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</div><!-- Field: Rule-Page --><div style="margin-top: 0pt; margin-bottom: 0pt; width: 100%"><div style="border-top: Black 2pt solid; font-size: 1pt; border-bottom: Black 1pt solid">&#160;</div></div><!-- Field: /Rule-Page --><div>

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

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

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

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><b>FORM <ix:nonNumeric contextRef="c0" name="dei:DocumentType">20-F</ix:nonNumeric></b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><b>REGISTRATION ST<span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">ATEMENT
PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934</span></b></p><div>

</div><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><div>

</div><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><div>

</div><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><div>

</div><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"><ix:nonNumeric contextRef="c0" format="ixt:fixed-true" name="dei:DocumentAnnualReport">&#9746;</ix:nonNumeric>&#160;<b>ANNUAL
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934</b></span></p><div>

</div><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><div>

</div><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>For
the fiscal year ended <ix:nonNumeric contextRef="c0" format="ixt:date-monthname-day-year-en" name="dei:DocumentPeriodEndDate"><ix:nonNumeric contextRef="c0" format="ixt:date-monthname-day-en" name="dei:CurrentFiscalYearEndDate">December 31</ix:nonNumeric>, <ix:nonNumeric contextRef="c0" name="dei:DocumentFiscalYearFocus">2022</ix:nonNumeric></ix:nonNumeric></b></span></p><div>

</div><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><div>

</div><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><div>

</div><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><div>

</div><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"><ix:nonNumeric contextRef="c0" format="ixt:fixed-false" name="dei:DocumentTransitionReport">&#9744;</ix:nonNumeric>
<b>TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934</b></span></p><div>

</div><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><div>

</div><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>For
the transition period from&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;
to&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;</b></span></p><div>

</div><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><div>

</div><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><div>

</div><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><div>

</div><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"><ix:nonNumeric contextRef="c0" format="ixt:fixed-false" name="dei:DocumentShellCompanyReport">&#9744;</ix:nonNumeric>
<b>SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934</b></span></p><div>

</div><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>&#160;</b></span></p><div>

</div><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">Commission
file number:</span></p><div>

</div><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><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><ix:nonNumeric contextRef="c0" name="dei:EntityRegistrantName"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Tiziana
L</b></span><b>ife Sciences Ltd</b></ix:nonNumeric></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">(Exact name of Registrant as specified in its
charter and translation of Registrant&#8217;s name into English)</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><ix:nonNumeric contextRef="c0" format="ixt-sec:edgarprovcountryen" name="dei:EntityIncorporationStateCountryCode"><b>Bermuda</b></ix:nonNumeric></p><div>

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

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><ix:nonNumeric contextRef="c0" name="dei:EntityAddressAddressLine1">Clarendon House</ix:nonNumeric>,</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><ix:nonNumeric contextRef="c0" name="dei:EntityAddressAddressLine2">2 Church Street,</ix:nonNumeric></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><ix:nonNumeric contextRef="c0" name="dei:EntityAddressCityOrTown">Hamilton HM</ix:nonNumeric> <ix:nonNumeric contextRef="c0" name="dei:EntityAddressPostalZipCode">11</ix:nonNumeric>,</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><ix:nonNumeric contextRef="c0" format="ixt-sec:countrynameen" name="dei:EntityAddressCountry">Bermuda</ix:nonNumeric>&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">(Address of principal executive offices)</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><ix:nonNumeric contextRef="c1" name="dei:ContactPersonnelName"><b>Keeren Shah</b></ix:nonNumeric></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><ix:nonNumeric contextRef="c1" name="dei:EntityAddressAddressLine1"><b>Chief Financial Officer</b></ix:nonNumeric></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><b><ix:nonNumeric contextRef="c1" name="dei:EntityAddressAddressLine2">14-15 Conduit Street</ix:nonNumeric>, <span style="-sec-ix-hidden: hidden-fact-0"><span style="-sec-ix-hidden: hidden-fact-1">LondonW1S</span></span> 2XJ <ix:nonNumeric contextRef="c1" format="ixt-sec:countrynameen" name="dei:EntityAddressCountry">United
Kingdom</ix:nonNumeric></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><b><ix:nonNumeric contextRef="c1" name="dei:CityAreaCode">+44</ix:nonNumeric> <ix:nonNumeric contextRef="c1" name="dei:LocalPhoneNumber">20 7495 2379</ix:nonNumeric></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">(Name, Telephone, E-mail and/or Facsimile number
and Address of Company Contact Person)</p><div>

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

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

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

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><b>Orrick, Herrington&#160;&amp; Sutcliffe (UK)
LLP </b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><b>107 Cheapside</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><b>London EC2V 6DN</b></p><div>

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

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

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><b>Sheppard, Mullin, Richter &amp; Hampton LLP</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><b>30 Rockefeller Plaza</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><b>New York, NY 10112-0015</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><b>(212) 653 8700</b></p><div>

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

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

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

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="vertical-align: top">
    <td style="width: 49%; border-bottom: black 1.5pt solid; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Title of each class</b></span></td>
    <td style="width: 2%; text-align: center">&#160;</td>
    <td style="width: 49%; border-bottom: black 1.5pt solid; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Name of each exchange on which registered</b></span></td></tr>
  <tr style="vertical-align: top; background-color: #CCEEFF">
    <td style="text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Common Shares</span></td>
    <td style="text-align: center">&#160;</td>
    <td style="text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">NASDAQ Capital Market</span></td></tr>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center; text-indent: 0.5in">&#160;&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><i>(*) Not for trading, but only in connection with the listing of
the American Depositary Shares </i></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">Securities registered or to be registered pursuant
to Section 12(g) of the Act: <b>None</b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">Securities for which there is a reporting obligation
pursuant to Section 15(d) of the Act: <b>None</b></p><div>

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

</div><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">Number
of outstanding shares of each of the issuer&#8217;s classes of capital or common stock as of December 31, 2022: <ix:nonFraction contextRef="c2" decimals="INF" format="ixt:num-dot-decimal" name="dei:EntityCommonStockSharesOutstanding" scale="0" unitRef="shares">102,272,614</ix:nonFraction> common shares.</span></p><div>

</div><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><div>

</div><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">Indicate
by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.</span></p><div>

</div><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><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: right"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9744;&#160;Yes&#160;&#160;&#9746;&#160;<ix:nonNumeric contextRef="c0" name="dei:EntityWellKnownSeasonedIssuer">No</ix:nonNumeric></span></p><div>

</div><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><div>

</div><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">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.</span></p><div>

</div><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><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: right"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9746;&#160;<ix:nonNumeric contextRef="c0" name="dei:EntityVoluntaryFilers">Yes</ix:nonNumeric>&#160;&#160;&#9744;&#160;No</span></p><div>

</div><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><div>

</div><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">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></p><div>

</div><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><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: right"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9744;&#160;Yes&#160;&#160;&#9744;&#160;<ix:nonNumeric contextRef="c0" name="dei:EntityCurrentReportingStatus">No</ix:nonNumeric></span></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: -0.05pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p><div>

</div><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">Indicate
by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data
File required to be submitted and posted 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></p><div>

</div><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><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: right"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9744;&#160;Yes&#160;&#160;&#9744;&#160;<ix:nonNumeric contextRef="c0" name="dei:EntityInteractiveDataCurrent">No</ix:nonNumeric></span></p><div>

</div><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><div>

</div><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">Indicate
by check mark whether the registrant is a large accelerated filer, an accelerated filer, or a non-accelerated filer, smaller reporting
company, or an emerging growth company. See definitions of &#8220;large accelerated filer, &#8220;accelerated filer&#8221;, &#8220;smaller
reporting company&#8221;, and &#8220;emerging growth company&#8221; in Rule 12b-2 of the Exchange Act. (Check one):</span></p><div>

</div><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><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse"> <tr style="vertical-align: top"> <td style="width: 27%; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Large accelerated filer &#9744;</span></td> <td style="width: 26%; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;&#160;Accelerated filer &#9744;</span></td> <td style="width: 26%; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><ix:nonNumeric contextRef="c0" format="ixt-sec:entityfilercategoryen" name="dei:EntityFilerCategory">Non-accelerated filer</ix:nonNumeric> &#9746;</span></td> <td style="white-space: nowrap; width: 21%"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Smaller reporting company &#9746;</span></td></tr> <tr style="vertical-align: top"> <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td> <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td> <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td> <td style="white-space: nowrap"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Emerging growth company <ix:nonNumeric contextRef="c0" format="ixt:fixed-true" name="dei:EntityEmergingGrowthCompany">&#9746;</ix:nonNumeric></span></td></tr> </table><div>
</div><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><div>

</div><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">If
an emerging growth company that prepares its financial statements in accordance with U.S. GAAP, indicate by checkmark 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 Exchange Act. <ix:nonNumeric contextRef="c0" format="ixt:fixed-false" name="dei:EntityExTransitionPeriod">&#9744;</ix:nonNumeric></span></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 5.85pt; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p><div>

</div><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">&#8224;
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.</span></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify">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.&#160;&#9744;</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; ">If the 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.&#160;&#9744;</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; ">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).&#160;&#9744;</p><div>

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

</div><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">Indicate
by check mark which basis of accounting the registrant has used to prepare the financial statements included in this filing:</span></p><div>

</div><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><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse"> <tr style="vertical-align: top"> <td style="width: 25%; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">U.S. GAAP &#9744;</span></td> <td style="width: 50%; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><span style="-sec-ix-hidden: hidden-fact-2">International Financial Reporting Standards</span> as issued by the<br/> International Accounting Standards Board &#9746;</span></td> <td style="width: 25%; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Other &#9744;</span></td></tr> </table><div>
</div><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><div>

</div><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">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:</span></p><div>

</div><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><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: right"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9744;&#160;
Item 17&#160;&#160;&#9744;&#160;Item 18</span></p><div>

</div><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><div>

</div><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">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).</span></p><div>

</div><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><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: right"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9744;&#160;Yes&#160;&#160;<ix:nonNumeric contextRef="c0" format="ixt:fixed-false" name="dei:EntityShellCompany">&#9746;</ix:nonNumeric>&#160;No</span></p><div>

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

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

</div><!-- Field: Rule-Page --><div style="margin-top: 0pt; margin-bottom: 0pt; width: 100%"><div style="font-size: 1pt; border-top: Black 1pt solid; border-bottom: Black 2pt solid">&#160;</div></div><!-- Field: /Rule-Page --><div>

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

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

</div><!-- Field: Page; Sequence: 1 --><div>
    </div><div style="border-bottom: Black 1.5pt solid; margin-top: 12pt; margin-bottom: 6pt"><p style="margin: 0pt">&#160;</p></div><div>
    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
    </div><!-- Field: /Page --><div>

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

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

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

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="vertical-align: top; background-color: rgb(204,238,255)">
    <td colspan="4" style="text-align: center"><a href="#a_001"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>PART
    I</b></span></a></td></tr>
  <tr style="vertical-align: top; ">
    <td style="width: 9%"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Item 1</span></td>
    <td style="width: 80%"><a href="#a_002"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Identity of Directors,
    Senior Management and Advisers</span></a></td>
    <td style="width: 1%">&#160;</td>
    <td style="width: 10%; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">1</span></td></tr>
  <tr style="vertical-align: top; background-color: rgb(204,238,255)">
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Item 2</span></td>
    <td><a href="#a_003"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Offer Statistics and Expected Timetable</span></a></td>
    <td>&#160;</td>
    <td style="text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">1</span></td></tr>
  <tr style="vertical-align: top; ">
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Item 3</span></td>
    <td><a href="#a_004"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Key Information</span></a></td>
    <td>&#160;</td>
    <td style="text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">1</span></td></tr>
  <tr style="vertical-align: top; background-color: rgb(204,238,255)">
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Item 4</span></td>
    <td><a href="#a_005"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Information on the Company</span></a></td>
    <td>&#160;</td>
    <td style="text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">36</span></td></tr>
  <tr style="vertical-align: top; ">
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Item 4A</span></td>
    <td><a href="#a_006"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Unresolved Staff Comments</span></a></td>
    <td>&#160;</td>
    <td style="text-align: center">73</td></tr>
  <tr style="vertical-align: top; background-color: rgb(204,238,255)">
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Item 5</span></td>
    <td><a href="#a_007"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Operating and Financial Review and
    Prospects</span></a></td>
    <td>&#160;</td>
    <td style="text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">73</span></td></tr>
  <tr style="vertical-align: top; ">
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Item 6</span></td>
    <td><a href="#a_008"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Directors, Senior Management and Employees</span></a></td>
    <td>&#160;</td>
    <td style="text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">87</span></td></tr>
  <tr style="vertical-align: top; background-color: rgb(204,238,255)">
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Item 7</span></td>
    <td><a href="#a_009"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Major Shareholders and Related Party
    Transactions</span></a></td>
    <td>&#160;</td>
    <td style="text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">104</span></td></tr>
  <tr style="vertical-align: top; ">
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Item 8</span></td>
    <td><a href="#a_010"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Financial Information</span></a></td>
    <td>&#160;</td>
    <td style="text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">105</span></td></tr>
  <tr style="vertical-align: top; background-color: rgb(204,238,255)">
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Item 9</span></td>
    <td><a href="#a_011"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The Offer and Listing</span></a></td>
    <td>&#160;</td>
    <td style="text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">106</span></td></tr>
  <tr style="vertical-align: top; ">
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Item 10</span></td>
    <td><a href="#a_012"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Additional Information</span></a></td>
    <td>&#160;</td>
    <td style="text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">106</span></td></tr>
  <tr style="vertical-align: top; background-color: rgb(204,238,255)">
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Item 11</span></td>
    <td><a href="#a_013"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Quantitative and Qualitative Disclosures
    About Market Risk</span></a></td>
    <td>&#160;</td>
    <td style="text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">113</span></td></tr>
  <tr style="vertical-align: top; ">
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Item 12</span></td>
    <td><a href="#a_014"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Description of Securities Other than
    Equity Securities</span></a></td>
    <td>&#160;</td>
    <td style="text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">113</span></td></tr>
  <tr style="vertical-align: top; background-color: rgb(204,238,255)">
    <td>&#160;</td>
    <td>&#160;</td>
    <td>&#160;</td>
    <td style="text-align: center">&#160;</td></tr>
  <tr style="vertical-align: top; ">
    <td colspan="4" style="text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><a href="#a_015">PART
    II</a></b></span></td></tr>
  <tr style="vertical-align: top; background-color: rgb(204,238,255)">
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Item 13</span></td>
    <td><a href="#a_016"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Defaults, Dividend Arrearages and
    Delinquencies</span></a></td>
    <td>&#160;</td>
    <td style="text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">114</span></td></tr>
  <tr style="vertical-align: top; ">
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Item 14</span></td>
    <td><a href="#a_017"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Material Modifications to the Rights
    of Security Holders and Use of Proceeds</span></a></td>
    <td>&#160;</td>
    <td style="text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">114</span></td></tr>
  <tr style="vertical-align: top; background-color: rgb(204,238,255)">
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Item 15</span></td>
    <td><a href="#a_018"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Controls and Procedures</span></a></td>
    <td>&#160;</td>
    <td style="text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">114</span></td></tr>
  <tr style="vertical-align: top; ">
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Item 16A</span></td>
    <td><a href="#a_019"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Audit Committee Financial Expert</span></a></td>
    <td>&#160;</td>
    <td style="text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">115</span></td></tr>
  <tr style="vertical-align: top; background-color: rgb(204,238,255)">
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Item 16B</span></td>
    <td><a href="#a_020"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Code of Ethics</span></a></td>
    <td>&#160;</td>
    <td style="text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">115</span></td></tr>
  <tr style="vertical-align: top; ">
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Item 16C</span></td>
    <td><a href="#a_021"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Principal Accountant Fees and Services</span></a></td>
    <td>&#160;</td>
    <td style="text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">115</span></td></tr>
  <tr style="vertical-align: top; background-color: rgb(204,238,255)">
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Item 16D</span></td>
    <td><a href="#a_022"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Exemptions From the Listing Standards
    for Audit Committees</span></a></td>
    <td>&#160;</td>
    <td style="text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">116</span></td></tr>
  <tr style="vertical-align: top; ">
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Item 16E</span></td>
    <td><a href="#a_023"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Purchases of Equity Securities by
    the Issuer and Affiliated Purchasers</span></a></td>
    <td>&#160;</td>
    <td style="text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">116</span></td></tr>
  <tr style="vertical-align: top; background-color: rgb(204,238,255)">
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Item 16F</span></td>
    <td><a href="#a_024"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Change in Registrant&#8217;s Certifying
    Accountant</span></a></td>
    <td>&#160;</td>
    <td style="text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">116</span></td></tr>
  <tr style="vertical-align: top; ">
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Item 16G</span></td>
    <td><a href="#a_025"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Corporate Governance</span></a></td>
    <td>&#160;</td>
    <td style="text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">116</span></td></tr>
  <tr style="vertical-align: top; background-color: rgb(204,238,255)">
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Item 16H</span></td>
    <td><a href="#a_026"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Mine Safety Disclosure</span></a></td>
    <td>&#160;</td>
    <td style="text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">116</span></td></tr>
  <tr style="vertical-align: top; ">
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Item 16I</span></td>
    <td><a href="#a_027"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Disclosure Regarding Foreign Jurisdictions
    that Prevent Inspections&#160;</span></a></td>
    <td>&#160;</td>
    <td style="text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">116</span></td></tr>
  <tr style="vertical-align: top; background-color: rgb(204,238,255)">
    <td>&#160;</td>
    <td>&#160;</td>
    <td>&#160;</td>
    <td style="text-align: center">&#160;</td></tr>
  <tr style="vertical-align: top; ">
    <td colspan="4" style="text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><a href="#a_028">PART
    III</a></b></span></td></tr>
  <tr style="vertical-align: top; background-color: rgb(204,238,255)">
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Item 17</span></td>
    <td><a href="#a_029"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Financial Statements</span></a></td>
    <td>&#160;</td>
    <td style="text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">117</span></td></tr>
  <tr style="vertical-align: top; ">
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Item 18</span></td>
    <td><a href="#a_030"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Financial Statements</span></a></td>
    <td>&#160;</td>
    <td style="text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">117</span></td></tr>
  <tr style="vertical-align: top; background-color: rgb(204,238,255)">
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Item 19</span></td>
    <td><a href="#a_031"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Exhibits</span></a></td>
    <td>&#160;</td>
    <td style="text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">117</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in"></p><div>

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    </div><!-- Field: /Page --><div>

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

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

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">In this Annual Report on
the Form 20-F references to &#8220;Tiziana,&#8221; &#8220;Tiziana Life Sciences plc,&#8221; &#8220;the company,&#8221; &#8220;we,&#8221;
&#8220;us&#8221; and &#8220;our&#8221; refer to Tiziana Life Sciences Ltd, Bermuda and its wholly owned subsidiaries, Tiziana Life Sciences
Ltd (formerly Tiziana Life Sciences plc), Tiziana Therapeutics Inc., Tiziana Pharma Limited and Longevia Genomics S.r.l.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Solely for convenience, the
trademarks, service marks and trade names in this registration statement may be referred to without the &#174; and &#8482; symbols, but
such references should not be construed as any indicator that their respective owners will not assert, to the fullest extent under applicable
law, their rights thereto. This annual report contains additional trademarks, service marks and trade names of others, which are the
property of their respective owners. We do not intend to use or display other companies&#8217; trademarks, service marks and trade names
to imply a relationship with, or endorsement or sponsorship of us by, any other companies.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">In this annual report, unless
otherwise stated, all references to &#8220;U.S. dollars&#8221; or &#8220;US$&#8221; or &#8220;$&#8221; or &#8220;cents&#8221; are to
the currency of the United States of America, and all references to &#8220;Pounds Sterling&#8221; or &#8220;Sterling&#8221; or &#8220;&#163;&#8221;
or &#8220;pence&#8221; are to the currency of the United Kingdom.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">In this annual report, any
reference to any provision of any legislation shall include any amendment, modification, re-enactment or extension thereof. Words importing
the singular shall include the plural and vice versa, and words importing the masculine gender shall include the feminine or neutral
gender.</p><div>

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

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

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    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
    </div><!-- Field: /Page --><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><span style="text-transform: uppercase"><b>Presentation
of Financial Information</b></span></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">This annual report includes
our audited consolidated financial statements as of and for the years ended December 31, 2022 and 2021, which are prepared in accordance
with International Financial Reporting Standards, or IFRS, as issued by the International Accounting Standards Board, or IASB. None of
our financial statements were prepared in accordance with generally accepted accounting principles in the United States.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Our financial information
is presented in United States dollars. For the convenience of the reader, in this prospectus, unless otherwise indicated, translations
from Pounds Sterling into U.S. dollars were made at the rate of &#163;1.00 to $1.2225, which was the noon buying rate of the Federal
Reserve Bank of New York on March 24, 2023. Such U.S. dollar amounts are not necessarily indicative of the amounts of U.S. dollars that
could actually have been purchased upon exchange of Pounds Sterling at the dates indicated.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">We have made rounding adjustments
to some of the figures included in this prospectus. Accordingly, numerical figures shown as totals in some tables may not be an arithmetic
aggregation of the figures that preceded them.</p><div>

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

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

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    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
    </div><!-- Field: /Page --><div>

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

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

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">This Annual Report contains
forward-looking statements that involve substantial risks and uncertainties. All statements contained in this Annual Report, other than
statements of historical fact, including statements regarding our strategy, future operations, future financial position, future revenues,
projected costs, prospects, plans and objectives of management, are forward-looking statements. The words &#8220;may,&#8221; &#8220;might,&#8221;
&#8220;will,&#8221; &#8220;could,&#8221; &#8220;would,&#8221; &#8220;should,&#8221; &#8220;expect,&#8221; &#8220;intend,&#8221; &#8220;plan,&#8221;
&#8220;objective,&#8221; &#8220;anticipate,&#8221; &#8220;believe,&#8221; &#8220;estimate,&#8221; &#8220;predict,&#8221; &#8220;potential,&#8221;
&#8220;continue&#8221; and &#8220;ongoing,&#8221; or the negative of these terms, or other comparable terminology intended to identify
statements about the future. These statements involve known and unknown risks, uncertainties and other important factors that may cause
our actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied
by these forward-looking statements. The forward-looking statements and opinions contained in this registration statement are based upon
information available to us as of the date of this registration statement and, while we believe such information forms a reasonable basis
for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted
an exhaustive inquiry into, or review of, all potentially available relevant information. Forward-looking statements include statements
about:</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 34.65pt; text-align: justify; text-indent: -0.2in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the development of Foralumab,
    anti-IL6R monoclonal antibody (TZLS-501), Milciclib, and any of our other product candidates, including statements regarding the
    timing of initiation, completion and the outcome of clinical studies or trials and related preparatory work, the period during which
    the results of the trials will become available and our research and development programs;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 34.65pt; text-align: justify; text-indent: -0.2in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">our ability to obtain and
    maintain regulatory approval of our product candidates, including Foralumab, anti-IL6R monoclonal antibody (TZLS-501), Milciclib,
    in the indications for which we plan to develop them, and any related restrictions, limitations or warnings in the label of an approved
    drug or therapy;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 34.65pt; text-align: justify; text-indent: -0.2in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">our plans to research,
    develop, manufacture and commercialize our product candidates;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 34.65pt; text-align: justify; text-indent: -0.2in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the timing of our regulatory
    filings for our product candidates;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 34.65pt; text-align: justify; text-indent: -0.2in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the size and growth potential
    of the markets for our product candidates;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 34.65pt; text-align: justify; text-indent: -0.2in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">our ability to raise additional
    capital;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 34.65pt; text-align: justify; text-indent: -0.2in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">our commercialization,
    marketing and manufacturing capabilities and strategy;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">our expectations regarding
    our ability to obtain and maintain intellectual property protection;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 34.65pt; text-align: justify; text-indent: -0.2in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">our ability to attract
    and retain qualified employees and key personnel;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 34.65pt; text-align: justify; text-indent: -0.2in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">our ability to contract
    with third-party suppliers and manufacturers and their ability to perform adequately;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 34.65pt; text-align: justify; text-indent: -0.2in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">our estimates regarding
    future revenue, expenses and needs for additional financing; and</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 34.65pt; text-align: justify; text-indent: -0.2in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">regulatory developments
    in the United States, European Union and foreign countries.</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">You should refer to the section
titled &#8220;Risk Factors&#8221; for a discussion of important factors that may cause our actual results to differ materially from those
expressed or implied by our forward-looking statements. As a result of these factors, we cannot assure you that the forward-looking statements
in this registration statement will prove to be accurate.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Furthermore, if our forward-looking
statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking
statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our
objectives and plans in any specified time frame, or at all. We undertake no obligation to publicly update any forward-looking statements,
whether as a result of new information, future events or otherwise, except as required by law.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">You should read this Annual
Report and the documents that we have filed as exhibits to this Annual Report completely and with the understanding that our actual future
results may be materially different from what we expect. We qualify all of our forward-looking statements by these cautionary statements.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"></p><div>

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    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
    </div><!-- Field: /Page --><div>

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

</div><div><a id="a_001"></a></div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><span style="text-transform: uppercase"><b>PART
I</b></span></p><div>

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

</div><div><a id="a_002"></a></div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><b>ITEM 1: IDENTITY OF DIRECTORS, SENIOR MANAGEMENT
AND ADVISERS</b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">Not Applicable</p><div>

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

</div><div><a id="a_003"></a></div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><b>ITEM 2: OFFER STATISTICS AND EXPECTED TIMETABLE</b></p><div>

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

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

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

</div><div><a id="a_004"></a></div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><b>ITEM 3: KEY INFORMATION</b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>A. Selected Financial Data</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 5.85pt; text-align: justify; text-indent: 0.2in">&#160;</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">The following table summarizes
our consolidated financial data as of the dates and for the periods indicated. The consolidated financial statement data as of December
31, 2022 and 2021 and for the years ended December 31, 2022, 2021 and 2020 have been derived from our consolidated financial statements,
as presented at the end of this Annual Report, which have been prepared in accordance with IFRS, as issued by the IASB, and audited in
accordance with the standards of the Public Company Accounting Oversight Board (United States). The consolidated financial statement data
as of December 31, 2019 and 2018 and for the years ended December 31, 2019 and 2018 have been derived from our consolidated financial
statements, which are not presented herein, which have also been prepared in accordance with IFRS as issued by the IASB.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Our functional and presentational currency is the U.S. dollar.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"></p><div>

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    </div><div style="margin-top: 12pt; margin-bottom: 6pt; border-bottom: Black 1.5pt solid"><p style="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><!-- Field: Sequence; Type: Arabic; Name: PageNo -->1<!-- Field: /Sequence --></p></div><div>
    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
    </div><!-- Field: /Page --><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Our historical results are
not necessarily indicative of the results that may be expected in the future. The following selected consolidated financial data should
be read in conjunction with our audited consolidated financial statements included at the end of this Annual Report and the related notes
and Item 5, &#8220;Operating and Financial Review and Prospects&#8221; below.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><b>Consolidated Statement of Operations and Comprehensive Loss Data:</b></p><div>

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

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

</div><table cellpadding="0" cellspacing="0" style="border-collapse: collapse; width: 100%; font: 10pt Times New Roman, Times, Serif">
  <tr style="vertical-align: bottom">
    <td>&#160;</td><td style="font-weight: bold; padding-bottom: 1.5pt">&#160;</td>
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  <tr style="vertical-align: bottom">
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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">(27,374</td><td style="text-align: left">)</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">(28,026</td><td style="text-align: left">)</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">(9,921</td><td style="text-align: left">)</td><td>&#160;</td>
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    <td style="text-align: left">&#160;</td><td style="text-align: right">(27,374</td><td style="text-align: left">)</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">(28,026</td><td style="text-align: left">)</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">(9,921</td><td style="text-align: left">)</td><td>&#160;</td>
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  <tr style="vertical-align: bottom; ">
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    <td style="text-align: left">&#160;</td><td style="text-align: right">(23,417</td><td style="text-align: left">)</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">(26,131</td><td style="text-align: left">)</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">(9,323</td><td style="text-align: left">)</td><td>&#160;</td>
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><b>&#160;&#160;</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><b>Consolidated Balance Sheet Data:</b></p><div>

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

</div><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><td style="font-weight: bold; padding-bottom: 1.5pt">&#160;</td>
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    <td style="text-align: left">&#160;</td><td style="text-align: right">519</td><td style="text-align: left">&#160;</td></tr>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in"><b>&#160;</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">We define working capital
as current assets less current liabilities.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>B. Capitalization and Indebtedness</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 20.25pt; text-indent: 0.5in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.25in; text-indent: 0.25in">Not applicable.</p><div>

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

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 20.25pt; text-indent: 0.5in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.25in; text-indent: 0.25in">Not applicable.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 20.25pt; text-indent: 0.5in">&#160;</p><div>

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

</div><!-- Field: Page; Sequence: 7; Value: 1 --><div>
    </div><div style="margin-top: 12pt; margin-bottom: 6pt; border-bottom: Black 1.5pt solid"><p style="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><!-- Field: Sequence; Type: Arabic; Name: PageNo -->2<!-- Field: /Sequence --></p></div><div>
    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
    </div><!-- Field: /Page --><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>D. Risk Factors</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 16.1pt; text-indent: 0.5in"><i>&#160;</i></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-align: justify"><i>Our business has significant risks.
You should consider carefully the risks described below, together with the other information contained in this Annual Report, including
our financial statements and the related notes. If any of the following risks occur, our business, financial condition, results of operations
and future growth prospects could be materially and adversely affected. This Annual Report also contains forward-looking statements that
involve risks and uncertainties. Our results could materially differ from those anticipated in these forward-looking statements, as a
result of certain factors including the risks described below and elsewhere in this Annual Report and our other SEC filings. See &#8220;Cautionary
Statement Regarding Forward-Looking Statements&#8221; above.</i></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 16.1pt; text-indent: 0.5in"><b>&#160;</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><b>Risks Related to the Development of our Product Candidates</b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>If we encounter substantial delays in clinical
trials of our product candidates, we may be unable to obtain required regulatory approvals, and therefore will be unable to commercialize
our product candidates on a timely basis or at all.</i></b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Before obtaining marketing
approval from regulatory authorities for the sale of our product candidates, we must conduct extensive clinical trials to demonstrate
the safety and utility of the product candidates. Clinical testing is expensive, time-consuming and uncertain as to outcome. We cannot
guarantee that any clinical trials will be conducted as planned or completed on schedule, if at all, as a failure of one or more clinical
trials can occur at any stage of testing. Events that may prevent successful or timely completion of clinical development include:</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
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    with the U.S. Food and Drug Administration, or FDA, European Medicines Agency, or EMA, or other regulatory authorities on trial design;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
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  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
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    instability of our CROs, CMOs and CDMOs</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.75in; text-align: justify; text-indent: -0.25in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">delays in opening clinical
    trial sites or obtaining required institutional review board or independent ethics committee approval at each clinical trial site;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">delays in recruiting suitable
    patients to participate in our future clinical trials;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">imposition of a clinical
    hold by regulatory authorities as a result of a serious adverse event or after an inspection of our clinical trial operations or
    clinical trial sites;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">failure by us, any CROs
    we engage or any other third parties to adhere to clinical trial requirements;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
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    with good clinical practice, or GCP, or applicable regulatory guidelines in Europe and other international markets;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">delays in the testing,
    validation, manufacturing and delivery of our product candidates to the clinical trial sites, including delays by third parties with
    whom we have contracted to perform certain of those functions;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">delays in having patients
    complete participation in a clinical trial or return for post-treatment follow-up;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">clinical trial sites or
    patients dropping out of a clinical trial;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">selection of clinical endpoints
    that require prolonged periods of clinical observation or analysis of the resulting data;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">occurrence of serious adverse
    events associated with the product candidate that are viewed to outweigh its potential benefits;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">occurrence of serious adverse
    events in clinical trials of the same class of agents conducted by other sponsors; and</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">changes in regulatory requirements
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  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Any inability to successfully
complete preclinical and clinical development could result in additional costs to us or impair our ability to generate revenues from
product sales, regulatory and commercialization milestones and royalties. In addition, if we make manufacturing or formulation changes
to our product candidates, we may need to conduct additional studies to bridge our modified product candidates to earlier versions. Clinical
trial delays also could shorten any periods during which we may have the exclusive right to commercialize our product candidates or allow
our competitors to bring products to market before we do, which could impair our ability to successfully commercialize our product candidates
and may harm our business, financial condition, results of operations and prospects.</p><div>

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

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

</div><!-- Field: Page; Sequence: 8; Value: 1 --><div>
    </div><div style="margin-top: 12pt; margin-bottom: 6pt; border-bottom: Black 1.5pt solid"><p style="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><!-- Field: Sequence; Type: Arabic; Name: PageNo -->3<!-- Field: /Sequence --></p></div><div>
    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
    </div><!-- Field: /Page --><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>We may fail to demonstrate the safety and
therapeutic utility of our product candidates to the satisfaction of applicable regulatory authorities, which would prevent or delay
regulatory approval and commercialization.</i></b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Before obtaining regulatory
approvals for the commercial sale of our product candidates, we must demonstrate through lengthy, complex and expensive preclinical testing
and clinical trials that our product candidates are both safe and effective for use in each target indication. Clinical testing is expensive
and can take many years to complete, and its outcome is inherently uncertain. Most product candidates that commence clinical trials are
never approved as products. If the results of our registrational trial or future pivotal trials for our other product candidates do not
demonstrate therapeutic utility of our product candidates, or if there are safety concerns or serious adverse events associated with
our product candidates, we may:</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">be delayed in obtaining
    marketing approval for our product candidates, if at all;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
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  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
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  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
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  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">be subject to changes in
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  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
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  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">be subject to the addition
    of labeling statements, such as warnings or contraindications; or</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
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  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>Success in preclinical studies or clinical
trials may not be indicative of results in future clinical trials.</i></b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Success in preclinical testing
and early clinical trials does not ensure that later clinical trials will generate the same results or otherwise provide adequate data
to demonstrate the effectiveness and safety of our product candidate. Frequently, product candidates that have shown promising results
in early clinical trials have subsequently suffered significant setbacks in later clinical trials. To date, some of our clinical trials
have involved small patient populations and because of the small sample size in such trials, the interim results of these clinical trials
may be subject to substantial variability and may not be indicative of either future interim results or final results. 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. &#160;In addition, there is a high failure rate for drugs and
biologic products proceeding through clinical trials. In fact, many companies in the pharmaceutical and biotechnology industries have
suffered significant setbacks in late-stage clinical trials even after achieving promising results in preclinical testing and earlier-stage
clinical trials. Moreover, data obtained from preclinical and clinical activities is subject to varying interpretations, which may delay,
limit or prevent regulatory approval. In addition, we may experience regulatory delays or rejections as a result of many factors, including
due to changes in regulatory policy during the period of our product candidate development. Any such delays could negatively impact our
business, financial condition, results of operations and prospects.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>We depend on enrollment of patients in
our clinical trials for our product candidates and may find it difficult to enroll patients in our clinical trials, which could delay
or prevent us from proceeding with clinical trials of our product candidates and could materially adversely affect our R&amp;D efforts
and business, financial condition and results of operations.</i></b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Identifying and qualifying
patients to participate in clinical trials of our product candidates is critical to our success. The timing of our clinical trials depends
on our ability to recruit patients to participate, and to see those patients through the completion of required follow-up periods. If,
for any reason, patients are unwilling to enroll in our clinical trials, then the timeline for recruiting patients, conducting studies
and obtaining regulatory approvals for our product candidates may be delayed. These delays could result in increased costs, delays in
advancing our product candidates, delays in testing the effectiveness of our product candidates or termination of clinical trials altogether.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

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

</div><!-- Field: Page; Sequence: 9; Value: 1 --><div>
    </div><div style="margin-top: 12pt; margin-bottom: 6pt; border-bottom: Black 1.5pt solid"><p style="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><!-- Field: Sequence; Type: Arabic; Name: PageNo -->4<!-- Field: /Sequence --></p></div><div>
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    </div><!-- Field: /Page --><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Our current product candidates
are being developed to treat oncology and immune diseases of high unmet medical need. However, we may not be able to initiate or continue
clinical trials if we cannot enroll a sufficient number of eligible patients to participate in the clinical trials required by the FDA,
EMA or other regulatory authorities. As a result, we may not be able to identify, recruit and enroll a sufficient number of patients,
or those with required or desired characteristics, to complete our clinical trials in a timely manner. Patient enrollment can be affected
by many factors, including:</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
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    and process for identifying patients;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
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    <td style="width: 48px">&#160;</td>
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    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">eligibility and exclusion
    criteria for our clinical trials;</span></td></tr>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
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    <td style="width: 48px">&#160;</td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">perceived risks and benefits
    of our product candidates;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
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    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">severity of the disease
    under investigation;</span></td></tr>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
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    of clinical trial sites for prospective patients;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">competition with other
    clinical trials for product candidates competing in the same therapeutic areas as our product candidates;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
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    patient consent;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">patient drop-outs prior
    to completion of clinical trials;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">patient referral practices
    of physicians; and</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">ability to monitor patients
    adequately during and after treatment.</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Our ability to successfully
initiate, enroll and complete clinical trials in any foreign country is subject to numerous risks unique to conducting business in foreign
countries, including:</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">difficulty in establishing
    or managing relationships with CROs and physicians;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">different standards for
    the conduct of clinical trials;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">absence in some countries
    of established groups with sufficient regulatory expertise for review of certain treatment protocols;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">inability to locate qualified
    local consultants, physicians and partners; and</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the potential burden of
    complying with a variety of foreign laws, medical standards and regulatory requirements, including the regulation of pharmaceutical
    and biotechnology products and treatment.</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">If we have difficulty enrolling
a sufficient number of patients or finding additional clinical trial sites to conduct our clinical trials as planned, we may need to
delay, limit or terminate ongoing or planned clinical trials, any of which could have an adverse effect on our business, financial condition,
results of operations and prospects.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>Our product candidates and the process
for administering our product candidates may cause undesirable side effects or have other properties that could delay or prevent their
regulatory approval, limit their commercial potential or result in significant negative consequences following any potential marketing
approval.</i></b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">During the conduct of clinical
trials, patients report changes in their health, including illnesses, injuries and discomforts, to their study doctor. Often, it is not
possible to determine whether the product candidate being studied caused these conditions. Regulatory authorities may draw different
conclusions or require additional testing to confirm these determinations. For Milciclib, the most frequent drug-related side effects
reported across studies, at all doses tested, were gastrointestinal, or GI, adverse events (nausea and diarrhea, followed by less frequent
vomiting), neurological effects (mainly tremor, then ataxia, dizziness and dysgeusia), skin disorders and asthenia, fatigue, headache
and anorexia. For Foralumab, the most frequent drug-related side effects reported following intravenous administration were infusion
related reactions, or IRR, including fever, headaches, chills, nausea, vomiting diarrhea and hypotension considered the result of cytokine
release also known as cytokine release syndrome, or CRS. Other adverse events included reactivation of Epstein-Barr virus (clinically
silent); moderate lymphocytopenia, abnormalities in liver function tests. Since most of these changes are related to the infusion route
of administration and dosage level, such systemic toxicities are not anticipated when administered orally or nasally due to what we assume
will be minimal systemic absorption.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">In addition, it is possible
that as we test our product candidates in larger, longer and more extensive clinical programs, or as use of these product candidates
becomes more widespread if they receive regulatory approval, illnesses, injuries, discomforts and other adverse events that were observed
in earlier trials, as well as conditions that did not occur or went undetected in previous trials, will be reported by patients. Many
times, side effects are only detectable after investigational products are tested in large-scale, Phase 3 clinical trials or, in some
cases, after they are made available to patients on a commercial scale after approval. If additional clinical experience indicates that
our product candidates cause serious or life-threatening side effects, the development of our product candidates may fail or be delayed,
or, if the product candidate has received regulatory approval, such approval may be revoked, which would harm our business, prospects,
operating results and financial condition.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

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

</div><!-- Field: Page; Sequence: 10; Value: 1 --><div>
    </div><div style="margin-top: 12pt; margin-bottom: 6pt; border-bottom: Black 1.5pt solid"><p style="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><!-- Field: Sequence; Type: Arabic; Name: PageNo -->5<!-- Field: /Sequence --></p></div><div>
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    </div><!-- Field: /Page --><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">If in the future we are unable
to demonstrate that such adverse events were caused by the administration process or related procedures, the FDA, EMA or other regulatory
authorities could order us to cease further development of, or deny approval of, our product candidates for any or all targeted indications.
Even if we are able to demonstrate that any serious adverse events are not product-related, such occurrences could affect patient recruitment
or the ability of enrolled patients to complete the clinical trial. Moreover, if we elect or are required to delay, suspend or terminate
any clinical trial of any of our product candidates, the commercial prospects of such product candidate may be harmed and our ability
to generate product revenues from such product candidate may be delayed or eliminated. Any of these occurrences may harm our ability
to develop other product candidates, and may harm our business, financial condition and prospects.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Additionally, if we or others
later identify undesirable side effects caused by any of our product candidates, several potentially significant negative consequences
could result, including:</p><div>

