aramchol meglumine in
    development, they may be of little or no commercial value.
Risks
Related to Ownership of Our Ordinary Shares
●
Our
    business, operating results and growth rates may be adversely affected by current or future unfavorable economic and market conditions
    and adverse developments with respect to financial institutions and associated liquidity risk.
6
●
The
    market price of our ordinary shares is volatile and you may sustain a complete loss of your investment.
●
If
    we fail to comply with the continued listing requirements of the Nasdaq Capital Market, our ordinary shares may be delisted and the
    price of our ordinary shares and our ability to access the capital markets could be negatively impacted.
●
Our
    President and Chief Executive Officer beneficially owns approximately 5.6% of our outstanding ordinary shares, as of March 27, 2024.
    Therefore, our principal shareholders will be able to exert significant control over matters submitted to our shareholders for approval.
●
Our
    U.S. shareholders may suffer adverse tax consequences due to our classification as a passive foreign investment company.
Risks
Related to Israeli Law and Our Operations in Israel
●
Our
    headquarters and other significant operations are located in Israel and, therefore, our results may be adversely affected by political,
    economic and military instability in Israel, such as the recent attacks by Hamas and other terrorist organizations from the Gaza
    Strip and elsewhere in the region and Israel's war against them and military hostilities with Hezbollah on the northern border
    of Israel
●
Provisions
    of Israeli law and our articles of association, or Articles, may delay, prevent or otherwise impede a merger with, or an acquisition
    of, our company, which could prevent a change of control, even when the terms of such a transaction are favorable to us and our shareholders.
●
Your
    rights, liabilities and responsibilities as a shareholder will be governed by Israeli law and differ in some material respects from
    those under U.S. law.
RISK
FACTORS
An
investment in our ordinary shares involves a high degree of risk. Prior to making a decision about investing in our ordinary shares,
you should carefully consider the risks, uncertainties and assumptions set forth below. Additional risks and uncertainties not presently
known to us, or that we currently see as immaterial, may also harm our business. If any of these risks occur, our business, financial
condition and operating results could be harmed, the trading price of our ordinary shares could decline and you could lose part or all
of your investment.
Risks
Related to Our Financial Position and Capital Requirements
We
are a biopharmaceutical company with a history of operating losses. We expect to incur significant additional losses in the future and
may never be profitable.
We
are a biopharmaceutical company with an operating history limited to pre-clinical and clinical drug development and no approved products.
During 2022, we discontinued the open-label part of the ARMOR Study having reached its objectives and initiated a strategic review process.
Following the discontinuation of our open label part of the ARMOR Study, we do not currently expect to initiate the second part of the
ARMOR Study. In addition, we have limited operating experience and have not yet demonstrated an ability to successfully overcome many
of the risks and uncertainties frequently encountered by companies in new and rapidly evolving fields, particularly in the pharmaceutical
industry. We have funded our research and development programs and operations to date primarily through proceeds from private placements
and public offerings. We currently have no products approved for marketing in the United States or any other jurisdiction and have not
generated any revenue from product sales to date, although we have generated revenue from our licensing agreement with Samil Pharm. Co.,
Ltd., or Samil. We have incurred operating losses in each year since the inception of our predecessor in 2000. Our loss attributable
to holders of our ordinary shares for the years ended December 31, 2022, and 2023 was approximately $17.4 million and $7.2 million, respectively.
As of December 31, 2023, we had an accumulated deficit of $193.0 million. Substantially all of our operating losses resulted from costs
incurred in connection with our development program and from general and administrative costs associated with our operations.
7
Our
ability to become profitable depends upon our ability to generate revenue in excess of our expenses. To date, we have not generated any
revenue, excluding the licensing revenue we recorded in connection with that certain Samil Agreement (as defined below), as our lead
product candidate, Aramchol and has not been approved by the FDA, nor has any other product candidate. We do not know when, or if, we
will generate any revenue from sales of Aramchol, Amilo-5MER and/or any other product candidate. We do not expect to generate revenue
other than subsequent royalties and/or milestones that can be earned in connection with the Samil Agreement or other potential license
agreements, unless and until we, or an ultimate third-party licensor or acquirer, obtain regulatory and marketing approval of, and commercialize,
Aramchol, Amilo-5MER or any other product candidate. Subject to our strategic review, we will continue to incur significant research
and development and general and administrative expenses related to our operations. We expect to continue to incur losses before we can
consummate any strategic alternatives, which may be significant.
Based
on our current operating plan, which is subject to change pursuant to our strategic review, we expect to continue to incur significant
expenses and operating losses for the foreseeable future. We anticipate that our expenses will increase substantially if and as we:
●
re-initiate
    the ARMOR Study and/or commence any additional clinical trials for Aramchol and Amilo-5MER, or any other product candidate and initiate
    additional research and development programs;
●
seek
    regulatory approvals for Aramchol, Amilo-5MER or any other product candidate;
●
seek
    to in-license additional products or technologies to develop;
●
expand
    our operational, financial and management systems and personnel, including personnel to support our clinical development, manufacturing
    and commercialization efforts and our operations as a public company;
●
hire
    additional management and other personnel;
●
move
    towards commercialization of Aramchol or any other product candidate;
●
explore
    and review a range of strategic alternatives for our company.
We
may out-license Aramchol, Amilo-5MER or any other product candidate including through a territorial license, a worldwide license, or
a license for a particular indication, before it is approved by any applicable regulatory agency, commercialized and/or generates revenue,
depending on a number of factors, including, but not limited to, our ability to:
●
demonstrate
    a compelling and/or novel, pre-clinical, unique mechanism of action of Aramchol, Amilo-5MER or any other product candidate;
●
obtain
    adequate clinical results from and progress from the clinical development of Aramchol or any other product candidate;
●
develop
    and obtain regulatory approvals in the countries and for the uses we intend to pursue for Aramchol, Amilo-5MER or any other product
    candidate;
●
contract
    for the manufacture of commercial quantities of Aramchol, Amilo-5MER or any other product candidate by a current good manufacturing
    practice, or cGMP, compliant manufacturing facility at acceptable cost levels if marketing approval is received; and
●
establish
    external, and potentially in the future, internal, sales and marketing capabilities to effectively market and sell Aramchol, Amilo-5MER
    or any other product candidate in the United States and other countries.
8
Even
if Aramchol, Amilo-5MER or any other product candidate is approved for commercial sale, it may not gain market acceptance or achieve
commercial success. In addition, we anticipate incurring significant costs associated with seeking regulatory approval and commercialization.
We may not achieve profitability soon after generating product revenue, if ever. If we are unable to generate product revenue, we will
not become profitable and would be unable to continue operations without additional funding.
We
expect our research and development expenses to significantly increase if we re-initiate our ARMOR Study and initiate any other pre-clinical
or clinical trials. In addition, if we obtain marketing approval for Aramchol, Amilo-5MER or any other product candidate and opt to commercialize
it ourselves, we will likely initially incur significant expenses associated with outsourcing sales, marketing and manufacturing functions
to third parties, as well as continued research and development expenses. Furthermore, we expect to incur additional costs associated
with operating as a public company. As a result, and subject to our strategic review, we expect to continue to incur significant and
increasing operating losses for the foreseeable future. Because of the numerous risks and uncertainties associated with developing pharmaceutical
products, we are unable to predict the extent of any future losses or when we will become profitable, if at all.
Our
limited operating history makes it difficult to evaluate our business and prospects.
Our
operating history is limited to pre-clinical and clinical development of two products, and our operations to date have been limited primarily
to research and development, raising capital and recruiting scientific and management personnel and third-party partners. Therefore,
it may be difficult to evaluate our business and prospects. We have not yet demonstrated an ability to commercialize or obtain regulatory
approval for any product candidate. Consequently, any predictions about our future performance may not be accurate, and you may not be
able to fully assess our ability to complete development and/or commercialize our product candidates, obtain regulatory approvals or
achieve market acceptance or favorable pricing for our product candidates.
We
have not yet commercialized any products and we may never be able to do so, and even if we do, the products may not gain market acceptance.
We
have not yet commercialized any products and we may never be able to do so. During 2022, we discontinued the open-label part of the
ARMOR Study having reached its objectives and initiated a strategic review process. Following the discontinuation of our open label
part of the ARMOR Study, we do not currently expect to initiate the second part of the ARMOR Study and are currently developing Aramchol for PSC. We do not know when or if we
will complete development of Aramchol, Amilo-5MER or any other product candidate, obtain regulatory approval, or successfully
commercialize any approved products. Even if we are successful in developing products that are approved for marketing, we will not
be successful unless these products gain market acceptance for appropriate indications at favorable reimbursement rates. The degree
of market acceptance for these products will depend on a number of factors, including:
●
the
    timing and scope of regulatory approvals in the countries we intend to pursue with respect to the commercialization of Aramchol,
    Amilo-5MER or any other product candidate, including the indications for which they are approved;
●
the
    competitive environment;
●
the
    ability for Aramchol, Amilo-5MER or any other product candidate to be manufactured, whether by us or third parties, in compliance
    with applicable regulatory requirements, including cGMP;
●
our
    ability to effectively promote Aramchol or any other product candidate, whether directly or using third parties, consistent with
    the approved indications and labeling in the countries in which we intend to pursue approval;
●
the
    acceptance by the medical community of the safety and clinical efficacy of Aramchol, Amilo-5MER or any other product candidate and
    their potential advantages over other therapeutic products;
9
●
the
    development of a non-invasive method for diagnosing NASH as an alternative to the current gold standard of liver biopsy, which we
    view as a rate-limiting factor to complete market uptake because of its expense and its risks and discomfort to patients;
●
the
    adequacy and success of distribution, sales and marketing efforts, including through strategic agreements with pharmaceutical and
    biotechnology companies; and
●
the
    pricing and reimbursement policies of government and third-party payors, such as insurance companies, health maintenance organizations
    and other plan administrators.
Physicians,
patients, third-party payors or the medical community in general may be unwilling to accept, utilize or recommend, and in the case of
third-party payors, reimburse any of our planned future products. As a result, we are unable to predict the extent of future losses or
the time required to achieve profitability, if at all. Even if we successfully develop one or more products, we may not become profitable.
We
will need substantial, additional capital in the future. If additional capital is not available, we will have to delay, reduce or cease
operations.
As
of December 31, 2023, we had a net working capital of $10.5 million, cash and cash equivalents of $2.9 million, restricted cash of $0.1
million, short term deposits of $2.3 million and marketable debt securities of $7.5 million. Based on our current operating plan, which
is subject to change pursuant to our strategic review, we currently estimate that our cash position will support our current operations
as currently conducted for more than 12 months from the date of issuance of this annual report. We will need to raise substantial, additional
capital to fund our operations and to re-initiate the ARMOR Study and develop Aramchol and Amilo-5MER for, and beyond their current development
stage, and ultimately commercialize them, if we opt to do so ourselves. In addition, we may expand our current research and development
focus and clinical operations as well as the development of Aramchol or any other product candidate for other indications or development
of other molecules and/or combination of Aramchol with other molecules for NASH or other liver and inflammatory diseases as well as non-invasive
biomarkers, which we expect will also require additional capital. Our future capital requirements will depend on many factors including:
●
the
    outcome of our review of our strategic alternatives:
●
the
    progress and costs of our pre-clinical studies, clinical trials and other research and development activities;
●
the
    regulatory pathway of Aramchol, Amilo-5MER or any other product candidate;
●
the
    scope, prioritization and number of our clinical trials and other collaboration, research and development programs;
●
the
    amount of revenues and contributions we receive under future licensing, development and commercialization arrangements with respect
    to Aramchol, Amilo-5MER or any other product candidate;
●
the
    costs of the development and expansion of our operational infrastructure;
●
the
    costs and timing of obtaining regulatory approval for Aramchol, Amilo-5MER or any other product candidate;
●
the
    ability of us, or our collaborators, to achieve development milestones, marketing approval and other events or developments under
    our potential future licensing agreements;
●
the
    costs of filing, prosecuting, enforcing and defending patent claims and other intellectual property rights;
●
the
    costs and timing of securing manufacturing arrangements for clinical or commercial production;
10
●
the
    costs of contracting with third parties to provide sales and marketing capabilities for us;
●
the
    costs of acquiring or undertaking development and commercialization efforts for any future products, product candidates or platforms;
●
the
    magnitude of our general and administrative expenses;
●
any
    cost that we may incur under future in- and out-licensing arrangements relating to Aramchol, Amilo-5MER or any other product candidate;
●
market
    conditions;
●
our
    ability to maintain the listing of our orindary share on The Nasdaq Capital Market; and
●
the
    impact of any resurgence of the COVID-19 pandemic and the war between Israel and Hamas, which may exacerbate the magnitude of the factors discussed
    above.
Under
General Instruction I.B.5 to Form F-3, or the Baby Shelf Rule, the amount of funds we can raise through primary public offerings of securities
in any 12-month period using our registration statement on Form F-3 is limited to one-third of the aggregate market value of the ordinary
shares held by non-affiliates of the Company. As of March 27, 2024, our public float was approximately $1.8 million, based on 5,777,351
ordinary shares held by non-affiliates and a price of $0.32 per share, which was the last reported sale price of our ordinary shares
on the Nasdaq Capital Market on March 26, 2024. We therefore are limited by the Baby Shelf Rule as of the filing of this annual report,
until such time as our public float exceeds $75 million. If we are required to file a new registration statement on another form, we
may incur additional costs and be subject to delays due to review by the SEC Staff.
Changing
circumstances may cause us to consume capital significantly faster than we currently anticipate, such as losing our Small and Medium
Enterprise status at the EMA, which entitles us to significant fee reductions. Because there are numerous risks and uncertainties associated
with the development and commercialization of Aramchol, Amilo-5MER or any other product candidate, we are unable to estimate the amount
of increased capital outlays and operating expenditures associated with our anticipated clinical trials. We have no committed external
sources of funds. Additional financing may not be available when we need it or may not be available on terms that are favorable to us
and additional financing may cause significant dilution to our existing shareholders. If adequate funds are not available to us on a
timely basis, or at all, we may be required to terminate or delay planned or ongoing clinical trials or other development activities
for Aramchol, Amilo-5MER or any other product candidate.
Raising
additional capital may be costly or difficult to obtain and will dilute current shareholders' ownership interests, potentially
substantially.
Any
debt, equity or structured financing that we may need or desire may not be available on terms favorable to us, or at all. If we obtain
funding through a strategic collaboration or licensing arrangement, we may be required to relinquish our rights to certain of our technologies,
products or marketing territories. If we are unable to obtain required additional capital, we may have to curtail our growth plans or
cut back on existing business, and we may not be able to continue operating if we do not generate sufficient revenues from operations
needed to stay in business.
We
may incur substantial costs in pursuing future capital financing, including investment banking fees, legal fees, accounting fees, securities
law compliance fees, printing and distribution expenses and other costs. We may also be required to recognize non-cash expenses in connection
with certain securities we issue, such as convertible notes and warrants, which may adversely impact our capital structure, financial
condition and results of operations.
In
addition, our authorized share capital consists of 20,000,000 ordinary shares, par value NIS 0.15 per share. As of March 27, 2024, we
had 6,009,654 ordinary shares issued and outstanding. As of the date of this Annual Report, we also had outstanding pre-funded warrants
to purchase 1,280,000 ordinary shares and warrants to purchase 5,200,000 ordinary shares with an exercise price of $1.25 per share. To
the extent that pre-funded warrants and warrants are exercised, holders of our ordinary shares will experience dilution.
11
Any
additional capital raised through the sale of equity or equity-linked securities, will dilute our current shareholders' ownership
in us, potentially substantially, and could also result in a decrease in the market price of our ordinary shares. The terms and conditions
of those securities issued by us in future capital transactions may be more favorable to new investors and may include the issuance of
warrants or other derivative securities, which may have a further dilutive effect.
We
are unable to estimate our long-term capital requirements due to uncertainties associated with our strategic review and the development
and commercialization of Aramchol, Amilo-5MER or any other product candidate. If we fail to obtain necessary funds for our operations,
we will be unable to develop and commercialize Aramchol, Amilo-5MER or any other product candidate.
Our
long-term capital requirements are expected to depend on many potential factors, including, among others:
●
the
    outcome of our review of our strategic alternatives;
●
the
    number of product candidates in development;
●
the
    size, duration and scope of existing and future clinical trials and pre-clinical studies;
●
the
    regulatory pathway for the approval of Aramchol, Amilo-5MER or any other product candidate;
●
the
    results of our clinical trials, which are unpredictable in product candidate development;
●
our
    ability to successfully commercialize Aramchol, Amilo-5MER or any other product candidate, including securing commercialization and
    out-licensing agreements with third parties and favorable pricing and market share;
●
the
    progress, success and cost of our clinical trials and research and development programs, including those associated with milestones
    and royalties;
●
the
    costs, timing and outcome of regulatory review and obtaining regulatory approval of Aramchol, Amilo-5MER or any other product candidate
    and addressing regulatory and other issues that may arise post-approval;
●
the
    breadth of the labeling, assuming that Aramchol, Amilo-5MER or any other product candidate are approved for commercialization by
    a relevant regulatory authority, which may not occur;
●
our
    need, or decision, to acquire or in-license complementary technologies or new platform technologies or product candidates;
●
the
    costs of enforcing our issued patents and defending intellectual property-related claims;
●
the
    costs of investigating patents that might block us from developing potential product candidates;
●
the
    costs of recruiting and retaining qualified personnel;
●
the
    costs associated with contracting with third parties to manufacture the product and to perform other necessary services;
●
our
    revenue, if any; and
●
our
    consumption of available resources more rapidly than currently anticipated, resulting in the need for additional funding sooner than
    anticipated.
12
If
we are unable to obtain the funds necessary for our operations, we will be unable to develop and commercialize Aramchol, Amilo-5MER or
any other product candidate which would materially and adversely affect our business, liquidity and results of operations.
Risks
Related to Our Business, Industry and Regulatory Requirements
Our
activities to evaluate and pursue strategic alternatives may not be successful.
In
May 2022, we announced that we will expand into new anti-fibrotic indications to maximize the potential of Aramchol while at the
same time discontinuing the open label part of the ARMOR Study having reached its objectives. Simultaneously, we initiated a cost
reduction plan and at various times have been evaluating our strategic options alternatives and our structuring to best optimize our
resources to enhance shareholder value and achieve our goals. In June 2023, we announced the closing of a strategic investment in
OnKai, Inc., or OnKai, (see "Item 4. Information on the Company— Strategic Collaborations, Research Arrangements and
other Agreements—Onkai.").
We
also may acquire additional businesses, products or product candidates. Integrating any newly acquired business, product or product candidate
could be expensive and time-consuming. We may not be able to integrate any acquired business, product or product candidate successfully.
If we do acquire any additional business, products, or product candidates, our future financial performance will depend, in part, on
our ability to manage any future growth effectively and our ability to integrate any such acquired businesses, products or product candidates.
Any
strategic transaction may require us to incur non-recurring or other charges, may increase our near- and long-term expenditures and may
pose significant integration challenges or disrupt our management or business, which could adversely affect our operations and financial
results. For example, these transactions may entail numerous operational and financial risks, including:
●
exposure
    to unknown liabilities;
●
incurrence
    of substantial debt or dilutive issuances of equity securities to pay for acquisitions;
●
higher
    than anticipated acquisition and/or integration costs;
●
write
    downs of assets or goodwill or impairment charges;
●
increased
    amortization expenses;
●
difficulty
    and cost in combining the operations and personnel of any acquired businesses with our operations and personnel;
●
impairment
    of relationships with key suppliers or customers of any acquired businesses due to changes in management and ownership; and
●
the
    inability to retain our key employees or our other service providers or those of any acquired businesses.
Accordingly,
there can be no assurance that we will undertake or successfully complete any strategic transactions of the nature described above and
any transactions that we do complete may be subject to the foregoing or other risks and could have a material adverse effect on our business,
financial condition and prospects.
We
are substantially dependent on our remaining employees to facilitate the consummation of a strategic transaction. We could lose such
key employees.
Our
cash conservation activities may yield unintended consequences, such as attrition and reduced employee morale, which may cause remaining
employees to seek alternative employment. Our ability to successfully complete a strategic transaction depends in large part on our ability
to retain certain personnel. Despite our efforts to retain these employees, one or more may terminate their employment on short notice.
The loss of the services of any of these employees could potentially harm our ability to evaluate and pursue strategic alternatives,
as well as fulfill our reporting obligations as a public company.
13
The
clinical trial process is complex and expensive, and commencement and completion of clinical trials can be delayed or prevented for a
number of reasons.
We
may not be able to complete or commence the clinical trials that would support our submission of an NDA to the FDA, a Marketing Authorization
Application or MAA, to the EMA or MHRA or any similar submission to regulatory authorities in other countries. Drug development is a
long, expensive and uncertain process, and delay or failure can occur at any stage of any of our clinical trials. The fact that the FDA,
EMA, MHRA or other regulatory authorities permit a company to conduct human clinical trials is no assurance or guarantee that the trials
will be successful. On the contrary, most candidate drugs that begin clinical trials do not prove to be successful and do not result
in the filing of an NDA, MAA or similar filing. Drug candidates that successfully complete one phase of clinical trials may prove unsuccessful
at a subsequent phase. Human clinical trials are very expensive and difficult to design and implement, in part because they are subject
to rigorous regulatory requirements and in part because the results of clinical trials are inherently uncertain and unpredictable. In
addition, the design of a clinical trial can determine whether its results will support approval of a product, and flaws in the design
of a clinical trial may not become apparent until the clinical trial is well advanced. Regulatory authorities, such as the FDA, may decline
to permit a clinical trial to proceed or may suspend a clinical trial that it has previously permitted to proceed. Additionally, the
clinical trial process is time-consuming, and failure can occur at any stage of the trials. We may encounter problems that cause us to
abandon, delay or repeat clinical trials. The commencement and completion of clinical trials may be delayed by several factors, including:
●
difficulties
    obtaining regulatory authorization to commence a clinical trial or complying with regulatory requirements for clinical trials or
    with the conditions imposed by a regulatory authority regarding the scope, duration or conduct of a clinical trial;
●
delays
    in reaching or failing to reach agreement on acceptable terms with prospective contract research organizations, or CROs, and trial
    sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites;
●
insufficient
    or inadequate supply or quality of a product candidate or other materials necessary to conduct our clinical trials;
●
difficulties
    in obtaining institutional review board, or IRB, approval to conduct a clinical trial at a prospective site;
●
challenges
    in recruiting and enrolling patients to participate in clinical trials for a variety of reasons, including size and nature of patient
    population, proximity of patients to clinical sites, eligibility and exclusion criteria for the trial, nature of trial protocol,
    the availability of approved effective treatments for the relevant disease and competition from other clinical trial programs for
    similar indications;
●
challenges
    in identifying or recruiting sufficient study sites or investigators for clinical trials;
●
limitations
    on employee resources that would otherwise be focused on the conduct of our business including because of military reserve duty call-ups
    in the future that impact our employees and the affect the current war between Israel and Hamas on the productivity of our employees
    and external partners;
●
delays
    in necessary interactions with vendors, local regulators, and other important agencies and contractors due to limitations in employee
    resources;
●
impacts
    from prolonged remote work arrangements, such as increased cybersecurity risks and strains on our business continuity plans; and
●
lack
    of adequate funding to initiate or continue our clinical trials.
14
Even
if we re-initiate the Phase 3 ARMOR Study, the ARMOR Study may still be terminated as a result of, but not limited to, safety signals,
lack of efficacy, uncertainties with regard to the regulatory pathway for the approval of NASH drugs, or commercial considerations based
on the cost-benefit of continuing to run the study. In addition, the ARMOR Study or other clinical trials may be suspended or terminated
by us, the FDA or other regulatory authorities, the principal investigator at a site, the IRBs at the sites where such boards are overseeing
a trial or the data safety monitoring board, or the DSMB, that is overseeing the clinical trial at issue, or other regulatory authorities
due to a number of factors, including:
●
irregularities
    in conducting a clinical trial, including by way of example, failure to conduct the clinical trial in accordance with regulatory
    requirements, in particular good clinical practice requirements, or GCP, or the FDA-authorized clinical protocols;
●
negative
    findings upon inspection of the clinical trial operations or trial sites by the FDA or other regulatory authorities;
●
safety
    issues or lack of clinical drug activity or effectiveness; and
●
lack
    of adequate funding to continue the clinical trials.
To
date, we have already experienced material delays in both the ARMOR Study largely related to significantly slower than expected recruitment
and the ARREST Study largely related to significantly slower than expected recruitment and the length of time required to obtain regulatory
authorizations to proceed with clinical trials. We may experience further delays in any or all of our clinical trials and there can be
no assurance that we will not experience such risks in the future as we progress with our planned clinical trials.
Furthermore,
positive results in previous clinical studies of our product candidates may not be predictive of similar results in future clinical trials.
Also, interim results, if at all, during a clinical trial do not necessarily predict final results. A number of companies in the pharmaceutical
and biotechnology industries have suffered significant setbacks in late-stage clinical trials even after achieving promising results
in early- and mid-stage development. Accordingly, the results from the completed pre-clinical studies and clinical trials for our product
candidates may not be predictive of the results we may obtain in later stage trials. Our clinical trials may produce negative or inconclusive
results, and we may decide, or regulators may require us, to conduct additional clinical and/or pre-clinical trials, or to even terminate
the development program entirely. Many companies that believed their product candidates performed satisfactorily in pre-clinical and
clinical studies have nonetheless failed to obtain FDA or EMA, or other regulatory agency, approval for their products.
In
addition, we or regulatory authorities may suspend our clinical trials at any time if it appears that we are exposing participants to
unacceptable health risks or if the regulatory authorities find deficiencies in our regulatory submissions or the conduct of such trials.
Any suspension of clinical trials will delay possible regulatory approval, if any, and adversely impact our ability to develop products
and generate revenue.
We
have historically developed Aramchol for the treatment of NASH and there is
significant uncertainty regarding the regulatory approval process. In addition, during 2022, we discontinued our open label part of the
ARMOR Study and we do not currently expect to initiate the second part of the ARMOR Study. This makes it difficult to predict the timing
and costs of the clinical development of Aramchol for the treatment of NASH.
Pharmaceutical
products generally are subject to rigorous nonclinical testing and clinical studies and other approval procedures mandated by the FDA
and foreign regulatory authorities. We have historically developed Aramchol for the treatment of NASH.
15
In
September 2019, we initiated the ARMOR Study and during 2022 we discontinued the open-label part of the ARMOR Study having reached its
objectives. Following the discontinuation of our open label part of the ARMOR Study, we do not currently expect to initiate the second
part of the ARMOR Study.
Although
there are guidelines issued by the FDA for the development of drugs for the treatment of NASH, it is our current assessment that despite
considerable efforts from the scientific community and regulatory agencies, there are significant uncertainties that remain unresolved
with regards to the conduct of NASH Phase 3 registrational studies. These risks include dependence on biopsies as the primary surrogate
endpoint which are subjective in nature and prone to sampling errors and inadequacy; high screen failure rates which pose a burden to
patients, investigators, and study budget; lack of validated biomarkers and the heterogenous population included under the NASH diagnosis.
Moreover, pathology plays a role in NASH clinical trials with histology being the current reference method to determine inclusion in
trials and change in disease activity and fibrosis stage. Manual histological review is complex, subjective, and prone to inter- and
intra-reader variability and error. Existing pathology scoring systems and practices show only moderate to fair reproducibility, limiting
their utility for clinical research and practice.
In
addition, the FDA has indicated that the results of the ARMOR Study must be unequivocal and highly persuasive for a single Phase 3 study
to support approval of an NDA. Therefore, even if the ARMOR Study meets all of its statistical goals and protocol endpoints, the FDA
may not view the results as sufficient to support an NDA.
We
expect that the path for regulatory approval for NASH drugs to continue to evolve in the near term as we and other companies in late-stage
development of NASH drugs refine our regulatory approval strategies and interact with the FDA and other regulatory authorities. In particular,
FDA expectations about interpretation of liver biopsy data may evolve especially as more information is published about the inherent
variability in interpretation of liver biopsy data. Certain of our competitors have experienced regulatory setbacks for NASH therapies
following communications from the FDA. See also "Item 4. Information on the Company—Competition." Even after we receive
and incorporate guidance from the FDA or other regulatory authorities, they could disagree that we have satisfied their requirements,
which may require us to complete additional preclinical studies or clinical trials or impose stricter approval conditions than we currently
expect. Furthermore, as the path for regulatory approval for NASH drugs evolves, it may impact our ARMOR Study in ways that could significantly
increase the development costs and call into question the future viability of continuing to conduct the ARMOR Study. Additionally, we
are considering more robust changes to our development program for NASH. Changes may include focusing on higher risk patients (F3), evaluating
patients with compensated cirrhosis (F4) as well as changes to study design such as two smaller studies instead of one pivotal study
and the addition of a combination arm.
Any
additional delays in the completion of the ARMOR Study or any additional preclinical studies or clinical trials would require us to expend
substantial additional resources and could significantly extend the timeline for clinical development prior to market approval. As a
result of the foregoing, the research and development, preclinical studies and clinical testing of Aramchol and any other product candidate
is expensive and can take many years to complete, and its outcome is inherently uncertain. Failure can occur at any time during the development
process. If we experience delays in the completion of, or if we terminate, any of our clinical trials, this would have a material adverse
effect on our business, liquidity, operating results and financial condition and may force us to cease operations.
We
depend largely on the success of our lead product candidate, Aramchol, and we may not obtain regulatory approval of Aramchol.
We
have invested almost all of our efforts and financial resources in the research and development (clinical and pre-clinical) of our lead
product candidate, Aramchol. As a result, subject to our strategic review, our business is largely dependent on  our ability to complete the development of, obtain regulatory approval for and successfully commercialize Aramchol in a timely
manner. The process to develop, obtain regulatory approval for and commercialize Aramchol is long, complex, costly and uncertain as to
its outcome and we do not currently expect to initiate the second part of the ARMOR Study.
The
research, development, testing, clinical trials, manufacturing, labeling, approval, sale, marketing and distribution of drugs are subject
to extensive regulation by the FDA and other regulatory agencies in other countries. These regulations differ from jurisdiction to jurisdiction.
We have not received marketing approval for Aramchol in any jurisdiction. We are not permitted to market Aramchol, or any other product
candidate, in the United States until we receive approval of a New Drug Application, or NDA, from the FDA, or in any foreign countries
until we receive the requisite approval from the respective regulatory agencies in such countries. The results of clinical trials may
be unsatisfactory, and even if we believe those clinical trials to be successful, the FDA, or other regulatory authorities, may not grant
marketing authorization should we be in a position to request it.
16
Even
if we re-initiate the ARMOR Study, the requirements and length of time for approval vary in different jurisdictions and could involve
additional studies of Aramchol beyond those we currently anticipate, including potentially post-approval studies. The time required to
obtain approval in other countries might differ from that required to obtain FDA approval in the United States. The marketing approval
process in other countries may include all of the risks detailed above regarding FDA approval as well as other risks. In particular,
in many countries outside the United States, it is required that a product receive pricing and reimbursement approval before the product
can be commercialized. This can result in substantial delays in such countries. In other countries, product approval depends on showing
superiority to an approved therapy. This can result in significant expense to conduct complex clinical trials. Finally, we do not have
any products approved for sale in any jurisdiction, including international markets, and we do not have experience in obtaining regulatory
approval in international markets. If we fail to comply with regulatory requirements in international markets or to obtain and maintain
required approvals or if regulatory approvals in international markets are delayed, our target market will be reduced and our ability
to realize the full market potential of Aramchol or any other product candidate will be harmed.
Marketing
approval in one jurisdiction does not ensure marketing approval in another, but a failure or delay in obtaining marketing approval in
one jurisdiction may have a negative effect on the regulatory process in others. Failure to obtain marketing approval in other countries
or any delay or setback in obtaining such approval would impair our ability to develop foreign markets for Aramchol. This would reduce
our target market and limit the full commercial potential of Aramchol.
Commencement
of our ARMOR Study in jurisdictions outside the United States is subject to acceptance of the foreign equivalent of our IND by regulatory
authorities.
In
the event that the FDA or any other regulatory authority requires us to complete additional preclinical and/or clinical studies or we
are required to satisfy other FDA or other regulatory requests, the start of the ARMOR Study in the applicable jurisdiction or any of
our other programs may be delayed or not started at all. For example, certain regulatory agencies in Europe have required that we conduct
additional clinical studies prior to initiating ARMOR in those jurisdictions. Even after we receive and incorporate guidance from these
regulatory authorities, the FDA or other regulatory authorities could disagree that we have satisfied their requirements to commence
our clinical trial or change their position on the acceptability of our planned trial design or the clinical endpoints selected, which
may require us to complete additional preclinical studies or clinical trials or impose stricter approval conditions than we currently
expect. As a result of the foregoing, the research and development, preclinical studies and clinical testing of any product candidate
is expensive and can take many years to complete, and its outcome is inherently uncertain. Failure can occur at any time during the development
process.
We
may be forced to abandon development of Aramchol or any other product candidate which would have a material adverse effect on our business
and may force us to cease operations.
Upon
the completion of any clinical or pre-clinical trial and/or tests, the results might not support the desired indications for use. Further,
success in earlier clinical trials does not ensure that later clinical trials will be successful, and the results of later clinical trials
may not replicate the results of prior clinical trials or pre-clinical testing. In addition, the design of a clinical trial can determine
whether its results will support approval of a product, and flaws in the design of a clinical trial or variability in interpretation
of results may not become apparent until the clinical trial is well advanced. The clinical trial process may fail to demonstrate that
Aramchol or any other product candidate is sufficiently safe and/or effective for the indications we seek to receive FDA or other regulatory
approval. Any such failure may cause us to abandon Aramchol or any other product candidate and may delay development of other potential
product candidates. Any delay in, or termination or suspension of, our clinical trials may delay the requisite filings with the FDA or
other regulatory agencies and, ultimately, our ability to commercialize Aramchol or any other product candidate and generate product
revenues. If the results of the ARMOR Study or any other study, including in any interim readout, are not sufficiently compelling, then
the completion of development of our product candidates may be significantly delayed or abandoned which would have material adverse effect
on our business, liquidity, operating results and financial condition and may force us to cease operations.
17
We
have in the past and may in the future develop Aramchol in combination with other therapies, which exposes us to additional risks.
We
have in the past and, subject to our strategic review, may in the future develop Aramchol in combination with investigational therapies.
We will not be able to market and sell Aramchol or any product candidate we develop in combination with an unapproved therapy for a combination
indication if that unapproved therapy does not ultimately obtain marketing approval either alone or in combination with our product candidate.
In addition, unapproved therapies face the same risks described with respect to Aramchol or any other product candidate currently in
development and clinical trials, including the potential for serious adverse effects, delay in their clinical trials and lack of FDA,
EMA or MHRA approval. If the FDA, EMA, MHRA or comparable foreign regulatory authorities do not approve these other drugs or revoke their
approval of, or if safety, efficacy, quality, manufacturing or supply issues arise with the product candidates we choose to evaluate
in combination with our product candidate we develop, we may be unable to obtain approval of or market such combination therapy.
The
lack of a reliable non-invasive method for the diagnosis of NASH and fibrosis is likely to present a major challenge to Aramchol's
market penetration, if ever commercialized.
Liver
biopsy is the standard approach for the diagnosis of inflammation and fibrosis associated with NASH. However, the procedure-related morbidity
and, in rare cases, mortality, sample errors, costs, patient discomfort and thus lack of patient interest in undergoing the procedure
limit its use. As such, only patients with a high risk of NASH, which includes patients with metabolic syndrome and an indication of
Non-Alcoholic Fatty Liver Disease, or NAFLD, are generally sent for liver biopsy. Because NASH tends to be asymptomatic until the disease
progresses, many individuals with NASH remain undiagnosed until the disease has reached its late stages, if at all. The lack of a reliable
non-invasive method for the diagnosis of NASH and fibrosis is likely to present a major challenge to Aramchol's market penetration,
as many practitioners and patients may not be aware that a patient suffers from NASH and requires treatment. As such, use of Aramchol
might not be as wide-spread as our actual target market and this may limit the commercial potential of Aramchol.
A
further challenge to Aramchol's market penetration is that currently a liver biopsy is the standard approach for measuring improvement
in NASH patients. Because it would be impractical to subject all patients that take Aramchol, when and if it is approved, to regular
and repeated liver biopsies, it will be difficult to demonstrate Aramchol's effectiveness to practitioners and patients unless
and until a reliable non-invasive method for the diagnosis and monitoring of NASH becomes available, as to which there can be no assurance.
While
other companies in the industry are currently working on advancing non-invasive diagnostic approaches, none of these has been clinically
validated, and the timetable for commercial validation, if at all, is uncertain. Moreover, such diagnostics may also be subject to regulation
by FDA or other regulatory authorities as medical devices and may require premarket clearance or approval. See also "Item 3. Key
Information—Risk Factors —Risk Factors—Risks Related to Our Business, Industry and Regulatory Requirements —-
We are developing Aramchol for the treatment of NASH, an indication for which there are no approved products, and there is significant
uncertainty regarding the regulatory approval process. This makes it difficult to predict the timing and costs of the clinical development
of Aramchol for the treatment of NASH."
Our
Amilo-5MER program is being conducted under a license agreement with Yissum Research Development Company of the Hebrew University of
Jerusalem, or Yissum.
Our
Amilo-5MER program is being conducted under a license agreement from Yissum and is subject to various additional obligations, including
obligations with respect to funding, development and commercialization activities, and payment obligations upon entering into the license
agreement and achievement of certain milestones and royalties on product sales. Furthermore, if the license agreement is terminated or
breached, we may:
●
lose
    our rights to research, develop or commercialize Amilo-5MER;
●
not
    be able to secure trade secret protection for Amilo-5MER;
18
●
experience
    significant delays in the development or commercialization of Amilo-5MER; or may have to cease development entirely;
●
incur
    liability for damages.
Additionally,
even if not terminated or breached, our intellectual property licenses may be subject to disagreements over contract interpretation which
could narrow the scope of our rights to the relevant intellectual property or technology or increase our financial or other obligations.
If we experience any of the foregoing, it could have a materially adverse effect on our business.
In
January 2022, we announced the completion of our Phase 1 clinical trial of Amilo-5MER. The Phase 1 study was conducted in a single-center,
using a double-blind, randomized, placebo-controlled design. Results demonstrated that all doses of Amilo-5MER were well tolerated with
no clinically significant adverse events and none considered related to the investigational product. Due to its early stage of development,
Amilo-5MER will require significant additional research, development, manufacturing, preclinical and clinical testing, marketing authorization,
and commitment of significant additional resources prior to any commercialization. These activities will require significant cash for
which we will need to raise additional capital. In addition, Amilo-5MER is prone to the risks of failure inherent in pharmaceutical product
development, including the possibility that Amilo-5MER will not be shown to be sufficiently safe and effective for approval by regulatory
authorities.
If
we acquire or in-license additional technologies or product candidates, we may incur significant, incremental expenses, may have integration
difficulties and may experience other risks that could harm our business and results of operations.
We
evaluate from time-to-time the acquisition or in-licensing of additional product candidates and technologies. Any product candidate or
technologies we in-license or acquire will likely require additional development efforts prior to commercial sale, including extensive
pre-clinical or clinical testing, or both, and approval by the FDA and applicable foreign regulatory authorities, if any. All product
candidates are prone to risks of failure inherent in pharmaceutical product development, including the possibility that the product candidate,
or product developed based on in-licensed technology, will not be shown to be sufficiently safe and effective for approval by regulatory
authorities. In addition, we cannot assure that any product candidate that we develop based on acquired or in-licensed technology that
is granted regulatory approval will be manufactured or produced economically, successfully commercialized or widely accepted or competitive
in the marketplace. Moreover, integrating any newly acquired or in-licensed product candidates could be expensive and time-consuming.
If we cannot effectively manage these aspects of our business strategy, our business may not succeed.
Obtaining
approval of an NDA, or other regulatory approval, even after clinical trials that are believed to be successful, is an uncertain process.
Even
if we complete clinical trials and believe that the clinical data confirms that Aramchol, Amilo-5MER or any other product candidate is
sufficiently safe and effective for its intended use or uses, obtaining approval of an NDA, or other regulatory approval, is an extensive,
lengthy, expensive and uncertain process, and the FDA and other regulatory agencies may delay, limit or deny approval of such product
candidate for many reasons, including, without limitation, the fact that:
●
we
    may not be able to demonstrate to the satisfaction of the applicable regulatory agencies that the product candidate is safe and effective
    for treatment of the targeted indication in patients;
●
the
    results of clinical trials may not meet the level of statistical significance or clinical significance required by the applicable
    regulatory agencies for approval;
●
the
    applicable regulatory agencies may disagree with the number, design, size, conduct or implementation of our clinical trials;
19
●
the
    applicable regulatory agencies may not find the data from pre-clinical studies and clinical trials sufficient to demonstrate the
    clinical and other benefits outweigh its safety risks;
●
the
    applicable regulatory agencies may disagree with our interpretation of data from pre-clinical studies or clinical trials;
●
the
    applicable regulatory agencies may not accept data generated at our clinical trial sites;
●
the
    data collected from pre-clinical studies and clinical trials may not be sufficient to support the submission of an NDA or similar
    regulatory application;
●
the
    applicable regulatory agencies may not schedule an advisory committee meeting in a timely manner or the advisory committee may recommend
    against approval of our application or may recommend that the applicable regulatory agencies require, as a condition of approval,
    additional pre-clinical studies or clinical trials, limitations on approved labeling or distribution and use restrictions;
●
the
    applicable regulatory agencies may require development of a risk evaluation and mitigation strategy, or REMS, as a condition of approval;
●
the
    applicable regulatory agencies may require simultaneous approval for both adults and children, which would delay required approvals,
    or we may have successful clinical trial results for adults, but not children, or vice versa;
●
the
    applicable regulatory agencies may change their approval policies or adopt new regulations that may impede consideration or approval
    of our NDA, or similar regulatory application;
●
the
    applicable regulatory agencies may identify deficiencies in the manufacturing processes or facilities of third-party manufacturers,
    or suppliers of active pharmaceutical ingredients, or APIs, with which we enter into agreements for clinical and commercial supplies;
    and
●
the
    applicable regulatory agencies may require post-marketing approval studies, such as Phase 4 clinical trials, in connection with Aramchol
    or any other product candidate.
Before
we can submit an NDA to the FDA or a similar approval application to other regulatory authorities, as applicable, we (or our commercialization
partner, as the case may be) must conduct one or more clinical trials that will be substantially broader than our prior completed trials.
We will also need to agree on a protocol with the FDA or any other regulatory authorities for any clinical trial(s) before commencing
any such trial. Clinical trials frequently produce unsatisfactory results even though prior clinical trials were successful. Therefore,
the results of any prior trial or any future clinical trials that we may conduct may or may not be successful. The applicable regulatory
agencies may suspend all clinical trials or require that we conduct additional clinical, pre-clinical, manufacturing, validation or drug
product quality studies and submit data from these additional studies before considering or reconsidering the NDA or similar regulatory
application. Depending on the extent of these, or any other studies, approval of any applications that we submit may be delayed by several
years, or may require us to expend more resources than we have available. It is also possible that additional studies, if performed and
completed, may not be considered sufficient by the applicable regulatory agencies to provide regulatory approval. If any of these outcomes
occur, we would not receive approval for Aramchol, Amilo-5MER or any other product candidate and may be forced to cease operations.
Even
if we obtain regulatory approval for Aramchol, Amilo-5MER or any other product candidate, the approval might contain significant limitations
related to the indications for use for which the drug is approved, use restrictions including, without limitation, for certain labeled
populations, age groups, warnings, precautions or contraindications, or may be subject to significant post-marketing studies or risk
mitigation requirements. If we are unable to successfully commercialize Aramchol, Amilo-5MER or any other product candidate, we may be
forced to cease operations.
20
Our
product candidates may produce undesirable side effects or have other properties that could delay or prevent its regulatory approval
or result in significant negative consequences following marketing approval, if any, which could substantially increase commercialization
costs or even force us to cease operations.
Undesirable
side effects caused by Aramchol or any other product candidate could cause us or regulatory authorities to interrupt, delay or halt clinical
trials and could result in a more restrictive label or the delay or denial of regulatory approval by the FDA or applicable foreign regulatory
authorities. To date, we have completed seven clinical trials of Aramchol, and additionally one proof of concept study in patient with
gallstones, and a Phase 2a, investigator initiated clinical trial were completed. Although we have not seen any evidence of reactions
causing a safety concern in our completed clinical trials, it is possible that the FDA may ask for additional data regarding any adverse
events seen in our trials. Results of our future trials could reveal a high and unacceptable severity and prevalence of these or other
side effects. In such an event, our trials could be suspended or terminated and the FDA or applicable foreign regulatory authorities
could order us to cease further development of or deny approval for Aramchol, Amilo-5MER or any other product candidate for any or all
targeted indications. The drug-related side effects could affect patient recruitment or the ability of enrolled patients to complete
future trials or result in potential product liability claims. Any of these occurrences may harm our business, financial condition and
prospects significantly.
Even
if Aramchol or any other product candidate receives marketing approval, we or others may later identify undesirable side effects caused
by the product. In such an event, regulatory authorities may:
●
suspend
    or withdraw their approval of the product;
●
require
    the addition of labeling statements, such as warnings, so-called "black box warnings," contraindications or restrictions
    on the product's intended use;
●
require
    us to issue specific communications to healthcare professionals, such as "Dear Doctor" letters;
●
issue
    negative publicity regarding the affected product, including safety communications;
●
impose
    a risk evaluation and mitigation strategy (REMS), in the case of FDA, or similar risk management strategies in the case of foreign
    regulators;
In
addition to these potentially significant negative consequences, we could be required to change the way the product is administered,
conduct additional pre-clinical studies or clinical trials or restrict or cease the distribution or use of the product, and/or be sued
and held liable for harm caused to patients. The foregoing or other events could prevent us from achieving or maintaining market acceptance
of the affected product candidate and could substantially increase commercialization costs or even force us to cease operations.
If
we encounter difficulties enrolling patients in our clinical trials, our clinical development activities could be delayed or otherwise
adversely affected.
Patient
enrollment, a significant factor in the timing of clinical trials, is affected by many factors including the size and nature of the patient
population, the proximity of patients to clinical sites, the eligibility criteria for the trial, the design of the clinical trial, patient
willingness to undergo a liver biopsy in our NASH trials, competing clinical trials and clinicians' and patients' perceptions
as to the potential advantages and disadvantages of the product candidate being studied in relation to other available therapies, including
any new drugs that may be approved for the indications we are investigating, and actual or threatened public health emergencies and outbreaks
of disease (including, for example, any resurgence of the COVID-19 pandemic). Potential patients for Aramchol, Amilo-5MER or any other
product candidate may not be adequately diagnosed or identified with the diseases which we are targeting or may not meet the entry criteria
for our studies.
We
will be required to identify and enroll a sufficient number of patients in the U.S. with NASH for each of our clinical trials of Aramchol
in this indication. We also may encounter difficulties in identifying and enrolling U.S. NASH patients who meet the eligibility criteria
for our planned clinical trials. We may not be able to initiate or continue clinical trials if we are unable to locate a sufficient number
of eligible patients to participate in the clinical trials required by the FDA or other foreign regulatory agencies. In addition, the
process of finding and diagnosing patients may prove costly. To date, we have already experienced significant delays in our clinical
trials largely related to significantly slower than expected recruitment and the length of time required to obtain regulatory authorizations
to proceed with clinical trials. Our inability to enroll a sufficient number of patients for any of our clinical trials could result
in further significant delays, additional expenses, or may require us to abandon one or more clinical trials.
21
Changes
in regulatory requirements and guidance or unanticipated events during our clinical trials may occur, which may result in necessary changes
to clinical trial protocols, which could result in increased costs to us, delay our development timeline or reduce the likelihood of
successful completion of our clinical trials.
Changes
in regulatory requirements or guidance or unanticipated events during our clinical trials may result in the need for us to amend clinical
trial protocols.  Amendments may require review and approval by regulators and/or IRBs, and re-consent subjects, which
may adversely affect the cost, timing or successful completion of a clinical trial. Even if we re-initiate the ARMOR Study, if we experience
delays in the completion of, or if we terminate, any of the ARMOR Study or any other clinical trials, this could have a material adverse
effect on our business, liquidity, operating results and financial condition and may force us to cease operations. See also "Item
3. Key Information—Risk Factors—Risk Factors—Risks Related to Our Business, Industry and Regulatory Requirements -
We are developing Aramchol for the treatment of NASH, an indication for which there are currently no approved products, and there is
significant uncertainty regarding the regulatory approval process. This makes it difficult to predict the timing and costs of the clinical
development of Aramchol for the treatment of NASH."
Even
if Aramchol, Amilo-5MER or any other product candidate that we develop, receives marketing approval, we will continue to face extensive
regulatory oversight and requirements, and any such product may still face future regulatory risks or new requirements.
Even
if we receive regulatory approval to market a particular product candidate, any such product will remain subject to extensive regulatory
requirements, including requirements relating to manufacturing, labeling, packaging, adverse event reporting, storage, advertising, promotion,
distribution and recordkeeping. Even if regulatory approval of a product is granted, the approval may be subject to limitations on the
uses for which the product may be marketed or the conditions of approval, or may contain requirements for costly post-marketing testing
and surveillance to monitor the safety or efficacy of the product, which could negatively affect us by reducing revenues or increasing
expenses, and cause the approved product candidate not to be commercially viable. In addition, as clinical experience with a drug expands
after approval, typically because it is used by a greater number and more diverse group of patients after approval than during clinical
trials, side effects and other problems may be observed over time after approval that were not seen or anticipated during pre-approval
studies. Any adverse effects observed after the approval and marketing of a product candidate could result in limitations on the use
of the approved product, withdrawal of FDA approval of the previously approved product, or voluntary withdrawal from the marketplace
of the approved product. Absence of long-term safety data may also limit the approved uses of Aramchol or any other product candidate,
if any. If we fail to comply with the regulatory requirements of the FDA, and other applicable U.S. and foreign regulatory authorities,
or previously unknown problems with any approved commercial products, manufacturers or manufacturing processes are discovered, we could
be subject to administrative or judicially imposed sanctions or other setbacks, including the following:
●
suspension
    or imposition of restrictions on operations, including costly new manufacturing requirements;
●
refusal
    to approve pending applications or supplements to applications;
●
suspension
    of any ongoing clinical trials;
●
suspension
    or withdrawal of marketing approval;
●
an
    injunction or imposition of civil or criminal penalties or monetary fines;
●
seizure
    or detainment of products;
22
●
banning
    or restriction of imports and exports;
●
issuance
    of warning letters or untitled letters;
●
suspension
    or imposition of restrictions on operations, including costly new manufacturing requirements; or
●
refusal
    to approve pending applications or supplements to applications.
In
addition, various aspects of our operations are subject to federal, state or local laws, rules and regulations, any of which may change
from time to time. Costs arising out of any regulatory developments could be time-consuming and expensive and could divert management
resources and attention and, consequently, could adversely affect our business operations and financial performance.
Delays
in regulatory approval, limitations in regulatory approval and withdrawals of regulatory approval may have a material adverse effect
on us. If we experience significant delays in testing or receiving approvals or sign-offs to conduct clinical trials, Aramchol or any
other product candidate development costs will increase and our ability to out-license our product candidates may be impeded.
If
we obtain approval to commercialize any product candidate outside of the United States or out-license a product candidate to additional
territories outside the United States, a variety of risks associated with international operations could materially adversely affect
our business.
If
any product candidate is approved for commercialization outside the United States or we out-license a product candidate to additional
territories outside the United States, we will likely enter into agreements with third parties to commercialize a product candidate outside
the United States. We expect that we will be subject to additional risks related to entering into or maintaining international business
relationships, including, without limitation:
●
different
    regulatory requirements for drug approvals in foreign countries;
●
differing
    U.S. and foreign drug import and export rules;
●
reduced
    protection for intellectual property rights in foreign countries;
●
unexpected
    changes in tariffs, trade barriers and regulatory requirements;
●
different
    reimbursement systems;
●
economic
    weakness, including inflation, or political instability in particular foreign economies and markets;
●
compliance
    with tax, employment, immigration and labor laws for employees living or traveling abroad;
●
foreign
    currency fluctuations, which could result in increased operating expenses and reduced revenues, and other obligations incident to
    doing business in another country;
●
workforce
    uncertainty in countries where labor unrest is more common than in the United States;
●
production
    shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad;
●
potential
    liability resulting from development work conducted by these distributors;
23
●
business
    interruptions resulting from geopolitical actions, including war and terrorism, or natural disasters, emergence of a pandemic, or
    other widespread health emergencies (or concerns over the possibility of such an emergency, including for example, the COVID-19 pandemic);
    and
●
risks
    associated with clinical co-development agreements in other jurisdictions prior to or post-regulatory approval.
A
failure to timely and effectively address the additional risks related to entering into or maintaining international business relationships
could have a material adverse effect on our business, liquidity, operating results and financial condition.
If
we receive marketing approval for a product candidate, sales will be limited unless the product achieves broad market acceptance.
The
commercial success of a product candidate for which we obtain marketing approval from the FDA, or other regulatory authorities, will
depend on the breadth of its approved labeling and upon the acceptance of the product by the medical community, including physicians,
patients and healthcare payors. The degree of market acceptance of any approved product will depend on a number of factors, including,
without limitation:
●
demonstration
    of clinical safety and efficacy compared to other products;
●
ability
    of physicians to accurately diagnose NASH in its early stages;
●
the
    relative convenience and ease of administration;
●
the
    prevalence and severity of any adverse side effects;
●
limitations,
    warnings or contraindications contained in the product's approved labeling;
●
distribution
    and use restrictions imposed by the FDA, or other regulatory agencies, or agreed to by us as part of a mandatory or voluntary REMS;
●
availability
    of alternative treatments, including, any competitive products already approved or expected to be commercially launched in the near
    future;
●
pricing
    and cost effectiveness;
●
the
    effectiveness of our, or any future collaborators', sales and marketing strategies;
●
our
    ability to obtain sufficient third-party coverage or reimbursement; and
●
the
    willingness of patients to pay for drugs out of pocket in the absence of third-party coverage.
If
a product candidate is approved, but does not achieve an adequate level of acceptance by physicians, healthcare payors and patients,
we may not generate sufficient revenue from the product, and we may not become profitable. In addition, our efforts to educate the medical
community and third-party payors on the benefits of the product may require significant resources and may never be successful.
24
The
FDA and other regulatory agencies may actively enforce the laws and regulations prohibiting the promotion of off-label uses. If we are
found to have improperly promoted off-label uses, we may become subject to significant liability.
The
FDA and other regulatory agencies strictly regulate the promotional claims that may be made about prescription products. In particular,
a product may not be promoted for uses that are inconsistent with the FDA-approved indications and other conditions or restrictions contained
in the approved labeling, including the prescribing information, for the product. In particular, any labeling approved by FDA or other
foreign regulatory agencies for a product candidate necessarily limits its use for certain conditions in certain patient populations.
Also, regulatory agencies may impose further requirements or restrictions on the distribution or use of Aramchol, Amilo-5MER or any other
product candidate as part of a mandatory plan, such as limiting prescribing to certain physicians or medical centers that have undergone
specialized training, limiting treatment to patients who meet certain safe-use criteria and requiring treated patients to enroll in a
registry. If we receive marketing approval for a product candidate, physicians may nevertheless prescribe the product candidate to their
patients in a manner that is inconsistent with the approved labeling, which is commonly known as "off label" use. If we are
found to have promoted any product candidate for such "off label" uses, we may become subject to significant liability under
a variety of statutory theories typically alleged by U.S. regulatory authorities. In particular, the U.S. federal government has levied
large civil and criminal fines against companies for alleged improper promotion, has enjoined several companies from engaging in off-label
promotion, and has requested that companies enter into consent decrees or permanent injunctions under which specified promotional conduct
is changed or curtailed.
Our
business and operations may be materially adversely affected in the event of computer system failures or security or breaches due to
cyber-attacks or cyber intrusions, including ransomware, phishing attacks and other malicious intrusions.
In
recent years, cybersecurity threats have become a greater risk and focus for companies. In particular, ransomware attacks, where a hacker
locks and threatens to delete or disclose the victim's data unless a ransom is paid, has become a major risk. We and those of our
CROs and other third parties on which we rely are at risk of cyber-attacks or cyber intrusions via the Internet, computer viruses, break-ins,
malware, ransomware, phishing attacks, hacking, denial-of-service attacks or other attacks and similar disruptions from the unauthorized
use of, or access to, computer systems (including from internal and external sources). These types of incidents continue to be prevalent
and pervasive across industries, including in our industry. In addition, we expect information security risks to continue to increase
due to the proliferation of new technologies and the increased sophistication and activities of organized crime, hackers, terrorists
and other external parties, including foreign state actors.
Despite
the implementation of security measures, our internal computer systems, and those of our CROs and other third parties on which we rely,
are vulnerable to damage from computer viruses, unauthorized access, cyber-attacks, cyber intrusions, natural disasters, fire, terrorism,
war, and telecommunication and electrical failures. If such an event were to occur and interrupt our operations, it could result in a
material disruption of our drug development programs and inflict reputational harm upon us that may result in decreased market value
and erode public trust. For example, the loss of clinical trial data from ongoing or planned clinical trials could result in delays in
our regulatory approval efforts and significantly increase our costs to recover or reproduce the data. To the extent that any disruption
or security breach results in a loss of or damage to our data or applications, loss of trade secrets or inappropriate disclosure of confidential
or proprietary information, including protected health information or personal data of employees or former employees, access to our clinical
data, or disruption of the manufacturing process, we could incur liability and the further development of our drug candidates could be
delayed.
We
may be subject to extensive environmental, health and safety, and other laws and regulations in multiple jurisdictions.
Our
business involves the controlled use, through our service providers, of hazardous materials, various biological compounds and chemicals,
and as such, we, our agents and our service providers may be subject to various environmental, health and safety laws and regulations,
including those governing air emissions, water and wastewater discharges, noise emissions, the use, management and disposal of hazardous,
radioactive and biological materials and wastes and the cleanup of contaminated sites. The risk of accidental contamination or injury
from these materials cannot be eliminated. If an accident, spill or release of any regulated chemicals or substances occurs, we could
be held liable for resulting damages, including for investigation, remediation and monitoring of the contamination, including natural
resource damages, the costs of which could be substantial. We may incur substantial capital costs and operating expenses and may be required
to obtain consents to comply with any environmental and health laws or regulations and the terms and conditions of any permits required
pursuant to such laws and regulations, including costs incurred by us to install new or updated pollution control equipment for our service
providers, modify our operations or perform other corrective actions at our facilities or the facilities of our service providers. In
addition, fines and penalties may be imposed on us, our agents and/or our service providers for noncompliance with environmental, health
and safety and other laws and regulations or for the failure to have, or comply with the terms and conditions of, required environmental
or other permits or consents.
25
We
expect the healthcare industry to face increased limitations on coverage of and reimbursement, rebates and other payments as a result
of healthcare reform, which could adversely affect third-party coverage of Aramchol, Amilo-5MER or any other product candidate and how
much or under what circumstances healthcare providers will prescribe or administer Aramchol, Amilo-5MER or any other product candidate.
In
both the United States and other countries, sales of Aramchol Amilo-5MER or any other product candidate will depend in part upon coverage
of the product and the availability of reimbursement from third party payors, including governmental authorities, managed care organizations
and other private health insurers. Third-party payors are increasingly challenging the price and examining the coverage of products based
on cost effectiveness of the medical products and services.
Increasing
expenditures for healthcare have been the subject of considerable public attention in the United States. Both private and government
entities are seeking ways to reduce or contain healthcare costs. Numerous proposals that would effect changes in the U.S. healthcare
system have been introduced or proposed in the U.S. Congress, or Congress, and in some state legislatures, including reducing reimbursement
for prescription products and reducing the levels at which consumers and healthcare providers are reimbursed for purchases of pharmaceutical
products.
In
the United States, the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, or the Modernization Act, changed the
way Medicare covers and pays for most pharmaceutical products in a number of ways. Medicare is the single largest third-party payment
program and is administered by the Centers for Medicare & Medicaid Services, or the CMS. Medicare traditionally covered prescription
drugs administered by physicians. The Modernization Act introduced a new reimbursement methodology based on average sales prices for
many of these drugs. The Modernization Act also established a new competitive acquisition program for the purchase of Part B drugs. This
program, when fully implemented, will likely reduce the prices of these drugs. While the Medicare provisions of the Modernization Act
apply only to drug benefits for Medicare beneficiaries, private payors often follow Medicare coverage policy and payment limitations
in setting their own reimbursement rates. Therefore, any reduction in reimbursement that results from federal legislation or regulation
may result in a similar reduction in payments from private payors.
Most
notably, the Modernization Act also expanded coverage through a new Part D to include ordinary self-administered outpatient drugs. Medicare
part D though operates through private insurers, and these insurers negotiate prices with pharmacies and with manufacturers. Intense
negotiations can result in reduced revenues to manufacturers.
Increasing
expenditures for healthcare have been the subject of considerable public attention in the United States. Both private and government
entities are seeking ways to reduce or contain healthcare costs. Numerous proposals that would effect changes in the U.S. healthcare
system have been introduced or proposed in U.S. Congress, and in some state legislatures, including reducing reimbursement for prescription
products and reducing the levels at which consumers and healthcare providers are reimbursed for purchases of pharmaceutical products.
In
March 2010, President Barack Obama signed into law the Patient Protection and Affordable Care Act and the Health Care and Education Affordability
Reconciliation Act of 2010, or the Affordable Care Act, a sweeping law intended to broaden access to health insurance, reduce or constrain
the growth of healthcare spending, enhance remedies against fraud and abuse, add new transparency requirements for healthcare and health
insurance industries, impose new taxes and fees on pharmaceutical and medical device manufacturers and impose additional health policy
reforms. The Affordable Care Act expanded manufacturers' Medicaid rebate liability to include covered drugs dispensed to individuals
who are enrolled in Medicaid managed care organizations, increased the minimum rebate due for innovator drugs from 15.1% of average manufacturer
price, or the AMP, to 23.1% of AMP. The rebate on innovator drugs is the greater of 23.1% of the AMP per unit or the difference between
the AMP and the best price per unit and adjusted by the Consumer Price Index-Urban (CPI-U) based on a launch date and current quarter
AMP. The total rebate amount for innovator drugs is capped at 100.0% of AMP. The Affordable Care Act and subsequent legislation also
narrowed the definition of AMP. Furthermore, the Affordable Care Act imposes a significant annual, nondeductible fee on companies that
manufacture or import certain branded prescription drug products. The Affordable Care Act appears likely to continue to put pressure
on pharmaceutical pricing, especially under the Medicare and Medicaid programs, and may also increase our regulatory burdens and operating
costs.
26
There
have been judicial and congressional challenges to the Affordable Care Act. If successful in the challenges, many if not all of the provisions
of the PPACA may no longer apply to prescription drugs. While we are unable to predict what changes may ultimately be enacted, to the
extent that future changes affect how any future products are paid for and reimbursed by government and private payers our business could
be adversely impacted. On December 14, 2018, a federal district court in Texas ruled that the PPACA is unconstitutional as a result of
the Tax Cuts and Jobs Act, the federal income tax reform legislation previously passed by Congress and signed by President Trump on December
22, 2017, that eliminated the individual mandate portion of the PPACA. The case, Texas, et al, v. United States of America, et al., (N.D.
Texas), is an outlier, and the ruling has been stayed by the ruling judge, but in 2019, the Fifth Circuit Court of Appeals subsequently
upheld the lower court decision which was then appealed to the United States Supreme Court. The U.S. Supreme Court declined to hear the
appeal on an expedited basis and so no decision is expected until sometime in 2021 before the end of the next Supreme Court's current
term in early 2021. We are not able to state with any certainty what will be the impact of this court decision on our business pending
further court action and possible appeals. In November 2020, Joseph Biden was elected President and, in January 2021, the Democratic
Party obtained control of the Senate. As a result of these electoral developments, it is unlikely that continued legislative efforts
will be pursued to repeal PPACA. Instead, it is possible that executive and regulatory initiatives, as well as legislation will be pursued
to enhance or reform PPACA. We are not able to state with certainty what the impact of potential legislation will be on our business.
In
addition, other legislative changes have been proposed and adopted since the Affordable Care Act was enacted. In August 2011, President
Obama signed into law the Budget Control Act of 2011, which, among other things, created the Joint Select Committee on Deficit Reduction
to recommend to Congress proposals in spending reductions. The Joint Select Committee did not achieve a targeted deficit reduction of
an amount greater than $1.2 trillion for the years 2013 through 2021, triggering the legislation's automatic reduction to several
government programs. This includes aggregate reductions to Medicare payments to healthcare providers of up to 2.0% per fiscal year, starting
in 2013. These reductions will stay in effect through 2030 unless additional congressional action is taken. However, COVID-19 relief
legislation suspended the 2% Medicare sequester from May 1, 2020 through March 31, 2021. In January 2013, President Obama signed into
law the American Taxpayer Relief Act of 2012, which, among other things, reduced Medicare payments to several categories of healthcare
providers and increased the statute of limitations period for the government to recover overpayments to providers from three to five
years. If we ever obtain regulatory approval and commercialization of Aramchol or any other product candidate, these laws may result
in additional reductions in Medicare and other healthcare funding, which could have a material adverse effect on our customers and accordingly,
our financial operations. Legislative and regulatory proposals have been made to expand post-approval requirements and restrict sales
and promotional activities for pharmaceutical products. We cannot be sure whether additional legislative changes will be enacted, or
whether the FDA regulations, guidance or interpretations will be changed, or what the impact of such changes on the marketing approvals
of Aramchol or any other product candidate may be. Further, the Deficit Reduction Act of 2010, directed CMS to contract a vendor to determine
"retail survey prices for covered outpatient drugs that represent a nationwide average of consumer purchase prices for such drugs,
net of all discounts and rebates (to the extent any information with respect to such discounts and rebates is available)." This
survey information can be used to determine the National Average Drug Acquisition Cost, NADAC. Some states have indicated that they will
reimburse based on the NADAC and this can result in further reductions in the prices paid for various outpatient drugs.
Various
states, such as California and Florida, have also taken steps to consider and enact laws or regulations that are intended to increase
the visibility of the pricing of pharmaceutical products with the goal of reducing the prices at which pharmaceutical products are sold.
On August 16, 2022, President Biden signed into law the Inflation Reduction Act of 2022 that contains significant reforms affecting the
pricing of drugs and biologics paid by Medicare. The new requirements establish a timeline for certain drugs to negotiate with the federal
government a "maximum fair price" for certain selected drugs beginning in 2026. The numbers of drugs, as well as the selection
criteria, is established for each year. Because these various actual and proposed legislative changes are intended to operate on a state-by-state
level and the new national law, we cannot predict what the full effect of state legislative activities, and the IRA may be on our business
in the future.
27
Although
we cannot predict the full effect on our business of the implementation of existing legislation or the enactment of additional legislation
pursuant to healthcare and other legislative reform, we believe that legislation or regulations that would reduce reimbursement for,
or restrict coverage of, Aramchol or any other product candidate, could adversely affect how much or under what circumstances healthcare
providers will prescribe or administer our products. This could materially and adversely affect our business by reducing our ability
to generate revenue, raise capital, obtain additional collaborators and market Aramchol or any other product candidate. In addition,
we believe the increasing emphasis on managed care in the United States has and will continue to put pressure on the price and usage
of pharmaceutical products, which may adversely impact any other product sales.
It
will be difficult for us to profitably sell any product candidate if reimbursement for the product is limited by government authorities
and third-party payor policies.
In
addition to any healthcare reform measures that may affect reimbursement, the market acceptance and sales of any product candidate will
depend on the reimbursement policies of government authorities and third-party payors. It will be difficult for us to profitably sell
a product candidate if reimbursement for the product is limited by government authorities or third-party payors. Government authorities
and third-party payors, such as private health insurers and health maintenance organizations, decide which medications they will pay
for and establish reimbursement levels. A primary trend in the U.S. healthcare industry and elsewhere is cost containment. Government
authorities and these third-party payors have attempted to control costs by limiting coverage and the amount of reimbursement for particular
medications. We cannot be sure that coverage or reimbursement will be available for any product candidate and, if coverage and reimbursement
are available, of the extent of coverage and the level of reimbursement. Reimbursement may affect the demand for, or the price of, any
product for which we obtain marketing approval. In addition, third-party payors are likely to impose strict requirements for reimbursement
in order to limit off-label use of a higher priced drug. Reimbursement by a third-party payor may depend upon a number of factors including
the third-party payor's determination that use of a product is:
●
a
    covered benefit under its health plan;
●
safe,
    effective and medically necessary;
●
appropriate
    for the specific patient;
●
cost-effective;
    and
●
neither
    experimental nor investigational.
Obtaining
coverage and reimbursement approval for a product from a government or other third-party payor is a time-consuming and costly process
that could require us to provide supporting scientific, clinical and cost effectiveness data for the use of a product candidate to the
payor. We may not be able to provide data sufficient to gain acceptance with respect to coverage and reimbursement. We cannot be sure
that coverage or adequate reimbursement will be available for any product candidates. Also, we cannot be sure that reimbursement amounts
will not reduce the demand for, or the price of, any product candidates. If reimbursement is not available, or is available only to limited
levels, we may not be able to commercialize any product candidates, profitably, or at all, even if approved. In addition, if physicians,
government agencies and other third-party payors do not accept the use or efficacy of any product candidates, we will not be able to
generate significant revenue, if any.
Governments
outside the United States tend to impose strict price controls, which may adversely affect our revenues, if any.
In
some countries, particularly the countries of the EU, the pricing of prescription pharmaceuticals is subject to governmental control.
In these countries, pricing negotiations with governmental authorities can take considerable time after the receipt of marketing approval
for a product. To obtain reimbursement or pricing approval in some countries, we may be required to conduct a clinical trial that compares
the cost-effectiveness of Aramchol or any other product candidate to other available therapies. If reimbursement of our products is unavailable
or limited in scope or amount, or if pricing is set at unsatisfactory levels, our business could be harmed, possibly materially.
28
If
we or any of our independent contractors, consultants, collaborators, manufacturers, or service providers fail to comply with healthcare
and data privacy laws and regulations, we or they could be subject to enforcement actions, which could result in penalties and affect
our ability to develop, market and sell Aramchol or any other product candidate and may harm our reputation.
We
are or may in the future be subject to federal, state, and foreign healthcare and data privacy laws and regulations pertaining to, among
other things, fraud and abuse of patients' rights. These laws and regulations include:
●
The
    federal Anti-Kickback Statute prohibits, among other things, knowingly and willfully soliciting, offering, receiving, or paying any
    remuneration, directly or indirectly, in cash or in kind, to induce or reward purchasing, ordering or arranging for or recommending
    the purchase or order of any item or service for which payment may be made, in whole or in part, under a federal healthcare program
    such as Medicare and Medicaid. Liability may be established without a person or entity having actual knowledge of the federal Anti-Kickback
    Statute or specific intent to violate it. This statute has been interpreted to apply broadly to arrangements between pharmaceutical
    manufacturers on the one hand and prescribers, patients, purchasers and formulary managers on the other. In addition, the Affordable
    Care Act amended the Social Security Act to provide that the U.S. government may assert that a claim including items or services
    resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the federal
    civil False Claims Act. A conviction for violation of the Anti-kickback Statute requires mandatory exclusion from participation in
    federal health care programs. Although there are a number of statutory exemptions and regulatory safe harbors protecting certain
    common activities from prosecution, the exemptions and safe harbors are drawn narrowly, and those activities may be subject to scrutiny
    or penalty if they do not qualify for an exemption or safe harbor.
●
The
    federal civil False Claims Act, or FCA, prohibits, among other things, knowingly presenting, or causing to be presented claims for
    payment of government funds that are false or fraudulent, or knowingly making, using or causing to be made or used a false record
    or statement material to such a false or fraudulent claim, or knowingly concealing or knowingly and improperly avoiding, decreasing,
    or concealing an obligation to pay money to the federal government. This statute also permits a private individual acting as a "whistleblower"
    to bring actions on behalf of the federal government alleging violations of the FCA and to share in any monetary recovery. The FCA
    prohibits anyone from knowingly presenting, conspiring to present, making a false statement in order to present, or causing to be
    presented, for payment to federal programs (including Medicare and Medicaid) claims for items or services, including drugs, that
    are false or fraudulent, claims for items or services not provided as claimed, or claims for medically unnecessary items or services.
    This law also prohibits anyone from knowingly underpaying an obligation owed to a federal program. Increasingly, U.S. federal agencies
    are requiring nonmonetary remedial measures, such as corporate integrity agreements in FCA settlements. The U.S. Department of Justice
    announced in 2016 its intent to follow the "Yates Memo," taking a far more aggressive approach in pursuing individuals
    as FCA defendants in addition to the corporations. FCA liability is potentially significant in the healthcare industry because the
    statute provides for treble damages and mandatory penalties assessed on a per false claim or statement basis. Government enforcement
    agencies and private whistleblowers have investigated pharmaceutical companies for or asserted liability under the FCA for a variety
    of alleged promotional and marketing activities, such as providing free product to customers with the expectation that the customers
    would bill federal programs for the product; providing consulting fees and other benefits to physicians to induce them to prescribe
    products; engaging in promotion for "off-label" uses; and submitting inflated best price information to the Medicaid
    Rebate Program.
●
The
    federal False Statements Statute prohibits knowingly and willfully falsifying, concealing, or covering up a material fact or making
    any materially false, fictitious or fraudulent statement or representation, or making or using any false writing or document knowing
    the same to contain any materially false, fictitious or fraudulent statement or entry, in connection with the delivery of or payment
    for healthcare benefits, items, or services.
●
The
    federal Civil Monetary Penalties Law authorizes the imposition of substantial civil monetary penalties against an entity, such as
    a pharmaceutical manufacturer, that engages in activities including, among others (1) knowingly presenting, or causing to be presented,
    a claim for services not provided as claimed or that is otherwise false or fraudulent in any way; (2) arranging for or contracting
    with an individual or entity that is excluded from participation in federal healthcare programs to provide items or services reimbursable
    by a federal healthcare program; (3) violations of the federal Anti-Kickback Statute; or (4) failing to report and return a known
    overpayment.
29
●
The
    federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, imposes criminal and civil liability for knowingly
    and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program, or knowingly and willfully
    falsifying, concealing or covering up a material fact or making any materially false statement in connection with the delivery of,
    or payment for, healthcare benefits, items or services; similar to the federal Anti-Kickback Statute, a person or entity does not
    need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation.
●
HIPAA,
    as amended by the Health Information Technology for Economic and Clinical Health Act (HITECH), which imposes requirements on certain
    types of people and entities relating to the privacy, security, and transmission of individually identifiable health information,
    requires notification to affected individuals and regulatory authorities of certain breaches of security of individually identifiable
    health information.
●
The
    federal Physician Payment Sunshine Act, which requires certain manufacturers of drugs, devices, biologics and medical supplies for
    which payment is available under Medicare, Medicaid, or the Children's Health Insurance Program, to report annually to the
    Centers for Medicare & Medicaid Services (CMS) information related to payments and other transfers of value to physicians (defined
    to include doctors, dentists, optometrists, podiatrists and chiropractors) and teaching hospitals, and ownership and investment interests
    held by physicians and other healthcare providers and their immediate family members, which is published in a searchable form on
    an annual basis. Effective January 1, 2022, covered manufacturers will also be required to report on payments and other transfers
    of value to physician assistants, nurse practitioners or clinical nurse specialists, anesthesiologist assistants, certified registered
    nurse anesthetists, and certified nurse-midwives during the previous year.
●
State
    laws comparable to each of the above federal laws, such as, for example, anti-kickback and false claims laws that may be broader
    in scope and also apply to commercial insurers and other non-federal.
●
Payors
    requirements for mandatory corporate regulatory compliance programs, and laws relating to patient data privacy and security. Other
    state laws require pharmaceutical companies to comply with the pharmaceutical industry's voluntary compliance guidelines and
    the relevant compliance guidance promulgated by the federal government; require drug manufacturers to report information related
    to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures; and state and foreign
    laws govern the privacy and security of health information in some circumstances, many of which differ from each other in significant
    ways and often are not preempted by HIPAA, thus complicating compliance efforts.
●
In
    the European Union, the General Data Protection Regulation, or GDPR,—Regulation EU 2016/679—was adopted in May 2016 and
    became applicable on May 25, 2018, or GDPR. The GDPR further harmonizes data protection requirements across the European Union member
    states by establishing new and expanded operational requirements for entities that collect, process or use personal data generated
    in the European Union, including consent requirements for disclosing the way personal information will be used, information retention
    requirements, and notification requirements in the event of a data breach.
●
In
    the United Kingdom, following the UK's exit from the European Union on 31 December 2020, the GDPR continues to form part of
    the law in the UK with some amendments (UK GDPR). There is a risk of divergence in the future, which may increase our overall data
    protection compliance costs.
●
The
    California Consumer Privacy Act of 2018, or CCPA, effective as of January 1, 2020, gives California residents expanded rights to
    access and require deletion of their personal information, opt out of certain personal information sharing, and receive detailed
    information about how their personal information is used. The CCPA provides for civil penalties for violations, as well as a private
    right of action for data breaches, that is expected to increase data breach litigation.
●
In
    addition, failure to comply with the Israeli Privacy Protection Law of 1981, and its regulations, as well as the guidelines of the
    Israeli Privacy Protection Authority, may expose us to administrative fines, civil claims (including class actions) and in certain
    cases criminal liability. Current pending legislation may result in a change of the current enforcement measures and sanctions.
30
If
our operations are found to be in violation of any such health care laws and regulations, we may be subject to penalties, including significant
administrative, civil and criminal penalties, monetary damages, disgorgement, imprisonment, the curtailment or restructuring of our operations,
loss of eligibility to obtain approvals from the FDA or foreign regulatory authorities, or exclusion from participation in government
contracting, healthcare reimbursement or other government programs, including Medicare and Medicaid, any of which could adversely our
financial results. Any action against us for an alleged or suspected violation could cause us to incur significant legal expenses and
could divert our management's attention from the operation of our business, even if our defense is successful. In addition, achieving
and sustaining compliance with applicable laws and regulations may be costly to us in terms of money, time and resources.
Our
employees, principal investigators, consultants, commercial partners or vendors may engage in misconduct or other improper activities,
including non-compliance with regulatory standards.
We
are also exposed to the risk of employees, independent contractors, principal investigators, consultants, commercial partners or vendors
engaging in fraud or other misconduct. Misconduct by employees, independent contractors, principal investigators, consultants, commercial
partners and vendors could include intentional failures to comply with EU or UK regulations, to provide accurate information to the EMA,
MHRA or EU Member States authorities or to comply with manufacturing or quality standards we have or will have established. In particular,
sales, marketing and business arrangements in the healthcare industry are subject to extensive laws and regulations intended to prevent
fraud, misconduct, kickbacks, self-dealing and other abusive practices such as promotion of products by medical practitioners. The EU
Member States in which we operate have different statutory provisions regulating the cooperation of pharmaceutical companies with healthcare
professionals. In addition to these statutory provisions, codes of conduct issued by business associations or other non-statutory standards
may be applicable to our activities. Both statutory provisions and non-statutory codes or standards restrict payments or other benefits
provided to healthcare professionals, and in case of non-compliance, may result in severe sanctions such as bans, administrative fines,
criminal fines or even imprisonment. The advertising of medicinal products for human use in the EU is regulated by Title VIII of European
Directive 2001/83/EC, as amended. These provisions have been implemented into the law of the EU member States. Such laws inter alia restrict
or prohibit a wide range of pricing, discounting, marketing and promotion, sales commission, customer incentive programs and other business
arrangements. Misconduct could also involve the improper use of information obtained in the course of clinical studies, which could result
in regulatory sanctions and serious and irreparable harm to our reputation.
This
could also apply with respect to data privacy. In the EU (at that time including the United Kingdom), the EU Directive 95/46/EEC was
replaced by the GDPR on May 25, 2018. The GDPR as an EU regulation does not have to be implemented into Member States' national
law, but applies directly in all Member States since May 25, 2018. It applies to companies with an establishment in the European Economic
Area (EEA) and to certain other companies not in the EEA that offer or provide goods or services to individuals located in the EEA or
monitor individuals located in the EEA. The GDPR implements more stringent operational requirements for controllers of personal data,
including, for example, expanded disclosures about how personal information is to be used, limitations on retention of information, increased
requirements pertaining to health data and pseudonymized (i.e., key-coded) data, increased cyber security requirements, mandatory data
breach notification requirements and higher standards for controllers to demonstrate that they have obtained a valid legal basis for
certain data processing activities. The GDPR provides that EU Member States may continue to make their own further laws and regulations
in relation to the processing of genetic, biometric or health data, which could result in continued or new differences between Member
States, limit our ability to use and share personal data or could cause our costs to increase, and harm our business and financial condition.
The GDPR continues to form part of law in the United Kingdom with some amendments following the United Kingdom's exit from the
European Union on 31 December 2020 (UK GDPR) although there is a risk of divergence in the future which may increase our overall data
protection compliance cost. We are also subject to evolving and strict rules on the transfer of personal data out of the European Union
and United Kingdom to the United States. Further prospective revision of the Directive on privacy and electronic communications (Directive
2002/58/EC, as amended), or ePrivacy Directive, and equivalent United Kingdom Legislation may affect our marketing communications.
31
We
have implemented procedures to ensure compliance with the GDPR and UK GDPR and its requirements. Our actual or alleged failure to comply
with this regulation, or to protect personal data, could result in enforcement actions and significant penalties against us, which could
result in negative publicity, increase our operating costs, subject us to claims or other remedies and have a material adverse effect
on our business, financial condition, and results of operations. It is not always possible to identify and deter misconduct by employees
or other parties. The precautions we take to detect and prevent such activity may not protect us from legal or regulatory action resulting
from a failure to comply with applicable laws or regulations. Misconduct by our employees, principal investigators, consultants, commercial
partners or vendors could result in significant financial penalties, criminal sanctions, civil law claims and/or negative media coverage,
and thus have a material adverse effect on our business, including through the imposition of significant fines or other sanctions, and
our reputation. In particular, failure to comply with EU laws, including failure under the GDPR, UK GDPR, ePrivacy Directive and other
laws relating to the security of personal data may result in fines up to €20,000,000 or up to 4% of the total worldwide annual turnover
of the preceding financial year, if greater, and other administrative penalties including criminal liability, which may be onerous and
adversely affect our business, financial condition, results of operations and prospects. Failure to comply with the GDPR, UK GDPR and
related laws may also give risk to increase risk of private actions, including a new form of class action that is available under the
GDPR and UK GDPR.
If
we or our manufacturers fail to comply with manufacturing regulations, our financial results and financial condition could be adversely
affected.
Before
an NDA is approved, and before we begin the commercial manufacture of any product candidate, contract manufacturers must register with
FDA or foreign regulators undergo regulatory inspection of their manufacturing facilities, processes and quality systems. In addition,
pharmaceutical manufacturing facilities are subject to periodic inspection by the FDA and foreign regulatory authorities after product
approval. Due to the complexity of the processes used to manufacture pharmaceutical products and product candidates, any potential third-party
manufacturer may be unable to meet local, federal, or international regulatory requirements either at the outset or on an ongoing basis,
in a cost-effective manner, if at all.
We
do not intend to engage in the manufacture of Aramchol or any other product candidate other than for pre-clinical and clinical studies,
but we or our materials suppliers may face manufacturing or quality control problems causing product production and shipment delays or
a situation where we or the supplier may not be able to maintain compliance with the FDA's or foreign regulators' requirements
necessary to continue manufacturing Aramchol or any other product candidate. Drug manufacturers are subject to ongoing periodic unannounced
inspections by the FDA and corresponding foreign regulators to ensure continuing compliance with applicable requirements. Any failure
to comply with FDA or foreign regulatory requirements could adversely affect our clinical research activities and our ability to develop
and market Aramchol or any other product candidate.
If
a third-party manufacturer with whom we contract is unable to comply with manufacturing requirements, we may be subject to fines, unanticipated
compliance expenses, recall or seizure of Aramchol or any other product candidate, total or partial suspension of production and/or enforcement
actions, including injunctions, and criminal or civil prosecution. These possible sanctions could adversely affect our financial results
and financial condition.
Our
market is subject to intense competition. If we are unable to compete effectively, Aramchol, Amilo-5MER or any other product candidate
that we develop may be rendered suboptimal, noncompetitive or obsolete.
There
are a number of products in development for our target indications, many of which are being developed by pharmaceutical companies that
are far larger than us, with significantly greater resources and more experience than us in all aspects of drug development and commercialization.
Further, our industry is highly competitive and subject to rapid and significant technological change. Our potential competitors include
large, fully-integrated pharmaceutical and biotechnology companies, specialty pharmaceutical and generic drug companies, academic institutions,
government agencies and research institutions. All of these competitors currently engage in, have engaged in or may engage in the future
in the development, manufacturing, marketing and commercialization of new pharmaceuticals, some of which may compete with Aramchol, Amilo-5MER
or other product candidates. Smaller or early stage companies may also prove to be significant competitors, particularly through collaborative
arrangements with large, established companies. These companies may have products in development that are superior to any Aramchol or
any other product candidate. Key competitive factors affecting the commercial success of Aramchol or any other product candidate that
we develop are likely to be efficacy, time of onset, safety and tolerability profile, reliability, convenience of dosing, price and reimbursement.
32
Many
of our potential competitors have substantially greater financial, technical and human resources than we do and significantly greater
experience in the discovery and development of drug candidates, obtaining FDA and other regulatory approvals of products and the commercialization
of those products. Accordingly, our competitors may be more successful than us in obtaining FDA and other marketing approvals for drugs
and achieving widespread market acceptance. Our competitors' drugs may be more effective, or more effectively marketed and sold,
than any drug we may commercialize and may render the product candidates that we develop suboptimal, obsolete or non-competitive before
we can recover the expenses of developing and commercializing the product. We anticipate that we will face intense and increasing competition
as new drugs enter the market and advanced technologies become available. Finally, the development of new treatment methods for the diseases
we are targeting could render Aramchol or any other product candidate that we develop, non-competitive or obsolete. If we cannot successfully
compete with new or existing products, our marketing and sales will suffer and we may never be profitable.
Our
competitors in the NASH field currently include companies with marketed
products and/or advanced clinical programs. Our main competitors of Aramchol include, but are not limited to Novo Nordisk, Akero Therapeutics,
Inc., Inc., Madrigal Pharmaceuticals Inc., and Viking Therapeutics among others.
In March 2024,
Madrigal Pharmaceuticals announced FDA approval of Rezdiffra (resmetirom) for the treatment of NASH with moderate to advanced liver fibrosis.
See also "Item 4. Information on the Company—Competition." Moreover, several additional companies have reported the
commencement of research projects and proof-of-concept trials related to our target indications, including those mentioned in the preceding
sentence.
We
operate in a competitive sector. Several companies are working on technologies, therapeutic targets or drug or biomarker candidates that
aim to treat or diagnose the same diseases or identify the same patient population as our product candidates. While we believe that our
drug candidates and diagnostic solutions, combined with our expertise and know-how, provide us with competitive advantages, we face potential
competition from various sources, including pharmaceutical and biotechnology companies, as well as from academic institutions, governmental
agencies and public and private research institutions. We anticipate that we will face intense and increasing competition as new drugs
and therapies enter the market and advanced technologies become available. In some indications, off-label use of non-approved drugs can
also be considered as competition.
We
face potential product and other liability exposure, and, if claims are brought against us, we may incur substantial liability.
Our
product candidates could cause adverse events. These adverse events may not be observed in clinical trials, but may nonetheless occur
in the future. If any of these adverse events occur, they may render Aramchol or any other product candidate ineffective or harmful in
some patients, and our sales would suffer, materially adversely affecting our business, financial conditions and results of operations.
In
addition, potential adverse events caused by Aramchol or any other product candidate, could lead to product liability claims. Product
liability claims might be brought against us by consumers, healthcare providers or others coming into contact with Aramchol or any other
product candidate. If we cannot successfully defend ourselves against product liability claims, we could incur substantial liabilities.
In addition, regardless of merit or eventual outcome, product liability claims may result in, among other things:
●
decreased
    demand for our product candidate for which we obtain marketing approval;
●
impairment
    of our business reputation and exposure to adverse publicity;
33
●
increased
    warnings on product labels or other regulatory actions;
●
withdrawal
    of clinical trial participants;
●
costs
    of related litigation;
●
distraction
    of management's attention from our primary business;
●
substantial
    monetary awards to patients or other claimants;
●
loss
    of revenue; and
●
the
    inability to successfully commercialize any product candidates, for which we obtain marketing approval.
If
we are unable to obtain adequate insurance with respect to our clinical trials against and from any losses or claims from third parties,
our financial condition could be adversely affected in the event of uninsured or inadequately insured loss or damage. We may not be able
to obtain insurance policies on terms affordable to us that would adequately cover loss or claims by third parties. To the extent our
business suffers any losses or claims by third parties, which are not covered, or adequately covered, by insurance, our financial condition
may be materially adversely affected.
If
product liability lawsuits are successfully brought against us, our insurance may be inadequate.
We
have obtained insurance coverage for our clinical trials in accordance with market standards and in compliance with applicable Israeli
law. However, our insurance coverage may not be sufficient to reimburse us for any expenses or losses we may suffer. Moreover, insurance
coverage is becoming increasingly expensive, and, in the future, we may not be able to maintain insurance coverage at a reasonable cost
or in sufficient amounts to protect us against losses due to liability. If and when we obtain marketing approval for any product candidate,
we intend to expand our insurance coverage to include the sale of commercial products; however, we may be unable to obtain this product
liability insurance on commercially reasonable terms. On occasion, large judgments have been awarded in class action lawsuits based on
drugs that had unanticipated side effects. The cost of any product liability litigation or other proceedings, even if resolved in our
favor, could be substantial. A successful product liability claim, or series of claims, brought against us could cause our share price
to decline and, if judgments exceed our insurance coverage, could decrease our cash and adversely affect our business.
The
product liability insurance we will need to obtain in connection with the commercial sales of any product candidate, if and when they
receive regulatory approval, may be unavailable in meaningful amounts or at a reasonable cost. If we are the subject of a successful
product liability claim that exceeds the limits of any insurance coverage we obtain, we would incur substantial charges that would adversely
affect our earnings and require the commitment of capital resources that might otherwise be available for the development and commercial
launch of any product candidate's programs.
We
manage our business through a small number of senior executive officers. We depend on them even more than similarly- situated companies.
Because
of the specialized scientific and managerial nature of our business, we rely heavily on our ability to recruit, attract, retain, manage
and motivate qualified senior executive officers with adequate operational, scientific and technical experience. The loss of the services
of our senior executive officers, including our President, Chief Executive Officer, or the inability to hire or retain experienced management
personnel, could adversely affect our ability to execute our business plan and harm our operating results. In particular, the loss of
one or more of our senior executive officers could be detrimental to us if we cannot recruit suitable replacements in a timely manner.
We
do not currently carry "key person" insurance on the lives of members of senior management. The competition for qualified
personnel in the pharmaceutical field is intense. Due to this intense competition, we may be unable to attract and retain qualified personnel
necessary for the development of our business or to recruit suitable replacement personnel. Additionally, our ability to effectively
recruit and retain qualified officers and directors could also be adversely affected if we experience difficulty in obtaining adequate
directors' and officers' liability insurance. We may be unable to maintain sufficient insurance as a public company to cover
liability claims made against our officers and directors. If we are unable to adequately insure our officers and directors, we may not
be able to retain or recruit qualified officers and directors to manage the Company.
34
Failure
to build our finance infrastructure and improve our accounting systems and controls could impair our ability to comply with the financial
reporting and internal control requirements for publicly traded companies.
As
a public company, we operate in an increasingly challenging regulatory environment which requires us to comply with the Sarbanes-Oxley
Act of 2002, or the Sarbanes-Oxley Act, and the related rules and regulations of the SEC and securities exchanges, expanded disclosures,
accelerated reporting requirements and more complex accounting rules. Company responsibilities required by the Sarbanes-Oxley Act include
establishing corporate oversight and adequate internal control over financial reporting and disclosure controls and procedures. Effective
internal controls are necessary for us to produce reliable financial reports and are important to help prevent financial fraud.
We are subject to the requirements of the Sarbanes-Oxley Act. Section 404
of the Sarbanes-Oxley Act requires companies subject to the reporting requirements of the U.S. securities laws to do a comprehensive evaluation
of its and its subsidiaries' internal control over financial reporting. To comply with this statute, we must document and test our
internal control procedures and our management and issue a report concerning our internal control over financial reporting. In addition,
as long as we do not become an accelerated or large accelerated filer, we are exempt from the auditor attestation requirements of Section
404(b) of the Sarbanes-Oxley Act. Under this exemption, our auditor will not be required to attest to and report on our management's
assessment of our internal control over financial reporting until the date we are no longer a non-accelerated filer. We have an ongoing program to perform the
system and process evaluation and testing necessary to continue to comply with these requirements. During the course of our review and
testing, we may identify deficiencies and be unable to remediate them before we must provide the required reports. Furthermore, if we
have a material weakness in our internal controls over financial reporting, we may not detect errors on a timely basis and our financial
statements may be materially misstated. We may not be able to conclude on an ongoing
basis that we have effective internal control over financial reporting, which could harm our operating results, cause investors to lose
confidence in our reported financial information and cause the trading price of our stock to fall.
To
build our finance infrastructure, we may need to improve our accounting systems, disclosure policies, procedures and controls. If we
are unsuccessful in building an appropriate accounting infrastructure, we may not be able to prepare and disclose, in a timely manner,
our financial statements and other required disclosures, or comply with existing or new reporting requirements. Any failure to report
our financial results on an accurate and timely basis could result in sanctions, lawsuits, delisting of our shares from the Nasdaq Capital
Market or other adverse consequences that would materially harm our business. If we cannot provide reliable financial reports or prevent
fraud, our business and results of operations could be harmed and investors could lose confidence in our reported financial information.
We
may need to significantly increase the size of our organization, and we may experience difficulties in managing growth.
Subject
to our strategic review, we may experience rapid and substantial growth in order to achieve our operating plans, which will place a strain
on our human and capital resources. Successful implementation of our business plan will require management of growth, which will result
in an increase in the level of responsibility for management personnel. Any future growth will impose significant added responsibilities
on members of management, including the need to identify, recruit, maintain and integrate additional employees. To that end, we must
be able to, among other things:
●
manage
    our clinical trials and the regulatory process effectively;
●
develop
    our administrative, accounting and management information systems and controls;
●
hire
    and train additional qualified personnel; and
●
integrate
    current and additional management, administrative, financial and sales and marketing personnel.
35
If
we are unable to establish, scale-up and implement improvements to our control systems in an efficient or timely manner, or if we encounter
deficiencies in existing systems and controls, investors may choose not to invest in us, which could cause our share price to decline
and negatively impact our ability to successfully commercialize Aramchol or any other product candidate.
Failure
to attract and retain sufficient numbers of talented employees will further strain our human resources and could impede our growth or
result in ineffective growth. If we are unable to manage our growth effectively, our losses could materially increase and it will have
a material adverse effect on our business, results of operations and financial condition.
Additional
clinical trials may divert a significant amount of our resources and may ultimately be unsuccessful.
We
are exploring the expansion of Aramchol for the treatment of other indications in order to expand our pipeline, commercial potential
and ultimately de-risk the Company for the success of any one given trial. If we initiate additional clinical trials, this may divert
a significant amount of Company resources and may be unsuccessful. The regulatory pathway may prove simpler than for NASH and as a result
this may shift the priorities for Aramchol in the future.
Environmental,
social and corporate governance (ESG) issues, including those related to climate change and sustainability, may have an adverse effect
on our business, financial condition and results of operations and damage our reputation.
There
is an increasing focus from certain investors, customers, consumers, employees and other stakeholders concerning ESG matters. Additionally,
public interest and legislative pressure related to public companies' ESG practices continue to grow. If our ESG practices fail
to meet regulatory requirements or investor, customer, consumer, employee or other shareholders' evolving expectations and standards
for responsible corporate citizenship in areas including environmental stewardship, support for local communities, Board of Director
and employee diversity, human capital management, employee health and safety practices, product quality, supply chain management, corporate
governance and transparency, our reputation, brand and employee retention may be negatively impacted, and our customers and suppliers
may be unwilling to continue to do business with us.
Customers,
consumers, investors and other shareholders are increasingly focusing on environmental issues, including climate change, energy and water
use, plastic waste and other sustainability concerns. Concern over climate change may result in new or increased legal and regulatory
requirements to reduce or mitigate impacts to the environment. Changing customer and consumer preferences or increased regulatory requirements
may result in increased demands or requirements regarding plastics and packaging materials, including single-use and non-recyclable plastic
products and packaging, other components of our products and their environmental impact on sustainability, or increased customer and
consumer concerns or perceptions (whether accurate or inaccurate) regarding the effects of substances present in certain of our products.
Complying with these demands or requirements could cause us to incur additional manufacturing, operating or product development costs.
If
we do not adapt to or comply with new regulations, including the SEC's newly adopted rules that require companies to provide expanded
climate-related disclosures in their periodic reporting, which may require us to incur significant additional costs to comply and impose
increased oversight obligations on our management and board of directors, or fail to meet evolving investor, industry or stakeholder
expectations and concerns regarding ESG issues, investors may reconsider their capital investment in our Company, we may become subject
to penalties, and customers and consumers may choose to stop purchasing our products, if approved for commercialization, which could
have a material adverse effect on our reputation, business or financial condition.
Our
business is subject to risks arising from epidemic diseases, such as the COVID-19 pandemic, which has impacted and could continue to
impact our business.
Public
health epidemics or outbreaks could adversely impact our business. In late 2019, a novel strain of COVID-19, also known as coronavirus,
was reported in Wuhan, China. Initially the outbreak was largely concentrated in China, but it rapidly spread to countries across the
globe, including in Israel and the United States. Many countries around the world, including in Israel and the United States, implemented
significant governmental measures to control the spread of the virus, including temporary closure of businesses, severe restrictions
on travel and the movement of people, and other material limitations on the conduct of business. In response, we implemented remote working
and workplace protocols for our employees in accordance with Israeli Ministry of Health requirements to ensure employees safety, experienced
delays in recruitment to our ARMOR Study, and took several cost-reduction measures.
36
If
there is a resurgence of COVID-19 its spread may materially affect us economically. While the potential economic impact brought by, and
the duration of, any future resurgence of the COVID-19 pandemic may be difficult to assess or predict, it has already caused, and could
result in further, significant disruption of global financial markets, reducing our ability to access capital, which could in the future
negatively affect our liquidity and financial position. In addition, the trading prices for other companies have been highly volatile
as a result of the COVID-19 pandemic. As a result, we may face difficulties raising capital through sales of our ordinary shares or other
securities and such sales may be on unfavorable terms. To the extent that future waves of COVID-19 disrupt normal business operations,
we may face operational challenges with our services, and we likely will have to adopt remote working and workplace protocols for employees
in accordance with government requirements and other measures to minimize such impact, and we may, subject to our strategic review, experience
disruptions that could impact our business, clinical trials, and supply chains.
The
extent to which COVID-19 impacts our operations will depend on future developments, which are highly uncertain and cannot be predicted
with confidence, including the duration and severity of the outbreak, and the actions that may be required to contain COVID-19 or treat
its impact. In particular, the extent to which any resurgence of the COVID-19 pandemic may impact our business and financial performance
will depend on future developments, which are highly uncertain and cannot be predicted with confidence. The impact of any resurgence
of the COVID-19 pandemic may also have the effect of heightening many of the other risks described in the "Risk Factors"
section of this Annual Report on Form 20-F.
Risks
Related to Our Reliance on Third Parties
We
have no manufacturing capacity and anticipate reliance on third-party manufacturers for Aramchol, Amilo-5MER or any other product candidates.
We
do not currently operate manufacturing facilities for the production of Aramchol, Amilo-5MER or their API. We still have not, and may
never, develop facilities for the manufacture of product candidates or products for clinical trials or commercial purposes. We rely on
third-party manufacturers to produce bulk drug products required for our clinical trials. Our contract manufacturers have not completed
commercial development and validation processes of the Aramchol and Amilo-5Mer API and we have experienced delays in the development
of the Aramchol meglumine formulation. Drug product manufacturing processes may experience further difficulties and delays in production.
Additionally,
if our contract manufacturers and their facilities, as applicable, are not approved by the FDA, or other applicable regulatory authorities,
our commercial supply of the drug substance will be significantly delayed and may result in significant additional costs. We purchase
finished Aramchol from a third-party under a clinical supply agreement. If we will be required to change the finished product manufacturer,
we may encounter significant delay and likely significant additional cost.
A
failure by our contract manufacturer to achieve and maintain high manufacturing standards, in accordance with applicable good manufacturing
practices and other applicable regulatory requirements could result in patient injury or death, product shortages, product recalls or
withdrawals, delays or failures in product testing or delivery, cost overruns or other problems that could seriously harm our business.
Contract manufacturers often encounter difficulties involving production yields, quality control and quality assurance, as well as shortages
of qualified personnel.
Our
existing manufacturers and any future contract manufacturers may not perform as agreed or may not remain in the contract manufacturing
business. In the event of a natural disaster, business failure, strike or other difficulty, we may be unable to replace a third-party
manufacturer in a timely manner and the production of our product candidates would be interrupted, resulting in delays and additional
costs.
37
We
intend to rely primarily on third parties to market and sell Aramchol, Amilo-5MER or any other product candidate.
We
have no sales or distribution capabilities. To the extent we rely on third parties to commercialize Aramchol, Amilo-5MER or any other
product candidate, if marketing approval is obtained, we may receive less revenue than if we commercialize them ourselves. In addition,
we would have less control over the sales efforts of any third parties involved in our commercialization efforts. In the event we are
unable to collaborate with a third-party marketing and sales organization to commercialize Aramchol, Amilo-5MER or any other product
candidate, particularly for broader patient populations, our ability to generate revenue will be limited.
Although
we may ultimately develop a marketing and sales force with technical expertise and supporting distribution capabilities in the longer
term, we do not currently intend to do so and, as such, we will be unable to market our product candidates directly in the near future.
To promote any of our potential products through third parties, we will have to locate acceptable third parties for these functions and
enter into agreements with them on acceptable terms, and we may not be able to do so. Any third-party arrangements we are able to enter
into may result in lower revenues than we could achieve by directly marketing and selling our potential products. In addition, to the
extent that we depend on third parties for marketing and distribution, any revenues we receive will depend upon the efforts of such third
parties, as well as the terms of our agreements with such third parties, which cannot be predicted in most cases at this time. As a result,
we might not be able to market and sell our product candidates in the United States or overseas, which would have a material adverse
effect on us.
Any
collaboration arrangements that we may enter into in the future may not be successful, which could adversely affect our ability to develop
and commercialize our current and potential other product candidates.
We
intend to seek collaboration arrangements with pharmaceutical or biotechnology companies for the continued development and commercialization
of our current and potential other product candidates. We will face, to the extent that we decide to enter into collaboration agreements,
significant competition in seeking appropriate collaborators. Moreover, collaboration arrangements are complex and time consuming to
negotiate, document and implement. We may not be successful in our efforts to establish and implement collaborations or other alternative
arrangements. The terms of any collaborations or other arrangements that we may establish may not be favorable to us.
Any
future collaborations that we enter into may not be successful. The success of our collaboration arrangements will depend heavily on
the efforts and activities of our collaborators. Collaborators generally have significant discretion in determining the efforts and resources
that they will apply to these collaborations. Disagreements between parties to a collaboration arrangement regarding clinical development
and commercialization matters can lead to delays in the development process or commercializing the applicable product candidate and,
in some cases, termination of the collaboration arrangement. These disagreements can be difficult to resolve if neither of the parties
has final decision making authority. Moreover, collaborations with pharmaceutical or biotechnology companies and other third parties
are often terminated or allowed to expire by the other party. Any lack of effort or ability by our collaborators or any such disagreement,
termination or expiration could adversely affect us financially and could harm our business reputation.
We
depend on third parties to conduct our clinical trials.
We
rely on third parties, such as contract research organizations, medical institutions, clinical investigators and contract laboratories
to oversee most of the operations of our clinical trials and to perform data collection and analysis. As a result, we may face additional
delays outside of our control if these parties do not perform their obligations in a timely fashion or in accordance with regulatory
requirements. If these third parties do not successfully carry out their contractual duties or obligations and meet expected deadlines,
if they need to be replaced, or if the quality or accuracy of the clinical data they obtain is compromised due to the failure to adhere
to our clinical protocols or for other reasons, our financial results and the commercial prospects for Aramchol, Amilo-5MER or any other
product candidate could be harmed, our costs could increase and our ability to obtain regulatory approval and commence product sales
could be delayed.
38
Risks
Related to Our Intellectual Property
The
failure to obtain or maintain patents, licensing agreements and other intellectual property rights that are sufficiently broad and protective
could impact our ability to compete effectively.
To
compete effectively, we must develop and maintain a proprietary position with regard to our own technologies, intellectual property,
licensing agreements, product candidates and business. Legal standards relating to the validity and scope of claims in the biotechnology
and biopharmaceutical fields are still evolving. We cannot predict the scope and extent of patent protection for Aramchol, Amilo-5MER
or any other product candidate because the patent positions of pharmaceutical products are complex and uncertain. Therefore, the degree
of future protection for our proprietary rights in our core technologies and any product candidates or products that might be developed
using these technologies is also uncertain. The risks and uncertainties that we face with respect to our patents and other proprietary
rights include, but are not limited to, the following:
●
while
    the patents we own have been issued, pending patent applications we have filed may not result in issued patents or may take longer
    than we expect to result in issued patents;
●
we
    may be subject to interference, reexamination, inter pares review, or post-grant review proceedings in the U.S.;
●
we
    may be subject to opposition proceedings in certain foreign countries;
●
any
    patents that are issued may not provide meaningful protection for any significant period of time, if at all;
●
any
    issued patents may not be broad or strong enough to prevent competition from other products including identical or similar products;
●
we
    may not be able to develop additional proprietary technologies that are patentable;
●
there
    may be prior art of which we are not aware that may affect the validity or enforceability of a patent claim;
●
there
    may be other patents or pending patent applications existing in the patent landscape that will affect our freedom to operate for
    our product candidates;
●
other
    companies may challenge and invalidate patents licensed or issued to us or our customers;
●
a
    court could determine that a competitor's technology or product does not infringe our patents;
●
other
    companies may independently develop similar or alternative technologies, or duplicate our technologies;
●
other
    companies may design around technologies we have licensed or developed;
●
if
    we are not awarded patents or if issued patents expire or are declared invalid or not infringed, there may be no protections against
    competitors making generic equivalents;
●
enforcement
    of patents is complex, uncertain and expensive, and our patents may be found invalid or enforceable;
●
our
    patents could irretrievably lapse due to failure to pay fees or otherwise comply with regulations, or could be subject to compulsory
    licensing; and
●
if
    we encounter delays in our development or clinical trials, the period of time during which we could market our product candidates
    under patent protection would be reduced.
39
We
cannot be certain that patents will be issued as a result of any of our pending applications, and we cannot be certain that any of our
issued patents, whether issued pursuant to our pending applications or licensed from third parties, will give us adequate protection
from competing products. For example, issued patents may be circumvented or challenged, declared invalid or unenforceable, or narrowed
in scope. In addition, because publication of discoveries in the scientific or patent literature often lags behind actual discoveries,
we cannot be certain that we were the first to make our inventions or to file patent applications covering those inventions. If any of
our composition of matter patents, or pending applications, was subject to a successful challenge or failed to issue, our business and
competitive advantage could be significantly affected. Our current patents will expire or they may otherwise cease to provide meaningful
competitive advantage, and we may be unable to adequately develop new technologies and obtain future patent protection to preserve our
competitive advantage or avoid adverse effects on our business.
Subject
to our strategic review, we plan to transition from Aramchol free acid to Aramchol meglumine (salt) in our double-blind, placebo-controlled
histology-based registrational part of the ARMOR Study and any other clinical trials of Aramchol. As part of our research and development
studies, we have confirmed that several Aramchol salts have improved solubility as compared to the existing form of Aramchol free acid.
We have pending patent applications and have been granted patents directed to composition of matter of Aramchol meglumine as well as
a wide range of other salts.
There
can be no assurance that the U.S. Patent and Trademark Office, or the USPTO, or any other foreign equivalent will issue any additional
patents based on the patent applications that we submitted to protect our Aramchol salts or Amilo-5MER, nor, should the USPTO or foreign
equivalent issue any patents to us with respect to the Aramchol salts or Amilo-5MER, that we will be provided with adequate protection
against potentially competitive products. Furthermore, if foreign equivalent issues us one or more patents for the Aramchol salts or
Amilo-5MER or with respect to already issued patents for the Aramchol salts or Amilo-5MER, there can be no assurance that the issued
patents will be of any commercial value, or that private parties or competitors will not successfully challenge these patents or circumvent
these patents in the United States or their counterparts abroad. In the absence of adequate patent protection, our business may be adversely
affected by competitors who develop comparable technology or products and our commercial prospects may be materially adversely affected.
Others
may obtain issued patents that could prevent us from commercializing our product candidates or require us to obtain licenses requiring
the payment of significant fees or royalties in order to enable us to conduct our business. As to those patents that we have licensed,
our rights depend on maintaining our obligations to the licensor under the applicable license agreement, and we may be unable to do so.
In
addition to patents and patent applications, we depend upon trade secrets and proprietary know-how to protect our proprietary technology.
We require our employees, consultants, advisors and collaborators to enter into confidentiality agreements that prohibit the disclosure
of confidential information to any other parties. We also require our employees and consultants to disclose and assign to us their ideas,
developments, discoveries and inventions. These agreements may not, however, provide adequate protection for our trade secrets, know-how
or other proprietary information in the event of any unauthorized use or disclosure.
Patent
terms may be inadequate to protect our competitive position on our product candidates for an adequate amount of time.
Patents
have a limited lifespan. In the United States, if all maintenance fees are timely paid, the natural expiration of a patent is generally
20 years from the PCT application. Various extensions may be available, but the life of a patent, and the protection it affords, is limited.
Even if patents covering our product candidates are obtained, once the patent life has expired, we may be open to competition from competitive
products, including generics or biosimilars. Given the amount of time required for the development, testing and regulatory review of
new product candidates, patents protecting such candidates might expire before or shortly after such candidates are commercialized. As
a result, our owned and licensed patent portfolio may not provide us with sufficient rights to exclude others from commercializing products
similar or identical to ours.
40
We
may not be able to enforce our intellectual property rights throughout the world. This risk is exacerbated for us because we expect Aramchol
or Aramchol meglumine and Amilo-5MER will be manufactured and used in a number of foreign countries.
The
laws of some foreign countries do not protect intellectual property rights to the same extent as the laws of the United States. Many
companies have encountered significant problems in protecting and defending intellectual property rights in certain foreign jurisdictions.
This risk is exacerbated for us because we expect Aramchol or Amilo-5MER will be manufactured and used in a number of foreign countries.
The
legal systems of some countries, particularly developing countries, do not favor the enforcement of patents and other intellectual property
protection, especially those relating to life sciences. This could make it difficult for us to stop the infringement of our other intellectual
property rights. For example, several foreign countries have compulsory licensing laws under which a patent owner must grant licenses
to third parties. In addition, some countries limit the enforceability of patents against third parties, including government agencies
or government contractors. In these countries, patents may provide limited or no benefit.
Although
most jurisdictions in which the Company has applied for, intends to apply for, or has been issued patents have patent protection laws
similar to those of the United States, some of them do not. For example, the Company expects to do business in South America, Eurasia,
China and Indochina in the future and the countries in these regions may not provide the same or similar protection as that provided
in the United States.
Proceedings
to enforce our patent rights in foreign jurisdictions could result in substantial costs and divert our efforts and attention from other
aspects of our business. Accordingly, our efforts to protect our intellectual property rights in such countries may be inadequate. In
addition, changes in the law and legal decisions by courts in the United States and foreign countries may affect our ability to obtain
adequate protection for our technology and the enforcement of intellectual property.
We
may rely on third party patents
.
We
may not have rights under some patents or patent applications related to products we may commercialize in the future. Third parties may
own or control these patents and patent applications in the United States and abroad. Therefore, in some cases, to manufacture, sell
or import some of our future products, we or our collaborators may choose to seek, or be required to seek, licenses under third party
patents issued in the United States and abroad or under patents that might be issued from United States and foreign patent applications.
In instances in which we must obtain a license for third party patents, we may be required to pay license fees or royalties or both to
the licensor. If licenses are not available to us on acceptable terms, we or our collaborators may not be able to develop, manufacture,
sell or import these products.
We
may be unable to protect the intellectual property rights of third parties from whom we may license certain of our intellectual property
or with whom we have entered into other strategic relationships, which could have a material adverse effect on our business, results
of operations and financial condition.
Certain
of our intellectual property rights may be licensed from third parties, including universities and strategic partners. Such third parties
may determine not to or fail to protect the intellectual property rights that we license from them and we may be unable to defend such
intellectual property rights on our own or we may have to undertake costly litigation to defend the intellectual property rights of such
third parties. There can be no assurances that we will continue to have proprietary rights to any of the intellectual property that we
license from such third parties or otherwise have the right to use through similar strategic relationships. Any loss or limitations on
use with respect to such intellectual property licensed from third parties or otherwise obtained from third parties with whom we have
entered into strategic relationships could have a material adverse effect on our business, results of operations and financial condition.
41
If
we fail to comply with our obligations in the agreements under which we license intellectual property rights from third parties or otherwise
experience disruptions to our business relationships with our licensors, we could lose intellectual property rights that are important
to our business.
We
may be party to license agreements with third parties and may need to obtain additional licenses from others to advance our research
and development activities or allow the commercialization product candidates we may identify and pursue. License agreements may impose
various development, diligence, commercialization, and other obligations on us. For example, we may be required to use commercially reasonable
efforts to engage in various development and commercialization activities with respect to licensed products, and satisfy specified milestone
and royalty payment obligations. In spite of our efforts, our licensors might conclude that we have materially breached our obligations
under such license agreements and might therefore terminate the license agreements, thereby removing or limiting our ability to develop
and commercialize products and technology covered by these license agreements. If these in-licenses are terminated, or if the underlying
patents fail to provide the intended exclusivity, competitors or other third parties would have the freedom to seek regulatory approval
of, and to market, products identical to ours and we may be required to cease our development and commercialization of product candidates
that we may identify. Any of the foregoing could have a material adverse effect on our competitive position, business, financial conditions,
results of operations, and prospects. Moreover, disputes may arise regarding intellectual property subject to a licensing agreement,
including:
●
the
    scope of rights granted under the license agreement and other interpretation-related issues;
●
the
    extent to which our product candidates, technology and processes infringe on intellectual property of the licensor that is not subject
    to the licensing agreement;
●
the
    sublicensing of patent and other rights under our collaborative development relationships;
●
our
    diligence obligations under the license agreement and what activities satisfy those diligence obligations;
●
the
    inventorship and ownership of inventions and know-how resulting from the joint creation or use of intellectual property by our licensors
    and us and our partners; and
●
the
    priority of invention of patented technology. In addition, the agreements under which we currently or in the future license intellectual
    property or technology from third parties are complex, and certain provisions in such agreements may be susceptible to multiple interpretations.
    The resolution of any contract interpretation disagreement that may arise could narrow what we believe to be the scope of our rights
    to the relevant intellectual property or technology, or increase what we believe to be our financial or other obligations under the
    relevant agreement, either of which could have a material adverse effect on our business, financial condition, results of operations,
    and prospects. Moreover, if disputes over intellectual property that we have licensed prevent or impair our ability to maintain our
    current licensing arrangements on commercially acceptable terms, we may be unable to successfully develop and commercialize the affected
    product candidates, which could have a material adverse effect on our business, financial conditions, results of operations, and
    prospects.
We
may infringe the intellectual property rights of others, which may prevent or delay our product development efforts and stop us from
commercializing, or increase the costs of commercializing, Aramchol or Amilo-5MER or any other product candidate.
Our
commercial success depends significantly on our ability to operate without infringing the patents and other intellectual property rights
of third parties. For example, there could be issued patents of which we are not aware that our product candidate infringes. There also
could be patents that we believe we do not infringe, but that we may ultimately be found to infringe. Moreover, patent applications are
in some cases maintained in secrecy until patents are issued. The publication of discoveries in the scientific or patent literature frequently
occurs substantially later than the date on which the underlying discoveries were made and patent applications were filed. Because patents
can take many years to issue, there may be currently pending applications of which we are unaware that may later result in issued patents
that our product candidates infringe. For example, pending applications may exist that provide support or can be amended to provide support
for a claim that results in an issued patent that our product candidates infringes.
42
Third
parties may assert that we are employing their proprietary technology without authorization. If a court held that any third-party patents
are valid, enforceable and cover any of our product candidates or their use, the holders of any of these patents may be able to block
our ability to commercialize any such product candidate unless we obtained a license under the applicable patents, or until the patents
expire. In addition to litigation proceedings which may be filed against us, we may not be able to enter into licensing arrangements
or make other arrangements at a reasonable cost or on reasonable terms. Any inability to secure licenses or alternative technology could
result in delays in the introduction of our product candidates or lead to prohibition of the manufacture or sale of products by us.
We
may become involved in lawsuits to protect or enforce our patents or other intellectual property, which could be expensive, time consuming
and unsuccessful.
Competitors
may infringe our patents or other intellectual property. Although we are not currently involved in any litigation, if we were to initiate
legal proceedings against a third party to enforce a patent covering our product candidates, the defendant could counterclaim that the
patent covering our product candidate is invalid and/or unenforceable. In patent litigation in the United States, defendant counterclaims
alleging invalidity and/or unenforceability are commonplace. Grounds for a validity challenge could be an alleged failure to meet any
of several statutory requirements, including lack of novelty, obviousness, written description or non-enablement. Grounds for an unenforceability
assertion could be an allegation that someone connected with prosecution of the patent withheld relevant information from the USPTO,
or made a misleading statement, during prosecution. The outcome following legal assertions of invalidity and unenforceability is unpredictable.
Interference
or derivation proceedings provoked by third parties or brought by us or declared by the USPTO may be necessary to determine the priority
of inventions with respect to our patents or patent applications. An unfavorable outcome could require us to cease using the related
technology or to attempt to license rights to it from the prevailing party. Our business could be harmed if the prevailing party does
not offer us a license on commercially reasonable terms or at all, or if a non-exclusive license is offered and our competitors gain
access to the same technology. Our defense of litigation or interference or derivation proceedings may fail and, even if successful,
may result in substantial costs and distract our management and other employees. In addition, the uncertainties associated with litigation
could have a material adverse effect on our ability to raise the funds necessary to continue our clinical trials, continue our research
programs, license necessary technology from third parties, or enter into development partnerships that would help us bring our product
candidates to market.
Furthermore,
because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some
of our confidential information could be compromised by disclosure during this type of litigation. There could also be public announcements
of the results of hearings, motions, or other interim proceedings or developments. If securities analysts or investors perceive these
results to be negative, it could have a material adverse effect on the price of our ordinary shares.
We
may be unable to adequately prevent disclosure and unauthorized use of trade secrets and other proprietary information by third parties.
Our
ability to obtain and maintain patent protection and trade secret protection for our intellectual property and proprietary technologies,
our product candidates and their uses is important to our commercial success. We rely on a combination of patent, copyright, trademark
and trade secret laws, non-disclosure and confidentiality agreements, licenses, assignment of inventions agreements and other restrictions
on disclosure and use to protect our intellectual property rights.
We
also rely on trade secrets to protect our proprietary know-how and technological advances, especially where we do not believe patent
protection is appropriate or obtainable. However, trade secrets are difficult to protect. We rely in part on confidentiality agreements
with our employees, consultants, outside scientific collaborators, sponsored researchers and other advisors to protect our trade secrets
and other proprietary information. These agreements may not effectively prevent disclosure of confidential information and may not provide
an adequate remedy in the event of unauthorized disclosure of confidential information. In addition, others may independently discover
our trade secrets and proprietary information. Costly and time-consuming litigation could be necessary to enforce and determine the scope
of our proprietary rights. Failure to obtain or maintain trade secret protection could enable competitors to use our proprietary information
to develop products that compete with our product candidates or cause additional material adverse effects upon our competitive business
position.
43
We
cannot be certain that the steps that we have taken will prevent the misappropriation or other violation of our confidential information
and other intellectual property, particularly in foreign countries in which laws may not protect our proprietary rights as fully as in
the United States and other developed economies. Moreover, if we lose any key personnel, we may not be able to prevent the unauthorized
disclosure or use of our technical knowledge or other trade secrets by those former employees. If we are unable to maintain the security
of our proprietary technology, this could materially adversely affect our competitive advantage, business and results of operations.
Under
applicable U.S. and Israeli law, we may not be able to enforce covenants not to compete and therefore may be unable to prevent our competitors
from benefiting from the expertise of some of our former employees. In addition, employees may be entitled to seek compensation for their
inventions irrespective of their agreements with us, which in turn could impact our future profitability.
We
generally enter into non-competition agreements with our employees and certain key consultants, or our employment and consulting agreements
contain non-competition provisions. These agreements, to the extent they are in place and in effect, prohibit our employees and certain
key consultants, if they cease working for us, from competing directly with us or working for our competitors or clients for a limited
period of time. We may be unable to enforce these agreements under the laws of the jurisdictions in which our employees work and it may
be difficult for us to restrict our competitors from benefitting from the expertise our former employees or consultants developed while
working for us. For example, Israeli courts have required employers seeking to enforce non-compete undertakings of a former employee
to demonstrate that the competitive activities of the former employee will harm one of a limited number of material interests of the
employer which have been recognized by the courts, such as the secrecy of a company's confidential commercial information or the
protection of its intellectual property. If we cannot demonstrate that such interests will be harmed, we may be unable to prevent our
competitors from benefiting from the expertise of our former employees or consultants and our ability to remain competitive may be diminished.
In
addition, under the Israeli Patent Law, 5727-1967, or the Patent Law, inventions conceived by an employee in the course and as a result
of or arising from his or her employment with a company are regarded as "service inventions," which belong to the employer,
absent a specific agreement between the employee and employer giving the employee service invention rights. The Patent Law also provides
that if there is no such agreement between an employer and an employee, the Israeli Compensation and Royalties Committee, or the Committee,
a body constituted under the Patent Law, shall determine whether the employee is entitled to remuneration for his or her inventions.
Case law clarifies that the right to receive consideration for "service inventions" can be waived by the employee and that
in certain circumstances, such waiver does not necessarily have to be explicit. The Committee will examine, on a case-by-case basis,
the general contractual framework between the parties, using interpretation rules of the general Israeli contract laws. Further, the
Committee has not yet determined one specific formula for calculating this remuneration, but rather uses the criteria specified in the
Patent Law. Although we generally enter into assignment-of-invention agreements with our employees pursuant to which such individuals
assign to us all rights to any inventions created in the scope of their employment or engagement with us, we may face claims demanding
remuneration in consideration for assigned inventions. As a consequence of such claims, we could be required to pay additional remuneration
or royalties to our current and/or former employees, or be forced to litigate such claims, which could negatively affect our business.
Any
lawsuits relating to infringement of intellectual property rights necessary to defend ourselves or enforce our rights will be costly
and time consuming.
We
may be required to initiate litigation to enforce our rights or defend our activities in response to alleged infringement of a third-party.
In addition, we may be sued by others who hold intellectual property rights and who claim that their rights are infringed by our product
candidates. These lawsuits can be very time consuming and costly. There is a substantial amount of litigation involving patent and other
intellectual property rights in the biotechnology and pharmaceutical industries generally.
A
third-party may claim that we are using inventions claimed by their patents and may go to court to stop us from engaging in our normal
operations and activities, such as research, development, and the sale of any future products. Such lawsuits are expensive and would
consume time and other resources. There is a risk that such court will decide that we are infringing the third-party's patents
and will order us to stop the activities claimed by the patents, redesign our products or processes to avoid infringement or obtain licenses,
which may not be available on commercially reasonable terms. In addition, there is a risk that a court will order us to pay the other
party damages for infringement.
44
Moreover,
there is no guarantee that any prevailing patent owner would offer us a license so that we could continue to engage in activities claimed
by the patent, or that such a license, if made available to us, could be acquired on commercially acceptable terms. In addition, third
parties may, in the future, assert other intellectual property infringement claims against us with respect to other product candidates,
technologies or other matters.
In
addition, our patents and patent applications could face challenges. Any of these challenges, if successful, could result in the invalidation
of, or in a narrowing of the scope of, any of our patents and patent applications subject to challenge. Any of these challenges, regardless
of their success, would likely be time consuming and expensive to defend and resolve and would divert our management's time and
attention.
Changes
in patent law could diminish the value of patents in general, thereby impairing our ability to protect Aramchol, Amilo-5MER or any other
product candidate.
As
is the case with other pharmaceutical companies, our success is heavily dependent on intellectual property, particularly patents. Obtaining
and enforcing patents in the biopharmaceutical industry involve both technological and legal complexity. Therefore, obtaining and enforcing
pharmaceutical patents is costly, time-consuming, and inherently uncertain. In particular, the United States has recently enacted, and
is currently implementing, wide-ranging patent reform legislation. The United States Supreme Court has ruled on several patent cases
in recent years, and could do so again in the future, either narrowing the scope of patent protection available in certain circumstances
or weakening the rights of patent owners in certain situations. In addition to increasing uncertainty regarding our ability to obtain
patents in the future, this combination of events has created uncertainty with respect to the value of patents, once obtained. Depending
on decisions by applicable courts and legislatures in the countries in which we may pursue patent protection, including those of the
U.S. Congress, the federal courts and the USPTO, the laws and regulations governing patents and the interpretations of such laws could
change in unpredictable ways that would weaken our ability to obtain new patents or to enforce our existing patents and patents that
we might obtain in the future.
Obtaining
and maintaining our patent protection depends on compliance with various procedural, documentary, fee payment and other requirements
imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
The
USPTO and various foreign governmental patent agencies require compliance with a number of procedural, documentary, fee payment and other
provisions during the patent process. There are situations in which noncompliance can result in abandonment or lapse of a patent or patent
application, resulting in partial or complete loss of patent rights in the relevant jurisdiction. In such an event, competitors might
be able to enter the market earlier than would otherwise have been the case.
Risks
Related to Ownership of Our Ordinary Shares
Our
business, operating results and growth rates may be adversely affected by current or future unfavorable economic and market conditions
and adverse developments with respect to financial institutions and associated liquidity risk.
Our
business depends on the economic health of the global economies. If the conditions in the global economies remain uncertain or continue
to be volatile, or if they deteriorate, including as a result of the impact of military conflict, such as the war between Russia and
Ukraine, terrorism or other geopolitical events, our business, operating results and financial condition may be materially adversely
affected.
In
addition, increases in inflation raise our costs for commodities, labor, materials and services and other costs required to grow and
operate our business, and failure to secure these on reasonable terms may adversely impact our financial condition. Additionally, increases
in inflation, along with the uncertainties surrounding any resurgence of the COVID-19, geopolitical developments and global supply chain
disruptions, have caused, and may in the future cause, global economic uncertainty and uncertainty about the interest rate environment,
which may make it more difficult, costly or dilutive for us to secure additional financing. A failure to adequately respond to these
risks could have a material adverse impact on our financial condition, results of operations or cash flows.
45
There
can be no assurance that future credit and financial market instability and a deterioration in confidence in economic conditions will
not occur. Our general business strategy may be adversely affected by any such economic downturn, liquidity shortages, volatile business
environment or continued unpredictable and unstable market conditions. If the current equity and credit markets deteriorate, or if adverse
developments are experienced by financial institutions, it may cause short-term liquidity risk and also make any necessary debt or equity
financing more difficult, more costly, more onerous with respect to financial and operating covenants and more dilutive. Failure to secure
any necessary financing in a timely manner and on favorable terms could have a material adverse effect on our growth strategy, financial
performance and stock price and could require us to alter our operating plans. In addition, there is a risk that one or more of our service
providers, financial institutions, manufacturers, suppliers and other partners may be adversely affected by the foregoing risks, which
could directly affect our ability to attain our operating goals on schedule and on budget.
The
market price of our ordinary shares is volatile and you may sustain a complete loss of your investment
.
Since
our initial public offering, the trading price of our ordinary shares has been volatile and is likely to continue to be volatile. In
addition, the trading volume is and has been volatile and oftentimes relatively illiquid. The following factors, some of which are beyond
our control, in addition to other risk factors described in this section, may have a significant impact on the market price and trading
volume of our ordinary shares:
●
the
    outcome of our review of strategic alternatives;
●
delays
    in existing clinical trials;
●
inability
    to obtain the approvals necessary to commence further clinical trials;
●
unsatisfactory
    or inconclusive results of clinical trials;
●
termination
    of clinical trials;
●
adverse
    events in our ongoing clinical trials;
●
announcements
    of regulatory approval or the failure to obtain it, or specific label indications or patient populations for its use, or changes
    or delays in the regulatory review process;
●
announcements
    of therapeutic innovations or new products by us or our competitors;
●
adverse
    actions taken by regulatory agencies with respect to our clinical trials, manufacturing supply chain or sales and marketing activities;
●
changes
    or developments in laws or regulations applicable to our product candidates;
●
any
    adverse changes to our relationship with manufacturers or suppliers;
●
any
    product liability actions or intellectual property infringement actions in which we may become involved;
●
announcements
    concerning our competitors or the pharmaceutical industry in general;
●
achievement
    of expected product sales and profitability or our failure to meet expectations;
●
our
    commencement of, or involvement in, litigation;
46
●
any
    major changes in our board of directors, management or other key personnel;
●
legislation
    in the United States, Europe and other foreign countries relating to the sale or pricing of pharmaceuticals;
●
announcements
    by us of significant strategic partnerships, out-licensing, in-licensing, joint ventures, acquisitions or capital commitments;
●
expiration
    or terminations of licenses, research contracts or other collaboration agreements;
●
public
    concern as to the safety of drugs we, our licensees or others develop;
●
success
    of research and development projects;
●
variations
    in our and our competitors' results of operations;
●
changes
    in earnings estimates, cash flow guidance, or recommendations by securities analysts;
●
developments
    by our licensees, if any;
●
future
    issuances of ordinary shares or other securities; and
●
natural
    disasters and political and economic instability, including wars, terrorism, political unrest, results of certain elections and votes,
    emergence of a pandemic, or other widespread health emergencies (or concerns over the possibility of such an emergency), boycotts,
    adoption or expansion of government trade restrictions, and other business restrictions.