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

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">regulatory authorities
    may suspend or withdraw approvals of such product candidate;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">regulatory authorities
    may require additional warnings on the label;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">we may be required to change
    the way a product candidate is administered or conduct additional clinical trials;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">we could be sued and held
    liable for harm caused to patients; and</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">our reputation may suffer.</span></td></tr>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Any of these events could
prevent us from achieving or maintaining market acceptance of our product candidates.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>Any contamination in our manufacturing
process, shortages of raw materials or failure of any of our key suppliers to deliver necessary components could result in delays in
our clinical development or marketing schedules.</i></b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Given the nature of biologics
and NCE manufacturing, there is a risk of contamination. Any contamination could adversely affect our ability to produce product candidates
on schedule and could, therefore, harm our results of operations and cause reputational damage. In addition, some of the raw materials
required in our manufacturing process are derived from biologic sources and are difficult to procure and may be subject to contamination
or recall. A material shortage, contamination, recall or restriction on the use of biologically derived substances in the manufacture
of our product candidates could adversely impact or disrupt the commercial manufacturing or the production of clinical material, which
could adversely affect our development timelines and our business, financial condition, results of operations and prospects.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>Risks Related to Our Financial Position and
Need for Capital</b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>We have incurred net losses in every year
since our inception. We anticipate that we will continue to incur losses for the foreseeable future and may never achieve or maintain
profitability.</i></b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">We are a clinical stage biotechnology
company with a limited operating history. Since our inception in May 2013, we have incurred significant net losses. Our net losses were
$15.4 million, $23.4 million and $26.1 million for the years ended December 31, 2022, 2021 and 2020, respectively. As of December 31,
2022, we had an accumulated loss of $116 million. We have devoted substantially all of our efforts to research and development of our
product candidates, including clinical development of our lead product candidates, Foralumab and Milciclib, as well as to building out
our management team and infrastructure. We expect that it could be several years, if ever, before we have a commercialized product candidate.
We expect to continue to incur significant expenses and increasing operating losses for the foreseeable future. These net losses will
adversely impact our shareholders&#8217; equity and net assets and may fluctuate significantly from quarter to quarter and year to year.
We anticipate that our expenses will increase substantially if, and as, we:</p><div>

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

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of a clinical trial with nasally administered Foralumab in patients with secondary&#160;progressive multiple sclerosis (SPMS), develop
a program for intranasal administration of Foralumab for the treatment or prevention of Type 1 Diabetes (TID), investigate intranasal
foralumab for the treatment of Long COVID, study intranasal foralumab in patients with mild to moderate Alzheimer&#8217;s Disease and
potentially study intranasal foralumab in rare Orphan pediatric diseases when funding becomes available.</p></td></tr>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p><div>

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    <td style="text-align: justify">cGMP manufacturing of anti-IL6R mAb drug substance and drug product
for treatment Interstitial lung disease associated with systemic sclerosis (SSc-ILD) is complete. An IND to conduct a Phase 1 clinical
trial was submitted in December 2021</td></tr>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p><div>

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

</div><!-- Field: Page; Sequence: 11; Value: 1 --><div>
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    </div><!-- Field: /Page --><div>

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

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
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    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">secure, maintain or obtain
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px; text-align: justify">&#160;</td>
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    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">address any competing technological
    and market developments; and</span></td></tr>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px; text-align: justify">&#160;</td>
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    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">expand our operations in
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">We may never succeed in any
or all of these activities and, even if we do, we may never generate revenues that are significant or large enough to achieve profitability.
If we do achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis. Our failure to
become and remain profitable would decrease the value of our company and could impair our ability to raise capital, maintain our R&amp;D
efforts, expand our business or continue our operations.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>We need substantial additional funding
to complete the development of our product candidates, which may not be available on acceptable terms, if at all. Failure to obtain this
necessary capital when needed may force us to delay, limit or terminate certain of our product development, research operations or future
commercialization efforts, if any.</i></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><b><i>&#160;</i></b></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Our operations have consumed
substantial amounts of cash since inception, and we expect our expenses to increase in connection with our ongoing activities, particularly
as we continue the R&amp;D of, initiate further clinical trials of and seek marketing approval for, our product candidates. In addition,
if we obtain marketing approval for our product candidates, we expect to incur significant expenses related to product sales, marketing,
manufacturing and distribution. Furthermore, we expect to incur additional costs associated with operating as a public company listed
on the Nasdaq in the United States. Our future capital requirements will depend on many factors, including:</p><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">

</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
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    and costs of laboratory testing, manufacturing, preclinical and clinical development for our current and future product candidates;</span></td></tr>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
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    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the extent to which we
    acquire or in-license and develop other product candidates and technologies;</span></td></tr>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
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    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">our ability to establish
    and maintain collaborations and license agreements on favorable terms, if at all;</span></td></tr>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
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    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the costs, timing and outcome
    of potential future commercialization activities, including manufacturing, marketing, sales and distribution for our product candidates
    for which we receive marketing approval;</span></td></tr>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
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    maintaining and enforcing our intellectual property rights and defending intellectual property-related claims; and</span></td></tr>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
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    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the sales price and availability
    of adequate third-party coverage and reimbursement for our product candidates, if and when approved.</span></td></tr>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Developing product candidates
and conducting preclinical studies and clinical trials is a time-consuming, expensive and uncertain process that takes years to complete,
and we may never generate the necessary data or results required to obtain marketing approval and achieve product sales. In addition,
our product candidates, if approved, may not achieve commercial success. Our product revenues, if any, will be derived from or based
on sales of product candidates that may not be commercially available for many years, if at all. Accordingly, we will need to continue
to rely on additional financing to achieve our business objectives. Adequate additional financing may not be available to us on acceptable
terms, if at all. To the extent that additional capital is raised through the issuance of equity or equity-linked securities, the issuance
of those securities could result in substantial dilution for our current shareholders and the terms of any future issuance may include
liquidation or other preferences that adversely affect the rights of our current shareholders. Debt financing, if available, may involve
covenants restricting our operations or our ability to incur additional debt. Any debt or additional equity financing that we raise may
contain terms that are not favorable to us or our shareholders. If we raise additional funds through collaboration and licensing arrangements
with third parties, it may be necessary to relinquish some rights to our technologies or our product candidates or grant licenses on
terms that are not favorable to us. Furthermore, the potential issuance of additional securities in the future, whether equity or debt,
by us, or the possibility of such issuance, may cause the market price of our Common shares, to decline and existing shareholders may
not agree with our financing plans or the terms of such financings.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">If we are unable to obtain
adequate funding on a timely basis, we may be required to significantly curtail, delay or discontinue our R&amp;D programs of our product
candidates or any future commercialization efforts, be unable to expand our operations or be unable to otherwise capitalize on our business
opportunities, as desired, which could harm our business and potentially cause us to discontinue operations.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>


</div><!-- Field: Page; Sequence: 12; Value: 1 --><div>
    </div><div style="margin-top: 12pt; margin-bottom: 6pt; border-bottom: Black 1.5pt solid"><p style="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><!-- Field: Sequence; Type: Arabic; Name: PageNo -->7<!-- Field: /Sequence --></p></div><div>
    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
    </div><!-- Field: /Page --><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>Our limited operating history and no history
of commercializing pharmaceutical products may make it difficult to evaluate the success of our business to date and to assess the prospects
for our future viability.</i></b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Since our inception, we have
devoted substantially all of our resources to developing Foralumab and Milciclib, and our other product candidates, building our intellectual
property portfolio and providing general and administrative support for these operations. Although our R&amp;D efforts to date have resulted
in a pipeline of product candidates, we have not yet demonstrated our ability to successfully complete Phase 3 or other pivotal clinical
trials, obtain regulatory approvals, or commercialize any of our product candidates. In addition, given our limited operating history,
we may encounter unforeseen expenses, difficulties, complications, delays and other known and unknown factors in achieving our business
objectives.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Additionally, we are not
profitable and have incurred losses in each year since our inception, and we expect that our financial condition and operating results
may continue to fluctuate significantly from quarter to quarter and year to year due to a variety of factors, many of which are beyond
our control. Consequently, any predictions you make about our future success or viability may not be as accurate as they could be if
we had a longer operating history.</p><div>

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

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

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>We rely, and expect to continue to rely,
on third parties to conduct our preclinical studies and clinical trials. If these third parties do not successfully carry out their contractual
duties or meet expected deadlines, we may not be able to obtain regulatory approval for or commercialize our product candidates.</i></b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">We have relied upon and plan
to continue to rely upon third parties, including independent clinical investigators and third-party CROs, to conduct our preclinical
studies and clinical trials and to monitor and manage data for our ongoing preclinical and clinical programs. In engaging these third
parties, we typically have to, and expect to have to, negotiate budgets and contracts, which may result in delays to our development
timelines and increases costs. Additionally, there is a limited number of qualified third-party service providers that specialize or
have the expertise required to achieve our business objectives, and so it may be challenging to find alternative investigators or CROs,
or do so on commercially reasonable terms. We rely on these parties for execution of our preclinical studies and clinical trials, and
control only certain aspects of their activities. Nevertheless, we are responsible for ensuring that each of our preclinical studies
and clinical trials is conducted in accordance with the applicable protocol and legal, regulatory and scientific standards, and our reliance
on these third parties does not relieve us of our regulatory responsibilities. We and our third-party contractors and CROs are required
to comply with GCP requirements, which are regulations and guidelines enforced by the FDA, the Competent Authorities of the Member States
of the European Economic Area and comparable foreign regulatory authorities for all of our product candidates in clinical development.
Regulatory authorities enforce these GCP requirements through periodic inspections of trial sponsors, principal investigators and clinical
trial sites. If we fail to exercise adequate oversight over any of our CROs or if we or any of our CROs fail to comply with applicable
GCP requirements, the clinical data generated in our clinical trials may be deemed unreliable and the FDA, EMA or other regulatory authorities
may require us to perform additional clinical trials before approving our marketing applications. We cannot assure you that upon a regulatory
inspection of us or our CROs or other third parties performing services in connection with our clinical trials, such regulatory authority
will determine that any of our clinical trials complies with GCP regulations. In addition, our clinical trials must be conducted with
product produced under applicable cGMP regulations. Our failure to comply with these regulations may require us to repeat clinical trials,
which would delay the regulatory approval process.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Further, these investigators
and CROs are not our employees and we will not be able to control, other than by contract, the amount of resources, including time, which
they devote to our product candidates and clinical trials. If independent investigators or CROs fail to devote sufficient resources to
the development of our product candidates, or if their performance is substandard, it may delay or compromise the prospects for approval
and commercialization of our product candidates. These investigators and CROs may also have relationships with other commercial entities,
including our competitors, for whom they may also be conducting clinical studies or other drug development activities, which could affect
their performance on our behalf. In addition, the use of third-party service providers requires us to disclose our proprietary information
to these parties, which increases the risk that a competitor will discover them or that this information will be misappropriated or disclosed.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">If any of our relationships
with these third-party CROs terminate, we may not be able to enter into arrangements with alternative CROs or to do so on commercially
reasonable terms. If CROs do not successfully carry out their contractual duties or obligations or 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, regulatory requirements or for other reasons, our clinical trials may be extended, delayed or terminated and we may not be
able to obtain regulatory approval for or successfully commercialize our product candidates. As a result, our results of operations and
commercial prospects would be harmed, our costs could increase and our ability to generate revenues could be delayed.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Repeating clinical trials
or switching or engaging additional CROs involves additional cost and requires our management&#8217;s time and focus. In addition, there
is a natural transition period when a clinical trial has to be repeated or when a new CRO commences work. As a result, delays could occur,
which could materially impact our ability to meet our desired clinical development timelines.</p><div>

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    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
    </div><!-- Field: /Page --><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>Our reliance on third parties requires
us to share our trade secrets, which increases the possibility that a competitor will discover them or that our trade secrets will be
misappropriated or disclosed.</i></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">We have engaged contract
manufacturing organizations, or CMOs, to cGMP manufacture Foralumab (TZLS-401) drug product, Milciclib (TZLS-201) and anti-Interleukin
6 Receptor monoclonal antibody (anti-IL6R mAb, TZLS-501) drug substance and drug product and to perform quality testing, and because
we collaborate with various organizations and academic institutions for the advancement of our platforms, we must, at times, share our
proprietary technology and confidential information, including trade secrets, with them. We seek to protect our proprietary technology,
in part, by entering into confidentiality agreements and, if applicable, material transfer agreements, collaborative research agreements,
consulting agreements or other similar agreements with our collaborators, advisors, employees and consultants prior to beginning research
or disclosing proprietary information. These agreements typically limit the rights of the third parties to use or disclose our confidential
information. Despite the contractual provisions employed when working with third parties, the need to share trade secrets and other confidential
information increases the risk that such trade secrets become known by our competitors, are inadvertently incorporated into the technology
of others or are disclosed or used in violation of these agreements. Given that our proprietary position is based, in part, on our know-how
and trade secrets, a competitor&#8217;s discovery of our proprietary technology and confidential information or other unauthorized use
or disclosure of such technology or information would impair our competitive position and may have an adverse effect on our business,
financial condition, results of operations and prospects.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Despite our efforts to protect
our trade secrets, our competitors may discover our trade secrets, either through breach of these agreements, independent development
or publication of information including our trade secrets by third parties. A competitor&#8217;s discovery of our trade secrets would
impair our competitive position and have an adverse impact on our business, financial condition, results of operations and prospects.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>We utilize, and expect to continue to utilize,
third parties to conduct our product manufacturing for the foreseeable future, and these third parties may not perform satisfactorily.</i></b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">We currently rely on CMOs
for the manufacturing of clinical batches and intend to continue to rely on third parties to manufacture our preclinical study and clinical
trial product supplies. If our current CMOs, or any future third-party manufacturers, do not successfully carry out their contractual
duties, meet expected deadlines or manufacture our product candidates in accordance with regulatory requirements, or if there are disagreements
between us and our CMOs or any future third-party manufacturers, we will not be able to complete, or may be delayed in completing, the
preclinical studies required to support future investigational new drug, or IND, submissions and the clinical trials required for approval
of our product candidates.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">In addition to our current
CMOs, we may rely on additional third parties to manufacture ingredients of our product candidates in the future and to perform quality
testing, and reliance on these third parties entails risks to which we would not be subject if we manufactured the product candidates
ourselves, including:</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">reduced control for certain
    aspects of manufacturing activities;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">termination or nonrenewal
    of manufacturing and service agreements with third parties in a manner or at a time that is costly or damaging to us; and</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">disruptions to the operations
    of our third-party manufacturers and service providers caused by conditions unrelated to our business or operations, including the
    bankruptcy of the manufacturer or service provider.</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Any of these events could
lead to clinical trial delays or failure to obtain regulatory approval or impact our ability to successfully commercialize any of our
product candidates. Some of these events could be the basis for FDA, EMA or other regulatory authority action, including injunction,
recall, seizure or total or partial suspension of product manufacture.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>To the extent we rely on a third-party
manufacturing facility for commercial supply, that third party will be subject to significant regulatory oversight with respect to manufacturing
our product candidates.</i></b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">The preparation of therapeutics
for clinical trials or commercial sale is subject to extensive regulation. Components of a finished therapeutic product approved for
commercial sale or used in late-stage clinical trials must be manufactured in accordance with cGMP requirements. These regulations govern
manufacturing processes and procedures, including record keeping, and the implementation and operation of quality systems to control
and assure the quality of investigational products and products approved for sale. Poor control of production processes can lead to the
introduction of outside agents or other contaminants, or to inadvertent changes in the properties or stability of a product candidate
that may not be detectable in final product testing. To the extent that we utilize third-party facilities for commercial supply, the
third party&#8217;s facilities and quality systems must pass an inspection for compliance with the applicable regulations as a condition
of regulatory approval. In addition, the regulatory authorities may, at any time, audit or inspect the third-party manufacturing facility
or the associated quality systems for compliance with the regulations applicable to the activities being conducted. If, for example,
these facilities do not pass a plant inspection, the FDA will not approve the applicable NDA or biologics license application, or BLA.</p><div>

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


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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">We do not directly control
the manufacturing of, and are completely dependent on, our CMOs for compliance with cGMP requirements. If our CMOs cannot successfully
manufacture material that conforms to our specifications and the strict regulatory requirements of the FDA, EMA or other regulatory authorities,
they will not be able to secure and/or maintain regulatory approval for their manufacturing facilities. In addition, we have no direct
control over the ability of our CMOs to maintain adequate quality control, quality assurance and qualified personnel. Furthermore, all
of our CMOs are engaged with other companies to supply and/or manufacture materials or products for such companies, which exposes our
CMOs to regulatory risks for the production of such materials and products. As a result, failure to meet the regulatory requirements
for the production of those materials and products may generally affect the regulatory clearance of our CMOs&#8217; facilities. Our failure,
or the failure of third parties, to comply with applicable regulations could result in sanctions being imposed on us, including clinical
holds, fines, injunctions, civil penalties, delays, suspension or withdrawal of approvals, license revocation, seizures or recalls of
product candidates or products, operating restrictions and criminal prosecutions, any of which could significantly and adversely affect
supplies of our products and product candidates.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Our potential future dependence
upon others for the manufacture of our product candidates may adversely affect our future profit margins and our ability to commercialize
any products that receive regulatory approval on a timely and competitive basis.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>Risks Related to Commercialization of Our
Product Candidates</b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>We currently have no marketing and sales
force. If we are unable to establish effective sales, marketing and distribution capabilities or enter into agreements with third parties
to market, sell and distribute our product candidates that may be approved, we may not be successful in commercializing our product candidates
if and when approved, and we may be unable to generate any product revenue.</i></b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">We currently do not have
a marketing or sales team for the marketing, sales and distribution of any of our product candidates. In order to commercialize any of
our product candidates that may be approved, we intend to build, on a territory-by-territory basis, marketing, sales, distribution, managerial
and other non-technical capabilities or make arrangements with third parties to perform these services. These efforts will require significant
capital expenditures, management resources and time, and we face competition in search for qualified personnel or third parties to assist
with marketing, sales and distribution of any of our product candidates. We may not be successful in building these capabilities.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">There are risks involved
with both establishing our own sales, marketing and distribution capabilities and entering into arrangements with third parties to perform
these services. For example, recruiting and training a sales force is expensive and time consuming and could delay any product launch.
If the commercial launch of a product candidate for which we recruit a sales force and establish marketing and/or distribution capabilities
is delayed or does not occur for any reason, we would have prematurely or unnecessarily incurred these commercialization expenses. This
may be costly, and our investment would be lost if we cannot retain or reposition our sales and marketing personnel.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Factors that may inhibit
our efforts to commercialize our product candidates on our own include:</p><div>

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

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">our inability to recruit,
    train and retain adequate numbers of effective sales and marketing personnel;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
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    <td style="width: 48px">&#160;</td>
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    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the inability of sales
    personnel to obtain access to physicians or persuade adequate numbers of physicians to prescribe any future product that we may develop;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
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    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the lack of complementary
    treatments to be offered by sales personnel, which may put us at a competitive disadvantage relative to companies with more extensive
    product lines; and</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">unforeseen costs and expenses
    associated with creating an independent sales and marketing organization.</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">If we enter into arrangements
with third parties to perform sales, marketing and distribution services, our product revenue or the profitability to us from these revenue
streams is likely to be lower than if we were to market and sell any product candidates that we develop ourselves. In addition, we may
not be successful in entering into arrangements with third parties to sell and market &#160;our product candidates or may be unable to
do so on terms that are favorable to us. We likely will have little control over such third parties and any of them may fail to devote
the necessary resources and attention to sell and market our product candidates effectively. If we do not establish sales and marketing
capabilities successfully, either on our own or in collaboration with third parties, we may not be successful in commercializing our
product candidates.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>We face significant competition in an environment
of rapid technological change and the possibility that our competitors may achieve regulatory approval before us or develop therapies
that are more advanced or effective than ours.</i></b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">The biotechnology and pharmaceutical
industries are characterized by rapidly changing technologies, significant competition and a strong emphasis on intellectual property.
We face substantial competition from many different sources, including large and specialty pharmaceutical and biotechnology companies,
academic research institutions, government agencies and public and private research institutions.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 14.35pt">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">New developments, including
the development of other pharmaceutical technologies and methods of treating disease, occur in the pharmaceutical and life sciences industries
at a rapid pace. Developments by competitors may render our product candidates obsolete or noncompetitive. We anticipate that we will
face intense and increasing competition as new treatments enter the market and advanced technologies become available.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>


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    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
    </div><!-- Field: /Page --><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Many of our potential competitors,
alone or with their strategic partners, have substantially greater financial, technical and other resources, such as larger R&amp;D,
clinical, sales and marketing and manufacturing organizations. These third parties also compete with us in recruiting and retaining qualified
scientific and management personnel, establishing clinical trial sites and patient registration for clinical trials, as well as in acquiring
technologies complementary to, or necessary for, the development of our products. In addition, mergers and acquisitions in the biotechnology
and pharmaceutical industries may result in even more resources being concentrated among a smaller number of competitors. Our commercial
opportunity could be reduced or eliminated if competitors develop and commercialize products that are safer, more effective, have fewer
or less severe side effects, are more convenient or are less expensive than any product candidate that we may develop. Competitors also
may obtain FDA, EMA or other regulatory approval for their products more rapidly or earlier than we may obtain approval for ours, which
could result in our competitors establishing a strong market position before we are able to enter the market. Additionally, technologies
developed by our competitors may render our product candidates uneconomical or obsolete, and we may not be successful in marketing our
product candidates against competitors.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">In addition, as a result
of the expiration or successful challenge of our patent rights, we could face more litigation with respect to the validity and/or scope
of patents relating to our competitors&#8217; products. The availability of our competitors&#8217; products could limit the demand, and
the price we are able to charge, for any product candidate that we may develop and commercialize.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>The market opportunities for our product
candidates may be smaller than we anticipate.</i></b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">We focus our R&amp;D efforts
on treatments for cancer and autoimmune disease. Our understanding of both the number of people who have these diseases, as well as the
subset of people with these diseases who have the potential to benefit from treatment with our product candidates, is based on estimates.
These estimates may prove to be incorrect and new studies may reduce the estimated incidence or prevalence of these diseases. The number
of patients in the United States, the European Union and elsewhere may turn out to be lower than expected, may not be otherwise amenable
to treatment with our product candidates or patients may become increasingly difficult to identify and access, all of which would adversely
affect our business, financial condition, results of operations and prospects.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Further, there are several
factors that could contribute to making the actual number of patients who receive our potential products, if and when approved, less
than the potentially addressable market. These include, for example, the lack of widespread availability of, and limited reimbursement
for, new therapies in many underdeveloped markets.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>The future commercial success of our product
candidates will depend upon the degree of each product candidates&#8217; market acceptance by physicians, patients, third-party payors
and others in the medical community.</i></b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Our product candidates are
at varying stages of development, and we may never have a product that is commercially successful. To date, we have no product authorized
for marketing. Due to the inherent risk in the development of pharmaceutical products, we may never successfully complete development
and commercialization of any of our product candidates. Even with the requisite approvals from the FDA, EMA and other regulatory authorities
internationally, the commercial success of our product candidates will depend, in part, on the acceptance of physicians, patients and
third-party payors of our product candidates as medically necessary, cost-effective and safe. Any product that we commercialize may not
gain acceptance by physicians, patients, third-party payors and others in the medical community. If these products do not achieve an
adequate level of acceptance, we may not generate significant product revenue and may not become profitable. Even if some product candidates
achieve market acceptance, the market may not prove to be large enough to allow us to generate significant revenues. The degree of market
acceptance of our product candidates, if approved for commercial sale, will depend on several factors, including:</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
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    <td style="width: 48px">&#160;</td>
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    of our product candidates as demonstrated in clinical trials;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
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    advantages of our product candidates over alternative treatments;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
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    <td style="width: 48px">&#160;</td>
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    of treatment relative to alternative treatments;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
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    <td style="width: 48px">&#160;</td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">changes in the standard
    of care for the targeted indications for any product candidate;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
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    <td style="width: 48px">&#160;</td>
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    to prescribe, and the target patient population to try, new therapies;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
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  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
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    <td style="width: 48px">&#160;</td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">product labeling or product
    insert requirements of the FDA, EMA or other regulatory authorities, including any limitations or warnings contained in a product&#8217;s
    approved labeling;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
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    of competitive products;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
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    marketing support;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">publicity concerning our
    product candidates or competing products and treatments;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">potential product liability
    claims;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">any restrictions on the
    use of our products together with other medications; and</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">favorable third-party payor
    coverage and adequate reimbursement.</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>


</div><!-- Field: Page; Sequence: 16; Value: 1 --><div>
    </div><div style="margin-top: 12pt; margin-bottom: 6pt; border-bottom: Black 1.5pt solid"><p style="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><!-- Field: Sequence; Type: Arabic; Name: PageNo -->11<!-- Field: /Sequence --></p></div><div>
    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
    </div><!-- Field: /Page --><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Even if a potential product
displays favorable clinical properties and safety profile in preclinical studies and clinical trials, market acceptance of the product
will not be fully known until after it is launched.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 14.35pt">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>The insurance coverage and reimbursement
status of newly approved products is uncertain. Failure to obtain or maintain adequate coverage and reimbursement for our product candidates,
if approved, could limit our ability to market those products.</i></b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">We expect that coverage and
adequate reimbursement by government and private payors will be essential for most patients to be able to afford these treatments. Accordingly,
sales of our product candidates will depend substantially, both domestically and abroad, on the extent to which the costs of our product
candidates will be paid by health maintenance, managed care, pharmacy benefit and similar healthcare management organizations, or will
be reimbursed by government authorities, private health coverage insurers and other third-party payors. Coverage and reimbursement by
a third-party payor may depend upon several factors, including the third-party payor&#8217;s determination that use of a product is:</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">a covered benefit under
    our health plan;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">safe, effective and medically
    necessary;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">appropriate for the specific
    patient;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">cost-effective; and</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">neither experimental nor
    investigational.</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Obtaining coverage and reimbursement
for a product from third-party payors is a time-consuming and costly process that could require us to provide to the payor supporting
scientific, clinical and cost-effectiveness data. We may not be able to provide data sufficient to gain acceptance with respect to coverage
and reimbursement. If coverage and reimbursement are not available, or are available only at limited levels, we may not be able to successfully
commercialize our product candidates. Even if coverage is provided, the approved reimbursement amount may not be adequate to realize
a sufficient return on our investment.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">There is significant uncertainty
related to third-party coverage and reimbursement of newly approved products. In the United States, third-party payors, including government
payors such as the Medicare and Medicaid programs, play an important role in determining the extent to which new drugs and biologics
will be covered and reimbursed. The Medicare and Medicaid programs increasingly are used as models for how private payors develop their
coverage and reimbursement policies. However, no uniform policy of coverage and reimbursement exists among third-party payors. Therefore,
coverage and reimbursement for products can differ significantly from payor to payor. One payor&#8217;s determination to provide coverage
for a product does not assure that other payors will also provide coverage, and adequate reimbursement. It is difficult to predict what
the Centers for Medicare and Medicaid Services, or CMS will decide with respect to coverage and reimbursement for fundamentally novel
products such as ours, as there is no body of established practices and precedents for these types of products. Moreover, reimbursement
agencies in the European Union may be more conservative than the CMS. For example, several cancer drugs have been approved for reimbursement
in the United States and have not been approved for reimbursement in certain European Union, or EU, member states, or Member States.
It is difficult to predict what third-party payors will decide with respect to the coverage and reimbursement for our product candidates.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Also, the containment of
healthcare costs has become a priority of federal, state and foreign governments, and the prices of drugs have been a focus in this effort.
The U.S. government, state legislatures, and foreign governments have shown significant interest in implementing cost-containment programs
to limit the growth of government-paid healthcare costs, including price controls, restrictions on reimbursement and requirements for
substitution of generic products for branded prescription drugs. For example, in the United States, the Patient Protection and Affordable
Care Act of 2010 (as amended by the Health Care and Education Reconciliation Act of 2010), or the PPACA, contains provisions that may
reduce the profitability of products, including, for example, increased rebates for products sold to Medicaid programs, extension of
Medicaid rebates to Medicaid managed care plans, mandatory discounts for certain Medicare Part D beneficiaries and annual fees based
on pharmaceutical companies&#8217; share of sales to federal health care programs. Further, there has been heightened governmental scrutiny
over the manner in which manufacturers set prices for their marketed products, which has resulted in several recent congressional inquiries
and proposed federal and state legislation designed to, among other things, bring more transparency to product pricing, contain the cost
of drugs, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies
for products.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Outside the United States,
international operations generally are subject to extensive government price controls and other market regulations and increasing emphasis
on cost-containment initiatives in the European Union, Canada and other countries may put pricing pressure on us. In many countries,
the prices of medical products are subject to varying price control mechanisms as part of national health systems. In general, the prices
of medicines under such systems are substantially lower than in the United States. Other countries allow companies to fix their own prices
for medical products but monitor and control company profits. Additional foreign price controls or other changes in pricing regulation
could restrict the amount that we are able to charge for our product candidates. Accordingly, in markets outside the United States, the
reimbursement for our product candidates may be reduced compared with the United States and may be insufficient to generate commercially
reasonable product revenues.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">In addition, there can be
considerable pressure by governments and other stakeholders on prices and reimbursement levels, including as part of cost containment
measures. Political, economic and regulatory developments may further complicate pricing negotiations, and pricing negotiations may continue
after reimbursement has been obtained. Reference pricing used by various Member States and parallel distribution, or arbitrage between
low-priced and high-priced Member States, can further reduce prices. To obtain reimbursement or pricing approval in some countries, we
may be required to conduct a clinical trial that compares the cost-effectiveness of our product candidates 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.</p><div>

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


</div><!-- Field: Page; Sequence: 17; Value: 1 --><div>
    </div><div style="margin-top: 12pt; margin-bottom: 6pt; border-bottom: Black 1.5pt solid"><p style="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><!-- Field: Sequence; Type: Arabic; Name: PageNo -->12<!-- Field: /Sequence --></p></div><div>
    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
    </div><!-- Field: /Page --><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Moreover, increasing efforts
by government and third-party payors in the United States and abroad to cap or reduce healthcare costs may cause such organizations to
limit both coverage and the level of reimbursement for new products approved and, as a result, they may not cover or provide adequate
payment for our product candidates.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Payors increasingly are considering
new metrics as the basis for reimbursement rates, such as average sales price, average manufacturer price and actual acquisition cost.
The existing data for reimbursement based on some of these metrics is relatively limited, although certain states have begun to survey
acquisition cost data for the purpose of setting Medicaid reimbursement rates, and CMS has begun making pharmacy National Average Drug
Acquisition Cost and National Average Retail Price data publicly available on at least a monthly basis. Therefore, it may be difficult
to project the impact of these evolving reimbursement metrics on the willingness of payors to cover product candidates that we or our
partners are able to commercialize. We expect to experience pricing pressures in connection with the sale of any of our product candidates
due to the trend toward managed healthcare, the increasing influence of health maintenance organizations and additional legislative changes.
The downward pressure on healthcare costs in general, particularly prescription drugs and surgical procedures and other treatments, has
become intense. As a result, increasingly high barriers are being erected to the entry of new products such as ours.</p><div>

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

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

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>Our rights to develop and commercialize
our product candidates are subject to the terms and conditions of licenses granted to us by others. If we fail to comply with our obligations
under our existing and any future intellectual property licenses with third parties, we could lose license rights that are important
to the business.</i></b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">We are heavily reliant upon
licenses and sublicenses from Nerviano, Lonza and Novimmune to certain patent rights and proprietary technology that are important or
necessary to the development of our technology and product candidates, including the patents and know-how relating to manufacture. These
and other licenses may not provide exclusive rights to use such intellectual property and technology or may not provide exclusive rights
to use such intellectual property and technology in all relevant fields of use and in all territories in which we may wish to develop
or commercialize our technology and product candidates in the future. As a result, we may not be able to prevent competitors from developing
and commercializing competitive products, including in territories covered by our licenses.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">In some circumstances, we
may not have the right to control the preparation, filing and prosecution of patent applications, or to maintain the patents, covering
technology that we license from third parties. If our licensors fail to maintain such patents or patent applications, or lose rights
to those patents or patent applications, the rights we have licensed may be reduced or eliminated and our right to develop and commercialize
any of our product candidates that are the subject of such licensed rights could be adversely affected. In addition to the foregoing,
the risks associated with patent rights that we license from third parties will also apply to patent rights we may own in the future.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Licenses to additional third-party
technology and materials that may be required for our development programs, including additional technology and materials owned by any
of our current licensors, may not be available in the future or may not be available on commercially reasonable terms, or at all, which
could have an adverse effect on our business and financial condition.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>If we are unable to obtain and maintain
patent protection for our current product candidates, any future product candidates we may develop and our technology, or if the scope
of the patent protection obtained is not sufficiently broad, our competitors could develop and commercialize products and technology
similar or identical to ours.</i></b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Our success depends, in large
part, on our ability to seek, obtain and maintain patent protection in the United States and other countries with respect to our product
candidates and to future innovation related to our manufacturing technology. Our licensors have sought, and we intend to seek to protect
our proprietary position by filing patent applications in the United States, the United Kingdom and elsewhere, related to certain technologies
and our product candidates that are important to our business. Our current patent portfolio contains a limited number of patent applications,
all of which are in-licensed from third parties and relate to either composition of matter, formulation, method of use or process of
manufacturing Foralumab, Milciclib and a fully human anti-interleukin-6 receptor, or IL-6r, mAb. However, the risks associated with patent
rights generally apply to patent rights that we in-license now or in the future, as well as patent rights that we may own in the future.
Moreover, the risks apply with respect to patent rights and other intellectual property applicable to our product candidates, as well
as to any intellectual property rights that we may acquire in the future related to future product candidates, if any. Tiziana was granted
a new patent by USPTO in June 2020 covering lyophilized formulation of Foralumab..</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">The patent prosecution process
is expensive, time-consuming, and complex, and we may not be able to file, prosecute, maintain, enforce or license all necessary or desirable
patent applications at a reasonable cost or in a timely manner.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">In some cases, the work of
certain academic researchers in the oncology and immunology fields has entered the public domain, which we believe precludes our ability
to obtain patent protection for certain inventions relating to such work.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Consequently, we will not
be able to assert any such patents to prevent others from using our technology for, and developing and marketing competing products to
treat, these indications. It is also possible that we will fail to identify patentable aspects of our R&amp;D output before it is too
late to obtain patent protection.</p><div>

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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Our existing license agreements
impose, and we expect that future license agreements will impose, various due diligence, development and commercialization timelines,
insurance, milestone payments, royalties, and other obligations on us. See the description in the section titled &#8220;Business-Collaboration
and License Agreements&#8221; herein. If we fail to comply with our obligations under these agreements, or we are subject to a bankruptcy,
or, in some cases, under other circumstances, the licensor may have the right to terminate the license, in which event we would not be
able to market product candidates covered by the license. In addition, certain of these license agreements are not assignable by us without
the consent of the respective licensor, which may have an adverse effect on our ability to engage in certain transactions.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">The patent position of biotechnology
and pharmaceutical companies generally is highly uncertain, involves complex legal and factual questions and has, in recent years, been
the subject of much litigation. As a result, the issuance, scope, validity, enforceability and commercial value of any patent rights
are highly uncertain. Our licensed patent applications may not result in patents being issued which protect our technology or product
candidates, effectively prevent others from commercializing competitive technologies and product candidates or otherwise provide any
competitive advantage. In fact, patent applications may not issue as patents at all. Even assuming patents issue from patent applications
in which we have rights, changes in either the patent laws or interpretation of the patent laws in the United States and other countries
may diminish the value of our patents or narrow the scope of our patent protection.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Other parties have developed
technologies that may be related or competitive to our own and such parties may have filed or may file patent applications, or may have
received or may receive patents, claiming inventions that may overlap or conflict with those claimed in our own patent applications or
issued patents. We may not be aware of all third-party intellectual property rights potentially relating to our current and future product
candidates.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Publications of discoveries
in the scientific literature often lag behind the actual discoveries, and patent applications in the United States and in other jurisdictions
are typically not published until 18 months after filing, or, in some cases, not at all. Therefore, we cannot know with certainty whether
the inventors of our licensed patents and applications were the first to make the inventions claimed in those patents or pending patent
applications, or that they were the first to file for patent protection of such inventions. Similarly, should we own any patents or patent
applications in the future, we may not be certain that we were the first to file for patent protection for the inventions claimed in
such patents or patent applications. As a result, the issuance, scope, validity and commercial value of our patent rights cannot be predicted
with any certainty.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">The degree of patent protection
we require to successfully compete in the marketplace may be unavailable or severely limited in some cases and may not adequately protect
our rights or permit us to gain or keep any competitive advantage. We cannot provide any assurances that any of our licensed patents
have, or that any of our pending licensed patent applications that mature into issued patents will include, claims with a scope sufficient
to protect our product candidates or otherwise provide any competitive advantage. In addition, the laws of foreign countries may not
protect our rights to the same extent as the laws of the United States. Furthermore, patents have a limited lifespan. In the United States,
the natural expiration of a patent is generally 20 years after it is filed. Various extensions may be available; however, the life of
a patent, and the protection it affords, is limited. 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 licensed patent portfolio may not provide us with adequate and continuing patent protection sufficient to exclude others
from commercializing products similar to our product candidates, including &#8220;highly similar,&#8221; or biosimilar, versions of such
products. In addition, the intellectual property portfolio licensed to us by Nerviano and Novimmune may be used by them or licensed to
third parties, and such third parties may have certain enforcement rights. Thus, patents licensed to us could be put at risk of being
invalidated or interpreted narrowly in litigation filed by or against our licensors or another licensee or in administrative proceedings
brought by or against our licensors or another licensee in response to such litigation or for other reasons.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Even if we acquire patent
protection that we expect should enable us to maintain some competitive advantage, third parties, including competitors, may challenge
the validity, enforceability or scope thereof, which may result in such patents being narrowed, invalidated or held unenforceable. In
litigation, a competitor could claim that our patents, if issued, are not valid for several reasons. If a court agrees, we would lose
our rights to those challenged patents.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">The issuance of a patent
is not conclusive as to its inventorship, scope, validity or enforceability and our licensed patents may be challenged in courts or patent
offices in the United States and abroad. For example, we may be subject to a third-party submission of prior art to the USPTO challenging
the validity of one or more claims of our licensed patents. Such submissions may also be made prior to a patent&#8217;s issuance, precluding
the granting of a patent based on one of our pending licensed patent applications. We may become involved in opposition, derivation,
re-examination, inter partes review, post-grant review or interference proceedings challenging the patent rights of others from whom
we have obtained licenses to such rights. Competitors may claim that they invented the inventions claimed in our licensed issued patents
or patent applications prior to the inventors of such patents or applications. A competitor who can establish an earlier filing or invention
date may also claim that we are infringing their patents and that we therefore cannot practice our technology as claimed under our licensed
patents, if issued. Competitors may also contest our licensed patents, if issued, by showing that the invention was not patent-eligible,
was not novel, was obvious or that the patent claims failed any other requirement for patentability.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">An adverse determination
by former employees or consultants asserting ownership rights to our patents may result in loss of exclusivity or freedom to operate
or in patent claims being narrowed, invalidated or held unenforceable, in whole or in part, which could limit our ability to stop others
from using or commercializing similar technology and therapeutics, without payment to us, or could limit the duration of the patent protection
covering our technology and product candidates. Such challenges may also result in our inability to manufacture or commercialize our
product candidates without infringing third-party patent rights. In addition, if the breadth or strength of protection provided by our
patents and patent applications is threatened, it could dissuade companies from collaborating with us to license, develop or commercialize
current or future product candidates.</p><div>

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    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Even if they are unchallenged,
our licensed patents and pending patent applications, if issued, may not provide us with any meaningful protection or prevent competitors
from designing around our patent claims to circumvent our licensed patents by developing similar or alternative technologies or therapeutics
in a non-infringing manner. For example, a third party may develop a competitive therapeutic that provides benefits similar to one or
more of our product candidates but that uses a different antibody or molecular active ingredient that falls outside the scope of our
patent protection. If the patent protection provided by the patents and patent applications we hold or pursue with respect to our product
candidates is not sufficiently broad to impede such competition, our ability to successfully commercialize our product candidates could
be negatively affected, which would harm our business.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>Our intellectual property licenses with
third parties 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 to our licensors.</i></b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">We currently depend, and
will continue to depend, on our license agreements whereby we obtain rights in certain patents and patent applications owned by them.
Further development and commercialization of our current product candidates may, and development of any future product candidates will,
require us to enter into additional license or collaboration agreements. The agreements under which we currently 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 an adverse effect on our business, financial condition, results of operations and prospects.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">If any of our licenses or
material relationships or any in-licenses upon which our licenses are based are terminated or breached, we may:</p><div>

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

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">lose our rights to develop
    and market our product candidates;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">lose patent protection
    for our product candidates;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">experience significant
    delays in the development or commercialization of our product candidates;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">not be able to obtain any
    other licenses on acceptable terms, if at all; or</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">incur liability for damages.</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">In addition, a third party
may in the future bring claims that our performance under our license agreements, including our sponsoring of clinical trials, interferes
with such third party&#8217;s rights under its agreement with one of our licensors. If any such claim were successful, it may adversely
affect our rights and ability to advance our product candidates as clinical candidates or subject us to liability for monetary damages,
any of which would have an adverse effect on our business, financial condition, results of operations and prospects.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 14.35pt">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">These risks apply to any
agreements that we may enter into in the future for our current or any future product candidates. If we experience any of the foregoing,
it could have a negative impact on our business, financial condition, results or operations and prospects.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><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 license rights that are important to our business.</i></b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">We have entered into license
agreements with third parties and may need to obtain additional licenses from one or more of these same third parties or from others
to advance our research or allow commercialization of our product candidates. It is possible that we may be unable to obtain additional
licenses at a reasonable cost or on reasonable terms, if at all. In that event, we may be required to expend significant time and resources
to redesign our product candidates or the methods for manufacturing them or to develop or license replacement technology, all of which
may not be feasible on a technical or commercial basis. If we are unable to do so, we may be unable to develop or commercialize our product
candidates, which would harm our business. We cannot provide any assurances that third-party patents or other intellectual property rights
do not exist which might be enforced against our current product candidates or future product candidates, resulting in either an injunction
prohibiting our manufacture or sales, or, with respect to our sales, an obligation on our part to pay royalties and/or other forms of
compensation to third parties.</p><div>

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    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">In each of our existing license
agreements, and we expect in our future agreements, patent prosecution of our licensed technology is controlled solely by the licensor,
and we may be required to reimburse the licensor for their costs of patent prosecution. If our licensors fail to obtain and maintain
patent or other protection for the proprietary intellectual property we license from them, we could lose our rights to the intellectual
property, or our exclusivity with respect to those rights, and our competitors could market competing products using the intellectual
property. Our license agreements with Nerviano and Novimmune also require us to meet development thresholds to maintain each license,
including establishing a set timeline for developing and commercializing product candidates. Disputes may arise regarding intellectual
property subject to a licensing agreement, including:</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="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>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the extent to which our
    technology and processes infringe on intellectual property of the licensor that is not subject to the licensing agreement;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the sublicensing of patent
    and other rights pursuant to our collaborative development relationships;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">our diligence obligations
    under the license agreements and what activities satisfy those diligence obligations;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
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    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the inventorship or 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>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">If disputes over intellectual
property that we have licensed prevent or impair our ability to maintain our current licensing arrangements on acceptable terms, we may
be unable to successfully develop and commercialize our product candidates.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>We may not be successful in obtaining or
maintaining necessary rights to our product candidates through acquisitions and in-licenses.</i></b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">We currently have certain
rights to the intellectual property, through licenses from third parties, to develop our product candidates. Because our programs may
require the use of additional proprietary rights held by these or other third parties, the growth of our business likely will depend,
in part, on our ability to acquire, in-license or use these proprietary rights. We may be unable to acquire or in-license any compositions,
methods of use, processes or other intellectual property rights from third parties that we identify as necessary for our product candidates.
The licensing or acquisition of third-party intellectual property rights is a competitive area, and several more established companies
may pursue strategies to license or acquire third-party intellectual property rights that we may consider attractive. These established
companies may have a competitive advantage over us due to their size, capital resources and greater clinical development and commercialization
capabilities. In addition, companies that perceive us to be a competitor may be unwilling to assign or license rights to us. We also
may be unable to license or acquire third-party intellectual property rights on terms that would allow us to make an appropriate return
on our investment.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">We may collaborate with non-profit
and academic institutions to accelerate our preclinical R&amp;D under written agreements with these institutions. These institutions
may provide us with an option to negotiate a license to any of the institution&#8217;s rights in technology resulting from the collaboration.
Regardless of such option, we may be unable to negotiate a license within the specified timeframe or under terms that are acceptable
to us. If we are unable to do so, the institution may offer the intellectual property rights to other parties, potentially blocking our
ability to pursue our program.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">If we are unable to successfully
obtain rights to required third-party intellectual property or maintain the existing intellectual property rights we have, we may have
to abandon development of our product candidates and our business, financial condition, results of operations and prospects could suffer.
Moreover, to the extent that we seek to develop other product candidates in the future, we will likely require acquisition or in-license
of additional proprietary rights held by third parties.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>Obtaining and maintaining our patent protection
depends on compliance with various procedural, document submission, fee payment and other requirements imposed by government patent agencies,
and our patent protection could be reduced or eliminated as a result of non-compliance with these requirements.</i></b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Periodic maintenance fees,
renewal fees, annuity fees and various other government fees on patents and/or applications will be due to be paid to the USPTO and various
government patent agencies outside of the United States over the lifetime of our licensed patents and/or applications and any patent
rights we may own in the future. We rely on our outside counsel or our licensing partners to pay these fees due to non-U.S. patent agencies.
The USPTO and various non-U.S. government patent agencies require compliance with several procedural, documentary, fee payment and other
similar provisions during the patent application process. We employ reputable law firms and other professionals to help us comply and
we are also dependent on our licensors to take the necessary action to comply with these requirements with respect to our licensed intellectual
property. In many cases, an inadvertent lapse can be cured by payment of a late fee or by other means in accordance with the applicable
rules. There are situations, however, in which non-compliance can result in abandonment or lapse of the patent or patent application,
resulting in partial or complete loss of patent rights in the relevant jurisdiction. In such an event, potential competitors might be
able to enter the market and this circumstance could have an adverse effect on our business.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>


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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>We may not be able to protect our intellectual
property rights throughout the world.</i></b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Filing, prosecuting and defending
patents on product candidates in all countries throughout the world would be prohibitively expensive, and our intellectual property rights
in some countries outside the United States could be less extensive than those in the United States. In some cases, we may not be able
to obtain patent protection for certain licensed technology outside the United States. In addition, the laws of some foreign countries
do not protect intellectual property rights to the same extent as federal and state laws in the United States, even in jurisdictions
where we do pursue patent protection. Consequently, we may not be able to prevent third parties from practicing our inventions in all
countries outside the United States, even in jurisdictions where we do pursue patent protection or from selling or importing products
made using our inventions in and into the United States or other jurisdictions.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Competitors may use our technologies
in jurisdictions where we have not pursued and obtained patent protection to develop their own products and, further, may export otherwise
infringing products to territories where we have patent protection, but enforcement is not as strong as that in the United States. These
products may compete with our product candidates, and our patents or other intellectual property rights may not be effective or sufficient
to prevent them from competing.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Many companies have encountered
significant problems in protecting and defending intellectual property rights in foreign jurisdictions. The legal systems of certain
countries, particularly certain developing countries, do not favor the enforcement of patents, trade secrets and other intellectual property
protection, particularly those relating to biotechnology products, which could make it difficult for us to stop the infringement of our
patents, if pursued and obtained, or marketing of competing products in violation of our proprietary rights generally. Moreover, many
countries have compulsory licensing laws under which a patent owner may be compelled to grant licenses to third parties. Many countries
limit the enforceability of patents against government agencies or government contractors. In these countries, the patent owner may have
limited remedies, which could materially diminish the value of such patent. If we or any of our licensors is forced to grant a license
to third parties with respect to any patents relevant to our business, our competitive position may be impaired, and our business and
results of operations may be adversely affected.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">In addition, 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, could put our patents at risk of being invalidated or interpreted narrowly and our patent applications at risk
of not issuing and could provoke third parties to assert claims against us. We may not prevail in any lawsuits that we initiate, and
the damages or other remedies awarded, if any, may not be commercially meaningful. Accordingly, our efforts to enforce our intellectual
property rights around the world may be inadequate to obtain a significant commercial advantage from the intellectual property that we
develop or license.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>We may not be able to protect our trade
secrets in court.</i></b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">In addition to the protection
afforded by patents, we rely on trade secret protection and confidentiality agreements to protect proprietary know-how that is not patentable
or that we elect not to patent, processes for which patents are difficult to enforce and any other elements of our product candidate
discovery and development processes that involve proprietary know-how, information or technology that is not covered by patents. However,
trade secrets can be difficult to protect and some courts inside and outside the United States are less willing or unwilling to protect
trade secrets. We seek to protect our proprietary technology and processes, in part, by entering into confidentiality agreements with
our employees, consultants, scientific advisors and contractors. However, we may not be able to prevent the unauthorized disclosure or
use of our technical know-how or other trade secrets by the parties to these agreements, despite the existence generally of confidentiality
agreements and other contractual restrictions.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Monitoring unauthorized uses
and disclosures is difficult and we do not know whether the steps we have taken to protect our proprietary technologies will be effective.
If any of the collaborators, scientific advisors, employees and consultants who are parties to these agreements breach or violate the
terms of any of these agreements, we may not have adequate remedies for any such breach or violation. As a result, we could lose our
trade secrets.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">We cannot guarantee that
we have entered into such agreements with each party that may have or have had access to our trade secrets or proprietary technology
and processes. We also seek to preserve the integrity and confidentiality of our data and trade secrets 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, agreements and security measures, they may still be breached, and we may not have adequate remedies for any
breach.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">In addition, our trade secrets
may otherwise become known or be independently discovered by competitors. Competitors could purchase our product candidates and attempt
to replicate some or all of the competitive advantages we derive from our development efforts, willfully infringe our intellectual property
rights, design around our protected technology or develop their own competitive technologies that fall outside of our intellectual property
rights. If any of our trade secrets were to be lawfully obtained or independently developed by a competitor, we would have no right to
prevent them, or those to whom they communicate such trade secrets, from using that technology or information to compete with us. If
our trade secrets are not adequately protected so as to protect our market against competitors&#8217; therapeutics, our competitive position
could be adversely affected, as could our business.</p><div>

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


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    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
    </div><!-- Field: /Page --><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>Third parties may initiate legal proceedings
alleging that we are infringing their intellectual property rights.</i></b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Our commercial success depends
upon our ability and the ability of our future collaborators to develop, manufacture, market and sell our product candidates and use
our proprietary technologies without infringing the proprietary rights and intellectual property of third parties. The biotechnology
and pharmaceutical industries are characterized by extensive and complex litigation regarding patents and other intellectual property
rights. We may in the future become party to, or be threatened with, adversarial proceedings or litigation regarding intellectual property
rights with respect to our product candidates and technology, including interference proceedings, post grant review and inter partes
review before the USPTO. Our competitors or other third parties may assert infringement claims against us, alleging that our therapeutics,
manufacturing methods, formulations or administration methods are covered by their patents. Given the vast number of patents in our field
of technology, we cannot be certain or guarantee that we do not infringe existing patents or that we will not infringe patents that may
be granted in the future. Since this area is competitive and of strong interest to pharmaceutical and biotechnology companies, there
will likely be additional patent applications filed and additional patents granted in the future, as well as additional R&amp;D programs
expected in the future. Furthermore, because patent applications can take many years to issue, may be confidential for 18 months or more
after filing and can be revised before issuance, there may be applications now pending which may later result in issued patents that
may be infringed by the manufacture, use, sale or importation of our product candidates and we may or may not be aware of such patents.
If a patent holder believes the manufacture, use, sale or importation of one of our product candidates infringes its patent, the patent
holder may sue us even if we have licensed other patent protection for our technology. Moreover, we may face patent infringement claims
from non-practicing entities that have no relevant product revenue and against whom our licensed patent portfolio may therefore have
no deterrent effect.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">It is also possible that
we have failed to identify relevant third-party patents or applications. For example, applications filed before November 29, 2000 and
certain applications filed after that date that will not be filed outside the United States may remain confidential until patents issue.
Moreover, it is difficult for industry participants, including us, to identify all third-party patent rights that may be relevant to
our product candidates and technologies because patent searching is imperfect due to differences in terminology among patents, incomplete
databases and the difficulty in assessing the meaning of patent claims. We may fail to identify relevant patents or patent applications
or may identify pending patent applications of potential interest but incorrectly predict the likelihood that such patent applications
may issue with claims of relevance to our technology. In addition, we may be unaware of one or more issued patents that would be infringed
by the manufacture, sale or use of a current or future product candidate, or we may incorrectly conclude that a third-party patent is
invalid, unenforceable or not infringed by our activities. Additionally, pending patent applications that have been published can, subject
to certain limitations, be later amended in a manner that could cover our technologies, our product candidates or the use of our product
candidates.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Third parties may assert
infringement claims against us based on existing patents or patents that may be granted in the future, regardless of their merit. There
is a risk that third parties may choose to engage in litigation with us to enforce or to otherwise assert their patent or other intellectual
property rights against us. Even if we believe such claims are without merit, a court of competent jurisdiction could hold that these
third-party patents are valid, enforceable and infringed, which could adversely affect our ability to commercialize our product candidates.
In order to successfully challenge the validity of any such U.S. patent in federal court, we would need to overcome a presumption of
validity. As this burden is a high one requiring us to present clear and convincing evidence as to the invalidity of any such U.S. patent
claim, there is no assurance that a court of competent jurisdiction would invalidate the claims of any such U.S. patent. Similarly, there
is no assurance that a court of competent jurisdiction would find that product candidates or our technology did not infringe a third-party
patent.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Patent and other types of
intellectual property litigation can involve complex factual and legal questions, and their outcome is uncertain. If we are found or
believe there is a risk that we may be found, to infringe a third party&#8217;s valid and enforceable intellectual property rights, we
could be required or may choose to obtain a license from such third party to continue developing, manufacturing and marketing our product
candidates and technology. However, we may not be able to obtain any required license on commercially reasonable terms or at all. Even
if we were able to obtain a license, it could be non-exclusive, thereby giving our competitors and other third parties access to the
same technologies licensed to us, and it could require us to make substantial licensing and royalty payments. We could be forced, including
by court order, to cease developing, manufacturing and commercializing the infringing technology or product candidate. In addition, we
could be found liable for monetary damages, including treble damages and attorneys&#8217; fees, if we are found to have willfully infringed
a patent or other intellectual property right. A finding of infringement could prevent us from manufacturing and commercializing our
product candidates or force us to cease some or all of our business operations, which could harm our business. Claims that we have misappropriated
the confidential information or trade secrets of third parties could have a similar negative impact on our business, financial condition,
results of operations and prospects.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>Intellectual property litigation could
cause us to spend substantial resources and distract our personnel from their normal responsibilities.</i></b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Litigation or other legal
proceedings relating to intellectual property claims, with or without merit, are unpredictable and generally expensive and time-consuming.
Competitors may infringe our patents or the patents of our licensing partners, should such patents issue, or we may be required to defend
against claims of infringement. To counter infringement or unauthorized use claims or to defend against claims of infringement can be
expensive and time consuming. Even if resolved in our favor, litigation or other legal proceedings relating to intellectual property
claims may cause us to incur significant expenses and could distract our technical and management personnel from their normal responsibilities.
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. In addition, there
could be public announcements of the results of hearings, motions or other interim proceedings or developments and if securities analysts
or investors perceive these results to be negative, it could have a substantial adverse effect on us. Such litigation or proceedings
could substantially increase our operating losses and reduce the resources available for development activities or any future sales,
marketing or distribution activities.</p><div>

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    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
    </div><!-- Field: /Page --><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">We may not have sufficient
financial or other resources to adequately conduct such litigation or proceedings. Some of our competitors may be able to sustain the
costs of such litigation or proceedings more effectively than we can because of their greater financial resources and more mature and
developed intellectual property portfolios.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Accordingly, despite our
efforts, we may not be able to prevent third parties from infringing, misappropriating or successfully challenging our intellectual property
rights. Uncertainties resulting from the initiation and continuation of patent litigation or other proceedings could have a negative
impact on our ability to compete in the marketplace.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>We may be subject to claims asserting that
our employees, consultants or advisors have wrongfully used or disclosed alleged trade secrets of their current or former employers or
claims asserting ownership of what we regard as our own intellectual property.</i></b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Certain of our employees,
consultants or advisors are currently, or were previously, employed at universities or other biotechnology or pharmaceutical companies,
including our competitors or potential competitors, as well as our academic partners. Although we try to ensure that our employees, consultants
and advisors do not use the proprietary information or know-how of others in their work for us, we may be subject to claims that these
individuals or we have used or disclosed intellectual property, including trade secrets or other proprietary information, of any such
individual&#8217;s current or former employer. Litigation may be necessary to defend against these claims. If we fail in defending any
such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights. An inability to incorporate such
technologies or features would harm our business and may prevent us from successfully obtaining necessary regulatory approvals and commercializing
our product candidates. In addition, we may lose personnel as a result of such claims, and any such litigation or the threat thereof
may adversely affect our ability to hire employees or contract with independent contractors. A loss of key personnel or their work product
could hamper or prevent our ability to obtain necessary regulatory approvals and commercialize our product candidates, which would have
an adverse effect on our business, results of operations and financial condition. Even if we are successful in defending against such
claims, litigation could result in substantial costs and be a distraction to management.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">In addition, while it is
our policy to require our employees and contractors who may be involved in the conception or development of intellectual property to
execute agreements assigning such intellectual property to us, we may be unsuccessful in executing such an agreement with each party
who, in fact, conceives or develops intellectual property that we regard as our own. Moreover, even when we obtain agreements assigning
intellectual property to us, the assignment of intellectual property rights may not be self-executing or the assignment agreements may
be breached, and we may be forced to bring claims against third parties, or defend claims that they may bring against us, to determine
the ownership of what we regard as our intellectual property. Furthermore, individuals executing agreements with us may have pre-existing
or competing obligations to a third party, such as an academic institution, and thus an agreement with us may be ineffective in perfecting
ownership of inventions developed by that individual. Disputes about the ownership of intellectual property that we may own may have
an adverse effect on our business.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>Changes in U.S. patent law could diminish
the value of patents in general, thereby impairing our ability to protect our product candidates.</i></b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Recent patent reform legislation
could increase the uncertainties and costs surrounding the prosecution of patent applications and the enforcement or defense of issued
patents. On September 16, 2011, the Leahy-Smith America Invents Act, or the Leahy-Smith Act, was signed into law. The Leahy-Smith Act
includes several significant changes to U.S. patent law. These include provisions that affect the way patent applications are prosecuted
and also may affect patent litigation. These also include provisions that switched the United States from a &#8220;first-to-invent&#8221;
system to a &#8220;first-to-file&#8221; system, allow third-party submission of prior art to the USPTO during patent prosecution and
set forth additional procedures to attack the validity of a patent through various post-grant proceedings administered by the USPTO.
Under a first-to-file system, assuming the other requirements for patentability are met, the first inventor to file a patent application
generally will be entitled to the patent on an invention regardless of whether another inventor had made the invention earlier. The USPTO
developed new regulations and procedures to govern administration of the Leahy-Smith Act, and many of the substantive changes to patent
law associated with the Leahy-Smith Act, and in particular, the first-to-file provisions, only became effective on March 16, 2013.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Accordingly, it is not clear
what, if any, impact the Leahy-Smith Act will have on the operation of our business. However, the Leahy-Smith Act and its implementation
could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our
issued patents, all of which could have a negative impact effect on our business, financial condition, results of operations and prospects.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Additionally, the U.S. Supreme
Court has ruled on several patent cases in recent years, 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 with regard to our ability to obtain
patents in the future, the combination of new federal legislation, federal court decisions, and guidance from the USPTO has created uncertainty
with respect to the value of patents, once obtained. Depending on the decisions by the U.S. Congress, federal courts, and the USPTO,
the laws and regulations governing patents could change in unpredictable ways that would weaken our ability to obtain new patents or
enforce our existing patents and patents we might obtain in the future.</p><div>

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    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
    </div><!-- Field: /Page --><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>If our trademarks and trade names are not
adequately protected, then we may not be able to build name recognition in our markets of interest.</i></b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">We do not currently have
any registered trademarks and we have not filed any trademark applications to date. Any trademark applications in the United States,
Europe and in other foreign jurisdictions where we may file may not be allowed or may subsequently be opposed. Once filed and registered,
our trademarks or trade names may be challenged, infringed, circumvented or declared generic or determined to be infringing on other
marks. As a means to enforce our trademark rights and prevent infringement, we may be required to file trademark claims against third
parties or initiate trademark opposition proceedings. This can be expensive and time-consuming, particularly for a company of our size.
We may not be able to protect our rights to these trademarks and trade names, which we need to build name recognition among potential
partners or customers in our markets of interest. At times, competitors may adopt trade names or trademarks similar to ours, thereby
impeding our ability to build brand identity and possibly leading to market confusion. In addition, there could be potential trade name
or trademark infringement claims brought by owners of other registered trademarks or trademarks that incorporate variations of our registered
or unregistered trademarks or trade names. Over the long term, if we are unable to establish name recognition based on our trademarks
and trade names, then we may not be able to compete effectively and our business may be adversely affected. Our efforts to enforce or
protect our proprietary rights related to trademarks, trade secrets, domain names, copyrights or other intellectual property may be ineffective
and could result in substantial costs and diversion of resources.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>Intellectual property rights and regulatory
exclusivity rights do not necessarily address all potential threats</i>.</b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">The degree of future protection
afforded by our intellectual property rights is uncertain because intellectual property rights have limitations and may not adequately
protect our business or permit us to maintain our competitive advantage. For example:</p><div>

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

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
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    products that are similar to our product candidates but that are not covered by the claims of the patents that we license or may
    own in the future;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
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    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">we, or our license partners
    or future collaborators, might not have been the first to make the inventions covered by the issued patent or pending patent applications
    that we license or may own in the future;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">we, or our license partners
    or future collaborators, might not have been the first to file patent applications covering certain of our or their inventions;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">others may independently
    develop similar or alternative technologies or duplicate any of our technologies without infringing our owned or licensed intellectual
    property rights;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">others may circumvent our
    regulatory exclusivities, such as by pursuing approval of a competitive product candidate via the traditional approval pathway based
    on their own clinical data, rather than relying on the abbreviated pathway provided for biosimilar applicants;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">it is possible that our
    pending licensed patent applications or those that we may own in the future will not lead to issued patents;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">issued patents that we
    hold rights to now or in the future may be held invalid or unenforceable, including as a result of legal challenges by our competitors;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">others may have access
    to the same intellectual property rights licensed to us on a non-exclusive basis;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">our competitors might conduct
    R&amp;D activities in countries where we do not have patent rights and then use the information learned from such activities to develop
    competitive products for sale in our major commercial markets;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">we may not develop additional
    proprietary technologies that are patentable;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the patents or other intellectual
    property rights of others may have an adverse effect on our business; or</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">we may choose not to file
    a patent for certain trade secrets or know-how, and a third party may subsequently file a patent covering such intellectual property.</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Should any of these events
occur, they could significantly harm our business, financial condition, results of operations and prospects.</p><div>

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


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    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
    </div><!-- Field: /Page --><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>Risks Related to Government Regulation</b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>Even if we complete the necessary clinical
trials, we cannot predict when, or if, we will obtain regulatory approval to commercialize our product candidates and the approval may
be for a narrower indication than we seek.</i></b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">We cannot commercialize a
product candidate until the appropriate regulatory authorities have reviewed and approved the product candidate. The FDA must review
and approve any new pharmaceutical product before it can be marketed and sold in the United States. The FDA regulatory review and approval
process, which includes evaluation of preclinical studies and clinical trials of a product candidate and proposed labeling, as well as
the evaluation of the manufacturing process and manufacturers&#8217; facilities, all of which is lengthy, expensive and uncertain. To
obtain approval, we must, among other things, demonstrate with substantial evidence from well-controlled clinical trials that the product
candidate is both safe and effective for each indication where approval is sought. Even if our product candidates meet the FDA&#8217;s
safety and effectiveness endpoints in clinical trials, the FDA may not complete their review processes in a timely manner, or we may
not be able to obtain regulatory approval. The FDA has substantial discretion in the review and approval process and may refuse to file
our application for substantive review or may determine after review of our data that our application is insufficient to allow approval
of our product candidates. The FDA may require that we conduct additional preclinical studies, clinical trials or manufacturing validation
studies and submit that data before it will reconsider our application. Additional delays may result if an FDA Advisory Committee or
other regulatory authority recommends non-approval or restrictions on approval. In addition, we may experience delays or rejections based
upon additional government regulation from future legislation or administrative action, or changes in regulatory authority policy during
the period of product development, clinical trials and the review process.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">The FDA, EMA or other regulatory
authorities also may approve a product candidate for more limited indications than requested or may impose significant limitations in
the form of narrow indications, warnings or a REMS. These regulatory authorities may require precautions or contraindications with respect
to conditions of use or may grant approval subject to the performance of costly post-marketing clinical trials. In addition, the FDA,
EMA or other regulatory authorities may not approve the labeling claims that are necessary or desirable for the successful commercialization
of our product candidates. Any of the foregoing scenarios could harm the commercial prospects for our product candidates and negatively
impact our business, financial condition, results of operations and prospects.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>Delays in obtaining regulatory approval
of our manufacturing process and facility or disruptions in our manufacturing process may delay or disrupt our product development and
commercialization efforts.</i></b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">We do not currently operate
manufacturing facilities for clinical or commercial production of our product candidates. Before we can begin to commercially manufacture
our product candidates, whether in a third-party facility or in our own facility, if and when established, we must obtain regulatory
approval from the FDA for our manufacturing process and facility. A manufacturing authorization must also be obtained from the appropriate
European Union regulatory authorities and from other foreign regulatory authorities, as applicable. In order to obtain approval, we will
need to ensure that all of our processes, methods and equipment are compliant with cGMP, and perform extensive audits of vendors, contract
laboratories and suppliers. If any of our vendors, contract laboratories or suppliers are found to be non-compliant with cGMP, we may
experience delays or disruptions in manufacturing while we work with these third parties to remedy the violation or while we work to
identify suitable replacement vendors. The cGMP requirements govern quality control of the manufacturing process and documentation policies
and procedures. In complying with cGMP, we will be obligated to expend time, money and effort in production, record keeping and quality
assurance to confirm that the product meets applicable specifications and other requirements. If we fail to comply with these requirements,
we would be subject to possible regulatory action and may not be permitted to sell any product candidate that we may develop.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">If we or our third-party
manufacturers fail to comply with applicable cGMP regulations, the FDA, EMA and other regulatory authorities can impose regulatory sanctions
including, among other things, refusal to approve a pending application for a new product candidate or suspension or revocation of a
pre-existing approval. Such an occurrence may cause our business, financial condition, results of operations and prospects to be harmed.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Additionally, if the supply
of our products from our third-party manufacturers to us is interrupted for any reason, including due to regulatory requirements or actions
(including recalls), adverse financial developments at or affecting the supplier, failure by the supplier to comply with cGMPs, contamination,
business interruptions or labor shortages or disputes, there could be a significant disruption in commercial supply of our products.
We do not currently have a backup manufacturer of our product candidate supply for clinical trials or commercial sale. An alternative
manufacturer would need to be qualified through a supplement to its regulatory filing, which could result in further delays. The regulatory
authorities also may require additional clinical trials if a new manufacturer is relied upon for commercial production. Switching manufacturers
may involve substantial costs and could result in a delay in our desired clinical and commercial timelines.</p><div>

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


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    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
    </div><!-- Field: /Page --><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>If our competitors are able to obtain orphan
drug exclusivity for products that constitute the same drug and treat the same indications as our product candidates, we may not be able
to have competing products approved by applicable regulatory authorities for a significant period of time. In addition, even if we obtain
orphan drug exclusivity for any of our products, such exclusivity may not protect us from competition.</i></b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Regulatory authorities in
some jurisdictions, including the United States and the European Union, may designate products for relatively small patient populations
as orphan drugs. Under the Orphan Drug Act of 1983, the FDA may designate a product candidate as an orphan drug if it is intended to
treat a rare disease or condition, which is generally defined as having a patient population of fewer than 200,000 individuals in the
United States, or a patient population greater than 200,000 in the United States where there is no reasonable expectation that the cost
of developing the drug will be recovered from sales in the United States. In the United States, orphan drug designation entitles a party
to financial incentives such as opportunities for grant funding towards clinical trial costs, tax advantages and user-fee waivers. In
the European Union, the EMA&#8217;s Committee for Orphan Medicinal Products grants orphan drug designation to promote the development
of products that are intended for the diagnosis, prevention or treatment of a life-threatening or chronically debilitating condition
affecting not more than five in 10,000 persons in the European Union. Additionally, orphan drug designation is granted for products intended
for the diagnosis, prevention or treatment of a life-threatening, seriously debilitating or serious and chronic condition and when, without
incentives, it is unlikely that sales of the drug in the European Union would be sufficient to justify the necessary investment in developing
the drug or biologic product. In Europe, orphan drug designation entitles a party to a number of incentives, such as protocol assistance
and scientific advice specifically for designated orphan medicines, and potential fee reductions depending on the status of the sponsor.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in"><b><i>&#160;</i></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">The designation as an orphan
product does not guarantee that any regulatory agency will accelerate regulatory review of, or ultimately approve, that product candidate,
nor does it limit the ability of any regulatory agency to grant orphan drug designation to product candidates of other companies that
treat the same indications as our product candidates prior to our product candidates receiving exclusive marketing approval.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in"><b><i>&#160;</i></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Generally, if a product candidate
with an orphan drug designation receives the first marketing approval for the indication for which it has such designation, the product
is entitled to a period of marketing exclusivity, which precludes the FDA or the EMA from approving another marketing application for
a product that constitutes the same drug treating the same indication for that marketing exclusivity period, except in limited circumstances.
If another sponsor receives such approval before we do (regardless of our orphan drug designation), we will be precluded from receiving
marketing approval for our product for the applicable exclusivity period. The applicable period is seven years in the United States and
ten years in the European Union. The exclusivity period in the European Union can be reduced to six years if a product no longer meets
the criteria for orphan drug designation or if the product is sufficiently profitable so that market exclusivity is no longer justified.
Orphan drug exclusivity may be revoked if any regulatory agency determines that the request for designation was materially defective
or if the manufacturer is unable to assure sufficient quantity of the product to meet the needs of patients with the rare disease or
condition.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in"><b><i>&#160;</i></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Even if we obtain orphan
drug exclusivity for a product candidate, that exclusivity may not effectively protect the product candidate from competition because
different drugs can be approved for the same condition. In the United States, even after an orphan drug is approved, the FDA may subsequently
approve another drug for the same condition if the FDA concludes that the latter drug is not the same drug or is clinically superior
in that it is shown to be safer, more effective or makes a major contribution to patient care. In the European Union, marketing authorization
may be granted to a similar medicinal product for the same orphan indication if:</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in"><b><i>&#160;</i></b></p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
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    <td style="width: 48px">&#160;</td>
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    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the second applicant can
    establish in its application that its medicinal product, although similar to the orphan medicinal product already authorized, is
    safer, more effective or otherwise clinically superior;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
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    authorization for the original orphan medicinal product consents to a second orphan medicinal product application; or</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><b><i>&#160;</i></b></p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
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    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the holder of the marketing
    authorization for the original orphan medicinal product cannot supply sufficient quantities of orphan medicinal product.</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>Even if we obtain regulatory approval for
a product candidate, our product candidates will remain subject to regulatory oversight.</i></b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Even if we obtain regulatory
approval for our product candidates, they will be subject to ongoing regulatory requirements for manufacturing, labeling, packaging,
storage, advertising, promotion, sampling, record-keeping and submission of safety and other post-market information. Any regulatory
approvals that we receive for our product candidates may also be subject to limitations on the approved indicated uses for which the
product may be marketed or to the conditions of approval, or contain requirements for potentially costly post-marketing testing, including
Phase 4 clinical trials, and surveillance to monitor the quality, safety and clinical effectiveness of the product.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in"><b><i>&#160;</i></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Some of our product candidates
are classified as biologics in the United States, and therefore, can only be sold if we obtain a BLA from the FDA. The holder of an approved
BLA also must submit new or supplemental applications and obtain FDA approval for certain changes to the approved product, product labeling
or manufacturing process. In addition, the holder of a BLA must comply with the FDA&#8217;s advertising and promotion requirements, such
as those related to the prohibition on promoting products for uses or in patient populations that are not described in the product&#8217;s
approved labeling (known as &#8220;off-label use&#8221;). Advertising and promotional materials must comply with FDA rules and are subject
to FDA review, in addition to other potentially applicable federal and state laws.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.75in"><b><i>&#160;</i></b></p><div>


</div><!-- Field: Page; Sequence: 27; Value: 1 --><div>
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    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
    </div><!-- Field: /Page --><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.75in"><b><i>&#160;</i></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">In addition, product manufacturers
and their facilities are subject to payment of user fees and continual review and periodic inspections by the FDA and other regulatory
authorities for compliance with cGMP requirements and adherence to commitments made in the BLA or foreign marketing application. If we,
or a regulatory authority, discover previously unknown problems with a product, such as adverse events of unanticipated severity or frequency,
or problems with the facility where the product is manufactured or if a regulatory authority disagrees with the promotion, marketing
or labeling of that product (in addition to our being obligated as holder of a BLA to monitor and report adverse events and any failure
of a product to meet the BLA specifications), a regulatory authority may impose restrictions relative to that product, the manufacturing
facility or us, including requiring recall or withdrawal of the product from the market or suspension of manufacturing.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">If we fail to comply with
applicable regulatory requirements following approval of our product candidates, a regulatory or enforcement authority may:</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 14.35pt">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
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    <td style="width: 48px">&#160;</td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">issue a warning letter
    asserting that we are in violation of the law;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">seek an injunction or impose
    administrative, civil or criminal penalties or monetary fines;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">suspend or withdraw regulatory
    approval;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">suspend any ongoing clinical
    trials;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">refuse to approve a pending
    BLA or comparable foreign marketing application (or any supplements thereto) submitted by us or our strategic partners;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">restrict the marketing
    or manufacturing of the product;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">seize or detain the product
    or otherwise require the withdrawal of the product from the market;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">refuse to permit the import
    or export of the product; or</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">refuse to allow us to enter
    into supply contracts, including government contracts.</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Any government investigation
of alleged violations of law could require us to expend significant time and resources in response and could generate negative publicity.
The occurrence of any event or penalty described above may inhibit our ability to commercialize our product candidates and adversely
affect our business, financial condition, results of operations and prospects.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">In addition, the FDA&#8217;s
policies, and those of the EMA and other regulatory authorities, may change and additional government regulations may be enacted that
could prevent, limit or delay regulatory approval of our product candidates. We cannot predict the likelihood, nature or extent of government
regulation that may arise from future legislation or administrative action, either in the United States or abroad. If we are slow or
unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we are not able to maintain
regulatory compliance, we may lose any marketing approval that we may have obtained and we may not achieve or sustain profitability,
which would negatively impact our business, financial condition, results of operations and prospects.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>Even if we obtain and maintain approval
for our product candidates in a major pharmaceutical market such as the United States, we may never obtain approval for our product candidates
in other major markets.</i></b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">In order to market any products
in a country or territory, we must establish and comply with numerous and varying regulatory requirements of such countries or territories
regarding safety and effectiveness. Clinical trials conducted in one country may not be accepted by regulatory authorities in other countries,
and regulatory approval in one country does not mean that regulatory approval will be obtained in any other country. Approval procedures
vary among countries and can involve additional product testing and validation and additional administrative review periods. Seeking
regulatory approvals in all major markets could result in significant delays, difficulties and costs for us and may require additional
preclinical studies or clinical trials, which would be costly and time consuming. Regulatory requirements can vary widely from country
to country and could delay or prevent the introduction of our product candidates in those countries. For example, in many jurisdictions
outside of the United States, a product candidate must be approved for reimbursement before it can be approved for sale in that jurisdiction.
In some cases, the price that we intend to charge for our products would also be subject to approval. Satisfying these and other regulatory
requirements is costly, time consuming, uncertain and subject to unanticipated delays. In addition, our failure to obtain regulatory
approval in any country may delay or have negative effects on the process for regulatory approval in other countries. We currently do
not have any product candidates approved for sale in any jurisdiction, whether in the United States, Europe or any other 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, our target market will be reduced and our ability
to realize the full market potential of our product candidates will be compromised.</p><div>

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


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    </div><div style="margin-top: 12pt; margin-bottom: 6pt; border-bottom: Black 1.5pt solid"><p style="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><!-- Field: Sequence; Type: Arabic; Name: PageNo -->23<!-- Field: /Sequence --></p></div><div>
    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
    </div><!-- Field: /Page --><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>We may seek a conditional marketing authorization
in Europe for some or all of our current product candidates, but we may not be able to obtain or maintain such designation.</i></b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">As part of its marketing
authorization process, the EMA may grant marketing authorizations for certain categories of medicinal products on the basis of less complete
data than is normally required, when doing so may meet unmet medical needs of patients and serve the interest of public health. In such
cases, it is possible for the Committee for Medicinal Products for Human Use, or CHMP, to recommend the granting of a marketing authorization,
subject to certain specific obligations to be reviewed annually, which is referred to as a conditional marketing authorization.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">This may apply to medicinal
products for human use that fall under the jurisdiction of the EMA, including those that aim at the treatment, the prevention, or the
medical diagnosis of seriously debilitating or life-threatening diseases and those designated as orphan medicinal products.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">A conditional marketing authorization
may be granted when the CHMP finds that, although comprehensive clinical data referring to the safety and therapeutic utility of the
medicinal product have not been supplied, all the following requirements are met:</p><div>

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

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the risk-benefit balance
    of the medicinal product is positive;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">it is likely that the applicant
    will be in a position to provide the comprehensive clinical data;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">unmet medical needs will
    be fulfilled; and</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the benefit to public health
    of the immediate availability on the market of the medicinal product concerned outweighs the risk inherent in the fact that additional
    data is still required.</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">The granting of a conditional
marketing authorization is restricted to situations in which only the clinical part of the application is not yet fully complete. Incomplete
preclinical or quality data may only be accepted if duly justified and only in the case of a product intended to be used in emergency
situations in response to public health threats. Conditional marketing authorizations are valid for one year, on a renewable basis. The
holder will be required to complete ongoing trials or to conduct new trials with a view to confirming that the benefit-risk balance is
positive. In addition, specific obligations may be imposed in relation to the collection of pharmacovigilance data.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Granting a conditional marketing
authorization allows medicines to reach patients with unmet medical needs earlier than might otherwise be the case and will ensure that
additional data on a product is generated, submitted, assessed and acted upon.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>Healthcare legislative reform measures
may have a negative impact on our business and results of operations.</i></b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">In the United States and
some foreign jurisdictions, there have been, and continue to be, several legislative and regulatory changes and proposed changes regarding
the healthcare system that could prevent or delay marketing approval of our product candidates, restrict or regulate post-approval activities
and affect our ability to profitably sell any product candidates for which we obtain marketing approval.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">In the United States, the
Medicare Prescription Drug, Improvement, and Modernization Act of 2003, or the MMA, changed the way Medicare covers and pays for pharmaceutical
products. The MMA expanded Medicare coverage for outpatient drug purchases by adding a new Medicare Part D program and introduced a new
reimbursement methodology based on average sales prices for Medicare Part B physician-administered drugs. In addition, the MMA authorized
Medicare Part D prescription drug plans to limit the number of drugs that will be covered in any therapeutic class in their formularies.
The MMA&#8217;s cost reduction initiatives and other provisions could decrease the coverage and price that we receive for any approved
products. While the MMA applies 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 the MMA
may result in a similar reduction in payments from private payors. Similar regulations or reimbursement policies may be enacted in international
markets, which could similarly impact our business.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">More recently, in March 2010,
the PPACA (as amended by the Health Care and Education Reconciliation Act of 2010) was passed, which substantially changes the way healthcare
is financed by both the government and private insurers, and significantly impacts the U.S. pharmaceutical industry. The PPACA, among
other things: (i) addresses a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated
for drugs that are inhaled, infused, instilled, implanted or injected; (ii) increases the minimum Medicaid rebates owed by manufacturers
under the Medicaid Drug Rebate Program and extends the rebate program to individuals enrolled in Medicaid managed care organizations;
(iii) establishes annual fees and taxes on manufacturers of certain branded prescription drugs; (iv) expands the availability of lower
pricing under the 340B drug pricing program by adding new entities to the program; and (v) establishes a new Medicare Part D coverage
gap discount program, in which manufacturers must agree to offer 50% point-of-sale discounts off negotiated prices of applicable brand
drugs to eligible beneficiaries during their coverage gap period, as a condition for the manufacturer&#8217;s outpatient drugs to be
covered under Medicare Part D. Additionally, in the United States, the Biologics Price Competition and Innovation Act of 2009 created
an abbreviated approval pathway for biologic products that are demonstrated to be biosimilar or &#8220;interchangeable&#8221; with an
FDA-approved biologic product. This new pathway could allow competitors to reference data from biologic products already approved after
12 years from the time of approval. This could expose us to potential competition by lower-cost biosimilars even if we commercialize
a product candidate faster than our competitors. Moreover, the creation of this abbreviated approval pathway does not preclude or delay
a third party from pursuing approval of a competitive product candidate via the traditional approval pathway based on their own clinical
trial data.</p><div>