These
factors and any corresponding price fluctuations may materially and adversely affect the market price and trading volume of our ordinary
shares and result in substantial losses by our investors.
In
addition, the stock market in general, and the Nasdaq Capital Market and the market for biotechnology companies in particular, have experienced
extreme price and volume fluctuations that have often been unrelated or disproportionate to the operating performance of our Company
and that of small companies. Broad market and industry factors may negatively affect the market price of our ordinary shares, regardless
of our actual operating performance. Further, a systemic decline in the financial markets and related factors beyond our control may
cause our share price to decline rapidly and unexpectedly. Price volatility of our ordinary shares might be worse if the trading volume
of our ordinary shares is low. Following periods of market volatility or a material decrease in the value of our ordinary shares, shareholders
may institute securities class action litigation. If we were involved in securities litigation, it could have a substantial cost and
divert resources and attention of management from our business, even if we are successful. Future sales of our ordinary shares could
also reduce the market price of such stock. Any adverse determination in litigation could also subject us to significant liabilities.
Moreover,
the liquidity of our ordinary shares has been limited, not only in terms of the number of shares that can be bought and sold at a given
price, but by delays in the timing of transactions and reduction in security analysts' and the media's coverage of us, if
any. These factors may result in lower prices for our ordinary shares than might otherwise be obtained and could also result in a larger
spread between the bid and ask prices for our ordinary shares. In addition, without a large float, our ordinary shares are less liquid
than the stock of companies with broader public ownership and, as a result, the trading prices of our ordinary shares are more volatile.
In the absence of an active public trading market, an investor may be unable to liquidate its investment in our ordinary shares. Trading
of a relatively small volume of our ordinary shares may have a greater impact on the trading price of our stock than would be the case
if our public float were larger. We cannot predict the prices at which our ordinary shares will trade in the future.
47
If
we fail to comply with the continued listing requirements of the Nasdaq Capital Market, our ordinary shares may be delisted and the price
of our ordinary shares and our ability to access the capital markets could be negatively impacted
Our
ordinary shares are listed on the Nasdaq Capital Market. As such, we are required to meet the continued listing requirements of the Nasdaq
Capital Market and other Nasdaq rules, including those regarding director independence and independent committee requirements, minimum
shareholders' equity, minimum share price and certain other corporate governance requirements. In particular, we are required to
maintain a minimum bid price for our listed ordinary shares of $1.00 per share.
On
September 19, 2023, we were notified by the Nasdaq Stock Market, LLC, or Nasdaq, that we were not in compliance with the minimum bid
price requirements set forth in Nasdaq Listing Rule 5550(a)(2) for continued listing on the Nasdaq Capital Market. Nasdaq Listing Rule
5550(a)(2) requires listed securities to maintain a minimum bid price of $1.00 per share, and Nasdaq Listing Rule 5810(c)(3)(A) provides
that a failure to meet the minimum bid price requirement exists if the deficiency continues for a period of 30 consecutive business days.
The notification provided that we had 180 calendar days, or until March 18, 2024, to regain compliance with Nasdaq Listing Rule 5550(a)(2).
To regain compliance, the bid price of our ordinary shares must have a closing bid price of at least $1.00 per share for a minimum of
10 consecutive business days. Since we did not regain compliance by March 18, 2024, we requested and received from The Nasdaq Capital
Market an additional 180 calendar days or until September 16, 2024 to comply with the minimum bid price. If we fail to regain compliance
during the second compliance period, then Nasdaq will notify us of its determination to delist our ordinary shares, at which point we
will have an opportunity to appeal the delisting determination to a Hearings Panel. No assurance can be given that we will be able to
regain compliance with the Rule. If we do not meet these or other continued listing requirements, our ordinary shares could be delisted.
A delisting of our ordinary shares from Nasdaq could materially reduce the liquidity of our ordinary shares and result in a corresponding
material reduction in the price of our ordinary shares. In addition, delisting could harm our ability to raise capital through alternative
financing sources on terms acceptable to us, or at all, and may result in the potential loss of confidence by investors, employees and
fewer business development opportunities and strategic alternatives. No assurance can be given that we will be able to regain compliance
with the Rule. If we do not meet these or other continued listing requirements, our ordinary shares could be delisted. Delisting of our
ordinary shares from the Nasdaq Capital Market would cause us to pursue eligibility for trading on other markets or exchanges, or on
the pink sheets. In such case, our shareholders' ability to trade, or obtain quotations of the market value of, our ordinary shares
would be severely limited because of lower trading volumes and transaction delays. These factors could contribute to lower prices and
larger spreads in the bid and ask prices for our securities. There can be no assurance that our ordinary shares, if delisted from the
Nasdaq Capital Market in the future, would be listed on a national securities exchange, a national quotation service, the Over-The-Counter
Markets or the pink sheets. Delisting from the Nasdaq Capital Market, or even the issuance of a notice of potential delisting, would
also result in negative publicity, make it more difficult for us to raise additional capital, adversely affect the market liquidity of
our ordinary shares, reduce security analysts' coverage of us and diminish investor, supplier and employee confidence. Additionally,
the threat of delisting or a delisting of our ordinary shares from the Nasdaq Capital Market, could reduce the number of investors willing
to hold or acquire our ordinary shares, thereby further restricting our ability to obtain equity financing, and it could reduce our ability
to retain, attract and motivate our directors, officers and employees. In addition, as a consequence of any such delisting, our share
price could be negatively affected and our shareholders would likely find it more difficult to sell, or to obtain accurate quotations
as to the prices of, our ordinary shares.
Our
President and Chief Executive Officer beneficially owns approximately 5.6% of our outstanding ordinary shares, as of March 27, 2024.
Therefore, our principal shareholders will be able to exert significant control over matters submitted to our shareholders for approval.
Our
President and Chief Executive Officer currently beneficially owns approximately 5.6% of our outstanding ordinary shares as of March 27,
2024. Therefore, our President and Chief Executive Officer will be able to exert significant control over matters submitted to our shareholders
for approval. As our President and Chief Executive Officer could significantly influence or even unilaterally approve matters requiring
approval by our shareholders, including the election of directors and the approval of mergers or other business combination transactions.
The interests of our President and Chief Executive Officer may not always coincide with our interests or the interests of other shareholders.
This significant concentration of share ownership may adversely affect the trading price for our ordinary shares because investors often
perceive disadvantages in owning stock in companies with controlling shareholders.
48
Sales
of a substantial number of our ordinary shares in the public market could cause our share price to fall.
Sales
of a substantial number of our ordinary shares in the public market, or the perception that these sales might occur, could depress the
market price of our ordinary shares and could impair our ability to raise capital through the sale of additional equity securities. We
are unable to predict the effect that sales may have on the prevailing market price of our ordinary shares. Sales of shares by our existing
shareholders would likely result in the supply of our ordinary shares far exceeding the demand for our ordinary shares and could have
a material adverse effect on the trading price of our ordinary shares.
Raising
additional capital would cause dilution to our existing shareholders, and may restrict our operations or require us to relinquish rights.
Subject
to our strategic review, we will need to raise additional capital and may seek additional capital through a combination of private and
public equity offerings, "at-the-market" issuances, equity-linked and structured transactions, debt (straight, convertible,
or otherwise) financings, collaborations and licensing arrangements. To the extent that we raise additional capital through the sale
of equity or convertible debt securities, your ownership interest will be diluted, and the terms may include liquidation or other preferences
that adversely affect your rights as a shareholder. Debt financing, if available, would result in increased fixed payment obligations
and may involve agreements that include covenants limiting or restricting our ability to take specific actions such as incurring debt,
making capital expenditures or declaring dividends. If we raise additional funds through collaboration, strategic alliance and licensing
arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams or product candidates,
or grant licenses on terms that are not favorable to us. Depending upon market liquidity at the time, additional sales of shares registered
at any given time could cause the trading price of our ordinary shares to decline.
Our
U.S. shareholders may suffer adverse tax consequences due to our expected classification as a passive foreign investment company.
Generally,
if for any taxable year 75% or more of our gross income is passive income, or at least 50% of the average value of our assets is
attributable to assets that are held for the production of, or produce, passive income, we would be characterized as a passive
foreign investment company, or PFIC, for U.S. federal income tax purposes. Based upon our review of our financial data, we believe
that we were a PFIC for our 2023 taxable year and expect to be a PFIC for the 2024 taxable year. Because PFIC status is determined
annually and is based on our income, assets and activities for the entire taxable year, it is not possible to determine with
certainty whether we will be characterized as a PFIC for the 2024 taxable year until after the close of the year, and there can be
no assurance that we will not be classified as a PFIC in any future year. If we were to be characterized as a PFIC for U.S. federal
income tax purposes in any taxable year during which a U.S. Holder (as defined below) owns ordinary shares, such U.S. Holder could
face adverse U.S. federal income tax consequences. For example, such U.S. Holder could be subject to additional taxes and interest
charges upon certain distributions by us and any gain recognized on a sale, exchange or other disposition of our shares, whether or
not we continue to be characterized as a PFIC. Certain adverse consequences of PFIC status can be mitigated if a U.S. Holder makes a
"mark -to -market" election or an election to treat us as a qualified electing fund, or QEF. Upon request, we expect to
provide the information necessary for U.S. Holders to make "qualified electing fund elections" if we are classified as a
PFIC. There is no assurance, however, that we will have timely knowledge of our status as a PFIC, or that the information that we
provide will be adequate to allow U.S. Holders to make a QEF election Each investor is urged to consult its tax advisor with respect
to the application of the PFIC rules. See also "Item 10. Additional Information—E. Taxation— Certain Material U.S.
Federal Income Tax Considerations."
If
a United States person is treated as owning at least 10% of our shares, such holder may be subject to adverse U.S. federal income tax
consequences.
49
If
a United States person is treated as owning (directly, indirectly or constructively) at least 10% of the value or voting power of our
shares, such person may be treated as a "United States shareholder" with respect to each "controlled foreign corporation"
in our group (if any). A United States shareholder of a controlled foreign corporation may be required to annually report and include
in its U.S. taxable income its pro rata share of "Subpart F income," "global intangible low-taxed income" and
investments in U.S. property by controlled foreign corporations, whether or not we make any distributions, and may be subject to tax
reporting obligations. An individual that is a United States shareholder with respect to a controlled foreign corporation generally would
not be allowed certain tax deductions or foreign tax credits that would be allowed to a United States shareholder that is a U.S. corporation.
A failure to comply with these reporting obligations may subject you to significant monetary penalties and may prevent the statute of
limitations with respect to your U.S. federal income tax return for the year for which reporting was due from starting. We cannot provide
any assurances that we will assist any shareholder in determining whether such shareholder is treated as a United States shareholder
with respect to any "controlled foreign corporation" in our group (if any) or furnish to any United States shareholders information
that may be necessary to comply with the aforementioned reporting and tax paying obligations. A United States investor should consult
its tax advisors regarding the potential application of these rules to its investment in the shares.
If
the securities analysts that currently cover our stock, or will do so in the future, or industry analysts do not publish or cease publishing
research or reports about us, our business or our market, or if they adversely change their recommendations or publish negative reports
regarding our business or our shares, our share price and trading volume could be negatively impacted.
The
trading market for our ordinary shares is influenced by the research and reports that industry or securities analysts may publish about
us, our business, our market or our competitors. We do not have any control over these analysts and we cannot provide any assurance that
analysts will cover us or provide favorable coverage. If any of the analysts who do cover, or may cover us in the future, adversely change
their recommendation regarding our shares, or provide more favorable relative recommendations about our competitors, our share price
would likely decline. If any analyst who cover us cease coverage of our company or fail to regularly publish reports on us, we could
lose visibility in the financial markets, which in turn could negatively impact our share price or trading volume.
Because
we do not intend to declare cash dividends on our ordinary shares in the foreseeable future, shareholders must rely on appreciation of
the value of our ordinary shares for any return on their investment.
We
have never declared or paid cash dividends on our ordinary shares. We currently anticipate that we will retain future earnings for the
development, operation and expansion of our business and do not anticipate declaring or paying any cash dividends in the foreseeable
future. Moreover, the Israeli Companies Law, 5759-1999, or the Companies Law, imposes certain restrictions on our ability to declare
and pay dividends. See "Item 8. Financial Information—Consolidated Financial Statements and Other Financial Information—Dividend
Policy" for additional information.
The
requirements associated with being a public company require significant company resources and management attention.
We
are subject to the reporting requirements of the Securities Exchange Act of 1934, or the Exchange Act, the Sarbanes-Oxley Act, the listing
requirements of the Nasdaq Capital Market, on which our ordinary shares are traded, and other applicable securities rules and regulations.
The Exchange Act requires that we file periodic reports with respect to our business and financial condition and maintain effective disclosure
controls and procedures and internal control over financial reporting. In addition, subsequent rules implemented by the SEC and the Nasdaq
Capital Market may also impose various additional requirements on public companies. As a result, we incurred and will continue to incur
additional legal, accounting and other expenses that we did not incur as a privately-held company, particularly since, as of December
31, 2020, we are no longer considered an "emerging growth company" as defined in the JOBS Act. Further, the need to establish
the corporate infrastructure demanded of a public company may divert management's attention from implementing our development plans.
We have made and will continue to make changes to our corporate governance standards, compensation policy, disclosure controls and financial
reporting and accounting systems to meet our reporting obligations and applicable law. The measures we take, however, may not be sufficient
to satisfy our obligations as a public company, which could subject us to delisting of our ordinary shares, fines, sanctions and other
regulatory action and potentially civil litigation.
50
As
a "foreign private issuer," we are permitted to and currently do follow certain home country corporate governance practices
instead of otherwise applicable SEC and Nasdaq Capital Market requirements, which may result in less protection than is accorded to investors
under rules applicable to domestic U.S. issuers.
As
a "foreign private issuer," we are permitted to, and currently do, follow certain home country corporate governance practices
instead of those otherwise required under the Listing Rules of the Nasdaq Capital Market, or the Nasdaq Listing Rules, for domestic U.S.
issuers. For instance, we currently follow home country practice in Israel with regard to, among other things, director nomination procedure
and approval of compensation of officers. In addition, we may follow our home country law instead of the Nasdaq Listing Rules that require
that we obtain shareholder approval for certain dilutive events, such as the establishment or amendment of certain equity based compensation
plans, an issuance that will result in a change of control of the company, certain transactions other than a public offering involving
issuances of a 20% or greater interest in the company, and certain acquisitions of the stock or assets of another company. Following
our home country governance practices as opposed to the requirements that would otherwise apply to a U.S. company listed on the Nasdaq
Capital Market may provide less protection to you than what is accorded to investors under the Nasdaq Listing Rules applicable to domestic
U.S. issuers. See "Item 16G. Corporate Governance."
In
addition, as a "foreign private issuer," we are exempt from the rules and regulations under the Exchange Act related to the
furnishing and content of proxy statements and certain individual executive compensation information, and our officers, directors and
principal shareholders are exempt from the reporting and short-swing profit recovery provisions contained in Section 16 of the Exchange
Act. Furthermore, foreign private issuers are not required to file their annual report on Form 20-F until 120 days after the end of each
fiscal year, while U.S. domestic issuers that are accelerated filers are required to file their annual report on Form 10-K within 75
days after the end of each fiscal year and U.S. domestic issuers that are large accelerated filers are required to file their annual
report on Form 10-K within 60 days after the end of each fiscal year. Additionally, as a "foreign private issuer," we are
also not subject to the requirements of Regulation FD (Fair Disclosure) promulgated under the Exchange Act. These exemptions and leniencies
reduce the frequency and scope of information and protections to which you are entitled as an investor.
If
our ordinary shares become a "penny stock," it may be more difficult for investors to sell their ordinary shares, and the
market price of our ordinary shares may be adversely affected.
Our
ordinary shares could become a "penny stock" if, among other things, the share price is below $5.00 per share, we are not
listed on a national securities exchange or we have not met certain net tangible asset or average revenue requirements. Broker-dealers
who sell penny stocks must provide purchasers of these stocks with a standardized risk-disclosure document prepared by the SEC. This
document provides information about penny stocks and the nature and level of risks involved in investing in the penny-stock market. A
broker must also give a purchaser, orally or in writing, bid and offer quotations and information regarding broker and salesperson compensation,
make a written determination that the penny stock is a suitable investment for the purchaser, and obtain the purchaser's written
agreement to the purchase. Broker-dealers must also provide customers that hold penny stock in their accounts with such broker-dealer
a monthly statement containing price and market information relating to the penny stock. If a penny stock is sold to an investor in violation
of the penny stock rules, the investor may be able to cancel its purchase and get its money back.
If
applicable, the penny stock rules may make it difficult for investors to sell their ordinary shares. Because of the rules and restrictions
applicable to a penny stock, there is less trading in penny stocks and the market price of our ordinary shares may be adversely affected.
Also, many brokers choose not to participate in penny stock transactions. Accordingly, investors may not always be able to resell their
ordinary shares publicly at times and prices that they feel are appropriate and the market price of our ordinary shares may be adversely
affected.
Inflation
could adversely affect our business and results of operations.
While
inflation in the United States and global markets had been relatively low in recent years, during 2021, 2022 and 2023, the economy in
the United States and global markets encountered a material increase in the level of inflation. The impact of COVID-19, geopolitical
developments such as the Russia-Ukraine conflict and global supply chain disruptions continue to increase uncertainty in the outlook
of near-term and long-term economic activity, including whether inflation will continue and how long, and at what rate. Increases in
inflation raise our costs for commodities, labor, materials and services and other costs required to grow and operate our business, and
failure to secure these on reasonable terms may adversely impact our financial condition. Additionally, increases in inflation, along
with the uncertainties surrounding any resurgence of the COVID-19, geopolitical developments and global supply chain disruptions, have
caused, and may in the future cause, global economic uncertainty and uncertainty about the interest rate environment, which may make
it more difficult, costly or dilutive for us to secure additional financing. A failure to adequately respond to these risks could have
a material adverse impact on our financial condition, results of operations or cash flows.
51
Risks
Related to Israeli Law and Our Operations in Israel
Our
headquarters and other significant operations are located in Israel and, therefore, our results may be adversely affected by political,
economic and military instability in Israel.
Our
executive office is located in Ramat Gan, Israel. In addition, certain of our key employees, officers and directors are residents of Israel.
Accordingly, political, economic and military conditions in the Middle East may affect our business directly. Since the establishment
of the State of Israel in 1948, a number of armed conflicts have occurred between Israel and its neighboring countries and terrorist
organizations active in the region, including Hamas (an Islamist militia and political group in the Gaza Strip) and Hezbollah (an Islamist
militia and political group in Lebanon).
In
October 2023, Hamas terrorists infiltrated Israel's southern border from the Gaza Strip and conducted a series of attacks on civilian
and military targets. Hamas also launched extensive rocket attacks on Israeli population and industrial centers located along Israel's
border with the Gaza Strip and in other areas within the State of Israel. These attacks resulted in extensive deaths, injuries and kidnapping
of civilians and soldiers. Following the attack, Israel's security cabinet declared war against Hamas and a military campaign against
these terrorist organizations commenced in parallel to their continued rocket and terror attacks. In addition, since the commencement
of these events, there have been continued hostilities along Israel's northern border with Lebanon (with the Hezbollah terror organization)
and southern border (with the Houthi movement in Yemen, as described below). It is possible that hostilities with Hezbollah in Lebanon
will escalate, and that other terrorist organizations, including Palestinian military organizations in the West Bank as well as other
hostile countries, such as Iran, will join the hostilities. Such clashes may escalate in the future into a greater regional conflict.
In
connection with the Israeli security cabinet's declaration of war against Hamas and possible hostilities with other organizations,
several hundred thousand Israeli military reservists were drafted to perform immediate military service. Although many of such military
reservists have since been released, they may be called up for additional reserve duty, depending on developments in the war in Gaza
and along Israel's other borders. While none of our employees in Israel have been called to active military duty, we rely on service
providers located in Israel and have entered into certain agreements with Israeli counterparties. Employees of such service providers
or contractual counterparties may be called for service in the current or future wars or other armed conflicts with Hamas as well as
the other pending or future armed conflicts in which Israel is or may become engaged, and such persons may be absent for an extended
period of time. As a result, our operations may be disrupted by such absences, which disruption may materially and adversely affect our
business and results of operations.
While
our executive offices are located in Ramat Gan, Israel, which is not near Israel's borders where the main hostilities are currently
taking place and none of our employees have been called into military reserve duty, to help mitigate the effects of Israel's war
with Hamas, we have taken several measures, including work-from-home measures and have a business continuity plan. Nevertheless, we experienced
disruptions to our work and over the past few weeks have been returning to full activity together with our local vendors and consultants.
As a result, in November 2023, we determined that the commencement of our Phase 2 PSC study was to be delayed by seven to nine months.
We expect to commence our Phase 2 PSC study following the end of such period.
Further
disruptions that could severely impact our business, clinical trials, and supply chains, include:
●
limitations
    on employee resources that would otherwise be focused on the conduct of our business including because of military reserve duty call-ups
    in the future that impact our employees and the affect the current war between Israel and Hamas on the productivity of our employees
    and external partners;
●
delays
    in necessary interactions with vendors, local regulators, and other important agencies and contractors due to limitations in employee
    resources; and
●
impacts
    from prolonged remote work arrangements, such as increased cybersecurity risks and strains on our business continuity plans.
52
The
intensity and duration of Israel's current war against Hamas is difficult to predict, as are such war's economic implications
on the Company's business and operations, on Israel's economy in general, on the trading price of shares of our ordinary shares
and could impact our ability to raise additional capital on a timely basis or at all. These events may be intertwined with wider macroeconomic
indications of a deterioration of Israel's economic standing that may involve a downgrade in Israel's credit rating by rating agencies
(such as the recent downgrade by Moody's of its credit rating of Israel from A1 to A2, as well as the downgrade of its outlook
rating from "stable" to "negative"), which may have a material adverse effect on the Company and its ability
to effectively conduct its operations. The impact of the current war between Israel and Hamas may also have the effect of heightening
many of the other risks described in this section and in the "Risk Factors" section of our 2022 Annual Report.
In
addition, some countries around the world restrict doing business with Israel and Israeli companies, and additional countries may impose
restrictions on doing business with Israel and Israeli companies if hostilities in Israel or political instability in the region continue
or increase. In addition, there have been increased efforts by countries, activists and organizations to cause companies and consumers
to boycott Israeli goods and services. In addition, in January 2024 the International Court of Justice, or ICJ, issued an interim
ruling in a case filed by South Africa against Israel in December 2023, making allegations of genocide amid and in connection
with the war in Gaza, and ordered Israel, among other things, to take measures to prevent genocidal acts, prevent and punish incitement
to genocide, and take steps to provide basic services and humanitarian aid to civilians in Gaza. There are concerns that companies and
businesses will terminate, and may have already terminated, certain commercial relationships with Israeli companies following the ICJ
decision. The foregoing efforts by countries, activists and organizations, particularly if they become more widespread, as well as the
ICJ rulings and future rulings and orders of other tribunals against Israel (if handed), may materially and adversely impact our business,
clinical trials, and supply chains.
Furthermore,
following Hamas' attack on Israel and Israel's security cabinet declaration of war against Hamas, the Houthi movement, which
controls parts of Yemen has launched attacks on Israeli-controlled or owned ships in the Red Sea, resulting in shipping companies rerouting
their cargo ships or ceasing shipments to Israel in the case of the latter. The hostilities with Hamas, Hezbollah, the Houthi movement
and other terrorist organizations, include and may include terror, missile and drone attacks. In the event that our facilities are damaged
as a result of hostile actions, or hostilities otherwise disrupt our ongoing operations, our ability to deliver or provide products and
services in a timely manner to meet our contractual obligations towards customers and vendors could be materially and adversely affected.
Any hostilities involving Israel or the interruption or curtailment of trade between Israel and its present trading partners could have
a material adverse effect on our business and could make it more difficult for us to raise capital. Our insurance policies do not cover
losses that may occur as a result of events associated with war and terrorism. Although the Israeli government currently covers the reinstatement
value of direct damages that are caused by terrorist attacks or acts of war, we cannot assure you that this government coverage will
be maintained or that it will sufficiently cover our potential damages. Any losses or damages incurred by us could have a material adverse
effect on our business. Any armed conflicts or political instability in the region would likely negatively affect business conditions
and could harm our results of operations.
Finally,
political conditions within Israel may affect our operations. Israel has held five general elections between 2019 and 2022, and prior
to October 2023, the Israeli government pursued extensive changes to Israel's judicial system, which sparked extensive political
debate and unrest. In response to such initiative, many individuals, organizations and institutions, both within and outside of Israel,
voiced concerns that the proposed changes may negatively impact the business environment in Israel including due to reluctance of foreign
investors to invest or transact business in Israel, as well as to increased currency fluctuations, downgrades in credit rating, increased
interest rates, increased volatility in security markets and other changes in macroeconomic conditions. To date, these initiatives have
been substantially put on hold. If such changes to Israel's judicial system are again pursued by the government and approved by
the parliament, this may have an adverse effect on our business, our results of operations and our ability to raise additional funds,
if deemed necessary by our management and board of directors.
53
Exchange
rate fluctuations between the U.S. dollar and the New Israeli Shekel currencies may negatively affect our earnings.
Our
functional currency is the U.S. dollar. We incur expenses in U.S. dollars and New Israeli Shekels, or NIS. As a result, we are exposed
to the risks that the NIS may appreciate relative to the U.S. dollar, or, if either the NIS devalues relative to the U.S. dollar, that
the inflation rate in Israel may exceed such rate of devaluation of the NIS, or that the timing of such devaluation may lag behind inflation
in Israel. In any such event, the U.S. dollar cost of our operations in Israel would increase and our U.S. dollar-denominated results
of operations would be adversely affected. The average exchange rate for the year ended December 31, 2023 was $1.00 = NIS 3.62. We cannot
predict any future trends in the rate of inflation in Israel or the rate of devaluation, if any, of the NIS against the U.S. dollar.
As of the date hereof, the inflation rate in Israel has exceeded the rate of devaluation of the NIS, respectively, during the calendar
years 2021, 2022 or 2023.
Provisions
of Israeli law and our articles of association, or Articles, may delay, prevent or otherwise impede a merger with, or an acquisition
of, our company, which could prevent a change of control, even when the terms of such a transaction are favorable to us and our shareholders.
The
Companies Law regulates, among others, mergers, requires tender offers for acquisitions of shares above specified thresholds, requires
special approvals for transactions involving directors, officers or significant shareholders and regulates other matters that may be
relevant to such types of transactions. See "Item 10. Additional Information—B. —Mergers and Acquisitions under Israeli
Law" for additional information.
Furthermore,
Israeli tax considerations may make potential transactions unappealing to us or to our shareholders whose country of residence does not
have a tax treaty with Israel exempting such shareholders from Israeli tax. See "Item 10. Additional Information—E. Taxation—Certain
Israeli Tax Considerations" for additional information.
Moreover,
the classification of our Board into three classes with terms of approximately three years each, per our Articles, the requirement of
affirmative vote of at least 75% of the voting rights of the Company represented personally or by proxy and voting thereon at a general
meeting in order to amend or replace our Articles, together with the other provisions of the Articles and Israeli law, could deter or
delay potential future merger, acquisition, tender or takeover offers, proxy contests or changes in control or management of the Company.
It
may be difficult to enforce a judgment of a United States court against us, our officers, directors and the Israeli experts named in
this annual report in Israel or the United States, to assert United States securities laws claims in Israel or to serve process on our
officers, directors and these experts.
We
were and continue to be organized in Israel. Most of our executive officers and directors reside outside of the United States, and all
of our assets and most of the assets of these persons are located outside of the United States. Therefore, a judgment obtained against
us, or any of these persons, including a judgment based on the civil liability provisions of the U.S. federal securities laws, may not
be collectible in the United States and may not necessarily be enforced by an Israeli court. It also may be difficult to effect service
of process on these persons in the United States or to assert U.S. securities law claims in original actions instituted in Israel. Additionally,
it may be difficult for an investor, or any other person or entity, to initiate an action with respect to United States securities laws
in Israel. Israeli courts may refuse to hear a claim based on an alleged violation of United States securities laws reasoning that Israel
is not the most appropriate forum in which to bring such a claim. In addition, even if an Israeli court agrees to hear a claim, it may
determine that Israeli law and not United States law is applicable to the claim. If United States law is found to be applicable, the
content of applicable United States law must be proven as a fact by expert witnesses, which can be a time consuming and costly process.
Certain matters of procedure will also be governed by Israeli law. There is little binding case law in Israel that addresses the matters
described above. As a result of the difficulty associated with enforcing a judgment against us in Israel, our shareholders may not be
able to collect any damages awarded by either a United States or foreign court.
54
Your
rights, liabilities and responsibilities as a shareholder will be governed by Israeli law and differ in some material respects from those
under U.S.
law.
Because
we are an Israeli company, the rights and responsibilities of our shareholders are governed by our Articles and Israeli law. These rights,
liabilities and responsibilities differ in some material respects from the rights, liabilities and responsibilities of shareholders in
a U.S. corporation. In particular, a shareholder of an Israeli company has a duty to act in good faith towards the company and other
shareholders and to refrain from abusing his, her or its power in the company, including, among other things, when voting at the general
meeting of shareholders on certain matters. Israeli law provides that these duties are applicable to shareholder votes on, among other
things, amendments to a company's articles of association, increases in a company's authorized share capital, mergers and
interested party transactions requiring shareholder approval. In addition, a controlling shareholder, a shareholder who knows that it
possesses the power to determine the outcome of a shareholders' vote or a shareholder who has the power to appoint or prevent the
appointment of a director or executive officer in the company, has a duty of fairness towards the company. However, Israeli law does
not define the substance of this duty of fairness. There is little case law available to assist in understanding the implications of
these provisions that govern shareholder behavior. These provisions may be interpreted to impose additional obligations and liabilities
on holders of our ordinary shares that are not typically imposed on shareholders of U.S. corporations. See "Item 10. Additional
Information—B Memorandum and Articles of Association—Shareholder Duties" for additional information.
Any
of the risk factors referred to above could significantly and negatively affect our business, results of operations or financial condition,
which may reduce our ability to pay dividends and lower the trading price of our ordinary shares. The risks referred to above are not
the only ones that may exist. Additional risks not currently known by us or that we deem immaterial may also impair our business operation
s.
ITEM
4. Information on the Company.
A.
Historical Background and Corporate Structure
Galmed
Pharmaceuticals Ltd., was incorporated in Israel on July 31, 2013 as a privately held company and is governed by the Companies Law. However,
our business has been operating since 2000 under a different group of companies established in the same year, or the Group. Originally,
we operated under the parent company, GHI. GHI held all of the equity rights in and to Galmed 2000 Inc., a holdings company incorporated
in the British Virgin Islands, or GTTI. GTTI held all of the equity rights in and to Galmed International Limited, a company incorporated
in Malta, or GIL (other than 0.1% of the share capital held by GHI). GIL held all of the equity rights in and to Galmed Medical Research
Ltd., an Israeli company, or GMR. Our intellectual property was held by GIL. The research and development was conducted by GMR as a service
to GIL on a cost plus basis. GIL was responsible for all product development.
On
February 2, 2014, we underwent the Reorganization, pursuant to which all of our intangible assets (including our intellectual property)
were transferred from GIL to Galmed Research and Development Ltd., or GRD. The Reorganization was effectuated by share transfers and
asset transfers, resulting in the Company as the parent company and 100% equity-owner of the following companies: (1) GRD, which holds
all the Group's intellectual property, including the Company's patent portfolio; (2) GIL, which is an inactive company; and
(3) GTTI, which was liquidated in 2017. GIL held GMR, which became an inactive company in 2015 and was liquidated in February 2019. The
Reorganization was conducted in order to simplify our capital structure, reduce our operating cost and to improve our ability to raise
funds. Immediately prior to the Reorganization, all our shareholders collectively held 9,739 ordinary shares of GHI. In connection with
the Reorganization, and in accordance with the Tax Pre-Ruling, we issued to all such shareholders ordinary shares, such that upon the
Reorganization all our shareholders collectively held 7,099,731 of our ordinary shares, in the same proportion among all shareholders,
which reflected a ratio of 729 of our ordinary shares for each ordinary share of GHI. In July 2023, GRD established a new wholly-owned
subsidiary incorporated under the laws of England and Wales called Galmed Therapeutics UK Limited, or Galmed UK.
The
following is a diagram of our corporate structure (following GTTI's liquidation and the incorporation of Galmed UK):
55
On
March 18, 2014, we completed our initial public offering and since then have been listed on the Nasdaq Capital Market under the symbol
"GLMD".
Our
principal executive offices and registered office in Israel is located at 16 Abba Hillel Road, Ramat Gan, Israel 5250608 and our
telephone number is +972-3-693-8448. Our lease at our prior principal executive offices expired on March 21, 2024. We did not extend
the lease and are currently headquartered in Ramat Gan, Israel while we are in the process of searching for a new permanent location
for our principal executive offices. Our website address is http://www.galmedpharma.com. The information contained on, or that can
be accessed through, our website is neither a part of nor incorporated into this annual report. We have included our website address
in this annual report solely as an inactive textual reference. Puglisi & Associates, or Puglisi, serves as our authorized
representative in the United States for certain limited matters. Puglisi's address is 850 Library Avenue, Newark, Delaware
19711.
The
SEC maintains an internet site that contains reports, proxy and information statements and other information regarding issuers that file
electronically with the SEC at http://sec.gov. We use our website (http://www.galmedpharma.com) as a channel of distribution of Company
information. The information we post through this channel may be deemed material. Accordingly, investors should monitor our website,
in addition to following our press releases, SEC filings and public conference calls and webcasts. The contents of our website are not,
however, a part of this annual report.
Other
than as described in "Item 5. Operating and Financial Review and Prospects—Contractual Obligations", we have not had
any material commitments for capital expenditures, including any anticipated material acquisition of plant and equipment or interests
in other companies, since January 1, 2014. Additionally, we have not had any material capital divestitures since January 1, 2014.
B.
Business Overview
We
are a biopharmaceutical company focused on the development of Aramchol. We have focused almost exclusively on developing Aramchol for
the treatment of liver disease and are currently developing Aramchol for PSC and exploring the feasibility of developing Aramchol for
other fibro-inflammatory indications outside of liver disease. We are also collaborating with the Hebrew University in the development
of Amilo-5MER, a 5 amino acid synthetic peptide.
56
We
believe that our lead product candidate, Aramchol, has the potential to be a disease modifying treatment for fatty liver disorders, including
NASH, which is a chronic disease that constitutes a large unmet medical need.
Aramchol
is a synthetic conjugate of 3-amino cholic acid, or a type of modified bile acid, and arachidic acid, or a type of saturated fatty acid,
which in its non-synthetic forms, is naturally occurring. The conjugated molecule acts upon important metabolic pathways, reducing fat
accumulation in the liver, improving fatty acid oxidation and regulating the transport of cholesterol. The ability of Aramchol to decrease
liver fat content may also reduce the inflammation and fibrosis in the liver and the risk of cardiovascular complications associated
with NASH. Pre-clinical studies suggest Aramchol's effect on fibrosis is also direct via collagen production from human hepatic
stellate cells. We believe that Aramchol's ability to reduce liver fat and liver fibrosis and the safety profile observed to date
will enable it to be a treatment for all stages of NASH in patients who are overweight or obese and have pre diabetes or type II diabetes
mellitus and prevent the hepatic complications associated therewith.
In
September 2019, we initiated our Phase 3 ARMOR Study to evaluate the efficacy and safety of Aramchol in subjects with NASH and fibrosis.
The ARMOR Study was originally comprised of two parts, a randomized, double-blind, placebo-controlled histology-based registrational
part and a clinically based part where subjects will continue with the same treatment for approximately five years. In December 2020,
we announced the addition of a 150-patient open label part to the ARMOR Study and suspended randomization of new patients into the double-blind,
placebo-controlled histology-based registrational part of ARMOR as all enrolled patients were transitioned to the open label part.
In
May 2022, we announced our plan to expand into new anti-fibrotic indications to maximize the potential of Aramchol while at the same
time discontinuing the open label part of its ARMOR Study having reached its objectives. Simultaneously, we initiated a cost reduction
plan and initiated a process to evaluate our strategic alternatives. Following the discontinuation of our open label part of the ARMOR
Study, we do not currently expect to initiate the second part of the ARMOR Study in the near term.
In
May 2023, we announced the initiation of a new clinical program to evaluate Aramchol meglumine for the treatment of PSC, a rare disease
for which there is no approved treatment. We initially planned to initiate a Phase 2a study in the last quarter of 2023 however as a
result of Hamas-Israel war, we currently estimate a delay of ~7-9 months in the initiation of the study.
The
randomized, double-blind, proof-of-concept clinical study (NCT06095986) will evaluate the effects of 48 weeks of treatment with Aramchol
meglumine vs. placebo in approximately 24 patients with PSC. The study's endpoints will include the conventional relevant laboratory
parameters (alkaline phosphatase and bilirubin), sophisticated imaging including liver stiffness using MR Elastography (MRE), imaging
of the biliary tract using MR cholangiopancreatography, or MRCP, and hepatocyte-specific contrast agents, histological fibrosis and molecular
assessment as well as a range of biomarkers of disease activity and fibrosis. These endpoints are expected to provide a robust assessment
of the underlying disease and the effects of Aramchol.
While
PSC is more common in men, especially in Northern European heritage, and is often diagnosed between ages 30-40, we currently estimate
that the number of patients to be around 60,000, or 1 per 10,000, consisting of around 33,5000 patients in the United States and 32,500
patients collectively in France, Germany, Italy, Spain and the United Kingdom. In the preclinical stage, PSC likely involves ulcerative
colitis (UC) leading to biliary inflammation. As biliary fibrosis progresses to cirrhosis, it is coupled with complications and competing
risks, while about 50% of patients with PSC report clinical symptoms. While there are currently no approved drugs for the treatment of
PSC, there is a potential to gain orphan drug status.
We
initially planned to initiate a Phase 2 study in the last quarter of 2023 to evaluate Aramchol meglumine for the treatment of PSC. This study will be followed by a Phase 2b or a phase 2/3 confirmatory adaptive design trial. As a result
of the outbreak of the Hamas-Israel war, in November 2023, we determined that there would be a delay of seven to nine months in the initiation
of the Phase 2 PSC study. We expect to commence our Phase 2 PSC study following the end of such period. As PSC is a fibro-obliterative
cholangiopathy where the disease progression is predominantly determined by biliary fibrosis, Aramchol meglumine has been shown to downregulate
Stearoyl-CoA desaturase 1 (SCD1), a key liver enzyme involved in lipid metabolism, attenuate fibrogenesis by hepatic stellate cells (HSCs).
Aramchol meglumine may have direct effects on cholangiocytes to reduce the production of fibrogenic and inflammatory signals that activate
HSCs suggesting that Aramchol meglumine may be beneficial in treating PSC.
57
In
addition, in May 2023, we entered into a definitive agreement, or the OnKai Agreement, for a $1.5 million equity investment in
OnKai, a US-based technology company developing an AI-based platform to advance healthcare for underserved populations across the
United States by facilitating alignment between healthcare stakeholders. The signing of the definitive agreement followed an
announcement that we made in January 2023 that we had entered into a non-binding termsheet for an equity investment in OnKai. The
OnKai Agreement provided that we will invest $1.5 million in exchange for series seed preferred shares of OnKai (which is in
addition to a $1.5 million investment that was made by us in OnKai through a Simple Agreement for Future Equity, or SAFE, and which
converted at a 15% discount into series seed preferred shares upon consummation of the Investment Round (as defined below)). Our
investment in OnKai was part of an approximately $6 million investment round, or the Investment Round, with other investors that was
led by us of which SAFE notes of approximately $3.8 million were converted into preferred shares. On June 19, 2023, the Investment
Round closed. Following the Investment Round, we hold approximately 23.9% of the outstanding share capital of OnKai on an
as-converted and fully diluted basis and our Chief Executive Officer and director, Allen Baharaff serves as a board member of OnKai.
In connection with the OnKai Agreement, our wholly-owned subsidiary, Galmed Research and Development Ltd., or GRD, entered into a
services agreement, or the OnKai Services Agreement, with OnKai. The OnKai Services Agreement provides that GRD shall on a
non-exclusive basis (i) provide support services to OnKai relating to finance, business development, strategic planning, execution
and others; and (ii) lend its experience to OnKai in building a strategy and for the development of treatments for the underserved
and that OnKai shall on a non-exclusive basis (i) take part in plan preparation to serve GDR's vision of developing drugs for
the underserved population and (ii) when relevant, design a process on the clinical trial dashboard that could potentially serve
GDR's future trial. See "Item 4. Information on the Company— Strategic Collaborations, Research Arrangements and
other Agreements—Onkai." In July 2023, we announced that OnKai will apply its artificial intelligence
models for enrollment and execution of clinical trials in underserved communities, starting with our PSC clinical program.
While
we previously announced that we were no longer evaluating our strategic alternatives following the initiation of our PSC clinical program
and our investment and collaboration with Onkai, we have recently reinitiated the process of evaluating our strategic options alternatives
and our structuring to best optimize our resources to enhance shareholder value and achieve our goals. See "Item 3. Key Information—Risk
Factors—Risks Related to Our Business, Industry and Regulatory Requirements—Our activities to evaluate and pursue strategic
alternatives may not be successful" for additional information.
Non-Alcoholic
Fatty Liver Disease (NAFLD) / Non-Alcoholic Steato-Hepatitis (NASH)
It
is estimated that the global prevalence of NAFLD, the precondition to NASH, is approximately 25% in the general population and much higher
in certain high risk groups. This disease is also now recognized as one of the most common liver disorders, and a significant growing
public health problem. In the US alone, 80 - 100 million people are said to be affected by NAFLD, and its prevalence is rapidly growing
in parallel with metabolic syndromes, particularly obesity and diabetes.
NAFLD
is characterized by the accumulation of fat of 5% or greater in the liver of people who drink alcohol only in moderation, or not at all.
There may be numerous causes of NAFLD, however, the disease is mostly associated with a high fat, fructose-rich diet. Although NAFLD
is generally asymptomatic, it is a major risk factor for liver inflammation (NASH) and scarring (fibrosis and cirrhosis). In addition,
NAFLD is also associated with metabolic syndrome and cardiovascular disease. Currently, NAFLD can only be managed through lifestyle improvements,
such as weight reduction and physical activity.
NASH
is an emerging world crisis impacting an estimated 3% to 5% of the U.S. population and an estimated 2% to 4% globally, and is associated
with increased risk of liver cirrhosis, liver failure, hepatocellular cancer, as well as metabolic and cardiovascular diseases. The major
characteristics of NASH are elevated liver fat, inflammation, ballooning and fibrosis.
However,
despite the growing need, there are currently no approved therapeutic treatments for NASH. Modification of risk factors, such as obesity
and hyperlipidemia, and proper diabetic control is generally recommended for the treatment of NASH, and the standard of care includes
lifestyle changes to promote weight loss, including low-calorie, low-fat diets and physical activity. Although weight loss can be potentially
significant in delaying the progression of NASH, studies have shown that, for most individuals, it is generally very difficult to maintain
over the long-term, even following bariatric surgery.
58
There
are currently no drugs approved by regulatory authorities for the treatment of NASH. Even though certain drugs, such as insulin sensitizers
and antihyperlipidemic agents, are prescribed for some NASH patients, they are not approved for the treatment of NASH and their efficacy
has not been proven in adequate and well-controlled clinical studies.
Currently,
it is impossible to predict which of the NAFLD patients will deteriorate to NASH as it is unclear what causes NASH to develop. Researchers
are now focusing on several factors that may contribute to the development of NASH. Therefore, lifestyle changes are recommended for
all patients with NAFLD.
There
is an exceptionally wide range of estimates regarding the potential commercial market for NASH. This uncertainty stems from (i) the overall
size of the patient population, (ii) the percentage of the addressable market that will be diagnosed and, subsequently, seek treatment,
(iii) the ultimate cost of the therapies, (iv) the number of approved drugs for NASH and their profile, and (v) uncertainty regarding
the regulatory approval process. Some of these factors cannot be known until NASH drugs begin to hit the market or biomarkers replacing
the biopsy diagnosis are validated. Independent estimates generally estimate a commercial multi billion market in developed countries,
though we do not endorse any estimates, which are based on a number of different underlying assumptions.
Aramchol
for NASH
Overview
Our
product candidate, Aramchol, is a first-in-class synthetic fatty acid-bile acid conjugate molecule, or FABAC, molecule that we are developing
for oral treatment for NASH in patients who are overweight or obese and have prediabetes or type II diabetes mellitus.
Early
in its development, Aramchol's ability to modulate hepatic lipid metabolism was observed and validated in numerous pre-clinical
trials with different animal species. Mice fed a high fat diet and treated with Aramchol did not develop fatty liver as compared to non-treated
mice. In these early studies, we also observed that the mechanism of this effect was not a result of malabsorption of fat in the intestines
because the FABAC-treated mice gained weight throughout the test periods to a similar degree to the control mice. This led us to conclude
that FABAC therapy triggers a beneficial modulation of intra-hepatic lipid metabolism and reduces liver fat content.
In
in-vitro
and in vivo studies, Aramchol down regulates the SCD1 enzyme, an enzyme recognized as playing an important role in the
metabolism of fatty acids. The SCD1 enzyme is essentially the gateway that regulates the use and storage of fat in the body by converting
saturated fatty acids to monounsaturated fatty acids. Experimental animal studies showed that complete inhibition of the SCD1 enzyme
protects against diet-induced obesity, hepatic steatosis, or fatty liver, and insulin resistance by instructing the body to use, rather
than store, all fatty acids. However, various animal studies have indicated that such complete SCD1 enzyme inhibition has mechanism based
serious side effects, such as atherosclerosis, and eye and skin disorders. As observed by us in our pre-clinical and clinical studies
performed to date, and subsequently published in the European Journal of Gastroenterology and Hepatology and Archives of Medical Research
in 2008 and 2010 respectively, one of Aramchol's unique characteristics is that it down regulates the SCD1 enzyme but does not
inhibit it completely – a partial effect. To date, side effects that have been observed in animals with knock out of SCD1 have
not been observed in our toxicology and clinical studies.
To
better understand the role of Aramchol in NASH, we analyzed the effect of Aramchol in MCD diet model. The aim of this study was to investigate
Aramchol's mechanism of action and its effect on fibrosis using the methionine- and choline-deficient (MCD) diet model of NASH.
We collected liver and serum from mice fed a MCD diet containing 0.1% methionine (0.1MCD) for four weeks, which developed steatohepatitis
and fibrosis, as well as mice receiving a control diet; the metabolomes and proteomes were determined. 0.1MCD fed mice were given Aramchol
(5mg/kg/day for the last 2 weeks); liver samples were analyzed histologically. Aramchol administration was found to reduce features of
steatohepatitis and fibrosis in 0.1MCD fed mice. Aramchol downregulated the SCD1 enzyme, a key enzyme involved in triglyceride biosynthesis
whose loss enhances fatty acid β-oxidation. In addition, Aramchol increased the flux through the transsulfuration pathway, leading
to a rise in glutathione (GSH) and GSH/GSSG ratio, the main cellular antioxidant that maintains intracellular redox status. Comparison
of the serum metabolomic pattern between 0.1MCD-fed mice and patients with NAFLD showed a substantial overlap. These findings were published
in Hepatology Communications, Vol. 1, No. 9, 2017.
59
As
the effect of Aramchol on fibrosis was first reported we further analyzed the direct effect of Aramchol on collagen production and reported
down regulation of collagen production from the hepatic stellate cells (HSCs) by Aramchol. With that we could conclude that Aramchol
has potential direct effect on collagen production and therefore reduces fibrosis indirectly by down regulation of steatosis by reducing
the sequence of events but also directly affecting collagen producing cells. These findings were published in Hepatology Communications,
Vol. 1, No. 9, 2017.
These
findings led us to further analyze the effect of Aramchol using the Thiocatemide (TAA) rat model. TAA is the most commonly used toxic
agents to induce liver fibrosis. Repeated IP injections of TAA leads to sever fibrosis / cirrhosis. Among all models for fibrosis, the
TAA model share multiple characteristics with human liver fibrosis and is considered to best predict efficacy in humans. Results demonstrated
that treatment with Aramchol 5mg/kg, significantly prevented TAA induced fibrosis in a dose dependent manner. These findings were presented
at EASL, Amsterdam in April 2017 (The anti Fibrotic effect of Aramchol on liver Fibrosis in TAA animal model).
Phase
1 Single and Multiple-Dose Study of Aramchol in Healthy Male Volunteers (NCT00776841)
Aramchol
was evaluated in two Phase 1 clinical trials (under a single protocol) to study its safety, tolerability and PK profile in healthy volunteers,
in both single and multiple dose administrations. The first Phase 1 clinical trial was an escalating single-dose trial conducted in 17
healthy subjects testing Aramchol doses ranging from 30 mg to 900 mg, performed in one center in Israel. The subsequent Phase 1 clinical
trial was a repeated-dose trial conducted over four days in 25 healthy subjects testing repeated daily doses of Aramchol of 30 mg and
300 mg, performed in one center in Israel. The profiles for the groups were similar and the maximal plasma concentration of Aramchol
increased with the higher doses. The PK profile demonstrated that Aramchol is suitable at each dose for once-daily administration and
there were neither significant adverse events observed in either Phase 1 trial nor any notable changes in biochemical, hematologic, cardiovascular
or other safety parameters.
Phase
2a Trial: Aramchol Treatment in NAFLD or NASH Patients (NCT01094158)
In
January 2012, we completed a 60 patient multi-center, randomized, double-blind, placebo-controlled Phase 2a clinical trial of Aramchol
in patients with NAFLD or NASH between the ages of 18 and 75 in 12 centers in Israel. The Phase 2a study results were published in July
2014 in the peer-reviewed Clinical Gastroenterology and Hepatology Journal. The trial was performed in patients with either NAFLD or
NASH, which design was deemed acceptable by the FDA in 2007 at a pre-IND scientific advisory meeting. The trial's primary efficacy
endpoint was a reduction in liver fat content, and did not consider inflammation or fibrosis, which can be diagnosed only by liver biopsy.
We believe that the short study duration of three months of treatment followed by a one-month follow-up period did not warrant repeated
biopsies. The trial evaluated the effects on liver fat content of 100 mg and 300 mg once-daily doses of Aramchol compared to a placebo.
At the end of the three month treatment period, statistically significant reductions in liver fat concentration as measured by MRS were
observed in the 300 mg patient group. Specifically, a 12.57% mean liver fat content reduction was observed in the 300 mg group, as compared
to a mean reduction of 2.89% in the 100 mg group and a mean increase of 6.39% in the placebo-treated patients. These results indicate
that the effects of Aramchol are dose-dependent, as demonstrated in the graph below, which presents the results with respect to the 57
patients who successfully completed the entire treatment period (three patients were excluded from data analysis because of one protocol
violation and two withdrawal consents).
Relative
Change in MRS from Baseline after Three Months of Treatment
60
The
table above shows that the primary endpoint of the study was attained. The study demonstrated a statistically significant, dose dependent
reduction in fat content in the livers of patients treated with Aramchol, with a 19% difference between the 300 mg dose group and the
placebo group, while the difference between the 100 mg dose group and the placebo group was not statistically significant. Notably, the
minimal effective dose of Aramchol for fat reduction has been defined.
There
were no statistically significant differences among the three treatment groups for any of the secondary end points. There was a non-statistically
significant trend of mild weight reduction (P=.1) in the high dose Aramchol group. Serum adiponectin levels increased (0.2 ± 1.7
μg/mL) in the high-dose Aramchol group but decreased in the low-dose (-0.3 ± 1.5 μg/mL) and placebo groups (-0.7 ±_1.3
μgg/mL) (P= 0.88 for trend of dose-response relationship by linear regression). FMD increased non-statistically significantly by 1.28%
± 2.92% in the high-dose group, by 0.34% ±3.54% in the low-dose group, and by 0.46% ± 2.28% in the placebo group.
The
frequency of adverse events was similar in all treatment groups, and none of them were considered to be related to the treatment. All
adverse events in the active treatment arms were mild or moderate and none were serious. None of the patients withdrew as a result of
adverse events. The following table shows the most frequent adverse events (occurring in ≥ 2 patients in any group) in the study.
Placebo
Aramchol 100mg/d
Aramchol 300mg/d
(N=20)
(N=20)
(N=20)
MedDRA
No.
No.
No.
No.
No.
No.
preferred term
Events
Subjects
%
Events
Subjects
%
Events
Subjects
%
Abdominal pain
2
2
10
%
2
1
5
%
1
1
5
%
Abdominal pain
upper
1
1
5
%
2
2
10
%
—
—
—
Constipation
2
2
10
%
—
—
—
—
—
—
Asthenia
2
2
10
%
—
—
—
—
—
—
Back pain
3
3
15
%
—
—
—
—
—
—
Musculoskeletal
pain
2
2
10
%
—
—
—
—
—
—
Upper
respiratory tract
infection
—
—
—
—
—
—
2
2
10
%
61
The
results of our Phase 2a clinical trial of Aramchol in the peer-reviewed Clinical Gastroenterology and Hepatology Journal were
published in December 2014. The trial manuscript, entitled "The Fatty Acid-Bile Acid Conjugate Aramchol Reduced Liver Fat
Content in Patients with Nonalcoholic Fatty Liver Disease," provides the full report of the Phase 2a trial, which was
completed in January 2012 and presented at the 47
th
Annual Meeting of the European Association for the Study of the Liver
in 2012. Based on this Phase 2a proof-of-concept results, we established a development plan that we believe may confirm: (i) the
good safety profile of Aramchol, (ii) the optimal dose of Aramchol, and (iii) efficacy on steatosis as well as fibrosis in patients
with NASH.
Pharmacokinetics
of Single and Multiple Escalating Doses of Aramchol and Food Effect in Healthy Volunteers (NCT02374437)
On
April 28, 2014, we commenced PK and food effect studies of Aramchol. In written correspondence from December 2013 regarding a requested
pre-IND meeting, the FDA recommended that we conduct such studies prior to commencing our Phase 2b ARREST Study.
We
conducted the food effect and PK study at the Sourasky Medical Center in Tel Aviv, Israel involving 66 healthy volunteers to evaluate
the PK of Aramchol following single and multiple escalating doses (200 mg, 400 mg and 600 mg), as well as to evaluate the effect of a
high-fat, high-calorie meal on the PK of Aramchol following a single dose in healthy volunteers.
The
results showed dose-related, but less than dose-proportional, increases in the mean Aramchol plasma concentrations, or Cmax, area under
the curve, or AUC, (0-t), and AUC (inf) of 200 mg, 400 mg and 600 mg doses administered under fasting conditions or following a light
meal, both at single and repeated dose administration. Cmax and AUC are metrics used to indicate the significance of a drug's exposure.
Steady-state was achieved by 144 hours (day seven). Administration of Aramchol after a high-fat, high-calorie meal afforded a 2.6 fold
increase in exposure, as measured by Cmax, AUC(0-t), and AUC(inf) compared to the fasting group.
No
serious adverse events or deaths occurred during the study. Adverse events were equally distributed between placebo and Aramchol doses,
were mild (with only one moderate adverse event) and the majority defined unrelated to Aramchol. The PK study provides additional safety
data to further support existing safety data from our pre-clinical studies and our Phase 1 and Phase 2a clinical trials of Aramchol.
Pharmacokinetics
of Single and Multiple Escalating Doses of Aramchol Administered under Fed Conditions in Healthy Chinese Volunteers (NCT 02803996)
In
2016, we performed the Chinese PK Study involving Chinese patients who are domiciled in the United States. We enrolled 66 patients in
this study, consisting of two parts. In part A, 32 subjects received a single escalating dose; Part B enrolled 34 subjects which received
a multiple escalating dose. Dr. Evelyn Darius served as the Study Investigator. No safety signal was identified in this study and we
deemed no changes were required in the enrollment of Chinese patients into the ARREST Study.
Phase
2b ARREST Study for Aramchol (NCT 02279524)
In
September 2014, the FDA granted Fast Track designation status to Aramchol for the treatment of NASH. Fast Track designation may accelerate
the development process and may expedite the review of drugs that show promise in treating serious, life-threatening medical conditions
for which no other drug either exists or is as effective.
On
February 1, 2015, we began our ARREST Study. The ARREST Study was a Phase 2b, multicenter, global, randomized, double-blind, placebo
controlled study to evaluate the efficacy and safety and of two doses of Aramchol for the treatment of NASH in patients who are overweight
or obese and have pre diabetes or type II diabetes mellitus. In order to be eligible to participate in the ARREST Study, patients had
to be affected by NASH, as diagnosed by a biopsy centrally read (steatosis ≥1 + inflammation ≥1 + ballooning ≥1, total activity
NAS score of 4 or more), have a fibrosis stage of 1-3, be overweight or obese as measured by a Body Mass Index between 25 and 40 or waist
circumference between 88cm to 200cm for women, and between 102cm to 200cm for men, and who are pre diabetic or type II diabetic. We targeted
this specific population as it is at the greatest risk of developing NASH and its complications. We have generated data from animal models
that lead us to believe that Aramchol targets all three main pathologies of the disease: steatosis, inflammation and fibrosis.
62
A
total of 247 patients (approximately one third in the US, one third in Latin America and one third in Europe and Israel) with liver biopsy-proven
NASH who were overweight or obese and had pre-diabetes or type II diabetes mellitus were randomized. Patients were randomized in a ratio
of 2:2:1 (600mg, 400mg and placebo) taking once-daily oral Aramchol (in the Aramchol treatment arms) or a placebo (in the placebo arm).
The treatment part of the trial was 12 months in duration and patients completing this phase were observed for a three month follow-up
period. In February 2017, we completed randomization of the ARREST Study. Baseline histology of patients enrolled into the ARREST study
demonstrated a population with advanced disease, with 60% having stage 2 and 3 fibrosis and 70% have NAS>5 at baseline.
The
primary endpoint of the study was the change from baseline to end of study in liver triglycerides ratio as measured by magnetic resonance
spectroscopy, or MRS (Aramchol 600mg vs. placebo). Secondary endpoints, demonstrated through biopsy, included fibrosis improvement by
at least one stage or more without worsening of NASH (defined by an increase of inflammation and or ballooning) and NASH resolution (defined
by ballooning score 0 and inflammation score 0-1 at termination) without worsening of fibrosis. Other secondary endpoints included improvement
(2 points or more) in NASH activity index, as measured by NAS or SAF, without worsening fibrosis and change in baseline to week 52/termination
in ALT (U/L).
On
June 12, 2018, we announced top-line results of the ARREST Study and on November 13, 2018 an oral abstract presentation of one-year results
of the ARREST Study was presented during a Late Breaking Abstract Oral Session at The Liver Meeting® 2018 during the American Association
for the Study of Liver Diseases 2018 Annual Meeting.
Of
the 247 patients, 48 patients were in the placebo arm, 101 patients in the Aramchol 400mg arm and 98 in the Aramchol 600mg treatment
arm. The majority of subjects completed 52 weeks of treatment and 13 weeks of follow up (89.1%, 89.8%, 85.4% in the 400 mg, 600 mg and
placebo arms, respectively). The leading cause of discontinuation was consent withdrawal and early termination due to adverse events;
the incidence of early termination due to AEs was very low and similar across study arms.
Patients
in the ARREST study were planned to undergo MRS, and a liver biopsy at baseline and week 52, which were centrally read, blinded to treatment
allocation. The statistical analysis plan included pre-defined analysis sets: (i) a full analysis set for MRI (FAS -— MRI): all
intent to treat, or ITT, patients with baseline and at least one second MRS. 214 patients were included in this analysis set (41 in placebo;
90 in Aramchol 400mg; and 83 in Aramchol 600mg); and (ii) a full analysis set for liver biopsy (FAS -— biopsy): all ITT patients
with baseline and a second biopsy. 198 patients were included in this analysis set (40 in placebo; 80 in Aramchol 400mg; and 78 in Aramchol
600mg).
Results
from the study showed a statistically significant reduction in liver fat by MRS with Aramchol 400mg vs. placebo (p=0.0450) and not with
600mg (p=0.0655) and thus did not reach the primary endpoint of the study. In a post-hoc analysis, a cutoff of 5% absolute reduction
in liver fat was used as a surrogate for potentially clinically meaningful MRI reduction. In this responder's analysis, a dose-response
could be observed; the responder rate was 47.0%, 36.7% and 24.2%, in the Aramchol 600mg, 400mg and placebo arms, respectively. The proportion
of the Aramchol 600mg arm compared to placebo was statistically-significant (p=0.0279).
Results
for the two biopsy endpoints, which may currently constitute a primary endpoint for a Phase 3 trial to support an FDA marketing application,
demonstrated the following: (i) significantly more patients treated with Aramchol 600mg vs. placebo achieved NASH resolution without
worsening of fibrosis (16.7% vs. 5.0%; p=0.0514); and (ii) a higher proportion of patients showed at least one-point improvement in fibrosis
score without worsening of NASH in Aramchol 600mg vs. placebo (29.5% vs. 17.5%; p=0.2110).
Statistically
significant reductions in live enzymes alanine transaminase (ALT) and aspartate transaminase (AST) were demonstrated in both Aramchol
arms vs. placebo (p≤0.0002) and (p<0.0001), respectively.
Secondary
endpoints based on NAS and SAF activity score, ≥2 points improvement, showed a higher proportion of patients with improvement in the
Aramchol arms (600mg>400mg>placebo; P>0.05).
Exploratory
endpoints of glycemic parameters showed statistically significant reductions in HbA1c with both Aramchol arms vs. placebo (p<0.007)
implying a potential effect on glycemic control.
At
52 weeks of treatment, Aramchol continued to show a favorable safety and tolerability profile. Serious adverse events were reported in
12.5%, 8.9% and 9.2% of patients in placebo, Aramchol 400mg and 600mg arms, respectively. No clustering of event type or atypical events
for the studied population was reported in either Aramchol arms. Severe adverse events were reported in 10.4%, 6.9%, and 6.1% of patients
in placebo, Aramchol 400mg, and 600mg arms, respectively. Early terminations due to adverse events occurred in 4.2%, 3.0% and 4.1% in
placebo, Aramchol 400mg and 600mg arms, respectively.
The
following table summarizes the most frequent adverse events.
63
The
following table summarizes the ARREST results:
Aramchol
Aramchol
Placebo
400 mg
600 mg
MRS- –Absolute change from baseline in mean liver fat (1)
(0.09
)%
(3.41
)%
(3.18
)%
P=0.0450
P=0.0655
MRS responders- Reduction of  ≥5% in absolute change from baseline (1)
24.4
%
36.7
%
47.0
%
P=0.0878
P=0.0279
NASH resolution without worsening of fibrosis (2)
5
%
7.5
%
16.7
%
P=0.4955
P=0.0514
NASH resolution (2)
7.5
%
12.5
%
19.2
%
P=0.2237
P=0.0462
Fibrosis improvement (≥1 stage) without worsening of NASH (2)
17.5
%
21.3
%
29.5
%
P=0.8425
P=0.2110
Progression to Cirrhosis (Post-Hoc Analysis) worsening of NASH (2)
7.5
%
7.5
%
1.3
%
P=0.5693
P=0.1008
ALT (U/L) Change from baseline (3)
+11.82
-12.0
(17.3
)
P=0.0002
P<0.0001
AST (U/L) Change from baseline (3)
+6.67
(7.20
)
(10.83
)
p=0.0011
p<.0001
HbA1C Change from baseline (4)
+0.32
(0.04
)
(0.13
)
p=0.0061
p=0.0008
(1)
Placebo
    N=41; 400mg N=90, 600mg N=83; Mixed Effect Model Repeat Measurement (MMRM) adjusted mean changes from baseline; p-values for comparison
    of active treatment arm vs. placebo.
(2)
Placebo
    N=40, 400mg N=80, 600mg N=78; Baseline adjusted logistic regression; p-values for comparison of active treatment arm vs. placebo.
(3)
Placebo
    N=47, 400mg N=100, 600mg N=98; MMRM adjusted mean changes from baseline; p-values for comparison of active treatment arm vs. placebo.
(4)
Placebo
    N=47, 400mg N=98, 600mg N=96; MMRM adjusted mean changes from baseline; p-values for comparison of active treatment arm vs. placebo.