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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Additional changes that may
affect our business include those governing enrollments in federal healthcare programs, reimbursement changes, rules regarding prescription
drug benefits under the health insurance exchanges and fraud and abuse and enforcement. Continued implementation of the PPACA and the
passage of additional laws and regulations may result in the expansion of new programs such as Medicare payment for performance initiatives,
and may impact existing government healthcare programs, such as by improving the physician quality reporting system and feedback program.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">For each state that does
not choose to expand its Medicaid program, there likely will be fewer insured patients overall, which could impact the sales, business
and financial condition of manufacturers of branded prescription drugs. Where patients receive insurance coverage under any of the new
options made available through the PPACA, manufacturers may be required to pay Medicaid rebates on that resulting drug utilization. The
U.S. federal government also has announced delays in the implementation of key provisions of the PPACA. The implications of these delays
for our and our potential partners&#8217; business and financial condition, if any, are not yet clear.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">In addition, there have been
judicial and congressional challenges to certain aspects of the PPACA, and we expect the current administration and Congress will likely
continue to seek legislative and regulatory changes, including repeal and replacement of certain provisions of the PPACA. In January
2017, President Trump signed an Executive Order directing federal agencies with authorities and responsibilities under the PPACA to waive,
defer, grant exemptions from, or delay the implementation of any provision of the PPACA that would impose a fiscal or regulatory burden
on states, individuals, healthcare providers, health insurers, or manufacturers of pharmaceuticals or medical devices. More recently,
the U.S. House of Representatives passed legislation known as the American Health Care Act of 2017, and Senate Republicans have released
a draft bill known as the Better Care Reconciliation Act of 2017, each of which would repeal certain aspects of the PPACA if ultimately
enacted. The prospects for enactment of these legislative initiatives remain uncertain. Further, Congress also could consider other legislation
to replace elements of the PPACA. We cannot know how efforts to repeal and replace the PPACA or any future healthcare reform legislation
will impact our business.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">We expect that the PPACA,
as well as other healthcare reform measures that may be adopted in the future, may result in more rigorous coverage criteria and in additional
downward pressure on the price that we receive for any approved product. Any reduction in reimbursement from Medicare or other government
programs may result in a similar reduction in payments from private payors. The implementation of cost containment measures or other
healthcare reforms may prevent us from being able to generate revenue, attain profitability, or commercialize our products.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">We expect that additional
state and federal healthcare reform measures will be adopted in the future, any of which could limit the amounts that federal and state
governments will pay for healthcare products and services, which could result in reduced demand for our product candidates or additional
pricing pressures.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>We are subject to governmental regulation
and other legal obligations related to privacy, data protection and data security. Our actual or perceived failure to comply with such
obligations could harm our business.</i></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">We are subject to diverse
laws and regulations relating to data privacy and security in the UK and EU, including the EU and UK GDPR. New global privacy rules are
being enacted and existing ones are being updated and strengthened. We are likely to be required to expend capital and other resources
to ensure ongoing compliance with these laws and regulations.</p><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">

</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">The EU and UK GDPR applies
extraterritorially and implements stringent operational requirements for controllers and processors of personal data. For example, the
EU and UK GDPR: (i) require detailed disclosures to data subjects; (ii) require disclosure of the legal basis on which personal data is
processed; (iii) make it harder to obtain valid consent for processing; (iv) require the appointment of a data protection officers where
sensitive personal data (i.e. health data) is processed on a large scale; (v) provide more robust rights for data subjects; (vi) introduce
mandatory data breach notification through the EU and in the UK; (vii) impose additional obligations when contracting with service providers;
and (viii) require an appropriate privacy governance framework to be implemented including policies, procedures, training and data audit.
The EU GDPR permits Member State derogations for certain issues and, accordingly, we are also subject to EU national laws relating to
the processing of certain data such as genetic data, biometric data and data concerning health. Complying with these numerous, complex
and often changing regulations is expensive and difficult. Failure by us, or our partners or service providers, to comply with the EU
and/or UK GDPR could result in regulatory investigations, enforcement notices and/ or fines of up to the higher of 20,000,000 Euros/17,500,000
GBP or up to 4% of our total worldwide annual turnover. In addition to the foregoing, any breach of privacy laws or data security laws,
particularly those resulting in any security incident or breach involving the misappropriation, loss or other unauthorized use or disclosure
of sensitive or confidential patient or consumer information, could have a material adverse effect on our business, reputation and financial
condition.</p><div>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">As a data controller, we are
accountable for any third-party data service providers we engage to process personal data on our behalf. We attempt to address the associated
risks by performing security assessments, detailed due diligence and regularly performing privacy and security reviews of its vendors
and requiring all such third-party providers with data access to sign agreements, including business associate agreements, and where required
under EU or UK law, obligating them to only process data according to our instructions and to take sufficient security measures to protect
such data. There is no assurance that these contractual measures and our own privacy and security-related safeguards will protect us from
the risks associated with the third-party processing, storage and transmission of such information. Any violation of data or security
laws by our third-party processors could have a material adverse effect on our business and result in the fines and penalties outlined
above. We are also subject to evolving European privacy laws on electronic marketing and cookies. The EU is in the process of replacing
the e-Privacy Directive (2002/58/EC) with a new set of rules taking the form of a regulation, which will be directly implemented in the
laws of each Member State. The draft e-Privacy Regulation imposes strict opt-in marketing rules with limited exceptions for business-to-business
communications, alters rules on third-party cookies, web beacons and similar technology and significantly increases fining powers to the
same levels as GDPR (i.e. the greater of 20,000,000 Euros or 4% of total global annual revenue). While the e-Privacy Regulation was originally
intended to be adopted on May 25, 2018 (alongside the GDPR), it is still going through the European legislative process and commentators
do not expect it to be enacted before mid to end 2023 and would not come into force before mid to end 2025. The UK is also updating its
data protection law via the Data Protection and Digital Information Bill that is currently being considered by the UK Parliament. This
is expected to be passed at the end of 2023 and will modify certain aspects of the UK GDPR and Data Protection Act 2018. These proposed
changes will require us to modify certain aspects of our data protection compliance program.</p><div>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>We are subject to the U.K. Bribery Act,
the U.S. Foreign Corrupt Practices Act and other anti-corruption laws, as well as export control laws, import and customs laws, trade
and economic sanctions laws and other laws governing our operations.</i></b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Our operations are subject
to anti-corruption laws, including the U.K. Bribery Act 2010, or the U.K. Bribery Act, the U.S. Foreign Corrupt Practices Act of 1977,
or the FCPA, the U.S. domestic bribery statute contained in 18 &#167;201, the U.S. Travel Act, and other anti-corruption laws that apply
in countries where we do business. The U.K. Bribery Act, the FCPA and these other laws generally prohibit us and our employees and intermediaries
from authorizing, promising, offering, or providing, directly or indirectly, improper or prohibited payments, or anything else of value,
to government officials or other persons to obtain or retain business or gain some other business advantage. Under the U.K. Bribery Act,
we may also be liable for failing to prevent a person associated with us from committing a bribery offense. We and our commercial partners
operate in a number of jurisdictions that pose a high risk of potential U.K. Bribery Act or FCPA violations, and we participate in collaborations
and relationships with third parties whose corrupt or illegal activities could potentially subject us to liability under the U.K. Bribery
Act, FCPA or local anti-corruption laws, even if we do not explicitly authorize or have actual knowledge of such activities. In addition,
we cannot predict the nature, scope or effect of future regulatory requirements to which our international operations might be subject
or the manner in which existing laws might be administered or interpreted.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">We are also subject to other
laws and regulations governing our international operations, including regulations administered by the governments of the United Kingdom
and the United States, and authorities in the European Union, including applicable export control regulations, economic sanctions and
embargoes on certain countries and persons, anti-money laundering laws, import and customs requirements and currency exchange regulations,
collectively referred to as the Trade Control laws.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">There is no assurance that
we will be completely effective in ensuring our compliance with all applicable anti-corruption laws, including the U.K. Bribery Act,
the FCPA or other legal requirements, including Trade Control laws. If we are not in compliance with the U.K. Bribery Act, the FCPA and
other anti-corruption laws or Trade Control laws, we may be subject to criminal and civil penalties, disgorgement and other sanctions
and remedial measures, and legal expenses, which could have an adverse impact on our business, financial condition, results of operations
and liquidity. Likewise, any investigation of any potential violations of the U.K. Bribery Act, the FCPA, other anti-corruption laws
or Trade Control laws by United Kingdom, United States or other authorities could also have an adverse impact on our reputation, our
business, results of operations and financial condition.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>Our relationships with customers, physicians
and third-party payors will be subject, directly or indirectly, to federal and state healthcare fraud and abuse laws, false claims laws,
health information privacy and security laws and other healthcare laws and regulations. If we are found in violation of these laws and
regulations, we may be required to pay a penalty or be suspended from participation in federal or state healthcare programs, which may
adversely affect our business, financial condition and results of operations.</i></b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">If we obtain FDA approval
for our product candidates and begin commercializing them in the United States, our operations will be directly, or indirectly through
our prescribers, customers and purchasers, subject to various federal and state fraud and abuse laws and regulations, including, without
limitation, the federal Anti-Kickback Statute, the federal civil and criminal laws and Physician Payments Sunshine Act of 2010 and regulations.
These laws will impact, among other things, our proposed sales, marketing and educational programs. In addition, we may be subject to
patient privacy laws by both the U.S. federal government and the states in which we conduct our business. The laws that will affect our
operations include, but are not limited to:</p><div>

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

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
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    <td style="width: 48px">&#160;</td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the federal Anti-Kickback
    Statute, which prohibits, among other things, persons or entities from knowingly and willfully soliciting, receiving, offering or
    paying any remuneration (including any kickback, bribe or rebate), directly or indirectly, overtly or covertly, in cash or in kind,
    in return for either the referral of an individual, or the purchase, leasing, furnishing or arranging for the purchase, lease or
    order of a good, facility, item or service reimbursable under a federal healthcare program, such as the Medicare and Medicaid programs.
    This statute has been interpreted to apply to arrangements between pharmaceutical manufacturers on the one hand, and prescribers,
    purchasers and formulary managers on the other. The PPACA amended the intent requirement of the federal Anti-Kickback Statute, such
    that a person or entity no longer needs to have actual knowledge of this statute or specific intent to violate it;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">federal civil and criminal
    false claims laws and civil monetary penalty laws which prohibit, among other things, individuals or entities from knowingly presenting,
    or causing to be presented, claims for payment or approval from Medicare, Medicaid or other government payors that are false or fraudulent.
    The PPACA provides, and recent government cases against pharmaceutical and medical device manufacturers support the view that federal
    Anti-Kickback Statute violations and certain marketing practices, including off-label promotion, may implicate the False Claims Act
    of 1863;</span></td></tr>
  </table><div>
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</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
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    <td style="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, which created new federal criminal statutes that prohibit, among other things,
    a person from knowingly and willfully executing a scheme or from making false or fraudulent statements to defraud any healthcare
    benefit program, regardless of the payor (e.g., public or private);</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="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 of 2009), and their implementing regulations, which impose certain
    requirements relating to the privacy, security and transmission of individually identifiable health information without appropriate
    authorization by entities subject to the rule, such as health plans, health care clearinghouses and health care providers, and their
    respective business associates that perform certain functions or activities that involve the use or disclosure of protected health
    information on their behalf;</span></td></tr>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">federal transparency laws,
    including the federal Physician Payment Sunshine Act, that require 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, with specific
    exceptions, to report annually to the CMS information related to: (i) payments or other &#8220;transfers of value&#8221; made to
    physicians and teaching hospitals and (ii) ownership and investment interests held by physicians and their immediate family members;</span></td></tr>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">federal consumer protection
    and unfair competition laws, which broadly regulate marketplace activities and activities that potentially harm consumers; and</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">state and foreign law equivalents
    of each of the above federal laws, state and local laws that 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 governing
    the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways
    and may not have the same effect, thus complicating compliance efforts.</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Efforts to ensure that our
business arrangements with third parties will comply with applicable healthcare laws and regulations will involve substantial costs.
Because of the breadth of these laws and the narrowness of the statutory exceptions and safe harbors available, it is possible that some
of our business activities could be subject to challenge under one or more of such laws. It is possible that governmental authorities
will conclude that our business practices may not comply with current or future statutes, regulations or case law involving applicable
fraud and abuse or other healthcare laws and regulations. If our operations are found to be in violation of any of these laws or any
other governmental regulations that may apply to us, we may be subject to significant criminal, civil and administrative sanctions including
monetary penalties, damages, fines, disgorgement, individual imprisonment, and exclusion from participation in government funded healthcare
programs, such as Medicare and Medicaid, additional reporting requirements and oversight if we become subject to a corporate integrity
agreement or similar agreement to resolve allegations of non-compliance with these laws, reputational harm, and we may be required to
curtail or restructure our operations, any of which could adversely affect our ability to operate our business and our results of operations.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">The risk of our being found
in violation of these laws is increased by the fact that many of them have not been fully interpreted by the regulatory authorities or
the courts, and their provisions are open to a variety of interpretations. Any action against us for violation of these laws, even if
we successfully defend against it, could cause us to incur significant legal expenses and divert our management&#8217;s attention from
the operation of our business. The shifting compliance environment and the need to build and maintain robust and expandable systems to
comply with multiple jurisdictions with different compliance and/or reporting requirements increases the possibility that a healthcare
company may run afoul of one or more of the requirements.</p><div>

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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>If we fail to comply with environmental,
health and safety laws and regulations, we could become subject to fines or penalties or incur substantial costs.</i></b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">We are subject to numerous
environmental, health and safety laws and regulations, including those governing laboratory procedures and the generation, handling,
use, storage, treatment, manufacture, transportation and disposal of, and exposure to, hazardous materials and wastes, as well as laws
and regulations relating to occupational health and safety. We contract with third parties that conduct operations on our behalf that
involve the use of hazardous and flammable materials, including chemicals and biologic materials. Our contractors also produce and dispose
of hazardous waste products. We cannot eliminate the risk of contamination or injury from these materials. In the event of contamination
or injury resulting from our contractors&#8217; use of hazardous materials, we could be held liable for any resulting damages and any
liability could exceed our resources, and our clinical trials or regulatory approvals could be suspended. We also could incur significant
costs associated with civil or criminal fines and penalties. Our third-party contractors may not carry specific biological or hazardous
waste insurance coverage, and their property, casualty and general liability insurance policies specifically exclude coverage for damages
and fines arising from biological or hazardous waste exposure or contamination.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Although we maintain workers&#8217;
compensation insurance for certain costs and expenses, we may incur due to injuries to our employees resulting from the use of hazardous
materials or other work-related injuries, this insurance may not provide adequate coverage against potential liabilities. We do not maintain
insurance for toxic tort claims that may be asserted against us in connection with our storage or disposal of biologic, hazardous or
radioactive materials.</p><div>

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


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    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
    </div><!-- Field: /Page --><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">In addition, we may incur
substantial costs in order to comply with current or future environmental, health and safety laws and regulations, which have tended
to become more stringent over time. These current or future laws and regulations may impair our research, development or production efforts.
Failure to comply with these laws and regulations also may result in substantial fines, penalties or other sanctions or liabilities,
which could adversely affect our business, financial condition, results of operations and prospects.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>Risks Related to our Business Operations</b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>We may not be successful in our efforts
to identify or discover additional product candidates and may fail to capitalize on programs or product candidates that may be a greater
commercial opportunity or for which there is a greater likelihood of success.</i></b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">The success of our business
depends upon our ability to identify, develop and commercialize product candidates. Research programs to identify new product candidates
require substantial technical, financial and human resources. Although a substantial amount of our efforts will focus on the continued
preclinical and clinical testing and potential approval of our product candidates, a key element of our long-term growth strategy is
to develop and market additional products and product candidates. However, we may fail to identify other potential product candidates
for clinical development for several reasons. For example, our research may be unsuccessful in identifying potential product candidates
or our potential product candidates may be shown to have harmful side effects, may be commercially impracticable to manufacture or may
have other characteristics that may make the products unmarketable or unlikely to receive marketing approval.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Additionally, because we
have limited resources, we may forego or delay pursuit of opportunities with certain programs or product candidates or for indications
that later prove to have greater commercial potential. Our spending on current and future R&amp;D programs may not yield any commercially
viable products. If we do not accurately evaluate the commercial potential for a particular product candidate, we may relinquish valuable
rights to that product candidate through strategic collaboration, licensing or other arrangements in cases in which it would have been
more advantageous for us to retain sole development and commercialization rights to such product candidate. Alternatively, we may allocate
internal resources to a product candidate in a therapeutic area in which it would have been more advantageous to enter into a partnering
arrangement.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Our long-term growth strategy
to develop and market additional products and product candidates is heavily dependent on precise, accurate and reliable scientific data
to identify, select and develop promising pharmaceutical product candidates and products. Our business decisions may therefore be adversely
influenced by improper or fraudulent scientific data sourced from third parties. Any irregularities in the scientific data used by us
to determine our focus in R&amp;D of product candidates and products could have a material adverse effect on our business, prospects,
financial condition and results of operations.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">If any of these events occur,
we may be forced to abandon our development efforts with respect to a particular product candidate or fail to develop a potentially successful
product candidate, which could have a negative impact on our business, financial condition, results of operations and prospects.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>Our future success depends on our ability
to retain key employees, consultants and advisors and to recruit, retain and motivate qualified personnel.</i></b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Our ability to compete in
the highly competitive biotechnology and pharmaceutical industries depends upon our ability to attract and retain highly qualified managerial,
scientific and medical personnel. While we have entered into employment agreements with each of our executive officers, any of them could
leave our employment at any time. We currently do not have &#8220;key person&#8221; insurance on any of our employees. The loss of the
services of one or more of our current employees might impede the achievement of our research, development and commercialization objectives.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Recruiting and retaining
other qualified employees, consultants and advisors for our business, including scientific and technical personnel, also will be critical
to our success. We may not be able to attract and retain personnel on acceptable terms given the competition among numerous pharmaceutical
and biotechnology companies and academic institutions for individuals with similar skill sets. In addition, failure to succeed in preclinical
studies or clinical trials or applications for marketing approval may make it more challenging to recruit and retain qualified personnel.
The inability to recruit, or loss of services of certain executives, key employees, consultants or advisors, may impede the progress
of our research, development and commercialization objectives and have an adverse effect on our business, financial condition, results
of operations and prospects.</p><div>

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


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    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
    </div><!-- Field: /Page --><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>If we are unable to manage expected growth
in the scale and complexity of our operations, our performance may suffer</i>.</b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">At December 31, 2022, we
had 3 full-time employees, who were engaged in R&amp;D activities. If we are successful in executing our business strategy, we will need
to expand our managerial, operational, financial and other systems and resources to manage our operations, continue our R&amp;D activities
and, in the longer term, build a commercial infrastructure to support commercialization of any of our product candidates that are approved
for sale. Future growth would impose significant added responsibilities on members of management and, to a potentially significant extent,
divert our management and business development resources away from their current uses. It is likely that our management, finance, development
personnel, systems and facilities currently in place may not be adequate to support this future growth. Our need to effectively manage
our operations, growth and any future product candidates requires that we continue to develop more robust business processes and improve
our systems and procedures in each of these areas, to attract and retain sufficient numbers of talented employees and to expand the group
of contractors we use.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">We may be unable to successfully
implement these tasks on a larger scale and, accordingly, may not achieve our research, development and growth goals.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>Our employees, principal investigators,
consultants and commercial partners may engage in misconduct or other improper activities, including non-compliance with regulatory standards
and requirements and insider trading, which could have a material adverse impact on our business.</i></b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">We are exposed to the risk
of fraud or other misconduct by our employees, principal investigators, consultants and commercial partners. Misconduct by these parties
could include intentional failures to: comply with FDA or EMA regulations or the regulations applicable in other jurisdictions, provide
accurate information to the FDA, EMA and other regulatory authorities, comply with healthcare fraud and abuse laws and regulations in
the United States and abroad, report financial information or data accurately or disclose unauthorized activities to us. 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. These laws and regulations restrict or prohibit a wide range
of pricing, discounting, marketing and promotion, sales commission, customer incentive programs and other business arrangements. Such
misconduct also could involve the improper use of information obtained in the course of clinical trials or interactions with the FDA,
EMA or other regulatory authorities, which could result in regulatory sanctions and cause serious harm to our reputation. Additionally,
we are subject to the risk that a person could allege fraud or other misconduct, even in none occurred. We have adopted a code of conduct
applicable to all of our employees, but it is not always possible to identify and deter employee misconduct, and the precautions we take
to detect and prevent these activities may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from
government investigations or other actions or lawsuits stemming from a failure to comply with these laws or regulations. If any such
actions are instituted against us, and we are not successful in defending ourselves or asserting our rights, those actions could have
a significant impact on our business, financial condition, results of operations and prospects, including the imposition of significant
criminal, civil and administrative sanctions, such as monetary penalties, damages, fines, disgorgement, individual imprisonment, and
exclusion from participation in government funded healthcare programs, such as Medicare and Medicaid, additional reporting requirements
and oversight if we become subject to a corporate integrity agreement or similar agreement to resolve allegations of non-compliance with
these laws, reputational harm, and we may be required to curtail or restructure our operations. We are also subject to the data privacy
regime in the EU, which imposes obligations and restrictions on the collection and use of personal data relating to individuals located
in the EU and includes the General Data Protection Regulation, or the GDPR, and any national laws implementing or supplementing the GDPR.
If we do not comply with our obligations under the EU privacy regime, we could be exposed to significant fines and we may be the subject
of litigation and/or adverse publicity, which could have a material adverse effect on our reputation and business.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>Product liability lawsuits against us could
cause us to incur substantial liabilities and could limit commercialization of any product candidate that we may develop.</i></b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">We face an inherent risk
of product liability exposure related to the testing of our current and future product candidates in clinical trials and may face an
even greater risk if we commercialize any product candidate that we may develop. For example, we may be sued if our current or future
product candidates cause or are perceived to cause injury or are found to be otherwise unsuitable during clinical testing, manufacturing,
marketing or sale. Any such product liability claims may include allegations of defects in manufacturing, defects in design, a failure
to warn of dangers inherent in the product, negligence, strict liability or a breach of warranties. Claims could also be asserted under
state consumer protection acts. If we cannot successfully defend ourselves against product liability claims, we could incur substantial
liabilities. Regardless of merit or eventual outcome, liability claims may result in:</p><div>

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

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
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    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">decreased demand for any
    product candidate that we may develop;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>


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    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
    </div><!-- Field: /Page --><div>

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

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">substantial monetary awards
    to trial participants or patients;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
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    to defend the related litigation;</span></td></tr>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
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    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">withdrawal of clinical
    trial participants;</span></td></tr>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
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    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the inability to commercialize
    any product candidates that we may develop; or</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
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    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">injury to our reputation
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  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Although we maintain product
liability insurance coverage, such insurance may not be adequate to cover all liabilities that we may incur. We anticipate that we will
need to increase our insurance coverage each time we commence a clinical trial and if we successfully commercialize any product candidate.
Insurance coverage is increasingly expensive. We may not be able to maintain insurance coverage at a reasonable cost or in an amount
adequate to satisfy any liability that may arise.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>A pandemic, epidemic or outbreak of an
infectious disease, such as COVID-19, may materially and adversely affect our business and operations.</i></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.3in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">The outbreak of COVID-19
originated in Wuhan, China, in December 2019 and has since spread to multiple countries, including the United States and several European
countries. On March 11, 2020, the World Health Organization declared the outbreak a pandemic. The COVID-19 pandemic is affecting the
United States and global economies and may affect our operations and those of third parties on which we rely, including by causing disruptions
in the supply of our product candidates and the conduct of future clinical trials. Disruptions caused by the COVID-19 pandemic may increase
the likelihood that we encounter such difficulties or delays in initiating, enrolling, conducting or completing our planned and ongoing
preclinical studies and clinical trials, as applicable.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">In addition, the COVID-19
pandemic may affect the operations of the FDA and other health authorities, which could result in delays of reviews and approvals, including
with respect to our product candidates. Additionally, while the potential economic impact brought by, and the duration of the COVID-19
pandemic is difficult to assess or predict, the impact of the COVID-19 pandemic on the global financial markets may reduce our ability
to access capital, which could negatively impact our short-term and long-term liquidity. The ultimate impact of the COVID-19 pandemic
is highly uncertain and subject to change. We do not yet know the full extent of potential delays or impacts on our business, financing
or clinical trial activities or on healthcare systems or the global economy as a whole. However, these effects could have a material
impact on our liquidity, capital resources, operations and business and those of the third parties on which we rely.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>Exchange rate fluctuations may materially
affect our results of operations and financial condition.</i></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Owing to the international
scope of our operations, fluctuations in exchange rates, particularly between Pounds Sterling and the U.S. dollar, may adversely affect
us. Although we are based in the United Kingdom, we may source R&amp;D, manufacturing, consulting and other services from the United States
and the European Union. Further, potential future revenue may be derived from abroad, particularly from the United States. As a result,
our business and the potential value of our Common shares may be affected by fluctuations in foreign exchange rates not only between the
Pounds Sterling and the U.S. dollar, but also the euro, which may have a significant impact on our results of operations and cash flows
from period to period. Currently, we do not have any exchange rate hedging arrangements in place.</p><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>Our internal computer systems, or those
of our collaborators or other contractors or consultants, may fail or suffer security breaches, which could result in a material disruption
of our product development programs.</i></b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Our internal computer systems
and those of our current and any future collaborators and other contractors or consultants are vulnerable to damage from computer viruses,
unauthorized access, natural disasters, terrorism, war and telecommunication and electrical failures. While we have not experienced any
such material system failure, accident or security breach to date, if such an event were to occur and cause interruptions in our operations,
it could result in a material disruption of our development programs and our business operations, whether due to a loss of our trade
secrets or other proprietary information or other similar disruptions. For example, the loss of clinical trial data from completed or
future 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 were to result in a loss of, or damage to, our data or applications, or
inappropriate disclosure of confidential or proprietary information, we could incur liability, our competitive position could be harmed,
and the further development and commercialization of our product candidates could be delayed.</p><div>

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    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
    </div><!-- Field: /Page --><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>Risks Related to the Ownership of Our Securities</b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>The prices of our common shares may be
volatile and fluctuate substantially, which could result in substantial losses for holders of our common shares.</i></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">The market prices of our common
shares on the Nasdaq Capital Market may be volatile and fluctuate substantially. The stock market in general and the market for smaller
pharmaceutical and biotechnology companies in particular have experienced extreme volatility that has often been unrelated to the operating
performance of particular companies. As a result of this volatility, holders our common shares may not be able to sell their common shares
at or above the price at which they were purchased. The market price for the common shares may be influenced by many factors, including:</p><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">

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

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
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  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in"><b>&#160;</b></p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&#160;&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
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    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
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    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
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  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 8pt; text-align: justify; "><b><i>Our common shares
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 8pt; text-align: justify; ">&#160;If we fail to
meet any of the continued listing standards of The Nasdaq Capital Market, our common shares could be delisted from The Nasdaq Capital
Market. These continued listing standards include specifically enumerated criteria, such as:</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
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    <td style="text-align: justify; font-size: 10pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">a $1.00 minimum closing bid price;</span></td></tr>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 8pt; "></p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
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    <td style="text-align: justify; font-size: 10pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">stockholders&#8217; equity of $2.5&#160;million;</span></td></tr>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 8pt; "></p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
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    <td style="width: 48px">&#160;</td>
    <td style="width: 24px; font-size: 10pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify; font-size: 10pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">500,000 shares of publicly-held common stock with a market value of at least $1&#160;million;</span></td></tr>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 8pt; "></p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
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    <td style="width: 48px">&#160;</td>
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    <td style="text-align: justify; font-size: 10pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">300 round-lot stockholders; and</span></td></tr>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 8pt; "></p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 8pt; text-align: justify; "></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0">On June 14, 2022, we received a written notice (the &#8220;Notice&#8221;)
from the Nasdaq Stock Market LLC (&#8220;Nasdaq&#8221;) notifying us that were not in compliance with Nasdaq Listing Rule 5550(a)(2) (the
&#8220;Rule&#8221;), as the minimum bid price of the Company&#8217;s common shares has been below $1.00 per share for 30 consecutive business
days. On December 13, 2022, Nasdaq notified us that we were eligible for an additional 180 calendar day period, or until June 12, 2023<b>,
</b>to regain compliance.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 8pt; "></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 8pt; ">On April 21, 2023, we received notice from
Nasdaq that we had regained compliance with the minimum bid price requirement for continued listing on The Nasdaq Capital Market.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 8pt; text-align: justify; ">&#160;If we fail to
comply with Nasdaq&#8217;s continued listing standards, we may be delisted and our common shares will trade, if at all, only on the over-the-counter
market, such as the OTC Bulletin Board or OTCQX market, and then only if one or more registered broker-dealer market makers comply with
quotation requirements. In addition, delisting of our common shares could depress our stock price, substantially limit liquidity of our
common shares and materially adversely affect our ability to raise capital on terms acceptable to us, or at all. Finally, delisting of
our common shares could result in our common shares becoming a &#8220;penny stock&#8221; under the Exchange Act.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; "><b>Because we are a
foreign corporation, you may not have the same rights as a shareholder in a U.S. corporation.</b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; ">We
are a Bermuda exempted company. Our Memorandum of Association and&#160;Bye-laws&#160;and the Companies Act 1981 of Bermuda (the &#8220;<span style="text-decoration:underline">Companies
Act</span>&#8221;) govern our affairs Bermudan 1981 While many provisions of the Companies Act resemble provisions of the corporation laws
of a number of states in the United States, Bermuda law may not as clearly establish your rights and the fiduciary responsibilities of
our directors as do statutes and judicial precedent in some U.S. jurisdictions. In addition, apart from three&#160;non-executive&#160;directors,
our directors and officers are not resident in the United States and all or substantially all of our assets are located outside of the
United States. As a result, investors may have more difficulty in protecting their interests and enforcing judgments in the face of actions
by our management, directors or controlling shareholders than would shareholders of a corporation incorporated in a U.S. jurisdiction.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 24.5pt; ">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">In addition, you should not
assume that courts in the country in which we are incorporated or where our assets are located would enforce judgments of U.S. courts
obtained in actions against us based upon the civil liability provisions of applicable U.S. federal and state securities laws or would
enforce, in original actions, liabilities against us based on those laws.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 24.5pt; ">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Shareholders of Bermuda exempted
companies such as the Company also have no general rights under Bermuda law to inspect corporate records and accounts other than rights
to review the Company&#8217;s memorandum of association and bye-laws, financial statements, minutes of the shareholder meetings and the
shareholder register. This could make it more difficult for you to obtain the information needed to establish any facts necessary for
a shareholder motion or to solicit proxies from other shareholders in connection with a proxy contest.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; ">As
a result of all of the above, public shareholders might have more difficulty in protecting their interests in the face of actions taken
by management, members of the board of directors or controlling shareholders than they would as public shareholders of a U.S. company.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24.5pt; ">&#160;</p><div>


</div><!-- Field: Page; Sequence: 36; Value: 1 --><div>
    </div><div style="margin-top: 12pt; margin-bottom: 6pt; border-bottom: Black 1.5pt solid"><p style="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><!-- Field: Sequence; Type: Arabic; Name: PageNo -->31<!-- Field: /Sequence --></p></div><div>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24.5pt; ">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>U.S. persons who own our securities may
have more difficulty in protecting their interests than U.S. persons who are shareholders of a U.S. corporation.</i></b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">The Companies Act, which
applies to the Company, differs in some material respects from laws generally applicable to U.S. corporations and their shareholders.
These differences include, but are not limited to, the manner in which directors must disclose transactions in which they have an interest,
the rights of shareholders to bring class action and derivative lawsuits, the scope of indemnification available to directors and officers
and provisions relating to amalgamations, mergers and acquisitions and takeovers. Holders of our common shares may therefore have more
difficulty protecting their interests than would shareholders of a corporation incorporated in a jurisdiction within the U.S.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Generally, the duties of
directors and officers of a Bermuda company are owed to the company and not, in the absence of special circumstances, to the shareholders
as individuals. Shareholders of Bermuda companies typically do not have rights to take action against directors or officers of the company
and may only do so in limited circumstances. Class actions and derivative actions are typically not available to shareholders under Bermuda
law. The Bermuda courts, however, would ordinarily be expected to permit a shareholder to commence an action in the name of a company
to remedy a wrong to the company where the act complained of is alleged to be beyond the corporate power of the company or illegal, or
would result in the violation of the company&#8217;s memorandum of association or bye-laws.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>Certain Other Bermuda Law Considerations</i>.
</b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">All Bermuda &#8220;exempted
companies&#8221; are exempt from certain Bermuda laws restricting the percentage of share capital that may be held by non-Bermudians.
However, exempted companies may not participate in certain business transactions, including (1) the acquisition or holding of land in
Bermuda except that required for their business and held by way of lease or tenancy for a term not exceeding 50 years or, with the consent
of the Minister of Economic Development (the &#8220;Minister&#8221;) granted in his discretion by way of lease or tenancy for a term
not exceeding 21 years in order to provide accommodation or recreational facilities for officers and employees of the Company, (2) the
taking of mortgages on land in Bermuda to secure an amount in excess of $50,000 without the consent of the Minister, (3) the acquisition
of any bonds or debentures secured by any land in Bermuda, other than certain types of Bermuda government securities or securities issued
by Bermuda public authorities or (4) the carrying on of business of any kind in Bermuda, except in furtherance of business carried on
outside Bermuda or under license granted by the Minister.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">All Bermuda companies must
comply with the provisions of the Companies Act regulating the payment of dividends and making distributions from contributed surplus.
A company may not declare or pay a dividend, or make a distribution out of contributed surplus, if there are reasonable grounds for believing
that: (a) the company is, or would after the payment be, unable to pay its liabilities as they become due; or (b) the realizable value
of the company&#8217;s assets would thereby be less than its liabilities.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><i>Bermuda Exchange Control
Regulation</i>. The permission of the Bermuda Monetary Authority is required, under the provisions of the Exchange Control Act 1972 of
Bermuda and related regulations, for all issuances and transfers of shares (which includes our common shares) of Bermuda companies to
or from a non-resident of Bermuda for exchange control purposes, other than in cases where the Bermuda Monetary Authority has granted
a general permission. The Bermuda Monetary Authority, in its notice to the public dated June 1, 2005, has granted a general permission
for the issue and subsequent transfer of any securities of a Bermuda company from and/or to a non-resident of Bermuda for exchange control
purposes for so long as any &#8220;Equity Securities&#8221; of the company (which include our common shares) are listed on an &#8220;Appointed
Stock Exchange&#8221; (which include Nasdaq). In granting the general permission the Bermuda Monetary Authority accepts no responsibility
for our financial soundness or the correctness of any of the statements made or opinions expressed in this annual report.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Although the Company is incorporated
in Bermuda, as an exempted company, the Company is classified as a non-resident of Bermuda for exchange control purposes by the Bermuda
Monetary Authority. Other than transferring Bermuda Dollars out of Bermuda, there are no restrictions on the Company&#8217;s ability
to transfer funds into and out of Bermuda or to pay dividends in currency other than Bermuda Dollars to nonresidents of Bermuda who are
holders of our common shares.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 24.5pt; ">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>If we engage in future acquisitions or
strategic partnerships, this may increase our capital requirements, dilute our shareholders, cause us to incur debt or assume contingent
liabilities and subject us to other risks.</i></b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">We intend to continue to
evaluate various acquisitions and strategic partnerships, including licensing or acquiring complementary drugs, intellectual property
rights, technologies or businesses. Any potential acquisition or strategic partnership may entail numerous risks, including:</p><div>

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

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>


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

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
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    and regulatory approvals; and</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
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    <td style="width: 48px">&#160;</td>
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    revenue from acquired technology and/or drugs sufficient to meet our objectives in undertaking the acquisition or even to offset
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: -0.05pt"><b><i>As an FPI, we are
exempt from a number of rules under the U.S. securities laws and are permitted to file less information with the SEC than U.S. public
companies</i>.</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: -0.05pt"><b>&#160;</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">We are an FPI, as defined
in the SEC rules and regulations and, consequently, we are not subject to all of the disclosure requirements applicable to companies
organized within the United States. For example, we are exempt from certain rules under the Exchange Act, that regulate disclosure obligations
and procedural requirements related to the solicitation of proxies, consents or authorizations applicable to a security registered under
the Exchange Act. In addition, our officers and directors are exempt from the reporting and &#8220;short-swing&#8221; profit recovery
provisions of Section 16 of the Exchange Act and related rules with respect to their purchases and sales of our securities. Moreover,
we are not required to file periodic reports and financial statements with the SEC as frequently or as promptly as U.S. public companies.
Accordingly, there may be less publicly available information concerning our company than there is for U.S. public companies.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">As an FPI, we will file an
annual report on Form 20-F within four months of the close of each fiscal year ended December 31 and reports on Form 6-K relating to
certain material events promptly after we publicly announce these events. However, because of the above exemptions for FPIs, our common
shareholders will not be afforded the same protections or information generally available to investors holding shares in public companies
organized in the United States.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>While we are an FPI, we are not subject
to certain Nasdaq corporate governance rules applicable to U.S. listed companies.</i></b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">We are entitled to rely on
a provision in Nasdaq&#8217;s corporate governance rules that allows us to follow our home country corporate law and the Companies Act
with regard to certain aspects of corporate governance. This allows us to follow certain corporate governance practices that differ in
significant respects from the corporate governance requirements applicable to U.S. companies listed on Nasdaq.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">For example, we are exempt
from Nasdaq regulations that require a listed U.S. company to (i) have a majority of the board of directors consist of independent directors,
(ii) require non-management directors to meet on a regular basis without management present and (iii) promptly disclose any waivers of
the code for directors or executive officers that should address certain specified items.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">In accordance with our Nasdaq
listing, our audit committee is required to comply with the provisions of Section 301 of the Sarbanes-Oxley Act and Rule 10A-3 of the
Exchange Act, both of which are also applicable to Nasdaq-listed U.S. companies. Because we are an FPI, however, our audit committee
is not subject to additional Nasdaq requirements applicable to listed U.S. companies, including an affirmative determination that all
members of the audit committee are &#8220;independent,&#8221; using more stringent criteria than those applicable to us as an FPI. Furthermore,
Nasdaq&#8217;s corporate governance rules require listed U.S. companies to, among other things, seek shareholder approval for the implementation
of certain equity compensation plans and issuances of ordinary shares, which we are not required to follow as an FPI.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>We may lose our FPI status, which would
then require us to comply with the Exchange Act&#8217;s domestic reporting regime and cause us to incur significant legal, accounting
and other expenses.</i></b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">As an FPI, we are not required
to comply with all of the periodic disclosure and current reporting requirements of the Exchange Act applicable to U.S. domestic issuers.
In order to maintain our current status as an FPI, either (a) a majority of our Common shares must be either directly or indirectly owned
of record by non-residents of the United States or (b)(i) a majority of our executive officers or directors cannot be U.S. citizens or
residents, (ii) more than 50% of our assets must be located outside the United States and (iii) our business must be administered principally
outside the United States. If we lose our status as an FPI, we would be required to comply with the Exchange Act reporting and other
requirements applicable to U.S. domestic issuers, which are more detailed and extensive than the requirements for FPIs. We may also be
required to make changes in our corporate governance practices in accordance with various SEC and Nasdaq rules. The regulatory and compliance
costs to us under U.S. securities laws if we are required to comply with the reporting requirements applicable to a U.S. domestic issuer
may be significantly higher than the cost we would incur as an FPI. As a result, we expect that a loss of FPI status would increase our
legal and financial compliance costs and is likely to make some activities highly time consuming and costly. We also expect that if we
were required to comply with the rules and regulations applicable to U.S. domestic issuers, it would make it more difficult and expensive
for us to obtain director and officer liability insurance, and we may be required to accept reduced coverage or incur substantially higher
costs to obtain coverage. These rules and regulations could also make it more difficult for us to attract and retain qualified members
of our board of directors.</p><div>

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


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    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
    </div><!-- Field: /Page --><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>We are an emerging growth company within
the meaning of the Securities Act of 1933 and will take advantage of certain reduced reporting requirements.</i></b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">We are an EGC, as defined
in the JOBS Act. For as long as we continue to be an EGC, we may take advantage of exemptions from various reporting requirements that
are applicable to other public companies that are not EGCs, including not being required to comply with the auditor attestation requirements
of Section 404 of the Sarbanes-Oxley Act, or Section 404, exemptions from the requirements of holding a nonbinding advisory vote on executive
compensation and shareholder approval of any golden parachute payments not previously approved. As an EGC, we are required to report
only two years of financial results and selected financial data compared to three and five years, respectively, for comparable data reported
by other public companies. We may take advantage of these exemptions until we are no longer an EGC. We could be an EGC for up to five
years, although circumstances could cause us to lose that status earlier, including if the aggregate market value of our common shares
held by non-affiliates exceeds $700 million as of any June 30 (the end of our second fiscal quarter) before that time, in which case
we would no longer be an EGC as of the following December 31 (our fiscal year-end). We cannot predict if investors will find our common
shares less attractive because we may rely on these exemptions. If some investors find our common shares less attractive as a result,
there may be a less active trading market for our common shares and the price of our common shares may be more volatile in the event
that we decide to make an offering of our common shares.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>If we fail to establish and maintain proper
internal controls, our ability to produce accurate financial statements or comply with applicable regulations could be impaired.</i></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.05in"><b><i>&#160;</i></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Section 404(a) of the Sarbanes-Oxley
Act, or Section 404(a), requires that beginning with our second annual report following our IPO, management assess and report annually
on the effectiveness of our internal control over financial reporting and identify any material weaknesses in our internal control over
financial reporting. Although Section 404(b) of the Sarbanes-Oxley Act, or Section 404(b), requires our independent registered public
accounting firm to issue an annual report that addresses the effectiveness of our internal control over financial reporting, we have
opted to rely on the exemptions provided in the JOBS Act, and consequently will not be required to comply with SEC rules that implement
Section 404(b) until such time as we are no longer an EGC.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Pursuant to Section 404,
we will be required to furnish a report by our senior management on our internal control over financial reporting. However, while we
remain an EGC, we will not be required to include an attestation report on internal control over financial reporting issued by our independent
registered public accounting firm. To prepare for eventual compliance with Section 404, once we no longer qualify as an EGC, we will
be engaged in a process to document and evaluate our internal control over financial reporting, which is both costly and challenging.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">In this regard, we will need
to continue to dedicate internal resources, potentially engage outside consultants and adopt a detailed work plan to assess and document
the adequacy of internal control over financial reporting, continue steps to improve control processes as appropriate, validate through
testing that controls are functioning as documented and implement a continuous reporting and improvement process for internal control
over financial reporting. Despite our efforts, there is a risk that we will not be able to conclude, within the prescribed timeframe
or at all, that our internal control over financial reporting is effective as required by Section 404. If we identify one or more material
weaknesses, it could result in an adverse reaction in the financial markets due to a loss of confidence in the reliability of our financial
statements.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; "><b><i>Our 10% or more
stockholders and management own a significant percentage of our stock and are able to exercise significant influence over matters subject
to stockholder approval.</i></b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">As of the date of this annual
report, our executive officers, directors and 10% or more stockholders, together with their respective affiliates, owned approximately
42.03% of our outstanding securities. Accordingly, this group of security holders will be able to exert a significant degree of influence
over our management and affairs and over matters requiring security holder approval, including the election of our Board of Directors,
future issuances of our securities, declaration of dividends and approval of other significant corporate transactions. As a result, if
these shareholders were to choose to act together, they would be able to exert significant influence over matters submitted to our shareholders
for approval, as well as our management and affairs. For example, these persons, if they choose to act together, would exercise sufficient
voting power to influence the election of directors and approve any merger, consolidation or sale of all or substantially all of our
assets. This concentration of ownership control may:</p><div>

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

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
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    a change in control;</span></td></tr>
  <tr style="vertical-align: top">
    <td>&#160;</td>
    <td>&#160;</td>
    <td style="text-align: justify">&#160;</td></tr>
  <tr style="vertical-align: top">
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    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">entrench our management
    and board of directors; or</span></td></tr>
  <tr style="vertical-align: top">
    <td>&#160;</td>
    <td>&#160;</td>
    <td style="text-align: justify">&#160;</td></tr>
  <tr style="vertical-align: top">
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    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">impede a merger, consolidation,
    takeover or other business combination involving us that other shareholders may desire.</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>Claims of U.S. civil liabilities may not
be enforceable against us.</i></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>&#160;</i></b></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">We are incorporated under
Bermudan law. The United States and Bermuda do not currently have a treaty providing for recognition and enforcement of judgments in civil
and commercial matters. Consequently, a final judgment for payment given by a court in the United States, whether or not predicated solely
upon U.S. securities laws, would not automatically be recognized or enforceable in Bermuda. In addition, uncertainty exists as to whether
the courts of Bermuda would entertain original actions brought in Bermuda against us or our directors or senior management predicated
upon the securities laws of the United States or any state in the United States. Any final and conclusive monetary judgment for a definite
sum obtained against us in U.S. courts would be treated by the courts of Bermuda as a cause of action in itself and sued upon as a debt
at common law so that no retrial of the issues would be necessary, provided that certain requirements are met. The courts of Bermuda will
not automatically accept that the foreign court had jurisdiction and was properly seized of the matter. For a Bermuda court to enforce
or recognize a foreign judgment either at common law or under the Judgments (Reciprocal Enforcement) Act 1958 of Bermuda, the foreign
court must have had jurisdiction according to Bermuda Conflict of Law principles. Whether these requirements are met in respect of a judgment
based upon the civil liability provisions of the U.S. securities laws, including whether the award of monetary damages under such laws
would constitute a penalty, is an issue for the court making such decision. If a Bermuda court gives judgment for the sum payable under
a U.S. judgment, the Bermuda judgment will be enforceable by methods generally available for this purpose. These methods generally permit
the Bermuda court discretion to prescribe the manner of enforcement.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">

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


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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">In addition, U.S. investors
may not be able to enforce against us or our senior management, certain of our board of directors or certain experts named herein (who
are residents of countries other than the United States) any judgments obtained in U.S. courts in civil and commercial matters, including
judgments under the U.S. federal securities laws.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>If we are a passive foreign investment
company, there could be adverse U.S. federal income tax consequences to U.S. holders.</i></b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Under the Internal Revenue
Code of 1986, as amended, or the Code, we will be a PFIC for any taxable year in which (1) 75% or more of our gross income consists of
passive income or (2) 50% or more of the average quarterly value of our assets consists of assets that produce, or are held for the production
of, passive income. For purposes of these tests, passive income includes dividends, interest, gains from the sale or exchange of investment
property and certain rents and royalties. In addition, for purposes of the above calculations, a non-U.S. corporation that directly or
indirectly owns at least 25% by value of the shares of another corporation is treated as if it held its proportionate share of the assets
and received directly its proportionate share of the income of such other corporation. If we are a PFIC for any taxable year during which
a U.S. Holder (as defined below under &#8220;Material Income Tax Considerations-Material U.S. Federal Income Tax Considerations for U.S.
Holders&#8221;) holds our shares, the U.S. Holder may be subject to adverse tax consequences regardless of whether we continue to qualify
as a PFIC, including ineligibility for any preferred tax rates on capital gains or on actual or deemed dividends, interest charges on
certain taxes treated as deferred, and additional reporting requirements.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">We believe that we were a
PFIC for our taxable year ended December 31, 2022 but cannot provide any assurances regarding our PFIC status for any past, current or
future taxable years. The determination of whether we are a PFIC is a fact-intensive determination made on an annual basis applying principles
and methodologies which in some circumstances are unclear and subject to varying interpretation. In particular, the characterization
of our assets as active or passive may depend in part on our current and intended future business plans, which are subject to change.
In addition, for our current and future taxable years, the total value of our assets for PFIC testing purposes may be determined in part
by reference to the market price of our common shares from time to time, which may fluctuate considerably. Under the income test, our
status as a PFIC depends on the composition of our income which will depend on the transactions we enter into in the future and our corporate
structure. The composition of our income and assets may also be affected by how, and how quickly, we spend the cash we raise in any offering.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">In certain circumstances,
a U.S. Holder of shares in a PFIC may alleviate some of the adverse tax consequences described above by making a qualified electing fund,
or QEF, election to include in income its pro rata share of the corporation&#8217;s income on a current basis. However, a U.S. Holder
may make a QEF election with respect to our common shares only if we agree to furnish such U.S. Holder annually with a PFIC annual information
statement as specified in the applicable U.S. Treasury Regulations. We currently do not intend to prepare or provide the information
that would enable U.S. Holders to make a QEF election if we are treated as a PFIC for any taxable year, and prospective investors should
assume that a QEF election will not be available.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">For further discussion of
the PFIC rules and the adverse U.S. federal income tax consequences in the event we are classified as a PFIC, see the section of this
report entitled &#8220;Material Income Tax Considerations-Material U.S. Federal Income Considerations For U.S. Holders.&#8221;</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>We may be unable to use net operating loss
and tax credit carryforwards and certain built-in losses to reduce future tax payments or benefit from favorable U.K. tax legislation.</i></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in"><b><i>&#160;</i></b></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">As a U.K. tax resident trading
entity, we are subject to U.K. corporate taxation. Due to the nature of our business, we have generated losses since inception. As of
December 31, 2022, we had cumulative carryforward tax losses of $60.0 million.&#160;&#160;Subject to any relevant restrictions, we expect
these to be available to carry forward and offset against future operating profits. As a company that carries out extensive research and
development activities, we benefit from the U.K. research and development tax credit regime for small and medium-sized companies, whereby
we are able to surrender the trading losses that arise from our qualifying research and development activities for a payable tax credit
of up to 33.35% of eligible research and development expenditures. Qualifying expenditures largely comprise employment costs for research
staff, consumables and certain internal overhead costs incurred as part of research projects. Certain subcontracted qualifying research
expenditures are eligible for a cash rebate of up to 21.67%. The majority of our pipeline research, clinical trials management and manufacturing
development activities are eligible for inclusion within these tax credit cash rebate claims. Our ability to continue to claim payable
research and development tax credits in the future may be limited because we may no longer qualify as a small or medium-sized company.</p><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">

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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">We may benefit in the future
from the United Kingdom&#8217;s &#8220;patent box&#8221; regime, which allows certain profits attributable to revenues from patented
products to be taxed at an effective rate of 10%. We are the exclusive licensee or owner of several patent applications which, if issued,
would cover our product candidates, and accordingly, future upfront fees, milestone fees, product revenues and royalties could be taxed
at this tax rate. When taken in combination with the enhanced relief available on our research and development expenditures, we expect
a long-term lower rate of corporation tax to apply to us. If, however, there are unexpected adverse changes to the U.K. research and
development tax credit regime or the &#8220;patent box&#8221; regime, or for any reason we are unable to qualify for such advantageous
tax legislation, or we are unable to use net operating loss and tax credit</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>Changes and uncertainties in the tax system
in the countries in which we have operations could materially adversely affect our financial condition and results of operations, and
reduce net returns to our shareholders.</i></b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Our tax position could be
adversely impacted by changes in tax rates, tax laws, tax practice, tax treaties or tax regulations or changes in the interpretation
thereof by the tax authorities in the United Kingdom, the United States and other jurisdictions as well as being affected by certain
changes currently proposed by the Organization for Economic Co-operation and Development and their action plan on Base Erosion and Profit
Shifting. Such changes may become more likely as a result of recent economic trends in the jurisdictions in which we operate, particularly
if such trends continue.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Our actual effective tax
rate may vary from our expectation and that variance may be material. A number of factors may increase our future effective tax rates,
including: (1) the jurisdictions in which profits are determined to be earned and taxed; (2) the resolution of issues arising from any
future tax audits with various tax authorities; (3) changes in the valuation of our deferred tax assets and liabilities; (4) increases
in expenses not deductible for tax purposes, including transaction costs and impairments of goodwill in connection with acquisitions;
(5) changes in the taxation of share-based compensation; (6) changes in tax laws or the interpretation of such tax laws, and changes
in generally accepted accounting principles; and (7) challenges to the transfer pricing policies related to our structure.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">A tax authority may disagree
with tax positions that we have taken, which could result in increased tax liabilities. For example, Her Majesty&#8217;s Revenue&amp;
Customs, or HMRC, the U.S. Internal Revenue Service, or IRS, or another tax authority could challenge our allocation of income by tax
jurisdiction and the amounts paid between our affiliated companies pursuant to our intercompany arrangements and transfer pricing policies,
including methodologies for valuing developed technology and amounts paid with respect to our intellectual property development. Similarly,
a tax authority could assert that we are subject to tax in a jurisdiction where we believe we have not established a taxable connection,
often referred to as a &#8220;permanent establishment&#8221; under international tax treaties, and such an assertion, if successful,
could increase our expected tax liability in one or more jurisdictions.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">A tax authority may take
the position that material income tax liabilities, interest and penalties are payable by us, for example where there has been a technical
violation of contradictory laws and regulations that are relatively new and have not been subject to extensive review or interpretation,
in which case we expect that we might contest such assessment. High-profile companies can be particularly vulnerable to aggressive application
of unclear requirements. Many companies must negotiate their tax bills with tax inspectors who may demand higher taxes than applicable
law appears to provide. Contesting such an assessment may be lengthy and costly and if we were unsuccessful in disputing the assessment,
the implications could increase our anticipated effective tax rate, where applicable.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 5.85pt">&#160;</p><div>

</div><div><a id="a_005"></a></div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><b>ITEM 4: INFORMATION ON THE COMPANY</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 5.85pt; text-indent: 0.5in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>A. History and Development of the Company</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 5.85pt; text-align: justify; text-indent: 0.2in">&#160;</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">We were originally incorporated
under the laws of England and Wales on February 11, 1998, with the goal of leveraging the expertise of our management team as well as
Napoleone Ferrara, M.D., Arun Sanyal, M.D., Howard Weiner, M.D. and Kevan Herold, M.D., and to acquire and exploit certain intellectual
property in biotechnology. We subsequently changed our name to Tiziana Life Sciences plc in April 2014 as a result of the acquisition
of Tiziana Pharma Limited in April 2014. On August 20, 2021 we announced that we had formally commenced a strategic plan to change our
corporate structure by establishing Tiziana Life Sciences Ltd, a Bermuda-incorporated company, to become the ultimate parent company of
the Tiziana Group. The reorganization was performed under a scheme of arrangement under Part 26 of the UK Companies Act 2006 and became
effective on October 20, 2021, at which point all shareholders became shareholders in the new Bermuda company.</p><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Our registered office is
located at Clarendon House, 2 Church Street, Hamilton HM 11, Bermuda and our telephone number is +44 20 7495 2379.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">The SEC maintains an Internet
site that contains reports, proxy and information statements, and other information regarding issuers, such as we, that file electronically,
with the SEC at&#160;www.sec.gov.&#160;Our website address is www.tizianalifesciences.com. The reference to our website is an inactive
textual reference only and the information contained in, or that can be accessed through, our website is not a part of this annual report.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Our agent for service of
process in the United States is Tiziana Therapeutics, Inc, 5 Penn Plaza, 19<sup>th</sup> Floor, Suite 1954, New York, NY 10001.</p><div>


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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>B. Business Overview</b></p><div>

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

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

</div><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: justify; text-indent: 0.5in">We are a biotechnology company
that specializes in the developing transformative therapies for neurodegenerative and lung diseases. Our clinical pipeline includes drug
assets for Secondary Progressive Multiple Sclerosis, ALS. Alzheimer's, Crohn's Disease and KRAS+ NSCLC. Tiziana is led by a team of highly
qualified executives with extensive drug development and commercialization experience.. Our mission is to bring breakthrough therapies
to patients with the aim of treating Secondary Progressive Multiple Sclerosis, ALS, Alzheimer's, and other CNS indications. Crohn's Disease,
lung diseases and optimizing health outcomes.. We are developing transformational formulation technologies, enabling&#160;to switch from
traditional routes to alternative routes of immunotherapy to facilitate local site of action. For example, nasal, oral and inhalation
administrations to target neurodegenerative and lung diseases. We believe, if we succeed in these alternative routes of immunotherapies
that has the potential to&#160;change the way immunotherapies are currently conducted.&#160;</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">We employ a lean and virtual
research and development, or R&amp;D, model using highly experienced teams of experts for each business function to maximize value accretion
by focusing resources on the drug discovery and development processes.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">

</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">We are developing Foralumab,
for which we in-licensed the intellectual property from Novimmune SA, or Novimmune, in December 2014, as a potential treatment for neurodegenerative
diseases such as Secondary Progressive Multiple Sclerosis (SPMS), Crohn&#8217;s disease and delayed onset of Type I Diabetes (T1D). On
November 10, 2022, Tiziana announced a short-term focus on administration of intranasal foralumab for treatment of neurodegenerative diseases,
especially SPMS, based on positive clinical findings of Expanded Access (EA) SPMS patients at Brigham and Women&#8217;s Hospital treated
with intranasal foralumab for up to 1 year. As the only fully human engineered human anti-CD3 mAb in clinical development, Foralumab has
significant potential advantages such as a shorter treatment duration and reduced immunogenicity. We believe that oral or intranasal administration
of Foralumab has the potential to reduce inflammation while minimizing the toxicity and related side effects. To date, Foralumab has been
studied in one Phase 1 and two Phase 2a clinical trials conducted by Novimmune in 68 patients dosed by the intravenous route of administration.
In these trials, Foralumab was observed to be safe and well-tolerated and produced immunologic effects consistent with potential clinical
benefit while demonstrating mild to moderate infusion related reactions, or IRRs. With completion of the intravenous dosing for Phase
2a trial in Crohn&#8217;s Disease, Foralumab&#8217;s ability to modulate T-cell response enables potential extension into a wide range
of other autoimmune and inflammatory diseases, such as Graft versus Host Disease (GvHD), ulcerative colitis (UC), multiple sclerosis(MS),
type-1 diabetes (T1D), inflammatory bowel disease (IBD), psoriasis (PSA) and rheumatoid arthritis (RA).</p><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Foralumab is being developed
as both an immunosuppressive and immunomodulatory agent, with therapeutic benefits of rendering T-cells unable to orchestrate an immune
response and induction of immune tolerance via maintenance of regulatory T-cells. There is further potential for Foralumab to be combined
with the Company&#8217;s TZLS-501, a fully human anti-IL-6R mAB in development to target autoimmune and inflammatory diseases.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">In November 2016, Tiziana
announced new data for oral efficacy in humanized mouse models with Foralumab, a major milestone and a potential breakthrough for the
treatment of NASH and autoimmune disease. This unique oral technology stimulates the natural gut immune system and potentially provides
a therapeutic effect in inflammatory and autoimmune diseases with greatly reduced toxicity. Positive therapeutic effects with Foralumab
were consistently demonstrated in animal studies conducted by Prof. Kevan Herold (Yale University) and Prof. Howard Weiner (Harvard University).</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">On 16 April, 2018, the Group
entered into an exclusive license agreement with The Brigham and Women&#8217;s Hospital, Inc. relating to a novel formulation of Foralumab
dosed in a medical device for nasal administration. An investigational new drug application (IND) for the first-in-human evaluation of
the nasal administration of Foralumab in healthy volunteers for progressive multiple sclerosis indication was filed in the second quarter
of 2018. Subsequent to IND approval, a single-site, double-blind, placebo-controlled, dose-ranging Phase 1 trial with nasally administered
Foralumab at 10, 50 and 250 &#181;g per day, consecutively for 5 days to evaluate biomarkers of immunomodulation of clinical responses
was initiated in November 2018. The trial conducted at the Brigham and Women&#8217;s Hospital, Harvard Medical School, Boston, MA, in
healthy volunteers. 18 subjects received Foralumab treatment and 9 patients received placebo. The study was completed in September 2019.
Phase 1 clinical data demonstrated that nasally administered Foralumab, was well-tolerated and no drug-related safety issues were reported
at any of the doses. No drug-related changes were observed in vital signs among subjects at predose, during treatment and at discharge.
Nasally administered Foralumab at the 50 &#181;g dose suppressed cytotoxic CD8+ as well as perforin-secreting CD8+ cells, which have
been implicated in neurodegeneration in multiple sclerosis (MS). Treatment at 50 &#181;g stimulated production of anti-inflammatory
cytokine IL-10 and suppressed production of pro-inflammatory cytokine IFN-&#947;. Taken together, the treatment showed significant positive
effects on the biomarkers for activation of mucosal immunity, which are capable of inducing site-targeted immunomodulation to elicit
anti-inflammatory effects. .&#160;Systemic levels of Foralumab were below the lower quantitation limit of 8 ng/mL suggesting that nasally
administered Foralumab appears to exert its effects via nasal epithelium utilizing local and lymphatic immune systems directly. These
data support other clinical and pre-clinical studies showing that this route of administration is capable of inducing site-targeted immunomodulation
and anti-inflammatory effects. Furthermore, these pharmacodynamic data point to a clinical dose range that Tiziana intends to test in
further clinical development among MS patients.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">On September&#160;9, 2019,
the FDA granted approval to initiate the Phase 1 clinical trials to evaluate the safety and pharmacokinetics of a novel enteric-coated
capsule formulation of oral Foralumab at 1.25, 2.5 and 5.0 mg/day as a single ascending dose study. The study was completed in December
2019 at Brigham and Women&#8217;s Hospital (Boston, MA USA). A total of 12 subjects were enrolled; 9 received the single dose of foralumab
and 3 received placebo. The median age (range) for the oral foralumab subjects was 23 (21 &#8211; 55) years, and for the placebo subjects
it was 34 (27 &#8211; 51). Of the foralumab subjects, 6 were male and 3 were female. All 3 of the placebo subjects were female. No subjects
discontinued the study. Formulated Foralumab powder blend encapsulated in enteric-coated capsule was well-tolerated at all doses tested
and there were no drug-related safety issues observed even at the highest dose of 5 mg in this trial.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Tiziana initiated a Phase
1b clinical trial in Crohn&#8217;s disease patients to evaluate oral capsules of foralumab, a fully human&#160;anti-CD3 monoclonal antibody.
The revised protocol allowed for the study of a broader patient population and a shorter dosing period. These protocol amendments or
revisions were intended to expedite patient enrollment with study completion targeted for the fourth quarter of 2022.&#160;This study
was the first multiple-dose study with orally administered enteric-coated capsules of foralumab in patients with Crohn&#8217;s disease.
Due to the refocus of the company after the first six months of 2022, this study was withdrawn.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">A collaborative clinical
trial was initiated on November 2, 2020 in&#160;Brazil&#160;investigating nasally administered Foralumab, either alone or in combination
with orally administered dexamethasone (&#8220;Dexa&#8221;) in COVID-19 patients. The clinical study was completed in collaboration with
scientific teams at the&#160;Harvard Medical School&#160;(Boston, USA), and INTRIALS, a full-service Latin American CRO based in&#160;S&#227;o
Paulo, Brazil.&#160;The objectives of the trial were to assess safety of the treatment and to evaluate if progression of the diseases
is delayed with nasally administered 100mcg/day Foralumab (50mcg/nostril). This study enrolled 39 patients randomized in three cohorts:
cohort 1, control with no treatment (n=16); cohort 2; nasally administered Foralumab plus 3 days of priming with orally administered
6 mg Dexamethasone (n=11) and cohort 3; nasally administered Foralumab (n=12). The Foralumab treatment regimen was once a day dosing
for 10 consecutive days. The trial was completed in January 2021. There were no significant differences between cohort 2 and 3. All treatments
were well-tolerated. There were no grade 3 or 4 severe adverse events (&#8220;SAEs&#8221;) in any of the cohorts<i>.</i>&#160;The CT
scans of the lungs showed the improvement was approximately double that shown in patients treated with Foralumab as compared to those
in the control group. &#160; The results of the study were published in the&#160;peer-reviewed journal,&#160;<i>Frontiers in Immunology</i>&#160;entitled
&#8220;Nasal Administration of Anti-CD3 Monoclonal Antibody (Foralumab) Reduces Lung Inflammation and Blood Inflammatory Biomarkers in
Mild to Moderate COVID-19 Patients: A Pilot Study&#8221; in&#160;August 2021. This program has been temporarily paused to pursue the
short term focus on clinical development of intranasal foralumab administration for treatment of SPMS patients.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">On September 2, 2021 the
Company and Precision BioSciences Inc announced an exclusive license agreement to explore Foralumab as an agent to induce tolerance of
allogeneic CAR T cells to potentially improve the clinical outcome of CAR T cell therapy. Precision&#8217;s approach to manufacturing
produces CAR T cells that are virtually CD3-negative. Foralumab will be used as a lymphodepletion or tolerizing agent, either alone or
in combination with other co-stimulatory molecules, to improve the long-term survival of CAR T cells in cancer treatment. Tiziana has
completed manufacturing of foralumab solution for injection to be used by Precision Biosciences.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: #FEFEFE">On
May 25, 2021 the Company announced that&#160;the first expanded access (EA) patient with secondary progressive multiple sclerosis (SPMS)
was dosed with nasally administered Foralumab at the&#160;Brigham and Women&#8217;s Hospital&#160;(BWH),&#160;Harvard Medical School,&#160;Boston,
MA.&#160;Nasal Foralumab 50 mcg (25 mcg/nostril) was administered in 3-week cycles, with 3 times/week dosing for the first 2 weeks followed
by 1 week of rest period. This first-ever clinical study in SPMS patients, under an Individual Patient Expanded Access IND, was to continue
for six months to evaluate routine safety, tolerability, and neurological behaviors. The study also examined microglial activation, by&#160;positron
emission tomography (PET), immunological and neurodegenerative markers to assess clinical responses following the dosing regimen</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: #FEFEFE">&#160;</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: #FEFEFE">On
March 10, 2022, the Company reported positive clinical data in the first EA SPMS patient following completion of six months of treatment
with intranasally administered foralumab, at the Brigham and Women&#8217;s Hospital (BWH),&#160;Harvard University,&#160;Boston, MA.&#160;In
addition to being well-tolerated, both biological and clinical improvements were seen in this patient using Tiziana&#8217;s novel immunotherapy
technology, which, importantly overcame the challenge of effecting immunomodulation in the brain using nasal administration.</p><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: #FEFEFE">

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: #FEFEFE">Foralumab
was given to an EA SPMS patient intranasally into each nostril on a regimen of M-W-F for two weeks followed by one week off therapy for
a period of six months. This regimen was well-tolerated with associated beneficial clinical and biomarker changes. Importantly, the PET
imaging data indicated inhibition of microglial cell activation observed at 3 months following treatment initiation and was sustained
at 6 months after treatment start (see Table 1). The reduction in microglial activation was seen in all parts of the brain.</p><div>

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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: #FEFEFE"><b>Table 1. Percent
Reduction* in Activated Microglial Cells (AMCs) PET Signal After Starting Intranasal Foralumab as Compared to Baseline, in Whole Brain
and Selected Brain Regions</b></p><div>

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

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 100%">
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    <td style="width: 1%; text-align: left">&#160;</td><td style="width: 9%; text-align: right">-20</td><td style="width: 1%; text-align: left">%</td><td style="width: 1%">&#160;</td>
    <td style="width: 1%; text-align: left">&#160;</td><td style="width: 9%; text-align: right">-25</td><td style="width: 1%; text-align: left">%</td><td style="width: 1%">&#160;</td>
    <td style="width: 1%; text-align: left">&#160;</td><td style="width: 9%; text-align: right">-22</td><td style="width: 1%; text-align: left">%</td></tr>
  <tr style="vertical-align: bottom; ">
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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>
    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td></tr>
  <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">-38</td><td style="text-align: left">%</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">-50</td><td style="text-align: left">%</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">-36</td><td style="text-align: left">%</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">-38</td><td style="text-align: left">%</td></tr>
  </table><div>

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

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
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    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">*</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Percent reduction is based
    on changes from baseline in SUVR-1, a surrogate index for PET binding potential. SUVR=Standardized Uptake Value Ratio, calculated
    with reference to a pseudo reference region in cerebral white matter that showed minimal change in PET SUV, across time points.</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: #FEFEFE">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Consistent with clinical
and PET observations, intranasally administered foralumab also downregulated serum levels of pro-inflammatory cytokines, including interferon-gamma
(IFN-g), interleukin (IL-18), IL-1&#946; and IL-6, which are associated with multiple sclerosis pathogenesis and progression. Clinical
evaluation showed improvement in Timed 25-Foot Walk Test (T25FW), 9-Hole&#160;Peg Test&#160;(9HPT) and Symbol Digit Modality Test (SDMT).
Other published PET studies have shown an increase in activated microglial cells (AMCs) in patients with secondary progressive MS (SPMS),
and the increase in AMCs associated with higher scores on the Expanded Disability Status Scale (EDSS), a widely-used scale to measure
disability<sup>1,2</sup>. Several FDA-approved drugs, such as TYSABRI<sup>&#174;</sup>, MAYZENT<sup>&#174;</sup>&#160;and ZEPOSIA<sup>&#174;</sup>&#160;have
been shown to suppress microglial activation and exert neuroprotective effects in the central nervous system (CNS) in animal studies
but longitudinal assessment of drug effects on microglial activation in exclusive cohorts of SPMS patients are lacking.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Prior to treatment, this
patient had continued to experience worsening disease progression despite several MS therapies, including B cell depletion. The patient&#8217;s
gait and limb strength had been deteriorating over the prior two years. The patient then started on intranasal foralumab, which stabilized
his disease course. Tiziana also received FDA authorization to continue treating this patient for an additional 6 months to determine
if 12 months of consistent treatment maintains clinical stabilization and provides sustained clinical benefits.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">On January 20, 2022, FDA
approved enrollment of a second EA SPMS patient for treatment with intranasal foralumab.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">These data were presented
in a virtual Key Opinion Leader (KOL) event hosted by Tiziana on&#160;March 14<sup>th</sup>, 2022, entitled &#8220;Foralumab Clinical
Update in Multiple Sclerosis; A Landmark Study with Intranasal Immunotherapy&#8221; featuring four Key Opinion Leaders and a live Q&amp;A
session. The company plans to continue treatment of EA SPMS patients at Brigham and Women&#8217;s Hospital and elsewhere and continue
evaluation of foralumab treatment.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">On April 5, 2022, Tiziana
announced that FDA granted permission to enroll up to eight additional (SPMS) patients in the Intermediate Size Patient Population EAP
with intranasal foralumab. As part of the original treatment plan, the foralumab dose will remain 50 mcg three times a week (MWF), which
is the same dose administered previously to the first two SPMS patients. The dosing regimen in this IND also has a provision for dose
escalation up to 100 mcg three times a week (MWF) as an option to improve clinical benefit, if needed.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Data from a Secondary Progressive
Multiple Sclerosis patient treated with intranasal foralumab were presented on&#160;June 2, 2022&#160;at the consortium of multiple sclerosis
centers (CMSC) 2022 annual meeting. Dr.&#160;Tanuja Chitnis, MD, Professor of Neurology and the Principal investigator of the clinical
study at the at the Brigham and Women&#8217;s Hospital (BWH),&#160;Boston, MA., presented a poster discussing clinical data from a patient
with SPMS, who was treated with intranasal foralumab for six months.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">On June 8, 2022, Tiziana
announced positive clinical results for the second patient (EA2) in the non-active SPMS Expanded Access (EA) Program following three
months of dosing with intranasal foralumab. These results confirm the previously reported data, from the first non-active SPMS patient
(EA1) that after three months of treatment, intranasal foralumab. was well-tolerated and improved clinical and PET imaging analyses.
The second patient was diagnosed with SPMS in 2014. Since then, the disease has been progressive, resulting in an accumulation of disability.
Patient EA2 started ocrelizumab in 2018 and stopped this treatment in 2021. During this time EA2&#8217;s non-active SPMS progressed as
measured by EDSS worsening from 3.5 in 2018 to 6.0 in 2021. At this point in time EA2 needed a cane to walk 100 meters. Patient EA2 was
subsequently enrolled in the intranasal foralumab expanded access program. On&#160;September 2022, 8 months after starting treatment
with intranasal foralumab, EA2 was able to walk 100 meters without a cane or need to rest. This improved the EDSS from 6.0 to 5.5. EA2&#8217;s
pyramidal score remained stable during this time. In&#160;December 2022, 11 months after starting treatment with intranasal foralumab,
EA2 was able to walk 200 meters without a cane or need to rest, resulting in further improvement in EDSS from 5.5 to 5.0. EA2&#8217;s
pyramidal score continued to remain stable. Lastly preliminary reading of EA2&#8217;s 11-month PET Scan (December 2022) demonstrated
improvement in microglial activation over baseline.</p><div>

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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">On&#160;September 20, 2022,
Tiziana announced that the second patient (&#8220;EA2&#8221;) with non-active secondary progressive multiple sclerosis (SPMS) receiving
intranasal foralumab had shown additional clinical improvements as measured by the Expanded Disability Status Scale (EDSS), a standard
clinical assessment.</p><div>

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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">On October 12, 2022, Tiziana
announced that it planned to submit an Investigational New Drug Application (IND) for a Phase 1 Trial of intranasal foralumab in Alzheimer's
disease patients after receiving an affirmative written response from the FDA on a Pre-Investigational New Drug Application (PIND). Tiziana
plans on filing the IND for Alzheimer&#8217;s disease by the third quarter of 2023 upon the completion of requested toxicology studies,
then starting its Phase 1 program by the end of 2023.<br/>
<br/></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">On&#160;November 2, 2022,
Tiziana announced the completion of enrollment of the first patient cohort in its Intermediate Size Patient Population Expanded Access
Program to evaluate foralumab in non-active SPMS patients.<br/>
<br/></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">On&#160;November 10, 2022,
Tiziana announced its near-term focus on developing intranasal foralumab for inflammatory diseases of the Central Nervous System (CNS)
such as non-active SPMS, Alzheimer&#8217;s disease and amyotrophic lateral sclerosis (ALS).</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: #FEFEFE">&#160;</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">During 2022, Tiziana completed
compatibility, stability and characterization studies of foralumab nasal solution in unit dose devices for nasal administration.</p><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">

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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">We are evaluating administrations
of Foralumab to delay onset and progression of T1D in at-risk individuals. T1D is characterized as a chronic and progressive autoimmune
disease leading to the destruction of insulin-producing &#946;-cells of the pancreas. Teplizumab (Provention Bio), a humanized Fc-mutated
anti-CD3 monoclonal antibody that alters the function of the T-lymphocytes that mediate the destruction of the insulin-producing &#946;-cell
is seeking FDA approval. The Company believes that Foralumab, a fully human anti-CD3 mAb, would have a better safety profile and clinical
benefit than Teplizumab based on Foralumab&#8217;s fully human protein sequence and binding affinity for CD3e compared to Teplizumab.
cGMP manufacturing of Foralumab solution for subcutaneous injection was initiated in April 2022 and IND submission is anticipated in 2023.
This program has been temporarily paused to pursue the short-term focus on clinical development of intranasal foralumab administration
for treatment of SPMS patients.</p><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">In 2022, Tiziana initiated
five Good Laboratory Practice (GLP) safety toxicology studies of foralumab administered intranasally and subcutaneously in HuGEMM CD3
transgenic mice. The five studies consisted of three intranasal toxicology studies of 14 days, 13 weeks and 26 weeks dosing duration
and two subcutaneous safety toxicology studies of 14 days and 28 days dosing duration. On&#160;December 15, 2022&#160;the Company announced
that it had successfully completed the 13-week toxicology trial and that intranasal foralumab was well-tolerated.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">In addition, on August 18,
2020 the United States Patent and Trademark Office, or USPTO, granted us a patent on use and methods of treatment of Crohn&#8217;s disease
with Foralumab, its proprietary fully human monoclonal antibody, and all other anti-CD3 mAbs.&#160;The CD3 (cluster of differentiation
3) is a protein complex on T-cells, which is important for the regulation of the immune system. The patent was published by the USPTO
on September 1, 2020 as Patent No.&#160;10,759,858.&#160;Recently, we also announced the issuance of the first-ever patent on oral administration
of anti-CD3 mAbs for treatment of human diseases (Patent No.&#160;10,688,186). We believe the grant of this additional composition-of-matter
and use patent further strengthens our intellectual property, consisting of proprietary technologies on oral and nasal administration
of Foralumab and other anti-CD3 mAbs for the treatment of human diseases.</p><div>

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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">On July 16, 2020, we&#160;announced
that we had submitted a patent application on the potential use of Foralumab, a fully human anti-CD3 mAbs, to improve success of chimeric
antigen receptor T-cell, or CAR-T, therapy for cancer and other human diseases. The patent application conveys inventions related lymphodepletion
to improving CAR-T expansion and/or survival using anti-CD-3 mAbs administered either alone or in combination with other co-stimulatory
molecules, such as an anti-IL-6R mAb, an anti-CD28 mAb or specific inhibitors of signaling pathways of phosphatidylinositol 3-kinase
(PI3K), protein kinase B (AKT), or mammalian target of rapamycin (mTOR).</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">On July 31, 2020, we announced
that we had submitted a patent application for the potential use of nasally administered Foralumab, a fully human anti-CD3 mAb, for the
treatment of COVID-19 either alone or in combination with other anti-viral drugs. Recent clinical studies implied that a combination
of anti-inflammatory and anti-viral drugs may be more effective to treat patients at different stages of COVID-19 disease.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">We are accelerating development
of a fully human mAb targeting the IL-6R (TZLS-501) for which the intellectual property was licensed from Novimmune in January 2017.
This fully human mAb has a novel mechanism of action, binding to both the membrane-bound and soluble forms of the IL-6R as well as depleting
circulating levels of the IL-6 in the blood. Excessive production of IL-6 is regarded as a key driver of acute inflammation resulting
from infection with viral agents such as Coronaviruses and of chronic inflammation, associated with autoimmune diseases such as multiple
myeloma, oncology indications and rheumatoid arthritis, and we believe that TZLS-501 may have potential therapeutic value for these indications.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">In preclinical studies, TZLS-501
demonstrated the potential for overcoming the limitations of other IL-6 blocking pathway drugs. Compared to tocilizumab and sarilumab,
while binding to the membrane-bound IL-6R complex, TZLS-501 has been observed to have a higher affinity for the soluble IL-6 receptor
from antibody binding studies conducted in cell culture. TZLS-501 also demonstrated the potential to block or reduce IL-6 signaling in
mouse models of inflammation. The soluble form of IL-6 has been implicated to have a larger role in disease progression compared to the
membrane- bound form (Kallen, K.J. (2002). &#8220;The role of trans-signaling via the agonistic soluble IL-6 receptor in human diseases.&#8221;
Biochimica et Biophysica Acta. 1592 (3): 323&#8211;343.)</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">The Company is advancing development
of TZLS-501 for treatment of Interstitial lung disease associated with systemic sclerosis (SSc-ILD). Tocilizumab (Actemra&#174;, Roche)
a humanized interleukin-6 (IL-6) receptor mAb antagonist. was approved by the FDA as a subcutaneous injection for slowing the rate of
decline in pulmonary function in adult patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD), a debilitating
condition with limited treatment options. Actemra&#174; is the first biologic therapy approved by the FDA for the treatment of the disease.</p><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">

</p><p style="font: 10pt Times New Roman, Times, Serif; text-align: justify; margin: 0pt 0; text-indent: 13.5pt; background-color: #FEFEFE">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">On April 9, 2020 The Company
announced that it had developed investigational new technology to treat COVID-19 infections, consisting of direct delivery of anti-IL-6
receptor (anti-IL-6R) monoclonal antibodies (mAbs) into the lungs using a handheld inhaler or nebulizer for treatment of patients infected
with COVID-19 (SARS-CoV-2)&#160;coronavirus.&#160;On June 29, 2020 the Company announced that it was advancing GMP manufacturing of TZLS-501
with STC Biologics concurrently with the development of inhalation technology using a hand-held nebulizer with Sciarra Laboratories and
safety toxicology studies in Cynomolgus monkeys with ITR Canada Laboratories. GMP batches were initiated in January 2021 and completed
in March 2021. Safety inhalation toxicology studies were initiated in November 2020 and completed in March 2021. Technological assessment
of nebulizers for inhalation treatment of patients was initiated in September 2020 and completed in February 2021. An additional 240L
cGMP batch of TZLS-501 drug substance was manufactured using an improved downstream process to support future development activities.
An IND for a Phase 1 Clinical Trial in Healthy Subjects for treatment of interstitial lung disease associated with systemic sclerosis
(SSc ILD) was filed in December 2021. This program has been temporarily paused to pursue the Company&#8217;s short term focus on clinical
development of intranasal foralumab administration for treatment of SPMS patients.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 13.5pt; background-color: #FEFEFE">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">We are developing Milciclib,
for which we in-licensed the intellectual property from Nerviano Medical Sciences S.r.l., or Nerviano, in January 2015, as a potential
treatment for pan KRAS mutations in NSCLC patients.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">To date, Milciclib has been
studied in a total of eight completed Phase 1 and 2 clinical trials in 316 patients. In these trials, Milciclib was observed to be well-tolerated
and showed initial signals of anti-tumor action. Prior to in-licensing, Milciclib was granted orphan designation by the European Commission
and by the U.S. Food and Drug Administration (&#8220;FDA&#8221;) for the treatment of malignant thymoma and an aggressive form of thymic
carcinoma in patients previously treated with chemotherapy. In two Phase 2a trials, CDKO-125a-006 and CDKO125a-007, Milciclib showed
signs of slowing disease progression and acceptable safety.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">In the first half of 2017,
the Group initiated a Phase 2a trial (CDKO-125a-010) of Milciclib to explore safety, tolerability and antitumor activity of milciclib
as a single therapy in Sorafenib-resistant patients with unresectable or metastatic HCC and good liver function.. Typically, this population
of patients have an advanced form of the disease with poor prognosis and an average overall survival expectancy of 3-5 months. The compound
was administered as home-based treatment at the dose of 100 mg/day for 4 consecutive days a week in a 4-week cycle (4 days on/3 days
off x q4 wks) for a total of 24 weeks.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">The Phase 2a trial was completed
in June 2019 with clinical safety result reported in July 2019 and efficacy results reported in September 2019.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Since overexpression of CDKs
and dysregulation in pRB pathway (regulates transcription factors critical for cell cycle progression) are prominently associated with
tumor cell resistance to certain chemotherapeutic drugs, inhibition of multiple CDKs is an appealing approach to improve clinical responses
in cancer patient&#8217;s refractory to existing treatment options. A Phase 1 dose-escalation&#160;study of Milciclib in combination
with gemcitabine in patients with refractory solid tumors exhibited clinical activity in patients including those refractory to gemcitabine.
Milciclib shows inhibitory effects against multiple cell lines with mutationally active G12D (non-small cell lung carcinoma), G13D (colorectal
cancer), G12V(pancreatic cancer), and G12C (pancreatic cancer<b>&#160;</b>The Company also intends to evaluate milciclib in combination
with gemcitabine for treatment of pan KRAS mutations in NSCLC patients. cGMP manufacturing of milciclib capsules was completed in January
2022 and IND filing was completed on December 15, 2022. This program has been temporarily paused to pursue the short-term focus on clinical
development of intranasal foralumab administration for treatment of SPMS patients.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-align: justify; text-indent: 0.25in; background-color: #FEFEFE">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><b>Our Competitive Strengths</b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Our mission is to design
and deliver next generation therapeutics and diagnostics for oncology and immune diseases of high unmet medical need by combining deep
understanding of disease biology with clinical development expertise. We believe the following strengths will allow us to continue to
pursue this mission:</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Advanced, novel pipeline</i></b>.
    We have an advanced pipeline of novel and proprietary drug candidates, including antibodies and small molecules, to address high
    unmet medical needs in the inflammation, autoimmune and oncology markets with significant commercial potential.</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Proprietary technology</i></b>.
    Our proprietary technology enables the development of alternative routes of administration of antibodies, including oral delivery.
    We believe that oral and nasal routes of delivery will alleviate the significant time and cost burden associated with other routes
    of administration, including intravenous delivery.</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&#160;&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Broad and engaged
    network of experts. </i></b>Our strong relationships with key opinion leaders contribute to our clinical development efforts and
    position us well to support our products, if approved. Dr. Napoleone Ferrara, Dr. Arun Sanyal, Dr. Kevan Herold, and Dr. Howard Weiner
    are among &#160;&#160;the thought leaders on our scientific advisory committee.</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Specialized expertise
    and focus on oncology and inflammation</i></b>. Our management team, including Dr. Matthew Davis, Jules Jacob, and Dr. Vaseem Palejwala,
    has considerable experience translating technologies from bench to market, and managing the global administration of clinical trials.</span></td></tr>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Strong intellectual
    property and know-how</i></b>. We believe our proprietary intellectual property portfolio, in-licensed from Nerviano and Novimmune,
    provides us with a substantial competitive advantage for the commercial development of small molecule NCEs, and biologics, as well
    as expanded possibilities for new development programs in the future. We have retained the worldwide development and commercialization
    rights to all of our product candidates. We have submitted additional patent applications to further strengthen our intellectual
    property.</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b><i>Lean research and
    development model, designed to maximize value</i></b>. We employ a lean and virtual R&amp;D model using highly experienced teams
    of experts for each business function to maximize value accretion by focusing resources on the drug discovery and development processes.</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>