64
Dose
Splitting Pharmcokinetic Study (NCT03774173)
As
a result of the dose response pattern observed in the ARREST Study, we recently conducted a Phase 1, open-label, crossover PK study to
assess whether dose splitting of Aramchol 600mg to twice daily 300mg will significantly increase plasma levels. 16 healthy subjects took
part in two study periods. Eight subjects received each regimen in the first period and the alternate regimen in the second period. A
PK profile was obtained over the dosing interval at steady state on day ten of each period.
Results
of the study showed that the administration of Aramchol 300 mg twice daily resulted in 24-hour plasma concentrations significantly greater
than those observed with the administration of Aramchol 600 mg once daily. (P<0.0001). The average plasma levels (exposure) were 53%
higher and exposure was greater in all 16 subjects with the twice daily dosing. The treatment in both dosing regimens were similar in
terms of safety and were well tolerated.
First
in Human Aramchol Meglumine Pharmcokinetic Study
In
December 2020, we announced new data from a Phase 1, first in human study that compared Aramchol meglumine to Aramchol acid.
Armachol
acid and Aramchol megluine was administered twice daily to 12 subjects. Below is a summary of the results:
65
These
initial results demonstrated that the new salt form of Aramchol meglumine has a plasma PK profile that is very similar to Aramchol acid.
It also showed that the administration of both forms resulted in the same form of Aramchol in the blood, regardless of which drug product
is administered and that less Aramchol meglumine is needed for the same exposure of Aramchol acid in the blood.
Phase
3 ARMOR Study for Aramchol
In
September 2019, we initiated the ARMOR Study, a Phase 3 pivotal study of Aramchol for the treatment of NASH, following a successful End-of-Phase
2 meeting with the FDA in April 2019 in which we reached general agreement on key aspects of the Phase 3 development and registration
plan for Aramchol. The ARMOR Study was originally comprised of two parts, a randomized, double-blind, placebo-controlled histology -based
registrational part where 1200 subjects will be treated with Aramchol or matching placebo for 52 weeks and a clinically based part where
subjects will continue with the same treatment for approximately five years, taking into consideration draft guidance issued by the FDA
in December 2018 entitled "Noncirrhotic Nonalcoholic Steatohepatitis with Liver Fibrosis: Developing Drugs for Treatment",
or the "December Guidance". The histology-based data is intended to serve as the basis for the submission of a marketing
authorization application under regulatory provisions of Sub-part H accelerated/conditional approval.
In
light of the rapid development of the Aramchol meglumine program and due to the delays resulting from the COVID-19 pandemic, in December
2020, we announced the addition of an open label part to the ARMOR Study and temporarily suspended randomization of new patients into
the double-blind, placebo-controlled histology-based registrational phase of ARMOR as currently enrolled patients are transitioned to
the open label part.
In
August 2021, we announced that the FDA agreed with our plan to use Aramchol meglumine (in lieu of Aramchol free acid) in our ARMOR Study
without the need to conduct additional nonclinical and clinical studies other than planned limited pharmacology studies relating to Aramchol
meglumine. In addition, the Medicines and Healthcare products Regulatory Agency, or MHRA, the pharmaceuticals regulator in the UK, also
agreed with our plan to proceed with our proposed clinical studies with Aramchol meglumine in lieu of Aramchol free acid without the
need to repeat nonclinical and clinical studies other than planned limited pharmacology studies relating to Aramchol meglumine.
In
November 2021, we announced positive interim data on the open label part of the ARMOR Study showing clinically significant effect on
fibrosis improvement based on histology in the first 16 patients. Subsequently in November 2021, we announced that new analyses of biomarkers
corroborate this effect showing statistically significant reductions in biomarkers associated with liver fibrosis including ALT, AST,
Fib-4 and ProC-3. Reductions of a similar magnitude were seen in a cohort of the first 20 patients for which paired biopsy have been
analyzed and a cohort of 50 patients for which biomarker data was analyzed based on all available data at that time. In addition, we
reported that Aramchol continues to show excellent safety and tolerability profile. Data support that a higher dose of Aramchol could
provide statistically and clinically meaningful effect on fibrosis in the double-blind placebo controlled part for submission of the
ARMOR Study to support an NDA under Sub-part H.
66
In
April 2022, we announced further positive interim data on the open label part of the ARMOR Study showing robust fibrosis improvement
across multimodality histological assessment. Results of post baseline biopsies performed either at 24 weeks or at 48 weeks from 46 subjects
with NASH and F1-3 that received Aramchol support the anti-fibrotic effect of Aramchol and reinforce the favorable safety profile of
Aramchol.
In
May 2022, we announced the discontinuation of the open label part of our ARMOR Study having reached its objectives and in January 2023,
we announced full results from the open label part of the ARMOR Study. Following the discontinuation of our open label part of the ARMOR
Study, we do not currently expect to initiate the second part of the ARMOR Study.
The
Phase 3 study is a two-part study, an open-label part and a randomized, double-controlled, placebo part, designed to evaluate the safety
and efficacy of Aramchol and to be conducted in approximately 200 sites in the U.S., Europe and Latin America.
Part
One: Open Label Study
The
first part, an open-label study, was originally designed to evaluate treatment response kinetics, pharmacokinetics and safety of twice
daily administration of Aramchol 300mg in approximately 150 subjects with NASH and liver fibrosis stage 1-3 (F1 capped at 30 subjects),
subjects with NASH who may or may not be overweight, and subjects with NASH who may or may not have type 2 diabetes or be pre-diabetic.
Patients were randomized (1:1:1) into three groups with post-baseline liver biopsy being performed at 24 weeks, 48 weeks, or 72 weeks,
respectively. A second post-baseline liver biopsy was conducted after one year for subjects whose post-baseline liver biopsy at week
24, 48 or 72 does not show at least one stage improvement in fibrosis. The open label part was being conducted at approximately 50 selected
sites in the U.S., and around the world which have been less affected by the COVID-19 pandemic.
The
open label study enrolled 157 subjects. Fifty-one (51) subjects underwent post-baseline biopsies prior to study discontinuation (28 subjects
at <48 weeks and 23 subjects at ≥48 weeks). The study was designed to assess the safety, pharmacokinetics (PK) and efficacy kinetics
as a function of treatment duration. Three independent pathologists and three different histopathology reading methodologies were used
to assess the antifibrotic effect of Aramchol: fibrosis stage based on NASH CRN; ranked assessment (improvement/worsening/stable) of
paired (pre- and post-baseline) biopsies, blinded to sequence; and an automated and continuous score of Fibrosis Composite Severity (FCS),
using FibroNest™, a quantitative AI digital pathology image analysis method. Noninvasive tests (NITs) included imaging (fibroscan)
and biomarkers (liver enzymes, FIB-4, Pro-C3 and ELF).
Aramchol
treatment resulted in a high proportion of subjects showing fibrosis improvement based on all three biopsy reading methodologies, with
a larger treatment effect with longer duration of therapy. Following a treatment duration of 48 weeks or more, improvement in fibrosis
was demonstrated in 39% of subjects according to NASH CRN and 61% of subjects according to ranked assessment. At Week 48 AI demonstrated
fibrosis improvement in 100% of subjects when responders were defined by an absolute reduction of the FCS score >0.3, 65% when responders
were defined by a relative reduction of >25%, and a statistically significant reduction from baseline in mean FCS score (p<0.0001).
NASH resolution without worsening of fibrosis was demonstrated in 26.5% of subjects.
Fibroscan,
ALT, AST, and FIB4 were analyzed using MMRM, based on all subjects (N=154). Fibroscan results were consistent, with an improvement in
fibrosis showing a mean absolute reduction from baseline to week 72 of 2.5 kPa (p<0.0001). At Week 72, ALT was reduced by 22 U/L (p<0.0001),
AST was reduced by 18 U/L (p<0.0001), and FIB-4 was reduced by 0.30 (p<0.0001).
Pro-C3
and ELF were analyzed for 43 subjects at week 24 showing reduction in both Pro-C3 levels (p<0.0001) and ELF (p=0.0038).
The
Open Label part demonstrated the good safety profile of Aramchol 300mg BID including long-term follow up. The incidence of serious adverse
events (SAEs) was consistent with the population (10.4%) and early discontinuation rates due to adverse events (AEs) were low (4.5%).
67
Part
Two: Histology-Based and Clinically-Based Study
The
second part of the ARMOR Study is a randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of Aramchol
300 mg BID to support regulatory approval, with both a histology-based phase and a clinically-based phase. As currently designed, a total
of 2000 subjects with NASH and liver fibrosis stage 2 and 3 who are overweight and are either pre-diabetic or have type 2 diabetes would
be randomized 2:1 to receive Aramchol 300mg BID or matching placebo. In the histology-based phase, we intend to treat 1000 subjects with
Aramchol or matching placebo for 72 weeks until the second biopsy. The histology-based data is intended to serve as the basis for the
submission of a Sub-part H marketing authorization application under regulatory provisions of accelerated/conditional approval. The primary
histology-based endpoint is NASH resolution without worsening of fibrosis or fibrosis improvement without NASH worsening. In the clinically-based
phase, all subjects will continue with the same treatment assignment for up to seven years until study completion to confirm clinical
efficacy. We may announce end-of-study at the time when a total of 380 subjects have experienced at least one pre-specified clinical
event or at five years from last subject randomization, whichever comes first. The primary clinically-based endpoint is expected to be
based on clinical events including all-cause mortality, histological progression to cirrhosis, MELD score >15, and hepatic decompensation
events (e.g., hepatic encephalopathy, variceal bleeding, ascites). If the clinical trial results in the histology-based phase are positive,
we plan to submit an NDA for Sub-part H accelerated/conditional approval to the FDA. As discussed elsewhere, we suspended the initiation
of the double-blind placebo-controlled histology-based registrational part of ARMOR and are seeking to initiate the double-blind placebo-controlled
histology-based registrational part of ARMOR in the second half of 2023, subject to, among other things, the results of our open label
part, sufficient funding and clarification of the regulatory approval process for NASH drugs.
The
following is a depiction of part two of the ARMOR Study:
Amilo-5MER
In
August 2020, we announced significant progress in the development of Amilo-5MER, a 5 amino acid synthetic peptide MTADV (Methionine,
Threonine, Alanine, Aspartic acid, Valine). The 5 amino acids sequence of Amilo-5MER is homologue to a specific MTADV sequence in the
human CD44 variant found in synovial fluid cells from joints of rheumatoid arthritis, or RA patients.
Amilo-5MER
is being developed through a research collaboration between us and the Hebrew University of Jerusalem. The molecule originated in the
laboratory of Prof. David Naor, from the Lautenberg Center for Immunology and Cancer Research, Faculty of Medicine, The Hebrew University.
Prof. Naor and his team were the first to publish this specific sequence in the prestigious scientific communication Journal of Clinical
Investigation 1.
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Amilo-5MER
binds to three pro-inflammatory amyloid proteins, Serum Amyloid A, or SAA, Transthyretin and Apolipoprotein B with high affinity. The
first two are known to be active only in their aggregated forms. By binding to SAA, Amilo-5MER interferes with SAA aggregation and therefor
inhibits the destructive autocrine, self-amplifying cytokine loop that causes additional inflammatory reaction.
SAA
constitutes acute phase reactants, whose concentration in serum rise rapidly in response to acute stimuli such as infection and trauma.
An elevated concentration of SAA was identified in sera of patients with multiple autoimmune diseases and more recently, an outstanding
increase of SAA was also detected in COVID-19 infected patients2-3. SAA in its aggregated form, is a potent and rapid inducer of cytokine
secretion (particularly Interleukin 6 (IL-6). IL-6 plays an important role in chronic inflammation and is implicated in the pathogenesis
of many autoimmune diseases, such as Multiple Sclerosis, or MS, RA, Inflammatory Bowel Disease, or IBD and acute COVID 19. Interference
with SAA polymerization and aggregation is a valid target to prevent chronic inflammatory conditions.
Amilo-5MER
has been shown to significantly reduce chronic inflammation in animal models of RA, IBD and MS (research work supported by a grant to
Prof. Naor from the National Multiple Sclerosis Society (NMSS) of the USA). Amilo-5MER provides a unique mechanism of action to interfere
with this vicious cycle, enabling a specific treatment for chronic inflammatory diseases. Data generated from multiple in-vitro, in-vivo
and human ex-vivo models have shown that Amilo-5MER significantly improves clinical symptoms. Histological improvements and reduction
of pro-inflammatory cytokine secretion were also observed.
Amilo-5MER
is considered a New Chemical Entity. As such, it is eligible for NCE patent protection until July 2034. Patents have been granted and
maintained in the US (US 1061181937), Europe (EP 3169343) and Australia (AU 2015291151) and have been allowed in Japan (JP 6671363).
In
March 2021, we dosed the first subject in our first in human Phase 1 trial of Amilo-5MER for the treatment of chronic inflammatory diseases.
The trial was a three-part, single center, double-blind, randomized, placebo-controlled first in human study of single ascending doses
(Part 1) and multiple doses (Part 2) of Amilo-5MER in young healthy adult male subjects and a single dose cohort in healthy elderly male
and female subjects (Part 3). Overall, 55 healthy male and female subjects were enrolled in the study. Cohorts of 8 subjects were randomized
to receive Amilo-5MER or placebo by subcutaneous injection in a ratio of 6:2. In Part 1, cohorts of young male adults received single
ascending doses of 10, 30, 90, 180 and 360 mg; in Part 2, a single cohort received doses of 180 mg BID for 5 consecutive days and in
Part 3 a single cohort of healthy elderly male and female subjects received a single dose of 180 mg. The primary objectives of the trial
were to evaluate the safety, tolerability, and pharmacokinetics of Amilo-5MER. In January 2022, we announced results in which all doses
of Amilo-5MER were well tolerated with no clinically significant adverse events and none considered related to the investigational product.
All subjects completed the study as per protocol. Overall exposure to Amilo-5MER increased with an increase in dose, with statistically
significant dose proportionality over the 10 mg to 360 mg dose range. We are currently evaluating which indication to pursue further
development of Amilo-5MER.
Additional
Pre-clinical and Clinical Studies Required for Regulatory Submissions
Toxicology
Studies
Since
the completion of the Phase 2a study, pre-clinical toxicology studies have been conducted to support our ongoing clinical programs and
regulatory submissions. These studies were performed in compliance with the EMA's ICH M3 (R2) guidelines. The toxicity program
for Aramchol included repeat dose studies of up to six months in rats and up to nine months in dogs by oral administration, the intended
route of administration in the clinical trials and beyond. The dose level of 1000 mg/kg/day in rats and 1500 mg/kg/day in dogs, which
is the maximal feasible dose in both species showed no side effect and therefore the highest dose of the study was selected as the no-observed-adverse-effect-level,
or NOAEL. There were no observations noted in the rat study. The findings in the dog study were limited to changes in plasma lipids,
including decreases in total blood cholesterol levels, LDL, HDL and phospholipids, and a slight increase in the size of the adrenal glands,
which were considered to be an extension of the primary pharmacology of Aramchol and non-toxic effects, and skin scales from week 13
onwards in all Aramchol-treated groups, with a dose-related incidence. After six months this was not accompanied by any microscopic alteration
of the skin and therefore considered not toxicologically relevant. Results from the study show that after nine months the presence of
scales in all Aramchol-treated groups was accompanied by minor test item-related microscopic findings in the skin: Hyperkeratosis of
the epidermis, correlating to the scales, and keratin plugs in the hair follicles (in males at 750/500 and 1500 mg/kg). After a 12-week
treatment-free recovery period, fewer scales were noted and microscopically there was partial recovery. As these findings were minor
and no clinical symptoms like scratching were noted, these findings were considered not adverse.
69
Aramchol
was non-mutagenic in vitro in the Ames test and chromosomal aberrations test, each of which is a test to determine whether the subject
chemical can cause mutations in the DNA of an organism. In addition, in bone marrow micronucleus test in male rats at a 2000 mg/kg oral
dose (the maximum recommended dose in accordance with ICH S2 (R1)), Aramchol was not clastogenic, meaning it did not give rise to or
induce disruption or breakages of chromosomes, nor was it aneugenic, meaning it did not cause the number of chromosomes in the nucleus
of a cell to not be an exact multiple of the monoploid number of a particular species.
Embryo-fetal
development toxicity was assessed in rats and rabbits. No maternal or fetal development toxicity was observed in either species. The
NOAEL for maternal and development toxicity was at least 1000 mg/kg in rats and 750 mg/kg in rabbits (the maximum feasible dose in both
species).
No
maximum tolerated doses were reached in the studies. Over 50-fold safety margin exposure was achieved in dogs but not in rats. However,
for rats, at least three of the four ICH M3(R2) safety margin criteria were met, and for dogs all four criteria were met. Blood tests
revealed a decrease in total blood cholesterol levels, including LDL, HDL and phospholipids, and there was a slight increase in the size
of the adrenal glands of the dogs, which WIL Research assessed as a physiologic compensatory response to the decrease in blood cholesterol
levels. WIL Research did not consider the decrease in blood cholesterol levels or the physiologic response of the adrenal glands as a
toxic effect, but rather as a pharmacodynamic effect, which is a biochemical and physiological effect of the drug on the body. Based
on the above, it was concluded that the overall safety data for Aramchol is sufficient to support the proposed Phase 2b clinical trial.
To
support any potential future NDA, we have commenced or are planning to commence several safety studies. Additionally, we plan in the
future to conduct a study of Aramchol in the pediatric population.
In
addition, we have conducted carcinogenicity studies to identify whether Aramchol has any tumorigenic potential upon long-term administration
in support of any future NDAs or MAAs. Under FDA guidance, we are required to perform two studies, one in rats and the other in mice.
The carcinogenicity study in rats is a two-year study which was initiated in February 2020 and finalized during 2022. There were no significant
adverse findings reported over the course of the study.
Aramchol
for the Treatment of Other Indications
On
February 14, 2018, we announced topline results from the investigator initiated ARRIVE Study for HIV associated lipodystrophy and NAFLD
patients. HIV patients have advanced liver disease which is a major cause for morbidity and mortality. ARRIVE, a Phase 2a, investigator
initiated clinical trial conducted at the University of California
San
Diego by Professor Rohit Loomba was a randomized, double-blinded, placebo-controlled, 12 weeks, proof-of-concept study that evaluated
the safety and efficacy of Aramchol at 600mg/day versus placebo in 50 patients with HIV-associated lipodystrophy and NAFLD. The primary
end point of successful therapy was improvement in hepatic steatosis at 12 weeks, as measured by MRI-PDFF. Secondary endpoints were improvement
in total body fat, metabolic profile, and liver biochemistry. Liver biopsies were not included as part of the evaluation in this pilot
trial. The trial showed no difference between HIV patients receiving Aramchol for 12 weeks when compared with HIV patients in the placebo
arm. Aramchol showed a favorable safety and tolerability profile. Although the pathology (fatty liver) is similar to "garden variety"
NASH, the pathogenesis involved in the HIV lipodystrophy and NAFLD is different and multi factorial including the effect of the virus
itself and the anti-HIV medications.
70
On
November 13, 2014, we announced the first administration of Aramchol in a proof-of-concept Phase 2a clinical trial for the treatment
of newly formed cholesterol gallstones following bariatric surgery. The primary end-point was to prove that Aramchol dissolves newly
formed gallbladder gallstones following bariatric surgery. Patients were to be assigned to one of three treatment arms; 400mg tablets,
600mg tablets and placebo. Only 9 patients were enrolled, and 7 patients completed the study. Due to poor patient recruitment and change
in Company focus, we decided to terminate the study on October 1, 2015. We currently believe that it is unlikely that we will revive
another study in cholesterol gallstones.
In
July 2022, we announced results showing significant effects of Aramchol in pre-clinical model of both lung and gastrointestinal (GI)
fibrosis. Fibrosis is a common complication of chronic inflammation and can affect all organs and tissues. To date, only limited anti-fibrotic
drugs are approved or are in development, most of which have restricting side effects. Aramchol is a partial inhibitor of SCD1 with distinctive,
direct, anti-fibrotic activity demonstrated in several pre-clinical models. Treatment with Aramchol resulted in statistically significant
fibrosis improvement in a validated bleomycin model of lung fibrosis (IPF), comparable to Pirfenidone which is the gold standard treatment.
Findings were seen across all important indicators for the severity of fibrosis including hydroxyproline (a marker for collagen deposition
in the fibrotic tissue) P< 0.05, Ashcroft score P < 0.005, % CPA (Percentage Collagen Proportionate Area of the lung) P < 0.001,
and immunohistochemistry (type I collagen and a SMA) P < 0.005 for both staining. Statistically significant improvements were also
demonstrated in a validated DSS model of inflammatory bowel disease (IBD). Dextran sulfate sodium (DSS) induced colitis model is widely
used because of its similarities with human ulcerative colitis. Clinical improvements were statistically significant at least by p value
< 0.05 while in histological score (based on inflammation and colon structural changes) significance was as low as p
<
0.01.
Aramchol was found to be the most effective compound tested. Control groups included 5-ASA and local steroids which are the gold standards
for current treatment.
In May 2023, we announced the initiation of a new clinical program to evaluate
Aramchol meglumine for the treatment of PSC, a rare disease for which there is no approved treatment. We initially planned to initiate
a Phase 2a study in the last quarter of 2023 however as a result of Hamas-Israel war, we currently estimate a delay of ~7-9 months in
the initiation of the study. While PSC is more common in men, especially in Northern European heritage, and is often diagnosed between
ages 30-40, we currently estimate that the number of patients to be around 60,000, or 1 per 10,000, consisting of around 33,5000 patients
in the United States and 32,500 patients collectively in France, Germany, Italy, Spain and the United Kingdom. In the preclinical stage,
PSC likely involves ulcerative colitis (UC) leading to biliary inflammation. As biliary fibrosis progresses to cirrhosis, it is coupled
with complications and competing risks, while about 50% of patients with PSC report clinical symptoms. While there are currently no approved
drugs for the treatment of PSC, there is a potential to gain orphan drug status.
Strategic
Collaborations, Research Arrangements and other Agreements
Samil
Pharma. Co., Ltd.
On
July 28, 2016, we entered into a license agreement, referred to herein as the Samil Agreement, with Samil for the commercialization of
Aramchol (with the option to manufacture) in the Republic of Korea, or the Territory.
Under
the terms of the Samil Agreement, the Company has granted Samil an exclusive licence, or the Samil License, for fatty liver indications
including NASH, or the Field of Use, in the Republic of Korea, or the Territory to such information concerning Aramchol as may be required
to support Samil's applications for regulatory approvals, or the Licensed Information, and the patents for the import, marketing,
use, sale, offer for sale, commercialisation and distribution (and, if the option is exercised, manufacture) of Aramchol in tablet form,
or any other physical form as may be produced or manufactured by or on behalf of Galmed or by a third party for Galmed and, if the option
set out below is exercised, any products within the Field of Use, the development, manufacture or sale of which is based, in whole or
in part, on, or involves the use of, the Licensed Information or covered under any patent, or the Product.
The
Samil License shall remain in force with respect to each Product (if the Samil Agreement is not early terminated) until the later of:
(i) the date of expiry in the Territory of the last of any patent covering such Product or any formulation, dosing or administration
form thereof; and (ii) the date of expiry of a period of 20 years commencing on the date of first commercial sale by Samil or a sublicensee
of such Product in the Territory.
Upon
the signing of the Samil Agreement, Samil paid the Company a gross upfront fee of approximately $2.1 million and in September 2018, we
received a milestone payment of $1.5 million. Samil has also agreed to pay additional clinical and regulatory-based milestone payments,
which may aggregate to an additional $4.5 million, as well as tiered, double-digit royalties payable on sales (lower if sales of a generic
equivalent commence in the Territory).
Pursuant
to the terms of the Samil Agreement, following the first achievement of US$25 million of net sales in any calendar year following the
first commercial sale of the Product in the Territory, Samil shall have the option to request that the Licensed Information include methods
for the formulation of Aramchol from its API, to allow for the manufacture of Aramchol by Samil; provided, however, that we shall have
the option, to widen the definition of the Licensed Information as aforesaid at any time.
71
We
shall be entitled, at our option: (i) to modify the Samil License with respect to any Product so that it is non-exclusive only; or (ii)
to terminate the Samil License hereunder, with respect to any Product if: (a) a first purchasing order from Samil for at least one Product
shall not have been placed by 6 months following the grant of the Korean Ministry of Food and Drug Safety new drug approval; or (b) commercial
sale of such Product having commenced and either (i) there shall be a period of 1 year during which no sales of any Product shall take
place, or (ii) within 1 year of such commencement, aggregate sales of Products shall not have reached a reasonable level, as determined
by the joint development committee, in each case, except as a result of force majeure or other factors beyond the control of Samil. Further,
we shall be entitled to terminate the Samil Agreement if Samil challenges the validity of any of the patents. If any such challenge is
unsuccessful, Samil shall (in addition to our right to terminate) pay us liquidated damages in the amounts of US $8,000,000. Either party
may terminate the Samil Agreement (i) upon the other party's material breach if such party fails to cure such breach within 30
days, or, in the case of failure by Samil to pay any amount due from Samil to us pursuant to or in connection with the Samil Agreement
14 days after receiving written notice thereof, or (ii) upon customary events such as the granting of a winding-up order if such order
or act is not cancelled within 60 days.
In
the event that we do not achieve the primary endpoint as defined in the study protocol, or Successful Completion, of the ARREST Study,
we shall as soon as practicable notify Samil of the non-achievement of such Successful Completion, and within 60 days thereof, notify
Samil in writing either:
(i)
that we have decided not to develop the Licensed Information further for the Field of Use, or the Cessation Notice, or (ii) that we intend
to continue with such development notwithstanding the non-achievement of such Successful Completion, or the Licensor Continuation Notice.
Also, in the event that we do not achieve the Successful Completion of the potential Phase 3 Study, we shall, as soon as practicable,
notify Samil accordingly, or the Notice of Non-Success. Samil shall thereafter have the option, by notice in writing served to us within
45 days of Samil's receipt of either a Cessation Notice, a Licensor Continuation Notice or a Notice of Non-Success, as applicable,
to indicate its intention either: (i) to terminate the Samil License, or (ii) to continue research and development of the Licensed Information
in the Field of Use in the Territory, or the Licensee Continuation Notice. In the event Samil shall serve a Licensee Continuation Notice
following the service of a Cessation Notice or a Notice of Non-Success, any such continuation by Samil shall be subject to the entry
by Samil into a written agreement with us as to the terms and conditions which would govern such continued research and development,
which would be carried out according to Samil's own development plan and at its sole expense. In the event Samil serves a Licensee
Continuation Notice following the service of a Licensor Continuation Notice, or Agreed Continuation, the Samil Agreement shall continue
in accordance with its terms. In August 2018, Samil sent a Licensee Continuation Notice to us.
Additionally,
following the Successful Completion of the ARREST Study or Agreed Continuation following non-achievement of Successful Completion of
the ARREST Study, Samil shall, for a period of 90 days following the date of written notification to it by us of such Successful Completion
or following the date of Agreed Continuation following non-achievement of Successful Completion, have the option to require that the
Territory be extended to include Vietnam, or the Extension Option. In the event that Samil exercises its Extension Option, the parties
shall conduct negotiations in good faith for up to 30 days thereafter in order to agree on milestone payments which would replace those
set out in the Samil Agreement. In the event that agreement is not reached in such regard within such period, the Extension Option shall
terminate. Discussions for the extension of the Samil License to Vietnam are ongoing.
Amilo
5-MER
We
have entered into a research and option agreement with Yissum, the tech transfer company of the Hebrew University with respect to our
Amilo-5MER, a 5 amino acid synthetic peptide MTADV (Methionine, Threonine, Alanine, Aspartic acid, Valine). Under this agreement, we
are able to research and initially develop Amilo-5MER, are required to fund the initial research and have been granted an exclusive option
to negotiate and enter into a definitive license agreement with Yissum for Amilo-5MER upon certain pre-agreed upon terms and such other
terms to be agreed upon.
72
As
a result of the success in the Phase 1 study, we exercised our option and on June 28, 2021, we entered into a license agreement with
Yissum pursuant to which Yissum granted us a worldwide, exclusive and irrevocable license to develop and commercialize Amilo-5MER. In
November, 2021, the grant of the license took effect when it was approved by the Israel Innovation Authority. Under the license agreement,
we are responsible for carrying out the development and commercialization of Amilo-5MER and the prosecution and maintenance of the licensed
patents under the license agreement. In consideration for the grant of the license, we have agreed to pay to Yissum an upfront license
fee of $100,000, payments of up to $950,000 upon meeting certain regulatory milestones, single digit royalties on any future net sales
and a share of any sublicense fees. Unless earlier terminated, the license will continue in effect on a product-by-product and country-by-country
basis until the later of (i) the expiration of the last to expire patent covering the licensed technology in such country, (ii) the expiration
of any exclusivity on Amilo-5MER granted by a regulatory body in such country, and (iii) 15 years from the first commercial sale in such
country. The license agreement may be terminated early for material breach or bankruptcy. In addition, we may terminate the license agreement
without cause upon 90 days prior written notice to Yissum and Yissum may terminate the license agreement upon written notice to us under
certain limited circumstances.
Onkai
In
May 2023, we entered into the OnKai Agreement for a $1.5 million equity investment in OnKai, a US-based technology company developing
an AI-based platform to advance healthcare for underserved populations across the United States by facilitating alignment between healthcare
stakeholders. The signing of the definitive agreement followed an announcement that we made in January 2023 that we had entered into
a non-binding termsheet for an equity investment in OnKai. The OnKai Agreement provided that we will invest $1.5 million in exchange
for series seed preferred shares of OnKai (which is in addition to a $1.5 million investment that was made by us in OnKai through a SAFE
and which converted at a 15% discount into series seed preferred shares upon consummation of the Investment Round). Our investment in
OnKai was part of an approximately $6.0 million Investment Round with other investors that was led by us of which SAFE notes of approximately
$3.8 million were converted into preferred shares. On June 19, 2023, the Investment Round closed. Following the Investment Round, we
hold approximately 23.9% of the outstanding share capital of OnKai on an as-converted and fully and our Chief Executive Officer and director,
Allen Baharaff serves as a board member of OnKai. In connection with the OnKai Agreement, our wholly-owned subsidiary, GRD entered into
the OnKai Services Agreement with OnKai. The OnKai Services Agreement provides that GRD shall on a non-exclusive basis (i) provide support
services to OnKai relating to finance, business development, strategic planning, execution and others; and (ii) lend its experience to
OnKai in building a strategy and for the development of treatments for the underserved and that OnKai shall on a non-exclusive basis
(i) take part in plan preparation to serve GDR's vision of developing drugs for the underserved population and (ii) when relevant,
design a process on the clinical trial dashboard that could potentially serve GDR's future trial. In July 2023, we announced that OnKai will apply its artificial intelligence
models for enrollment and execution of clinical trials in underserved communities, starting with our PSC clinical program.
OnKai
is developing a proprietary technology, a "smart grid", that maps local clinics serving millions of underserved Americans
and streams to these clinics resources, including funding, specialists, training, and access to clinical studies. This is intended to
facilitate faster clinical trial enrollment and provide clinical trials as a healthcare option in these communities by bringing novel
medications, such as access to orphan drugs, to communities in need. We believe that it will potentially benefit in the future from enhanced
access to a pool of clinical trial participants for the advancement of our product candidates.
Competition
The
pharmaceutical industry is characterized by rapidly evolving technology, intense competition and a highly risky, costly and lengthy research
and development process. Adequate protection of intellectual property, successful product development, adequate funding and retention
of skilled, experienced and professional personnel are among the many factors critical to success in the pharmaceutical industry.
We
operate in a competitive sector. Several companies are working on technologies, therapeutic targets or drug or biomarker candidates that
aim to treat or diagnose the same diseases or identify the same patient population as our product candidates. While we believe that our
drug candidates and diagnostic solutions, combined with our expertise and know-how, provide us with competitive advantages, we face potential
competition from various sources, including pharmaceutical and biotechnology companies, as well as from academic institutions, governmental
agencies and public and private research institutions. We anticipate that we will face intense and increasing competition as new drugs
and therapies enter the market and advanced technologies become available. In some indications, off-label use of non-approved drugs can
also be considered as competition.
73
Companies, including Inventiva Pharma,
Cirius Therapeutics and Novo Nordisk A/S, have molecules currently in Phase 3 clinical development. Additionally, there are a host of
other potential competitors in earlier stages of clinical development relative to us for the treatment of NASH. Eli Lilly and Company,
Pfizer, Novartis, Bristol-Myers Squibb, Novo Nordisk A/S, Merck, Viking Therapeutics, Inc., Metacrine, Inc., Poxel SA, Can-Fite BioPharma,
89bio, Inc., Sagimet Biosciences Inc. Terns, Inc., AstraZeneca and Hepanova Inc. and others.
In
December 2022, Madrigal announced positive topline results from its pivotal Phase 3 MAESTRO-NASH biopsy clinical trial of resmetirom,
a liver-directed selective thyroid hormone receptor agonist. MAESTRO-NASH, in which Madrigal reported that it achieved both liver histological
improvement endpoints that FDA proposed as reasonably likely to predict clinical benefit to support accelerated approval for the treatment
NASH with liver fibrosis.
In
March 2024, Madrigal announced FDA approval of Rezdiffra (resmetirom) for the treatment of NASH with moderate to advanced liver fibrosis.
Notwithstanding
the foregoing, see "Item 3. Key Information—Risk Factors—Risks Related to Our Business, Industry and Regulatory Requirements—Our
market is subject to intense competition. If we are unable to compete effectively, Aramchol or any other product candidate that we develop
may be rendered noncompetitive or obsolete" and "Item 3. Key Information—Risk Factors—Risks Related to Our Business,
Industry and Regulatory Requirements—We are developing Aramchol for the treatment of NASH, an indication for which there are no
approved products, and there is significant uncertainty regarding the regulatory approval process. This makes it difficult to predict
the timing and costs of the clinical development of Aramchol for the treatment of NASH."
Intellectual
Property and Patent Strategy
The
proprietary nature of, and protection for, Aramchol or Amilo-5MER or any other product candidate and our discovery programs for new indications,
processes and know-how are important to our business. We own patent rights to Aramchol and Amilo-5MER in various jurisdictions worldwide,
including within and outside of Israel. We have sought patent protection in the United States and internationally for Aramchol and Amilo-5MER,
our discovery programs, and any other inventions to which we have rights, where available and when appropriate.
We
have granted patents and pending patent applications in various jurisdictions relating to (1) the composition of matter of Aramchol meglumine
as well as a wide range of other salts, or the CoM Patent; (2) a method for treating/inhibiting hepatic fibrosis and non-hepatic fibrosis
associated or non-associated with NASH or NAFLD, or the Hepatic Fibrosis Patent; and (3) a method of treating dysbiosis, or the Dysbiosis
Patent. In addition, we have pending patent applications for Aramchol meglumine and other salts, including a granted U.S. patent for
low dose composition of Aramchol (US 10,849,911 B2) and other salts. We have been allowed or granted patents for Aramchol and other salts
which includes claims for the treatment of fatty liver in Europe and certain other countries. The CoM Patent application was granted
in the United States, Brazil and India. The CoM Patent that was granted in the United States and the expected term is December2034,.
The Hepatic Fibrosis Patent has been granted in United States (US 11,197,870 B2), Europe, Japan, Canada and in Israel and has an expected
term in each jurisdiction of 2037. The Dysbiosis Patent was granted in U.S., Israel and Mexico and has an expected term in US of 2038
and of 2037 in Israel and Mexico; and was allowed in Brazil. In addition, patent applications were granted in Israel relating to Aramchol
use in hepatic fibrosis treatment, optionally associated with NAFLD and NASH ; and in Mexico relating to Aramchol use to treat pulmonary
fibrosis. Also, a patent was granted in Mexico and Europe relating to Aramchol use for inhibition of fibrosis in NAFLD patients (having
fibrosis score of zero (0)). We also have granted patentsfor combination therapy for the treatment of liver disease in Canada, Europe,
and Mexico.
74
We
have an exclusive license to a US granted patent directed to Amilo-5MER and anti-inflammatory compositions thereof On 2023 our collaborator,
YISSUM RESEARCH DEVELOPMENT COMPANY OF THE HEBREW UNIVERSITY OF JERUSALEM LTD was granted a new patent (US 11,560, 417 B2, a division
of US 10,611,819 B2) for using the 5MER for the treatment of inflammatory diseases which has an expected term until 2035.
Our
policy is to pursue, maintain and defend patent rights, whether developed internally or licensed from third parties, and to protect the
technology, inventions and improvements that are commercially important to the development of our business. We also rely on trade secrets
that may be important to the development of our business.
Patent
Portfolio for Aramchol and Aramchol Meglumine
The
patent portfolio for Aramchol contains eight patent families including pending patent applications and granted patents directed to composition
of matter, manufacturing methods and methods of use.
All
patents in this family are expired (term ended).
A
patent family directed to topical uses of FABAC compounds (anti-acne) was granted in Europe and maintained in Germany, France, Italy,
the Netherlands and the United Kingdom. Expected term is 2033.
A
patent family discloses and claims second generation FABAC salt compounds include Aramchol meglumine. This patent family includes Granted
U.S., Brazil, India, Europe (maintained in Albania, Austria, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Greece,
Hungary, Iceland, Italy, Latvia, Lithuania, Macedonia, Malta, Norway, Poland, Portugal, Romania, San Marino, Serbia, Slovakia, Slovenia,
Spain, Sweden, The Netherlands, Turkey, Belgium, France, Germany, Ireland, Luxembourg, Malta, Monaco, Switzerland and United Kingdom),
China, Hong Kong, Macau, Canada, Israel, Korea, Japan, and Australia patents. If the appropriate maintenance, renewal, annuity or other
governmental fees are paid, the expected term for this patent family is December 2034.
A
patent family having one U.S. patent application, discloses and claims compositions comprising low doses of the second generation FABAC
compounds Aramchol meglumine and other salts which was granted by the USPTO. When the appropriate maintenance, renewal, annuity or other
governmental fees are paid, the expected term for this patent family is December2034.
A
family is directed to treatment for modulating gut microbiota and/or dysbiosis using Aramchol. This patent family includes a granted
patents in Israel, U.S. and in Mexico; and pending foreign patent applications in Brazil, Canada, China, Europe, Hong Kong and Japan.
Expected term for this patent family is 2037,expect for U.S. where the term is 2038.
A
patent family and eighth family are directed to uses of Aramchol and Aramchol meglumine for treating and inhibiting fibrosis. The families
have pending patent applications in in Australia, Brazil, Canada, China, Europe, Hong-Kong, Israel, Japan, Korea, Mexico and US. It was
granted in Canada, Europe, Japan and Mexico; and the treatment of pulmonary fibrosis was granted in Mexico and Japan (also dermal fibrosis
in Japan). Expected term of this patent family is 2037. Additionally, a U.S. patent application directed to a method for treating hepatic
fibrosis non-associated with non-alcoholic fatty acid liver disease – was granted, and the expected term is 2037. In addition,
a US applications have been filed and claims the treatment pulmonary, kidney, dermal, gastro intestinal and heart fibrosis by Aramchol.
The improved bio-availability of Aramchol is supported by the pharmacological model based on the preclinical and the ARREST data. Also,
treatment and inhibition of fibrosis by a regimen of 300 mg of Aramchol twice daily is pending in: Australia and China and granted in
Israel. Expected term of this patent family is 2039.
75
A
patent family is directed to a combination therapy of aramchol and MGL3196 for treating fatty liver disease; and has a PCT application
which entered National Phase in: Australia, Brazil, Canada, China, Europe, Hong Kong, Israel, India, Japan, Korea, Mexico and U.S. It
was granted in Canada, Europe and Mexico. Expected term for this patent family is 2039.
Patent
Portfolio for Amilo-5MER
The
patent portfolio for Amilo-5MER contains two patent families including pending patent applications and granted patents directed to composition
of matter and methods of use.
A
t patent family is directed to Amilo-5MER and anti-inflammatory compositions thereof. Galmed Research and Development Ltd. has an exclusive
license to the U.S. granted patent within this family, and the expected term of this U.S. patent is 2035. Galmed Research and Development
Ltd. has also exclusive licenses to the corresponding granted patents in Europe, Australia, Japan, China and India. The corresponding
applications in Brazil, Korea and Canada are pending. The non-US expected patent term is 2035. A divisional application claiming the
use of Amilo-5MER for the treatment of inflammatory diseases was granted in 2023.
A
patent family is directed to peptides for treating acute respiratory distress syndrome. This family includes a pending PCT international
patent application. Galmed Research and Development Ltd. is a co-applicant in this PCT application with Yissum. The expected patent term
for this patent family is 2041.
Our
commercial success will depend in part on obtaining and maintaining patent protection and trade secret protection of our current and
other product candidates and the methods used to develop and manufacture them, as well as successfully defending these patents against
third-party challenges. Our ability to stop third parties from making, using, selling, offering to sell or importing our products depends
on the extent to which we have rights under valid and enforceable patents or trade secrets that cover these activities. We believe that
our patents provide broad and comprehensive coverage of Aramchol and the Amilo-5MER and uses thereof. However, the patent positions of
biopharmaceutical companies, such as ourselves, are generally uncertain and involve complex legal and factual questions. Our ability
to maintain and solidify our proprietary position for the technology will depend on our success in obtaining effective claims and enforcing
those claims once granted. There is no certainty that any of the Company's pending patent applications will result in the issuance
of any patents. The issued patents and those that may be issued in the future, may be challenged, narrowed, circumvented or found to
be invalid or unenforceable, which could limit our ability to stop competitors from marketing related products or the length of term
of patent protection that we may have for our products. In addition, our competitors may independently develop similar technologies or
duplicate any technology developed by us, and the rights granted under any issued or future patents may not provide us with any meaningful
competitive advantages against these competitors. Furthermore, because of the extensive time required for development, testing and regulatory
review of a potential product, before any of our products can be commercialized, any related patent may expire or remain in force for
only a short period following commercialization, thereby reducing any advantage of such patent. For more risks associated with the protection
of our licensed intellectual property, see "Item 3. Key Information— Risk Factors—Risks Related to Our Intellectual
Property."
Trade
Secrets
In
addition to patents, we rely on trade secrets and know-how to develop and maintain our competitive position. Trade secrets and know-how
can be difficult to protect. We seek to protect our proprietary processes, in part, by confidentiality agreements and invention assignment
agreements with our employees, consultants, scientific advisors, contractors and commercial partners. These agreements are designed to
protect our proprietary information. We also seek to preserve the integrity and confidentiality of our data, trade secrets and know-how
by maintaining physical security of our premises and physical and electronic security of our information technology systems. While we
have confidence in these individuals, organizations and systems, such agreements or security measures may be breached, and we may not
have adequate remedies for any breach. In addition, our trade secrets may otherwise become known or be independently discovered by competitors
or others.
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Seasonality
Our
business and operations are generally not affected by seasonal fluctuations or factors.
Raw
Materials and Suppliers
We
believe that the raw materials that we require to manufacture Aramchol are readily available commodities commonly used in the pharmaceutical
industry.
Manufacturing
We
do not own or operate manufacturing facilities for the production of Aramchol or any other product candidate, nor do we have plans to
develop our own manufacturing operations in the foreseeable future. We currently rely on third-party contract manufacturers for all of
our required raw materials, API and finished product for our non-clinical research and clinical trials. We do not have long term agreements
with any of these third parties. We also do not have any current contractual relationships for the manufacture of commercial supplies
of Aramchol if it is approved. If Aramchol or any other product candidate are approved by any regulatory agency, we intend to enter into
agreements with a third-party contract manufacturer or collaboration partner and one or more back-up manufacturers for the commercial
production of those products. Development and commercial quantities of any products that we develop will need to be manufactured in facilities,
and by processes, that comply with the requirements of the FDA and the regulatory agencies of other jurisdictions in which we are seeking
approval. We currently employ internal resources to manage our manufacturing contractors. The relevant manufacturers of our drug substance
and drug products for our current pre-clinical and clinical trials have advised us that they are compliant with both cGMP and, cGLP.
There
can be no assurance that Aramchol, if approved, can be manufactured in sufficient commercial quantities, in compliance with regulatory
requirements and at an acceptable cost. We and our contract manufacturers are, and will be, subject to extensive governmental regulation
in connection with the manufacture of any pharmaceutical products or medical devices. We and our contract manufacturers must ensure that
all of the processes, methods and equipment are compliant with cGMP and cGLP for drugs on an ongoing basis, as mandated by the FDA and
other regulatory authorities, and conduct extensive audits of vendors, contract laboratories and suppliers.
Contract
Research Organizations
We
outsource certain clinical trial activities to CROs. Our clinical CROs comply with guidelines from the International Conference on Harmonisation
of Technical Requirements for Registration of Pharmaceuticals for Human Use, which attempt to harmonize the FDA, the EMA, and the Pharmaceuticals
and Medical Devices Agency of Japan regulations and guidelines. We create and implement the drug development plans and manage the CROs
according to the specific requirements of the drug candidate under development. To the extent clinical research is overseen by the CROs
(or directly by us), compliance with certain federal regulations, including but not limited to 21 C.F.R. parts 50, 54, 56, 58 and 312,
which pertain to, among other things, IRBs, informed consent, financial conflicts of interest by investigators, correct administration
of treatment, follow up of adverse events, good laboratory practices and submitting IND applications, may be required.
Marketing,
Sales and Commercialization
Given
our stage of development, we do not have any internal sales, marketing or distribution infrastructure or capabilities. In the event we
receive regulatory approval for any product candidate we intend, where appropriate, to pursue commercialization relationships, including
strategic alliances and licensing, with pharmaceutical companies and other strategic partners, which are equipped to market and/or sell
our product candidates through their well-developed sales, marketing and distribution organizations in order to gain access to global
markets. In addition, we may out-license some or all of our worldwide patent rights to more than one party to achieve the fullest development,
marketing and distribution of any products we develop. Over the longer term, we may consider ultimately building an internal marketing,
sales and commercial infrastructure. See "Item 4. Information on the Company— Business Overview—Strategic Collaborations,
Research Arrangements and other Material Agreements—Samil Pharm Co." for information regarding the license agreement we entered
with Samil for the commercialization of Aramchol (with an option to manufacture) for the treatment of fatty liver indications including
NASH, in the Republic of Korea.
77
Environmental
Matters
We,
our agents and our service providers, including our manufacturers, may be subject to various environmental, health and safety laws and
regulations, including those governing air emissions, water and wastewater discharges, noise emissions, the use, management and disposal
of hazardous, radioactive and biological materials and wastes and the cleanup of contaminated sites. We believe that our business, operations
and facilities, including, to our knowledge, those of our agents and service providers, are being operated in compliance in all material
respects with applicable environmental and health and safety laws and regulations. All information with respect to any chemical substance
is filed and stored as a Material Safety Data Sheet, as required by applicable environmental regulations. Based on information currently
available to us, we do not expect environmental costs and contingencies to have a material adverse effect on us. However, significant
expenditures could be required in the future if we, our agents or our service providers are required to comply with new or more stringent
environmental or health and safety laws, regulations or requirements.
Government
Regulation and Product Approval
Governmental
authorities in the United States and in other countries extensively regulate, among other things, the research, development, testing,
manufacture, labeling, packaging, promotion, storage, advertising, distribution, marketing and export and import of products such as
those we are developing. Aramchol or any other product candidate must be approved by the FDA through the NDA process before they may
be legally marketed in the United States and by the Committee on Human Medicinal Products, or CHMP, via the EMA and European Commission
through the MAA process before they may be legally marketed in Europe, or MHRA through its authorization procedures before they may be
legally marketed in the UK. Aramchol or any other product candidate will be subject to similar requirements in other countries prior
to marketing in those countries. The process of obtaining regulatory approvals and the subsequent compliance with applicable federal,
state, local and foreign statutes and regulations require the expenditure of substantial time and financial resources.
United
States Government Regulation
NDA
Approval Processes
In
the United States, the FDA regulates drugs under the Federal Food, Drug, and Cosmetic Act, or the FDCA, and implementing regulations
and guidance documents. Failure to comply with the applicable U.S. requirements at any time during the product development process or
approval process, or after approval, may subject an applicant to administrative or judicial sanctions, any of which could have a material
adverse effect on us. These sanctions could include refusal to approve pending applications, withdrawal of an approval, imposition of
a clinical hold, issuance of warning letters, product seizures, total or partial suspension of production or distribution, injunctions,
fines, disgorgement, and civil or criminal penalties.
The
process required by the FDA before a drug may be marketed in the United States generally involves the following:
●
completion of pre-clinical
    laboratory tests, animal studies and formulation studies conducted according to GLPs, or other applicable regulations;
●
submission to the FDA of
    an IND application, which must become effective before human clinical trials may begin;
●
performance of adequate
    and well-controlled human clinical trials according to GCPs, to establish the safety and efficacy of the proposed drug for its intended
    use;
●
submission to the FDA of an NDA;
78
●
satisfactory completion
    of an FDA inspection of the manufacturing facility or facilities at which the product is produced to assess compliance with cGMPs
    to assure that the facilities, methods and controls are adequate to preserve the drug's identity, strength, quality and purity;
●
satisfactory completion of FDA inspections of clinical
    sites and GLP toxicology studies; and
●
FDA review and approval of the NDA.
The
testing and approval process requires substantial time, effort and financial resources, and we cannot be certain that any approvals for
Aramchol, Amilo-5MER or any other product candidate will be granted on a timely basis, if at all.
Once
a product candidate is identified for development, it enters the pre-clinical testing stage. Pre-clinical tests include laboratory evaluations
of product chemistry, toxicity and formulation, as well as animal studies. An IND sponsor must submit the results of the pre-clinical
tests, together with manufacturing information and analytical data, to the FDA as part of the IND. Some pre-clinical testing may continue
after the IND is submitted. In addition to including the results of the pre-clinical studies, the IND will also include a clinical trial
protocol detailing, among other things, the objectives of the clinical trial, the parameters to be used in monitoring safety and, depending
on the phase of the study, the effectiveness criteria to be evaluated. The IND automatically becomes effective 30 days after receipt
by the FDA, unless the FDA, within the 30-day time period, places the IND on clinical hold. In such a case, the IND sponsor and the FDA
must resolve any outstanding concerns before clinical trials can begin. A clinical hold may occur at any time during the life of an IND,
due to safety concerns or non-compliance, and may affect one or more specific studies or all studies conducted under the IND.
All
clinical trials must be conducted under the supervision of one or more qualified investigators in accordance with the FDA's GCP
regulations. These regulations include the requirement that all research subjects provide informed consent. Further, an IRB must review
and approve the plan for any clinical trial, including the informed consent document, before it commences at any institution. An IRB
considers, among other things, whether the risks to individuals participating in the trials are minimized and are reasonable in relation
to anticipated benefits. The IRB also approves the investigator brochure and other information about the trial distributed by the sponsor
and the consent form that must be provided to each trial subject or his or her legal representative and must monitor the study until
completed. All clinical trials must be conducted under protocols detailing the objectives of the trial, dosing procedures, research subject
inclusion and exclusion criteria and the safety and effectiveness criteria to be evaluated. Each protocol must be submitted to the FDA
as part of the IND, and progress reports detailing the status of the clinical trials must be submitted to the FDA annually. Sponsors
must also report within set timeframes to FDA serious and unexpected adverse reactions, any clinically important increase in the rate
of a serious suspected adverse reaction over that listed in the protocol or investigation brochure, or any findings from other studies
or animal or in-vitro testing that suggest a significant risk in humans exposed to the drug. Sponsors must also report to FDA certain
amendments to the protocol and other essential information concerning the IND that does not fall within the scope of other required reports.
Human
clinical trials are typically conducted in three sequential phases that may overlap or be combined:
●
Phase 1.
The drug
    is initially introduced into healthy human subjects and tested for safety, dosage tolerance, absorption, metabolism, distribution
    and elimination. In the case of some products for severe or life-threatening diseases, such as cancer, especially when the product
    may be inherently too toxic to ethically administer to healthy volunteers, the initial human testing is often conducted in patients.
●
Phase 2.
Clinical
    trials are performed on a limited patient population intended to identify possible adverse effects and risks, to preliminarily evaluate
    the efficacy of the product for specific targeted diseases and to determine dosage tolerance and optimal dosage.
●
Phase 3.
Clinical
    trials are undertaken to further evaluate dosage, clinical efficacy and safety in an expanded patient population at geographically
    dispersed clinical study sites. Phase 3 clinical trials are conducted to provide sufficient data for the statistically valid evidence
    of safety and efficacy.
79
●
Phase 4.
The FDA
    may require that the sponsor conduct additional clinical trials following new drug approval. The purpose of these trials, known as
    Phase 4 studies, is to monitor long-term risks and benefits, study different dosage levels or evaluate safety and effectiveness.
    In recent years, the FDA has increased its reliance on these trials. Phase 4 studies usually involve thousands of participants. Phase
    4 studies also may be initiated by the company sponsoring the new drug to gain broader market value for an approved drug.
Human
clinical trials are inherently uncertain and Phase 1, Phase 2, Phase 3 and Phase 4 testing may not be successfully completed. The FDA
or the sponsor may suspend a clinical trial at any time for a variety of reasons, including a finding that the research subjects or patients
are being exposed to an unacceptable health risk. Similarly, an IRB can suspend or terminate approval of a clinical trial at its institution
if the clinical trial is not being conducted in accordance with the IRB's requirements or if the drug has been associated with
unexpected serious harm to patients.
During
the development of a new drug, sponsors are given opportunities to meet with the FDA at certain points. These points are typically prior
to the submission of an IND, at the end of Phase 2 and before an NDA is submitted. Meetings at other times may also be requested. These
meetings can provide an opportunity for the sponsor to share information about the data gathered to date and for the FDA to provide advice
on the next phase of development. Sponsors typically use the meeting at the end of Phase 2 to discuss their Phase 2 clinical results
and present their plans for the pivotal Phase 3 clinical trial that they believe will support the approval of the NDA.
Concurrent
with clinical trials, sponsors usually complete any remaining animal safety studies and also develop additional information about the
chemistry and physical characteristics of the drug and finalize a process for manufacturing commercial quantities of the product in accordance
with cGMP requirements. The manufacturing process must be capable of consistently producing quality batches of the drug and the manufacturer
must develop methods for testing the quality, purity and potency of the drug. Additionally, appropriate packaging must be selected and
tested and stability studies must be conducted to demonstrate that the drug candidate does not undergo unacceptable deterioration over
its proposed shelf-life.
The
results of product development, pre-clinical studies and clinical trials, along with descriptions of the manufacturing process, analytical
tests and other control mechanisms, proposed labeling and other relevant information are submitted to the FDA as part of an NDA requesting
approval to market the product for one or more specified indications. The submission of an NDA is subject to the payment of an application
fee, but a waiver of such fees may be obtained under specified circumstances. We will seek a waiver of these fees as a small business
submitting its first human drug application to the FDA. If the waiver is granted it would not extend to establishment or product fees.
The FDA reviews all NDAs submitted to ensure that they are sufficiently complete for substantive review before it accepts them for filing.
It may request additional information rather than accept an NDA for filing. In this event, the NDA must be resubmitted with the additional
information. The resubmitted application also is subject to review before the FDA accepts it for filing.
Once
the submission is accepted for filing, the FDA begins an in-depth review. The FDA may refuse to approve an NDA if the applicable statutory
and regulatory criteria are not satisfied or may require additional clinical or other data. Even if such data are submitted, the FDA
may ultimately decide that the NDA does not satisfy the criteria for approval. The FDA reviews an NDA to determine, among other things,
whether a product is safe and effective for its intended use and whether its manufacturing is cGMP-compliant. The FDA may refer the NDA
to an advisory committee for review and recommendation as to whether the application should be approved and under what conditions. The
FDA is not bound by the recommendation of an advisory committee, but it generally follows such recommendations. Before approving an NDA,
the FDA will typically inspect the facility or facilities where the product is manufactured and tested. The FDA will also inspect selected
clinical sites that participated in the clinical studies and may inspect the testing facilities that performed the GLP toxicology studies
cited in the NDA.
80
Expedited
Review and Approval
The
FDA has various specific programs, including Fast Track, Breakthrough Therapy, Priority Review, and Accelerated Approval, which, in different
ways, are each intended to expedite the process for reviewing and approving drugs. Even if a drug qualifies for one or more of these
programs, the FDA may later decide that the drug no longer meets the conditions for qualification or that the time period for FDA review
or approval will be shortened. Generally, drugs that are eligible for these programs are those for serious or life-threatening conditions,
those with the potential to address unmet medical needs and those that offer meaningful benefits over existing treatments. For example,
Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious or life-threatening
diseases or conditions and fill unmet medical needs, and Breakthrough Therapy designation is designed to expedite the development and
review of drugs that are intended to treat a serious condition where preliminary clinical evidence indicates that the drug may demonstrate
substantial improvement over available therapy on a clinically significant endpoint(s). Priority review is designed to give drugs that
offer major advances in treatment or provide a treatment where no adequate therapy exists an initial review within six months as compared
to a standard review time of ten months. Although Fast Track, Breakthrough Therapy designation and priority review do not affect the
standards for approval, the FDA will attempt to facilitate early and frequent meetings with a sponsor of a Fast Track or Breakthrough
Therapy designated drug and expedite review of the application for a drug designated for priority review. The FDA will also provide Breakthrough
Therapy designated drugs intensive guidance on an efficient drug development program and provide these drug developers with an organizational
commitment from the FDA involving senior managers. Since sponsors can design clinical trials in a number of ways, in providing its guidance
for drugs designated as breakthrough therapies, the FDA will seek to ensure that the sponsor of the product designated as a breakthrough
therapy receives timely advice and interactive communications in order to help the sponsor design and conduct a development program as
efficiently as possible. During these interactions, the FDA may suggest, or a sponsor can propose, alternative clinical trial designs
(e.g., adaptive designs, an enrichment strategy, use of historical controls) that may result in smaller trials or more efficient trials
that require less time to complete. Such trial designs could also help minimize the number of patients exposed to a potentially less
efficacious treatment (i.e., the control group treated with available therapy). On September 23, 2014, the FDA granted Fast Track designation
status to Aramchol for the treatment of patients who are overweight or obese and have pre diabetes or type II diabetes mellitus with
NASH.
Accelerated
Approval, which is described in 21 C.F.R. § 314.500
et seq
., provides for approval of a new drug that is intended to treat
a serious or life-threatening disease or condition and that fills an unmet medical need based on a surrogate endpoint. A surrogate endpoint
is a laboratory measurement or physical sign used as an indirect or substitute measurement representing a clinically meaningful outcome.
To be used in accelerated approval, a surrogate endpoint must be "reasonably likely, based on epidemiologic, therapeutic, pathophysiologic,
or other evidence to predict benefit on irreversible morbidity or mortality." The term "reasonably likely" implies
that some uncertainty remains about the relationship of the surrogate to the clinical benefit to the patient. Therefore, accelerated
approval is typically contingent on a sponsor's agreement to conduct additional post-approval studies to verify and describe the
drug's clinical benefit. Accelerated Approval does not change the standards for approval, but by allowing a demonstration of efficacy
based on a surrogate endpoint may expedite the approval process.
FDA
Guidance
In
December 2018, the FDA issued "Noncirrhotic Nonalcoholic Steatohepatitis with Liver Fibrosis: Developing Drugs for Treatment",
or "the December Guidance". The December Guidance, though nonbinding on the FDA or us, is intended to assist sponsors in
the clinical development of drugs for the treatment of noncirrhotic NASH with liver fibrosis, describes the FDA's current thinking
regarding the necessary components of a drug development program for noncirrhotic NASH with liver fibrosis and identifies knowledge gaps
that represent important challenges in the development of drugs for the indication. According to the FDA, the ultimate goal of NASH treatment
is to slow the progress of, halt, or reverse disease progression and improve clinical outcomes (i.e., prevent progression to cirrhosis
and cirrhosis complications, reduce the need for liver transplantation, and improve survival). Because of the slow progression of NASH
and the time required to conduct a trial that would evaluate clinical endpoints such as progression to cirrhosis or survival, the FDA
recommends sponsors consider the following liver histological improvements as endpoints reasonably likely to predict clinical benefit
to support accelerated approval under the regulations:
●
Resolution of steatohepatitis
    on overall histopathological reading and no worsening of liver fibrosis on NASH CRN fibrosis score. Resolution of steatohepatitis
    is defined as absent fatty liver disease or isolated or simple steatosis without steatohepatitis and a NAS score of 0–1 for
    inflammation, 0 for ballooning, and any value for steatosis; or
81
●
Improvement in liver fibrosis
    greater than or equal to one stage (NASH CRN fibrosis score) and no worsening of steatohepatitis (defined as no increase in NAS for
    ballooning, inflammation, or steatosis)
Further,
according to the FDA, for NASH drugs approved on the basis of liver histology under the accelerated approval pathway, randomized, double-blind,
placebo-controlled clinical trials designed to describe and verify the drug's clinical benefit should be underway at the time of
submission of the marketing application. Clinical benefit can be verified by demonstrating superiority to placebo in delaying disease
progression measured by a composite endpoint.
The
EMA also issued a reflection paper to provide guidance on drug development in the field of NASH. However, the EMA indicated, among other
things, that both resolution of NASH without worsening of fibrosis and improvement in fibrosis without worsening of NASH would both be
required as intermediate endpoints for demonstrating statistical significance for stage 2 and 3 fibrosis.
See
also "Item 3. Key Information—Risk Factors—Risk Factors—Risks Related to Our Business, Industry and Regulatory
Requirements - We are developing Aramchol for the treatment of NASH, an indication for which there are no approved products, and there
is significant uncertainty regarding the regulatory approval process. This makes it difficult to predict the timing and costs of the
clinical development of Aramchol for the treatment of NASH."
Patent
Term Restoration and Marketing Exclusivity
Depending
upon the timing, duration and specifics of FDA approval of the use of Aramchol or any other product candidate, U.S. patents may be eligible
for limited patent term extension under the Hatch-Waxman Act. The Hatch-Waxman Act permits a patent restoration term of up to five years
as compensation for patent term lost during product development and the FDA regulatory review process. However, patent term restoration
cannot extend the remaining term of a patent beyond a total of 14 years from the product's approval date. The patent term restoration
period is generally one-half the time between the effective date of an IND, and the submission date of an NDA, plus the time between
the submission date of an NDA and the approval of that application. Only one patent applicable to an approved drug is eligible for the
extension and the application for extension must be made prior to expiration of the patent. The USPTO, in consultation with the FDA,
reviews and approves the application for any patent term extension or restoration. In the future, we intend to apply for restorations
of patent term for some of our currently owned patents to add patent life beyond their current expiration date, depending on the expected
length of clinical trials and other factors involved in the submission of the relevant NDA.
Market
exclusivity provisions under the FDCA can also delay the submission or the approval of certain applications. The FDCA provides a five-year
period of non-patent marketing exclusivity within the United States to the first applicant to gain approval of an NDA for a new chemical
entity. A drug is a new chemical entity if the FDA has not previously approved any other new drug containing the same active moiety,
which is the molecule or ion responsible for the action of the drug substance. During the exclusivity period, the FDA may not accept
for review an abbreviated new drug application, or ANDA, or a 505(b)(2) NDA submitted by another company for another version of such
drug where the applicant does not own or have a legal right of reference to all the data required for approval. However, an application
may be submitted after four years if it contains a certification of patent invalidity or non-infringement. The FDCA also provides three
years of marketing exclusivity for an NDA, 505(b)(2) NDA or supplement to an approved NDA if new clinical investigations, other than
bioavailability studies, that were conducted or sponsored by the applicant are deemed by the FDA to be essential to the approval of the
application, for example, for new indications, dosages or strengths of an existing drug. This three-year exclusivity covers only the
conditions associated with the new clinical investigations and does not prohibit the FDA from approving ANDAs for drugs containing the
original active agent. Five-year and three-year exclusivity will not delay the submission or approval of a full NDA; however, an applicant
submitting a full NDA would be required to conduct or obtain a right of reference to all of the pre-clinical studies and adequate and
well-controlled clinical trials necessary to demonstrate safety and effectiveness.
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Post-approval
Requirements
Once
an approval is granted, the FDA, European authorities and other regulatory authorities may withdraw the approval if compliance with regulatory
requirements is not maintained or if problems occur after the product reaches the market. Later discovery of previously unknown problems
with a product may result in restrictions on the product or even complete withdrawal of the product from the market. After approval,
some types of changes to the approved product, such as adding new indications, manufacturing changes and additional labeling claims,
are subject to further regulatory authority review and approval. Some of these modifications, especially adding indications, would likely
require additional clinical studies. In addition, the FDA may require testing and surveillance programs to monitor the effect of approved
products that have been commercialized, and the FDA has the power to prevent or limit further marketing of a product based on the results
of these post-marketing programs.
Any
drug product manufactured or distributed by us pursuant to FDA approvals are subject to continuing regulation by the FDA, including,
among other things record-keeping requirements; cGMPs; reporting of adverse experiences with the drug; providing the FDA with updated
safety and efficacy information; drug sampling and distribution requirements; notifying the FDA and gaining its approval of specified
manufacturing or labeling changes; and complying with FDA promotion and advertising requirements.