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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

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

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Our goal is to become a leading
biotechnology company focused on developing and delivering therapies and related diagnostics in both oncology and immunology. The key
elements of our strategy to achieve this goal are to:</p><div>

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

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Advance the clinical development of intranasally-administered
Foralumab for treatment of neurodegenerative diseases, particularly SPMS, and potentially including Alzheimer&#8217;s Disease, ALS and
intracerebral hemorrhage (hemorrhagic stroke). Tiziana will continue to supply foralumab for intranasal treatment of up to 10 EA patients
at Brigham and Women&#8217;s Hospital and plans to initiate a multisite Phase 2 trial for treatment of SPMS patients in Q3 2023.&#160;</p>
    <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">The following programs have been paused temporarily to focus Tiziana&#8217;s
clinical development efforts on intranasal foralumab for treatment of SPMS and other neurodegenerative disease.&#160;</p><div>

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

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Development of our product
candidate, TZLS-501, a fully human mAb targeting the IL-6 receptor (a biological mAb which may control the proteins involved in cell
signaling relevant to many inflammatory diseases and cancers), for treatment of inflammatory and oncology indications especially SSc-ILD.
Additional cGMP manufacturing and IND-enabling GLP safety toxicology studies in Cynomolgus monkeys, have been completed evaluation/qualification
of hand-held nebulizers for pulmonary administration of TZLS-501&#160;for SSc-ILD treatment have been completed </span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><tr style="vertical-align: top; text-align: justify">
<td style="width: 0.5in"></td><td style="width: 0.25in; text-align: left"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td><td style="text-align: justify">Clinical
                                            development and obtain regulatory approval for our lead oncology product candidate, Milciclib,
                                            as a combination therapy for the treatment of refractory solid tumors (being cancers which
                                            are non-responsive or become resistant to treatment), especially NSCLC. An IND was filed
                                            on December 15, 2022.</td>
</tr></table><div>


</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 34.65pt">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin-left: 0.75in; margin-top: 0pt; margin-bottom: 0in">The following activities
will continue to be pursued aggressively:</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin-left: 0.75in; margin-top: 0pt; margin-bottom: 0in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px; font-size: 10pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font-size: 10pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Continue development of platform drug delivery technologies that provide competitive advantage over existing approved products, e.g. inhalation delivery, nasal delivery and enteric delivery of mAbs.</span></td></tr>
  </table><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin-left: 0.75in; margin-top: 0pt; margin-bottom: 0in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px; font-size: 10pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify; font-size: 10pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Continue relationship with Precision Biosciences to improve CAR-T therapy using foralumab immunomodulation to enhance survival of CAR-T cells</span></td></tr>
  </table><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin-left: 0.75in; margin-top: 0pt; margin-bottom: 0in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Continue to leverage relationships
    with key opinion leaders to promote clinical trial success and enhance future commercialization.&#160;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Opportunistically identify
    and acquire or in-license complimentary product and technology candidates.</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Seek orphan drug, fast
    track or breakthrough designation for our product candidates where warranted.</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><b>Our Product Candidates</b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Our product candidate pipeline
is set forth below:</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><b>DEVELOPMENT PIPELINE</b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><img alt="" src="image_001.jpg"/></p><div>

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


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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><b>Foralumab (TZLS-401 formerly known as NI-0401)</b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">We believe Foralumab is
the only fully human anti-CD3 mAb in clinical development, in contrast to the previous non-human or humanized anti-CD3 mAbs.
Foralumab targets the CD3 epsilon (CD3&#949;) receptor, which is a recognized approach for modulating T-Cell response and
achieving immunosuppression. We believe Foralumab could have broad application to autoimmune and inflammatory diseases, such as
inflammatory bowel disease such as MS, Crohn&#8217;s disease type-1 diabetes (T1D) psoriasis and rheumatoid arthritis, where
modulation of a T-cell response is desirable. In July 2017, we announced publication of a research article in, Clinical Immunology,
entitled: &#8220;Oral treatment with Foralumab, a fully human anti-CD3 mAb, prevents skin xenograft rejection in humanized
mice.&#8221; We believe this is the first-ever published report demonstrating the potential of oral therapy with Foralumab for
inflammatory diseases and is based on the landmark discovery by Prof. Howard Weiner of Harvard University, one of our Scientific
Advisory Committee members.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">On April 16, 2018, the Group
entered into an exclusive license agreement with The Brigham and Women&#8217;s Hospital, Inc. relating to a novel formulation of Foralumab
dosed in a medical device for nasal administration. An investigational new drug application (IND) for the first-in-human evaluation of
the nasal administration of Foralumab in healthy volunteers for progressive multiple sclerosis indication was filed in the second quarter
of 2018. Subsequent to IND approval, a single-site, double-blind, placebo-controlled, dose-ranging Phase 1 trial with nasally administered
Foralumab at 10, 50 and 250 &#181;g per day, consecutively for 5 days to evaluate biomarkers of immunomodulation of clinical responses
was initiated in November 2018. The trial conducted at the Brigham and Women&#8217;s Hospital, Harvard Medical School, Boston, MA, in
healthy volunteers. 18 subjects received Foralumab treatment and 9 patients received placebo. The study was completed in September 2019.
Phase 1 clinical data demonstrated that nasally administered Foralumab, was well-tolerated and no drug-related safety issues were reported
at any of the doses. No drug-related changes were observed in vital signs among subjects at predose, during treatment and at discharge.
The mean blood pressure (BP) during the 5 days of treatment were; Cohort A (10 &#181;g/d):124/73, Cohort B (50 &#181;g/d): 119/67 and
Cohort C (250 &#181;g/d):113/65 compared to placebo:118/67). Heart rates, respiratory rates and oral temperatures were unchanged among
the 3 cohorts compared to the placebo. Nasally administered Foralumab at the 50 &#181;g dose suppressed cytotoxic CD8+ as well as perforin
secreting CD8+ cells, which have been implicated in neurodegeneration in multiple sclerosis (MS). Treatment at 50 mg stimulated production
of anti-inflammatory cytokine IL-10 and suppressed production of pro-inflammatory cytokine IFN-&#947;. Taken together, the treatment
showed significant positive effects on the biomarkers for activation of mucosal immunity, which are capable of inducing site-targeted
immunomodulation to elicit anti-inflammatory effects. Based on the results we intend to conduct a Phase 2 trial in secondary progressive
MS (SPMS) patients starting in Q3 2023.</p><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">An enteric-coated capsule
formulation using a proprietary and novel technology has been developed for oral administration of Foralumab. cGMP manufacturing of clinical
trial materials for a Phase 1 study has been completed and an IND was submitted in March 2019.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">On September&#160;9, 2019,
the FDA granted approval to initiate the Phase 1 clinical trial to evaluate the safety and pharmacokinetics of a novel enteric-coated
capsule formulation of oral Foralumab at 1.25, 2.5 and 5.0 mg/day as a single ascending dose study. The study was completed in December
2019 at Brigham and Women&#8217;s Hospital (Boston, MA USA). A total of 12 subjects were enrolled; 9 received the single dose of foralumab
and 3 received placebo. The median age (range) for the oral foralumab subjects was 23 (21 &#8211; 55) years, and for the placebo subjects
it was 34 (27 &#8211; 51). Of the foralumab subjects, 6 were male and 3 were female. All 3 of the placebo subjects were female. No subjects
discontinued the study. Formulated Foralumab powder blend encapsulated in enteric-coated capsules was well-tolerated at all doses tested
and there were no drug-related safety issues observed even at the highest dose of 5 mg in this trial.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Tiziana initiated a Phase
1b clinical trial in Crohn&#8217;s disease patients to evaluate oral capsules of foralumab, a fully human&#160;anti-CD3 monoclonal antibody.
The revised protocol allowed for the study of a broader patient population and a shorter dosing period. These protocol amendments or
revisions were intended to expedite patient enrollment with study completion targeted for the fourth quarter of 2022.&#160;This study
was to be the first multiple-dose study with orally administered enteric-coated capsules of foralumab in patients with Crohn&#8217;s
disease. Due to the refocus of the company subsequent to the first six months of 2022, this study has been withdrawn to focus
on nasal administration studies for SPMS indication</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">A collaborative clinical
study was initiated on November 2, 2020, investigating nasally administered Foralumab either alone or in combination with orally administered
dexamethasone in COVID-19 patients in Brazil. In view of the importance and urgency, scientific teams at the Harvard Medical School,
Santa Casa de Miseric&#243;rdia de Santos Hospital (Jabaquara, Santos, Brazil) and at our company closely collaborated to facilitate
initiation of this study in expedited time frames. The clinical trial was coordinated by the team at INTRIALS, a leading, full-service
Latin America Clinical Research Organization, (CRO) based in Sao Paulo City, Brazil. The trial was completed in January 2021. This trial,
the first-ever trial on nasal administration of Foralumab for treatment of COVID-19, is of enormous significance because the underlying
scientific approach is to modulate immune system, which is dysregulated and crippled to protect against the virus The results of the
trial were All treatments were well-tolerated. There were no grade 3 or 4 severe adverse events (&#8220;SAEs&#8221;) in any of the cohorts<i>.</i>&#160;The
CT scans of the lungs showed the improvement was approximately double that shown in patients treated with Foralumab as compared to those
in the control group. &#160; The results of the study were published in the&#160;peer-reviewed journal,&#160;<i>Frontiers in Immunology</i>&#160;entitled
&#8220;Nasal Administration of Anti-CD3 Monoclonal Antibody (Foralumab) Reduces Lung Inflammation and Blood Inflammatory Biomarkers in Mild
to Moderate COVID-19 Patients: A Pilot Study&#8221; in&#160;August 2021. The study served as &#8220;proof of concept&#8221; that nasal
administration of foralumab could be used to treat systemic inflammatory response related to COVID infection and could be used for treatment
of other systemic inflammatory diseases. The Company has refocused development of Foralumab for treatment of Crohn&#8217;s disease (oral
treatment) and progressive MS (nasal treatment) utilizing site specific delivery technologies to limit systemic exposure of foralumab
which achieving local delivery to inflamed tissue. Further development has been paused because of the Company&#8217;s refocus on administration
of nasal foralumab for SPMS and other neurodegenerative diseases.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">MS is an inflammatory-mediated
demyelinating disease of the human central nervous system. The disease develops in young adults with a complex predisposing genetic trait
and most likely involves an environmental insult such as a viral infection to trigger the disease. The activation of CD4+ autoreactive
T cells and their differentiation are crucial initial steps in the progression of this disease. The therapeutic use of monoclonal antibodies
was initially viewed with great skepticism owing to the high rates of sensitization against mouse proteins, their pharmacokinetic properties,
and the difficulties in their production. However, most of these problems have been overcome, and monoclonal antibodies are now among
the most promising therapies for MS.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">The innate immune system
plays a central role in the chronic central nervous system inflammation that drives neurological disability in progressive forms of multiple
sclerosis, for which there are few effective treatments. The mucosal immune system is a unique tolerogenic organ that provides a physiological
approach for the induction of regulatory T&#160;cells. Nasal administration of CD3-specific antibody ameliorates disease in a progressive
animal model of multiple sclerosis. This effect is IL-10-dependent and is mediated by the induction of regulatory T cells that share
a similar transcriptional profile to Tr1 regulatory cells and that suppress the astrocyte inflammatory transcriptional program. Treatment
results in an attenuated inflammatory milieu in the central nervous system decreased microglia activation, reduced recruitment of peripheral
monocytes, stabilization of the blood-brain barrier, less neurodegeneration, and decreased accumulation of neurologic disability (Mayo,&#160;2016).
Patients with non-active secondary progressive MS, demonstrate increased microglial activation that drives disease progression. These
nonclinical findings suggest foralumab may be a new therapeutic approach for the treatment of progressive forms of multiple sclerosis.
Based on this work, we hypothesize that nasal foralumab will slow disability accumulation and microglial activation measured by PET imaging
in non-active secondary progressive multiple sclerosis. Two patients with non-active SPMS have been treated for 12 or more months with
a suggestion of clinical improvement and no clinically significant adverse events.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Binding of foralumab to the
T-cell receptor complex, through the nasal, results in suppression of effector T-cells involved in various inflammatory and autoimmune
diseases along with a reduction in inflammatory cytokines and increase in Tregs anti inflammatory cytokines resulting in site-targeted
immunomodulation.</p><div>

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</div><p style="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><img alt="" src="image_002.jpg" style="height: 179.25pt; width: 468pt"/></p><div>

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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><i>Autoimmune and Inflammatory Diseases</i></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Autoimmune diseases are primarily
due to a malfunction when the immune system attacks certain cells in the body as foreign invaders. This can result in irreparable damage
to critical organs and tissues eventually resulting in autoimmune diseases.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">In humans, CD3-epsilon is
encoded by the CD3&#949; gene on Chromosome 11. The CD3&#949; molecule, along with four other membrane-bound polypeptides (CD3-gamma,
-delta, -zeta, and -eta) form the CD3 complex, which is associated with the T-cell receptor. Upon antigen bindings, the CD3 complex sends
signals through the cell membrane to the cytoplasm inside the T-cell. This leads to activation of the T-cell that rapidly divides to
produce new T-cells sensitized to fight the particular antigen to which the TCR was exposed. While T-cell activation is critical for
the human immune system to properly fight bacterial, viral or parasitic infections, abnormal T-cell induction can cause and worsen numerous
human diseases, including T-cell lymphoma and leukemia, human malignancies, autoimmune disorders, cardiovascular disease and transplant
rejection.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

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

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">We believe Foralumab is the
only fully human anti-CD3 mAb in clinical development. Since the discovery of the hybridoma technology, a method to generate large quantities
of a single (monoclonal) antibody, the production and manufacture of mAbs has become widely available showing promise in several autoimmune
and inflammatory disease clinical trials and therapeutic utility in animal models. The first murine anti-CD3 mAb (IgG2a) was developed
and approved by the FDA in 1985 under the name of muromonab, OKT3, (Ortho Kung T3; Orthoclone&#174;) to treat allograft rejection in kidney,
liver and heart transplantation by exerting its potent immunosuppressive effects, mainly due to depletion of T-cells in tissues and thereby
preventing rejection of the allografts. Subsequently, OKT3 was administered in clinical trials to patients with MS, T1D, inflammatory
bowel disease, rheumatoid arthritis and NASH. Although showing promise to alleviate the disease process, the mAb being of murine origin
and extremely immunogenic in humans, was associated with a wide range of side effects that included the typical Cytokine Release Syndrome
(CRS) or flu-like syndrome, limiting its clinical development. The side effect profile of OKT3 is a consequence of T-cell activation
resulting in the release of numerous cytokines into the systemic circulation. These shortcomings of the murine OKT3 led to the development
of a new generation of anti-CD3 mAbs using genetic engineering of the mAb structure, as depicted below.</p><div>

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

</div><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"><img alt="" src="image_003.jpg" style="height: 135pt; width: 371.25pt"/></span></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Foralumab dosed intravenously
has been observed to alter T-cell function via antigenic modulation, that is, removal of the CD3/TCR complex from the T-cell surface.
Modulation has two therapeutic benefits:</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">It transiently renders
    the T-cells incapable of recognizing an antigen and thus unable to orchestrate an immune response such as an allograft rejection;
    and</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.25in; text-indent: -0.25in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">It has a favorable long-term
    effect on generation and maintenance of regulatory T-cells, a specialized subset of T-cells that promote immunological tolerance.</span></td></tr>
  </table><div>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">In comparison with the two
other anti-CD3 mAbs evaluated in patients with T1D (otelixizumab and teplizumab), Foralumab, being fully human, was less mitogenic (capable
of causing cell division), therefore allowing re-treatment, and to have a better risk/benefit profile. As such, Foralumab was previously
developed by Novimmune as an intravenous formulation for the treatment of autoimmune indications: Crohn&#8217;s disease and in renal
allograft recipients.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Further, recent data from
studies conducted in the laboratories of our Scientific Advisory Committee members, Prof. Howard Weiner of Harvard University and Prof.
Kevan Herold of Yale University, suggest that oral administration of Foralumab has the potential for therapeutic utility while minimizing
toxicity associated with intravenous administration, such as Cytokine Release Syndrome (CRS). Importantly, recent clinical studies conducted
by Prof. Yaron Ilan with oral administration of anti-CD3 (OKT3; murine mAb) in HCV infected patients (non-respondents) and in NASH patients
suggested that the treatment was well-tolerated and produced immunologic effects consistent with potential clinical benefits.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">In addition, increasing appreciation
for the gut-liver cross-talk and of its role in the initiation of NASH-associated inflammation and fibrogenesis has led to the understanding
that systemic inflammatory processes can be alleviated by modulating the gut immune system, without inducing generalized immunosuppression.
This has been achieved in multiple approaches, including oral administration of fatty liver-derived proteins, anti-CD3 antibodies, TNF,
fusion protein, anti-lipopolysaccharide antibodies, glucosylceramide, delayed-release mercaptopurine and soy-derived extracts. Several
of these compounds were shown to be effective in patients with NASH.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Orally administered OKT3
was evaluated in a Phase 2 trial in 36 patients with NASH and type 2 diabetes and was found to be well tolerated. Increases in regulatory
T-cell markers consistent with induction of regulatory T-cells was observed as well as increases in other anti-inflammatory markers.
Although not powered sufficiently to evaluate efficacy endpoints, positive trends were observed including lowering of liver enzymes and
lowering of glucose levels (Lalazar et.al, J. Clin. Immunol. (2015) 34 (4):399-407).</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">More recent animal studies
conducted separately by Prof. Howard Weiner and Prof. Kevan Herold demonstrated therapeutic utility of orally administered Foralumab
for immune-inflammatory diseases. Our strategy is to build on these findings to develop orally administered Foralumab for the treatment
of Crohn&#8217;s disease and other autoimmune diseases. We believe Foralumab may also be combined with our other product candidate, TZLS-501,
a fully human anti-IL-6R mAb, for the treatment of rheumatoid arthritis and other diseases.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">On April 16, 2018, the Group
entered into an exclusive license agreement with The Brigham and Women&#8217;s Hospital, Inc. relating to a novel formulation of Foralumab
dosed in a medical device for nasal administration. An investigational new drug application (IND) for the first-in-human evaluation of
the nasal administration of Foralumab in healthy volunteers for progressive multiple sclerosis indication was filed in the second quarter
of 2018. Subsequent to IND approval, a single-site, double-blind, placebo-controlled, dose-ranging Phase 1 trial with nasally administered
Foralumab at 10, 50 and 250 &#181;g per day, consecutively for 5 days to evaluate biomarkers of immunomodulation of clinical responses
was initiated in November 2018. The trial conducted at the Brigham and Women&#8217;s Hospital, Harvard Medical School, Boston, MA, in
healthy volunteers. 18 subjects received Foralumab treatment and 9 patients received placebo. The study was completed in September 2019.
Phase 1 clinical data demonstrated that nasally administered Foralumab, was well-tolerated and no drug-related safety issues were reported
at any of the doses. No drug-related changes were observed in vital signs among subjects at Predose, during treatment and at discharge.
The mean blood pressure (BP) during the 5 days of treatment were; Cohort A (10 &#181;g/d):124/73, Cohort B (50 &#181;g/d): 119/67 and
Cohort C (250 &#181;g/d):113/65 compared to placebo:118/67). Heart rates, respiratory rates and oral temperatures were unchanged among
the 3 cohorts compared to the placebo. Nasally administered Foralumab at the 50&#181;g dose suppressed cytotoxic CD8+ as well as perforin
secreting CD8+ cells, which have been implicated in neurodegeneration in multiple sclerosis (MS). Treatment at 50 &#181;g stimulated
production of anti-inflammatory cytokine IL-10 and suppressed production of pro-inflammatory cytokine IFN-&#947;. Taken together, the
treatment showed significant positive effects on the biomarkers for activation of mucosal immunity, which are capable of inducing site-targeted
immunomodulation to elicit anti-inflammatory effects.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">An enteric-coated capsule
formulation using a proprietary and novel technology has been developed for oral administration of Foralumab. cGMP manufacturing of clinical
trial materials for a Phase 1 study has been completed and an IND was submitted in March 2019.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">On September&#160;9, 2019,
the FDA granted approval to initiate the Phase I clinical trials to evaluate the safety and pharmacokinetics of oral Foralumab at 1.25,
2.5 and 5.0 mg/day as a single ascending dose study. The study was completed in December 2019 at Brigham and Women&#8217;s Hospital (Boston,
MA USA). Formulated Foralumab powder blend encapsulated in enteric-coated capsule was well-tolerated at all doses tested and there were
no drug-related safety issues observed even at the highest dose of 5 mg in this trial.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Tiziana initiated a Phase
1b clinical trial in Crohn&#8217;s disease patients to evaluate oral capsules of foralumab, a fully human&#160;anti-CD3 monoclonal antibody.
The revised protocol allowed for the study of a broader patient population and a shorter dosing period. These protocol amendments or
revisions were intended to expedite patient enrollment with study completion targeted for the fourth quarter of 2022.&#160;This study
was the first multiple-dose study with orally administered enteric-coated capsules of foralumab in patients with Crohn&#8217;s disease.
Due to the refocus of the company subsequent to the first six months of 2022, this study has been withdrawn.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><i>Clinical Development Plan</i></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; text-align: justify; margin-top: 0pt; margin-bottom: 0pt"><b><i>Phase 1a Clinical
Trial for Oral Foralumab in Healthy Volunteers</i></b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">This Phase 1a trial, conducted
at the Brigham and Women&#8217;s Hospital, Harvard Medical School, Boston, MA, USA, was a single-site, double-blind, placebo-controlled,
single ascending dose (&#8220;SAD&#8221;) study in healthy subjects in which Foralumab was orally administered at 1.25, 2.5 and 5.0 mg
per dose as enteric-coated capsules. The primary endpoint of the Phase 1 study is safety and tolerability of Foralumab in humans. Each
cohort comprised of 4 subjects, of whom 3 received Foralumab treatment and 1 received a placebo capsule. All subjects completed the trial
without any safety concerns at any of the doses.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; text-align: justify; margin-top: 0pt; margin-bottom: 0pt"><b><i>Phase 1 Clinical
Trial of Nasally-Administered Foralumab for Treatment of Secondary Progressive Multiple Sclerosis</i></b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">This Phase 1 trial, conducted
at the Brigham and Women&#8217;s Hospital, Harvard Medical School, Boston, MA, was a single-site, double-blind, placebo-controlled, dose-ranging
study with nasally administered Foralumab at 10, 50 and 250 &#181;g per day, consecutively for 5 days in healthy volunteers for the
treatment of progressive multiple sclerosis (pMS). 18 subjects received Foralumab treatment and 9 patients received placebo. All nasal
doses were well tolerated. Biomarker analysis showed significant positive immune effects, that were most prominent in the 50 &#181;g
cohort with minimal immunomodulatory effects at the 10 &#181;g and 250 &#181;g doses. &#160;Prominent results included:</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 13.5pt">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
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  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-align: justify; text-indent: -0.25in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-align: justify; text-indent: -0.25in"></p><div>

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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-align: justify; text-indent: -0.25in">&#160;</p><div>

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  </table><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-align: justify; text-indent: -0.25in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
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  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-align: justify; text-indent: -0.25in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-align: justify; text-indent: -0.25in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
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    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
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  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; text-align: justify; margin-top: 0pt; margin-bottom: 0pt"><b><i>Treatment of Expanded
Access SPMS Patients at Brigham and Women&#8217;s Hospital (Boston) with Nasally-Administered Foralumab </i></b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: #FEFEFE">On
May 25, 2021 the Company announced that&#160;the first expanded access (EA) patient with secondary progressive multiple sclerosis (SPMS)
was dosed with nasally administered Foralumab at the&#160;Brigham and Women&#8217;s Hospital&#160;(BWH),&#160;Harvard Medical School,&#160;Boston,
MA.&#160;Nasal Foralumab 50 mcg (25 mcg/nostril) was administered in 3-week cycles, with 3 times/week dosing for the first 2 weeks followed
by 1 week of rest period. This first-ever clinical study in SPMS patients, under an Individual Patient Expanded Access IND, was to continue
for six months to evaluate routine safety, tolerability, and neurological behaviors. The study also examined microglial activation, by&#160;positron
emission tomography (PET), immunological and neurodegenerative markers to assess clinical responses following the dosing regimen</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: #FEFEFE">&#160;</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: #FEFEFE">On
March 10, 2022, the Company reported positive clinical data in the first SPMS EA patient following completion of six months of treatment
with intranasally administered foralumab, at the Brigham and Women&#8217;s Hospital (BWH),&#160;Harvard University,&#160;Boston, MA.&#160;In
addition to being well-tolerated, both biological and clinical improvements were seen in this patient using Tiziana&#8217;s novel immunotherapy
technology, which, importantly effected immunomodulation in the brain using nasal administration.</p><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: #FEFEFE">

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: #FEFEFE">Foralumab
was given to an SPMS patient intranasally into each nostril on a regimen of M-W-F for two weeks followed by one week off therapy for
a period of six months. This regimen was well-tolerated with associated beneficial clinical and biomarker changes. Importantly, the PET
imaging data indicated inhibition of microglial cell activation observed at 3 months following treatment initiation and was sustained
at 6 months after treatment start (see Table 1). The reduction in microglial activation was seen in all parts of brain.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: #FEFEFE"><b>Table 1. Percent Reduction* in Activated
Microglial Cells (AMCs) PET Signal After Starting Intranasal Foralumab as Compared to Baseline, in Whole Brain and Selected Brain Regions</b></p><div>

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

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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: #FEFEFE">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: #FEFEFE">&#160;</p><div>


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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: #FEFEFE">Consistent
with clinical and PET observations, intranasally administered foralumab also downregulated serum levels of pro-inflammatory cytokines,
including interferon-gamma (IFN-g), interleukin (IL-18), IL-1&#946; and IL-6, which are associated with multiple sclerosis pathogenesis
and progression. Clinical evaluation showed improvement in Timed 25-Foot Walk Test (T25FW), 9-Hole&#160;Peg Test&#160;(9HPT) and Symbol
Digit Modality Test (SDMT). Other published PET studies have shown an increase in activated microglial cells (AMCs) in patients with
secondary progressive MS (SPMS), and the increase in AMCs associated with higher scores on the Expanded Disability Status Scale (EDSS),
a widely-used scale to measure disability<sup>1,2</sup>. Several FDA-approved drugs, such as TYSABRI<sup>&#174;</sup>, MAYZENT<sup>&#174;</sup>&#160;and
ZEPOSIA<sup>&#174;</sup>&#160;have been shown to suppress microglial activation and exert neuroprotective effects in the central nervous
system (CNS) in animal studies but longitudinal assessment of drug effects on microglial activation in exclusive cohorts of SPMS patients
are lacking.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: #FEFEFE">Prior
to treatment, this patient had continued to experience worsening disease progression despite several MS therapies, including B cell depletion.
The patient&#8217;s gait and limb strength had been deteriorating over the prior two years. The patient then started on intranasal foralumab,
which stabilized his disease course. Tiziana also received FDA authorization to continue treating this patient for an additional 6 months
to determine if 12 months of consistent treatment maintains clinical stabilization and provides sustained clinical benefits.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: #FEFEFE">On
January 20, 2022, FDA allowed enrollment of a second EA SPMS patient for treatment with intranasal foralumab.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">These data were presented
in a virtual Key Opinion Leader (KOL) event hosted by Tiziana on&#160;March 14<sup>th</sup>, 2022, entitled &#8220;Foralumab Clinical
Update in Multiple Sclerosis; A Landmark Study with Intranasal Immunotherapy&#8221; featuring four Key Opinion Leaders and a live Q&amp;A
session. The company plans to continue treatment of EA SPMS patients at Brigham and Women&#8217;s Hospital and elsewhere and continue
evaluation of foralumab treatment.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">On April 5, 2022, Tiziana
announced that FDA granted permission to enroll up to eight additional (SPMS) Intermediate Size Patient Population EAP with intranasal
foralumab. As part of the original treatment plan, the foralumab dose will remain 50 mcg three times a week (MWF), which is the same
dose administered previously to the first two SPMS patients. The dosing regimen in this IND also has a provision for dose escalation
up to 100 mcg three times a week (MWF) as an option to improve clinical benefit, if needed.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Data from a Secondary Progressive
Multiple Sclerosis patient treated with intranasal foralumab were presented on&#160;June 2, 2022&#160;at the consortium of multiple sclerosis
centers (CMSC) 2022 annual meeting. Dr.&#160;Tanuja Chitnis, MD, Professor of Neurology and the Principal investigator of the clinical
study at the at the Brigham and Women&#8217;s Hospital (BWH),&#160;Boston, MA., presented a poster discussing clinical data from a patient
with SPMS, who was treated with intranasal foralumab for six months.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">On June 8, 2022, Tiziana
announced positive clinical results for the second patient (EA2) in the non-active SPMS Expanded Access (EA) Program following three
months of dosing with intranasal foralumab. These results confirm the previously reported data, from the first non-active SPMS patient
(EA1) that after three months of treatment, intranasal foralumab. was well-tolerated and improved clinical and PET imaging analyses.
The second patient was diagnosed with SPMS in 2014. Since then, the disease has been progressive, resulting in an accumulation of disability.
Patient EA2 started ocrelizumab in 2018 and stopped this treatment in 2021. During this time EA2&#8217;s non-active SPMS progressed as
measured by EDSS worsening from 3.5 in 2018 to 6.0 in 2021. At this point in time EA2 needed a cane to walk 100 meters. Patient EA2 was
subsequently enrolled in the intranasal foralumab expanded access program. On&#160;September 2022, 8 months after starting treatment
with intranasal foralumab, EA2 was able to walk 100 meters without a cane or need to rest. This improved the EDSS from 6.0 to 5.5. EA2&#8217;s
pyramidal score remained stable during this time. In&#160;December 2022, 11 months after starting treatment with intranasal foralumab,
EA2 was able to walk 200 meters without a cane or need to rest, resulting in further improvement in EDSS from 5.5 to 5.0. EA2&#8217;s
pyramidal score continued to remain stable. Lastly preliminary reading of EA2&#8217;s 11-month PET Scan (December 2022) demonstrated
improvement in microglial activation over baseline.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 22.5pt; background-color: #FEFEFE">&#160;</p><div>

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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: #FEFEFE">On&#160;September
20, 2022, Tiziana announced that the second patient (&#8220;EA2&#8221;) with non-active secondary progressive multiple sclerosis (SPMS)
receiving intranasal foralumab had shown additional clinical improvements as measured by the Expanded Disability Status Scale (EDSS),
a standard clinical assessment.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 22.5pt; background-color: #FEFEFE">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">On October 12, 2022, Tiziana
announced that it planned to submit an Investigational New Drug Application (IND) for a Phase 1 Trial of intranasal foralumab in Alzheimer's
disease patients after receiving an affirmative written response from the FDA on a Pre-Investigational New Drug Application (PIND). Tiziana
plans on filing the IND for Alzheimer&#8217;s disease by the third quarter of 2023 upon the completion of requested toxicology studies,
then starting its Phase 1 program by the end of 2023.<br/>
<br/></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">On&#160;November 2, 2022,
Tiziana announced the completion of enrollment of the first patient cohort in its Intermediate Size Patient Population Expanded Access
Program to evaluate foralumab in non-active SPMS patients.<br/>
<br/></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">On&#160;November 10, 2022,
Tiziana announced its near-term focus on developing intranasal foralumab for inflammatory diseases of the Central Nervous System (CNS)
such as non-active SPMS, Alzheimer&#8217;s disease and amyotrophic lateral sclerosis (ALS).</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: #FEFEFE">The company plans
to continue treatment of EA SPMS patients at Brigham and Women&#8217;s Hospital and continue evaluation of foralumab treatment.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; text-align: justify; margin-top: 0pt; margin-bottom: 0pt"><b><i>Phase 2a Clinical
Trial of Nasally-Administered Foralumab for Treatment of Secondary Progressive Multiple Sclerosis</i></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&#160;</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">A multisite Phase 2a study
evaluating intranasal foralumab for treatment of SPMS is anticipated to start in Q3 2023 by holding the first investigator&#8217;s meeting.
This is a double-blinded, placebo-controlled study of two (2) doses of foralumab nasal solution (50 &#181;g and 100 &#181;g) delivered
intranasally compared to placebo, administered in non-active secondary progressive MS patients who are continuing to deteriorate despite
standard of care therapy.</p><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: #FEFEFE"><b><i>Earlier Phase
1 and 2 Studies Conducted by Novimmune with Intravenous Administration of Foralumab</i></b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Intravenous Foralumab has
been studied in a total of three Phase 1 and Phase 2 clinical trials conducted by Novimmune. A total of 68 patients were exposed to Foralumab:</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><b>Study NI-0401-01:</b>
a Phase 1/2a randomized, double-blind, placebo-controlled and dose escalation study NI-0401-01 in subjects with moderate to severe active
CD. The study was completed and 33 subjects were exposed to Foralumab. The study NI-0401-01 was designed to assess tolerability of Foralumab
and was not powered to evaluate efficacy parameters included the proportion of patients achieving, clinical response and change from
baseline of Crohn&#8217;s Disease Endoscopy Index of Severity. A trend, although not statistically significant, was seen when analyzing
the clinical response and endoscopic response. Single and repeat intravenous doses of 0.05, 0.1, 0.5, 1.0, 2.0 and 10.0 mg Foralumab
were administered to subjects and serum pharmacokinetics evaluated for up to five days. Limited pharmacokinetic data was collected, however
it was observed that at doses over 1.0 mg, severe infusion related reactions (IRRs) were observed that led to discontinuation of the
2 and 10 mg groups. Therefore, the 1.0 mg dose was considered the MTD in this study. CD3 modulation on CD4 positive and CD8 positive
T cells was related to Foralumab dose. There was a dose response for the reduction of peripheral T-cell (CD2 positive) count. The main
adverse events were infusion related reactions related to the route of administration of the drug.</p><div>


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</div><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"><b>Study
NI-0401-02:</b> an open-label, dose titration, multicenter Phase 1 study of Foralumab for the treatment of subjects with biopsy-proven
acute cellular renal allograft rejection (BpACR). The study was completed and 11 subjects were exposed to Foralumab. Patients were dosed
with 1.0 mg, 1.5 mg, 2.0 mg and 2.5 mg of Foralumab daily for five days and most were pre-treated with methylprednisolone. The data from
study NI-0401-02 has confirmed the dose response in terms of CD3 modulation and reduction of peripheral T-cell count. A CD3 modulation
of up to 90% was achieved at study NI-0401-02 day five with a daily dose of 2.5 mg during the 5 days of treatment period. Although there
was no dose-response relationship, treatment with foralumab seems to be globally effective to reverse protocol defined acute cellular
rejection and in the mormalization of serum creatinine levels, a primary efficacy objective. The main adverse events were infusion related
reactions in patients that were not premedication with prednisolone.</span></p><div>

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</div><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"><b>Study
NI-0401-03:</b> a Phase 2a study with an open label dose escalation phase followed by a double-blind phase to assess safety and efficacy
of Foralumab in subjects with moderate to severe active CD. The study NI-0401-03 was completed and 24 subjects were exposed to Foralumab.
74% of patients had achieved a clinical response at week 2 and 87% of patients at week 4. At weeks 6, 8 and 12 the proportion of patients
with a clinical response decreased to 75%, 70% and 67%, respectively. 30% of patients had achieved clinical remission at week 2, 42%
by weeks 4, 38% by week 6, 43% at week 8 and 46% at week 12. Treatment failures were 12.5%. There was a reduction in the mean Crohn&#8217;s
Disease Activity Index (CDAI) scores in all treatment cohorts and an overall improvement in the Crohn&#8217;s Disease Endoscopic Index
of Severity (CDEIS) scores across all treatment groups following 5 daily doses of Foralumab treatment. Pharmacokinetic evaluations were
performed, and no dose-response relationship was established due to variability between patients. The observed half-life of Foralumab
was approximately 180 hours. A rapid and almost complete disappearance of CD45 positive lymphocytes, CD3 positive T-cells, CD3 positive
and CD4 positive helper T-cells and CD3 positive and CD8 positive cytotoxic T-cells from the circulation was observed was observed within
24 hours of infusion for all dose cohorts. The lowest unit dose in the study NI-0401-03 was equivalent to the 1 mg daily unit dose that
was the maximum tolerated dose in study NI-0401-01. Pre-medication with prednisolone reduced the severity and frequency of infusion related
reactions.</span></p><div>

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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">In two Phase 2a trials conducted
by Novimmune, patients with Crohn&#8217;s disease and renal allograft rejection in kidney transplants demonstrated Foralumab&#8217;s immunomodulatory
activity in humans. We have decided not to pursue evaluation of intravenous Foralumab in Crohn&#8217;s Disease because we believe the
market for this disease is saturated by other FDA approved drugs. Further, while intravenous administration of antibodies has been widely
used, side effects from the intravenous administration still are prevalent as well as patient compliant issues come into play. We intend
to move forward with an oral formulation of Foralumab for treatment of Crohn&#8217;s disease at a later date.</p><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">

</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">&#160;</span></p><div>

</div><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">Two
of Novimmune&#8217;s clinical trials were in patients with Crohn&#8217;s disease and the third clinical trial was conducted in patients
undergoing kidney transplantation and suffering with renal allograft rejection. Sixty-eight subjects with active Crohn&#8217;s disease
and 11 subjects with acute cellular renal allograft rejection were treated with Foralumab. The route of administration of Foralumab in
these studies was via intravenous administration.</span></p><div>

</div><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><div>

</div><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
these trials, it was observed that:</span></p><div>

</div><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><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The short-term tolerability
    profile of Foralumab was very similar to those reported with other anti CD3 antibodies and no new emerging concerns have been identified.</span></td></tr>
  </table><div>
</div><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><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Total daily doses of up
    to 1mg (~ 500 &#181;g/m2) per patient were generally well tolerated without corticosteroid premedication. The most common adverse
    events following exposure to Foralumab were IRRs, which occurred in all patients treated with the compound. In the majority of cases,
    these symptoms were mild (66%) in intensity and were reported following the first two infusions of the 5-infusion treatment course.
    The number of affected patients and the severity of symptoms tended to increase with increasing dose level, or DL.</span></td></tr>
  </table><div>
</div><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><div>


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    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="width: 24px; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">A clear reduction of CRS
    and its associated IRRs were observed with steroid pre-medication. All patients who received pre-medication with steroids had mild
    or no IRRs, and CRS was reduced. Only one patient who did not receive steroid pre-medication had significant levels of CRS, in particularly
    IL-6.</span></td></tr>
  </table><div>
</div><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><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="width: 24px; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Usage of steroid pre-medication
    allows the administration of higher doses.</span></td></tr>
  </table><div>
</div><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><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="width: 24px; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Both the magnitude and
    duration of CD3 modulation increased in a dose related manner.</span></td></tr>
  </table><div>
</div><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><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="width: 24px; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">No anti-drug antibodies
    were detected.</span></td></tr>
  </table><div>
</div><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><div>

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

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

</div><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">Oral
anti-CD3 antibodies, as opposed to the narrow therapeutic window of its intravenous counterpart, have been shown to impact the gut immune
system and mesenteric lymph nodes, thereby promoting regulatory T-cells activity, without inducing immunosuppression. The treatment alleviated
experimental autoimmune encephalitis and T1D mellitus, which was associated with regulatory T-cells induction. Orally and nasally administered
anti-CD3 suppressed autoantibody production in a mouse lupus model. Oral anti-CD3 yielded reduced pancreatic hyperplasia, hepatic fat
accumulation and muscle inflammation in a leptin-deficient model of NASH and diabetes.</span></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><i>Pharmacology
Summary (In Vitro Studies)</i></span></p><div>

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

</div><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
key conclusions arising from the non-clinical studies of Foralumab by Novimmune are:</span></p><div>

</div><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><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Foralumab is a specific
    anti-CD3 epsilon mAb, as it binds to human T-cells and the recombinant human CD3 epsilon chain, and can be displaced by another specific
    anti-CD3 epsilon mAb, muromonab CD3.</span></td></tr>
  </table><div>
</div><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><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">When bound to its target,
    Foralumab triggers calcium flux into the cell and modulates the CD3/TCR complex causing its&#8217; transient removal from the cell
    surface.</span></td></tr>
  </table><div>
</div><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><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The combination of the
    two-point mutations introduced into the Fc portion (the constant region of the antibody that has limited structural variability and
    is responsible for adverse side effects) of Foralumab, resulting in the abrogation of the binding to Fc gamma receptors, and C1q,
    consequently eliminates T-cell proliferation and the release of numerous cytokines including TNF, and interferon gamma, or IFN&#947;
    <i>in vitro</i>.</span></td></tr>
  </table><div>
</div><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><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Foralumab does not cross
    react with CD3 molecules expressed by T-cells of other species including baboon, <i>Rhesus </i>monkey, <i>Cynomolgus </i>monkey,
    rabbit, dog, rat and mouse. As a consequence, options for the most relevant species selection for pharmacology and toxicology assessment
    of Foralumab are limited. Novimmune addressed this limitation by studying LCD3 transgenic mice. This transgenic mouse line expresses
    the human as well as the mouse CD3 epsilon chain on the surface of their T-cells.</span></td></tr>
  </table><div>
</div><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><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Using a transgenic line
    of mice expressing both human and mouse CD3 molecules (1:1 ratio) at the surface of T-cell (LCD3<i>), </i>following a single intravenous
    injection, Foralumab dose dependently:</span></td></tr>
  </table><div>
</div><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><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><tr style="vertical-align: top; text-align: justify">
<td style="width: 0.5in"></td><td style="width: 0.25in; text-align: left"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td><td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Modifies
                                            human CD3 epsilon expression; that is, more than 80% of the cell surface protein was removed
                                            within 24 hours when given at a saturating dose. This modulation was transient as receptor
                                            expression levels returned to baseline values within 7 days of dosing.</span></td>
</tr></table><div>
</div><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><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><tr style="vertical-align: top; text-align: justify">
<td style="width: 0.5in"></td><td style="width: 0.25in; text-align: left"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td><td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Caused
                                            a reduction of 70-80% in the number of circulating T-cells when given at a saturating dose.
                                            The maximal effect was observed at hour 6 post dose. Cell counts returned to baseline levels
                                            within 3.5 days.</span></td>
</tr></table><div>
</div><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><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><tr style="vertical-align: top; text-align: justify">
<td style="width: 0.5in"></td><td style="width: 0.25in; text-align: left"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td><td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Demonstrated
                                            a half-life of 1.4 and 1.7 days for doses of 5 and 200 &#181;g per mouse, respectively.
                                            This seemingly short half-life is similar to that observed in vivo for other anti-CD3 mAbs
                                            and reflects internalization of Foralumab by the human CD3 molecule on the T-cells of these
                                            transgenic mice. It was therefore expected that Foralumab will be internalized by human T-cells
                                            in patients and consequently have a half-life comparable to other therapeutic anti-CD3 mAbs.</span></td>
</tr></table><div>

</div><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><div>

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

</div><!-- Field: Page; Sequence: 58; Value: 1 --><div>
    </div><div style="margin-top: 12pt; margin-bottom: 6pt; border-bottom: Black 1.5pt solid"><p style="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><!-- Field: Sequence; Type: Arabic; Name: PageNo -->53<!-- Field: /Sequence --></p></div><div>
    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
    </div><!-- Field: /Page --><div>

</div><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><div>

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

</div><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">Safety
Toxicology Studies</span></p><div>

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

</div><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">Tiziana
conducted Intranasal and Subcutaneous Safety Toxicology Studies in HuGEMM Transgenic Mice Expressing human CD3 and mouse CD3 molecules.</span></p><div>

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

</div><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">Study
700656 14 Days Intranasal Dosing Duration/7 days Recovery</span></p><div>

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

</div><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">Three
times/week intranasal dosing of 1, 10 and 50 &#181;g foralumab /animal</span></p><div>

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

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt" width="100%"><tr style="vertical-align: top">
<td style="width: 0.5in"></td><td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td><td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">There
                                            were no test item related mortalities during the course of the study. </span></td></tr></table><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-align: justify; text-indent: -0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt" width="100%"><tr style="vertical-align: top">
<td style="width: 0.5in"></td><td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td><td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
                                            three times weekly intranasal instillation of Foralumab at doses of up to 50 &#181;g of
                                            Foralumab/animal were well tolerated. There were no foralumab related changes in clinical
                                            signs, body weights, hematology or clinical pathology. </span></td></tr></table><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-indent: -0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt" width="100%"><tr style="vertical-align: top">
<td style="width: 0.5in"></td><td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td><td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Intranasal
                                            instillation of a high dose (50 &#181;g) of Foralumab promoted a neat depletion of the mCD3/hCD3
                                            coexpressing T lymphocyte compartment, including the mCD3<sup>+</sup>hCD3<sup>+</sup>mCD4<sup>+
                                            </sup>and mCD3<sup>+</sup>hCD3<sup>+</sup>mCD8<sup>+</sup> subsets. </span></td></tr></table><div>

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

</div><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">Study
700800 13 Weeks Dosing Duration/8 weeks Recovery</span></p><div>

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

</div><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">Three
times/week intranasal dosing of 1, 10 and 50 &#181;g foralumab /animal</span></p><div>

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

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt" width="100%"><tr style="vertical-align: top">
<td style="width: 0.5in"></td><td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td><td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">There
                                            were no test item related mortalities during the course of the study. </span></td></tr></table><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-indent: -0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt" width="100%"><tr style="vertical-align: top">
<td style="width: 0.5in"></td><td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td><td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">There
                                            were no foralumab related changes in clinical signs, body weights, hematology or clinical
                                            pathology.</span></td></tr></table><div>

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

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><tr style="vertical-align: top; text-align: justify">
<td style="width: 0.5in"></td><td style="width: 0.25in; text-align: left"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td><td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Intranasal
                                            instillation of foralumab to mouse three times weekly for 13 weeks was well tolerated at
                                            dose levels up to 50 &#956;g/dose and did not produce foralumab-related macroscopic or microscopic
                                            pathology findings</span></td>
</tr></table><div>

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

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt" width="100%"><tr style="vertical-align: top">
<td style="width: 0.5in"></td><td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td><td><p style="margin: 0pt 0; font: 10pt Times New Roman, Times, Serif">The no-observed-adverse-effect level (NOAEL) is considered to be 50
&#956;g/animal (equivalent to a 10 mg dose administered to a 60 kg adult human).</p></td></tr></table><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p><div>

</div><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">Study
700657 26 Weeks Dosing Duration/12 weeks Recovery</span></p><div>

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

</div><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">Three
times/week intranasal dosing of 1, 10 and 50 &#181;g foralumab /animal</span></p><div>

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

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt" width="100%"><tr style="vertical-align: top">
<td style="width: 0.5in"></td><td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td><td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Study
                                            in progress. Dosing initiated on December 5 2022</span></td></tr></table><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Study 700680 14 Days Subcutaneous
Dosing Duration/7 days Recovery</p><div>

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

</div><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">Once
daily subcutaneous dosing of 5, 15 and 50 &#181;g foralumab /animal</span></p><div>

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

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt" width="100%"><tr style="vertical-align: top">
<td style="width: 0.5in"></td><td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td><td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">There
                                            was no evidence of local (subcutaneous injection site) or systemic toxicity.</span></td></tr></table><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-align: justify; text-indent: -0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt" width="100%"><tr style="vertical-align: top">
<td style="width: 0.5in"></td><td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td><td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
                                            administration at 50 &#181;g/animal of Foralumab promoted a neat reduction of the mCD45<sup>+</sup>mCD3/hCD3
                                            co-expressing T lymphocyte compartment, especially in the mCD3<sup>+</sup>hCD3<sup>+</sup>mCD8<sup>+
                                            </sup>subset. Meanwhile, the number of mCD45<sup>+</sup>mCD3<sup>+</sup>hCD3<sup>-</sup>
                                            cells increased including the mCD3<sup>+</sup>hCD3<sup>-</sup>mCD4<sup>+</sup> and mCD3<sup>+</sup>hCD3<sup>-</sup>mCD8<sup>+
                                            </sup>subsets</span></td></tr></table><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-align: justify; text-indent: -0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt" width="100%"><tr style="vertical-align: top">
<td style="width: 0.5in"></td><td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td><td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
                                            no observable adverse effect level (NOAEL) was determined to be 50 &#181;g/animal based
                                            on parameters monitored on the study.</span></td></tr></table><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-align: justify; text-indent: -0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p><div>

</div><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">Study
700681 28 Days Subcutaneoous Dosing Duration/28 days Recovery</span></p><div>

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

</div><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">Three
times/week intranasal dosing of 1, 10 and 50 &#181;g foralumab /animal</span></p><div>

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

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt" width="100%"><tr style="vertical-align: top">
<td style="width: 0.5in"></td><td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td><td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
                                            three times weekly (Day 1, 3 and 5 of the week) administration of Foralumab for 4 consecutive
                                            weeks by subcutaneous injection at doses of 5, 15 and 50 &#181;g/animal/dose to HuGEMM mice
                                            was well-tolerated.</span></td></tr></table><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-align: justify; text-indent: -0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt" width="100%"><tr style="vertical-align: top">
<td style="width: 0.5in"></td><td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td><td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">There
                                            was no evidence of local (subcutaneous injection site) or systemic toxicity.</span></td></tr></table><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-align: justify; text-indent: -0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt" width="100%"><tr style="vertical-align: top">
<td style="width: 0.5in"></td><td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td><td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
                                            administration of Foralumab promoted the decrease of mCD3/hCD3 co-expressing T cells and
                                            subsets in a dose-independent manner.</span></td></tr></table><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-align: justify; text-indent: -0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt" width="100%"><tr style="vertical-align: top">
<td style="width: 0.5in"></td><td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td><td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
                                            no observable adverse effect level (NOAEL) was determined to be 50 &#181;g/animal/dose based
                                            on parameters monitored on the study.</span></td></tr></table><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-align: justify; text-indent: -0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-align: justify; text-indent: -0.25in"></p><div>

</div><!-- Field: Page; Sequence: 59; Value: 1 --><div>
    </div><div style="margin-top: 12pt; margin-bottom: 6pt; border-bottom: Black 1.5pt solid"><p style="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><!-- Field: Sequence; Type: Arabic; Name: PageNo -->54<!-- Field: /Sequence --></p></div><div>
    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
    </div><!-- Field: /Page --><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-align: justify; text-indent: -0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p><div>

</div><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>Milciclib
(TZLS-201)</i></b></span></p><div>

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

</div><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">Milciclib
is an orally bioavailable, small molecule broad spectrum inhibitor of CDKs (CDKs): 1, 2, 4, 5 and 7 and Src family kinases. CDKs are
a family of highly conserved enzymes that are involved in regulating the cell cycle, which is a series of events that takes place in
cells leading to division and duplication of its DNA to produce two daughter cells. Src family kinases regulate cell growth and potential
transformation of normal cells to cancer cells. A novel feature of Milciclib is its ability to reduce microRNAs, miR-221 and miR-222,
that silence gene expression. miR-221 and miR-222 promote the formation of blood vessels (angiogenesis) that are important for spread
of cancer cells (metastasis). Levels of these microRNAs are consistently increased in HCC patients and may contribute towards resistance
to treatment with Sorafenib. As a result, we are investigating Milciclib both as a monotherapy and plan a combination treatment with
Sorafenib. To date, Milciclib has been studied in a total of eight completed and ongoing Phase 1 and Phase 2 clinical trials in 316 patients.
In these trials, Milciclib was observed to be well-tolerated and showed initial signals of anti-tumor action. A Phase 2a trial (CDKO-125a-010)
for Milciclib as a single therapy in patients with HCC was completed in June 2019.</span></p><div>

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

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

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

</div><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">Tiziana
plans to conduct a Phase 2 study combination therapy of milciclib and gemcitabine in Non-Small Cell Lung Cancer (NSCLC) patients with
a broad-spectrum of KRAS mutations (except G12C mutation) after failure of at least one line of standard-of-care (SoC) therapy. NSCLC
is the most common type of lung cancer, occurring in approximately 80% of patients. Due to the asymptomatic nature of early disease,
many patients are diagnosed with later stages of disease, and typically have short overall survival. In the United States, at initial
diagnosis of NSCLC, approximately 55% of patients have distant metastases with a 5-year survival rate of 7%, despite the recent development
of novel anticancer therapies and regimens. The results of clinical trials with sotorasib (Lumakras&#8482;) demonstrated that selective
targeting of a single KRAS mutation is a promising therapeutic strategy. Although there is a clear benefit to target KRAS directly, KRAS
represents a challenging molecular target due to the lack of suitable drug pockets where a small molecule can bind. An alternative approach
is to target downstream signaling pathways. The rationale for evaluation of milciclib in combination with gemcitabine is suggested by
preclinical studies conducted on a non-small cell lung xenograft model that demonstrated the efficacy of milciclib in terms of antitumor
activity, both as a single agent and in combination with gemcitabine, at well tolerated doses. Given that gemcitabine is used for treatment
of both pancreatic cancer (for which gemcitabine is the standard therapy) and NSCLC (for which gemcitabine is used in combination with
cisplatin), an evaluation of the feasibility of the combination of milciclib and gemcitabine is considered appropriate in view of future
uses in these diseases. In addition, the 2 compounds showed non-overlapping toxicities when administered as single agents, providing
an additional rationale for their evaluation in combined treatment in the clinical setting.</span></p><div>

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

</div><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,
in the Phase 1 CDKO-125a-004 study, 16 patients were treated with milciclib at 3 dose levels administered once daily for 7 days, followed
by 7 days off treatment in a 4-week cycle and with a fixed dose of gemcitabine administered intravenously on Days 1, 8, and 15 in a 4-week
cycle1, Overall, the combination was well tolerated and showed clinical benefit with 1 PR and 10 patients with SD. The PR was documented
in a patient with NSCLC whose disease was refractory to gemcitabine.</span></p><div>

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

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

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

</div><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">Milciclib
has been studied in a total of eight completed Phase 1 and Phase 2 clinical trials in approximately 316 patients. Milciclib was observed
to be well tolerated by patients with thymoma in Phase 1 and Phase 2 clinical trials.</span></p><div>

</div><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><div>


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    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
    </div><!-- Field: /Page --><div>

</div><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><div>

</div><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>Phase
1 Development</i></b></span></p><div>

</div><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><div>

</div><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">Milciclib
has been investigated in each of the below, open-label, multi-center, non-randomized, dose-escalation Phase 1 clinical trials.</span></p><div>

</div><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><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="vertical-align: top">
    <td style="border-bottom: black 1.5pt solid; width: 15%"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Trial</b></span></td>
    <td style="width: 1%; 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; width: 15%; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Patient
    Population</b></span></td>
    <td style="width: 1%; 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; width: 28%; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Treatment&#160;Schedule&#160;/&#160;Dosing</b></span></td>
    <td style="width: 1%; 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; width: 39%; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Key
    Findings</b></span></td></tr>
  <tr style="vertical-align: top">
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">CDKO-125a-001</span></td>
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td><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">Advanced/metastatic
        solid tumors</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"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">37
    patients</span></p></td>
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td><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">1st
        Schedule: Orally, once daily</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">for
    7 consecutive days every 14 days in a 2-week cycle at escalating doses of 50, 100, 150, 200 and 300 mg</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"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">2nd
    Schedule: Orally, once daily for 4 consecutive days a week for 3 weeks in a 4-week cycle at escalating doses of 150, 180 and 200
    mg</span></p></td>
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td><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"><i>Pharmacokinetics:</i></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"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Comparable
    plasma pharmacokinetic parameters between the two schedules were observed.</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"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
    exposure to Milciclib increased with the dose and there was a 3-fold accumulation in the daily systemic exposure after repeated dosing,
    in good agreement with expectations on the basis of the half-life of the compound (24-43 h).</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"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><i>Clinical
    observations:</i></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: -0.05pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">No
    objective responses were achieved on 1st schedule; Disease stabilizations, defined as cancer disease that is neither increasing nor
    decreasing in extent or severity, was observed in 6 of 14 evaluable patients (42.9%).</span></p>
    <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: -0.05pt"><span style="font-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">A
    partial response, or PR, was achieved in 2 out of 14 evaluable patients (14.3%) on 2nd schedule; Disease stabilization (no change
    in extent or severity of disease state) was reported in 3 patients (21.4%), all treated at 180 mg/day DL, including a stabilization
    lasting 31 weeks in a patient with pancreatic cancer and stable disease, or SD, lasting 29 weeks in a patient with carcinoid.</span></p></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p><div>


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    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
    </div><!-- Field: /Page --><div>

</div><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><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="vertical-align: top">
    <td style="border-bottom: black 1.5pt solid; width: 15%; text-align: left"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Trial</b></span></td>
    <td style="text-align: center; width: 1%"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="border-bottom: black 1.5pt solid; width: 15%; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Patient
    Population</b></span></td>
    <td style="text-align: center; width: 1%"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="border-bottom: black 1.5pt solid; width: 28%; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Treatment&#160;Schedule&#160;/&#160;Dosing</b></span></td>
    <td style="text-align: center; width: 1%"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="border-bottom: black 1.5pt solid; width: 39%; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Key
    Findings</b></span></td></tr>
  <tr style="vertical-align: top">
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">CDKO-125a-002</span></td>
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Recurrent
        malignant glioma 28 patients (Phase 1)</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">34
    patients (Phase 2)</span></p></td>
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td><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">Escalating
        oral doses of 18, 36, 54 and 72 mg/m2 once a day for 14 consecutive days followed by 7 days of rest in a 3-week cycle</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"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">54
    mg/m2 (RP2D)</span></p></td>
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td><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"><i>Pharmacokinetics:</i></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"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Results
    indicated that the pharmacokinetics of Milciclib was dose-independent in the dose range 18</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"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#8211;
    72 mg/m2.</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></td></tr>
  <tr style="vertical-align: top">
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Systemic exposure values
    of Milciclib maleate accumulated by a factor of 3</span></td></tr>
  <tr style="vertical-align: top">
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="vertical-align: top">
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td><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"><i>Clinical
        observations:</i></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"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Phase
    1: No evidence of clinical effect was observed in all the 28 treated patients. However 5 patients seemed to have benefitted from
    therapy with SD observed (no change in extent or severity of cancer).</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"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Phase
    2: One out of 34 patients achieved the primary endpoint. PFS at 6 months or PFS-6 rate was 2.9%. No complete response, or CR (disappearance
    of all signs of cancer in response to treatment) or PR (decrease in tumor size or extent of cancer in the body) were reported. 4
    patients showed SD as best overall response (11.8%). Prolonged SD (&#8805; 6 months) was observed in one patient whose SD lasted for
    24.9 months.</span></p></td></tr>
  <tr style="vertical-align: top">
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="vertical-align: top">
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td><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"><i>Safety:</i></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"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">34
    patients were enrolled and treated: 29 patients of non-Enzyme Inducing Anti-Epileptic Drugs, or non-EIAED, population and 5 of EIAEDs
    population. The primary clinical endpoint was not met. Only one patient (non-EIAEDs) achieved the study primary endpoint out of 34
    treated patients. PFS-6 rate evaluated in the treated patients was 2.9% (95% CI, 0.07-15.33). No CR or PR was reported; 4 patients
    in the treated patients showed SD as best overall response on treatment (11.8%). Prolonged SDs (&#8805;6 months) was observed in one
    patient whose SD lasted for 24.9 months. Median OS in treated patients was 7.03 months (95% CI, 5.72-10.58). The exploration of the
    role play by potential prognostic factors, such as Karnofsky&#160;Performance Scale&#160;(&#8805;90 vs. &lt;90), age (&lt;40 vs. &#8805;40)
    and interval between initial diagnosis and current recurrence (&#8805;52 weeks vs. &lt;52 weeks) indicated a better survival outcome
    for patients whose interval between initial diagnosis and current recurrence was (&#8805;52 weeks). Given the non-comparative nature
    of the study, it cannot be said whether the treatment played any role in this result.</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"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
    influence of other factors cannot be excluded but was not apparent in the current sample.</span></p></td></tr>
  </table><div>
</div><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><div>


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    </div><div style="margin-top: 12pt; margin-bottom: 6pt; border-bottom: Black 1.5pt solid"><p style="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><!-- Field: Sequence; Type: Arabic; Name: PageNo -->57<!-- Field: /Sequence --></p></div><div>
    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
    </div><!-- Field: /Page --><div>

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</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="vertical-align: top">
    <td style="border-bottom: black 1.5pt solid; width: 15%"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Trial</b></span></td>
    <td style="width: 1%; 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; width: 15%; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Patient
    Population</b></span></td>
    <td style="width: 1%; 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; width: 28%; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Treatment&#160;Schedule&#160;/&#160;Dosing</b></span></td>
    <td style="width: 1%; 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; width: 39%; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Key
    Findings</b></span></td></tr>
  <tr style="vertical-align: top">
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">CDKO-125a-003</span></td>
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Advanced/metastatic
        solid tumors</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"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">30
    patients</span></p></td>
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td><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">1st
        Schedule: Orally, once daily for 21 consecutive days followed by 7 days of rest in a 4-week cycle at escalating doses of 16 and
        24 mg/m2</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"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">2nd
    Schedule: Orally, once daily for 14 consecutive days followed by 7 days of rest in a 3-week cycle at escalating doses of 24, 48,
    54 and 72 mg/m2</span></p></td>
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td><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"><i>Pharmacokinetics:</i></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"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">No
    differences in the pharmacokinetics were observed between the two schedules after both single and repeated dosing.</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"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
    systemic exposure to Milciclib (amount of Milciclib available systemically in the patient) increased with dose in terms of both Cmax
    (maximum concentration of Milciclib in plasma) and daily Area Under the Plasma Drug Concentration, or AUC, vs Time Curve, a measure
    of drug bioavailability without deviations from dose-proportionality (plasma concentration changes in a linear relationship to amount
    of drug dosed).</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></td></tr>
  <tr style="vertical-align: top">
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td><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">After
        repeated administrations, Milciclib Cmax and AUC accumulated by a factor of 2-4, independent of the dose-level.</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></td></tr>
  <tr style="vertical-align: top">
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td><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"><i>Clinical
        observations:</i></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"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">No
    objective (measurable) responses were achieved. SDs were reported in 5 out of 16 evaluable patients (31.3%), starting from the dose
    of 48 mg/m2/day. One disease stabilization maintained for 12 cycles (10.5 months) at 48 mg/m2/day, was achieved in a parotid gland
    patient.</span></p></td></tr>
  <tr style="vertical-align: top">
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="vertical-align: top">
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">CDKO-125a-004</span></td>
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Advanced/metastatic
        solid tumors</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"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">16
    patients</span></p></td>
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Orally administered at
    45, 60 and 80 mg/m2 once daily for 7 days on / 7 days off (Days 1 to 7 and 15 to 21) in a 4-week cycle in combination with fixed
    dose of IV gemcitabine (1000 mg/m2/day) on Days 1, 8, 15 over 30 minutes every 4 weeks</span></td>
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td><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"><i>Pharmacokinetics:</i></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"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Pharmacokinetic
    parameters (Cmax, AUC) of Milciclib after Milciclib maleate/ gemcitabine combination were consistent with those previously observed
    after Milciclib maleate administration as single agent, suggesting no influence of gemcitabine on the pharmacokinetics of the compound.</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"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><i>Clinical
    observations:</i></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"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">One
    PR in 14 evaluable patients (7.1%) and one SD in 10 patients (71.4%).</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"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Disease
    stabilizations lasting z 6 months were recorded in 4 cases (28.6%) in thyroid, prostatic, pancreatic carcinoma and peritoneal mesothelioma,
    in 2 of them lasting 13.4 months (peritoneal mesothelioma) and 14.3 months (prostate cancer).</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"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
    PR and 3 of the 4 long lasting disease stabilizations were obtained at the recommended Phase 2 dose (RP2D) of 80 mg/m2/day plus 1000
    mg/m2/day gemcitabine, supporting development of combination therapies with Milciclib in advanced cancer patients.</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"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Results
    of trial CDKO-125a-004 were published: S. Aspeslagh et.al. Cancer Chemother. Pharmacol (2017) 79: 1257-1265</span></p></td></tr>
  </table><div>
</div><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><div>


</div><!-- Field: Page; Sequence: 63; Value: 1 --><div>
    </div><div style="margin-top: 12pt; margin-bottom: 6pt; border-bottom: Black 1.5pt solid"><p style="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><!-- Field: Sequence; Type: Arabic; Name: PageNo -->58<!-- Field: /Sequence --></p></div><div>
    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
    </div><!-- Field: /Page --><div>

</div><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><div>

</div><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>Phase
2 Development</i></b></span></p><div>

</div><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"><b><i>&#160;</i></b></span></p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="vertical-align: top">
    <td style="border-bottom: black 1.5pt solid; text-align: left; width: 15%"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Trial</b></span></td>
    <td style="text-align: center; width: 1%"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="border-bottom: black 1.5pt solid; width: 15%; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Patient
    Population</b></span></td>
    <td style="text-align: center; width: 1%"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="border-bottom: black 1.5pt solid; width: 28%; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Treatment&#160;Schedule&#160;/&#160;Dosing</b></span></td>
    <td style="text-align: center; width: 1%"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="border-bottom: black 1.5pt solid; width: 39%; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Key
    Findings</b></span></td></tr>
  <tr style="vertical-align: top">
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">CDKO-125a-005</span></td>
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Malignant
        pleural mesothelioma</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"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">38
    patients</span></p></td>
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">150 mg/day orally administered
    for 7 consecutive days every 14 days in 2-week cycles</span></td>
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td><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"><i>Pharmacokinetics:</i></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"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Plasma
    levels of Milciclib were comparable to those previously obtained in the Phase 1 study CDK0-125a-001 at the same dosage and with the
    same schedule, confirming the reliability of the pharmacokinetic profile of the compound.</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"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><i>Clinical
    observations:</i></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"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">No
    objective responses were reported; prolonged SDs were observed in 2 patients, lasting 8.9 months and 8.7 months, respectively.</span></p></td></tr>
  <tr style="vertical-align: top">
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="vertical-align: top">
    <td><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">CDKO-125a-006</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">&#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">&#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">Trial
    cutoff: 1/9/2017</span></p></td>
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Malignant B3 thymoma / thymic carcinoma 72 patients</span></td>
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Single
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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">150
    mg once daily 7days on/7days off q2wks</span></p></td>
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td><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"><i>Clinical
        Observations:</i></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"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Treatment
    with Milciclib met the primary endpoint of PFS at 3 months (PFS-3). 56 of 72 treated patients had median PFS of 5.78 months with
    upper and lower 95% confidence limits of 3.48 months and 7.89 months, respectively. The secondary endpoint, OS, was also met in this
    trial. 36 of 72 patients (50%) had median OS of 24.44 months with upper and lower 95% confidence limits of 22.05 and 54.55 months,
    respectively. Five patients from this study are continuing treatment with Milciclib.</span></p></td></tr>
  <tr style="vertical-align: top">
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="vertical-align: top">
    <td><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">CDKO-125a-007</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">&#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">&#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">Trial
    cutoff: 1/9/2017</span></p></td>
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Malignant B3 thymoma / thymic carcinoma 30 patients</span></td>
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Single agent (flat dose) 150 mg once daily 7days on/7days
    off q2wks</span></td>
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td><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"><i>Clinical
        Observations:</i></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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    with Milciclib met the primary endpoint of PFS-3. 18 of 30 patients had median PFS of 5.65 months with upper and lower 95% confidence
    limits of 3.94 months and 17.45 months, respectively. The secondary endpoint, OS, was met in this trial. 18 of 30 treated patients
    (54.5%) had OS of 48 months. Upper and lower 95% confidence limits could not be calculated because the median survival probability
    was not reached.</span></p></td></tr>
  </table><div>
</div><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><div>


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    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
    </div><!-- Field: /Page --><div>

</div><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><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="vertical-align: top">
    <td style="border-bottom: black 1.5pt solid; text-align: left"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Trial</b></span></td>
    <td style="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; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Patient
    Population</b></span></td>
    <td style="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; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Treatment&#160;Schedule&#160;/&#160;Dosing</b></span></td>
    <td style="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; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Key
    Findings</b></span></td></tr>
  <tr style="vertical-align: top">
    <td style="width: 15%; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">CDKO-125a-010</span></td>
    <td style="width: 1%"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="width: 15%"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Recurrent or metastatic unresectable
    HCC</span></td>
    <td style="width: 1%"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="width: 28%"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Single
                           agent (flat dose)</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">100
    mg once daily</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">4days
    on/3days off x 4 wks q4 wks</span></p></td>
    <td style="width: 1%"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
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                           trial successfully met the primary endpoint that oral treatment with Milciclib was well tolerated with manageable
                           toxicities and no recorded drug related deaths.</span></p>
    <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.2in; text-align: justify; text-indent: -0.2in; background-color: #FEFEFE"><span style="font-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; text-indent: -0.2in; background-color: #FEFEFE"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;&#160;&#160;The
    secondary endpoints for clinical activity assessment were based on the independent radiological review using the modified Response
    Evaluation Criteria in Solid Tumors (mRECIST)</span></p>
    <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.2in; text-align: justify; text-indent: -0.2in; background-color: #FEFEFE"><span style="font-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; text-indent: -0.2in; background-color: #FEFEFE"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;&#160;&#160;Positive
    demonstrated clinical activity included:</span></p>
    <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.2in; text-align: justify; text-indent: -0.2in; background-color: #FEFEFE"><span style="font-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; text-indent: -0.2in; background-color: #FEFEFE"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">1.&#160;&#160;&#160;50%
    (14 out of 28) evaluable patients completed 6-month duration of the trial.</span></p>
    <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.2in; text-align: justify; text-indent: -0.2in; background-color: #FEFEFE"><span style="font-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; text-indent: -0.2in; background-color: #FEFEFE"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">2.&#160;&#160;&#160;64%
    (9 out of 14) patients requested and were approved by their respective ethical committees to continue the treatment.</span></p>
    <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.2in; text-align: justify; text-indent: -0.2in; background-color: #FEFEFE"><span style="font-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; text-indent: -0.2in; background-color: #FEFEFE"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">3.&#160;&#160;&#160;Both
    median time to progression (TTP) and progression free survival (PFS) were 5.9 months (95% Confidence Interval (&#8220;CI&#8221;)
    1.5-6.7 months) out of the 6-months duration of the trial.</span></p>
    <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.2in; text-align: justify; text-indent: -0.2in; background-color: #FEFEFE"><span style="font-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; text-indent: -0.2in; background-color: #FEFEFE"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">4.&#160;&#160;&#160;Approximately
    57% of evaluable patients showed &#8216;Stable Disease&#8217; (SD; met at least once in an 8-week interval) and 3.6% patients showed
    &#8216;Partial Response&#8217; (PR).</span></p>
    <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.2in; text-align: justify; text-indent: -0.2in; background-color: #FEFEFE"><span style="font-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; text-indent: -0.2in; background-color: #FEFEFE"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">5.&#160;&#160;&#160;Approximately
    61% of patients showed &#8216;Clinical Benefit Rate&#8217; defined as CBR=CR+PR+SD (with CR representing Complete Remission).</span></p>
    <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.2in; text-align: justify; text-indent: -0.2in; background-color: #FEFEFE"><span style="font-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; text-indent: -0.2in; background-color: #FEFEFE"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">6.&#160;&#160;&#160;Five
    patients on compassionate use continued the treatment for a total of 9, 9, 11, 13 and 16 months, respectively. Two patients continuing
    the treatment have reached 16 months.</span></p></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p><div>

</div><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">Source:
Milciclib Investigators Brochure version 14</span></p><div>

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

</div><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>Safety</i></b></span></p><div>

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

</div><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">Overall,
Milciclib has indicated a similar pattern of toxicity across studies. Consistent with preclinical findings, the safety profile of the
compound in humans is characterized by a dose-limiting neurological toxicity and, to a lesser extent, by GI toxicity. Asthenia (weakness)
and fatigue have also been observed, as well as effects on liver, especially with prolonged schedules of administration. Mild/moderate
tremors are a common finding, reported also at recommended Phase 2 doses (RP2Ds) (only one case of grade 3), whereas ataxia (loss of
muscle control and balance) was observed primarily during the first dose-escalation study (one case of grade 3 ataxia occurred also at
the RP2D in the combination study CDKO-125a-004 and one in CDKO-125a-006 trial). Both tremor and ataxia were generally reversible in
all cases in up to 7-9 days, upon drug discontinuation or dose reduction in some cases. Grade 1-2 dizziness was also reported, with only
one grade 3 occurrence, overall. Mild dysgeusia (disorder of sense of taste) is another event that was reported across studies, as well
as headache and anorexia (loss of appetite). Grade 3 myasthenia (muscle weakness) was also reported in two patients. Nausea and/or vomiting
and/or diarrhea were mostly of grade 1-2 in severity and were manageable with appropriate therapy. Diarrhea was occasionally severe,
leading to dehydration in several instances. Skin disorders were also reported across studies; the events were mainly of grade 1-2 in
severity except for one case of grade 3 rash maculopapular and one case grade 3 of erythema multiforme. Hematological toxicity was mainly
represented by lymphocytes (white blood cells) decrease and, to a lesser extent by all the other hematological parameters. Severe thrombocytopenia
(decrease in number of platelets in blood) was sporadically observed, especially at the highest doses tested and in combination with
gemcitabine. Effects on liver were dose-dependent and mainly represented by transient transaminase elevation (with bilirubin slightly
less affected). ALT/AST (liver enzymes measured to monitor liver damage) elevations were usually mild using the 7 days on / 7 days off
schedule (even if prolonged transaminases (liver enzymes) were occasionally observed). The more prolonged administrations were associated
with a more frequent and pronounced effect on liver function tests. Asymptomatic grade 3-4 lipase (a pancreatic enzyme that breaks down
fats, measured to monitor pancreatic function) elevations were sometimes reported, without clinical manifestation. No important effects
on renal function were noted.</span></p><div>

</div><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><div>


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    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
    </div><!-- Field: /Page --><div>

</div><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><div>

</div><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">Monitoring
of visual function was performed through visual acuity, funduscopy (ophthalmic examination of the back of the eye) and, in a subset of
studies, electroretinography examinations, or ERG. Overall, no clinically relevant abnormalities for these parameters emerged during
treatment across studies, except for ERG worsening, compared to baseline, observed in three patients, who for this reason discontinued
study treatment as per protocol, and one case of retinal detachment reported as a serious event in one patient (CDKO-125a-006 trial)
and assessed as probably related to Milciclib maleate.</span></p><div>

</div><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><div>

</div><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
interim review in trial CDKD-125A-010, as noted above, found Milciclib to be well-tolerated with no drug-related serious adverse events
in 6 patients with unresectable or metastatic HCC who had concluded a first cycle of treatment with Milciclib.</span></p><div>

</div><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;&#160;</span></p><div>

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

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

</div><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
pharmacokinetics of Milciclib were investigated in mouse, rat, dog and monkey models after single intravenous and oral administration
of the compound. Since the compound is intended for the oral administration route, the pharmacokinetics were further characterized after
single and repeated oral administrations. These preclinical studies were performed with Milciclib formulated as maleate or mono/di/tri-hydrochloride
salt. Following intravenous administration, Milciclib was characterized by a moderate clearance in mice, rats and monkeys and a high
clearance in dogs. The volume of distribution was higher than the total body water in all tested species, suggesting an extensive tissue
distribution. Following oral administration to rats and monkeys, Milciclib crossed the blood-brain barrier and distributed in the brain.
In all species, Milciclib plasma levels increased largely in direct proportion with the dose.</span></p><div>

</div><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><div>

</div><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">Preclinical
toxicology studies conducted with Milciclib have shown that the hemolymphopoietic system, the GI tract and the male reproductive organs
are the major target organs considered related to the pharmacological activity of the compound in all species. The effects on the hemolymphopoietic
system and GI tract were reversible after drug withdrawal. Reversibility could not be demonstrated in the male reproductive organs at
the end of the 2-3-week recovery period because of the longtime of maturation of the seminiferous epithelium. Additional toxicities,
that are considered not related to the mechanism of action of the compound, were Central Nervous System, or CNS, ocular and renal toxicities.
In addition, hemorrhages in different organs were observed in dogs and monkeys. Clinical signs of CNS toxicity were observed at high
doses given as single or repeated administrations in all species.</span></p><div>

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    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
    </div><!-- Field: /Page --><div>

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</div><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>Anti-IL6R
Fully Human mAb TZLS-501 (formerly known as NI-1201)</i></b></span></p><div>

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

</div><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">TZLS-501
is a fully human mAb targeting the IL-6R. We licensed the intellectual property from Novimmune in January 2017. This fully human mAb
has a novel mechanism of action, binding to both the membrane-bound and soluble forms of the IL-6R and depleting circulating levels of
the IL-6 in the blood. An excessive production of IL-6 is regarded as a key driver of chronic inflammation, associated with autoimmune
diseases such as multiple myeloma, oncology indications and rheumatoid arthritis, and we believe that TZLS-501 may have potential therapeutic
value for these indications.</span></p><div>

</div><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><div>

</div><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
preclinical studies, TZLS-501 demonstrated the potential for overcoming the limitations of other IL-6 blocking pathway drugs. Compared
to tocilizumab and sarilumab, while binding to the membrane-bound IL-6R complex, TZLS-501 has been observed to have a higher affinity
for the soluble IL-6 receptor from antibody binding studies conducted in cell culture. TZLS-501 also demonstrated the potential to block
or reduce IL-6 signaling in mouse models of inflammation. The soluble form of IL-6 has been implicated to have a larger role in disease
progression compared to the membrane- bound form (Kallen, K.J. (2002). &#8220;The role of transsignaling via the agonistic soluble IL-6
receptor in human diseases.&#8221; Biochimica et Biophysica Acta. 1592 (3): 323&#8211;343.).</span></p><div>

</div><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><div>

</div><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">Originally
TZLS-501 clinical development was intended or treatment of &#8220;cytokine storm&#8221;-induced lung damage in COVID-19 patients by aerosol
delivery to lung, however, with the increasing number of effective therapies and vaccines now available for COVID patients the Company
decided to refocus TZLS-501 development for SSc-ILD indication.</span></p><div>

</div><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><div>

</div><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">On
April 9, 2020 The Company announced that it had developed investigational new technology to treat COVID-19 infections, consisting of
direct delivery of anti-IL-6 receptor (anti-IL-6R) monoclonal antibodies (mAbs) into the lungs using a handheld inhaler or nebulizer
for treatment of patients infected with COVID-19 (SARS-CoV-2)&#160;coronavirus.&#160;On June 29, 2020 the Company announced that it was
advancing GMP manufacturing of TZLS-501 with STC Biologics concurrently with the development of inhalation technology using a hand-held
nebulizer with Sciarra Laboratories and safety toxicology studies in Cynomolgus monkeys with ITR Canada Laboratories. GMP batches were
initiated in January 2021 and completed in March 2021. Safety inhalation toxicology studies were initiated in November 2020 and completed
in March 2021. Technological assessment of nebulizers for inhalation treatment of patients was initiated in September 2020 and completed
in February 2021.</span></p><div>

</div><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><div>

</div><p style="text-align: justify; 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">An
additional 250L cGMP batch of TZLS-501 drug substance was manufactured using an improved downstream process to support future development
activities. An IND for a Phase 1 Clinical Trial in Healthy Subjects for treatment of interstitial lung disease associated with systemic
sclerosis (SSc ILD) was filed in December 2021. This program has been temporarily paused to pursue the Company&#8217;s short-term focus
on clinical development of intranasal foralumab administration for treatment of SPMS patients</span></p><div>

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

</div><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"><i>&#160;</i></span></p><div>

</div><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
biotechnology and pharmaceutical industries are characterized by rapidly changing technologies, significant competition and a strong
emphasis on intellectual property. We face substantial competition from many different sources, including large and specialty pharmaceutical
and biotechnology companies, academic research institutions, government agencies and public and private research institutions.</span></p><div>

</div><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><div>

</div><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 aware of a number of companies focused on developing therapies in various indications. Any advances made by a competitor may be used
to develop therapies that could compete against any of our product candidates.</span></p><div>

</div><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><div>

</div><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">For
our specific product candidates, the main competitors include:</span></p><div>

</div><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><div>

</div><table cellpadding="0" cellspacing="0" style="width: 100%; font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt">
  <tr style="vertical-align: top">
    <td style="width: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">We believe that Foralumab
    is currently the only fully human anti-CD3 mAb in clinical development for treatment of Crohn&#8217;s disease, progressive MS and
    other autoimmune and inflammatory diseases.</span></td></tr>
  </table><div>
</div><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><div>