Drug
manufacturers and other entities involved in the manufacture and distribution of approved drugs are required to register their establishments
with the FDA and certain state agencies, and are subject to periodic unannounced inspections by the FDA and some state agencies for compliance
with cGMP and other laws.
We
rely, and expect to continue to rely, on third parties for the production of clinical and commercial quantities of Aramchol. Future FDA
and state inspections may identify compliance issues at the facilities of our contract manufacturers that may disrupt production or distribution,
or require substantial resources to correct.
From
time to time, legislation is drafted, introduced and passed in Congress that could significantly change the statutory provisions governing
the approval, manufacturing and marketing of products regulated by the FDA. In addition, FDA regulations and guidance are often revised
or reinterpreted by the agency in ways that may significantly affect our business and our products. It is impossible to predict whether
legislative changes will be enacted, or FDA regulations, guidance or interpretations changed or what the impact of such changes, if any,
may be. In particular, it is unknown whether any of the provisions of the 2016 21
st
Century Cures Act that are intended to
accelerate drug approval will result in any change in the current approval pathway for Aramchol.
Pursuant
to the Affordable Care Act (discussed in greater detail below), the Centers for Medicare & Medicaid Services (CMS) is required to
collect and publish information reported by applicable manufacturers about payments and other transfers of value manufacturers have made
to physicians and teaching hospitals. Such a law, when applicable to our products, could increase the company's regulatory liability
through the imposition of additional reporting and regulatory requirements. There are also an increasing number of state laws that require
manufacturers to make similar reports to states on pricing and marketing information.
Reimbursement
We
face uncertainties over the pricing of pharmaceutical products. Sales of Aramchol or any other product candidate will depend, in part,
on the extent to which the costs of Aramchol or any other product candidate will be covered by third-party payors, such as federal health
programs, commercial insurance and managed care organizations. These third-party payors are increasingly challenging the prices charged
for medical products and services. Additionally, the containment of healthcare costs has become a priority of federal and state governments
and the prices of drugs have been a focus in this effort. The U.S. government, state legislatures, foreign governments and third party
payors have shown significant interest in implementing cost-containment programs, including price controls, pricing transparency disclosure
obligations, restrictions on reimbursement and requirements for substitution of generic products. Adoption of price controls and cost-containment
measures, and adoption of more restrictive policies in jurisdictions with existing controls and measures, could further limit our net
revenue and results. If these third-party payors do not consider Aramchol or any other product candidate to be cost-effective compared
to other therapies, they may not cover Aramchol or any other product candidate after approved as a benefit under their plans or, if they
do, the level of payment may not be sufficient to allow us to sell Aramchol or any other product candidate on a profitable basis.
83
The
Medicare Modernization Act imposed new requirements for the distribution and pricing of prescription drugs for Medicare beneficiaries
under Part D. Under Part D, Medicare beneficiaries may enroll in prescription drug plans offered by private entities that provide coverage
of outpatient prescription drugs. Part D prescription drug plan sponsors are not required to pay for all covered Part D drugs, and each
drug plan can develop its own drug formulary that identifies which drugs it will cover and at what tier or level. However, Part D prescription
drug formularies must include drugs within each therapeutic category and class of covered Part D drugs, though not necessarily all the
drugs in each category or class. The Centers for Medicare & Medicaid Services published a final rule in 2014 implementing the Medicare
Modernization Act. Contrary to the proposed rule, which would have enabled Part D plans to offer fewer drugs, the final rule maintained
the existing six protected classes of drug categories, but stated that some of the proposals not included in the final rule could still
be finalized in the future, which would impact payor formulary and coverage decisions.
The
American Recovery and Reinvestment Act of 2009 provides funding for the federal government to compare the effectiveness of different
treatments for the same illness. A plan for the research will be developed by the Department of Health and Human Services, the Agency
for Healthcare Research and Quality and the National Institutes for Health, and periodic reports on the status of the research and related
expenditures will be made to Congress. Although the results of the comparative effectiveness studies are not intended to mandate coverage
policies for public or private payors, it is not clear what effect, if any, the research will have on the sales of any product, if any
such product or the condition that it is intended to treat is the subject of a study. It is also possible that comparative effectiveness
research demonstrating benefits in a competitor's product could adversely affect the sales of Aramchol or any other product candidate.
If third-party payors do not consider Aramchol or any other product candidate to be cost-effective compared to other available therapies,
they may not cover Aramchol or any other product candidate as a benefit under their plans or, if they do, the level of payment may not
be sufficient to allow us to sell Aramchol or any other product candidate on a profitable basis.
The
Affordable Care Act, enacted in March 2010, has had a significant impact on the health care industry. Some of the key changes made to
date pursuant to the Affordable Care Act include an expansion of coverage for the uninsured, the creation of insurance marketplaces and
increased protection of insureds with new benefits, rights and protections. With regard to pharmaceutical products, among other things,
the Affordable Care Act made major changes to the Medicare prescription drug program, which helped reduce drug costs for seniors and
increased rebates and other costs for the pharmaceutical industry.
There
have been judicial and congressional challenges to the Affordable Care Act. In December 2017, Congress passed and then the President
Trump signed into law tax reform legislation that made significant changes to the Affordable Care Act including the repeal of the "individual
mandate" that was in place to strongly encourage broad participation in the health insurance markets. On December 14, 2018, a federal
district court in Texas ruled that the PPACA is unconstitutional as a result of the Tax Cuts and Jobs Act, the federal income tax reform
legislation previously passed by Congress and signed by President Trump on December 22, 2017, that eliminated the individual mandate
portion of the PPACA. The case, Texas, et al, v. United States of America, et al., (N.D. Texas), is an outlier, but in 2019, the Fifth
Circuit Court of Appeals subsequently upheld the lower court decision which was then appealed to the United States Supreme Court. The
U.S. Supreme Court declined to hear the appeal on an expedited basis and so no decision is expected until sometime in 2021 before the
end of the Supreme Court's current term. We are not able to state with any certainty what will be impact of this court decision
on our business pending further court action and possible appeals. Given these changes and other statements of political leaders, we
cannot predict the ultimate impact on the Affordable Care Act and the subsequent effect on the pharmaceutical industry at this time.
In November 2020, Joseph Biden was elected President and, in January 2021, the Democratic Party obtained control of the Senate. As a
result of these electoral developments, it is unlikely that continued legislative efforts will be pursued to repeal PPACA. Instead, it
is possible that executive and regulatory initiatives, as well as legislation, will be pursued to enhance or reform PPACA. We are not
able to state with certainty what the impact of potential legislation will be on our business.
In
addition, in some non-U.S. jurisdictions, the proposed pricing for a drug must be approved before it may be lawfully marketed. The requirements
governing drug pricing vary widely from country to country. For example, the EU provides options for its member states to restrict the
range of medicinal products for which their national health insurance systems provide reimbursement and to control the prices of medicinal
products for human use. A member state may approve a specific price for the medicinal product or it may instead adopt a system of direct
or indirect controls on the profitability of the company placing the medicinal product on the market. There can be no assurance that
any country that has price controls or reimbursement limitations for pharmaceutical products will allow favorable reimbursement and pricing
arrangements for Aramchol, Amilo-5MER or any other product candidate. Historically, products launched in the EU do not follow price structures
of the United States and generally tend to be significantly lower.
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Healthcare
Fraud and Abuse Laws
In
the U.S., the research, development, testing, manufacturing, handling, storage, distribution, sale and promotion of drug products and
medical devices are potentially subject to regulation by various federal, state and local authorities in addition to the FDA, including
the Centers for Medicare & Medicaid Services, other divisions of the U.S. Department of Health and Human Services (e.g., the Office
of Inspector General), the U.S. Department of Justice, state Attorneys General, and other state and local government agencies. For example,
sales, marketing and scientific/educational grant programs must comply with the fraud and abuse provisions applicable to pharmaceutical
manufacturers, including the federal "Anti-Kickback Statute", the Civil Monetary Penalty Statute, the Stark Law, the federal
False Claims Act, as amended, state and federal "Physician Payment Sunshine Act" laws and regulations, the privacy regulations
promulgated under the Health Insurance Portability and Accountability Act, or HIPAA, and similar state laws. Pricing and rebate programs
must comply with the Medicaid Drug Rebate Program requirements of the Omnibus Budget Reconciliation Act of 1990, as amended, and the
Veterans Health Care Act of 1992, as amended. If products are made available to authorized users of the Federal Supply Schedule of the
General Services Administration, additional laws and requirements apply. All of these activities are also potentially subject to federal
and state consumer protection and unfair competition laws. Some of these health care laws include:
The
Anti- Kickback Statute makes it illegal for any person, including a prescription drug manufacturer (or a party acting on its behalf)
to knowingly and willfully solicit, receive, offer, or pay any remuneration that is intended to induce the referral of business, including
the purchase, order, or prescription of a particular drug, for which payment may be made under a federal healthcare program, such as
Medicare or Medicaid.
The
federal False Claims Act prohibits anyone from knowingly presenting, conspiring to present, making a false statement in order to present,
or causing to be presented, for payment to federal programs (including Medicare and Medicaid) claims for items or services, including
drugs, that are false or fraudulent, claims for items or services not provided as claimed, or claims for medically unnecessary items
or services. This law also prohibits anyone from knowingly underpaying an obligation owed to a federal program. Increasingly, U.S. federal
agencies are requiring nonmonetary remedial measures, such as corporate integrity agreements in False Claims Act settlements. The U.S.
Department of Justice announced in 2016 its intent to follow the "Yates Memo," taking a far more aggressive approach in pursuing
individuals as False Claims Act defendants in addition to the corporations.
The
Physician Payment Sunshine Act, enacted in 2010 as part of the Affordable Care Act, requires certain manufacturers of pharmaceuticals
and medical devices to annually report certain payments and other transfers of value to physicians (defined to include doctors, dentists,
optometrists, podiatrists and chiropractors) and teaching hospitals, as well as investment interests held by physicians and their immediate
family members. Effective January 1, 2022, covered manufacturers will also be required to report on payments and other transfers of value
to physician assistants, nurse practitioners or clinical nurse specialists, anesthesiologist assistants, certified registered nurse anesthetists,
and certified nurse-midwives during the previous year. In recent years, several states in the United States have also enacted legislation
requiring pharmaceutical companies to file periodic reports with the state, make periodic public disclosures on sales, marketing, pricing,
clinical trials and other activities, and/or register their sales representatives, as well as establish marketing compliance programs.
These laws may affect our sales, marketing, and other promotional activities by imposing administrative and compliance burdens on us.
Failure to meet these requirements, to the extent they are applicable to our activities, could also result in a variety of governmental
sanctions that could have a material adverse effect on our business.
If
our operations are found to be in violation of any of the foregoing or other applicable health care laws and regulations, we may be subject
to penalties, including significant administrative, civil and criminal penalties, monetary damages, disgorgement, imprisonment, the curtailment
or restructuring of our operations, loss of eligibility to obtain approvals from the FDA, or exclusion from participation in government
contracting, healthcare reimbursement or other government programs, including Medicare and Medicaid.
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European
Economic Area
In
addition to approval in the United States, we currently intend to seek regulatory approval of Aramchol in the EU. As such, a summary
of the EU regulatory processes follows below.
A
medicinal product may only be placed on the market in the European Economic Area, or the EEA, composed of the 27 EU member states of
the EU, plus Norway, Iceland and Lichtenstein, when a marketing authorization has been issued by the competent authority of the respective
member state pursuant to member states' law based on Directive 2001/83/EC, as amended, or an authorization has been granted under
the centralized procedure in accordance with Regulation (EC) No. 726/2004, as amended, or its predecessor, Regulation 2309/93. There
are essentially three community procedures created under prevailing European pharmaceutical legislation that, if successfully completed,
allow an applicant to place a medicinal product on the market in the respective EU or EEA member states.
The
withdrawal of the United Kingdom (UK) from the EU took effect on January 1, 2021, and there are 27 member states remaining in the EU.
As of January 1, 2021, the UK is a "third country" with regard to the EU (subject to the terms of the EU UK Trade Agreement)
and EU law ceased to apply directly in the UK. However, the UK has retained the EU medicines regulatory regime with certain modifications
as standalone UK legislation. Therefore, the UK regulatory regime is currently similar to EU regulations, but under new legislation,
the Medicines and Medical Devices Act 2021, the UK may adopt changed regulations that may diverge from the EU legislative regime for
medicines and their research, development and commercialization. In order to market a medicinal product in the UK, a license or marketing
authorization must be obtained from the UK Medicines and Healthcare Products Regulatory Agency (MHRA). The UK legislation includes multiple
assessment routes for applications for medicinal products, including a 150-day national assessment or a rolling review application. Further,
and for a transitional period until 31 December 2022, the MHRA may rely on a decision taken by the European Commission on the approval
of a new marketing authorization in the centralized procedure. In addition, the MHRA has the power to have regard to marketing authorizations
approved in EU member states through the decentralized and mutual recognition procedures.
Centralized
Procedure
Regulation
726/2004/EC, as amended, governs the centralized procedure when a marketing authorization is granted by the European Commission, acting
in its capacity as the European Licensing Authority on the advice of the EMA. That authorization is valid throughout the entire community
and directly or (as to Norway, Iceland and Liechtenstein) indirectly allows the applicant to place the product on the market in all member
states of the EEA. The EMA is the administrative body responsible for coordinating the existing scientific resources available in the
member states for evaluation, supervision and pharmacovigilance of medicinal products. Certain medicinal products, as described in the
Annex to Regulation 726/2004, must be authorized centrally. These are products that are developed by means of certain biotechnological
processes in accordance with Paragraph 1 to the Annex to the Regulation. Medicinal products for human use containing a new active substance
that, on the date of effectiveness of the Regulation, was not authorized in the European Union, and for which the therapeutic indication
is the treatment of acquired immune deficiency syndrome, or AIDS, cancer, neurodegenerative disorder or diabetes, autoimmune diseases
and other immune dysfunctions and viral diseases must also be authorized centrally. Finally, all medicinal products that are designated
as orphan medicinal products pursuant to Regulation 141/2000 and Advanced Therapy Medicinal Products (ATMP) according to Reg. (EC) No.
1394/2007 and medicinal products for veterinary use that are used primarily as performance enhancers must be authorized under the centralized
procedure. An applicant may also opt for assessment through the centralized procedure if the medicinal product contains a new active
substance which was not authorized in the EU when Reg. (EC) No. 726/2004 entered into force, or if the applicant can show that the medicinal
product constitutes a significant therapeutic, scientific or technical innovation or that the granting of authorization centrally is
in the interests of patients or animal health at the community level. For each application submitted to the EMA for scientific assessment,
the EMA is required to ensure that the opinion of the Committee for Medicinal Products for Human Use, or CHMP, is given within 210 days
after receipt of a valid application. This 210 days period does not include the time that the applicant needs to answer any questions
raised during the application procedure, the so-called 'clock stop' period. If the opinion is positive, the EMA is required
to send the opinion to the European Commission, which is responsible for preparing the draft decision granting a marketing authorization.
This draft decision may differ from the CHMP opinion, stating reasons for diverging from the CHMP opinion. The draft decision is sent
to the applicant and the member states, after which the European Commission takes a final decision. If the initial opinion of the CHMP
is negative, the applicant is afforded an opportunity to seek a re-examination of the opinion. In that case, the applicant may, within
15 days after receipt of the opinion, give written notice to EMA that he wishes to request a re-examination of the opinion. The applicant
is then required to forward the detailed grounds for request within 60 days after receipt of the opinion. The CHMP is required to re-examine
its opinion within 60 days following receipt of the request by the applicant. All CHMP refusals and the reasons for refusal are made
public on the EMA website. Without a centralized marketing authorization it is prohibited to place a medicinal product that must be authorized
centrally on the market in the EU. Once a centralized marketing authorization has been granted by the European Commission, it is valid
in all EEA States for 5 years on a renewable basis.
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Mutual
Recognition and Decentralized Procedures
With
the exception of products that are authorized centrally, the competent authorities of the member states are responsible for granting
marketing authorizations for medicinal products placed on their national markets. If the applicant for a marketing authorization intends
to market the same medicinal product in more than one member state, the applicant may seek an authorization progressively in the community
under the mutual recognition or decentralized procedure. Mutual recognition procedure, or MRP is used if the medicinal product has already
been authorized in a member state. In this case, the holder of this marketing authorization requests the member state where the authorization
has been granted to act as reference member state by preparing an assessment report on the product or, if necessary, to update any existing
assessment report that is then used to facilitate mutual recognition of the existing authorization in the other member states in which
approval is sought (the so-called concerned member state(s)). The reference member state must prepare an updated assessment report within
90 days of receipt of a valid application. This report together with the approved Summary of Product Characteristics, the SmPC (which
sets out the conditions of use of the product), and a labeling and package leaflet are sent to the concerned member states for their
consideration. The concerned member states are required to approve the assessment report, the SmPC and the labeling and package leaflet
within 90 days of receipt of these documents. The reference member state shall record the agreement of all parties, close the procedure
and inform the applicant accordingly. Each member state in which an application has been submitted shall adopt a decision in conformity
with the approved documents, within 30 days after acknowledgement of the agreement. In most cases, the total procedural time of the MRP
is 180 days.
The
decentralized procedure, or DCP, is used in cases where the medicinal product has not received a marketing authorization in the EU at
the time of application. The applicant requests a member state of its choice to act as reference member state to prepare an assessment
report that is then used to facilitate agreement with the concerned member states and the grant of a national marketing authorization
in all of these member states. In this procedure, the reference member state must prepare, for consideration by the concerned member
states, the draft assessment report, a draft SmPC and a draft of the labeling and package leaflet within 120 days after receipt of a
valid application. As in the case of mutual recognition, the concerned member states are required to approve these documents within 90
days of their receipt. The reference member state shall record the agreement of all parties, close the procedure and inform the applicant
accordingly. Each member state in which an application has been submitted shall adopt a decision in conformity with the approved documents,
within 30 days after acknowledgement of the agreement. In most cases the total time of the DCP will be 210 days
For
both MRP and DCP, if a concerned member state objects to the grant of a marketing authorization on the grounds of a potential serious
risk to public health, it shall give a detailed exposition of the reasons for its position to with the reference member state. The points
of disagreement are in the first instance referred to the Co-ordination Group on MRP and DCP to reach an agreement within 60 days of
the communication of the points of disagreement. If member states fail to reach an agreement, the reference Member State shall record
the agreement, close the procedure and inform the applicant accordingly. If the member states fail to reach an agreement within the 60-day
period, then the matter is referred to the EMA and CHMP for arbitration. The CHMP is required to deliver a reasoned opinion within 60
days of the date on which the matter is referred. The scientific opinion adopted by the CHMP forms the basis for a binding European Commission
decision.
Irrespective
of whether the medicinal product is assessed centrally, de-centrally or through a process of mutual recognition, the medicinal product
must be manufactured in accordance with the principles of GMP for human use as set out in Directive 2001/83/EC and 2017/1572/EU and Delegated
Regulation 2017/1569 that have replaced Directive 2003/94/EC.
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Directive
2017/1572/EU and Volume 4 of the rules governing medicinal products in the European Union govern GMP in the EU. Moreover, EU law requires
the clinical results in support of clinical safety and efficacy based upon clinical trials conducted in the EU to be in compliance with
the requirements of Regulation (EU) 536/2014 on clinical trials with medicinal products for human use and Implementing Regulation 556/2017
on GCP-inspections which implement good clinical practice in the conduct of clinical trials on medicinal products for human use. Clinical
trials conducted outside the European community and used to support applications for marketing within the EU must have been conducted
in a way consistent with the principles set out in Regulation (EU) 536/2017. The conduct of a clinical trial in the EU requires, pursuant
to Regulation (E) 536/2017, authorization by the relevant national competent authority where a trial takes place, and subject to the
relevant national law, an ethics committee to have issued a favorable opinion in relation to the arrangements for the trial. It also
requires that the sponsor of the trial, or a person authorized to act on his behalf in relation to the trial, be established in the community.
In comparison to the former regime, Regulation (EU) 536/2014 further harmonizes EU law on clinical trials and to some extent facilitates
clinical trials conducted in more than one EU Member State. Under Regulation (EU) 536/2014, trial sponsors submit their application for
trial approval via an EU Portal, Clinical Trials Information System (CTIS). The approvals will still have to be granted by the competent
authorities of the EU Member States where a trial takes place, however, the procedure for approval is conducted in a coordinated manner
among the concerned EU Member States as provided under Regulation (EU) 536/2014. While the process for the application and granting of
the approvals was streamlined, it is still a complex process that can significantly delay the start of a multinational clinical trial.
The
UK has not adopted Regulation (EU) 536/2014 with respect to clinical trials in the UK. Instead, the Medicines for Human Use (Clinical
Trials) Regulations 2004 applies with respect to clinical trials in the UK. The UK has adopted new legislation, the Medicines and Medical
Devices Act 2021 and has issued a consultation with respect to changes to clinical trial legislation to be made under this Act.
National
Procedure
This
procedure is available for medicinal products that do not fall within the scope of mandatory centralized authorization. Specific procedures
and timelines differ between member states, but the duration of the procedure without clock-stop time is generally 210 days and based
on a risk/efficacy assessment by the competent authority of the member state concerned, followed by determination of SmPC, package leaflet
and label text/layout and subsequently grant of the marketing authorization. Marketing authorizations granted on this basis are not mutually
recognized by other member states, but the national marketing authorization can later be used in an MRP to obtain marketing authorizations
in other member states.
There
are various types of applications for marketing authorizations:
●
Full Applications
.
    A full application is one that is made under any of the community procedures described above and that "stands alone"
    in the sense that it contains all of the particulars and information required by Article 8(3) of Directive 2001/83 (as amended) to
    allow the competent authority to assess the quality, safety and efficacy of the product and in particular the balance between benefit
    and risk. Article 8(3)(i) in particular refers to the need to present the results of the applicant's research on (i) pharmaceutical
    (physical-chemical, biological or microbiological) tests, (ii) pre-clinical (toxicological and pharmacological) studies and (iii)
    clinical trials in humans. The nature of these tests, studies and trials is explained in more detail in Annex I to Directive 2001/83/EC.
    Full applications would be required for products containing new active substances not previously approved by the competent authority,
    but may also be made for other products.
●
Abridged Applications
.
    Article 10 of Directive 2001/83/EC contains exemptions from the requirement that the applicant has to provide the results of its
    own pre-clinical and clinical research. There are three regulatory routes for an applicant to seek an exemption from providing such
    results, namely (i) cross-referral to an innovator's results without consent of the innovator, (ii) well established use according
    to published literature and (iii) consent to refer to an existing dossier of research results filed by a previous applicant.
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Cross-referral
to Innovator's Data
Articles
10(1) and 10(2)(b) of Directive 2001/83/EC provide the legal basis for an applicant to seek a marketing authorization on the basis that
its product is a generic medicinal product (a copy) of a reference medicinal product that has already been authorized, in accordance
with community provisions. A reference product is, in principle, an original product granted an authorization on the basis of a full
dossier of particulars and information. This is the main exemption used by generic manufacturers for obtaining a marketing authorization
for a copy product. The generic applicant is not required to provide the results of pre-clinical studies and of clinical trials if its
product meets the definition of a generic medicinal product and the applicable regulatory results protection period for the results submitted
by the innovator has expired. A generic medicinal product is defined as a medicinal product:
●
having the same qualitative
    and quantitative composition in active substance as the reference medicinal product; having the same pharmaceutical form as the reference
    medicinal product; and
●
whose bioequivalence with
    the reference medicinal product has been demonstrated by appropriate bioavailability studies.
Applications
in respect of a generic medicinal product cannot be made before the expiry of the protection period. Where the reference product was
granted a national marketing authorization pursuant to an application made before October 30, 2005, the protection period is either six
years or 10 years, depending upon the election of the particular member state concerned. Where the reference product was granted a marketing
authorization centrally, pursuant to an application made before November 20, 2005, the protection period is 10 years. For applications
made after these dates, Regulation 726/2004 and amendments to Directive 2001/83/EC provide for a harmonized protection period regardless
of the approval route utilized. The harmonized protection period is in total 10 years, including eight years of research data protection
and two years of marketing protection. The effect is that the originator's results can be the subject of a cross-referral application
after eight years, but any resulting authorization cannot be exploited for a further two years. The rationale of this procedure is that
the relevant particulars can, if the research data protection period has expired, be found on the originator's file and used for
assessment of the generic medicinal product. The 10-year protection period can be extended to 11 years where, in the first eight years
post-authorization, the holder of the authorization obtains approval for a new therapeutic indication assessed as offering a significant
clinical benefit in comparison with existing therapies.
If
the copy product does not meet the definition of a generic medicinal product or if bioequivalence could not be demonstrated through bioavailability
studies or in case of certain types of changes in the active substance(s) or in the therapeutic indications, strength, pharmaceutical
form or route of administration in relation to the reference medicinal product, Article 10(3) of Directive 2001/83/EC provides that the
results of the appropriate pre-clinical studies or clinical trials must be provided by the applicant.
Well-established
Medicinal Use
Under
Article 10a of Directive 2001/83/EC, an applicant may, in substitution for the results of its own pre-clinical and clinical research,
present detailed references to published literature demonstrating that the active substance(s) of a product have a well- established
medicinal use within the community for at least ten years with recognized efficacy and an acceptable level of safety in terms of the
conditions set out in Annex I of Directive 2001/83/EC. In that event, the test and trial results shall be replaced by appropriate scientific
literature. The applicant is entitled to refer to a variety of different types of literature, including reports of clinical trials with
the same active substance(s) and epidemiological studies that indicate that the constituent or constituents of the product have an acceptable
safety/efficacy profile for a particular indication. However, use of the published literature exemption is restricted by stating that
in no circumstances active substances be treated as having a well- established use if they have been used for less than 10 years from
the first systematic and documented use of the substance as a medicinal product in the EU. Even after 10 years' systematic use,
the threshold for well-established medicinal use might not be met. European pharmaceutical law requires the competent authorities to
consider among other factors the period over which a substance has been used, the amount of patient use of the substance, the degree
of scientific interest in the use of the substance (as reflected in the scientific literature) and the coherence (consistency) of all
the scientific assessments made in the literature. For this reason, different substances may reach the threshold for well-established
use after different periods, but the minimum period is 10 years. If the applicant seeks approval of an entirely new therapeutic use compared
with that to which the published literature refers, additional pre-clinical and/or clinical results would have to be provided.
89
Authorization
Holder's Consent
Under
Article 10c of Directive 2001/83/EC, following the grant of a marketing authorization the holder of such authorization may consent to
a competent authority utilizing the pharmaceutical, pre-clinical and clinical documentation that it submitted to obtain approval for
a medicinal product to assess a subsequent application relating to a medicinal product possessing the same qualitative and quantitative
composition with respect to the active substances and the same pharmaceutical form.
Law
Relating to Pediatric Research
Regulation
(EC) 1901/2006 (as amended by Regulation (EC) 1902/2006) was adopted on December 12, 2006. This Regulation governs the development of
medicinal products for human use in order to meet the specific therapeutic needs of the pediatric population. It requires any application
for marketing authorization made after July 26, 2008 in respect of a product not authorized in the European Community on January 26,
2007 (the time the Regulation entered into force), to include the results of all studies performed and details of all information collected
in compliance with a pediatric investigation plan agreed by the Pediatric Committee of the EMA, unless the product is subject to an agreed
waiver or deferral or unless the product is excluded from the scope of Regulation 1901/2006 (generics, hybrid medicinal products, biosimilars,
homeopathic and traditional (herbal) medicinal products and medicinal products containing one or more active substances of well-established
medicinal use) according to its Art. 9. Waivers can be granted in certain circumstances where pediatric studies are not required or desirable.
Deferrals can be granted in certain circumstances where the initiation or completion of pediatric studies should be deferred until appropriate
studies in adults have been performed. The EMA does not evaluate an application for market authorization that is not exempt from Regulation
(EC) 1901/2006 if there is no agreed PIP, deferral or waiver. Moreover, this regulation imposes the same obligation from January 26,
2009 on an applicant seeking approval of a new indication, pharmaceutical form or route of administration for a product already authorized
and still protected by a supplementary protection certificate granted under Regulation EC 469/2009 and its precursor Regulation (EEC)
1768/92 or by a patent that qualifies for the granting of such a supplementary protection certificate. The pediatric Regulation (EC)
1901/2006 also provides, subject to certain conditions, a reward for performing such pediatric studies, regardless of whether the pediatric
results provided resulted in the grant of a pediatric indication. This reward comes in the form of an extension of six months to the
supplementary protection certificate granted in respect of the product, unless the product is subject to orphan drug designation, in
which case the 10-year market exclusivity period for such an orphan product is extended to 12 years. If any of the non-centralized procedures
for marketing authorization have been used, the six-month extension of the supplementary protection certificate is only granted if the
medicinal product is authorized in all member states.
Post-authorization
Obligations
In
the pre-authorization phase, the applicant must provide a detailed pharmacovigilance plan that it intends to implement post- authorization.
An authorization to market a medicinal product in the EU carries with it an obligation to comply with many post- authorization organizational
and behavioral regulations relating to the marketing and other activities of authorization holders. These include requirements relating
to post-authorization efficacy studies, post-authorization safety studies, adverse event reporting and other pharmacovigilance requirements,
advertising, packaging and labeling, patient package leaflets, distribution and wholesale dealing. The regulations frequently operate
within a criminal law framework and failure to comply with the requirements may not only affect the authorization, but also can lead
to financial and other sanctions levied on the company in question and responsible officers. EU pharmacovigilance legislation has been
significantly modified by the Pharmacovigilance Directive, Dir. 2010/84/EC which amended the legal framework of pharmacovigilance for
medicines marketed within the EU provided in Regulation (EC) No 726/2004 with respect to EU authorized medicinal products and in Directive
2001/83/EC with respect to nationally authorized medicinal products (including those authorized through the mutual recognition and decentralized
systems). In addition, Commission Implementing Regulation (EU) No 520/2012 outlines the practical details to be respected by marketing
authorization holders, national competent authorities and the EMA, Regulation (EU) No 1027/2012 and Directive 2012/26/EU which further
amended the pharmacovigilance legislation to further strengthen the protection of patient health by allowing prompt notification and
assessment of safety issues and Commission Delegated Regulation (EU) No 357/2014 on post-authorization efficacy studies specifies the
situations in which such studies may be required. Furthermore, EU good pharmacovigilance practice (GVP) rules apply. With these pharmacovigilance
requirements, the financial and organizational burden on market authorization holders is significant, such as the obligation to maintain
a pharmacovigilance system master file that applies to all holders of marketing authorizations granted in accordance with Directive 2001/83/EC,
as amended, or Regulation (EC) No 726/2004, as amended. Marketing authorization holders must furthermore collect data on adverse events
associated with use of the authorized product outside the scope of the authorization. Pharmacovigilance for biological products and medicines
with a new active substance is even stricter, as their authorization is subject to additional monitoring activities.
90
Any
authorization granted by member state authorities, which within three years of its granting is not followed by the actual placing on
the market of the authorized product in the authorizing member state, ceases to be valid (Art. 24 (4) Directive 2001/83/EC). When an
authorized product previously placed on the market in the authorizing member state is no longer actually present on the market for a
period of three consecutive years, the authorization for that product shall cease to be valid (Art. 24 (5) Directive 2001/83/EC). The
same two three-year periods apply to authorizations granted by the European Commission based on the centralized procedure (Art. 14 (4)
and (5) Regulation (EC) 726/2004).
Other
Countries
In
addition to regulations in the United States, the EU, the UK and Israel, we are subject to a variety of other regulations governing clinical
trials and commercial sales and distribution of drugs in other countries. Whether or not Aramchol or any other product candidate receive
approval from the FDA, approval of such product candidates must be obtained by the comparable regulatory authorities of countries other
than the United States before we can commence clinical trials or marketing of the product in those countries. The approval process varies
from jurisdiction to jurisdiction, and the time may be longer or shorter than that required for FDA approval. The requirements governing
the conduct of clinical trials and product licensing vary greatly from country to country.
The
requirements that we and our collaborators must satisfy to obtain regulatory approval by government agencies in other countries prior
to commercialization of Aramchol or any other product candidate in such countries can be rigorous, costly and uncertain. In the European
countries, UK, Canada and Australia, regulatory requirements and approval processes are similar in principle to those in the United States.
Additionally, depending on the type of drug for which approval is sought, there are currently two potential tracks for marketing approval
in the European countries: mutual recognition and the centralized procedure. These review mechanisms may ultimately lead to approval
in all EU countries, but each method grants all participating countries some decision-making authority in product approval. The UK has
a separate review period but for a transitional period until 31 December 2022, may rely on approvals under the EU mutual recognition
and/or centralized procedure. Foreign governments also have stringent post-approval requirements including those relating to manufacture,
labeling, reporting, record keeping and marketing. Failure to substantially comply with these on-going requirements could lead to government
action against the product, us and/or our representatives.
Related
Matters
From
time to time, legislation is drafted, introduced and passed in governmental bodies that could significantly change the statutory provisions
governing the approval, manufacturing and marketing of products regulated by the FDA, MHRA or EMA and other applicable regulatory bodies
to which we are subject. In addition, regulations and guidance are often revised or reinterpreted by the national agency in ways that
may significantly affect our business and our therapeutic candidates. It is impossible to predict whether such legislative changes will
be enacted, whether FDA, MHRA or EMA regulations, guidance or interpretations will change, or what the impact of such changes, if any,
may be. We may need to adapt our business and therapeutic candidates and products to changes that occur in the future.
C.
Organizational Structure
See
"Item 4. Information on the Company—Historical Background and Corporate Structure" above.
91
D.
Description of Property and Facilities
Our
principal executive offices and registered office in Israel is located at 16 Abba Hillel Road, Ramat Gan, Israel 5250608 and our telephone
number is +972-3-693-8448. Our lease at our prior principal executive offices expired on March 21, 2024. We did not extend the lease
and are currently headquartered in Ramat Gan, Israel while we are in the process of searching for a new permanent location for our principal
executive offices.
ITEM
4A. Unresolved Staff Comments.
None.
ITEM
5. Operating and Financial Review and Prospects.
The
following discussion and analysis of our financial condition and results of operations should be read in conjunction with our financial
statements and related notes that appear elsewhere in this annual report. In addition to historical financial information, the following
discussion contains forward-looking statements that reflect our plans, estimates and beliefs. Our actual results could differ materially
from those discussed in the forward-looking statements. Factors that could cause or contribute to these differences include those discussed
below and elsewhere in this prospectus, particularly in the sections titled "Risk Factors" and "Cautionary Note Regarding
Forward-Looking Statements." Our discussion and analysis for the year ended December 31, 2022 can be found in our Annual Report
on Form 20-F for the fiscal year ended December 31, 2022, filed with the SEC on March 29, 2023 (File No. 001-36345).
Overview
We
are a biopharmaceutical company focused on the development of Aramchol. We have focused almost exclusively on developing Aramchol for
the treatment of liver disease and are currently developing Aramchol for PSC and exploring the feasibility of developing Aramchol for
other fibro-inflammatory indications outside of liver disease. We are also collaborating with the Hebrew University in the development
of Amilo-5MER, a 5 amino acid synthetic peptide.
To
date, we have not generated revenue from the sale of any product, excluding the licensing revenue we recorded in connection with the
Samil Agreement, and we do not expect to generate any significant revenue other than the amortization of the upfront payments under the
license agreement with Samil and of the subsequent royalties and/or milestones that may be earned in connection with the Samil Agreement
or potential other license Agreements, unless and until we commercialize Aramchol, or license the product to additional third parties.
As of December 31, 2023, we had an accumulated deficit of approximately $193.0 million.
Our
financing activities are described below under "Liquidity and Capital Resources." Obtaining approval of an NDA, MMA, or other
similar application is an extensive, lengthy, expensive and uncertain process, and the FDA, EMA, MHRA and other regulatory agencies may
delay, limit or deny approval of Aramchol, Amilo-5MER or any other product candidate.
Financial
Overview
To
date, we have funded our operations primarily through proceeds from private placements and public offerings. At December 31, 2023, we
had current assets of $13.2 million, which is mainly comprised of cash and cash equivalents of $2.9 million, restricted cash of $0.1
million, short-term deposits of $2.3 million and short-term marketable securities of $7.5 million. This compares with current assets
of $14.7 million at December 31, 2022, which is mainly comprised of cash and cash equivalents of $2.0 million, restricted cash of $0.1
million and short-term marketable securities of $11.8 million. We believe that such existing funds will be sufficient to continue our
business and operations as currently conducted for more than 12 months from the date of issuance of this annual report. However, significant
additional funding will be necessary to fund our ARMOR Study, our Amilo-5MER program and ongoing research and development work and to
advance our product candidates through regulatory approval and into commercialization, if approved. Subject to our strategic review,
we intend to obtain additional funding through debt or equity financings, governmental grants or through entering into collaborations,
strategic alliances or license agreements to increase the funds available to support our operating and capital needs. Although we have
been successful in raising capital in the past, there is no assurance that we will be successful in obtaining additional financing on
terms acceptable to us. If funds are not available, we may be required to delay, reduce the scope of or eliminate research or development
plans for, or commercialization efforts with respect to Aramchol, Amilo-5MER and/or our other pre-clinical and clinical programs. This
may raise substantial doubts about our ability to continue as a going concern.
92
Revenues
We
have entered into the Samil Agreement for the commercialization of Aramchol in Korea. Under the terms of the Samil Agreement, we have
received upfront and milestone payments of $3.6 million, and may be eligible to receive up to approximately $4.5 million in additional
payments for development and regulatory milestones for Aramchol in the licensed territories.
In
accordance with ASC 606 the Company determined that the Agreement included a combined performance obligation representing the delivery
of the exclusive license and completion of the ARREST study.
As
of December 31, 2023, management evaluated the remaining clinical and regulatory milestones and determined that the variable consideration
should not be recorded as revenue for the period ended December 31, 2023. The Company will re-evaluate the transaction price in each
reporting period when events whose outcomes are resolved or other changes in circumstances occur that would indicate it is appropriate
to recognize variable consideration as revenue
Costs
and Operating Expenses
Our
current costs and operating expenses consist of two components: (i) research and development expenses; and (ii) general and administrative
expenses.
Research
and Development Expenses
Our
research and development expenses consist primarily of outsourced development expenses, salaries and related personnel expenses and fees
paid to external service providers, patent and regulatory related legal fees, costs of pre-clinical studies and clinical trials and drug
and laboratory supplies. We account for all research and development expenses as they are incurred. Subject to our strategic review,
we expect our research and development expense to remain our primary expense in the near future as we continue to develop Aramchol and
Amilo-5MER. Increases or decreases in research and development expenditures are primarily attributable to the number and/or duration
of the pre-clinical and clinical studies that we conduct.
We
expect that a substantial amount of our research and development expense in the future will be incurred in support of our current and
anticipated pre-clinical and clinical development projects. Due to the inherently unpredictable nature of pre-clinical and clinical development
studies, we are unable to estimate with any certainty the costs we will incur in the continued development of Aramchol, Amilo-5MER and
any other potential product candidate. Clinical development timelines, the probability of success and development costs can differ materially
from expectations. We currently expect to continue testing Aramchol and Amilo-5MER in pre-clinical studies for toxicology, safety and
efficacy, and to conduct additional clinical trials for Aramchol and to initiate a first-in-human clinical study for Amilo-5MER.
While
we are currently focused on advancing Aramchol's and Amilo-5MER's development, our future research and development expenses
will depend largely on the outcome of our strategic review, the duration of the ARMOR study, the number of enrolled patients, the clinical
success of Aramchol, as well as ongoing assessments of the Aramchol's commercial potential. As we obtain results from clinical
trials, we may elect to discontinue or delay clinical trials for our product candidate in certain indications in order to focus our resources
on more promising indications for such product candidate. Completion of clinical trials may take several years or more, but the length
of time generally varies according to the type, complexity, novelty and intended use of a product candidate.
We
expect our research and development expenses to increase in the future from current levels as we continue to advance our clinical product
development into a pivotal stage trial and, potentially, the in-licensing of additional product candidates.
93
The
lengthy process of completing clinical trials and seeking regulatory approval for Aramchol and Amilo-5MER or any other product candidate
requires the expenditure of substantial resources. Any failure or delay in completing clinical trials, or in obtaining regulatory approvals,
could cause a delay in generating product revenue and cause our research and development expenses to increase and, in turn, have a material
adverse effect on our operations. Because of the factors set forth above, we are not able to estimate with any certainty when we would
recognize any net cash inflows from our projects.
General
and Administrative Expenses
General
and administrative expenses consist primarily of compensation for employees in executive and operational roles, including finance, /accounting,
legal and other operating positions in connection with our activities. Our other significant general and administrative expenses include
non-cash stock-based compensation costs and facilities costs (including the rental expense for our offices in Tel Aviv, Israel), professional
fees for outside accounting and legal services, travel costs, investors relations, insurance premiums and depreciation.
Financial
Income, Net
Our
financial income consists mainly of interest income from marketable debt securities, as well as gains from realization of marketable
debt securities,
income from change in fair value of convertible
note
and foreign currency gains. Our financial expense consists of fees associated with banking activities and losses from
realization of marketable debt securities and foreign currency losses.
A.
Results of Operations
The
table below provides our results of operations for the year ended December 31, 2023 as compared to the year ended December 31, 2022.
Year Ended December 31,
2022
2023
(thousands)
Research and development expenses
$
12,995
$
3,569
General and administrative expenses
4,656
3,923
Operating loss
17,651
7,492
Financial loss (income), net
215
(580
)
Net loss
$
17,866
6,912
Comprehensive loss
$
18,440
$
6,621
Basic and diluted net loss per share from continuing operations
$
10.65
$
2.50
Research
and Development Expenses
Our
research and development expenses amounted to approximately $3.6 million during the year ended December 31, 2023, representing a decrease
of approximately $9.4 million, or approximately 72%, compared to approximately $13.0 million for the year ended December 31, 2022. The
decrease primarily resulted from a decrease in clinical trial expenses in the amount of approximately $5.9 million as well as a decrease
in drug development expenses in the amount of approximately $1.8 million.
General
and Administrative Expenses
Our
general and administrative expenses amounted to approximately $3.9 million for the year ended December 31, 2023, representing a decrease
of approximately $0.8 million, or 15%, compared to approximately $4.7 million for the year ended December 31, 2022. The decrease primarily
resulted from a decrease in insurance premium expenses of $0.3 million, as well as a decrease in non-cash stock based compensation expenses
of approximately $0.2 million.
94
Operating
Loss
As
a result of the foregoing research and development and general and administrative expenses, as well as our failure to generate substantial
operating revenues, our operating loss for the year ended December 31, 2023 was approximately $7.5 million, representing a decrease in
our operating loss of approximately $10.2 million, or approximately 58%, compared to approximately $17.7 million for the year ended December
31, 2022.
Financial
Loss (income), Net
Our
financial income, net, for the year ended December 31, 2023 was approximately $0.6 million, representing an increase of approximately
$0.8 million, compared to a financial loss of approximately $0.2 million for the year ended December 31, 2022. The increase primarily
resulted from a decrease in loss of realization of marketable securities of approximately $0.5 million as compared to such loss
for the comparable period in 2022, as well as from income from change in the fair value of convertible SAFE note of $0.3 million.
Net
Loss
Our
net loss for the year ended December 31, 2023 was approximately $6.9 million, representing a decrease of approximately $11.0 million,
or approximately 61%, compared to approximately $17.9 million for the year ended December 31, 2022. The decrease primarily resulted from
the above-mentioned decrease in research development expenses and as well from the increase in financial income.
B.
Liquidity and Capital Resources
Overview
To
date, we have funded our operations primarily through proceeds from private placements and public offerings.
We
have incurred substantial losses since our inception. As of December 31, 2023, we had an accumulated deficit of approximately $193.0
million and working capital (current assets less current liabilities) of approximately 10.5 million. Due to our expectation that we will
continue to not generate substantial revenues for the foreseeable future, we expect that losses will continue for the foreseeable future.
As
of December 31, 2023, we had cash and cash equivalents of approximately $2.9 million, restricted cash of $0.1 million, short-term deposits
of $2.3 million and short-term marketable debt securities of approximately $7.5 million invested in accordance with our investment policy,
totaling approximately $12.8 million, as compared to cash and cash equivalents of approximately $2.0 million, restricted cash of $0.1
million and short-term marketable debt securities of approximately $11.8 million, totaling approximately $13.9 million as of December
31, 2022. Our cash requirements from known contractual obligations within the next twelve months include lease obligations of approximately
$0.04 million.
We
generally enter into contracts in the ordinary course of business with CROs for clinical trials and clinical supply manufacturing and
with vendors for pre-clinical research studies and other services and products for operating purposes, which generally provide for termination
within 30 to 90 days of notice, and therefore are cancelable contracts and not included in the discussion above. We have included as
purchase obligations our commitments under agreements to the extent they are quantifiable and are not cancelable.
Other
than as described above, we did not have any material commitments for capital expenditures, including any anticipated material acquisition
of plant and equipment or interests in other companies, as of December 31, 2023.
Cash
Flow from Operating Activities
We
had negative cash flow from operating activities of approximately $6.1 million for the year ended December 31, 2023 as compared to a
negative cash flow from operating activities of approximately $18.5 million for the year ended December 31, 2022. The negative cash flow
from operating activities for the year ended December 31, 2023 was mainly attributable to our net loss of approximately $6.9 million,
as well as a decrease in trade payables of approximately $0.7 million, partially offset by non-cash stock based compensation expenses
of approximately $1.0 million.
95
Cash
Flow from Investing Activities
We
had positive cash flow from investing activities of approximately $0.8 million for the year ended December 31, 2023 as compared to a
positive cash flow from investing activities of approximately $17.6 million for the year ended December 31, 2022. The positive cash flow
from investing activities for the year ended December 31, 2023 was primarily due to the net sale of marketable debt securities in the
amount of approximately $4.5 million, partially offset by an investment of $1.5 million in an associate and a net investment of $2.2
million in short-term deposits.
Cash
Flow from Financing Activities
We
had positive cash flow from financing activities of approximately $6.2 million for the year ended December 31, 2023 as compared to a
positive cash flow from financing activities of $0.1 million for the year ended December 31, 2022. The positive cash flow from financing
activity for the year ended December 31, 2022 was due to net proceeds from our public offering in July 2023.
On
March 26, 2021, we entered into a Sales Agreement with Cantor and Canaccord Genuity LLC as sales agents, or the Sale Agents, pursuant
to which we may offer and sell our ordinary shares having an aggregate offering price of up to $50.0 million, from time to time through
the Sales Agents. Under the new Sales Agreement, we may sell, from time to time, up to approximately $50.0 million of additional ordinary
shares subject to limitations under the Baby Shelf Rule. As of December 31, 2023, we sold 7,721 ordinary shares under our ATM program
for total net proceeds of approximately $0.1 million. We did not sell any ordinary shares under our ATM program in 2023.
On
July 14, 2023, we entered into a definitive securities purchase agreement with investors for the purchase and sale in a public offering
of (i) 380,000 of our ordinary shares, (ii) 5,220,000 pre-funded warrants to purchase 5,220,000 ordinary shares, or the Pre-Funded Warrants,
and (iii) 5,600,000 warrants to purchase 5,600,000 ordinary shares, or the Investor Warrants, at a purchase price of $1.25 per Share
and accompanying Investor Warrant and $1.249 per Pre-Funded Warrant and accompanying Investor Warrant. The net proceeds to the offering
were approximately $6.5 million before deducting estimated offering expenses payable by us. As of the date hereof, 3,940,000 Pre-Funded
Warrants have been exercised into 3,937,312 ordinary shares.
Current
Outlook
Although
we provide no assurance, we believe that our existing funds will be sufficient to continue our business and operations as currently conducted
for more than 12 months from the date of issuance of this Annual Report on Form 20-F. However, significant additional funding will be
necessary to fund our ARMOR Study, our Amilo-5MER program and ongoing research and development work and to advance our product candidates
through regulatory approval and into commercialization, if approved. Subject to our strategic review, we intend to obtain additional
funding through debt or equity financings, governmental grants or through entering into collaborations, strategic alliances or license
agreements to increase the funds available to support our operating and capital needs. Although we have been successful in raising capital
in the past, there is no assurance that we will be successful in obtaining additional financing on terms acceptable to us. If funds are
not available, we may be required to delay, reduce the scope of or eliminate research or development plans for, or commercialization
efforts with respect to Aramchol, Amilo-5MER and/or our other pre-clinical and clinical programs. This may raise substantial doubts about
our ability to continue as a going concern.
The
extent of our future capital requirements will depend on many other factors, including:
●
the outcome of our review
    of our strategic alternatives:
96
●
the progress and costs
    of our pre-clinical studies, clinical trials and other research and development activities;
●
the regulatory pathway
    of Aramchol, Amilo-5MER or any other product candidate;
●
the scope, prioritization
    and number of our clinical trials and other collaboration, research and development programs;
●
the amount of revenues
    and contributions we receive under future licensing, development and commercialization arrangements with respect to Aramchol, Amilo-5MER
    or any other product candidate;
●
the costs of the development and expansion of our operational
    infrastructure;
●
the costs and timing of
    obtaining regulatory approval for Aramchol, Amilo-5MER or any other product candidate;
●
the ability of us, or our
    collaborators, to achieve development milestones, marketing approval and other events or developments under our potential future
    licensing agreements;
●
the costs of filing, prosecuting,
    enforcing and defending patent claims and other intellectual property rights;
●
the costs and timing of
    securing manufacturing arrangements for clinical or commercial production;
●
the costs of contracting
    with third parties to provide sales and marketing capabilities for us;
●
the
    costs of acquiring or undertaking development and commercialization efforts for any future products, product candidates or platforms;
●
the magnitude of our general
    and administrative expenses;
●
any cost that we may incur
    under future in- and out-licensing arrangements relating to Aramchol, Amilo-5MER or any other product candidate;
●
market conditions;
●
our ability to maintain
    the listing of our ordinary shares on The Nasdaq Capital Market; and
●
the impact of any resurgence of the COVID-19
    pandemic and the war between Hamas and Israel, which may exacerbate the magnitude of the factors discussed above.
C.
Research and Development, Patents and Licenses
For
information concerning our research and development policies and a description of the amount spent during each of the last three fiscal
years on company-sponsored research and development activities, see "Item 5. Operating and Financial Review and Prospects—Results
of Operations."
D.
Trend Information
We
are a development stage company and it is not possible for us to predict with any degree of accuracy the outcome of our research, development
or commercialization efforts. As such, it is not possible for us to predict with any degree of accuracy any known trends, uncertainties,
demands, commitments or events that are reasonably likely to have a material effect on our net sales or revenues, income from continuing
operations, profitability, liquidity or capital resources, or that would cause reported financial information to not necessarily be indicative
of future operating results or financial conditions. However, to the extent possible, certain trends, uncertainties, demands, commitments
and events are in this "Operating and Financial Review and Prospects."
97
E.
Critical Accounting Policies and Estimates
We
prepare our financial statements in accordance with U.S. GAAP. In doing so, we must make estimates and assumptions that affect our reported
amounts of assets, liabilities and expenses, as well as related disclosure of contingent assets and liabilities. In some cases, we could
reasonably have used different accounting policies and estimates. Changes in the accounting estimates are reasonably likely to occur
from period to period. Accordingly, actual results could differ materially from our estimates. To the extent that there are material
differences between these estimates and actual results, our financial condition or results of operations will be affected.
While
our significant accounting policies are described in more detail in the notes to our audited consolidated financial statements appearing
elsewhere in this Annual Report on Form 20-F we believe that the following accounting policies are those most critical to the judgments
and estimates used in the preparation of our consolidated financial statements:
Accounting
for stock-based compensation:
We
grant equity-based awards under share-based compensation plans. We estimate the fair value of share-based payment awards using the Black-Scholes
option valuation model. The Black-Scholes option valuation model requires the input of subjective assumptions, including price volatility
of the underlying stock, risk-free interest rate, dividend yield, and expected life of the option. Share-based compensation expense is
based on awards ultimately expected to vest, and therefore is reduced by expected forfeitures. Changes in assumptions used under the
Black-Scholes option valuation model could materially affect our net loss and net loss per share.
Accounting
for Marketable Debt Securities
Our
debt securities are classified as available-for-sale and recorded at fair value. We determine the appropriate classification of investments
in debt securities at the acquisition date and re-evaluates the classification at each balance sheet date. Unrealized gains and losses
during the year, net of the related tax effect applicable to available-for-sale are excluded from income and reflected in other comprehensive
income (loss) as a separate component of shareholders' equity until realized. As the result of the adoption of Accounting Standards
Update ("ASU") 2016-13, Financial Instruments-Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instrument
("ASU 2016-13") we assess the need at each period end to record an allowance for credit loss. Any portion of the market decline
related to debt securities that is believed to arise from factors other than credit is recorded as a component of other comprehensive
income (loss) rather than against income.
Accounting
for Investment in Associate at Fair Value
We
hold an equity investment of a privately-owned company Onkai, over which  have the ability to exercise significant influence, but
not control. The investment was included as a non-current asset in our balance sheet as of December 31, 2023. We have elected the fair
value option allowed by Accounting Standards Codification 825, Financial Instruments, with respect to this investment because our management
believes this approach will better reflect the economics of our equity interest. Under the fair value option, the investment is remeasured
at fair value (level 3) at each reporting period with changes in fair value, if any, recorded in the statement of operations.
98
ITEM
6. Directors, Senior Management and Employees.
A.
Directors and Senior Management.
Set
forth below is information concerning the directors, senior management and executive officers of the Company as of March 27, 2024, the
latest practicable date for inclusion in this annual report. The business address for each of our directors, senior management and corporate
officers is c/o Galmed Pharmaceuticals Ltd., 16 Abba Hillel Road, Ramat Gan, Israel 5250608.
Name
Age
Position
Allen Baharaff
59
President and Chief Executive Officer, Class II Director
Dr. Liat Hayardeny
57
Chief Scientist Officer
Doron Cohen
57
Chief Financial Officer
Yohai Stenzler
41
Chief Accounting Officer
Guy Nehemya
39
Chief Operating Officer and Data Protection Officer
David Sidransky, M.D.
(1)(2)(3)(4)(5)
63
Lead Independent Director and Chairman of the R&D
    Committee, Chairman of our Nomination Committee, Chairman of our Remuneration Committee, and Class III director
Shmuel Nir
(2)(3)(4)(5)
62
Class I Director
Amir Poshinski
(2)(3)(4)(5)
63
Chairman of our Audit Committee, Class III director
Carol L. Brosgart, M.D.
(1) (2)
72
Class I Director
(1)
A member of our research & development committee.
(2)
Independent director under
    applicable Nasdaq Capital Market and SEC rules, as affirmatively determined by our Board.
(3)
A member of our audit committee.
(4)
A member of our remuneration committee.
(5)
A member of our nomination committee.
Allen
Baharaff
, our President and Chief Executive Officer of our Board, co-founded the Group in 2000, served as the Chief Financial Officer
of GHI from 2000 until January 2015, and has served as our Chief Executive Officer since January 2012 and as our President since March
2015. Previously, he held a senior executive position at Isramex Projects Ltd., an energy project financing company, and Managing Director
of T+M Trusteeship & Management Services (Israel) Ltd., a subsidiary of a Swiss company providing trust and similar services. Since
2005, Mr. Baharaff serves as a Director of the Rubin Museum. Since October 2023, Allen serves as a director of Onkai Inc, a private US-based
technology company Mr. Baharaff holds a Bachelor of Science degree in economics from the London School of Economics, University of London
and LLB and MA degrees from Cambridge University. Since 1993, Mr. Baharaff has been a member of the Israel Bar Association.
Dr.
Liat Hayardeny
, our Chief Scientific Officer joined the Company in September 2016 bringing more than 17 years of experience in drug
development at all stages as part of Teva Pharmaceuticals' global Research and Development Division. Prior to joining Galmed, Dr.
Hayardeny served as Teva's Senior Director and Head of Research Scientific Affairs. In that capacity, Dr. Hayardeny established
the scientific positioning of Teva's innovative compounds. Additionally, Dr. Hayardeny was responsible for Teva's relationship
with institutions of higher education; managing Teva's global research collaborations and publications. Dr. Hayardeny holds a Ph.D.
from Sackler School of Medicine and an MBA from Recanati Business School at Tel Aviv University.
99
Doron
Cohen,
our Chief Financial Officer, joined the Company in February 2022, after providing the Company consulting services, including
with respect to management of the Company's funds, since 2018. Mr. Cohen brings more than twenty-five years of experience in the
global financial markets, including significant experience on the buy side of life sciences companies. Since 2016, Mr. Cohen has served
as Chief Executive Officer at Tangram Strategic Ltd., a boutique investment firm offering strategic solutions in economic & financial
research, risk and regulation. Before that, between 1992 and 2017, Mr. Cohen served as Research Director at Gems Investments Research
Ltd., an investment research company. During his tenure there, he provided research to hedge funds and managed three teams of analysts,
focusing on investment research, operations research, and risk analysis. Prior to that from 1990 to 1992, Mr. Cohen served as Director
of Public Relations at the World Union of Jewish Students. Since October 2023, Doron serves as the interim CFO of Onkai Inc, a private
US-based technology company Mr. Cohen holds a Master of Science degree in management from Boston University, and a Bachelor's degree
in philosophy and political science from the University of New South Wales.
Yohai
Stenzler
, our Chief Accounting Officer, has served in such capacity since February 2022. Mr. Stenzler joined the Company in June
2014 as the Company's corporate controller, and later on served as the Company's Director of Finance. Between February 2017
to February 2022, Mr. Stenzler served as our Chief Financial Officer. Mr. Stenzler has six years of financial management experience as
an accountant at the real estate department at Ernst & Young LLP, where he was involved in financing, taxes, auditing, advising and
accounting of public and private companies, both domestic and international. Mr. Stenzler is a certified CPA and holds a MBA in Finance
from Recanati Business School at Tel Aviv University, and a BA in Economics and Accounting from Ben-Gurion University of the Negev.
Guy
Nehemya
, our Chief Operating Officer and Data Protection Officer, has served in each role since January 2019 and March 2021, respectively.
Between March 2017 and January 2019, Mr. Nehemya served as our Vice President, Operations. Mr. Nehemya joined the Company in October
2013 as the Company's Director of Operations, after completing his internship at Agmon, Rosenberg, HaCohen & Co. Law Offices.
Mr. Nehemya was a key member of management during the Company's initial public offering and execution thereof. Mr. Nehemya holds
a LL.B. from the College of Management and is currently completing his MBA degree at the IDC Herzliya. Mr. Nehemya has been a member
of the Israeli Bar Association since 2012.
David
Sidransky, M.D.
, the chairman of our Nomination, Remuneration and R&D Committees, joined our Board in June 2014, originally as
an external director. Dr. Sidransky is a renowned oncologist and research scientist named and profiled by TIME magazine in 2001 as one
of the top physicians and scientists in America, recognized for his work with early detection of cancer. He serves as the Director of
the Head and Neck Cancer Research Program at the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University. He is a Professor
of Oncology, Otolaryngology, Cellular & Molecular Medicine, Urology, Genetics, and Pathology at Johns Hopkins University and Hospital.
Dr. Sidransky has written over 600 peer-reviewed publications and has contributed to more than 60 cancer reviews and chapters. Dr. Sidransky
is a founder of a number of biotechnology companies and holds numerous biotechnology patents. He has been the recipient of many awards
and honors, including the 1997 Sarstedt International prize from the German Society of Clinical Chemistry, 1998 Alton Ochsner Award Relating
Smoking and Health by the American College of Chest Physicians and the 2004 Hinda Rosenthal Award and 2017 Team Award presented by the
American Association of Cancer Research. Dr. Sidransky has served as Vice Chairman of the Board of Directors of ImClone. He is Chairman
of the Board of Ayala Pharma (Nasdaq: AYLA), and is a lead director at Champions Oncology and on the board of directors of Orgenesis
(Nasdaq: ORGS) and Ascentage Pharma. He is serving and has served on scientific advisory boards of corporations and institutions, including
Amgen, MedImmune, Roche and Veridex, LLC (a Johnson & Johnson diagnostic company), among others. In addition, Dr. Sidransky served
as Director of American Association for Cancer Research from 2005 to 2008. Dr. Sidransky received his B.A. from Brandeis University and
his M.D. from the Baylor College of Medicine.
Shmuel
Nir
, a director of the Company since 2007, serves as President and Chief Executive Officer of Tushia Consulting Engineers Ltd., an
investment and management services company. From January 2001 to January 2016, Mr. Nir served as Chairman of the board of directors of
Matan Digital Printers Ltd. From March 1998 to January 2008, he served as President and Chief Executive Officer of Macpell Industries
Ltd., a leading industrial group. Between January 1991 and March 1998, Mr. Nir was an Executive Vice President of Operations at Macpell
Industries Ltd. and President and Chief Executive Officer of two of its subsidiaries, New Net Industries Ltd. and New Net Assets Ltd.
Prior to January 1991, Mr. Nir had held various positions with Intel Corporation in Jerusalem, Israel and Tefen Management Consulting.
Between 1999 and 2006, Mr. Nir served as managing partner at Spring Venture Capital Fund. Mr. Nir holds a B.Sc. in Industrial Engineering
and Management from the Technion - Israel Institute of Technology in Haifa, which was awarded in 1989.
100
Amir
Poshinski
, joined our Board in June 2020. Mr. Poshinski is an entrepreneur with over 20 years' management and leadership experience
across multiple industries, including technology, biotechnology, banking and real estate. Mr. Poshinski is the owner of DAP Holdings,
through which he has acted since 2010 as a management consultant and strategic advisor to global companies. Mr. Poshinski currently serves
as a member of the advisory board of Benson Oak Ventures, a venture focused fund, as well as several other private companies. Prior to
2010, Mr. Poshinski served as Deputy CEO of Primsa Investment House, which at the time was Israel's largest investment house, Deputy
CEO of Discount Mortgage Bank, the real estate lending arm of one of Israel's largest banks, VP of Marketing at Comverse, a telecommunications
software company that was listed on Nasdaq, VP Marketing, Sales and Advertising of Mifal Hapayis, Israel's national lottery, and
VP and Deputy CEO of the Economic Company of the Israeli Local Authorities Association. Mr. Poshinski previously served on the board
of directors of each of TAS-AGT (a TATA joint venture), Excellence Nessuah Mutual Funds, and Therapix Biosciences (Nasdaq: TRPX) as well
as several other private companies. Mr. Poshinski holds a B.A. in Business Administration and Marketing from the New York Institute of
Technology.
Carol
L. Brosgart, M.D.
joined our Board on June 7, 2017. Dr. Brosgart served as a member of Tobira Therapeutics's Board of Directors
from 2009 until it was acquired by Allergan in 2016 and on the Board of Juvaris, a vaccine company acquired by Bayer. Since January 2018,
she serves on the Board of Directors of Abivax, a biotechnology company, headquartered in Paris, working on HIV Cure and inflammatory
diseases. Since 2022 Dr. Brosgart also seves on the Board of of Eradivir Biotech and Merlin Biotech. Since June 2021, Dr. Brosgart also
serves on the Board of Intrivo Diagnostic. Dr. Brosgart also served on the Board of Mirum Pharmaceuticals Inc. (Nasdaq: MIRM) from 2021
to 2023, and serves since then as a clinical consultant to Mirum. Dr. Brosgart serves as a consultant to Dynavax, Allergan and a number
of biotechnology companies in the areas of liver diseases and infectious diseases and on the Board of Renovaro Inc. (Nasdaq: RENB), focusing
on HIV Cure. Dr. Brosgart also currently serves as a consultant for Dynavax Technologies Corp (Nasdaq: DVAX). Dr. Brosgart currently
serves on the Steering Committee of the National Viral Hepatitis Roundtable, the Executive Committee of the Forum for Collaborative Research,
the Steering Committee of the HBV Cure Group at the Forum, and is on the Board of Directors of the Hepatitis B Foundation and the Northern
California American Liver Foundation and the Board of Berkeley Community Scholars. She is active in the public policy arena for AASLD
and IDSA/HIVMA. Dr. Brosgart served as Senior Advisor on Science and Policy to the Division of Viral Hepatitis at the CDC and to the
Viral Hepatitis Action Coalition at the CDC Foundation from 2011 to 2013. Dr. Brosgart has also served as a member of the clinical faculty
of the School of Medicine at the University of California, San Francisco for the past four decades, where she is a Clinical Professor
of Medicine, Biostatistics and Epidemiology in the Division of Global Health and Infectious Diseases. In 2011, Dr. Brosgart served as
Chief Medical Officer at biotechnology company Alios BioPharma, Inc. Prior to Alios, Dr. Brosgart served as Senior Vice President and
Chief Medical Officer of Children's Hospital & Research Center in Oakland, California, from 2009 until February 2011. Previously,
she served for eleven years, from 1998 until 2009, at the biopharmaceutical company Gilead Sciences, Inc., where she held a number of
senior management roles, most recently as Vice President, Public Health and Policy and earlier as Vice President, Clinical Research and
Vice President, Medical Affairs. Prior to Gilead, Dr. Brosgart was the Medical Director of the East Bay AIDS Center in Berkeley, California
(1987-1998) and the Medical Director of the Central Health Center for the Alameda County Public Health Department (1978-1987). Dr. Brosgart
received a B.S. in Community Medicine from the University of California, Berkeley and received an M.D. from the University of California,
San Francisco. Her residency training was in pediatrics, public health and preventive medicine at UCSF and UC Berkeley School of Public
Health. She has published extensively in the areas of HIV, HBV, CMV, and liver disease.
There
are no family relationships between any director or executive officer. There are no arrangements or understandings with major shareholders,
customers, suppliers or others, pursuant to which any director or executive officer was selected as a director or member of senior management,
as the case may be.
Board
Diversity Matrix (As of March 27, 2024)
Country of Principal Executive Offices
Israel
Foreign Private Issuer
Yes
Disclosure Prohibited under Home Country Law
No
Total Number of Directors
5
101
Part I:
    Gender Identity
Female
Male
Non-Binary
Did
    Not Disclose
Gender
Directors
1
4
0
0
Part II: Demographic Background
Underrepresented Individual
    in Home Country Jurisdiction
0
LGBTQ+
0
Did Not Disclose Demographic Background
0
Scientific
Advisory Board
We
seek advice from our Scientific Advisory Board generally on scientific and medical matters. Our Scientific Advisory Board includes the
following: Professor Vlad Ratziu from the University Pierre et Marie Curie in Paris, France and coordinator of the EU FP7 FLIP consortium;
Professor Scott Friedman from the Icahn School of Medicine at Mount Sinai in New York, United States; Professor Arun Sanyal, from the
Virginia Commonwealth University in Richmond, Virginia; Professor Jose Mato, from CIC bioGUNE Spain; and Professor Shomron Ben-Horin,
Chief of the Gastroenterology Department at Sheba Medical Center.
B.
Compensation.
Certain
Approvals Required for Office Holders' Compensation of the Companies Law
Pursuant
to the Companies Law, the Company is required to adopt a compensation policy regarding the terms of office and employment of its Office
Holders (as such terms are defined below), which includes exemption and release of the Office Holders from liability for breach of his
or her duty of care to the Company, an undertaking to indemnify the Office Holder, post factum indemnification or insurance; any grant,
payment, remuneration, compensation, or other benefit provided in connection with termination of service; and any benefit, other payment
or undertaking to provide any payment as aforesaid, or the Terms of Office and Employment.
The
Company's current amended and restated compensation policy with respect to the terms of office and employment of the Company's
Office Holders, or the Compensation Policy, was adopted by the Board on May 30, 2023, and will remain in effect for a period of three
years according to the Companies Law, unless replaced prior. The Compensation Policy was approved in accordance with the mechanism set
forth in the Companies Law, which allows the Board to approve the Compensation Policy, notwithstanding the resolution of the general
meeting on May 11, 2023, provided that the remuneration committee and thereafter the Board have concluded, following further and detailed
discussion of the matter and for specified reasons, that such approval is in the Company's best interests. To that end, the remuneration
committee and our Bord considered the results of the general meeting vote, details of the Compensation Policy and its alignment with
the Company's compensation philosophy and other relevant considerations and thereafter determined that the approval of the Compensation
Policy is in the best interest of the Company.
The
term 'Office Holder' as defined in the Companies Law includes a general manager, chief business manager, deputy general manager,
vice general manager, any other person fulfilling or assuming the responsibilities of any of the foregoing positions without regard to
such person's title, as well as a director, or a manager directly subordinate to the general manager or the chief executive officer.
Pursuant
to the Companies Law, arrangements between the Company and its Office Holders must generally be approved by the remuneration committee
and the Board and be consistent with the Compensation Policy. However, under certain circumstances, the Company may approve an arrangement
that is not consistent with the Compensation Policy, if such arrangement is approved by a majority of the Company's shareholders,
provided that (i) such majority includes a majority of the votes cast by shareholders who are not controlling shareholders and who do
not have a personal interest in the matter, present and voting (abstentions are disregarded), or (ii) the votes cast by shareholders
who are not controlling shareholders and who do not have a personal interest in the matter who were present and voted against the arrangement
constitute two percent or less of the voting power of the company, or the Special Majority.
102
The
terms of office and employment of directors (including an officer who is a director but is not a controlling shareholder) further require
the approval of the shareholders by a simple majority in addition to the approval of the Remuneration Committee and the Board, in that
order, and under certain circumstances, a Special Majority; with respect to a chief executive officer who is not also a director or an
officer who is a controlling shareholder, the approval of the shareholders must be made by the Special Majority. In addition, under certain
circumstances, a company may be temporarily exempt from receiving the shareholders' approval with respect to the terms of office
and employment of a non-affiliated candidate for chief executive officer.
Under
certain circumstances, if the terms of office and employment of Office Holders (who are not directors or controlling shareholders) are
not approved by the shareholders, where such approval is required, the remuneration committee and the Board may subsequently override
the resolution of the shareholders following a new discussion of the matter and for specified reasons. In addition, amendment of terms
of office and employment of Office Holders (who are not directors or controlling shareholders) requires the approval of the remuneration
committee only, if the remuneration committee determines that the amendment is not material.
Aggregate
Executive Compensation
The
aggregate compensation, including share-based compensation, paid by us to all of our Office Holders as a group, with respect to the year
ended December 31, 2023, was approximately $2.76 million. This amount includes approximately $0.3 million set aside or accrued to provide
pension, severance, retirement, vacation or similar benefits or expenses, but does not include business travel, relocation, professional
and business association dues and expenses reimbursed to Office Holders, and other benefits commonly reimbursed or paid by companies
in our industry. In addition to the five current members of the Board (including the Company's President and Chief Executive Officer),
the Company considers four other individuals, namely, the Chief Scientist Officer, Chief Financial Officer, Chief Accounting Officer
and the Chief Operating Officer, to have been Office Holders in 2023.
As
of December 31, 2023, options to purchase 217,273 of our ordinary shares granted to our Office Holders as a group were outstanding, of
which options to purchase 165,955 of our ordinary shares have vested, with a weighted average exercise price of $49.61 per ordinary share
and 1,315,000 restricted share units, or RSUs granted to our Office Holders were outstanding, of which none were settled.
For
outstanding equity-based awards granted to our Office Holders, see below under "Item 6. Directors, Senior Management and Employees—E.
Share Ownership—Certain Information Concerning Equity Awards to Office Holders."
Individual
Compensation of Covered Executives
The
following table sets forth the compensation granted to the five most highly compensated Office Holders during or with respect to the
year ended December 31, 2023. All amounts reported in the table reflect the cost to the Company, as recognized in its financial statements
for the year ended December 31, 2023. The five individuals for whom disclosure is provided are referred to herein as "Covered Executives."
Information
    Regarding the Covered Executives
Compensation
    for Services
(1)
Base
Benefits
    and
Cash
Equity-Based
Salary
Perquisites
Bonus
Compensation
Other
Name
    and Principal Position
(1)
($)
($)
(2)
($)
(3)
($)
(4)
($)
(5)
Total
    ($)
Allen
    Baharaff (President and Chief Executive Officer)
550,874
145,056
236,228
384,026
40,000
1,356,183
Yohai
    Stenzler (Chief Accounting Officer)
167,855
50,733
71,980
87,751
-
378,319
Guy
    Nehemya (Chief Operating Officer and Data Protection Officer)
167,855
47,201
71,980
87,744
-
374,799
Doron
    Cohen (Chief Financial Officer)
145,820
37,631
62,531
27,828
273,792
Dr.
    Liat Hayardeny (Chief Scientific Officer)
37,330
10,604
66,756
-
114,690
(1)
The above-mentioned executives
    are all full-time employee of the Company. Cash compensation amounts denominated in currencies other than the Dollar were converted
    into Dollars at an exchange rate of NIS 3.62 = $1.00, which reflects the average conversion rate for fiscal year ended December 31,
    2023.
103
(2)
Amounts reported in this
    column include benefits and perquisites, including those mandated by applicable law. Such benefits and perquisites may include, to
    the extent applicable to the Covered Executives, payments, contributions and/or allocations for savings funds, pension, severance,
    vacation, car allowance, risk insurance (e.g., life, disability, accident), telephone, convalescence pay, payments for social security
    and other benefits and perquisites consistent with the Company's policies.
(4)
Amounts reported in this
    column represent the expense recorded in the Company's financial statements for the year ended December 31, 2023 with respect
    to equity-based compensation. Assumptions and key variables used in the calculation of such amounts are discussed in Note 10 to the
    Financial Statements. For outstanding equity-based awards granted to Covered Executives see below under "Item 6. Directors,
    Senior Management and Employees—E. Share Ownership—Certain Information Concerning Equity Awards to Office Holders."
(3)
Amounts
    reported in this column refer to the cash bonuses provided by the Company with respect to 2023, which have been provided for in the
    Company's financial statements for the year ended December 31, 2023 (including if such bonuses were paid in 2024).
    They exclude bonuses paid in 2023 which were provided for in the Company's financial statements for previous years. Cash
    bonuses are paid in accordance with the Company's 2023 Annual Cash Bonus Plan and are intended to promote the Company's
    work plan and business strategy by rewarding officers for achievement of the Company's business and financial goals through
    teamwork and collaboration. Key performance indicators which are factored into cash bonus determinations are based both on personal
(5)
Amounts reported in this
    column include payments made with respect to the year 2023 and recorded in the financial statements for the year ended December 31,
    2023 relating to directors' fees.
Compensation
of Directors
As
approved by our shareholders at our 2020 annual meeting of shareholders, in connection with their services as directors of the Company,
each of our directors from time to time, is entitled to an annual payment of $40,000, plus value-added tax, or VAT, if applicable, and
with respect to an expert external director (if applicable), $50,000 plus VAT, payable quarterly at the end of each quarter, and, upon
first becoming a member of the Board. As approved by our shareholders at our 2023 special meeting of shareholders, (i) each of our non-management
directors, except Dr. Carol L. Brosgart, received a grant of RSU's to purchase 75,000 ordinary shares, or the Director RSUs. The
Director RSUs were granted under the 2013 Plan and (ii) our director, Dr. Carol L. Brosgart, received a grant of options to purchase
75,000 ordinary shares, or the Director Options. The Director Options were granted under the 2013 Plan at an exercise price equal to
$0.92, the closing price of our Ordinary Shares on the Nasdaq Stock Market on August 6, 2023, the day prior to the meeting of the Board
approving such grant. The Director RSUs and the Director Options vest over a period of three years, such that Director RSUs and the Director
Options will vest with respect to 1/3 of the underlying Ordinary Shares on the first anniversary of the grant (i.e., the date of the
Board's approval on August 7, 2023), and thereafter, Director RSUs and the Director Options will vest with respect to the additional
2/3 of the underlying ordinary shares on an equally quarterly basis, provided that each non-management director continues to serve as
a director of us or our affiliates throughout each such vesting date. All unvested options held by a non-management director in office
will automatically vest and become exercisable upon the consummation of a Transaction, as such term is defined in the 2013 Plan. The
grant is subject to the execution by each director of an option agreement with us confirming the terms and conditions applying to the
grant.
Our
Board has determined that each of Mr. Nir, Mr. Poshinski, and Dr. Sidransky are entitled to receive compensation equivalent to what an
'expert external director' would have received. See also "Item 6. Directors, Senior Management and Employees—C.
Board Practices—External Directors" and "Item 7. Major Shareholders and Related Party Transactions—C. Related
Party Transactions" below.
For
the outstanding equity-based awards granted to our directors, see below under "Item 6. Directors, Senior Management and Employees—E.
Share Ownership—Certain Information Concerning Equity Awards to Office Holders."
104
Employment
Agreements and Arrangements with Directors and Related Parties
We
entered into written employment agreements with each of our executive officers. These agreements provide for notice periods of varying
duration for termination of the agreement by us or by the relevant executive officer, during which time the executive officer will continue
to receive base salary and benefits. These agreements also contain customary provisions regarding non-competition, confidentiality of
information and assignment of inventions. However, the enforceability of the non-competition and assignment of inventions provisions
may be limited under applicable law. See "Item 3. Key Information—Risk Factors—Risks Related to Our Business, Industry
and Regulatory Requirements."
Employment
Agreement with Our President and Chief Executive Officer
On
December 30, 2013, we entered into a personal employment agreement with our controlling shareholder, Mr. Allen Baharaff who serves as
our president and chief executive officer and as the chairman of our Board, as amended on March 15, 2016, July 20, 2017, August 1, 2019,
and August 30, 2021 which provides that Mr. Baharaff's terms of office and employment are for an undefined term, subject to re-approval
under the Companies Law and termination in accordance with the terms of the employment agreement.
Under
the current terms of his employment agreement, Mr. Baharaff is entitled to a gross monthly salary of NIS 170,000, following shareholder
approval which was obtained at our 2021 annual meeting of shareholders. In addition, Mr. Baharaff will be entitled to an annual cash
bonus based on achievement of qualitative and quantitative performance goals and objectives. As approved at our 2021 annual meeting of
shareholders the annual cash bonus amount may be of up to six times Mr. Baharaff's monthly base salary, and the actual bonus paid
in a given year shall be determined based on the achievement of certain qualitative and quantitative performance goals and objectives
set by our remuneration committee and Board, which effective as of January 1, 2022, does not require further shareholder approval.
Mr.
Baharaff is also entitled to receive the following bonuses (i) upon execution of a Strategic Agreement (as defined below), and subject
to the discretion of the Board, a cash bonus in an amount of up to twelve times his monthly base salary. A "Strategic Agreement"
means: a license agreement or any other strategic agreement (i.e. research and development, manufacture, distribution, etc.) for the
U.S., Europe, Japan or China; (ii) upon consummation of a fund raising (excluding funds received from a Strategic Agreement), and, subject
to the discretion of the Board, a cash bonus in an amount of up to ten times his monthly base salary if the funds received by the Company
are between $8 Million to $10 million and up to twelve times his monthly base salary if the funds received by the Company are $10 million
or more; (iv) upon a Change of Control Event (as defined below), and, subject to the discretion of the Board, a cash bonus in an amount
of up to twelve times his monthly base salary, a "Change of Control Event" means: (a) the acquisition of the Company by another
entity or individual or group of individuals by means of any transaction or series of related transactions (including, without limitation,
any reorganization, merger, share purchase or consolidation), unless the Company's shareholders of record as constituted immediately
prior to any such transaction will, immediately after such transaction (by virtue of securities issued as consideration for the Company's
share capital, assets or otherwise) hold more than 50% of the voting power of the surviving or acquiring entity; or (b) a sale of all
or substantially all of the assets of the Company.
Mr.
Baharaff will also be entitled to the following equity based compensation: (i) in the event that our options are cashed-out upon a Change
of Control Event, all unvested options granted to Mr. Baharaff will vest immediately prior to the consummation of the Change of Control
Event; (ii) if upon a Change of Control Event (a) Mr. Baharaff's employment as chief executive officer of the Company or the surviving
entity is terminated within twelve months as of the Change of Control Event, and (b) unvested options are replaced for new options of
the surviving entity as part of the Change of Control Event with a vesting schedule and terms identical to the replaced options, or the
Replacement Options, then (x) all unvested Replacement Options granted to Mr. Baharaff will vest immediately prior to the termination
of Mr. Baharaff's employment, and (y) Mr. Baharaff's Replacement Options will be exercisable until the earlier of (a) two
years from termination, and (b) expiration of the Replacement Options.
105
Mr.
Baharaff will also receive other benefits required under Israeli law or that are customary for senior executives in Israel such as confidentiality,
reimbursement of expenses, payment for absence days, sick leave, pension and/or a manager's insurance policy and study fund.
Mr.
Baharaff is also entitled to accumulate vacation days for no more than two years. As approved at our 2021 annual meeting of shareholders,
unused accumulated vacation days that exceed the number of vacation days that may be accumulated over a two-year period (currently, 48
vacation days) shall be redeemed once a year, on March 1, provided that the redemption will not result in the number of accumulated vacation
days following the redemption being less than 48 days, or as otherwise required by law. Accumulated vacation days shall also be redeemed
in the event of termination of employment of Mr. Baharaff.
Mr.
Baharaff's employment agreement is terminable by either party upon six months prior written notice, or Prior Notice Period, and
contains customary provisions regarding noncompetition, confidentiality of information and assignment of inventions. Upon termination,
provided such termination was not for cause, Mr. Baharaff shall be entitled, in addition to the Prior Notice Period, to a payment in
an amount of up to twelve times his monthly base salary, to be paid in twelve equal monthly installments, in exchange for Mr. Baharaff's
undertaking not to compete with the Company for a period of twelve months, or Non-Compete Grant. Other than in case of resignation by
Mr. Baharaff, excluding resignation for a Good Reason Event (as defined below), or termination for cause: (i) all Mr. Baharaff's
unvested options will vest upon termination; and (ii) unexercised options granted to Mr. Baharaff may be exercised until the earlier
of (a) two years from his termination, and (b) expiration of his options. A "Good Reason Event" means: any of the following
events, provided that the event is effected by the Company without the written consent of Mr. Baharaff: (i) a material reduction or adverse
change in Mr. Baharaff's authority, duties or responsibilities; (ii) a reduction in Mr. Baharaff's monthly base salary, other
than a reduction of no more than 10% of his then current monthly base salary as part of an across the board reduction in all salaries
for employees of the Company; (iii) a material breach by the Company of Mr. Baharaff's employment agreement or any other agreements
pertaining directly to Mr. Baharaff's compensation or employment or (iv) death, disability or severe illness. Upon termination
for cause by the Company, Mr. Baharaff shall not be entitled to any Prior Notice Period, Non-Compete Grant or any other payment, and
any unvested outstanding equity awards shall terminate immediately upon the date of such termination for cause.
For
cash bonuses granted to Mr. Baharaff see "Item 6. Directors, Senior Management and Employees— B. Compensation—Individual
Compensation of Covered Executives." For outstanding equity-based awards granted to Mr. Baharaff see below under "Item 6.
Directors, Senior Management and Employees—E. Share Ownership—Certain Information Concerning Equity Awards to Office Holders."
C.
Board Practices.
We
are incorporated in Israel, and, therefore, we are subject to various corporate governance practices under Israeli law relating to such
matters as external directors (if required), independent directors, audit committees, remuneration committees and internal auditors.
These Israeli law requirements are in addition to the requirements of the Nasdaq Listing Rules and other relevant provisions of U.S.
securities laws. Under such Nasdaq Listing Rules, a foreign private issuer may generally follow its home country practices for corporate
governance in lieu of such comparable listing rules' requirements, except for certain matters such as composition and responsibilities
of the audit committee and the SEC-mandated standards for the independence of its members. See below under "Item 16G. Corporate
Governance" for further information.
Membership
of the Board
Our
Articles provide that the minimum number of members of the Board is three and the maximum number of members is eleven. The Board is presently
comprised of five members. Pursuant to regulations
promulgated under the Companies Law,
or the Relief Regulations,, companies with no controlling shareholder whose shares are listed for trading on specified exchanges outside
of Israel, including the Nasdaq Capital Market, may adopt exemptions from various corporate governance requirements of the Companies
Law so long as the company satisfies the applicable foreign country laws and regulations, including applicable stock exchange rules,
that apply to companies organized in that country relating to the appointment of independent directors and the composition of audit and
remuneration committees. Such exemptions include an exemption from the requirement to appoint external directors and the requirement
that an external director be a member of the audit and remuneration committees.
106
In
March 2020, our Board adopted this exemption , and our directors then in office who were elected and classified as an external director,
were no longer classified as such under the Companies Law.
The
minimum and maximum number of directors may be changed, at any time and from time to time, by a majority vote of our directors then in
office, provided that no decrease in the number of directors shall shorten the term of any incumbent director. Under our Articles, the
Board consists of three classes of directors which are appointed for fixed terms of office in accordance with the Companies Law and our
Articles, with one class being elected each year for a term of approximately three years by our shareholders at our annual general meeting.
Directors
so elected cannot be removed from office by the shareholders until the expiration of their term of office. The directors do not receive
any benefits upon the expiration of their term of office.
The
three classes of directors are Class I Directors, Class II Directors and Class III Directors. Shmuel Nir and Dr. Carol Brosgart serve
as our Class I Directors until the close of the annual general meeting to be held in 2024; Allen Baharaff serves as our Class II Director
until the close of the annual general meeting to be held in 2025; and Dr. David Sidransky and Amir Poshinski serve as our Class III Directors
until the close of the annual general meeting to be held in 2026.
In
accordance with the Articles, any vacancies on the Board of, including unfilled positions, may be filled by a vote of a majority of the
directors then in office, and each director chosen in this manner would hold office until the next annual general meeting of the Company
(or until the earlier termination of his or her appointment as provided for in the Companies Law or the Articles).
Any
amendment of our Articles regarding the election of directors, as described above, requires the affirmative vote of at least 75% of the
voting rights in the Company, represented personally or by proxy and voting thereon at a general meeting. See "Item 6. Directors,
Senior Management and Employees—C. Board Practices—External Directors" for a description of the procedure for the election
of external directors.
A
nominee for service as a director in a public company may not be elected without submitting a declaration to the company, prior to election,
specifying that he or she has the requisite qualifications to serve as a director, independent director or external director (if required),
as applicable, and the ability to devote the appropriate time to performing his or her duties as such.
A
director, who ceases to meet the statutory requirements to serve as a director, external director or independent director, as applicable,
must notify the company to that effect immediately and his or her service as a director will expire upon submission of such notice.
Alternate
Directors
Our
Articles provide, as allowed by the Companies Law, that any director may, subject to the conditions set thereto, appoint a person as
an alternate to act in his place, to remove the alternate and appoint another in his place and to appoint an alternate in place of an
alternate whose office is vacated for any reason whatsoever. Under the Companies Law, a person who is not qualified to be appointed as
a director, a person who is already serving as a director or a person who is already serving as an alternate director for another director,
may not be appointed as an alternate director. Nevertheless, a director who is already serving as a director may be appointed as an alternate
director for a member of a committee of the board of directors so long as he or she is not already serving as a member of such committee.
A person who is not qualified to be appointed as an independent director, pursuant to the Companies Law, may not be appointed as an alternate
director of an independent director qualified as such under the Companies Law. Unless the appointing director limits the time or scope
of the appointment, the appointment is effective for all purposes until the appointing director ceases to be a director or terminates
the appointment.
107
External
Directors
Generally,
unless a regulatory relief is available, under the Companies Law and the regulations promulgated pursuant thereto, Israeli companies
whose shares have been offered to the public, or that are publicly traded outside of Israel, which we refer to as a public company, are
required to appoint at least two natural persons as "external directors."
Pursuant
the Relief Regulations, companies with shares traded on certain U.S. stock exchanges, including Nasdaq, which do not have a "controlling
shareholder," may, subject to certain conditions, "opt out" from the Companies Law requirements to appoint external
directors and related Companies Law rules concerning the composition of the audit committee and remuneration committee of the board of
directors. In accordance with these regulations, in March 2020, our Board elected to "opt out" from the Companies Law requirement
to appoint external directors and related Companies Law rules concerning the composition of the audit committee and remuneration committee
of our Board.
Director
Independence
Following
our "opt-out" of the requirement to have external directors serving on our Board, we comply with the director independence
requirements and the audit committee and the remuneration committee composition requirements under U.S. laws (including applicable Nasdaq
Capital Market rules) applicable to U.S. domestic issuers. Our Board has undertaken a review of the independence of each director. Based
on information provided by each director concerning their background, employment and affiliations, our Board has determined that Mr.
Nir, Mr. Poshinski, Dr. Sidransky, and Dr. Brosgart do not have a relationship that would interfere with the exercise of independent
judgment in carrying out the responsibilities of a director and that each of these directors is "independent" as that term
is defined under the listing standards of the Nasdaq. In making these determinations, our Board considered the current and prior relationships
that each non-employee director has with our company and all other facts and circumstances our Board deemed relevant in determining their
independence, including the beneficial ownership of our capital shares by each non-employee director.
Committees
of the Board
Our
Articles also provide that the Board may delegate any, or all, of its powers to one or more committees of the Board, and may entrust
to and confer upon a "managing director" such of its powers as it deems appropriate. However, the Companies Law provides
that certain powers and authorities (for example, the power to approve the financial statements) may not be delegated and may be exercised
only by the Board. Notwithstanding the foregoing, we currently do, and intend to continue to, comply with the corporate governance requirements
of the Nasdaq Capital Market, except to the extent indicated elsewhere in this annual report, including as set forth under "Item
16G. Corporate Governance" below. The Companies Law requires public companies such as the Company to appoint an audit committee
and a remuneration committee.
Audit
Committee
The
Companies Law requires public companies to appoint an audit committee comprised of at least three directors, including all of the external
directors, if any the majority of whom must be independent directors under the Companies Law. The Companies Law further stipulates that
the following may not be members of the audit committee: (i) the chairman of the board of directors; (ii) any director employed by or
providing services on an ongoing basis to the company, to a controlling shareholder of the company or an entity controlled by a controlling
shareholder of the company; (iii) a director whose livelihood mainly depends on a controlling shareholder; and (iv) a controlling shareholder
or any relative of a controlling shareholder.
The
Companies Law further requires that: (i) the chairperson of the audit committee must be an external director; (ii) generally, any person
who is not entitled to be a member of the audit committee may not attend the audit committee's meetings and voting sessions, unless
such person was invited by the chairperson of the committee for the purpose of presenting a specific subject matter thereof; and (iii)
the quorum required for the convening of meetings of the audit committee and for adopting resolutions by the audit committee is a majority
of the members of the audit committee, provided that the majority of the members present are independent directors and at least one of
them is an external director. As noted, under the Relief Regulation, companies with no controlling shareholder whose shares are listed
for trading on specified exchanges outside of Israel, including the Nasdaq Capital Market, may adopt exemptions from various corporate
governance requirements of the Companies Law so long as the company satisfies the applicable foreign country laws and regulations, including
applicable stock exchange rules, that apply to companies organized in that country relating to the appointment of independent directors
and the composition of audit and remuneration committees. Such exemptions include an exemption from the requirement to appoint external
directors and the requirement that an external director be a member of certain committees. In accordance with these Regulations, we elected
to "opt out" from such requirements of the Companies Law.
108
The
responsibilities of the audit committee under the Companies Law include: (i) identifying flaws in the management of a company's
business and making recommendations to the board of directors as to how to correct them; (ii) with respect to certain actions involving
conflicts of interest and with respect to certain related party transactions, deciding whether such actions are material actions and
whether such transactions are extraordinary transactions, respectively, all for the purpose of approving such actions or transactions;
(iii) reviewing and deciding whether to approve certain related party transactions and certain actions involving conflicts of interest;
(iv) reviewing the internal auditor's work program; (v) examining the company's internal control structure and processes,
the performance of the internal auditor and whether the internal auditor has at his or her disposal the tools and resources required
to perform his or her duties, considering, inter alia, the special needs of the company and its size; (vi) examining the independent
auditor's scope of work as well as the independent auditor's fees and providing its recommendations to the appropriate corporate
organ; (vii) providing for arrangements as to the manner in which the company will deal with employee complaints with respect to deficiencies
in the management of the company's business and the protection to be provided to such employees; and (viii) with respect to related
party transactions with a controlling shareholder, regardless of whether such transactions are extraordinary transactions, that prior
to entering into such transaction, to establish the requirement of having a competitive process under the supervision of the audit committee
or any individual, committee or body on its behalf and according to criteria established by the audit committee and to determine procedures
for approving certain related party transactions with a controlling shareholder, which were determined by the audit committee to be non-extraordinary
transactions, but which are not negligible transactions.
Our
Board has adopted an audit committee charter setting forth the responsibilities of the audit committee consistent with the rules of the
SEC and the Nasdaq Listing Rules, as well as the requirements for such committee under the Companies Law, as described below.
Our
audit committee oversees the accounting and financial reporting processes of the Company. It also provides assistance to the Board in
fulfilling its legal and fiduciary obligations with respect to matters involving the accounting, auditing, financial reporting and internal
control functions of the Company. In carrying out its duties, our audit committee meets with management at least once a quarter, at which
time, among other things, it reviews, and either approves or disapproves, the financial results of the Company for the immediately preceding
calendar quarter and conveys its conclusions in this regard to the Board. Our audit committee also monitors generally the services provided
by the Company's independent auditors to ensure their independence and reviews all audit and non-audit services provided by them.
Our
Board has resolved to delegate to the audit committee the power to pre-approve non-auditing services rendered by the Company's
independent auditors without the need for further approval by our Board. As such, on March 15, 2016, our audit committee approved the
adoption of a pre-approval policy, such that the Chairman of the audit committee is authorized to pre-approve any engagement of our independent
auditors during a period of twelve months from the date of such approval, for the provision of non-auditing services, for fees not to
exceed $20,000, and any such engagement which exceeds $20,000 shall require a pre-approval by the entire audit committee. Once services
have been pre-approved, our management must then report to the audit committee on a periodic basis regarding the extent of services actually
provided in accordance with the pre-approval policy, and regarding the fees for the services performed.
The
Company's independent and internal auditors also report regularly to our audit committee, and our audit committee discusses with
the Company's independent auditors the quality, not just the acceptability, of the accounting principles, the reasonableness of
significant judgments and the clarity of disclosures in the Company's financial statements, as and when it deems it appropriate
to do so.
Under
the provisions of the Sarbanes-Oxley Act, the audit committee is directly responsible for the appointment, compensation and oversight
of the work of the company's independent auditors. However, under Israeli law, the appointment of independent auditors and their
compensation require the approval of the shareholders of a public company. Pursuant to Israeli law, the shareholders may delegate the
authority to determine the compensation of the independent auditors to the board of directors. In addition, pursuant to the Companies
Law, the audit committee is required to examine the independent auditors' fees and to provide its recommendations with respect
thereto to the appropriate corporate body. Accordingly, the appointment of our independent auditors is required to be approved and recommended
to the shareholders by our audit committee and Board and approved by the shareholders. The compensation of the independent auditors for
audit services is required to be approved and recommended to the Board by our audit committee and approved by the Board. The Board has
delegated its authority to approve the compensation of independent auditors for non-auditing services to the audit committee.
109
Mr.
Nir, Mr. Poshinski and Dr. Sidransky are the current members of our audit committee, with Mr. Poshinski serving as chairperson. Each
of our audit committee members are "independent directors" in accordance with the Nasdaq Capital Market corporate governance
requirements, as affirmatively determined by our Board. In addition, our Board has affirmatively determined that Mr. Poshinski also qualifies
as an audit committee financial expert pursuant to the applicable SEC rules, and accordingly has the necessary financial sophistication
as required by the Nasdaq Capital Market rules.
Remuneration
Committee
The
Companies Law requires public companies to appoint a remuneration committee comprised of at least three directors, including all of the
external directors, who must generally also constitute a majority of the members. All other members of the committee, who are not external
directors, must be directors who receive compensation consistent with that of external directors and that is in compliance with the compensation
related regulations promulgated under the Companies Law. In addition, the chairperson of the remuneration committee must be an external
director. As noted, under the Relief Regulations, we elected to "opt out" from such requirements of the Companies Law.
The
Companies Law further stipulates that directors who are not qualified to serve on the audit committee, as described above, may not serve
on the remuneration committee either and that similar to the audit committee, generally, any person who is not entitled to be a member
of the remuneration committee may not attend the remuneration committee's meetings. Our Board has adopted a remuneration committee
charter setting forth the responsibilities of our remuneration committee, as described below.
The
responsibilities of the remuneration committee under the Companies Law include: (i) making recommendations to the board of directors
with respect to the approval of the compensation policy and any extensions thereto; (ii) periodically reviewing the implementation of
the compensation policy and providing the board of directors with recommendations with respect to any amendments or updates thereto;
(iii) reviewing and resolving whether or not to approve transactions with respect to the terms of office and employment of Office Holders;
and (iv) resolving, under certain circumstances prescribed under the Companies Law, whether or not to exempt a transaction with a candidate
for chief executive officer who meets non-affiliation criteria from shareholder approval.
Our
remuneration committee also oversees the administration of the Company's various compensation plans and arrangements, in particular,
the incentive compensation, deferred compensation and equity based plans of the Company (and to the extent appropriate, of the subsidiaries
of the Company) and assists the Board in fulfilling its responsibilities relating to the compensation of directors, the Chief Executive
Officer and other Office Holders of the Company. In carrying out these duties, our remuneration committee meets on an ad hoc basis. Under
the Companies Law, our remuneration committee may need to seek the approval of the Board and the shareholders for certain compensation
decisions as described above. Each member of our remuneration committee is an "independent director" in accordance with the
Nasdaq Capital Market corporate governance requirements, as affirmatively determined by our Board. Mr. Nir, Mr. Poshinksi and Dr. Sidransky
are the current members of our remuneration committee, with Dr. Sidransky serving as chairperson.
110
Compensation
Policy
As
approved by our shareholders, and as required by the Companies Law, we have adopted a Compensation Policy regarding the terms of office
and employment of our "office holders" (as defined under the Companies Law, which includes directors, the CEO, other executive
officers and any other managers directly subordinate to the CEO), including cash compensation, equity-based awards, releases from liability,
indemnification and insurance, severance and other benefits. Each of the named executive officers is an "office holder" within
the meaning of the Companies Law. The Compensation Policy is reviewed from time to time by our remuneration committee and our Board to
ensure its appropriateness, and is required to be brought at least once every three years to our shareholders for approval. See "Item
6. Directors, Senior Management and Employees — B. Compensation — Certain Approvals Required for Office Holders' Compensation
of the Companies Law".
Our
current Compensation Policy was approved and adopted on May 30, 2023 and will be in effect for a period of three years until May 29,
2026, unless replaced in accordance with the Companies Law prior. The Compensation Policy links pay to performance and aligns our executive
officers' interests with those of the Company and of our shareholders. It allows us to provide meaningful incentives that reflect
both our short and long-term goals and performance, as well as the executive officers' individual performance and impact on shareholder
value, while providing compensation that is competitive in the global marketplace in which we recruit talent and is designed to reduce
incentives for our executive officers to take excessive risks.
The
Compensation Policy emphasizes each executive officer's individual characteristics (such as his or her respective position, education,
scope of responsibilities and contribution to the attainment of our goals) as the basis for compensation variation among executive officers,
taking into account the internal ratios between compensation of our executive officers and directors and other employees of the Company.
Pursuant to the Compensation Policy, the compensation that may be granted to an executive officer may include: base salary and benefits,
annual cash bonuses and other cash bonuses (such as retention and special bonuses), as well as equity-based compensation, retirement
and termination of employment benefits, change of control provisions and other benefits. The cash bonuses that may be granted under the
Compensation Policy are limited to a maximum amount linked to the executive officer's base salary.
Under
the Compensation Policy, an annual cash bonus that will be awarded to executive officers (other than the CEO) will be based on performance
objectives and a discretionary evaluation of the executive officer's overall performance by the CEO and may be subject to minimum
thresholds. The remuneration committee and the Board will determine any applicable minimum thresholds that must be met for entitlement
to the annual cash bonus (all or any portion thereof) and the formula for calculating any annual cash bonus payout on the basis of, but
not limited to, company and individual objectives. Notwithstanding the above, we may determine that, with respect to any executive officer
subordinated to the CEO, which does not serve as a director, a portion or all of his or her annual cash bonus will be based on the evaluation
of the CEO.
The
Compensation Policy provides that the annual bonus awarded to the Company's CEO will be mainly based on measurable objectives of
the Company, subject to a minimum threshold on the basis of, but not limited to, company and personal objectives. 30% or less of the
annual cash bonus granted to the Company's CEO may be based on a discretionary evaluation of the CEO's overall performance
by the remuneration committee and the Board. The measurable objectives will be determined annually by the remuneration committee and
the Board at the commencement of each calendar year, or upon engagement, in case of newly hired CEO, or in other special circumstances
as set forth in the Compensation Policy.
The
equity-based compensation under the Compensation Policy for our executive officers is designed in a manner intended to attract and retain
officers and align their interests with shareholders' interests to maximize creation of long-term economic value for the Company,
and to strengthen the retention and the motivation of executive officers in the long term. Equity-based awards may be granted from time
to time in the form of options and/or other equity- based awards, such as RSUs in accordance with our 2013 Plan as may be updated from
time to time.
The
Compensation Policy contains compensation recovery provisions in the event of accounting restatement, which would allow us, under certain
conditions, to recover bonuses or performance-based equity paid in excess of what would have been paid under the financial statements,
as restated. The Compensation Policy also contains provisions that allow us to exculpate, indemnify and insure our executive officers
and directors subject to certain updated limitations set forth in the Compensation Policy.
111
The
Compensation Policy also governs the compensation of our non-management Board members and provides that our directors will be entitled
to an annual cash fee retainer, which shall not exceed US$100,000 plus VAT, or the Maximum Amount, and with respect to an Expert External
Director, as defined in the compensation related regulations promulgated under the Companies Law, plus 33% to the Maximum Amount. Our
non-management Board members may also receive equity awards up to the limits set forth in the Compensation Policy.
Nominating
Committee
The
Nasdaq Capital Market corporate governance requires each company adopting a nominating committee to certify that it has adopted a formal
written charter or board resolution, as applicable, addressing the nominations process and such related matters as may be required under
U.S. federal securities laws. Although not required as a foreign private issuer to adopt a nominating committee, we have decided to follow
such requirement.
Our
Board has adopted a nominating committee charter setting forth the responsibilities of the nominating committee consistent with the Nasdaq
Listing Rules.
The
nominating committee is responsible for identifying individuals qualified to be appointed as board members, and recommending to the Board
appropriate director nominees for election at the general meeting of shareholders.
Independent
director oversight of nominations enhances investor confidence in the selection of well-qualified director nominees, as well as independent
nominees as required by the rules. The Nasdaq Capital Market listing rule is also intended to provide flexibility for a company to choose
an appropriate board structure and reduce resource burdens, while ensuring that independent directors approve all nominations.
Mr.
Nir, Mr. Poshinski, and Dr. Sidransky are the current members of our nominating committee, with Dr. Sidransky serving as chairperson.
Nasdaq Capital Market Listing Rule 5605(e) requires that our nominating committee be comprised solely of independent directors unless
the nominating committee is comprised of at least three members and the Board determines that such non-independent director's membership,
which shall not be longer than two years, is required by the best interests of the Company and our shareholders.
R&D
Committee
Our
R&D Committee, which was established by the Board on May 2014, advises and assists the Board in its oversight of our research and
development programs, including the rationale and timeline of clinical trials and other studies, as well as market surveys in connection
therewith. The R&D Committee operates in accordance with the purposes and objectives determined by the Board from time to time. Dr.
Sidransky, Dr. Brosgart and Mr. Baharaff are the current members of our R&D Committee, with Dr. Sidransky serving as chairperson.
Internal
Auditor
Under
the Companies Law, the board of directors of an Israeli public company must appoint an internal auditor recommended by the audit committee
and nominated by the board of directors. The role of the internal auditor is to examine, among other things, our compliance with applicable
law and orderly business procedures. An internal auditor should comply with the requirements of the Companies Law and the Internal Audit
Law, 5752-1992, and may not be:
(a)
a person (or a relative
    of a person) who holds more than 5% of the Company's outstanding shares or voting rights;
(b)
a person (or a relative
    of a person) who has the power to appoint a director or the general manager of the Company;
(c)
an Office Holder, including
    a director, of the Company (or a relative thereof); or
(d)
a member of the Company's
    independent accounting firm, or anyone on his or her behalf.
Pursuant
to Israeli law, an internal auditor's tenure cannot be terminated without his or her consent, nor can he or she be suspended from
such position unless the board of directors of the company has so resolved following the recommendations of the company's audit
committee and, after providing the internal auditor with the opportunity to present his or her position to the board of directors of
the company and to the audit committee.
112
On
January 12, 2021, our Board appointed Zach Refaeli, CPA, from Ernst & Young Israel - Kost Forer Gabbay & Kasierer, Tel Aviv,
Israel, as the Company's internal auditor for a period of three years, effective as of January 12, 2021.
Exculpation
and Indemnification of Directors and Officers
Under
the Companies Law, a company may not exculpate an Office Holder from liability for a breach of the duty of loyalty. An Israeli company
may exculpate an Office Holder in advance from liability to the company, in whole or in part, for damages caused to the company as a
result of a breach of the duty of care but only if a provision authorizing such exculpation is included in its articles of association.
Our Articles include such a provision. The Company may not exculpate in advance a director from liability arising out of a prohibited
dividend or distribution to shareholders.
Under
the Companies Law, and the Israeli Securities Law, 5738—1968, or the Securities Law, a company may indemnify, or undertake in advance
to indemnify, an Office Holder for the following liabilities and expenses, imposed on Office Holder or incurred by Office Holder due
to acts performed by him or her as an Office Holder, provided its articles of association include a provision authorizing such indemnification:
●
a monetary liability incurred
    by or imposed on him or her in favor of another person pursuant to a judgment, including a settlement or arbitrator's award
    approved by a court. However, if an undertaking to indemnify an Office Holder with respect to such liability is provided in advance,
    then such an undertaking must be limited to events which, in the opinion of the board of directors, can be foreseen based on the
    company's activities when the undertaking to indemnify is given, and to an amount or according to criteria determined by the
    board of directors as reasonable under the circumstances, and such undertaking shall detail the abovementioned foreseen events and
    amount or criteria;
●
reasonable litigation expenses,
    including attorneys' fees, incurred by the Office Holder as a result of an investigation or proceeding instituted against him
    or her by an authority authorized to conduct such investigation or proceeding, provided that (i) no indictment was filed against
    such Office Holder as a result of such investigation or proceeding; and (ii) no financial liability was imposed upon him or her as
    a substitute for the criminal proceeding as a result of such investigation or proceeding or, if such financial liability was imposed,
    it was imposed with respect to an offense that does not require proof of criminal intent or as a monetary sanction;
●
a monetary liability imposed
    on him or her in favor of an injured party at an Administrative Procedure (as defined below) pursuant to Section 52(54)(a)(1)(a)
    of the Securities Law;
●
expenses incurred by an
    office holder or certain compensation payments made to an injured party that were instituted against an office holder in connection
    with an Administrative Procedure under the Securities Law, including reasonable litigation expenses and reasonable attorneys'
    fees; and
●
reasonable litigation expenses,
    including attorneys' fees, incurred by the Office Holder or imposed by a court in proceedings instituted against him or her
    by the company, on its behalf, or by a third-party, or in connection with criminal proceedings in which the Office Holder was acquitted,
    or as a result of a conviction for an offense that does not require proof of criminal intent.
●
An
    "Administrative Procedure" is defined as a procedure pursuant to chapters H3 (Monetary Sanction by the Israeli Securities
    Authority), H4 (Administrative Enforcement Procedures of the Administrative Enforcement Committee) or I1 (Arrangement to prevent
    Procedures or Interruption of procedures subject to conditions) to the Securities Law.
113
Under
the Companies Law and the Securities Law, a company may insure an Office Holder against the following liabilities incurred for acts performed
by him or her as an Office Holder if and to the extent provided in the company's articles of association:
●
a breach of the duty of
    loyalty to the company, provided that the Office Holder acted in good faith and had a reasonable basis to believe that such act would
    not prejudice the company;
●
a breach of the duty of care to the company or to a
    third-party;
●
a monetary liability imposed on the Office Holder in
    favor of a third-party;
●
a monetary liability imposed
    on the office holder in favor of an injured party at an Administrative Procedure pursuant to Section 52(54) (a)(1)(a) of the Securities
    Law; and
●
expenses incurred by an
    office holder in connection with an Administrative Procedure instituted against him or her, including reasonable litigation expenses
    and reasonable attorneys' fees.
Nevertheless,
under the Companies Law, a company may not indemnify, exculpate or insure an Office Holder against any of the following:
●
a breach of the duty of
    loyalty, except for indemnification and insurance for a breach of the duty of loyalty to the company in the event Office Holder acted
    in good faith and had a reasonable basis to believe that the act would not prejudice the company;
●
a breach of the duty of
    care committed intentionally or recklessly, excluding a breach arising out of the negligent conduct of the Office Holder;
●
an act or omission committed
    with intent to derive unlawful personal benefit; or
●
a fine, monetary sanction,
    penalty or forfeit levied against the Office Holder.
Under
the Companies Law, exculpation, indemnification and insurance of Office Holders require the approval of the remuneration committee, board
of directors and, in certain circumstances, the shareholders, as described above under "Item 6
—
Directors, Senior Management
and Employees—B. Compensation."
Our
Articles permit us to exculpate, indemnify and insure our Office Holders to the fullest extent permitted by the Companies Law. Each of
our Office Holders have entered into an indemnification agreement with us, exculpating them, to the fullest extent permitted by Israeli
law, from liability to us for damages caused to us as a result of a breach of the duty of care and undertaking to indemnify them to the
fullest extent permitted by Israeli law, including with respect to liabilities resulting from certain acts performed by such Office Holders
in their capacity as an Office Holder of the Company, our subsidiaries or our affiliates.
In
the opinion of the SEC, indemnification of directors and Office Holders for liabilities arising under the Securities Act, however, is
against public policy and therefore unenforceable.
Agreements
with Directors
Other
than a written agreement with our President, Chief Executive Officer and Chairman, as detailed in "Item 6. Directors, Senior Management
and Employees—B. Compensation—Employment Agreements and Arrangements with Directors and Related Parties—Employment
Agreement with Our President, Chief Executive Officer and Chairman of the Board," we do not have written agreements with any director
providing for benefits upon the termination of his or her services with our Company.
114
D.
Employees.
As
of December 31, 2023, we had eight employees, of which three were full-time employees and five were part-time employees. Four of our
employees were involved in our clinical and product development operations and 4 served in general and administrative capacities.
While
none of our employees are party to any collective bargaining agreements or represented by any labor unions, certain provisions of the
Israeli labor laws and certain collective bargaining agreements between the Histadrut (General Federation of Labor in Israel) and the
Coordination Bureau of Economic Organizations (including the Industrialists' Associations) are applicable to our employees by order
of the Israel Ministry of Economics. These provisions primarily concern the length of the workday, minimum daily wages for professional
workers, pension fund benefits for all employees, insurance for work-related accidents, procedures for dismissing employees, determination
of severance pay and other conditions of employment. We generally provide our employees with benefits and working conditions beyond the
required minimums. We have never experienced any employment-related work stoppages and believe our relationship with our employees is
favorable.
E.
Share Ownership.
The
following table sets forth information regarding beneficial ownership of our ordinary shares as of March 27, 2024, the latest practicable
date for inclusion in this annual report, held by our directors and executive officers, individually and as a group and beneficial owners
of more than 5% of our outstanding shares.
Beneficial
ownership is determined in accordance with the rules of the SEC and includes voting or investment power with respect to ordinary shares.
Ordinary shares issuable under share options, warrants or other conversion rights currently exercisable or that are exercisable within
60 days after March 27, 2024 are deemed outstanding for the purpose of computing the percentage ownership of the person holding the options,
or other conversion rights, but are not deemed outstanding for the purpose of computing the percentage ownership of any other person.
Percentage of shares beneficially owned is based on 6,009,654 ordinary shares outstanding on March 27, 2024.
Except
as otherwise indicated, and subject to applicable community property laws, the persons named in the table have sole voting and investment
power and the right to receive the economic benefit of ownership with respect to all ordinary shares held by that person.
Unless
otherwise stated, the address for our directors and senior management is c/o Galmed Pharmaceuticals Ltd., 16 Abba Hillel Road, Ramat Gan, Israel 5250608.
Number of ordinary
Percentage of ordinary
shares beneficially
shares beneficially
owned
(1)
owned
More than 5% Holders
CVI Investments, Inc.
(2)
414,827
6.9
%
Directors and Executive Officers
Allen Baharaff
(3)
340,095
5.6
%
Shmuel Nir
(4)
9,093
*
Dr. David Sidransky
(5)
6,331
*
Dr. Carol L. Brosgart
(6)
4,498
*
Dr. Liat Hayardeny
(7)
12,997
*
Yohai Stenzler
(8)
12,206
*
Guy Nehemya
(9)
12,206
*
Amir Poshinski
(10)
3,165
*
Doron Cohen
(11)
1,333
*
All directors and executive officers as a group (9 persons)
401,923
6.6
%
*Less
than 1%.
(1)
All options included are either currently exercisable or will be exercisable within 60 days of March 27, 2023.
115
(2)
Based upon information contained in a Schedule 13G/A filed by the shareholder on February 14, 2024. Shares beneficially owned consist
of (i) 269,238 ordinary shares and (ii) 145,589 ordinary shares issuable upon the exercise of warrants. The warrants are subject to a
beneficial ownership limitation of 9.99%, which such limitation restricts the holder from exercising that portion of the warrants that
would result in the holder and its affiliates owning, after exercise, a number of ordinary share in excess of the beneficial ownership
limitation. Heights Capital Management, Inc., the authorized agent of CVI Investments, Inc. ("CVI"), has discretionary authority
to vote and dispose of the shares held by CVI and may be deemed to be the beneficial owner of these shares. Martin Kobinger, in his capacity
as Investment Manager of Heights Capital Management, Inc., may also be deemed to have investment discretion and voting power over the
shares held by CVI. Mr. Kobinger disclaims any such beneficial ownership of the shares. The principal business address of CVI is c/o
Heights Capital Management, Inc., 101 California Street, Suite 3250, San Francisco, California 94111.
(3)
Consists of (i) 227,790 ordinary shares are held through G. Yarom Medical Research Ltd., a company incorporated under the laws of the
State of Israel, of which Mr. Baharaff is the controlling shareholder and the chairman of its board of directors; and (ii) options to
purchase 112,305 ordinary shares that are currently exercisable within 60 days as of March 27, 2024. Of the 340,095 ordinary shares,
Mr. Baharaff exercises sole voting and dispositive power over 112,305 shares beneficially owned and shared voting and dispositive power
with G. Yarom Medical Research Ltd. over 227,790 shares.
(4)
Consists of (i) 500 ordinary shares held by Mr. Nir; and (ii) 2,762 ordinary shares
are held through Tushia Consulting Engineers Ltd., of which Shmuel Nir is its controlling shareholder and (iii) 5,831 ordinary shares
issuable upon the exercise of options that are currently exercisable or will be exercisable within 60 days as of March 27, 2024.
(5)
Consists of (i) 500 ordinary shares held by Dr. Sidransky; and (ii) 5,831 ordinary shares issuable upon the exercise of options that
are currently exercisable or will be exercisable within 60 days as of March 27, 2024.
(6)
Consists of 4,498 ordinary shares issuable upon the exercise of options that are currently exercisable or will be exercisable within
60 days as of March 27, 2024.
(7)
Consists of 12,997 ordinary shares issuable upon the exercise of options that are currently exercisable or will be exercisable within
60 days as of March 27, 2024.
(8)
Consists of (i) 375 ordinary shares held by Mr. Stenzler; and (ii) 11,831 ordinary shares issuable upon the exercise of options that
are currently exercisable or will be exercisable within 60 days as of March 27, 2024.
(9)
Consists of (i) 375 ordinary shares held by Mr. Nehemya; and (ii) 11,831 ordinary shares issuable upon the exercise of options that are
currently exercisable or will be exercisable within 60 days as of March 27, 2024.
(10)
Consists of 3,165 ordinary shares issuable upon the exercise of options that are currently exercisable or will be exercisable within
60 days as of March 27, 2024.
(11)
Consists of 1,133 ordinary shares issuable upon the exercise of options that are currently exercisable or will be exercisable within
60 days as of March 27, 2024.
Change
in Control
To
our knowledge, (i) we are not directly or indirectly owned or controlled by another corporation, by any foreign government or by any
other natural or legal person severally or jointly, except as disclosed in the above table regarding our major shareholders, and (ii)
there are no arrangements which would result in our change in control at a subsequent date.
116
Significant
Changes in the Ownership of Major Shareholders
To
our knowledge, other than as disclosed in the table above, our other filings with the SEC and this annual report, there has been no significant
change in the percentage ownership held by any major shareholder since January 1, 2020.
Major
Shareholders Voting Rights
Our
major shareholders do not have different voting rights.
Record
Holders
To
our knowledge, as of March 27, 2024, we had one holder of record of our ordinary shares with a U.S. address, Cede & Co., the nominee
of The Depository Trust Company. This holder held in the aggregate 5,779,871 ordinary shares, or 96.2% of our outstanding ordinary shares
as of March 27, 2024. The number of record holders in the United States is not representative of the number of beneficial holders of
our ordinary shares nor is it representative of where such beneficial holders are resident since many of these ordinary shares were held
by brokers or other nominees.
2013
Incentive Share Option Plan
We
maintain one equity-based incentive plan, our 2013 Plan. As of March 27, 2024, the latest practicable date for inclusion in this annual
report, a total of 2,000,000 shares were reserved for issuance under our 2013 Plan, of which (1) options to purchase 240,970 ordinary
were issued and outstanding thereunder (i.e., were granted but not canceled, expired or exercised); (2) RSU's to purchase 1,315,000
ordinary shares were issued and outstanding; (3) options to purchase 72,737 ordinary shares were exercised and 4,267 ordinary shares
were issued upon vesting of RSUs; and (3) 367,026 shares remain unallocated for future equity awards pursuant to our 2013 Plan.
Our
2013 Plan, which was adopted by our Board on September 2, 2013, and approved by our shareholders in December 30, 2013 (as amended on
March 30, 2015, May 11, 2015, August 30, 2018 and August 7, 2023), will be in effect until October 4, 2026 and provides for the grant
of options to purchase our ordinary shares and the issuance of RSUs to our officers, directors, employees, service providers and consultants.
Our 2013 Plan provides for such equity-based compensation under various and different tax regimes, including those detailed below.
The
2013 Plan is administered by our Board, which, on its own or upon the recommendation of our remuneration committee or any other similar
committee of the Board, shall determine, subject to applicable law, the identity of grantees of awards and various terms of the grant.
Consistent with our Compensation Policy, the 2013 Plan provides for granting options to purchase our ordinary shares pursuant to Section
102 of the Israeli Income Tax Ordinance, or the Ordinance, under the capital gains route, to directors, officers and employees who are
Israeli residents holding (or have a right to hold or to purchase) less than 10% of our total share capital and do not have a right to
receive 10% or more of the Company's profits.
Section
102 of the Ordinance allows Israeli employees, directors and officers, who are not controlling shareholders to receive favorable tax
treatment for compensation in the form of shares or options. However, under this route we are not allowed to deduct any expense with
respect to the issuance of the options or shares. Israeli non-employee service providers, consultants and shareholders who hold 10% or
more of our total share capital or are otherwise controlling shareholders, may be granted options pursuant to Section 3(i) of the Ordinance,
which does not provide for similar tax benefits. In order to comply with the terms of the capital gains route pursuant to Section 102
of the Ordinance, the granted options as well as the ordinary shares issued upon exercise of these options and other shares received
subsequently following any realization of rights with respect to such options (such as share dividends and share splits), must be granted
to a trustee for the benefit of the relevant grantee and should be held by the trustee for at least two years after the date of the grant.
If such options or shares are sold by the trustee or are transferred to the grantee before the end of the two-year period, then the grantee
would be taxed at top marginal rates upon selling the shares.
117
For
residents, or deemed residents, of the United States, the 2013 Plan provides grants, which are pursuant to Section 422 of the Internal
Revenue Code of 1986, as amended, or the Code, as incentive stock options, or ISOs, and any other participants which do not qualify for
ISOs, as non-statutory stock options, or NSOs, pursuant to the Code.
Section
422 of the Code allows employees, directors and officers, who are non-controlling shareholders (e.g., less than 10% shareholders) and
are considered residents of the United States or those who are deemed to be residents of the United States for purposes of the payment
of tax, or are otherwise subject to taxation in the United States with respect to the grant of awards, to receive favorable tax treatment
for compensation in the form of shares or ISOs. 10% shareholders or persons which are not service providers will receive NSOs, which
do not entitle them to receive similar tax benefits. Section 422(b) of the Code provides for the ISO track such that the individual does
not have to pay ordinary income tax (nor employment taxes) on the difference between the exercise price and the fair market value of
the shares issued (however, the holder may have to pay U.S. alternative minimum tax instead). However, if the shares are held for one
year from the date of exercise and two years from the date of grant, then the profit (if any) made on sale of the shares is taxed as
long-term capital gain. Section 422 of the Code requires that any grant of awards shall not be made at a price which is less than 100%
of the fair market value of such awards on the date of the grant, all pursuant to the terms of Section 409A of the Code. However, under
this ISO track, we are not allowed to deduct any expense with respect to the issuance of the options or shares. In order to comply with
the terms of the ISO track, the option granted thereunder must meet the requirements of Section 422 of the Code when granted and at all
times until the exercise thereof.
Options
and RSUs granted under the 2013 Plan will vest in accordance with the vesting dates as determined by the Board following the recommendation
of the remuneration committee or any other similar committee of the Board with respect to each grant. Generally, options that are not
exercised within ten years from the grant date expire, unless otherwise determined by the Board and the remuneration committee, as applicable,
provided, however, that, pursuant to our Compensation Policy, any equity-based awards to Office Holders must include both a gradual vesting
period of at least three years from the date of grant, and an exercise period of no more than ten years from the date of grant.
Upon
such date or dates designated in the applicable award agreement, unless earlier forfeited, subject to the receipt of any approvals required
from any relevant tax authority, we shall settle each RSU upon vesting by delivering one ordinary share.
In
case of termination for reasons of disability or death, the grantee or his legal successor may exercise options that have vested prior
to termination within a period of twelve months from the date of disability or death. If we terminate a grantee's employment or
service for cause, all of the grantee's vested and unvested unexercised options will expire and terminate on the date of termination.
If a grantee's employment or service is terminated for any other reason, the grantee may exercise his or her vested options within
90 days of the date of termination or within a longer period under specified circumstances determined by our Board. Any expired or unvested
options shall return to the option pool reserved under the 2013 Plan for reissuance.
In
the event of grantee's termination prior to a vesting date by reason of such grantee's death or disability, all of such grantee's
RSUs shall immediately become vested as of the date of such termination. In the event of a grantee's termination for cause prior
to settlement, all of such grantee's RSUs shall immediately be forfeited for no consideration as of the date of such termination.
If a grantee's employment or service is terminated for any other reason, (1) all vesting with respect to such grantee's RSUs
shall cease, (2) all of such grantee's unvested RSUs shall immediately be forfeited for no consideration as of the date of such
termination, and (3) to the extent not already settled, all of such grantee's vested RSUs shall be settled in accordance with the
settlement schedule set forth in the applicable award agreement.
In
the event of a merger or consolidation of our company subsequent to which we would no longer exist as a legal entity, or a sale of all,
or substantially all, of our ordinary shares or assets or other transaction having a similar effect on us, or a Transaction, any unexercised
options then outstanding will be cancelled. Notwithstanding the foregoing, the Board, or the relevant committee of the Board, may determine
that the options will not be cancelled but will be assumed or substituted for an appropriate number of the same type of shares or other
securities of the successor company as were distributed to the Company or the shareholders in connection with the Transaction. In addition,
the Board, or the relevant committee of the Board, may determine to include in certain option agreements either a clause that provides
for acceleration of vesting of all or part of the unvested options in the event of a Transaction or the occurrence of another event or
a clause which provides that if the optionee's employment with the successor company is terminated by the successor company without
cause within a certain period, not to exceed two years from the closing of such Transaction, all or part of the unvested options shall
be accelerated.
118
Certain
Information Concerning Equity Awards to Office Holders
The
following tables set forth information, as of March 27, 2024 concerning all outstanding equity awards to Office Holders as of such date.
Options
Name of Office Holder
Date of grant
Exercise price per
share ($)*
Shares subject
to the option
Shares vested and
unexercised
Shares
unvested
Schedule date of expiration
Allen Baharaff
December 30, 2013
NIS 0.15
16,069
16,069
(**)
0
Dec-12-2028
December 30, 2013
NIS 0.15
5,585
5,585
(**)
0
Dec-12-2028
February 4, 2016
$
82.35
9,333
9,333
0
Feb-04-2026
February 4, 2016
$
89.1
11,333
11,333
0
Feb-04-2026
July 10, 2018
$
173.4
14,666
14,666
0
Jul-10-2028
December 17, 2019
$
76.8
14,666
14,666
55,000
Dec-17-2029
November 10, 2020
$
49.95
11,000
3,666
1,8330
Nov-17-2030
Shmuel Nir
May 11, 2015
$
82.35
666
666
0
May-11-2025
February 4, 2016
$
89.1
2,000
2,000
0
Feb-04-2026
July 10, 2018
$
173.4
2,000
2,000
0
Jul-10-2028
July 15, 2021
$
46.5
1,133
998
335
Jul-10-2031
Amir Poshinski
August 13, 2020
$
71.55
2,000
2,000
5,000
August 13, 2030
July 15, 2021
$
46.5
1,333
998
335
Jul-10-2031
David Sidransky
May 11, 2015
$
82.35
666
666
0
May-11-2025
February 4, 2016
$
89.1
2,000
2,000
0
Feb-04-2026
July 10, 2018
$
173.4
2,000
2,000
0
Jul-10-2028
July 15, 2021
$
46.5
1,133
998
335
Jul-10-2031
Dr. Liat Hayardeny (***)
September 6, 2016
$
5.7
2,666
2,666
0
Sep-06-2026
January 31, 2017
$
5.7
2,166
2,166
0
Jan-31-2026
July 10, 2018
$
5.7
2,666
2,666
0
Jul-10-2028
December 17, 2019
$
5.7
2,666
2,666
0
Dec-17-2029
November 10, 2020
$
5.7
1,833
1,833
0
Nov-10-2030
Yohai Stenzler (***)
December 30, 2014
$
5.7
233
233
0
Dec-30-2024
January 3, 2016
$
5.7
1,500
1,500
0
Jan-03-2026
November 7, 2017
$
5.7
1,333
1,333
0
Nov-07-2020
July 10, 2018
$
5.7
2,666
42,666
0
Jul-10-2028
December 17, 2019
$
5.7
2,666
2,666
0
Dec-17-2029
November 10, 2020
$
5.7
2,666
2,000
666
Nov-10-2030
Guy Nehemya (***)
December 30, 2014
$
5.7
733
733
0
Dec-30-2024
January 3, 2016
$
5.7
1,500
1,500
0
Jan-03-2026
July 10, 2018
$
5.7
2,666
2,666
0
Jul-10-2028
December 17, 2019
$
5.7
2,666
2,666
0
Dec-17-2029
November 10, 2020
$
5.7
2,666
1,933
733
Nov-10-2030
Carol L. Brosgart
April 25, 2017
$
73.05
1,333
1,333
0
Apr-25-2027
July 10, 2018
$
173.4
2,000
2,000
0
Jul-10-2028
July 15, 2021
$
46.5
1,333
998
335
Jul-10-2031
August 7, 2023
$
1.05
75,000
0
75,000
Augt-7-2033
Doron Cohen (***)
February 23, 2022
$
5.7
2,666
1,500
1,166
Feb-23-2032
(*)
All exercise prices are in USD unless otherwise specified.
(**)
In September 2023, we extended the exercise period of 21,654 outstanding options previously granted our Chief Executive Officer (and
director), by approximately five years to December 31, 2028.
(***)
On May 11, 2023, we repriced outstanding options to purchase an aggregate of 35,598 ordinary shares held by several Office Holders to
$5.70 per share and extended their terms for one year following the date of termination of an optionee's employment or service
with us or an affiliate.
119
RSUs
Shares
Name of Office
subject to
Shares
Shares
Holder
Date of grant
the RSUs
vested
unvested
Allen Baharaff
Aug-7-2023
640,000
0
640,000
Shmuel Nir
Feb-04-2016
500
500
0
Aug-7-2023
75,000
0
75,000
David Sidransky
Feb-04-2016
7,500
7,500
0
Aug-7-2023
75,000
0
75,000
Amir Poshinski
Aug-7-2023
75,000
0
75,000
Yohai Stenzler
Jan-03-2016
5,625
5,625
0
Aug-7-2023
150,000
0
150,000
Guy Nehemya
Jan-03-2016
5,625
5,625
0
Aug-7-2023
150,000
0
150,000
Doron Cohen
Aug-7-2023
150,000
0
150,000
F.
Disclosure of a registrant's action to recover erroneously awarded compensation.
Not
applicable.
ITEM
7. Major Shareholders and Related Party Transactions.
A.
Major Shareholders.
Except
as set forth in "Item 6. Directors, Senior Management and Employees—E. Share Ownership," to the best of our knowledge,
no other person who we know beneficially owns 5% or more of the Company's ordinary shares outstanding as of March 27, 2024, the
latest practicable date for inclusion in this annual report. None of our shareholders has different voting rights from other shareholders.
Other than as described herein, to the best of our knowledge, we are not owned or controlled, directly or indirectly, by another corporation,
by any foreign government or by any natural person or legal persons, severally or jointly, and we are not aware of any arrangement that
may, at a subsequent date, result in a change of control of our company.
B.
Related Party Transactions.
The
following is a summary description of the material terms of those transactions with related parties to which we, or our subsidiaries,
are party and which were in effect since January 1, 2023.
Financing
Agreement with GRD
We
have provided financing to GRD from time to time, pursuant to which the Company and GRD have executed several capital notes for an aggregate
outstanding principal amount of approximately $147.0 million. The par value of such notes is in NIS, and they bear no interest nor repayment
date; provided, however, that no repayment shall be made before the fifth anniversary from the issuance date of each note.
120
Agreements
with Directors and Officers
Employment
and Consulting Agreements
. We have entered into written employment or consulting agreements with certain of our Office Holders. These
agreements provide for notice periods of varying duration for termination of the agreement by us or by the relevant Office Holder, during
which time the Office Holder will continue to receive base salary and benefits. We have also entered into customary non-competition,
confidentiality of information and ownership of inventions arrangements with these Office Holders. However, the enforceability of the
noncompetition provisions may be limited under applicable law.
Options.
Since our inception, we have granted options to purchase our ordinary shares to certain of our Office Holders. Such option agreements
may contain acceleration provisions upon certain merger, acquisition, or change of control transactions. During November 2022, we effected
a repricing of certain options. See also "Item 6. Directors, Senior Management and Employees—E. Share Ownership". We
describe our 2013 Plan under "Item 6. Directors, Senior Management and Employees—B. Compensation— 2013 Incentive Share
Option Plan." If the relationship between us and an Office Holder is terminated except for "cause" (as defined in the
2013 Plan and/or the applicable option award agreement), options that are vested will generally remain exercisable for 90 days after
such termination; provided, however, that prior to the date of such termination, our remuneration committee may authorize an extension
of the terms of all or part of the vested options beyond the date of such termination for a period not to exceed the period during which
the options by their terms would otherwise have been exercisable, and provided further that the vested options may lose their status
as incentive stock options and/or approved 102 options if such extension extends beyond the maximum extension authorized by the Ordinance
or the Code, as applicable
.
RSUs.
We have granted RSUs to certain of our Office Holders. Such award agreements may contain acceleration provisions upon certain merger,
acquisition, or change of control transactions. See also "Item 6. Directors, Senior Management and Employees—E. Share Ownership."
We describe our 2013 Plan under "Item 6. Directors, Senior Management and Employees—B. Compensation—2013 Incentive
Share Option Plan." If the relationship between us and an Office Holder is terminated, RSUs that are vested shall be settled in
accordance with the settlement schedule set forth in the applicable award agreement.
OnKai
In
May 2023, we entered into the OnKai Agreement for a $1.5 million equity investment in OnKai, a US-based technology company developing
an AI-based platform to advance healthcare for underserved populations across the United States by facilitating alignment between healthcare
stakeholders. The signing of the definitive agreement followed an announcement that we made in January 2023 that we had entered into
a non-binding termsheet for an equity investment in OnKai. The OnKai Agreement provided that we will invest $1.5 million in exchange
for series seed preferred shares of OnKai (which is in addition to a $1.5 million investment that was made by us in OnKai through a SAFE
and which converted at a 15% discount into series seed preferred shares upon consummation of the Investment Round). Our investment in
OnKai was part of an approximately $6 million Investment Round with other investors that was led by us of which SAFE notes of approximately
$3.8 million were converted into preferred shares. On June 19, 2023, the Investment Round closed. Following the Investment Round, we
hold approximately 23.9% of the outstanding share capital of OnKai on an as-converted and fully and our Chief Executive Officer and director,
Allen Baharaff serves as a board member of OnKai. In connection with the OnKai Agreement, our wholly-owned subsidiary, GRD entered into
the OnKai Services Agreement with OnKai. The OnKai Services Agreement provides that GRD shall on a non-exclusive basis (i) provide support
services to OnKai relating to finance, business development, strategic planning, execution and others; and (ii) lend its experience to
OnKai in building a strategy and for the development of treatments for the underserved and that OnKai shall on a non-exclusive basis
(i) take part in plan preparation to serve GDR's vision of developing drugs for the underserved population and (ii) when relevant,
design a process on the clinical trial dashboard that could potentially serve GDR's future trial.
C.
Interests of Experts and Counsel.
Not
applicable.
ITEM
8. Financial Information.
A.
Consolidated Financial Statements and Other Financial Information.
See
"Item 18. Financial Statements" for a list of all financial statements filed as part of this annual report.
121
Legal
Matters
We
are neither party to any legal or arbitration proceedings, including those relating to bankruptcy, receivership or similar proceedings
and those involving any third-party, nor any governmental proceedings pending or known to be contemplated, which may have, or have had
in the recent past, significant effects on the Company's financial position or profitability.
Dividend
Policy
We
have never declared or paid any cash dividends on our ordinary shares and do not anticipate paying any cash dividends in the foreseeable
future. Payment of cash dividends, if any, in the future will be at the discretion of our Board and will depend on then-existing conditions,
including our financial condition, operating results, contractual restrictions, capital requirements, business prospects and other factors
our Board may deem relevant.
Payment
of dividends may also be subject to Israeli withholding taxes. See "Item 10. Additional Information—E. Taxation—Certain
Israeli Tax Considerations" for additional information.
B.
Significant Changes.
Other
than as otherwise described in this Annual Report on Form 20-F and as set forth below, no significant change has occurred in our operations
since the date of our consolidated financial statements included in this Annual Report on Form 20-F.
ITEM
9. The Offer and Listing.
A.
Offer and Listing Details
Our
ordinary shares have been listed on the Nasdaq Capital Market under the symbol "GLMD" since March 13, 2014. Prior to that
date, there was no public trading market for our ordinary shares.
B.
Plan of Distribution
Not
applicable.
C.
Market for Ordinary Shares
Our
ordinary shares have been quoted on the NASDAQ Capital Market since March 18, 2014 under the symbol "GLMD."
D.
Selling Shareholders
Not
applicable.
E.
Dilution
Not
applicable.
F.
Expenses of the issue
Not
applicable.
ITEM
10. Additional Information.
A.
Share Capital.
Not
applicable.
122
B.
Memorandum and Articles of Association.
Our
registration number is 51-495351-2. At the 2014 annual general meeting of shareholders, our shareholders adopted our Articles, which
became effective on the consummation of our initial public offering in the United States in March 2014. Under Section 2 of our Articles,
the purpose of the Company is to engage in any lawful activity.
The
information set forth in Exhibit 2.1 of this Annual Report is incorporated herein by reference.
C.
Material Contracts
For
a description of our material agreements relating to our strategic collaborations and research arrangements and other material agreements,
please refer to "Item 4.B. Information on the Company—Business Overview—Strategic Collaborations, Research Arrangements
and other Material Agreements." "and "Item 7.B "Related Party Transactions".
Employment
Agreements
See
"Item 6. Directors, Senior Management and Employees—B. Compensation".
D.
Exchange Controls.
There
are no Israeli government laws, decrees, regulations or other legislation that restrict or that affect our export or import of capital,
including the availability of cash and cash equivalents for use by us and our wholly-owned subsidiaries, or the remittance of dividends,
interest or other payments to non-resident holders of our securities, except for ownership by nationals of certain countries that are,
or have been, declared as enemies of Israel or otherwise as set forth under "Item 10. Additional Information—E. Taxation."
E.
Taxation.
The
following description is not intended to constitute a complete analysis of all tax consequences relating to the ownership or disposition
of our ordinary shares. You should consult your own tax advisor concerning the tax consequences of your particular situation, as well
as any tax consequences that may arise under the laws of any state, local, foreign, including Israel, or other taxing jurisdiction.
Certain
Israeli Tax Considerations
The
following is a brief summary of the material Israeli income tax laws applicable to us. This section also contains a discussion of material
Israeli tax consequences concerning the ownership and disposition of our ordinary shares. This summary does not discuss all the aspects
of Israeli tax law that may be relevant to a particular investor in light of his or her personal investment circumstances or to some
types of investors subject to special treatment under Israeli law. Examples of this kind of investor include residents of Israel or investors
in securities who are subject to special tax regimes not covered in this discussion. To the extent that the discussion is based on new
tax legislation that has not yet been subject to judicial or administrative interpretation, we cannot assure you that the appropriate
tax authorities or the courts will accept the views expressed in this discussion. This summary is based on laws and regulations in effect
as of the date hereof and does not take into account possible future amendments which may be under consideration.
General
Corporate Tax Structure in Israel
Israeli
resident companies (as defined below), such as the Company, are generally subject to corporate tax at the rate of 23% on their taxable
income, as of January 1, 2018 (23% in 2023). However, the effective tax rate payable by a company that derives income from a Preferred
Enterprise or a Technology Enterprise, as discussed below, may be considerably less.
123
Capital
gains derived by an Israeli resident company are generally subject to tax at the same rate as the corporate tax rate. Under Israeli tax
legislation, a corporation will be considered an "Israeli resident" if it meets one of the following: (i) it was incorporated
in Israel; or (ii) the control and management of its business are exercised in Israel.
Law
for the Encouragement of Industry (Taxes), 5729-1969
The
Law for the Encouragement of Industry (Taxes), 5729-1969, which we refer to as the Industry Encouragement Law, provides several tax benefits
for "Industrial Companies," which are defined as Israeli resident-companies which were incorporated in Israel, of which 90%
or more of their income in any tax year, other than income from certain government loans, is derived from an "Industrial Enterprise"
that it owns and located in Israel or in the "Area", in accordance with the definition under Section 3A of the Israeli Tax
Ordinance. An "Industrial Enterprise" is defined as an enterprise whose principal activity in a given tax year is industrial
production. Eligibility for benefits under the Industry Encouragement Law is not contingent upon approval of any governmental authority.
The
following tax benefits, among others, are available to Industrial Companies:
●
amortization
    over an eight year period of the cost of purchasing a patent, rights to use a patent and rights to know-how, which are used for the
    development or advancement of the company, commencing in the year in which such rights were first exercised;
●
under limited conditions,
    an election to file consolidated tax returns with related Industrial Companies controlled by it; and
●
deductions
    of expenses related to a public offering in equal amounts over a three year period commencing on the year of the offering.
We
believe that we qualify as an "Industrial Company" within the meaning of the Industry Encouragement Law. There can be no
assurance that we will continue to qualify as an Industrial Company in the future or that the benefits described above will be available
to us at all.
Law
for the Encouragement of Capital Investments, 5719-1959
The
Law for the Encouragement of Capital Investments, 5719-1959, which we refer to as the Investment Law, provides certain incentives for
capital investments in production facilities (or other eligible assets) by "Industrial Enterprises" (as defined under the
Investment Law). Generally, an investment program that is implemented in accordance with the provisions of the Investment Law, is entitled
to benefits. These benefits may include cash grants from the Israeli government and tax benefits, based upon, among other things, the
geographic location in Israel of the facility in which the investment is made. In order to qualify for these incentives, an Approved
Enterprise, a Beneficiary Enterprise or a Preferred Enterprise is required to comply with the requirements of the Investment Law.
The
Investment Law was significantly amended effective April 1, 2005, further amended as of January 1, 2011, or the 2011 Amendment, and as
of January 1, 2017, or the 2017 Amendment. The 2011 Amendment introduced new benefits to replace those granted in accordance with the
provisions of the Investment Law in effect prior to the 2011 Amendment. However, companies entitled to benefits under the Investment
Law as in effect up to January 1, 2011 were entitled to choose to continue to enjoy such benefits, provided that certain conditions are
met, or elect instead, irrevocably, to forego such benefits and elect the benefits of the 2011 Amendment. The 2017 Amendment introduces
new benefits for Technological Enterprises, alongside the existing tax benefits.
The
following discussion is a summary of the Investment Law following its most recent amendments:
Tax
Benefits Under the 2011 Amendment
The
2011 Amendment canceled the availability of the benefits granted to Industrial Companies under the Investment Law prior to 2011 and,
instead, introduced new benefits for income generated by a "Preferred Company" through its "Preferred Enterprise"
(as such terms are defined in the Investment Law) as of January 1, 2011.
124
The
definition of a Preferred Company includes a company incorporated in Israel that is not fully owned by a governmental entity, and that
has, among other things, a Preferred Enterprise and is controlled and managed from Israel. Pursuant to the 2011 Amendment, beginning
in 2014 and in each year thereafter until 2016, a Preferred Company may only be entitled to a reduced corporate tax rate of 16% with
respect to its preferred income derived by its Preferred Enterprise, unless the Preferred Enterprise is located in a specified development
zone, in which case the rate will be 9%. Pursuant to the 2017 Amendment, in 2017 and thereafter, the corporate tax rate for Preferred
Enterprise which is located in a specified development zone was reduced to 7.5%, while the reduced corporate tax rate for other development
zones remains 16%. Income derived by a Preferred Company from a "Special Preferred Enterprise" (as such term is defined in
the Investment Law) would be entitled, during a benefit period of ten years, to further reduced tax rates of 8%, or 5% if the Special
Preferred Enterprise is located in a certain development zone. As of January 1, 2017, the definition for 'Special Preferred Enterprise'
includes less stringent conditions.
As
of January 1, 2014, dividends paid to Israeli shareholders out of income attributed to a Preferred Enterprise or to a Special Preferred
Enterprise are generally subject to withholding tax at source at the rate of 20% (in the case of non-Israeli shareholders - subject to
the receipt in advance of a valid certificate from the ITA allowing for a reduced tax rate, 20%, or such a lower tax rate as may be provided
under an applicable tax treaty). However, if such dividends are paid to an Israeli company, no tax is required to be withheld (although,
if such dividends are subsequently distributed to individuals or a non-Israeli company, the aforesaid will apply).
New
Tax benefits under the 2017 Amendment
The
2017 Amendment was enacted as part of the Economic Efficiency Law that was published on December 29, 2016, and is effective as of January
1, 2017. The 2017 Amendment provides new tax benefits for two types of "Technology Enterprises", as described below, and
is in addition to the other existing tax beneficial programs under the Investment Law.
The
2017 Amendment provides that a technology company satisfying certain conditions will qualify as a "Preferred Technology Enterprise"
and will thereby enjoy a reduced corporate tax rate of 12% on income that qualifies as "Preferred Technology Income", as
defined in the Investment Law. The tax rate is further reduced to 7.5% for a Preferred Technology Enterprise located in development zone
A. In addition, a Preferred Technology Company will enjoy a reduced corporate tax rate of 12% on capital gain derived from the sale of
certain "Benefitted Intangible Assets" (as defined in the Investment Law) to a related foreign company if the Benefitted
Intangible Assets were acquired from a foreign company on or after January 1, 2017 for at least NIS 200 million (approximately $56 million),
and the sale receives prior approval from the National Authority for Technological Innovation (previously known as the Israeli Office
of the Chief Scientist), to which we refer as IIA.
The
2017 Amendment further provides that a technology company satisfying certain conditions will qualify as a "Special Preferred Technology
Enterprise" and will thereby enjoy a reduced corporate tax rate of 6% on "Preferred Technology Income" regardless of
the company's geographic location within Israel. In addition, a Special Preferred Technology Enterprise will enjoy a reduced corporate
tax rate of 6% on capital gain derived from the sale of certain "Benefitted Intangible Assets" to a related foreign company
if the Benefitted Intangible Assets were either developed by the Special Preferred Technology Enterprise or acquired from a foreign company
on or after January 1, 2017, and the sale received prior approval from IIA. A Special Preferred Technology Enterprise that acquires Benefitted
Intangible Assets from a foreign company for more than NIS 500 million will be eligible for these benefits for at least ten years, subject
to certain approvals as specified in the Investment Law.
Dividends
distributed by a Preferred Technology Enterprise or a Special Preferred Technology Enterprise to Israeli shareholders, paid out of Preferred
Technology Income, are subject to withholding tax at source at the rate of 20% (in the case of non-Israeli shareholders - subject to
the receipt in advance of a valid certificate from the ITA allowing for a reduced tax rate, 20%, or such lower rate as may be provided
in an applicable tax treaty). However, if such dividends are paid to an Israeli company, no tax is required to be withheld (although,
if such dividends are subsequently distributed to individuals or a non-Israeli company, the aforesaid will apply). If such dividends
are distributed to a foreign parent company holding, alone or together with other foreign companies, at least 90% of the shares of the
distributing company and other conditions are met, the withholding tax rate will be 4% (or a lower rate under a tax treaty, if applicable,
subject to the receipt in advance of a valid certificate from the ITA allowing for a reduced tax rate).
125
After
examining the impact of the 2017 Amendment, we submitted a request to receive a tax ruling from the Israel Tax Authority to be recognized
as a Preferred Technology Enterprise and we received a tax ruling from the Israel Tax Authority granting GRD a Preferred Technology Enterprise
status, subject to terms and conditions determined in the tax ruling.
Taxation
of Our Israeli Individual Shareholders on Receipt of Dividends
Israeli
residents who are individuals are generally subject to Israeli income tax for dividends paid on our ordinary shares (other than bonus
shares or share dividends) at a rate of 25%, or 30% if the recipient of such dividend is a Substantial Shareholder (as defined below)
at the time of distribution or at any time during the preceding 12-month period. However, dividends distributed from taxable income accrued
from Preferred Enterprise or Preferred Technology Enterprise to Israeli individuals are subject to withholding tax at the rate of 20%.
However, if such dividends are distributed to an Israeli company, no tax is imposed (although, if such dividends are subsequently distributed
to individuals or a non-Israeli company, withholding tax at a rate of 20% or such lower rate as may be provided in an applicable tax
treaty (subject to the receipt in advance of a valid certificate from the Israel Tax Authority ("ITA") allowing for a reduced
tax rate will apply). An average rate will be set in case the dividend is distributed from mixed types of income (regular and preferred
income).
A
"Substantial Shareholder" is generally a person who alone, or together with his or her relative or another person who collaborates
with him or her on a regular basis, holds, directly or indirectly, at least 10% of any of the "means of control" of a corporation.
"Means of control" generally include the right to vote, receive profits, nominate a director or an officer, receive assets
upon liquidation or instruct someone who holds any of the aforesaid rights regarding the manner in which he or she is to exercise such
right(s), all regardless of the source of such right.
With
respect to individuals, the term "Israeli resident" is generally defined under Israeli tax legislation as a person whose
center of life is in Israel. The Israeli Tax Ordinance (as amended by Amendment Law No. 132 of 2002), states that in order to determine
the center of life of an individual, consideration will be given to the individual's family, economic and social connections, including:
(i) place of permanent residence; (ii) place of residential dwelling of the individual and the individual's immediate family; (iii)
place of the individual's regular or permanent occupation or the place of his or her permanent employment; (iv) place of the individual's
active and substantial economic interests; (v) place of the individual's activities in organizations, associations and other institutions.
The center of life of an individual will be presumed to be in Israel if: (i) the individual was present in Israel for 183 days or more
in the tax year; or (ii) the individual was present in Israel for 30 days or more in the tax year, and the total period of the individual's
presence in Israel in that tax year and the two previous tax years is 425 days or more. Such presumption may be rebutted either by the
individual or by the assessing officer.
Payers
of dividends on our ordinary shares, including the Israeli stockbroker effectuating the transaction, or the financial institution through
which the securities are held, are generally required, subject to any of the foregoing exemptions, reduced tax rates and the demonstration
of a shareholder regarding his, her or its foreign residency, to withhold tax upon the distribution of dividend at the rate of 25% (whether
the recipient is a Substantial Shareholder or not), so long as the shares are registered with a nominee company.
Taxation
of Israeli Resident Corporations on Payment of Dividends
Israeli
resident corporations are generally exempt from Israeli corporate income tax with respect to dividends paid on ordinary shares of Israeli
resident corporations as long as the profits out of which the dividends were paid were derived in Israel.
Capital
Gains Taxes Applicable to Israeli Resident Shareholders
The
income tax rate applicable to real capital gains derived by an Israeli individual resident from the sale of shares that were purchased
after January 1, 2012, whether listed on a stock exchange or not, is 25%. However, if such shareholder is considered a Substantial Shareholder
at the time of sale or at any time during the preceding 12 month period and/or claims a deduction for interest and linkage differences
expenses in connection with the purchase and holding of such shares, such gain will be taxed at the rate of 30%.
126
Moreover,
capital gains derived by an individual shareholder who is a dealer or trader in securities, or to whom such income is otherwise taxable
as ordinary business income, are taxed in Israel at their marginal rates applicable to business income (up to 50% in 2022 and 2023, including
Excess Tax as detailed below).
At
the sale of securities traded on a stock exchange, a detailed return, including a computation of the tax due, must be filed and an advanced
payment must be paid on January 31 and July 31 of every tax year in respect of sales of securities made within the previous six months.
However, if all tax due was withheld at source according to applicable provisions of the Israeli Tax Ordinance and regulations promulgated
thereunder, the aforementioned return is not required to be filed and no advance payment must be paid. Capital gain is also reportable
on the annual income tax return.
Taxation
of Non-Israeli Shareholders on Receipt of Dividends
Non-Israeli
residents are generally subject to Israeli income tax on the receipt of dividends paid on our ordinary shares at the rate of 25% (or
30% for individuals, if such person is a Substantial Shareholder at the time he or she receives the dividend or on any date in the 12
months preceding such date), or 20% if the dividend is distributed from income attributed to Preferred Enterprise unless a lower rate
is provided under an applicable tax treaty between Israel and the shareholder's country of residence and provided that a certificate
from the Israel Tax Authority allowing for a reduced withholding tax rate is obtained in advance.
A
non-Israeli resident who has dividend income derived from or accrued in Israel, from which the full amount of tax was withheld at source,
is generally exempt from the duty to file tax returns in Israel in respect of such income; provided that (i) such income was not derived
from a business conducted in Israel by the taxpayer, (ii) the taxpayer has no other taxable sources of income in Israel with respect
to which a tax return is required to be filed, and (iii) the taxpayer is not obligated to pay excess tax (as further explained below).
For
example, under the Convention Between the Government of the United States of America and the Government of Israel with Respect to Taxes
on Income, as amended, or the U.S.-Israel Tax Treaty, Israeli withholding tax on dividends paid to a U.S. resident for treaty purposes
may not, in general, exceed 25%, subject to certain conditions. Where the recipient is a U.S. corporation owning 10% or more of the voting
shares of the paying corporation during the part of the paying corporation's taxable year which precedes the date of payment of
the dividend and during the entirety of its prior taxable year (if any), the Israeli tax withheld may not exceed 12.5%, subject to certain
conditions.
Payers
of dividends on our ordinary shares, including the Israeli stockbroker effectuating the transaction, or the financial institution through
which the securities are held, are generally required, subject to any of the foregoing exemptions, reduced tax rates and the demonstration
of a shareholder regarding his, her or its foreign residency, to withhold tax upon the distribution of dividend at the rate of 25% (whether
the recipient is a Substantial Shareholder or not), so long as the shares are registered with a nominee company.
Capital
Gains Income Taxes Applicable to Non-Israeli Shareholders
Non-Israeli
resident shareholders are generally exempt from Israeli capital gains tax on any gains derived from the sale, exchange or disposition
of our ordinary shares, provided that such shareholders did not acquire their shares prior to January 1, 2009 or acquired their shares
after the Company was listed for trading on NASDAQ and such gains were not derived from a permanent business or business activity of
such shareholders in Israel. These provisions dealing with capital gain are not applicable to a person whose gains from selling or otherwise
disposing of the shares are deemed to be business income. However, non-Israeli corporations will not be entitled to the foregoing exemptions
if an Israeli resident (i) has a controlling interest of more than 25% in such non-Israeli corporation or (ii) is the beneficiary of
or is entitled to 25% or more of the revenues or profits of such non-Israeli corporation, whether directly or indirectly.
127
In
addition, a sale of securities by a non-Israeli resident may be exempt from Israeli capital gains tax under the provisions of an applicable
tax treaty. For example, under the U.S.-Israel Tax Treaty, the sale, exchange or disposition of our ordinary shares by a shareholder
who is a U.S. resident (for purposes of the U.S.-Israel Tax Treaty) holding the ordinary shares as a capital asset and is entitled to
claim the benefits afforded to such a resident by the U.S.-Israel Tax Treaty, or a Treaty U.S. Resident, is generally exempt from Israeli
capital gains tax unless: (i) such Treaty U.S. Resident is an individual and was present in Israel for 183 days or more in the aggregate
during the relevant taxable year; (ii) such Treaty U.S. Resident holds, directly or indirectly, shares representing 10% or more of our
voting power of the Company during any part of the 12 month period preceding such sale, exchange or disposition, subject to certain conditions;
(iii) the capital gains arising from such sale, exchange or disposition are attributable to a permanent establishment of the Treaty U.S.
Resident maintained in Israel, subject to certain conditions; (iv) the capital gains arising from such sale, exchange or disposition
is attributed to real estate located in Israel; or (v) the capital gains arising from such sale, exchange or disposition is attributed
to royalties. In any such case, the sale, exchange or disposition of our ordinary shares would be subject to Israeli tax, to the extent
applicable. However, under the U.S.-Israel Tax Treaty, such Treaty U.S. Resident would be permitted to claim a credit for such taxes
against U.S. federal income tax imposed on any gain from such sale, exchange or disposition, under the circumstances and subject to the
limitations specified in the U.S.-Israel Income Tax Treaty.
Regardless
of whether shareholders may be liable for Israeli income tax on the sale of our ordinary shares, the payment of the consideration may
be subject to withholding of Israeli tax at the source. Accordingly, shareholders may be required to demonstrate that they are exempt
from tax on their capital gains in order to avoid withholding at source at the time of sale. Specifically, in transactions involving
a sale of all of the shares of an Israeli resident company, in the form of a merger or otherwise, the Israel Tax Authority may require
from shareholders who are not liable for Israeli tax to sign declarations in forms specified by this authority or obtain a specific exemption
from the Israel Tax Authority to confirm their status as non-Israeli resident, and, in the absence of such declarations or exemptions,
may require the purchaser of the shares to withhold taxes at source.
Excess
Tax
Individuals
who are subject to tax in Israel are also subject to an additional tax at a rate of 3% on annual income exceeding a certain threshold
(NIS 698,280 for 2023, which amount is linked to the annual change in the Israeli consumer price index), including, but not limited to,
dividends, interest and capital gains.
Estate
and Gift Tax
Israeli
law presently does not impose estate or gift taxes.
Certain
Material U.S. Federal Income Tax Considerations
The
following is a general summary of certain material U.S. federal income tax consequences relating to the purchase, ownership and disposition
of our ordinary shares by U.S. Holders (as defined below). This summary is based on the Code, the regulations of the U.S. Department
of the Treasury issued pursuant to the Code, or the Treasury Regulations, the income tax treaty between the United States and Israel,
or the U.S.-Israel Tax Treaty, and administrative and judicial interpretations thereof, all as in effect on the date hereof and all of
which are subject to change, possibly with retroactive effect, or to different interpretation. No ruling has been sought from the Internal
Revenue Service, or the IRS, with respect to any U.S. federal income tax consequences described below, and there can be no assurance
that the IRS or a court will not take a contrary position. This summary is no substitute for consultation by prospective investors with
their own tax advisors and does not constitute tax advice. This summary applies only to U.S. Holders that hold our ordinary shares as
capital assets for U.S. federal income tax purposes (generally, property held for investment) and does not address all of the tax considerations
that may be relevant to specific U.S. Holders in light of their particular circumstances or to U.S. Holders subject to special treatment
under U.S. federal income tax law (including, without limitation, banks, insurance companies, tax-exempt entities, retirement plans,
regulated investment companies, partnerships, dealers in securities, brokers, real estate investment trusts, grantor trusts, certain
former citizens or residents of the United States, persons who acquire our ordinary shares as part of a straddle, hedge, conversion transaction
or other integrated investment, persons who acquire our ordinary shares through the exercise or cancellation of employee stock options
or otherwise as compensation for their services, persons that have a "functional currency" other than the U.S. dollar, persons
that own (or are deemed to own, indirectly, or by attribution) 10% or more of our shares (by vote or value), or persons that mark their
securities to market for U.S. federal income tax purposes). This summary does not address any U.S. state or local or non-U.S. tax considerations,
any U.S. federal estate, gift or alternative minimum tax considerations, or any U.S. federal tax consequences other than U.S. federal
income tax consequences.
128
As
used in this summary, the term "U.S. Holder" means a beneficial owner of our ordinary shares that is, for U.S. federal income
tax purposes, (i) an individual citizen or resident of the United States, (ii) a corporation, or other entity taxable as a corporation
for U.S. federal income tax purposes, created or organized in or under the laws of the United States, any state thereof, or the District
of Columbia, (iii) an estate the income of which is subject to U.S. federal income tax regardless of its source, or (iv) a trust with
respect to which a court within the United States is able to exercise primary supervision over its administration and one or more U.S.
persons have the authority to control all of its substantial decisions, or that has a valid election in effect under applicable Treasury
Regulations to be treated as a "United States person."
If
an entity or arrangement treated as a partnership for U.S. federal income tax purposes holds our ordinary shares, the tax treatment of
such entity or arrangement treated as a partnership and each person treated as a partner thereof generally will depend upon the status
and activities of the entity and such person. A holder that is treated as a partnership for U.S. federal income tax purposes should consult
its own tax advisor regarding the U.S. federal income tax considerations applicable to it and its partners of the purchase, ownership
and disposition of our ordinary shares.
Prospective
investors should be aware that this summary does not address the tax consequences to investors who are not U.S. Holders. Prospective
investors should consult their own tax advisors as to the particular tax considerations applicable to them relating to the purchase,
ownership and disposition of our ordinary shares, including the applicability of U.S. federal, state and local tax laws and non-U.S.
tax laws.
Taxation
of U.S. Holders
Distributions
.
Subject to the discussion below under "Passive Foreign Investment Company," a U.S. Holder that receives a distribution with
respect to an ordinary share generally will be required to include the amount of such distribution in gross income as a dividend (without
reduction for any Israeli tax withheld from such distribution) when actually or constructively received to the extent of the U.S. Holder's
pro rata share of our current and/or accumulated earnings and profits (as determined under U.S. federal income tax principles). Any distributions
in excess of our earnings and profits will be applied against and will reduce (but not below zero) the U.S. Holder's tax basis
in its ordinary shares, and, to the extent they exceed that tax basis, will be treated as gain from the sale or exchange of our ordinary
shares. We do not intend to calculate our earnings and profits under U.S. federal income tax principles. Therefore, a U.S. Holder should
expect that a distribution will be reported as a dividend even if that distribution would otherwise be treated as a non-taxable return
of capital or as capital gain under the rules described above.
As
noted above, we do not anticipate paying any cash dividends in the foreseeable future. If we were to pay dividends, we expect to pay
such dividends in NIS. A dividend paid in NIS, including the amount of any Israeli taxes withheld, will be includible in a U.S. Holder's
income at a U.S. dollar amount calculated by reference to the exchange rate in effect on the date such dividend is received, regardless
of whether the payment is in fact converted into U.S. dollars. If the dividend is converted to U.S. dollars on the date of receipt, a
U.S. Holder generally will not recognize a foreign currency gain or loss. However, if the U.S. Holder converts the NIS into U.S. dollars
on a later date, the U.S. Holder must include, in computing its income, any gain or loss resulting from any exchange rate fluctuations.
The gain or loss will be equal to the difference between (i) the U.S. dollar value of the amount included in income when the dividend
was received and (ii) the amount received on the conversion of the NIS into U.S. dollars. Such gain or loss generally will be ordinary
income or loss and will be U.S. source income or loss for U.S. foreign tax credit purposes. U.S. Holders should consult their own tax
advisors regarding the tax consequences to them if we pay dividends in NIS or any other non-U.S. currency.
Subject
to certain significant conditions and limitations, any Israeli taxes paid on or withheld from distributions from us and not refundable
to a U.S. Holder may be credited against the U.S. Holder's U.S. federal income tax liability or, alternatively, may be deducted
from the U.S. Holder's taxable income. However, as a result of recent changes to the U.S. foreign tax credit rules, a withholding
tax may need to satisfy certain additional requirements in order to be considered a creditable tax for a U.S. Holder. We have
not determined whether these requirements have been met and, accordingly, no assurance can be given that any withholding tax on dividends
paid by us will be creditable. The election to deduct, rather than credit, foreign taxes, is made on a year-by-year basis and applies
to all foreign taxes paid by a U.S. Holder or withheld from a U.S. Holder that year. Dividends paid on our ordinary shares generally
will constitute income from sources outside the United States and be categorized as "passive category income" or, in the
case of some U.S. Holders, as "general category income" for U.S. foreign tax credit purposes. Because the rules governing
foreign tax credits are complex, U.S. Holders should consult their own tax advisors regarding the availability of foreign tax credits
in their particular circumstances.
129
Dividends
paid on our ordinary shares will not be eligible for the "dividends-received" deduction generally allowed to corporate U.S.
Holders with respect to dividends received from U.S. corporations.
Certain
distributions treated as dividends that are received by an individual U.S. Holder from a "qualified foreign corporation"
may be classified as "qualified dividend income,"
—
which is
generally taxed at the lower applicable long term capital gains rates provided certain holding period and other requirements are
satisfied. A non-U.S. corporation (other than a PFIC for the taxable year in which the dividend is paid or the preceding taxable
year) generally will be considered to be a qualified foreign corporation (i) if it is eligible for the benefits of a comprehensive
tax treaty with the United States which the Secretary of Treasury of the United States determines is satisfactory for purposes of
this provision and which includes an exchange of information program, or (ii) with respect to any dividend it pays on stock which is
readily tradable on an established securities market in the United States. We will not be a qualified foreign corporation if we are
a passive foreign investment company, or PFIC, for the taxable year in which we pay a dividend or for the preceding taxable year. As
discussed below under "Passive Foreign Investment Company," we believe that we were a PFIC for our 2023 taxable year and
expect to be a PFIC for the 2024 taxable year. Because the PFIC determination is highly fact intensive, there can be no assurance
that we will not be a PFIC in 2024 or for any other taxable year. Our ordinary shares will generally be considered to be readily
tradable on an established securities market in the United States if they are listed on the Nasdaq Capital Market, as we intend our
ordinary shares will be. U.S. Holders should consult their own tax advisors regarding the availability of the lower rate for
dividends paid with respect to our ordinary shares.
The
additional 3.8% "net investment income tax" (described below) may apply to dividends received by certain U.S. Holders who
meet certain modified adjusted gross income thresholds.
Sale,
Exchange or Other Taxable Disposition of Ordinary Shares
. Subject to the discussion under "Passive Foreign Investment Company"
below, a U.S. Holder generally will recognize capital gain or loss upon the sale, exchange, or other taxable disposition of our ordinary
shares in an amount equal to the difference between the amount realized on the sale, exchange, or other taxable disposition and the U.S.
Holder's adjusted tax basis (determined under U.S. federal income tax rules) in such ordinary shares. This capital gain or loss
will be long-term capital gain or loss if the U.S. Holder's holding period in our ordinary shares exceeds one year. Preferential
tax rates for long-term capital gain (currently, with a maximum rate of 20%) will apply to individual U.S. Holders. The deductibility
of capital losses is subject to limitations. The gain or loss generally will be income or loss from sources within the United States
for U.S. foreign tax credit purposes, subject to certain possible exceptions under the U.S.-Israel Tax Treaty. The additional 3.8% "net
investment income tax" (described below) may apply to gains recognized upon the sale, exchange, or other taxable disposition of
our ordinary shares by certain U.S. Holders who meet certain modified adjusted gross income thresholds.
U.S.
Holders should consult their own tax advisors regarding the U.S. federal income tax consequences of receiving currency other than U.S.
dollars upon the disposition of their ordinary shares.
Passive
Foreign Investment Company.
In general, a non-U.S. corporation will be treated as a PFIC for U.S. federal income tax purposes in
any taxable year in which either (i) at least 75% of its gross income is "passive income," or (ii) on average at least 50%
of its assets by value produce passive income or are held for the production of passive income. Passive income for this purpose generally
includes, among other things, certain dividends, interest, royalties, rents and gains from commodities and securities transactions and
from the sale or exchange of property that gives rise to passive income. Passive income also includes amounts derived by reason of the
temporary investment of funds, including those raised in a public offering. Assets that produce or are held for the production of passive
income may include cash, even if held as working capital or raised in a public offering, as well as marketable debt securities and other
assets that may produce passive income. In determining whether a non-U.S. corporation is a PFIC, a proportionate share of the income
and assets of each corporation in which it owns, directly or indirectly, at least a 25% interest (by value) is taken into account.
130
A
foreign corporation's PFIC status is an annual determination that is based on tests that are factual in nature, and our status
for any year will depend on our income, assets, and activities for such year. Based upon our review of our financial data, we believe
that we were a PFIC for our 2023 taxable year and expect to be a PFIC for the 2024 taxable year. Because PFIC status is determined annually
and is based on our income, assets and activities for the entire taxable year, it is not possible to determine with certainty whether
we will be characterized as a PFIC for the 2024 taxable year until after the close of the year, and there can be no assurance that we
will not be classified as a PFIC in any future year.
Default
PFIC Rules
. If we are a PFIC for any tax year, a U.S. Holder who does not make a timely "qualified electing fund" election,
or "QEF election" or a mark-to-market election (as described below), referred to in this summary as a "Non-Electing
U.S. Holder," will be subject to special rules with respect to (i) any "excess distribution" (generally, the portion
of any distributions received by the Non-Electing U.S. Holder on the ordinary shares in a taxable year in excess of 125% of the average
annual distributions received by the Non-Electing U.S. Holder in the three preceding taxable years, or, if shorter, the Non-Electing
U.S. Holder's holding period for the ordinary shares), and (ii) any gain realized on the sale or other disposition of such ordinary
shares. Under these rules:
●
the excess distribution
    or gain would be allocated ratably over the Non-Electing U.S. Holder's holding period for such ordinary shares;
●
the amount allocated to the current taxable year and
    any year prior to us becoming a PFIC would be taxed as ordinary income; and
●
the amount allocated to
    each of the other taxable years would be subject to tax at the highest rate of tax in effect for the applicable class of taxpayer
    for that year, and an interest charge for the deemed deferral benefit would be imposed with respect to the resulting tax attributable
    to each such other taxable year.
If
a Non-Electing U.S. Holder who is an individual dies while owning our ordinary shares, the Non-Electing U.S. Holder's successor
would be ineligible to receive a step-up in tax basis of such ordinary shares. Non-Electing U.S. Holders should consult their tax advisors
regarding the application of the "net investment income tax" (described below) to their specific situation.
To
the extent a distribution on our ordinary shares does not constitute an excess distribution to a Non-Electing U.S. Holder, such Non-Electing
U.S. Holder generally will be required to include the amount of such distribution in gross income as a dividend to the extent of our
current and/or accumulated earnings and profits (as determined for U.S. federal income tax purposes) that are not allocated to excess
distributions. The tax consequences of such distributions are discussed above under "Taxation of U.S. Holders—Distributions."
Each U.S. Holder is encouraged to consult its own tax advisor with respect to the appropriate U.S. federal income tax treatment of any
distribution on our ordinary shares.
If
we are treated as a PFIC for any taxable year during the holding period of a Non-Electing U.S. Holder, we will continue to be treated
as a PFIC for all succeeding years during which the Non-Electing U.S. Holder is treated as a direct or indirect Non-Electing U.S. Holder
even if we are not a PFIC for such years. A U.S. Holder is encouraged to consult its tax advisor with respect to any available elections
that may be applicable in such a situation, including the "deemed sale" election of Section 1298(b)(1) of the Code (which
will be taxed under the adverse tax rules described above).
We
may invest in the equity of foreign corporations that are PFICs or may own subsidiaries that are PFICs (any such entity, a "lower-tier
PFIC"). If we are classified as a PFIC, under attribution rules, U.S. Holders will be subject to the PFIC rules with respect to
their indirect ownership interests in such lower-tier PFICs, such that a disposition by us of the shares of the lower-tier PFIC or receipt
by us of a distribution from the lower-tier PFIC generally will be treated as a deemed disposition of such shares or the deemed receipt
of such distribution by the U.S. Holder, subject to taxation under the PFIC rules even though the U.S. Holder does not receive any proceeds
from those dispositions or distributions. There can be no assurance that a U.S. Holder will be able to make a QEF election with respect
to any lower-tier PFICs in which we invest. Each U.S. Holder is encouraged to consult its own tax advisor with respect to tax consequences
of an investment by us in a lower-tier PFIC.
131
QEF
Election
. Certain adverse consequences of PFIC status can be mitigated for holders of our ordinary shares if a U.S. Holder makes
a QEF election. A U.S. Holder who makes a timely QEF election, referred to in this disclosure as an "Electing U.S. Holder,"
with respect to us must report for U.S. federal income tax purposes its pro rata share of our ordinary earnings and net capital gain,
if any, for our taxable year that ends with or within the taxable year of the Electing U.S. Holder. The "net capital gain"
of a PFIC is the excess, if any, of the PFIC's net long-term capital gains over its net short-term capital losses. The amount so
included in income generally will be treated as ordinary income to the extent of such Electing U.S. Holder's allocable share of
the PFIC's ordinary earnings and as long-term capital gain to the extent of such Electing U.S. Holder's allocable share of
the PFIC's net capital gains. Such Electing U.S. Holder generally will be required to translate such income into U.S. dollars based
on the average exchange rate for the PFIC's taxable year with respect to the PFIC's functional currency. Such income generally
will be treated as income from sources outside the United States for U.S. foreign tax credit purposes. Amounts previously included in
income by such Electing U.S. Holder under the QEF rules generally will not be subject to tax when they are distributed to such Electing
U.S. Holder. The Electing U.S. Holder's tax basis in our ordinary shares generally will increase by any amounts so included under
the QEF rules and decrease by any amounts not included in income when distributed.
An
Electing U.S. Holder will be subject to U.S. federal income tax on such amounts for each taxable year in which we are a PFIC, regardless
of whether such amounts are actually distributed to such Electing U.S. Holder. However, an Electing U.S. Holder may, subject to certain
limitations, elect to defer payment of current U.S. federal income tax on such amounts, subject to an interest charge. If an Electing
U.S. Holder is an individual, any such interest will be treated as non-deductible "personal interest."
Any
net operating losses or net capital losses of a PFIC will not pass through to the Electing U.S. Holder and will not offset any ordinary
earnings or net capital gain of a PFIC recognized by Electing U.S. Holder in subsequent years.
So
long as an Electing U.S. Holder's QEF election with respect to us is in effect with respect to the entire holding period for our
ordinary shares, any gain or loss recognized by such Electing U.S. Holder on the sale, exchange or other disposition of such shares generally
will be long-term capital gain or loss if such Electing U.S. Holder has held such shares for more than one year at the time of such sale,
exchange or other disposition. Preferential tax rates for long-term capital gain (currently, a maximum rate of 20%) will apply to individual
U.S. Holders. The deductibility of capital losses is subject to limitations.
In
general, a U.S. Holder must make a QEF election on or before the due date for filing its income tax return for the first year to which
the QEF election is to apply. A U.S. Holder makes a QEF election by completing the relevant portions of and filing IRS Form 8621 in accordance
with the instructions thereto. Upon request, we expect to provide U.S. Holders with the information needed to complete IRS Form 8621
(which form would be required to be filed with the IRS on an annual basis by the U.S. Holder) and to make and maintain a valid QEF election
for any year in which we are a PFIC. There is no assurance, however, that we will have timely
knowledge of our status as a PFIC or the status of a lower-tier PFIC, or that the information that we provide will be adequate to allow
U.S. Holders to make a QEF election. A QEF election will not apply to any taxable year during which we are not a PFIC, but will remain
in effect with respect to any subsequent taxable year in which we become a PFIC.
Each
U.S. Holder should consult its own tax advisor with respect to the advisability of, the tax consequences of, and the procedures for making
a QEF election with respect to us.
Mark-to-Market
Election
. Alternatively, if our ordinary shares are treated as "marketable stock," a U.S. Holder would be allowed to
make a "mark-to-market" election with respect to our ordinary shares, provided the U.S. Holder completes and files IRS Form
8621 in accordance with the relevant instructions and related Treasury Regulations. If that election is made, the U.S. Holder generally
would include as ordinary income in each taxable year the excess, if any, of the fair market value of our ordinary shares at the end
of the taxable year over such holder's adjusted tax basis in such ordinary shares. The U.S. Holder would also be permitted an ordinary
loss in respect of the excess, if any, of the U.S. Holder's adjusted tax basis in our ordinary shares over their fair market value
at the end of the taxable year, but only to the extent of the net amount previously included in income as a result of the mark-to- market
election. A U.S. Holder's tax basis in our ordinary shares would be adjusted to reflect any such income or loss amount. Gain realized
on the sale, exchange or other disposition of our ordinary shares would be treated as ordinary income, and any loss realized on the sale,
exchange or other disposition of our ordinary shares would be treated as ordinary loss to the extent that such loss does not exceed the
net mark-to-market gains previously included in income by the U.S. Holder, and any loss in excess of such amount will be treated as capital
loss. Amounts treated as ordinary income will not be eligible for the favorable tax rates applicable to qualified dividend income or
long-term capital gains.
132
Generally,
stock will be considered marketable stock if it is "regularly traded" on a "qualified exchange" within the meaning
of applicable Treasury Regulations. A class of stock is regularly traded on an exchange during any calendar year during which such class
of stock is traded, other than in de minimis quantities, on at least 15 days during each calendar quarter. To be marketable stock, our
ordinary shares must be regularly traded on a qualifying exchange (i) in the United States that is registered with the SEC or a national
market system established pursuant to the Exchange Act or (ii) outside the United States that is properly regulated and meets certain
trading, listing, financial disclosure and other requirements. Our ordinary shares are expected to constitute "marketable stock"
as long as they remain listed on the Nasdaq Capital Market and are regularly traded.
A
mark-to-market election will not apply to our ordinary shares held by a U.S. Holder for any taxable year during which we are not a PFIC,
but will remain in effect with respect to any subsequent taxable year in which we become a PFIC. Such election will not apply to any
lower-tier PFIC that we own. Each U.S. Holder is encouraged to consult its own tax advisor with respect to the availability and tax consequences
of a mark-to-market election with respect to our ordinary shares.
Each
U.S. Holder should consult its own tax adviser with respect to the applicability of the "net investment income tax" (discussed
below) where a mark-to-market election is in effect.
In
addition, U.S. Holders should consult their tax advisors regarding the IRS information reporting and filing obligations that may arise
as a result of the ownership of ordinary shares in a PFIC, including IRS Form 8621, Information Return by a Shareholder of a Passive
Foreign Investment Company or Qualified Electing Fund.
The
U.S. federal income tax rules relating to PFICs, QEF elections, and mark-to market elections are complex. U.S. Holders are urged to consult
their own tax advisors with respect to the purchase, ownership and disposition of our ordinary shares, any elections available with respect
to such ordinary shares and the IRS information reporting obligations with respect to the purchase, ownership and disposition of our
ordinary shares.
Certain
Reporting Requirements
Certain
U.S. Holders may be required to file IRS Form 926, Return by U.S. Transferor of Property to a Foreign Corporation and IRS Form 5471,
Information Return of U.S. Persons With Respect to Certain Foreign Corporations, reporting transfers of cash or other property to us
and information relating to the U.S. Holder and us. Substantial penalties may be imposed upon a U.S. Holder that fails to comply. See
also the discussion regarding Form 8621, Information Return by a Shareholder of a Passive Foreign Investment Company or Qualified Electing
Fund, above.
In
addition, certain U.S. Holders must report information on IRS Form 8938, Statement of Specified Foreign Financial Assets, with respect
to their investments in certain "specified foreign financial assets," which would include an investment in our ordinary shares,
if the aggregate value of all of those assets exceeds $50,000 on the last day of the taxable year (and in some circumstances, a higher
threshold). This reporting requirement applies to individuals and certain U.S. entities.
U.S.
Holders who fail to report required information could become subject to substantial penalties. U.S. Holders should consult their tax
advisors regarding the possible implications of these reporting requirements arising from their investment in our ordinary shares.
133
Backup
Withholding Tax and Information Reporting Requirements
Generally,
information reporting requirements will apply to distributions on our ordinary shares or proceeds on the disposition of our ordinary
shares paid within the United States (and, in certain cases, outside the United States) to U.S. Holders other than certain exempt recipients,
such as corporations. Furthermore, backup withholding (currently at 24%) may apply to such amounts if the U.S. Holder fails to (i) provide
a correct taxpayer identification number, (ii) report interest and dividends required to be shown on its U.S. federal income tax return,
or (iii) make other appropriate certifications in the required manner. U.S. Holders who are required to establish their exempt status
generally must provide such certification on IRS Form W-9.
Backup
withholding is not an additional tax. Amounts withheld as backup withholding from a payment may be credited against a U.S. Holder's
U.S. federal income tax liability and such U.S. Holder may obtain a refund of any excess amounts withheld by filing the appropriate claim
for refund with the IRS and furnishing any required information in a timely manner.
Medicare
Tax on Investment Income
Certain
U.S. persons, including individuals, estates and trusts, will be subject to an additional 3.8% Medicare tax, or "net investment
income tax," on unearned income. For individuals, the additional net investment income tax applies to the lesser of (i) "net
investment income" or (ii) the excess of "modified adjusted gross income" over $200,000 ($250,000 if married and filing
jointly or $125,000 if married and filing separately). "Net investment income" generally equals the taxpayer's gross
investment income reduced by the deductions that are allocable to such income. Investment income generally includes, among other things,
passive income such as interest, dividends, annuities, royalties, rents, and capital gains. U.S. Holders are urged to consult their own
tax advisors regarding the implications of the additional net investment income tax resulting from their ownership and disposition of
our ordinary shares.
THE
DISCUSSION ABOVE IS A GENERAL SUMMARY. IT DOES NOT COVER ALL TAX MATTERS THAT MAY BE OF IMPORTANCE TO A PROSPECTIVE INVESTOR. EACH PROSPECTIVE
INVESTOR IS URGED TO CONSULT ITS OWN TAX ADVISOR ABOUT THE TAX CONSEQUENCES RELATING TO THE PURCHASE, OWNERSHIP AND DISPOSITION OF OUR
ORDINARY SHARES IN LIGHT OF THE INVESTOR'S OWN CIRCUMSTANCES, INCLUDING THE CONSEQUENCES OF ANY PROPOSED CHANGE IN APPLICABLE LAWS.
F.
Dividends and Paying Agents.
Not
applicable.
G.
Statements by Experts.
Not
applicable.
H.
Documents on Display.
The
SEC maintains an Internet website that contains reports and other information regarding issuers that file electronically with the SEC.
You may read and copy this annual report, including the related exhibits and schedules, and any document we file with the SEC at http://www.sec.gov.
As
a "foreign private issuer," we are subject to the information reporting requirements of the Exchange Act that are applicable
to foreign private issuers, and under those requirements file reports with the SEC. Those other reports or other information may be inspected
without charge at the locations described above. As a "foreign private issuer," we are exempt from the rules under the Exchange
Act related to the furnishing and content of proxy statements, and our officers, directors and principal shareholders will be exempt
from the reporting and "short-swing" profit recovery provisions contained in Section 16 of the Exchange Act with respect
to their purchases and sales of ordinary shares. Furthermore, as a "foreign private issuer," we are also not subject to the
requirements of Regulation FD (Fair Disclosure) promulgated under the Exchange Act.
134
We
maintain a corporate website at http://www.galmedpharma.com. Information contained on, or that can be accessed through, our website is
not incorporated by reference into this annual report and does not constitute a part of this annual report. We have included our website
address in this annual report solely as an inactive textual reference.
I.
Subsidiary Information.
Not
applicable.
J.
Annual Report to Security Holders
Not
applicable.
ITEM
11. Quantitative and Qualitative Disclosures About Market Risk.
Quantitative
and Qualitative Disclosure About Market Risk
We
are exposed to market risks in the ordinary course of our business. Market risk represents the risk of loss that may impact our financial
position, results of operations or cash flows due to adverse changes in financial market prices and rates, including interest rates and
foreign exchange rates, of financial instruments.
Foreign
Currency Exchange Risk
Our
foreign currency exposures give rise to market risk associated with exchange rate movements of the Euro and NIS mainly against the U.S.
dollar because a large portion of our expenses are denominated in Euros and NIS. Our Euro expenses consist principally of payments made
to sub-contractors and consultants for pre-clinical studies, clinical trials and other research and development activities. Our NIS expenses
consist principally of payments made to employees, subcontractors and consultants for pre-clinical studies, clinical trials, professional
services, other research and development activities and general and administrative activities. We anticipate that a large portion of
our expenses will continue to be denominated in currencies other than the U.S. dollar. Our financial position, results of operations
and cash flow are subject to fluctuations due to changes in foreign currency exchange rates. Our results of operations and cash flow
are, therefore, subject to fluctuations due to changes in foreign currency exchange rates and may be adversely affected in the future
due to changes in foreign exchange rates. Approximately 35% of our expected expenses are denominated in NIS. Changes of 5% and 10% in
the U.S. dollar to NIS exchange rate will increase/decrease our operation expenses by 1.75% and 3.5%, respectively. Approximately 10%
of our expected expenses are denominated in Euros. Changes of 5% and 10% in the U.S. dollar to Euro exchange rate, will increase/decrease
our operation expenses by 0.5% and 1.0%, respectively. To date, fluctuations in the exchange rates have not materially affected our results
of operations or financial condition for the periods under review.
To
date, we have not engaged in hedging our foreign currency exchange risk. In the future, we may enter into formal currency hedging transactions
to decrease the risk of financial exposure from fluctuations in the exchange rates of our principal operating currencies. These measures,
however, may not adequately protect us from the material adverse effects of such fluctuations.
Interest
Rate Risk
Our
primary exposure to market risk is interest income sensitivity, which is affected by changes in the general level of U.S. interest rates.
We currently do not hedge interest rate exposure. Because of the short-term maturities of our cash equivalents and investment securities,
we do not believe that an increase in market rates would have any significant impact on the realized value of our investment securities.
If a 10% change in interest rates were to have occurred on December 31, 2023, this change would not have had a material effect on the
fair value of our investment portfolio as of that date.
135
Liquidity
We
do not believe that our cash and cash equivalents and available for sale investments have significant risk of default or illiquidity.
While we believe our cash, cash equivalents and available for sale investments do not contain excessive risk, we cannot provide absolute
assurance that in the future our investments will not be subject to adverse changes in market value. In addition, we maintain significant
amounts of cash and cash equivalents at one or more financial institutions that are in excess of federally insured limits.
ITEM
12. Description of Securities Other Than Equity Securities.
A.
Debt Securities.
Not
applicable.
B.
Warrants and Rights.
Not
applicable.
C.
Other Securities.
Not
applicable.
D.
American Depositary Shares.
Not
applicable.
PART
II
ITEM
13. Defaults, Dividend Arrearages and Delinquencies.
Not
applicable.
ITEM
14. Material Modifications to the Rights of Security Holders and Use of Proceeds.
Not
applicable.
ITEM
15. Controls and Procedures.
Disclosure
Controls and Procedures
We
performed an evaluation of the effectiveness of our disclosure controls and procedures that are designed to ensure that information required
to be disclosed in this annual report and filed with the SEC is recorded, processed, summarized and reported timely within the time period
specified in the SEC's rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures
designed to ensure that information required to be disclosed by an issuer in the reports that it files or submits under the Exchange
Act, is accumulated and communicated to the issuer's management, including its principal executive and principal financial officers,
or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure. There can be no assurance
that our disclosure controls and procedures will detect or uncover all failures of persons within our Company to disclose information
otherwise required to be set forth in our reports. Nevertheless, our disclosure controls and procedures are designed to provide reasonable
assurance of achieving the desired control objectives. Based on our evaluation, our management, including our President, Chief Executive
Officer and Chairman and Chief Accounting Officer, have concluded that our disclosure controls and procedures (as defined in Rules 13a-15(e)
and 15(d)-15(e) of the Exchange Act) as of the end of the period covered by this annual report are effective at such reasonable assurance
level.
136
Management's
Annual Report on Internal Control over Financial Reporting
Our
management is responsible for establishing and maintaining adequate internal control over our financial reporting. Internal control over
financial reporting is defined in Rule 13a-15(f) or 15d-15(f) promulgated under the Exchange Act as a process designed by, or under the
supervision of, the company's principal executive and principal financial officers and effected by the company's board of
directors, management and other personnel, to provide reasonable assurance regarding the reliability of financial reporting and the preparation
of financial statements for external purposes in accordance with generally accepted accounting principles and includes those policies
and procedures that:
●
pertain to the maintenance of records that in reasonable
    detail accurately and fairly reflect the transaction and dispositions of the assets of the company;
●
provide reasonable assurance
    that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting
    principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management
    and directors of the company; and
●
provide reasonable assurance regarding prevention or
    timely detection of unauthorized acquisition, use or disposition of the company's assets that could have a material effect
    on the financial statements.
Because
of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Projections of any evaluation
of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that
the degree of compliance with the policies or procedures may deteriorate.
Our
management assessed the effectiveness of our internal control over financial reporting as of December 31, 2023. In making this assessment,
our management used the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission (COSO) in Internal
Control-Integrated Framework (2013). Based on that assessment, our management concluded that as of December 31, 2023, our internal control
over financial reporting was effective.
Changes
in Internal Controls Over Financial Reporting
There
were no changes in our internal control over financial reporting that occurred during the year ended December 31, 2023 that have materially
affected, or are reasonably likely to materially affect, our internal control over financial reporting.
ITEM
16. [RESERVED]
ITEM
16A. Audit Committee Financial Expert.
Our
Board has determined that Mr. Poshinski qualifies as an audit committee financial expert pursuant to the applicable SEC rules and that
Mr. Poshinski is "independent" in accordance with the Nasdaq Capital Market corporate governance requirements. For information
relating to Mr. Poshinski's qualifications and experience, see "Item 6. Directors, Senior Management and Employees—A.
Directors and Senior Management."
ITEM
16B. Code of Ethics.
We
have adopted a Code of Business Conduct and Ethics applicable to all of our directors and employees, including our President, Chief Executive
Officer and Chairman, Chief Financial Officer, controller or principal accounting officer or other persons performing similar functions,
which is a "code of ethics" as defined in Item 16B of Form 20-F promulgated by the SEC and as required by the Nasdaq Listing
Rules, which refers to Section 406(c) of the Sarbanes-Oxley Act. Section 406(c) of the Sarbanes-Oxley Act provides that a "code
of ethics" means such standards as are reasonably necessary to promote (i) honest and ethical conduct, including the ethical handling
of actual or apparent conflicts of interest between personal and professional relationships; (ii) full, fair, accurate, timely and understandable
disclosure in the periodic reports required to be filed by the issuer; and (iii) compliance with applicable governmental rules and regulation.
137
The
full text of the Code of Business Conduct and Ethics is posted on our website at www.galmedpharma.com. Information contained on, or that
can be accessed through, our website does not constitute a part of this prospectus and is not incorporated by reference herein. We will
provide a copy of such code of ethics without charge upon request by mail or by telephone. If we make any amendment to the Code of Business
Conduct and Ethics or grant any waivers, including any implicit waiver, from a provision of the Code of Business Conduct and Ethics,
we will disclose the nature of such amendment or waiver on our website to the extent required by the rules and regulations of the SEC.
ITEM
16C. Principal Accountant Fees and Services.
Brightman
Almagor Zohar & Co., a Firm in the Deloitte Global Network, an independent registered public accounting firm, served as our independent
public accountants for the fiscal years ended December 31, 2023 and 2022, for which audited financial statements appear in this annual
report.
The
following table presents the aggregate fees for professional services rendered by such accountants to us during their respective term
as our principal accountants in 2023 and 2022.
2023
2022
(US$ in thousands)
(US$ in thousands)
Audit Fees (1)
120
120
Audit-Related fees (2)
40
20
Tax and incentives Fees (3)
0
27
Total
160
167
(1)
Includes professional services
    rendered in connection with the audit of our annual financial statements and the review of our interim financial statements.
(2)
Audit related services
    consist of services that were reasonably related to the performance of the audit or reviews of our financial statements and not included
    under "Audit Fees" above, including, principally, providing consents for registration statement filings.
(3)
Tax fees consist of services related to obtaining a
    tax rulings t.
Audit
Committee Pre-Approval Policies and Procedures
One
of our audit committee's main roles is to assist the board of directors in fulfilling its responsibility for oversight of the quality
and integrity of the accounting, auditing and reporting practices of the Company. The audit committee oversees the appointment, compensation,
and oversight of the public accounting firm engaged to prepare or issue an audit report on the financial statements of the Company. Our
Board has delegated to the audit committee the power to pre-approve non-auditing services rendered by the Company's independent
auditors without the need for further approval by the board of directors. As such, our audit committee has adopted a pre-approval policy
for the engagement of our independent registered public accounting firm to perform certain audit and non-audit services. Pursuant to
this policy, which is designed to assure that such engagements do not impair the independence of our auditors, the audit committee pre-approves
annually a list of specific audit and non-audit services in the categories of audit services, audit-related services, tax services and
other services that may be performed by our independent registered public accounting firm. The last pre-approval policy was adopted by
our audit committee on April 2, 2024 for a period of twelve months. Since its establishment in May 2014, the audit committee has approved
all of the audit-related fees, tax fees and all other fees. If a type of service that is to be provided by our auditors has not received
such general pre-approval, it will require specific pre-approval by our audit committee. The policy prohibits retention of the independent
registered public accounting firm to perform the prohibited non-audit functions defined in applicable SEC rules.
138
ITEM
16D. Exemptions from the Listing Standards for Audit Committees.
Not
applicable.
ITEM
16E. Purchases of Equity Securities by the Issuer and Affiliated Purchasers.
Not
applicable.
ITEM
16F. Change in Registrant's Certifying Accountant.
Not
applicable.
ITEM
16G. Corporate Governance.
Our
shares are listed on the Nasdaq Capital Market under the symbol "GLMD." In addition to the corporate governance requirements
of the Sarbanes-Oxley Act and the related rules implemented by the SEC, we must comply with the Nasdaq Listing Rules. Under those Nasdaq
Listing Rules, we may elect to follow certain corporate governance practices permitted under the Companies Law in lieu of compliance
with corresponding corporate governance requirements otherwise imposed by the Nasdaq Listing Rules for U.S. domestic issuers.
In
accordance with Israeli law and practice, and subject to the exemption set forth in Rule 5615 of the Nasdaq Listing Rules, we follow
the provisions of the Companies Law, rather than the Nasdaq Listing Rules, with respect to the following requirements:
●
Distribution of certain
    reports to shareholders
. As opposed to the Nasdaq Listing Rules, which require listed issuers to make certain reports, such as
    annual reports, interim reports and quarterly reports, available to shareholders in one of a number of specific manners, Israeli
    law does not require us to distribute periodic reports directly to shareholders, and the generally accepted business practice in
    Israel is not to distribute such reports to shareholders, but to make such reports available through a public website. In addition
    to making such reports available on a public website, we plan to make our audited financial statements available to our shareholders
    at our offices and will only mail such reports to shareholders upon request. As a foreign private issuer, we are generally exempt
    from the SEC's proxy solicitation rules. See "Item 10. Additional Information—Documents on Display" for a
    description of our Exchange Act reporting obligations.
●
Quorum
. While the
    Nasdaq Listing Rules require that the quorum for purposes of any meeting of the holders of a listed company's common voting
    stock be no less than 33.33% of the company's outstanding common voting stock, under Israeli law, a company is entitled to
    determine in its articles of association the number of shareholders and percentage of holdings required for a quorum at a shareholders
    meeting. Our articles of association provide that a quorum of two or more shareholders holding at least 33.33% of the voting rights
    in person or by proxy is required for commencement of business at a general meeting. However, the quorum set forth in our articles
    of association with respect to an adjourned meeting consists of any two shareholders present in person or by proxy even if, between
    them, they represent shares conferring 33.33% or less of the voting rights of the Company.
●
Nomination of directors
.
    With the exception of directors elected by our Board due to vacancy, our directors are elected by an annual meeting of our shareholders
    to hold office until the next annual meeting following three years from his or her election. See "Item 6. Directors, Senior
    Management and Employees—C. Board Practices." The nominations for directors, which are presented to our shareholders
    by our Board, are made by the nominating committee itself, in accordance with the provisions of Nasdaq Capital Market Listing Rule
    5605(e), our Articles and the Companies Law.
139
●
Compensation
    of officers
. We follow the provisions of the Companies Law with respect to matters in connection with the composition and responsibilities
    of our remuneration committee, Office Holder compensation and any required approval by the shareholders of such compensation. Israeli
    law and our Articles do not require that the independent members of our Board, or a remuneration committee composed solely of independent
    members of our Board, determine an executive officer's compensation, as is generally required under the Nasdaq Listing Rules
    with respect to the Chief Executive Officer and all other executive officers of a company. Instead, remuneration of Office Holders
    is determined and approved by our remuneration committee, and in general, by our Board as well, and in certain circumstances, by
    our shareholders, as detailed above. The requirements for shareholder approval of any Office Holder compensation, and the relevant
    majority or Special Majority for such approval, are all as set forth in the Companies Law. Thus, we seek shareholder approval for
    all corporate actions with respect to Office Holder compensation requiring such approval under the requirements of the Companies
    Law, including for our Compensation Policy and for certain Office Holder Compensation, rather than seeking approval for such corporate
    actions in accordance with Nasdaq Listing Rules. All members of our remuneration committee are independent directors under applicable
    Nasdaq Capital Market and SEC rules, as affirmatively determined by our Board. See "Item 6. Directors, Senior Management and
    Employees—B. Compensation."
●
Independent
    directors
. Although Israeli law does not require that a majority of the directors serving on our Board be "independent,"
    as defined under Nasdaq Capital Market Listing Rule 5605(a)(2), but rather requires we have at least two external directors who meet
    the requirements of the Companies Law, as described above under "Item 6. Directors, Senior Management and Employees—C.
    Board Practices—External Directors.", following our "opt-out" of the requirement to appoint external directors,
    a majority of our Board is independent based on the Nasdaq Capital Market rules. We are required, however, to ensure that all members
    of our audit committee are "independent" under the applicable Nasdaq Capital Market and SEC criteria for independence
    (as we cannot exempt ourselves from compliance with that SEC independence requirement, despite our status as a foreign private issuer).
    Our independent directors' conduct regularly scheduled meetings at which only such independent directors are present, as required
    by the Nasdaq Listing Rules. Our Board has affirmatively determined that each of Mr. Nir, Mr. Poshinski, Dr. Sidransky and Dr. Brosgart
    qualifies as "independent" under the Nasdaq Capital Market independence standards.
●
Shareholder
    approval
. We will seek shareholder approval for all corporate actions requiring such approval under requirements of the Companies
    Law, rather than seeking approval for corporate actions in accordance with Nasdaq Capital Market Listing Rule 5635. In particular,
    under this Nasdaq Capital Market rule, shareholder approval is generally required for: (i) an acquisition of shares or assets of
    another company that involves the issuance of 20% or more of the acquirer's shares or voting rights or if a director, officer
    or 5% shareholder has greater than a 5% interest in the target company or the consideration to be received; (ii) the issuance of
    shares leading to a change of control; (iii) adoption or amendment of equity compensation arrangements; and (iv) issuances of 20%
    or more of the shares or voting rights (including securities convertible into, or exercisable for, equity) of a listed company via
    a private placement (or via sales by directors, officers or 5% shareholders) if such equity is issued (or sold) at below the greater
    of the book or market value of shares. By contrast, under the Companies Law, shareholder approval is required for, among other things:
    (i) transactions with directors concerning the terms of their service or indemnification, exemption and insurance for their service
    (or for any other position that they may hold at a company), for which approvals of the remuneration committee, board of directors
    and shareholders are all required, (ii) Extraordinary Transactions with controlling shareholders of publicly held companies, which
    require the special approval described under "Item 6. Directors, Senior Management and Employees—C. Board Practices—Approval
    of Related Party Transactions under Israeli Law— Transactions with Controlling Shareholders," and (iii) terms of office
    and employment or other engagement of the controlling shareholder of the Company or such controlling shareholder's relative,
    which require the special approval described under "Item 6. Directors, Senior Management and Employees—B. Compensation"
    and "Item 6. Directors, Senior Management and Employees—C. Board Practices— Approval of Related Party Transactions
    under Israeli Law." In addition, under the Companies Law, a merger requires approval of the shareholders of each of the merging
    companies. See also "Compensation of officers" above.
140
ITEM
16H. Mine Safety Disclosure.
Not
applicable.
ITEM
16I. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections.
Not
applicable.
ITEM
16J. Insider Trading Policies.
Pursuant
to applicable SEC transition guidance, the disclosure required by Item 16J will only be applicable to the Company from the fiscal year
ending on December 31, 2024.
ITEM
16K. Cybersecurity.
We
have developed and maintain a cybersecurity risk management program, consisting of cybersecurity policies, procedures, compliance
and awareness programs to mitigate risk and to ensure compliance with security, availability and confidentiality trust principles.
The cybersecurity process has been integrated into our overall risk management system and process, and is solely internally managed.
Management is responsible for identifying risks that threaten achievement of the control activities stated in the management's
description of the services organizations systems. Management has implemented a process for identifying relevant risks that could
affect the organization's ability to provide secure and reliable service to its users. In addition, we maintain cybersecurity
insurance. The risk assessment occurs as business needs change, and covers identification of risks that could act
against the company's objectives as well as specific risks related to a compromise to the security of data. See "Item
3.D Risk Factors— Risks Related to Information Technology, Intellectual Property and Data Security and Privacy—If we or
our third-party service providers experience a security breach, data loss or other compromise, including if unauthorized parties
obtain access to our customers' data, our reputation may be harmed, demand for our products and services may be reduced, and
we may incur significant liabilities."
The
oversight of cybersecurity threats is undertaken by our IT external provider, who holds over 25 years of experience, and is supported
by management. Our audit committee is responsible for cybersecurity oversight and monitoring risk. Management informs the audit and remuneration
committee of such risk at committee meetings.
As
of the date of this report, we are not aware of any material risks from cybersecurity threats that have materially affected or are reasonably
likely to materially affect us, including our business strategy, results of operations or financial condition.
PART
III
ITEM
17. Financial Statements.
We
have responded to Item 18 in lieu of responding to this item.
ITEM
18. Financial Statements.
Please
refer to the financial statements beginning on page F-1. The following financial statements, financial statement schedules and related
notes are filed as part of this annual report, together with the report of the independent registered public accounting firm.
Page
Report of Independent Registered Public Accounting Firm
(PCAOB ID:
1197
)
F-1
Consolidated Balance Sheets
F-3
Consolidated Statements of Operations
F-4
Consolidated Statements of Comprehensive Loss
F-5
Consolidated Statements of Changes in Shareholders' Equity
F-6
Consolidated Statements of Cash Flows
F-7
Notes to Consolidated Financial Statements
F-8
141
REPORT
OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To
the shareholders and the Board of Directors of Galmed Pharmaceuticals Ltd.
Opinion
on the Financial Statements
We
have audited the accompanying consolidated balance sheets of Galmed Pharmaceuticals Ltd. and subsidiaries (the
"Company") as of December 31, 2023 and 2022, the related consolidated statements of operations, comprehensive loss,
changes in stockholders' equity and cash flows, for each of the three years in the period ended December 31, 2023, and the
related notes (collectively referred to as the "consolidated financial statements"). In our opinion, the consolidated
financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2023 and
2022, and the results of its operations and its cash flows for each of the three years in the period ended December 31, 2023, in
conformity with accounting principles generally accepted in the United States of America.
Basis
for Opinion
These
consolidated financial statements are the responsibility of the Company's management. Our responsibility is to express an opinion
on the Company's consolidated financial statements based on our audits. We are a public accounting firm registered with the Public
Company Accounting Oversight Board (United States) ("PCAOB") and are required to be independent with respect to the Company
in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission
and the PCAOB.
We
conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain
reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud.
Our audits included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether
due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence
regarding the amounts and disclosures in the consolidated financial statements. Our audits also included evaluating the accounting principles
used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements.
We believe that our audits provide a reasonable basis for our opinion.
Critical
Audit Matter
The
critical audit matter communicated below is a matter arising from the current-period audit of the financial statements that was communicated
or required to be communicated to the audit committee and that (1) relates to accounts or disclosures that are material to the financial
statements and (2) involved our especially challenging, subjective, or complex judgments. The communication of critical audit matters
does not alter in any way our opinion on the financial statements, taken as a whole, and we are not, by communicating the critical audit
matter below, providing a separate opinion on the critical audit matter or on the accounts or disclosures to which it relates.
Marketable
Debt Securities Classified as Available-for-Sale– Refer to Note 3 to the consolidated financial statements
Critical
Audit Matter Description
The
Company invests its excess cash primarily in available-for-sale marketable debt securities. Investments in marketable debt securities
classified as available-for-sale are reported at fair value in the financial statements. The investments totaled approximately $7.5 million
as of December 31, 2023.
F-
1
We
identified the investments in marketable debt securities classified as available-for-sale as a critical audit matter because of the magnitude
of these investments and due to the increased extent of audit effort in relation to our audit as a whole.
How
the Critical Audit Matter Was Addressed in the Audit
Our
audit procedures related to the Company's investments in marketable debt securities classified as available-for-sale included the
following, among others:
●
We
    assessed the accuracy and completeness of the quantities of marketable debt securities held by the Company as of December 31, 2023
    by comparing the Company's investment report to the custodians' balance confirmations.
●
We
    obtained independent estimates of the fair value of the investments in marketable debt securities classified as available-for-sale
    held by the Company as of December 31, 2023 and compared our estimates to the Company's estimates.
●
We
    agreed the recorded values of investments in marketable debt securities classified as available-for-sale to the fair values indicated
    in the custodians' balance confirmations.
/s/
Brightman Almagor Zohar & Co.
Brightman
Almagor Zohar & Co.
Certified
Public Accountants
A
Firm in the Deloitte Global Network
Tel
Aviv, Israel
April
4, 2024
We
have served as the Company's auditor since 2013.
F-
2
GALMED
PHARMACEUTICALS LTD.
Consolidated
Balance Sheet
s
U.S.
Dollars in thousands, except share data and per share data
As
    of December 31,
Note
2023
2022
Assets
Current assets
Cash and cash equivalents
$
2,861
$
2,016
Restricted cash
10
117
114
Short-term deposits
2,253
-
Marketable debt securities
3
7,528
11,769
Other receivables
4
480
825
Total
    current assets
13,239
14,724
Operating lease right-of-use assets
5
42
223
Property and equipment, net
6
83
114
Investment in associate at fair value
7
3,265
-
Investment in convertible
    note
7
-
1,500
Total
    non-current assets
3,390
1,837
Total
    assets
$
16,629
$
16,561
Liabilities and stockholders'
    equity
Current liabilities
Trade payables
$
1,879
$
2,560
Other payables
8
871
534
Total
    current liabilities
2,750
3,094
Non-current
                                    liabilities
Operating lease liabilities,
    net of current portion
5
$
-
$
44
Total
                                    non-current liabilities
-
44
Stockholders'
                                    equity
Ordinary shares, par value NIS
0.15
per share; Authorized
20,000,000
shares; Issued and outstanding:
5,045,324
shares as of December 31, 2023;
1,692,342
shares as of December 31, 2022
(*)
11
209
70
Additional paid-in capital
207,076
200,138
Accumulated other comprehensive loss
(
454
)
(
745
)
Accumulated deficit
(
192,952
)
(
186,040
)
Total
    stockholders' equity
13,879
13,423
Total
    liabilities and stockholders' equity
$
16,629
$
16,561
(*)
All
                                                         share and per share data has been retroactively adjusted to reflect the
1 for 15 reverse share split
effected on May 15, 2023 for all periods prior to the date of the reverse share split. See Note
                                                         11A4.
Accompanying
notes are an integral part of the consolidated financial statements.
F-
3
GALMED
PHARMACEUTICALS LTD.
Consolidated
Statements of Operations
U.S.
Dollars in thousands, except share data and per share data
Year
    ended December 31,
2023
2022
2021
Research and development expenses
12
3,569
12,995
27,220
General and administrative
    expenses
13
3,923
4,656
5,661
Total
    operating loss
7,492
17,651
32,881
Financial loss (income),
    net
14
(
580
)
215
(
414
)
Net
    loss
$
6,912
$
17,866
$
32,467
Basic and diluted net
    loss per share (*)
$
2.50
$
10.65
$
19.80
Weighted-average number
    of shares outstanding used in computing basic and diluted net loss per share (*)
2,769,539
1,676,183
1,639,843
(*)
All
                                                         share and per share data has been retroactively adjusted to reflect the
1 for 15 reverse share split
effected on May 15, 2023 for all periods prior to the date of the reverse share split. See Note
                                                         11A4.
Accompanying
notes are an integral part of the consolidated financial statements.
F-
4
GALMED
PHARMACEUTICALS LTD.
Consolidated
Statements of Comprehensive Loss
U.S.
Dollars in thousands, except share data and per share data
Year
    ended December 31,
2023
2022
2021
Net loss
$
6,912
$
17,866
$
32,467
Other comprehensive loss:
Net
    unrealized loss (gain) on available for sale securities
(
291
)
574
443
Comprehensive
    loss
$
6,621
$
18,440
$
32,910
Accompanying
notes are an integral part of the consolidated financial statements.
F-
5
GALMED
PHARMACEUTICALS LTD.
Statements
of Changes in Stockholders' Equity
U.S. Dollars
in thousands, except share data and per share data
Accumulated
Additional
other
Ordinary
    shares  (**)
paid-in
comprehensive
Accumulated
Shares
Amount
capital
income
    (loss)
deficit
Total
Balance - January 1, 2021
1,431,983
$
58
$
179,530
$
272
$
(
135,707
)
$
44,153
Stock-based compensation
—
—
1,886
—
—
1,886
Exercise of options and vesting of restricted
    stock units
1,560
(*)
(*)
—
—
(*)
Issuance of ordinary shares in at-the-market
    ("ATM") offering, net of issuance costs of $
295
103,501
5
8,142
—
—
8,147
Issuance of ordinary shares under Underwritten
    Public Offering agreement, net of issuance costs of $
786
147,577
7
9,214
—
—
9,221
Unrealized loss from marketable debt securities
—
—
—
(
443
)
—
(
443
)
Net loss
—
—
—
—
(
32,467
)
(
32,467
)
Balance - December 31, 2021
1,684,621
$
70
$
198,772
$
(
171
)
$
(
168,174
)
$
30,497
Stock-based compensation
-
-
1,296
-
-
1,296
Issuance of ordinary shares in ATM offering
    net of issuance costs of $
2
7,721
(*)
70
-
-
70
Unrealized loss from marketable debt securities
—
—
—
(
574
)
—
(
574
)
Net loss
—
—
—
—
(
17,866
)
(
17,866
)
Balance - December
    31, 2022
1,692,342
$
70
$
200,138
$
(
745
)
$
(
186,040
)
$
13,423
Issuance of ordinary shares, pre-funded warrants,
    and warrants net of issuance costs of $
815
(***)
380,000
16
6,169
-
-
6,185
Exercise of Pre-funded warrants
(***)
2,972,982
123
(
123
)
-
-
-
Stock-based compensation
-
-
892
-
-
892
Unrealized gain on marketable debt securities
-
-
-
291
-
291
Net loss
-
-
-
-
(
6,912
)
(
6,912
)
Balance - December
    31, 2023
5,045,324
209
207,076
(
454
)
(
192,952
)
13,879
(*)
Represents amount
less than $1
(**)
All share and per
share data has been retroactively adjusted to reflect the
1 for 15 reverse share split
effected
on
May 15, 2023 for all periods prior to the date of the reverse share split. See Note 11A4.
(***)
See also Note 11A.5
Accompanying
notes are an integral part of the consolidated financial statements.
F-
6
GALMED
PHARMACEUTICALS LTD.
Consolidated
Statements of Cash Flows
U.S.
Dollars in thousands, except share data and per share data
Year
    ended December 31,
2023
2022
2021
Cash flow from operating
    activities
Net loss for the year
$
(
6,912
)
$
(
17,866
)
$
(
32,467
)
Adjustments
    required to reconcile net loss to net cash used in
operating activities:
Depreciation
31
35
42
Amortization of discount (premium) on marketable
    debt securities
19
(
2
)
121
Gain (loss) on sale of marketable debt securities
13
523
(
37
)
Finance expenses (income)
6
(
36
)
6
Interest income from short-term deposits
(
53
)
-
7
Stock-based compensation expense
892
1,296
1,886
Change in fair value convertible note
(
265
)
-
-
Changes in operating assets
    and liabilities:
Decrease (increase) in other receivables
345
300
(
313
)
Decrease in trade payables
(
681
)
(
2,311
)
(
2,175
)
Increase (decrease)
    in other payables
468
(
440
)
38
Net
    cash used in operating activities
(
6,137
)
(
18,501
)
(
32,892
)
Cash flow from investing
    activities
Purchase of property and equipment
-
(
4
)
(
11
)
Increase in restricted deposit
-
-
(
1
)
Investment in available for sale securities,
(
4,133
)
(
2,373
)
(
13,569
)
Investment in Convertible note
(**)
-
(
1,500
)
-
Investment in Associate
(**)
(
1,500
)
-
-
Proceeds from sale of available for sale securities,
8,633
21,440
21,243
Proceeds from (investment
    in) short-term deposits, net
(
2,200
)
-
3,800
Net
    cash provided by investing activities
800
17,563
11,462
Cash flow from financing
    activities
Issuance of ordinary shares in at-the-market offering,
    net of issuance
costs
(***)
-
70
8,147
Issuance of ordinary shares,
    pre-funded warrants, and warrants net of issuance costs
(***)
6,185
-
Issuance of ordinary shares net of issuance
    costs
(***)
-
-
9,221
Proceeds from exercise
    of options and vesting of restricted stock units
-
-
(*)
Net
    cash provided by financing activities
6,185
70
17,368
Increase (decrease) in
    cash, cash equivalents and restricted cash
848
(
868
)
(
4,062
)
Cash
    and cash equivalents and restricted cash at the beginning of
the year
2,130
2,998
7,060
Cash,
    cash equivalents and restricted cash at the end of the year
$
2,978
$
2,130
$
2,998
Supplemental disclosure
    of cash flow information:
Cash received from interest
$
376
$
297
$
562
Non-cash investing and financing
    activities:
Right-of-use assets obtained
    in exchange for new operating lease
liabilities, net
$
-
$
-
$
199
Conversion of convertible note into investment
    in associate
1,765
-
-
(*)
Represents amount
less than $1
(**)
See also Note 7
(***)
See also Note 11.
The
accompanying notes are an integral part of the consolidated financial statements.
F-
7
GALMED
PHARMACEUTICALS LTD.
Notes
to Consolidated Financial Statements
Note
1 –
General
Galmed
Pharmaceuticals Ltd. (the "Company") was incorporated in Israel on
July 31, 2013
and commenced operations on
February 2,
2014
.
The
Company holds three wholly-owned subsidiaries, Galmed International Ltd., which is incorporated in Malta, and Galmed Research and Development
Ltd. ("GRD") and Galtopa Therapeutics Ltd., both of which are incorporated in Israel. In July 2023, GRD established a new
wholly-owned subsidiary incorporated under the laws of England and Wales called Galmed Therapeutics UK Limited.
The
Company is a biopharmaceutical company focused on the development of Aramchol. The Company has focused almost exclusively on developing
Aramchol for the treatment of liver disease and is currently developing Aramchol for Primary Sclerosing Cholangitis, or PSC, and exploring
the feasibility of developing Aramchol for other fibro-inflammatory indications outside of liver disease. The Company is also collaborating
with the Hebrew University in the development of Amilo-5MER. The Company has an operating history limited to pre-clinical and clinical
drug development.
The
Company funded its research and development programs and operations to date primarily through proceeds from private placements and public
offerings. The Company currently has no products approved for marketing and has not generated any revenue from product sales to date.
As of December 31, 2023, the Company had cash and cash equivalents of $
2.9
million, restricted cash of $
0.1
million, short-term deposits
of $
2.3
million and marketable debt securities of $
7.5
million.
The
Company has incurred operating losses in each year since inception. The Company's loss attributable to holders of its ordinary
shares for the years ended December 31, 2021, 2022, and 2023 was approximately $
32.4
million, $
17.9
million, and $
6.9
million, respectively.
As of December 31, 2023, the Company had an accumulated deficit of $
193.0
million. Substantially all of its operating losses resulted
from costs incurred in connection with the Company's development program and from general and administrative costs associated with
its operations.
The
Company will need to raise substantial, additional capital to fund its operations and to develop Aramchol and Amilo-5MER for, and beyond
its current development stage and any future commercialization, as well as any additional indications.
Based
on the Company's current operating plan, the Company's management currently estimates that its cash position will support
its current operations as currently conducted for more than 12 months from the date of issuance of these financial statements.
Note
2 –
Significant Accounting Policies
A.
Basis
    of presentation
The
consolidated financial statements have been prepared in accordance with United States Generally Accepted Accounting Principles ("U.S.
GAAP").
B.
Use
    of estimates
The
preparation of consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that
affect the reported amounts of assets and liabilities as of the date of the financial statements, and the reported amounts of expenses
during the reporting period. Actual results could differ from those estimates.
F-
8
GALMED
PHARMACEUTICALS LTD.
Notes
to Consolidated Financial Statements
Note
2 – Significant Accounting Policies (Cont.)
C.
Financial
    statement in U.S. dollars
The
functional currency of the Company and its subsidiaries is the U.S dollar (the "dollar"), because the dollar is the currency
of the primary economic environment in which the Company and its subsidiaries operate, and expect to continue operating in the foreseeable
future. Transactions and balances denominated in dollars are presented in their original amounts. Non-dollar denominated transactions
and balances have been re-measured to dollars in accordance with the provisions of ASC 830, "Foreign Currency Matters." All
transaction gains and losses from re-measurement of monetary balance sheet items denominated in non-dollar currencies are reflected in
the statement of operations as financial income or expenses, as appropriate.
D.
Principles
    of consolidation
The
consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries: Galmed Research and Development
Ltd., Galmed International Ltd., Galtopa Therapeutics Ltd and Galmed Therapeutics UK Limited. All intercompany balances and transactions
have been eliminated upon consolidation.
E.
Cash
    and cash equivalents
Cash
equivalents are short-term, highly liquid investments that are readily convertible into cash with maturities of three months or less
as of the date acquired.
F.
Restricted
    Cash
Cash
that is held for a specific purpose and is not available for immediate or general business use due to external restrictions is classified
in the Company's consolidated balance sheets as restricted cash.
G.
Short-term
    deposits
Bank
deposits with maturities of more than three months but less than one year are included in short-term bank deposits. Such short-term deposits
are stated at cost which approximates fair market value. Interest rates on the Company's short-term deposits were between
5.04
%
-
6.64
%
during the year ended December 31, 2023.
H.
Marketable
    debt securities
The
Company invests most of its excess cash primarily in debt securities.
The
Company accounts for its investments in investment grade debt securities in accordance with ASC 320 "Investments - Debt and Equity
Securities". Management determines the appropriate classification of its investments in debt securities at the time of purchase
and re-evaluates such determinations at each balance sheet date.
Marketable
debt securities are considered to be available for sale and are carried at fair value on the consolidated balance sheet. Unrealized gains
and losses net of tax, if any, are reported in a separate component of stockholders' equity in accumulated other comprehensive
income ("OCI"). Gains and losses are recognized when realized, on a specific identification basis, in the Company's
consolidated statements of operations.
Following
the adoption of ASC 326, current expected credit losses on the Company's marketable grade debt securities are recorded, if expected,
through an allowance for current expected credit losses. The amount of allowance for current expected credit losses is limited to the
amount that the fair value is less than the amortized cost basis. Any remaining unrealized losses are included in accumulated other comprehensive
loss in stockholders' equity.
If
the Company intends to sell the debt security (that is, it has decided to sell the security), or more likely than not will be required
to sell the security before recovery of its amortized cost basis, any allowance for current expected credit losses is written off and
the amortized cost basis shall be written down to the debt security's fair value at the reporting date with any incremental impairment
reported in earnings. Based on management's assessment, the Company does not intend to sell its securities for less than amortized
cost; therefore, an allowance for current expected credit losses has not been recorded as of December 31, 2023 and 2022.
F-
9
GALMED
PHARMACEUTICALS LTD.
Notes
to Consolidated Financial Statements
Note
2 – Significant Accounting Policies (Cont.)
H.
Concentrations
    of credit risk (Cont.)
Financial
instruments which potentially subject the Company to credit risk consist primarily of cash, cash equivalents, marketable debt securities
and short-term deposits. The Company hold these investments in highly-rated financial institutions, and, by policy, limit the amounts
of credit exposure to any one financial institution. These amounts at times may exceed federally insured limits. The Company has not
experienced any credit losses in such accounts and does not believe we are exposed to any significant credit risk on these funds. The
Company has no off-balance sheet concentrations of credit risk, such as foreign currency exchange contracts, option contracts, or other
hedging arrangements.
I.
Property
    and equipment
Property
and equipment are stated at cost, less accumulated depreciation. Depreciation is calculated using the straight-line method over the estimated
useful lives of the assets. The annual depreciation rates are as follows:
%
Office furniture and equipment
7
–
16
Computer software and electronic equipment
15
–
33
Leasehold improvements
Shorter of the remaining lease term or useful
    life
The
Company recorded a total of approximately $
0.03
million for each of the three years ended December 31, 2023.
J.
Severance
    pay
The
Company employees are included under section 14 of the Severance Compensation Act, 1963 ("Section 14") in Israel for a portion
of their salaries. According to Section 14, these employees are entitled to monthly deposits at a rate of
8.33
%
of their monthly salary,
contributed on their behalf with insurance companies. Under the Severance Compensation Act, 1963, payments in accordance with Section
14 release the Company from any future severance payments to those employees. Therefore, the Company does not recognize a liability for
severance pay due to these employees and the deposits under Section 14 are not recorded as an asset in the Company's consolidated
balance sheets. The Company's contributions to the defined contribution plans are charged to the consolidated statements of operations
as and when the services are received from the Company's employees.
F-
10
GALMED
PHARMACEUTICALS LTD.
Notes
to Consolidated Financial Statements
Note
2 – Significant Accounting Policies (Cont.)
K.
Fair
    value of financial instruments
The
estimated fair value of financial instruments was determined by the Company using available market information and valuation methodologies.
Considerable judgment is required in estimating fair values. Accordingly, the estimates may not be indicative of the amounts the Company
could realize in a current market exchange.
The
following methods and assumptions were used by the Company in estimating its fair value disclosures for financial instruments:
The
carrying amounts of cash and cash equivalents, short-term deposits, other accounts receivables, trade payables and other trade payables
approximate their fair value due to the short-term maturity of such instruments.
Fair
value is an exit price representing the amount that would be received upon selling an asset or that would be paid to transfer a liability
in an orderly transaction between market participants. As such, fair value is a market-based measurement that should be determined based
on assumptions used by market participants in pricing an asset or a liability.
A
three-tier fair-value hierarchy was established as a basis for considering such assumptions and for inputs used in the valuation methodologies
in measuring fair value:
●
Level
    1 - Observable inputs that reflect quoted prices (unadjusted) for identical assets or liabilities in active markets
●
Level
    2 - Other inputs that are directly or indirectly observable in the marketplace; and
●
Level
    3 - Unobservable inputs that are supported by little or no market activity
The
fair value hierarchy also requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when
measuring fair value.
The
fair value of the Company's assets measured at fair value on a recurring basis by level within the fair value hierarchy are as
follows (in thousands):
December
    31, 2023
Fair
Level
    1
Level
    2
Level
    3
Value
Corporate bonds
$
-
$
1,969
$
-
$
1,969
Treasury bills
-
409
-
409
Mutual funds
5,150
-
-
5,150
Investment in associate
3,265
3,265
Total
5,150
2,378
3,265
10,793
December
    31, 2022
Fair
Level
    1
Level
    2
Level
    3
Value
Corporate bonds
$
-
$
1,140
—
$
1,140
Mutual Funds
10,629
-
—
10,629
Investment in convertible
    note
-
1,500
—
1,500
Total
10,629
2,640
—
13,269
L.
Accounting
    for stock-based compensation
The
Company accounts for share-based compensation under ASC 718, Compensation - Stock Compensation ("ASC 718"), which requires
the measurement and recognition of compensation expense based on estimated fair values for all share-based payment awards made to employees,
non-employee consultants and directors, including options and restricted share units ("RSUs") based on the fair value of
the awards on the date of grant. ASC 718 requires companies to estimate the fair value of equity-based payment awards on the date of
grant using an option-pricing model. The expense for share-based compensation cost is recognized over the requisite service period of
each individual grant using the straight-line method for  service-based awards. Forfeitures are accounted for
as they occur.
F-
11
GALMED
PHARMACEUTICALS LTD.
Notes
to Consolidated Financial Statements
Note
2 – Significant Accounting Policies (Cont.)
L.
Accounting
    for stock-based compensation (Cont.)
The
Company calculates the fair value of RSUs based on the fair value on the closing trading price of the underlying shares at the date of
grant and estimates the fair value of stock options granted using a
Black-Scholes option-pricing model
. The option-pricing model requires
a number of assumptions, the most significant of which are the expected stock-price volatility and the expected option term (the time
from the grant date until the options are exercised or expire).
The
Company's calculations of the expected volatility were based upon actual historical stock-price movements over the period, which
was equal to the expected option term. The expected option term was calculated for options granted to employees and directors in accordance
with ASC-718-10-S99, using the "simplified" method, and grants to non-employees were based on the contractual term. Historically,
the Company has not paid dividends, and has no foreseeable plans to do so. The risk-free interest rate is based on the yield from U.S.
Treasury zero-coupon bonds with an equivalent term.
M.
Revenue
    Recognition
The
Company only has one license agreement for which it has recognized revenues to date, from a license agreement with Samil Pharm. Co.,
Ltd. ("Samil" or the "Samil Agreement"). The Samil Agreement was signed on July 28, 2016, for an exclusive, royalty-bearing
license for the commercialization of Aramchol (with an option to manufacture) for the treatment of fatty liver indications including
NASH in the Republic of Korea. Additionally, following the ARREST Study, Samil has an option to extend the license to Vietnam, which,
if exercised, would increase the clinical- and regulatory-based milestone payments.
Under
the terms of the Samil Agreement, the Company received an up-front payment of approximately $
2.1
million in 2016 and a milestone payment
of $
1.5
million from Samil in connection with the completion of its ARREST study in 2018. Samil has also agreed to pay additional clinical
and regulatory-based milestone payments, which may aggregate up to $
4.5
million, as well as tiered, double-digit royalties payable on
sales (under certain limitations).
As
of December 31, 2023, management evaluated the remaining clinical and regulatory milestones and determined that the variable consideration
should not be recorded as revenue for the period ended December 31, 2023. The Company will re-evaluate the transaction price in each
reporting period when events whose outcomes are resolved or other changes in circumstances occur that would indicate it is appropriate
to recognize variable consideration as revenue.
F-
12
GALMED
PHARMACEUTICALS LTD.
Notes
to Consolidated Financial Statements
Note
2 – Significant Accounting Policies (Cont.)
N.
Research and development
  expenses
Research
and development expenses are charged to the statements of operations as incurred.
O.
Income taxes
The
Company accounts for income taxes in accordance with ASC 740, Income Taxes ("ASC 740"), using the liability method whereby
deferred tax assets and liability account balances are determined based on the differences between financial reporting and the tax basis
for assets and liabilities and are measured using the enacted tax rates and laws that will be in effect when the differences are expected
to reverse. The Company provides a valuation allowance, if necessary, to reduce deferred tax assets to the amounts that are more likely-than-not
to be realized. As of December 31, 2023 and 2022, the Company recorded a full valuation allowance against its deferred tax assets.
The
Company applies a more-likely-than-not recognition threshold to uncertain tax positions based on the technical merits of the income tax
positions taken. The Company does not recognize a tax benefit unless it is more likely than not that the tax position will be sustained
upon examination, including resolution of any related appeals or litigation processes, based on the technical merits of the position.
The tax benefit that is recorded for these positions is measured at the largest amount of benefit that is greater than 50% likely of
being realized upon ultimate settlement. As of December 31, 2023 and 2022, no liability for unrecognized tax benefits was recorded due
to immateriality.
P.
Basic and diluted net
  loss per share
Basic
net loss per share is computed based on the weighted-average number of shares outstanding during each year. Diluted net loss per share
is computed based on the weighted-average number of shares outstanding during each year, plus the dilutive potential of the ordinary
shares considered outstanding during the year, in accordance with ASC 260-10, "Earnings Per Share."
All
outstanding stock options, RSU's, prefunded-warrants and warrants were excluded from the calculation of the diluted loss per share
for the years ended December 31, 2023, 2022 and 2021, because all such securities have an anti-dilutive effect.
F-
13
GALMED
PHARMACEUTICALS LTD.
Notes
to Consolidated Financial Statements
Note
2 – Significant Accounting Policies (Cont.)
Q.
Segment
    Reporting
The
chief operating decision maker for the Company is the Chief Executive Officer. The Chief Executive Officer reviews financial information
presented on a consolidated basis for purposes of allocating resources and evaluating financial performance. Accordingly, management
has determined that the Company operates in one operating and reportable segment.
R.
Leases
The
Company accounts for leases in accordance with ASC 842 "Leases." Arrangements that are determined to be operating leases
at inception are recognized as right-of-use operating lease assets and lease liabilities in the balance sheets at lease commencement.
The Company recognizes a lease liability at the present value of the lease payments to be made over the lease term, and concurrently
recognizes a right-of-use asset at the same amount of the liability, adjusted for any prepaid or accrued lease payments, plus initial
direct costs incurred in respect of the lease. The Company uses its incremental borrowing rate based on the information available at
the commencement date to determine the present value of the lease payments. The subsequent measurement depends on whether the lease is
classified as a finance lease or an operating lease. During the reporting periods, the Company has only operating leases. Lease terms
include options to extend the lease when it is reasonably certain that the Company will exercise that option. Lease expenses for operating
leases are recognized on a straight-line basis over the lease term.
The
Company has made a policy election not to capitalize leases with a term of 12 months or less,.the Company made has also made a policy
election to include lease and non-lease components as a single lease component.
Payments
for variable lease costs are expensed as incurred and are not included in the operating lease right-of-use assets and lease liabilities.
In
accordance with ASC 360-10, management reviews operating lease assets for impairment whenever events or changes in circumstances indicate
that the carrying amount of an asset may not be recoverable based on estimated future undiscounted cash flows. If so indicated, an impairment
loss would be recognized for the difference between the carrying amount of the asset and its fair value.
S.
Investment
    in Associate at Fair Value
The
Company holds an equity investment of a privately-owned company, Onkai Inc. ("Onkai"), over which it has the ability to exercise
significant influence, but not control. The investment was included as a non-current asset in the balance sheet as of December 31, 2023.
The Company has elected the fair value option allowed by ASC 825, Financial Instruments, with respect to this investment because management
believes this approach will better reflect the economics of its equity interest. Under the fair value option, the investment is remeasured
at fair value (level 3) at each reporting period with changes in fair value, if any, recorded in the statement of operations.
Management
determined the fair value of its investment in Onkai based on the acquisition price of the equity investment made during 2023. Management,
together with its fair valuation expert, assessed the qualitative aspects of the equity investment and macroeconomic factors as of December
31, 2023 and determined that there was no material change in the investment as of December 31, 2023
T.
Recently
    adopted accounting pronouncements
From
time to time, new accounting pronouncements are issued by FASB, or other standard setting bodies and adopted by the Company as of the
specified effective date. Unless otherwise discussed, the impact of recently issued standards that are not yet effective will not have
a material impact on our financial position or results of operations upon adoption.
In
November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures. The ASU expands
public entities' segment disclosures by requiring disclosure of significant segment expenses that are regularly reviewed by the
chief operating decision maker ("CODM") and included within each reported measure of segment profit or loss, an amount and
description of its composition for other segment items, and interim disclosures of a reportable segment's profit or loss and assets.
The ASU also allows, in addition to the measure that is most consistent with U.S. GAAP, the disclosure of additional measures of segment
profit or loss that are used by the CODM in assessing segment performance and deciding how to allocate resources. The ASU is effective
for the Company's Annual Report on Form 20-F for the fiscal year ended December 31, 2024, and subsequent interim periods, with
early adoption permitted. The Company is currently evaluating the impact of adopting this ASU on its consolidated financial statements
and disclosures.
In
December 2023, the FASB issued ASU No. 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures. This ASU requires disclosure
of specific categories in the rate reconciliation and additional information for reconciling items that meet a quantitative threshold.
The amendment also includes other changes to improve the effectiveness of income tax disclosures, including further disaggregation of
income taxes paid for individually significant jurisdictions. This ASU is effective for annual periods beginning after December 15, 2024.
Adoption of this ASU should be applied on a prospective basis. Early adoption is permitted. The Company is currently evaluating the impact
of adopting this ASU on its consolidated financial statements and disclosures.
F-
14
GALMED
PHARMACEUTICALS LTD.
Notes
to Consolidated Financial Statements
Note
3 –
Marketable debt securities
The
following table summarizes the Company's marketable debt securities as of December 31, 2023 and 2022.
As
    of December 31, 2023
Gross
Gross
Amortized
Unrealized
Unrealized
Estimated
Cost
Gains
Losses
Fair
    Value
(in thousands)
Corporate bonds
$
2,123
$
6
$
(
160
)
$
1,969
Treasury bills
400
9
-
409
Mutual funds
5,459
1
(
310
)
5,150
Total short-term investments
$
7,982
$
16
$
(
470
)
$
7,528
As
    of December 31, 2022
Gross
Gross
Amortized
Unrealized
Unrealized
Estimated
Cost
Gains
Losses
Fair
    Value
(in thousands)
Corporate bonds
$
1,327
$
-
$
(
187
)
$
1,140
Mutual funds
11,187
$
30
$
(
588
)
$
10,629
Total
    short-term investments
$
12,514
$
30
$
(
775
)
$
11,769
The
contractual maturities of the aforementioned corporate bonds and treasury bills are less than one year for the year ended December 31,
2023 and one year and a half of the aforementioned corporate bonds for the year ended December 31, 2022.
Note
4–
Other Receivables
As
    of December 31,
2023
2022
(in thousands)
Prepaid expenses
$
315
$
668
Government institutions
47
124
Other receivables
118
33
$
480
$
825
Note
5–
Leases
During
the year ended December 31, 2023, the Company leased, approximately
590
square meters at a facility located in Tel-Aviv, Israel. The
lease expired on
March 21, 2024
. The Company does not plan to extend the lease and the Company's employees are currently working
remotely while management is in the process of searching for a new permanent location for its principal executive offices. In addition,
the Company leases vehicles under various operating lease agreements.
During
2023, 2022 and 2021, the Company recorded lease expenses in its statement of operations in the amount of $
0.2
million, $
0.2
million,
and $
0.2
million respectively. During 2023, the Company subleased a portion of its facility for a total of $
44
thousand that were recorded
in its statement of operations.
F-
15
GALMED
PHARMACEUTICALS LTD.
Notes
to Consolidated Financial Statements
Note
5 – Leases (Cont.)
At
December 31, 2023, the Company's operating lease right-of-use assets and current lease liabilities for operating leases totaled
$
42
thousand and $
41
thousand, respectively, while at December 31, 2022, the Company's operating lease assets and lease liabilities
(both the current and non-current portion) for operating leases totaled $
223
thousand and $
216
thousand, respectively.
The
Company uses its incremental borrowing rate as the discount rate for its leases, as the implicit rate in the lease is not readily determinable.
As of December 31, 2023, the Company's operating leases had a weighted average remaining lease term of
0.25
years and a weighted
average borrowing rate of
2.3
%
.
The
following table summarizes the maturities of lease liabilities as of December 31, 2023:
2024
$
42
Imputed interest
1
Present value of lease liabilities
$
41
Note
6 –
Property and equipment, net
As
    of December 31,
2023
2022
(in thousands)
Medical equipment
$
737
$
737
Office furniture and equipment
55
54
Computer software and electronic equipment
75
76
Leasehold improvements
235
235
1,102
1,102
Less
    - Accumulated depreciation
1,019
988
Net book value
$
83
$
114
F-
16
GALMED
PHARMACEUTICALS LTD.
Notes
to Consolidated Financial Statements
Note
7 –
Investment in an Associate
On
May 4, 2023, the Company entered into a definitive agreement (the "Agreement") for a $
1.5
million equity investment in OnKai,
a US-based technology company developing an AI-based platform to advance healthcare for underserved populations across the United States
by facilitating alignment between healthcare stakeholders.
Previously,
in November, 2022 the Company invested $
1.5
million in OnKai through a Simple Agreement for
Future Equity ("SAFE") which converted at a
15
%
discount into series seed preferred shares upon
closing of the Investment Round (as defined below). The Company recorded in its statement of operations a change in the fair value of
the convertible note (the SAFE) which totaled $
0.3
million for the year ended December 31, 2023.
The
Company's investment in OnKai was part of an approximately $
60
. million investment round (the "Investment Round") with
other investors that was led by the Company of which SAFEs of approximately $
3.8
were converted into preferred shares of Onkai upon the
consummation of the Investment Round.. On June 19, 2023, the Investment Round closed. Following the closing of the Investment Round,
the Company holds
1,223,535
preferred shares which comprised approximately
24
%
of the outstanding share capital of OnKai on an as-converted
basis as of December 31, 2023. The Company's Chief Executive Officer and director, Allen Baharaff, serves as one of three board
member of OnKai.
Under
the terms of the Agreement, during the three-year period following the closing of the Investment Round the Company will have the right
to merge with OnKai subject to the approval of the boards of directors of each of the Company and OnKai. The Company was granted certain
customary pre-emptive rights as well as registration rights, first refusal rights, co-sale, a board seat, and certain customary protective
provisions.
In
connection with the Agreement, the Company's wholly-owned subsidiary, ("GRD"), entered into a services agreement (the
"Services Agreement") with OnKai. The Services Agreement provides that GRD will on a non-exclusive basis (i) provide support
services to OnKai relating to finance, business development, strategic planning, execution and others; and (ii) lend its experience to
OnKai in building a strategy and for the development of treatments for the underserved and that OnKai shall on a non-exclusive basis
(i) take part in plan preparation to serve GRD's vision of developing drugs for the underserved population and (ii) when relevant,
design a process on the clinical trial dashboard that could potentially serve GDR's future trial.
In
connection with the above mentioned service agreement, the Company recorded management fee income of $
12
thousand in general and administrative
expenses in its statement of operations for the year ended December 31, 2023.
Attached
is a summarized un-audited financial information of OnkaI:
Balance
sheet as of December 31, 2023
December 31,
2023
(in thousands)
Current assets
$
1,384
Non-current assets
5
Current liabilities
160
Non-current liabilities
628
Equity
601
Statement
of operations for the period from June 19, 2023 to December 31, 2023:
(in
    thousands)
Total operating loss
$
1,551
Financial income, net
23
Income tax
16
Net Loss
$
1,544
F-
17
GALMED
                                            PHARMACEUTICALS LTD.
Notes
to Consolidated Financial Statements
Note
8 –
Other Payables
As
    of December 31,
2023
2022
(in thousands)
Employees and related
$
571
$
160
Short-term lease obligation
41
171
Other Payables
-
7
Accrued Vacation
259
196
$
871
$
534
Note
9 –
Related Parties
1.
As
    of December 31, 2023, and 2022, the Company had an accrual in the amount of approximately $
0.6
million and $
0.2
million, respectively,
    pursuant to an employment agreements with its officers and directors' fee.
2.
As
    of December 31, 2023, the Company had a receivable balance of $
4
thousand, pursuant to a service agreement with OnKai.
3.
During
    2023, 2022 and 2021, the Company recorded salary expenses, stock-based compensation expenses and directors' fee to its related
    parties in the amount of $
2.8
million, $
2.8
million and $
4.1
million respectively.
4.
During
    2023, the Company recorded income from management fees pursuant to a service agreement with OnKai.
Note
10
–
Commitments and Contingencies
1.
As
    of December 31, 2023, the Company recorded a pledge on its short-term deposit in favor of its bank in the amount of approximately
    $
117
thousand to secure the Company's commitments to the bank, including a bank guarantee in favor Mintz K. Construction Company,
    the lessor of the Company's headquarters, totaling $
66
thousands as of December 31, 2023.
2.
The
    Company enters into contracts in the ordinary course of business with contract research organizations for clinical trials and clinical
    supply manufacturing and with vendors for non-clinical research studies and other services and products for operating purposes, which
    generally provide for termination upon 30 to 90 days' notice or less, and therefore are cancelable contracts and not considered
    as commitment or purchase obligations.
3.
For
    information regarding the Company's leases commitments, see note 5.
4.
On
    June 28, 2021, the Company entered into a license agreement with Yissum Research Development Company of the Hebrew University of
    Jerusalem ("Yissum") pursuant to which Yissum granted to the Company a worldwide, exclusive and irrevocable license to
    develop and commercialize Amilo-5Mer. Under the license agreement, the Company is responsible for carrying out the development and
    commercialization of Amilo-5Mer and the prosecution and maintenance of the licensed patents under the license agreement. In consideration
    for the grant of the license, the Company paid Yissum an upfront license fee of $
100
thousand which was included in research and
    development expenses for the period ended December 31, 2021. In addition, the Company may be required to make payments of up to $
950
thousand upon meeting certain regulatory milestones and may be entitled to pay single digit royalties on any future net sales and
    a share of any sublicense fees.
F-
18
GALMED
PHARMACEUTICALS LTD.
Notes
to Consolidated Financial Statements
Note
11 –
Stockholders' equity
A.
Ordinary
    shares
1.
Ordinary
    shares confer upon the holders the right to receive notice to participate and vote in general meetings of the Company and the right
    to receive dividends, if declared.
2.
During
    February 2021, the Company entered into an underwriting agreement (the "Underwriting Agreement") with Cantor Fitzgerald
    & Co. (the "Underwriter") in connection with an underwritten public offering (the "Underwritten Public Offering")
    of
147,577
ordinary shares (the "Firm Shares") of the Company (the "Ordinary Shares"). The Underwriter agreed
    to purchase the Firm Shares from the Company at a price of $
64.81
per share. The net proceeds to the Company were approximately $
9.2
million.
3.
On
    March 26, 2021, the Company entered into a Sales Agreement with Cantor Fitzgerald & Co. and Canaccord Genuity LLC, as sales agents,
    pursuant to which the Company may offer and sell ordinary shares "at the market" having an aggregate offering price of
    up to $
50.0
million from time to time through the sales agents. As of December 31, 2023, the Company sold
7,721
ordinary shares under
    its ATM program for total net proceeds of approximately $
0.1
million.
4.
On
    May 15, 2023, the Company effected a reverse share split of the Company's ordinary shares at the ratio of
1-for-15
, such that
    each fifteen (15) ordinary shares, par value NIS
0.01
per share, were consolidated into one (1) ordinary share, par value NIS
0.15
.
    As a result, all share and per share amounts prior to the reverse share split were adjusted retroactively for all periods presented
    in these consolidated financial statements.
5.
On
    July 18, 2023, the Company sold to investors in a public offering (i)
380,000
ordinary shares, (ii)
5,220,000
pre-funded warrants
    to purchase
5,220,000
ordinary shares (the "Pre-Funded Warrants"), and (iii)
5,600,000
warrants to purchase
5,600,000
ordinary shares (the "Investor Warrants"), at a purchase price of $
1.25
per ordinary share and accompanying Investor
    Warrant and $
1.249
per Pre-Funded Warrant and accompanying Investor Warrant.
The
    Pre-Funded Warrants are immediately exercisable at an exercise price of $
0.001
per ordinary share and will not expire until exercised
    in full. The Investor Warrants have an exercise price of $
1.25
per ordinary share, are immediately exercisable, and may be exercised
    until July 18, 2028. The net proceeds to the Company were approximately $
6.2
million.
6.
As
                                            of December 31, 2023, a total of
2,975,000
Pre-Funded Warrants were exercised into
2,972,982
ordinary shares, out of
which a total of
1,090,000
Pre-funded
                                            warrants were exercised on a cashless basis (as permitted under the terms of the Pre-Funded
                                            Warrants) into
1,087,982
ordinary shares. Subsequent to the balance sheet date, as April
                                            3, 2024 a total of
965,000
Pre-Funded Warrants were exercised into
964,330
ordinary shares,
                                            out of which, a total of
240,000
Pre-funded Warrants were exercised on a cashless basis (as
                                            permitted under the terms of the Pre-Funded Warrants)into
239,330
ordinary shares.
F-
19
GALMED
PHARMACEUTICALS LTD.
Notes
to Consolidated Financial Statements
Note
11 – Stockholders' equity (Cont.)
B.
Stock-based
    compensation
1.
The
    Company has an equity-based incentive plan, the 2013 Incentive Share Option Plan (the "2013 Plan"). As of December 31,
    2023, based on the latest amendment to the plan from August 7, 2023, a total of
2,000,000
ordinary shares were reserved for issuance
    under the 2013 Plan, of which a total of
367,026
ordinary shares remain reserved, but unallocated for future equity awards. The 2013
    Plan, which was adopted by the Board on September 2, 2013, and approved by the Company's shareholders on December 30, 2013
    (as was amended by the Board and the Company's shareholders on March 30, 2015, May 11, 2015, August 30, 2018 and August 7,
    2023 respectively), provides for the grant of options to purchase the ordinary shares and the issuance of RSUs to the Company's
    officers, directors, employees, service providers and consultants. The 2013 Plan provides for such equity-based compensation under
    various and different tax regimes.
2.
During
    February 2021, certain office holders exercised options into
1,249
ordinary shares of the Company for a total amount of less than
    $
1
thousand.
3.
In
    March 2021, the Company granted options to purchase
3,000
ordinary shares of the Company to an employee and a consultant. The options
    are exercisable at $
62.4
per share, have a
10
-year term and vest over a period of four years. The aggregate grant date fair value
    of such options was approximately $
0.1
million.
4.
In
    July, 2021, the Company granted options to purchase
6,667
ordinary shares of the Company to its non-management directors subject
    to shareholders' approval (which was obtained in August 2021). The options are exercisable at $
46.5
per share, have a
10
-year
    term and vest over a period of
three years
. The aggregate grant date fair value of such options was approximately $
0.2
million.
5.
In
    August, 2021, the Company granted options to purchase
2,500
ordinary shares of the Company to certain service providers. The options
    are exercisable at $
42.45
per share, have a
10
-year term and vest over a period of
three years
. The aggregate grant date fair value
    of such options was approximately $
0.01
million.
6.
In
    February 2022, the Company granted options to purchase
2,667
ordinary shares of the Company to one of its officers. The options are
    exercisable at $
24.15
per share, have a
10
-year term and vest over a period of
four years
.
7.
On
    March 23, 2023, the Company received a ruling from the Israel Tax Authority ("ITA") confirming the repricing of certain
    stock options. This repricing was accounted for as a modification of a share-based payment award. The incremental compensation expense
    recognized as a result of the modification during the year ended December 31, 2023 was approximately $
0.1
million.
8.
In
    August 2023, the Company granted
1,315,000
(RSUs) and
75,000
options to purchase
75,000
ordinary shares of the Company to its officers
    and directors. The options are exercisable at $
1.05
per share and have a
10
-year term. The options and RSUs vest over a period of
    three years. The aggregate grant date fair value of such RSUs and options was approximately $
0.9
million.
9.
In
    September 2023, the Company extended the exercise period of
21,654
options with an exercise price of
0.15
NIS previously granted
    to the Company's Chief Executive Officer (and director), by approximately
five years
to December 31, 2028. the exercise period
    represented a modification in accordance with ASC 718. The Incremental compensation expense on the modification date was less than
    $
1
thousand.
F-
20
GALMED
PHARMACEUTICALS LTD.
Notes
to Consolidated Financial Statements
Note
11 – Stockholders' equity (Cont.)
B.
Stock-based
    compensation (Cont.)
7.
A summary of the status of
  the Company's outstanding options as of December 31, 2023 and 2022 and changes during the years then ended are presented below:
2023
2022
Weighted
Weighted
Number of
average
Number of
average
share
exercise
share
exercise
options
price
options
price
Options outstanding
    at beginning of year
177,095
$
54.51
189,390
$
54.8
Granted
75,000
$
1.05
2,666
$
5.7
Forfeited
(
11,351
)
$
36.8
(
14,961
)
$
49.61
Outstanding
    at end of year
240,744
$
38.32
177,095
54.51
Options
    exercisable at year end
$
159,229
$
55.88
152,469
56.9
The
following assumptions were used for the fiscal year 2023, 2022 and 2021 grants:
-
dividend
    yield of
0.00
% for all periods.
-
risk-free
    interest rate between
0.80
% and
1.34
% for the fiscal year 2021,
1.94
% for the fiscal year 2022 and
4.16
% for the fiscal year 2023.
-
an
    expected life between
5
and
6.25
years for all periods.
-
and
    a volatility rate ranging between
64
% and
81
% for the fiscal year 2021,
65
% for the fiscal year 2022 and
108
% for the fiscal year
    2023.
As
of December 31, 2023, and 2022, the weighted-average remaining contractual term of the outstanding options, excluding the
2,575
options
granted in 2002 that have no expiration date, is
6.24
and
4.84
years, respectively.
The
weighted average grant date fair value of the options granted during the years ended December 31, 2023, 2022 and 2021 is $
0.63
, $
0.68
,
and $
2.19
respectively.
As
of December 31, 2023, a total of
21,654
outstanding and exercisable options are "in the money" with aggregate intrinsic value
of $
0.001
million; while as of December 31, 2022 a total of
21,654
outstanding and exercisable options were "in the money"
with aggregate intrinsic value of $
0.2
million.
The
unrecognized compensation expense calculated under the fair-value method for stock options expected to vest as of December 31, 2023,
2022 and 2021 is approximately $
0.3
million, $
0.9
million, and $
3.4
million, respectively, and is expected to be recognized over a weighted-average
period of
0.3
years,
1.41
years and
1.75
years, respectively.
For
the years ended 2023, 2022 and 2021, the Company recorded a total of $
0.8
million, $
1.3
million, and $
1.9
milliion of stock-based compensation
expenses, in connection with the above-mentioned options.
F-
21
GALMED
PHARMACEUTICALS LTD.
Notes
to Consolidated Financial Statements
Note
11 – Stockholders' equity (Cont.)
B.
Stock-based
    compensation (Cont.)
On
August 7, 2023, the Company issued a total of
1,315,000
RSU"s. Upon vesting, each RSU will settle by the issuance of one ordinary
share. The RSUs vest over
three years
. As of December 31, 2023, none of the RSU's were vested. with respect to the above-mentioned
RSU's, the Company recorded stock-based compensation expenses in the amount of $
0.1
million for the year ended December 31, 2023.
The
weighted average grant date fair value of the RSU's granted during the year ended December 31, 2023 was $
0.63
.
The
unrecognized compensation expense calculated for RSU's expected to vest as of December 31, 2023, is
approximately $
0.7
million and is expected to be recognized over a weighted-average period of
2.5
years.
Note
12 –
Research and Development Expenses
Year
    ended December 31,
2023
2022
2021
(in thousands)
Chemistry and formulation studies
$
573
$
2,448
$
5,009
Salaries
676
1,692
2,963
Stock-based compensation
243
383
660
Research and preclinical studies
460
1,346
2,163
Clinical studies
616
6,532
14,937
Regulatory and other
    expenses
1,001
594
1,488
$
3,569
$
12,995
$
27,220
Note
13 –
General and Administrative Expenses
Year
    ended December 31,
2023
2022
2021
(in thousands)
Stock-based compensation
$
649
$
913
$
1,225
Professional fees
908
1,084
897
Salaries and benefits
1,428
1,164
1,617
Rent and office-maintenance fees
261
401
530
Investor relations and business development
    expenses
14
59
242
Insurance and other
    expenses
663
1,035
1,150
$
3,923
$
4,656
$
5,661
F-
22
GALMED
PHARMACEUTICALS LTD.
Notes
to Consolidated Financial Statements
Note
14 –
Financial income, net
Year
    ended December 31,
2023
2022
2021
(in thousands)
Bank fees
$
11
$
22
$
43
Interest income
(
375
)
(
297
)
(
562
)
Loss (gain) from sale of marketable debt securities
13
526
80
Change in fair value of convertible note
(
265
)
-
-
Foreign currency (gains)
    losses
36
(
36
)
25
$
(
580
)
$
215
$
(
414
)
Note
15 –
Income Taxes
A.
General
The
Company is assessed for tax purposes on an unconsolidated basis. Each of the Company's subsidiaries is subject to the tax rules
prevailing in its country of incorporation.
B.
Corporate
    Taxation
Israeli
Companies:
The
Israeli corporate income tax rate is
23
% for the years 2021, 2022 and 2023.
On
February 7, 2018, the Israeli Tax Authority issued a ruling granting the Company's Israeli subsidiary, Galmed Research and Development
Ltd, a "Preferred Technological Enterprise" status as defined under the Encouragement of Capital Investment Law -1959 (the
"Approval"). The grant of the status means that the Company's Israeli subsidiary will be subject to a reduced Israeli
corporate tax rate that will range between 6%-12% on any future taxable "technological income" which includes sales, licenses
and royalties from its IP protected products. The tax ruling applies for five years until the end of 2022 and may be extended for further
periods subject to meeting certain requirements.
Maltese
subsidiary:
Taxable
income of Maltese companies was subject to tax at the rate of
35
% for the years 2021, 2022, and 2023.
C.
Net
    Operating Loss Carry forward
As
of December 31, 2023, the Company had approximately $
165.1
million net-operating-loss carry forwards, consisting of approximately $
11.7
million of Maltese net-operating-loss carry forwards and approximately $
153.4
million Israeli net-operating-loss carry forward. Additionally,
the Company had approximately $
3.1
million of capital loss carry forward from the sale of marketable debt securities in Israel. The Maltese
and the Israeli loss carry forwards have no expiration date.
F-
23
GALMED
PHARMACEUTICALS LTD.
Notes
to Consolidated Financial Statements
Note
15 – Income Taxes (Cont.)
D.
Deferred
    income taxes
As
of December 31, 2023, the significant components of the Company's deferred tax assets are net operating loss carryforward in the
amount of $
165.1
million and research and development expenses in the amount of $
6.4
million. The Company has evaluated the positive
and negative evidence bearing upon its ability to realize the deferred tax assets. Management has considered the Company's history
of cumulative net losses incurred since inception and its lack of commercialization of any products or generation of any revenue from
product sales since inception and has concluded that it is more likely than not that the Company will not realize the benefits of the
deferred tax assets. Accordingly, a full valuation allowance has been established against the deferred tax assets as of December 31,
2023. Management reevaluates the positive and negative evidence at each reporting period.
E.
Tax
    assessment
s
The
Israeli subsidiaries received final tax assessments through the year ended December 31, 2019.
F.
Effective
    tax expense
A
reconciliation of the Company's effective tax expense to the Company's theoretical statutory tax benefit is as follows:
Year
    ended December 31,
2023
2022
2021
(in thousands)
Loss before taxes on income, as reported
    in the consolidated statements of operations
$
6,912
$
17,866
$
32,467
Statutory
    tax rate
23
%
12
%
12
%
Theoretical tax benefit
1,590
2,144
3,896
Losses and other items
    for which a valuation allowance was provided or benefit from loss carry forwards
(
1,590
)
(
2,144
)
(
3,896
)
Actual tax expense
$
—
$
—
$
—
Note
16 –
Subsequent event
Subsequent
to the balance sheet date, as of April 3, 2024, a total of
965,000
Pre-Funded Warrants were exercised into
964,330
ordinary shares, out of which, a total of
240,000
Pre-funded Warrants were exercised on a cashless basis (as permitted under the terms of the Pre-Funded Warrants) into
239,330
ordinary shares.
F-
24
ITEM
19. Exhibits.
Exhibit
    No.
Description
1.1
Amended and Restated Articles of Association of Galmed Pharmaceuticals Ltd. (19)
2.1
Description of Securities Registered under Section 12 of the Exchange Act*
4.1
Form of Indemnification Agreement (1)
4.2
Galmed Pharmaceuticals Ltd. 2013 Incentive Share Option Plan as anemded on October 4, 2023 (4)
4.3
Registration and Information Rights Agreement, dated December 2013, by and among Galmed Pharmaceuticals Ltd., Shirat HaChaim Ltd., David & Debora Goldfarb, Medgal S.A. and G. Yarom Medical Research Ltd. (2)
4.4
Personal Employment Agreement, dated December 23, 2013, by and between Galmed Medical Research Ltd. and Allen Baharaff (2)
4.5
Amendment No.1 to Employment Agreement by and between Galmed Research and Development Ltd. and Allen Baharaff (10)
4.6
Amendment No.2 to Employment Agreement by and between Galmed Research and Development Ltd. and Allen Baharaff(12)
4.7
Amendment No.3 to Employment Agreement by and between Galmed Research and Development Ltd. And Allen Baharaff(13)
4.8
Compensation Policy of Galmed Pharmaceuticals Ltd.(5)
4.9
Lease, dated March 22, 2015, between Galmed Research and Development Ltd. and Mintz K. Construction Company Ltd.(8)
4.10
Addendum to Lease, dated February 27, 2017, between Galmed Research and Development Ltd. and Mintz K. Construction Company Ltd. (8)
4.11
Addendum to Lease, dated August 8, 2018, between Galmed Research and Development Ltd. and Mintz K. Construction Company Ltd.(11)
4.12
Addendum to Lease, dated March 11, 2021, between Galmed Research and Development Ltd. and Mintz K. Construction Company Ltd.(12)
4.13
Sales Agreement, dated March 26, 2021, among Galmed Pharmaceuticals Ltd., Cantor Fitzgerald & Co. and Canaccord Genuity LLC.(9)
4.14
Form of Securities Purchase Agreement (14)
4.15
Form of Placement Agency Agreement (15)
142
4.16
Form of Pre-Funded Warrant (16)
4.17
Form of Warrant (17)
4.18
Form of Placement Agent Warrant (18)
8.1
List of subsidiaries of Galmed Pharmaceuticals Ltd.*
11.1
Code of Business Conduct and Ethics of Galmed Pharmaceuticals Ltd.(7)
12.1
Certification of Chief Executive Officer pursuant to Exchange Act Rules 13a-14(a) and 15d-14(a) as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002*
12.2
Certification of Chief Accounting Officer pursuant to Exchange Act Rules 13a-14(a) and 15d-14(a) as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002*
13.1
Certification of Chief Executive Officer and Chief Accounting Officer pursuant to Exchange Act Rules 13a-14(b) and 15d-14(b) and 18 U.S.C. Section 1350 as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002*
15.1
Consent of Brightman Almagor Zohar & Co.*
97.1
Executive Officer Clawback Policy*
101.INS
Inline XBRL Instance Document*
101.SCH
Inline XBRL Taxonomy Extension Schema Document*
101.CAL
Inline XBRL Taxonomy Extension Calculation Linkbase
    Document*
101.DEF
Inline XBRL Taxonomy Extension Definition Linkbase
    Document*
101.LAB
Inline XBRL Taxonomy Extension Label Linkbase Document*
101.PRE
Inline XBRL Taxonomy Extension Presentation Linkbase
    Document*
104
Cover Page Interactive Data File (embedded within the
    Inline XBRL document)
(1)
Incorporated herein by
    reference to Amendment No. 1 to the Registration Statement on Form F-1, filed with the SEC on February 28, 2014.
(2)
Incorporated herein by
    reference to the Registration Statement on Form F-1, filed with the SEC on February 6, 2014.
(3)
Incorporated herein by
    reference to the Company's Report on Form 6-K filed with the SEC on June 1, 2016.
(4)
Incorporated herein by
    reference to Exhibit A to the Company's Report on Form 6-K filed with the SEC on April 2, 2015.
(5)
Incorporated herein by
    reference to Exhibit 10.8 to the Company's Registration Statement on Form F-1 filed with the SEC on June 16, 2023.
(6)
Incorporated herein by
    reference to the Company's Annual Report on Form 20-F filed with the SEC on March 31, 2015.
143
(7)
Incorporated herein by
    reference to the Company's Annual Report on Form 20-F filed with the SEC on March 22, 2016.
(8)
Incorporated herein by
    reference to the Company's Annual Report on Form 20-F filed with the SEC on March 23, 2017.
(9)
Incorporated herein by
    reference to Exhibit 1.1 to the Company's Report on Form 6-K filed with the SEC on March 26, 2021.
(10)
Incorporated herein by
    reference to the Company's Annual Report on Form 20-F filed with the SEC on March 13, 2018.
(11)
Incorporated herein by
    reference to the Company's Annual Report on Form 20-F filed with the SEC on March 13, 2019.
(12)
Incorporated herein by
    reference to the Company's Annual Report on Form 20-F filed with the SEC on March 18, 2021.
(13)
Incorporated herein by
    reference to the Company's Annual Report on Form 20-F filed with the SEC on May 2, 2022.
(14)
Incorporated herein by
    reference to Exhibit 10.1 to the Company's Report on Form 6-K filed with the SEC on July 18, 2023.
(15)
Incorporated herein by
    reference to Exhibit 10.2 to the Company's Report on Form 6-K filed with the SEC on July 18, 2023.
(16)
Incorporated herein by
    reference to Exhibit 10.3 to the Company's Report on Form 6-K filed with the SEC on July 18, 2023.
(17)
Incorporated herein by
    reference to Exhibit 10.4 to the Company's Report on Form 6-K filed with the SEC on July 18, 2023.
(18)
Incorporated herein by
    reference to Exhibit 10.5 to the Company's Report on Form 6-K filed with the SEC on July 18, 2023.
(19)
Incorporated herein by
    reference to Exhibit 3.1 to the Company's Registration Statement on Form F-1 filed with the SEC on June 16, 2023.
*Filed
herewith.
144
SIGNATURES
The
registrant hereby certifies that it meets all of the requirements for filing on Form 20-F and that it has duly caused and authorized
the undersigned to sign this annual report on its behalf.
GALMED PHARMACEUTICALS LTD.
By:
/s/
    Allen Baharaff
Allen Baharaff
President, Chief Executive Officer and Chairman
Date:
April 4, 2024
145