</div><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, alone or with their strategic partners, have substantially greater financial, technical and other resources
than we do, such as larger R&amp;D, clinical, marketing and manufacturing organizations. Mergers and acquisitions in the biotechnology
and pharmaceutical industries may result in even more resources being concentrated among a smaller number of competitors. Our commercial
opportunity could be reduced or eliminated if competitors develop and commercialize products that are safer, more effective, have fewer
or less severe side effects, are more convenient or are less expensive than any products that we may develop. Competitors also may obtain
FDA or other regulatory approval for their products more rapidly than we may obtain approval for ours, which could result in our competitors
establishing a strong market position before we are able to enter the market. Additionally, technologies developed by our competitors
may render our potential product candidates uneconomical or obsolete, and we may not be successful in marketing our product candidates
against competitors.</span></p><div>

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

</div><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><div>

</div><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
strive to protect and enhance the proprietary technologies, inventions and improvements that we believe are important to our business,
including seeking, maintaining and defending patent rights, whether developed internally or licensed from third parties. Our policy is
to seek to protect our proprietary position by, among other methods, pursuing and obtaining patent protection in the United States and
in jurisdictions outside of the United States related to our proprietary technology, inventions, improvements, platforms and our product
candidates that are important to the development and implementation of our business.</span></p><div>

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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">As of April 24, 2023, our
intellectual property portfolio was made up as follows:</p><div>

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</div><p style="text-align: center; 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"><img alt="" src="image_004.jpg" style="height: 398.25pt; width: 468pt"/></span></p><div>

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

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    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
    </div><!-- Field: /Page --><div>

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

</div><p style="text-align: center; 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"><img alt="" src="image_005.jpg" style="height: 260.25pt; width: 468pt"/></span></p><div>

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

</div><p style="text-align: center; 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"><img alt="" src="image_006.jpg" style="height: 189.75pt; width: 468pt"/></span></p><div>

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

</div><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 rights to a patent family that discloses the Milciclib compound, methods of using the compound, and processes for making the compound
licensed from Nerviano Medical Sciences S.R.L. (which is further described below). This patent family includes six granted U.S. patents,
one granted European patent, and one granted Eurasian patent. This patent family also includes granted patents in Africa (African Intellectual
Property Organization, African Regional Intellectual Property Organization), Algeria, Argentina, Australia, Brazil, Barbados, Bosnia
&amp; Herzegovina, Canada, Colombia, Costa Rica, Croatia, Cuba, Ecuador, Georgia, Iceland, India, Indonesia, Israel, Japan, Korea, Kosovo,
Malaysia, Mexico, Mongolia, Montenegro, New Zealand, Nicaragua, Norway, Pakistan, Philippines, Serbia, Singapore, South Africa, Sri Lanka,
Taiwan, Thailand, Trinidad &amp; Tobago, Tunisia, Ukraine, Uzbekistan, and Vietnam. Applications are also pending in the U.S., Egypt,
and Venezuela. The patents in this family will expire in April 2024, excluding any patent term adjustment and patent term extension in
the U.S. and similar regulatory extensions available in several other jurisdictions, such as Europe.</span></p><div>

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

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

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    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
    </div><!-- Field: /Page --><div>

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

</div><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 have rights to a patent family which covers related entities, such as salts and crystal forms, of Milciclib, and methods of using
the salts and crystal forms licensed from Nerviano Medical Sciences S.R.L. This patent family comprises one granted U.S. patent and one
granted patent in each of Europe, China, Japan, and Hong Kong. The patents in this family will expire in April 2030, excluding any patent
term adjustment and patent term extension in the U.S. and several other jurisdictions, such as Europe.</span></p><div>

</div><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><div>

</div><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, we have rights to five patent families which cover methods of using Milciclib in the treatment of multiple indications licensed
from Nerviano Medical Sciences S.R.L. These patent families comprise five granted U.S. patents, and granted patents in Europe, China,
Hong Kong, and Japan, and one pending patent application in Europe. The patents in these families will expire between February 2027 and
March 2030, excluding any patent term adjustment and patent term extension in the U.S. and similar regulatory extensions available in
several other jurisdictions, such as Europe.</span></p><div>

</div><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><div>

</div><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">Among
the above five patent families, two families also cover combination therapies of Milciclib with cytotoxic agents. These families comprise
two granted U.S. patents, and granted patents in Europe, China, Hong Kong, and Japan. The patents in these families will expire between
November 2029 and March 2030, excluding any patent term adjustment and patent term extension in the U.S. and similar regulatory extensions
available in several other jurisdictions, such as Europe.</span></p><div>

</div><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><div>

</div><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">One
family of the above five patent families also covers combination therapies of Milciclib with therapeutic antibodies. This patent family
includes one granted U.S. patent, and granted patents in Europe, China, and Japan. The patents in this family will expire in February
2027, excluding any patent term adjustment and patent term extension in the U.S. and similar regulatory extensions available in several
other jurisdictions, such as Europe.</span></p><div>

</div><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><div>

</div><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, we have rights to a patent family which covers methods of using Milciclib together with a second anti-cancer agent in the treatment
of cancer. This patent family includes granted patents in the U.S. and Japan and pending applications in the U.S., Europe, Canada, Japan,
and Hong Kong. The patent and patent applications in this family, if issued as patents, will expire in November 2038, excluding any patent
term adjustment and patent term extension in the U.S. and similar regulatory extensions available in several other jurisdictions, such
as Europe.</span></p><div>

</div><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><div>

</div><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 have rights to a U.S. provisional application which covers enteric-coated pharmaceutical formulations comprising Milciclib. The
patent applications in this family, if issued as patents, will expire in March 2043, excluding any patent term adjustment and patent
term extension in the U.S. and similar regulatory extensions available in several other jurisdictions, such as Europe.</span></p><div>

</div><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><div>

</div><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 have rights to a PCT application that discloses method of treating KRAS mutated cancers by administering Milciclib and a chemotherapy.
Any patents issued in this family will expire in August 2042, excluding any patent term adjustment and patent term extensions available
in the U.S and several other jurisdictions.</span></p><div>

</div><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><div>

</div><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 rights to a patent family that discloses methods of using Foralumab, licensed from NovImmune S.A. (which is further described below).
This patent family includes one granted European patent and one granted Eurasian patent. This patent family also includes granted patents
in Australia, Canada, China, Hong Kong, Israel, Japan, Mexico, Norway, Singapore, South Africa, and Ukraine. The patents in this family
will expire in April 2025, excluding any patent term extensions available in several jurisdictions, such as Europe.</span></p><div>

</div><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><div>

</div><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 have rights to a patent family that discloses the Foralumab compound and methods of using the compound also licensed from NovImmune
S.A. This patent family comprises four granted U.S. patents one granted European patent, and one granted Eurasian patent. This patent
family also includes granted patents in Australia, Brazil, Canada, China, Hong Kong, India, Israel, Japan, Mexico, Republic of Korea,
Singapore, South Africa, and Ukraine. An application is pending in the U.S. The patents in this family will expire in June 2025, excluding
any patent term adjustment in the U.S. and patent term extensions available in the U.S. and several other jurisdictions, such as Europe.</span></p><div>

</div><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><div>

</div><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, we have rights to a patent family that discloses combination therapies of Foralumab with IL-6 or IL-6R antibodies licensed
from NovImmune S.A. This patent family has one pending U.S. application. Once issued, the patents in this family will expire in January
2032, excluding any patent term adjustment and patent term extensions available in the U.S.</span></p><div>

</div><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><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"></p><div>

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    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
    </div><!-- Field: /Page --><div>

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

</div><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 rights to a patent family that discloses formulations of Foralumab and dosing regimens for treating various disorders. This patent
family has an issued patent in the U.S., issued patents in China and Japan, and applications pending in the U.S, Australia, Canada, China,
Europe, Israel, Hong Kong, and Japan. The patents in this family will expire in August 2037, excluding any patent term adjustment and
patent term extensions available in the U.S and several other jurisdictions.</span></p><div>

</div><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><div>

</div><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 rights to a patent family that discloses methods of using Foralumab for treating central nervous system (CNS) disorders, licensed
from Brigham and Women&#8217;s Hospital, Inc. (which is further described below). This patent family has applications pending in Canada,
Europe, Japan, and the United States that, if issued as patents, will expire in June 2038, excluding any patent term adjustment and patent
term extensions available in the U.S and several other jurisdictions.</span></p><div>

</div><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><div>

</div><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 rights to a PCT application that discloses methods of using Foralumab for microglial activation, which is co-owned with Brigham
and Women&#8217;s Hospital Inc. The patent applications in this family, if issued as patents, will expire in 2042, excluding any patent
term adjustment and patent term extensions available in the U.S and several other jurisdictions.</span></p><div>

</div><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><div>

</div><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 rights to a patent family that discloses methods of using Foralumab for treating gastrointestinal, autoimmune, and inflammatory
disorders. This family has pending applications in the U.S., Europe, Australia, Canada, China, Hong Kong, and Japan. The applications
in this family, if issued as patents, will expire in October 2039, excluding any patent term adjustment and patent term extensions that
may be available.</span></p><div>

</div><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><div>

</div><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 have rights to a patent family that discloses methods of using Foralumab in the treatment of coronavirus. This family has pending
applications in the U.S., Australia, Canada, China, Europe, Israel and Japan. The patent applications in this family, if issued as patents,
will expire in 2041, excluding any patent term adjustment and patent term extensions available in the U.S and several other jurisdictions.</span></p><div>

</div><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><div>

</div><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 have rights to a patent family that discloses methods of using Foralumab to enhance cell adoptive therapies. This family has pending
applications in the U.S., Australia, Canada, China, Europe, Israel and Japan. The patent applications in this family, if issued as patents,
will expire in 2041, excluding any patent term adjustment and patent term extensions available in the U.S and several other jurisdictions.</span></p><div>

</div><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><div>

</div><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 have rights to a PCT application that discloses methods of administering Foralumab subcutaneously for the treatment of various diseases.
Any patents issued in this family will expire in April 2042, excluding any patent term adjustment and patent term extensions available
in the U.S and several other jurisdictions.</span></p><div>

</div><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><div>

</div><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 have rights to a U.S. provisional application that discloses nasal formulations of Foralumab for the treatment of various diseases.
Any patents issued in this family will expire in 2043, excluding any patent term adjustment and patent term extensions available in the
U.S and several other jurisdictions.</span></p><div>

</div><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><div>

</div><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 rights to a patent family that discloses methods of using TZLS-501 to treat various disorders, licensed from NovImmune S.A. This
patent family includes five granted U.S. patents, one granted European patent, and granted patents in Australia, Canada, China, India,
Israel, Japan, and Mexico. Applications are pending in U.S. and Japan. The patents in this family will expire in May 2029, excluding
any patent term extensions available in several jurisdictions, such as Europe.</span></p><div>

</div><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><div>

</div><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 rights to a second patent family that discloses methods of using TZLS-501 to treat coronavirus alone and in combination with Actinomycin
D. This patent family includes pending applications in the U.S., Australia, Canada, China, Europe, Israel, and Japan. The patent applications
in this family, if issued as patents, will expire in March 2041, excluding any patent term extensions available in several jurisdictions.</span></p><div>

</div><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><div>

</div><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 have rights to two patent families related to Actinomycin D (ActD). The first family covers the use of ActD in the treatment of
acute myeloid leukemia, and includes granted patents in the U.S., Australia, Canada, Japan, and Europe. The patents in this family will
expire in September 2036, excluding any patent term adjustment and patent term extension in the U.S. and similar regulatory extensions
available in several other jurisdictions, such as Europe.</span></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"></p><div>

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    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
    </div><!-- Field: /Page --><div>

</div><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><div>

</div><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
second ActD family covers nanoparticle formulations of ActD and the use of the same in the treatment of acute myeloid leukemia and myelodysplastic
syndrome. In this family, there are granted patents in the U.S. and Japan and pending applications in the U.S., Europe, Australia, Canada,
and Japan. The patents and patent applications in this family, if issued as patents, will expire in September 2037, excluding any patent
term adjustment and patent term extension in the U.S. and similar regulatory extensions available in several other jurisdictions, such
as Europe.</span></p><div>

</div><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><div>

</div><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">Individual
patents extend for varying periods depending on the date of filing of the patent application or the date of patent issuance and the legal
term of patents in the countries in which they are obtained. Generally, patents issued for regularly filed applications in the United
States are granted a term of 20 years from the earliest effective non-provisional filing date. In addition, in certain instances, a patent
term can be extended to recapture a portion of the USPTO delay in issuing the patent as well as a portion of the term effectively lost
as a result of the FDA regulatory review period. However, as to the FDA component, the restoration period cannot be longer than five
years and the total patent term including the restoration period must not exceed 14 years following FDA approval. The duration of foreign
patents varies in accordance with provisions of applicable local law, but typically is also 20 years from the earliest effective filing
date. However, the actual protection afforded by a patent varies on a product by product basis, from country to country and depends upon
many factors, including the type of patent, the scope of its coverage, the availability of regulatory-related extensions, the availability
of legal remedies in a particular country and the validity and enforceability of the patent.</span></p><div>

</div><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><div>

</div><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,
we rely upon trade secrets and know-how and continuing technological innovation to develop and maintain our competitive position. We
seek to protect our proprietary information, in part, using confidentiality agreements with our collaborators, employees and consultants
and invention assignment agreements with our employees. We also have confidentiality agreements or invention assignment agreements with
our collaborators and selected consultants. These agreements are designed to protect our proprietary information and, in the case of
the invention assignment agreements, to grant us ownership of technologies that are developed through a relationship with a third party.
These agreements 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. To the extent that our collaborators, employees and consultants use intellectual
property owned by others in their work for us, disputes may arise as to the rights in related or resulting know-how and inventions.</span></p><div>

</div><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><div>

</div><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 will also depend in part on not infringing upon the proprietary rights of third parties. It is uncertain whether the
issuance of any third-party patent would require us to alter our development or commercial strategies, or our product candidates or processes,
obtain licenses or cease certain activities. Our breach of any license agreements or failure to obtain a license to proprietary rights
that we may require to develop or commercialize our future product candidates may have an adverse impact on us. If third parties have
prepared and filed patent applications prior to March 16, 2013 in the United States that also claim technology to which we have rights,
we may have to participate in interference proceedings in the USPTO, to determine priority of invention. For more information, see &#8220;Risk
Factors&#8212;Risks Related to Our Intellectual Property.&#8221;</span></p><div>

</div><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><div>

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

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    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
    </div><!-- Field: /Page --><div>

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

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

</div><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"><i>&#160;</i></span></p><div>

</div><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><i>Nerviano
Agreement</i></b></span></p><div>

</div><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"><b><i>&#160;</i></b></span></p><div>

</div><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
January 2015, we entered into an agreement with Nerviano, or the Nerviano Agreement, pursuant to which we obtained a worldwide, exclusive
license to patents owned or controlled by Nerviano, or the Nerviano License to develop and commercialize products and services incorporating
Milciclib as an active ingredient, and any product or service controlled or owned by Nerviano that is used to diagnose or assess responsiveness
to Milciclib therapy or dosage. The Nerviano License confers the right on us grant sub-licenses, and otherwise to employ third party
manufacturers and distributors to produce and sell licensed products and services.</span></p><div>

</div><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><div>

</div><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">Each
party to the Nerviano Agreement agreed to a development plan, or the Nerviano Development Plan, approved by a joint development committee,
or the JDC. The JDC is comprised of at least two members of each party, meets at least twice a year and endeavors to make decisions by
consensus, save that where there is a disagreement with respect to any aspect of the licensed products or services we shall have a deciding
vote.</span></p><div>

</div><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><div>

</div><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
the Nerviano Development Plan, we (or, as the case may be, our sub-licensee(s)) are obliged to use commercially reasonable efforts to
develop and commercialize a licensed product or service in at least one therapeutic indication that arises out of the Nerviano Development
Plan, and Nerviano is obliged to use commercially reasonable efforts to manufacture such product(s) or service(s). Pursuant to the Nerviano
Development Plan, we have sole responsibility for costs for further clinical development and Nerviano is obliged to perform Phase 2 studies
of licensed products and services, save that the amounts to be invoiced by Nerviano to us for Phase 2 studies shall be commercially reasonable
and not be greater than a low-double-digit percentage in excess than amounts estimated to be invoiced by another reputable clinical research
organization.</span></p><div>

</div><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><div>

</div><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">During
the term of the Nerviano Development Plan, or the Nerviano Exclusivity Period, we and our affiliates may not, directly or indirectly,
develop, make, use, sell, offer for sale or import any small molecule compound or other biological or chemical molecule other than Milciclib
that directly binds to, with an affinity indicated by an IC50 of 100nM or less, and modulates the following specified pharmacological
targets hit by Milciclib: Cdk-2, Cdc-4 and Cdc6.</span></p><div>

</div><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><div>

</div><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">Upon
entry into the Nerviano Agreement, we paid an upfront, non-refundable initial license fee of $3,500,000 to Nerviano. We issued 4,233,616
of ordinary shares, fully paid with a nominal value of three pence each, or the Consideration Shares, to Nerviano at an issue price of
50.5 pence (equivalent to an aggregate value of &#163;2,137,976.08).</span></p><div>

</div><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><div>

</div><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">Nerviano
granted us an option, or the Nerviano Option, to buy-back all the Consideration Shares for a de minimis aggregate consideration exercisable
on written notice at any time after the earlier of:</span></p><div>

</div><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><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="vertical-align: top">
    <td style="width: 48px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">(i)</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">an unsuccessful Phase 2
    trial for HCC or breast cancer with a licensed product or service and the concomitant decision of the company, our affiliates or
    sub-licensees to discontinue development of a licensed product or service;</span></td></tr>
  </table><div>
</div><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><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="vertical-align: top">
    <td style="width: 48px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">(ii)</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the fifth anniversary of
    the Nerviano Agreement, (provided that if on such date a Phase 2 trial has commenced but has not been completed our ability to exercise
    the Nerviano Option shall be delayed until the outcome of the Phase 2 trial has become clear); or</span></td></tr>
  </table><div>
</div><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><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="vertical-align: top">
    <td style="width: 48px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">(iii)</span></td>
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">our abandonment of any licensed product or service
    for bona fide scientific reasons.</span></td></tr>
  </table><div>
</div><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><div>


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    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
    </div><!-- Field: /Page --><div>

</div><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><div>

</div><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
Nerviano Option cannot be exercised if any of the following events (each, a Release Event), occurs:</span></p><div>

</div><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><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="vertical-align: top">
    <td style="width: 48px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">(i)</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">a successful completion
    of a Phase 2 trial for HCC or breast cancer with a licensed product or service, where such successful conclusion renders the licensed
    product or service eligible for entry into a Phase 3 trial with no further clinical study; or</span></td></tr>
  </table><div>
</div><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><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="vertical-align: top">
    <td style="width: 48px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">(ii)</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">our abandonment of the
    development of, or failure to exercise commercially reasonable efforts develop any, licensed product or service, save for where we
    have bona fide scientific reasons.</span></td></tr>
  </table><div>
</div><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><div>

</div><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
Nerviano Option effectively allows us to recover the Consideration Shares if it transpires that Milciclib proves to be unsuccessful in
the indications for which we licensed it or we fail to see satisfactory results in a period of 5 years from the date of the license agreement.</span></p><div>

</div><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><div>

</div><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">Prior
to a Release Event, Nerviano has agreed to not transfer, dispose of, or grant options or other rights over directly or indirectly any
interests in the Consideration Shares nor to derive any financial benefit from the Shares, but is entitled to exercise all voting rights
arising from the Consideration Shares.</span></p><div>

</div><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><div>

</div><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">Following
a Release Event, Nerviano has agreed to a 12 month lock-up, or the Nerviano Lock-Up, in respect of the Consideration Shares, subject
to customary exceptions, including the prior written consent of the company and our nominated adviser from time to time (which consent
may be approved, provided or provided subject to conditions as each may determine in its absolute discretion), acceptance of takeover
bids, share buy-backs by the company, or where required by law.</span></p><div>

</div><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><div>

</div><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">Following
the lapse of the term of the Nerviano Lock-Up, Nerviano has agreed to not directly or indirectly, transfer, sell, mortgage, charge or
otherwise dispose of more than 10% of the Consideration Shares (i.e. 423,362 ordinary shares) per calendar month, and to utilize the
company&#8217;s broker from time to time to execute those transactions in respect of the legal and or beneficial ownership or any other
interest in the Consideration Shares so as to ensure an orderly market.</span></p><div>

</div><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><div>

</div><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 obligated to pay Nerviano the following additional amounts in respect of the first licensed product or service which achieves the
stated development milestones:</span></p><div>

</div><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><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="vertical-align: top">
    <td style="width: 48px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">(a)</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">$100,000 upon initiation,
    first patient dosed, or FPD, of the first Phase 3 registration trial in thymic carcinoma.</span></td></tr>
  </table><div>
</div><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><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="vertical-align: top">
    <td style="width: 48px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
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    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">$4,000,000 upon FPD of
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  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: -25.3pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="vertical-align: top">
    <td style="width: 48px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">(c)</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">$6,000,000 upon FPD of
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  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: -24.85pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="vertical-align: top">
    <td style="width: 48px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
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    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Upon the first NDA equivalent
    in: thymic carcinoma, $900,000; HCC, $9,000,000; breast cancer, $15,000,000.</span></td></tr>
  </table><div>
</div><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><div>

</div><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 obliged to pay Nerviano a low-single-digit percentage royalty fee of the annual net sales of licensed products or services, subject
to certain royalty off-sets on a country-by-country basis and, subject to certain exclusions, a low-double-digit percentage of sub-licensing
revenues from the sale of licensed products or services for the life of the licensed patents.</span></p><div>

</div><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><div>

</div><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">During
the Nerviano Exclusivity Period, we have the right to terminate activities and funding to Nerviano after 24 months from the beginning
of the Nerviano Exclusivity Period but not prior thereto. If we exercise our termination right, we are obliged to transfer to Nerviano
all relevant data, licensed products and services and an exclusive license pertaining to the licensed product or services, and Nerviano
shall pay us a low-single-digit percentage royalty on annual net sales of licensed products and services, subject to certain exceptions.</span></p><div>

</div><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><div>

</div><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">Following
the expiry of the Nerviano Exclusivity Period, we may terminate the Nerviano Agreement at any time on 90 days&#8217; written notice,
and either party may terminate the Nerviano Agreement for material breach by the other party of any material obligation or condition
of the Nerviano Agreement by written notice, subject to a 45 day cure period for a payment breach, and a 120 day cure period for any
other breach.</span></p><div>

</div><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><div>


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    </div><div style="margin-top: 12pt; margin-bottom: 6pt; border-bottom: Black 1.5pt solid"><p style="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><!-- Field: Sequence; Type: Arabic; Name: PageNo -->69<!-- Field: /Sequence --></p></div><div>
    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
    </div><!-- Field: /Page --><div>

</div><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><div>

</div><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">Absent
early termination, the Nerviano Agreement shall remain in force until the later of, in all countries in which licensed products and services
are marketed pursuant to the Nerviano Agreement, (a) the expiration of the last claim in an issued, unexpired patent within the licensed
patents, subject to certain exceptions, which covers the sale of such licensed products or services, or (b) five years from the date
of first commercial sale of such licensed product or service in such country.</span></p><div>

</div><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><div>

</div><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"><b><i>Novimmune
CD3 Agreement</i></b></span></p><div>

</div><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"><b><i>&#160;</i></b></span></p><div>

</div><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
December 2014, we entered into a license and sublicense agreement with Novimmune, or the Novimmune CD3 Agreement, pursuant to which we
obtained a worldwide, exclusive license to certain patents owned or controlled by Novimmune, or the Novimmune CD3 License, together with
a sublicense to certain patent licenses from Bristol-Myers Squibb Company, or BMS, or the BMS CD3 Sublicense, and any associated know-how,
biologic materials, clinical data or other technology relating to CD3 receptor mAbs and their use in order to research, develop and commercialize
products and services. The Novimmune CD3 License and BMS CD3 Sublicense both confer the right to us to grant sublicenses, and otherwise
to employ third party manufacturers and distributors to produce and sell licensed products and services, respectively.</span></p><div>

</div><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><div>

</div><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">Pursuant
to the Novimmune CD3 Agreement, Novimmune granted the BMS CD3 Sub-License to us. Novimmune effected such grant pursuant to a research
and commercialization agreement between Novimmune and BMS dated September 20, 2014, or the BMS R&amp;C Agreement, and the agreement for
the exclusive commercial license for the CD3 licensed product (NI-0401) between Novimmune and BMS dated February 2005.</span></p><div>

</div><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><div>

</div><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
the Novimmune CD3 Agreement, we have full control and authority over the research, development and commercialization of licensed products
and services, and are required to exercise commercially reasonable efforts to commercialize such licensed products and services at all
times.</span></p><div>

</div><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><div>

</div><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">Upon
our entry into the Novimmune CD3 Agreement we paid an upfront fee of $750,000 to Novimmune (to be on paid by Novimmune to BMS pursuant
to the terms of the BMS R&amp;C Agreement), and a further upfront fee of $500,000 to Novimmune. We are required to pay Novimmune installments
of $250,000 on each of the 14 month, 26 month and 38 month anniversaries of the date of the Novimmune CD3 Agreement. For the term of
the Novimmune Agreement, we are obligated to pay to Novimmune a royalty of a low-single-digit percentage on net sales of licensed products
and services, together with any amounts owed to BMS incurred pursuant to the BMS CD3 Sub-License.</span></p><div>

</div><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><div>

</div><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 terminate the Novimmune CD3 Agreement at any time on 90 days&#8217; written notice, and either party may terminate the Novimmune
CD3 Agreement by written notice for a payment breach or any other breach, subject to 45 day and 120 day cure periods, respectively. Absent
early termination, the Novimmune CD3 Agreement will continue until the later of, in all countries in which licensed products are marketed
pursuant to the Novimmune CD3 Agreement, (a) the expiration of the last claim in an issued, unexpired patent within the licensed patents
or a claim that has not been pending more than five years, subject to certain exceptions, which covers the sale of such licensed product
or service, or (b) the end of any market exclusivity period granted by the relevant governmental authority in a country that prevents
another party from marketing the same licensed product or service.</span></p><div>

</div><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><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"></p><div>

</div><!-- Field: Page; Sequence: 75; Value: 1 --><div>
    </div><div style="margin-top: 12pt; margin-bottom: 6pt; border-bottom: Black 1.5pt solid"><p style="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><!-- Field: Sequence; Type: Arabic; Name: PageNo -->70<!-- Field: /Sequence --></p></div><div>
    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
    </div><!-- Field: /Page --><div>

</div><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><div>

</div><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"><b><i>Novimmune
IL-6r Agreement</i></b></span></p><div>

</div><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"><b><i>&#160;</i></b></span></p><div>

</div><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
December 2016, we entered into a license and sublicense agreement with Novimmune, or the Novimmune IL-6r Agreement, pursuant to which
we obtained a worldwide, exclusive license to certain patents owned or controlled by Novimmune, or the Novimmune IL-6r License, together
with a sub-license to certain patent licenses from BMS, or the BMS IL-6r Sub-License, and any associated know-how, biologic materials,
clinical data or other technology relating to IL-6r mAbs and their use in order to research, develop, commercialize products and services.
The Novimmune IL-6r License and BMS IL-6r Sub-License both confer the right to us to grant sub-licenses, and otherwise to employ third
party manufacturers and distributors to produce and sell licensed products and services, respectively.</span></p><div>

</div><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><div>

</div><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">Pursuant
to the Novimmune IL-6r Agreement, Novimmune granted the BMS IL-6r Sub-License. Novimmune effected such grant pursuant to the BMS R&amp;C
Agreement and the agreement for the IL-6r exclusive commercial license for the IL-6r antibody licensed product (NI-1201) between Novimmune
and BMS dated September 20, 2009, or the IL-6r Commercial License Agreement.</span></p><div>

</div><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><div>

</div><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
the Novimmune IL-6r Agreement, we have full control and authority over the research, development and commercialization of licensed products
and services, and are required to exercise commercially reasonable efforts to commercialize such licensed products and services at all
times.</span></p><div>

</div><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><div>

</div><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">Upon
our entry into the Novimmune IL-6r Agreement we paid an upfront fee of $100,000 to Novimmune. For the term of the Novimmune IL-6r Agreement,
we are obligated to pay to Novimmune a royalty of a low-single-digit percentage on net sales of licensed products and services, or low-double-digit
percentage of any sub-license royalty revenue which we receive that arises from sales of licensed products and services, together with
any amounts owed to BMS incurred pursuant to the BMS IL-6r Sub-License.</span></p><div>

</div><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><div>

</div><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
BMS R&amp;C Agreement and the IL-6r Commercial License Agreement were amended pursuant to an agreement between Novimmune and BMS dated
December 2016, or the Novimmune Amendment Agreement. Pursuant to the Novimmune Amendment Agreement, in the event that Novimmune (or,
as the case may be, a sublicensee) commercializes a combination product comprising NI-1201 and NI-0401, then such product shall be subject
to a single royalty.</span></p><div>

</div><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><div>

</div><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 terminate the Novimmune IL-6r Agreement at any time on 90 days&#8217; written notice, and either party may terminate the Novimmune
IL-6r Agreement by written notice for a payment breach or any other breach, subject to 45 day and 120 day cure periods, respectively.
Absent early termination, the Novimmune IL-6r Agreement will continue until the later of, in all countries in which licensed products
are marketed pursuant to the Novimmune IL-6r Agreement, (a) the expiration of the last claim in an issued, unexpired patent within the
licensed patents or a claim that has not been pending more than five years, subject to certain exceptions, which covers the sale of such
licensed product or service, or (b) the end of any market exclusivity period granted by the relevant governmental authority in a country
that prevents another party from marketing the same licensed product or service.</span></p><div>

</div><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><div>


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    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
    </div><!-- Field: /Page --><div>

</div><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><div>

</div><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"><b><i>Brigham
and Women&#8217;s Hospital License</i></b></span></p><div>

</div><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"><b><i>&#160;</i></b></span></p><div>

</div><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">On
May 29, 2018, we entered into a license agreement, or the BWH License, with BWH pursuant to which we obtained a worldwide exclusive license
to a patent owned by BWH for a novel technology discovered by Dr. Howard Weiner. The patent relates to a formulation of Foralumab in
a medical device developed for nasal administration of Foralumab. The BWH License extends to any associated know-how, clinical data and
use in order to research, develop and commercialize products and services. The BWH License confers on us the right to grant sub-licenses,
and otherwise to employ third party manufacturers and distributors to sell licensed products and services.</span></p><div>

</div><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><div>

</div><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
the BWH License we have full control and amnesty over the research, development and commercialization of licensed products and services
and are required to exercise commercially reasonable efforts to commercialize such licensed products and services at all times.</span></p><div>

</div><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><div>

</div><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">Upon
our entry into the BWH License we paid an upfront fee of $10,000 to BWH. We are required to pay annual maintenance fees, all ongoing
patent maintenance and prosecution costs and a low single-digit royalty on annual net sales (and a 12% royalty of non-royalty sub-license
revenues for the life of the intellectual property). We are also obliged to make certain milestone payments of: (a) US$300,000 within
60 days of first patient enrolled in a Phase 1 human clinical trial; (b) US$600,000 within 60 days of first patient enrolled in a Phase
2 human clinical trial; (c) US$1,500,000 within 60 days of first patient enrolled in a Phase 3 clinical trial; and (d) US$3,000,000 within
60 days of first commercial sale of a licensed product.</span></p><div>

</div><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><div>

</div><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 terminate the BWH License at any time on 90 days&#8217; written notice, and either party may terminate the BWH License by written
notice for payment or other breach, subject to a 60 day cure period. Absent early termination the BWH License will remain in effect until
the date on which all patents and filed patent applications have expired or been abandoned.</span></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 9pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p><div>

</div><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.
Organizational Structure</b></span></p><div>

</div><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><div>

</div><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">The
following table sets out details of the Company&#8217;s significant subsidiaries:</span></p><div>

</div><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><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="vertical-align: bottom">
    <td style="border-bottom: black 1.5pt solid"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Name</b></span></td>
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="border-bottom: black 1.5pt solid; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Principal
    activity</b></span></td>
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="border-bottom: black 1.5pt solid; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Registered
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    <td colspan="2" style="border-bottom: black 1.5pt solid; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Percentage
    <br/>
    shareholding</b></span></td>
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
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    incorporation</b></span></td></tr>
  <tr style="vertical-align: bottom">
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td colspan="2"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="background-color: #CCEEFF">
    <td style="vertical-align: top; width: 18%"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Tiziana Life
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    <td style="vertical-align: top; width: 1%"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
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    <td style="vertical-align: bottom; width: 26%"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">107 Cheapside,
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    <td style="vertical-align: bottom; width: 1%"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="vertical-align: bottom; width: 1%"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="vertical-align: top; width: 9%; text-align: right"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">100</span></td>
    <td style="vertical-align: top; width: 1%; text-align: right"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">%</span></td>
    <td style="vertical-align: bottom; width: 1%"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="vertical-align: top; width: 15%; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">England
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  <tr>
    <td style="vertical-align: top"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Tiziana Pharma Limited</span></td>
    <td style="vertical-align: top"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="vertical-align: top"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Clinical stage biotechnology
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    <td style="vertical-align: bottom"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="vertical-align: bottom"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">107 Cheapside, London
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    <td style="vertical-align: bottom"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="vertical-align: bottom"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="vertical-align: top; text-align: right"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">100</span></td>
    <td style="vertical-align: top; text-align: right"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">%</span></td>
    <td style="vertical-align: bottom"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="vertical-align: top; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">England
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  <tr style="background-color: #CCEEFF">
    <td style="vertical-align: top"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Tiziana Therapeutics Inc.</span></td>
    <td style="vertical-align: top"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="vertical-align: top"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Clinical stage biotechnology
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    <td style="vertical-align: bottom"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="vertical-align: bottom"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">5
                                       Penn Plaza, Floor 19&#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">New
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    <td style="vertical-align: bottom"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="vertical-align: bottom"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="vertical-align: top; text-align: right"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">100</span></td>
    <td style="vertical-align: top; text-align: right"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">%</span></td>
    <td style="vertical-align: bottom"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="vertical-align: top; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">USA</span></td></tr>
  <tr>
    <td style="vertical-align: top"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Longevia Genomics S.r.l.</span></td>
    <td style="vertical-align: top"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="vertical-align: top"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Biotechnology discovery
    company</span></td>
    <td style="vertical-align: bottom"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="vertical-align: bottom"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Via Constantinopli 42
    <br/>
    09100- Cagliria (CA)</span></td>
    <td style="vertical-align: bottom"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="vertical-align: bottom"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="vertical-align: top; text-align: right"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">100</span></td>
    <td style="vertical-align: top; text-align: right"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">%</span></td>
    <td style="vertical-align: bottom"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="vertical-align: top; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Italy</span></td></tr>
  </table><div>
</div><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><div>

</div><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.
Property, Plant and Equipment</b></span></p><div>

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

</div><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
below table contains information regarding existing or planned material tangible fixed assets owned or leased by Tiziana and its subsidiaries.
We believe that suitable additional or substitute space will be available as needed to accommodate any future expansion of our operations.</span></p><div>

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

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="vertical-align: top; ">
    <td style="border-bottom: black 1.5pt solid; width: 25%"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Location</b></span></td>
    <td style="width: 1%"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="border-bottom: black 1.5pt solid; width: 24%; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Tenure</b></span></td>
    <td style="width: 1%"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="border-bottom: black 1.5pt solid; width: 24%; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Principal
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    <td style="width: 1%"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="border-bottom: black 1.5pt solid; width: 24%; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Size</b></span></td></tr>
  <tr style="vertical-align: top; background-color: #CCEEFF">
    <td><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">14-15
        Conduit Street</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">London
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    Kingdom</span></p></td>
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">4-year Lease</span></td>
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Principal Office</span></td>
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    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">821 square feet</span></td></tr>
  <tr style="vertical-align: top; ">
    <td><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">5
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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">19<sup>th
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    York, United States</span></p></td>
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Monthly lease</span></td>
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Principal Office</span></td>
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">450 square feet</span></td></tr>
  <tr style="vertical-align: top; background-color: #CCEEFF">
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;601 New Britain Road <br/>
    Building 100, Suite 102<br/>
    Doylestown, PA, United States</span></td>
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Annual lease</span></td>
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Research &amp; Development Centre</span></td>
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">408 square feet</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.2in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p><div>


</div><!-- Field: Page; Sequence: 77; Value: 1 --><div>
    </div><div style="margin-top: 12pt; margin-bottom: 6pt; border-bottom: Black 1.5pt solid"><p style="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><!-- Field: Sequence; Type: Arabic; Name: PageNo -->72<!-- Field: /Sequence --></p></div><div>
    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
    </div><!-- Field: /Page --><div>

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

</div><div><a id="a_006"></a></div><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>ITEM
4A: UNRESOLVED STAFF COMMENTS</b></span></p><div>

</div><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><div>

</div><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><div>

</div><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><div>

</div><div><a id="a_007"></a></div><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>ITEM
5: OPERATING AND FINANCIAL REVIEW AND PROSPECTS</b></span></p><div>

</div><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><div>

</div><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"><i>You
should read the following discussion and analysis of our financial condition and results of operations together with &#8220;Selected
Consolidated Financial Data&#8221; and our consolidated financial statements and the related notes thereto appearing at the end of this
Annual Report. We present our consolidated financial statements in U.S. dollars and in accordance with International Financial Reporting
Standards, or IFRS, as issued by the International Accounting Standards Board, or IASB.</i></span></p><div>

</div><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><div>

</div><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"><i>Some
information included in this discussion and analysis, including statements regarding industry outlook, our expectations regarding our
future performance, liquidity and capital resources and other statements regarding our plans and strategy for our business and related
financing, are forward-looking statements. These forward-looking statements are subject to numerous risks and uncertainties. You should
read the &#8220;Risk Factors&#8221; section of this Annual Report for a discussion of important factors that could cause actual results
to differ materially from the results described in or implied by the forward-looking statements contained in the following discussion
and analysis.</i></span></p><div>

</div><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"><i>&#160;</i></span></p><div>

</div><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"><i>We
maintain our books and records in Pounds Sterling, and we prepare our financial statements in accordance with IFRS as issued by the IASB.
We report our financial results in U.S. dollars.</i></span></p><div>

</div><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"><i>&#160;</i></span></p><div>

</div><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>Overview</b></span></p><div>

</div><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><div>

</div><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>Introduction
to Tiziana</i></b></span></p><div>

</div><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><div>

</div><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 biotechnology company that is focused on the discovery and development of novel molecules and related diagnostics to treat high
unmet medical needs in oncology and immunology. Our lead product candidate in immunology is Foralumab (TZLS-401), which we believe is
the only fully human anti-CD3 monoclonal antibody, or mAb, in clinical development. MAbs represent a single pure antibody produced by
single clones and are an important class of human therapeutics for treating cancers and autoimmune diseases. Generation of antibodies
for use in humans developed in animals, leads to strong, immune responses limiting their effectiveness and potentially leading to severe
side effects. A process known as &#8220;humanization&#8221; removes most of the animal components of the antibody thereby lowering the
immune response from the human immune system. The entire omission of other animal material, as in fully human antibodies, is the optimal
goal to avoid incompatibility with the human immune system. Our lead product candidate in oncology is Milciclib (TZLS-201), which is
an orally bioavailable, small molecule broad spectrum inhibitor of cyclin-dependent kinases, or CDKs, and Src family kinases. CDKs are
a highly conserved family of enzymes that phosphorylate a specific group of proteins that are involved in regulating the cell cycle.
The cell cycle is a series of events that takes place in cells leading to division and duplication of its DNA to produce two daughter
cells. Src family kinases are non-receptor tyrosine kinase proteins encoded by the Src gene also involved in regulating cell growth and
potential transformation of normal cells to cancer cells. We are developing a fully human mAb targeting the IL-6R (TZLS-501) for which
the intellectual property was licensed from Novimmune in January 2017. This fully human mAb has a novel mechanism of action, binding
to both the membrane-bound and soluble forms of the IL-6R as well as depleting circulating levels of the IL-6 in the blood. Excessive
production of IL-6 is regarded as a key driver of acute inflammation resulting from infection with viral agents such as Coronaviruses
and of chronic inflammation, associated with autoimmune diseases such as multiple myeloma, oncology indications and rheumatoid arthritis,
and we believe that TZLS-501 may have potential therapeutic value for these indications.</span></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"></p><div>

</div><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
employ a lean and virtual research and development, or R&amp;D, model using highly experienced teams of experts for each business function
to maximize value accretion by focusing resources on the drug discovery and development processes. Our mission is to design and deliver
next generation therapeutics and diagnostics for oncology and immune diseases of high unmet medical need by combining deep understanding
of disease biology with clinical development expertise.</span></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"></p><div>

</div><!-- Field: Page; Sequence: 78; Value: 1 --><div>
    </div><div style="margin-top: 12pt; margin-bottom: 6pt; border-bottom: Black 1.5pt solid"><p style="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><!-- Field: Sequence; Type: Arabic; Name: PageNo -->73<!-- Field: /Sequence --></p></div><div>
    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
    </div><!-- Field: /Page --><div>

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



</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">We are developing Foralumab,
for which we in-licensed the intellectual property from Novimmune SA, or Novimmune, in December 2014, as a potential treatment for neurodegenerative
diseases such as Secondary Progressive Multiple Sclerosis (SPMS), Crohn&#8217;s disease and delayed onset of Type I Diabetes (T1D). On
November 10, 2022, Tiziana announced a short-term focus on administration of intranasal foralumab for treatment of neurodegenerative diseases,
especially SPMS, based on positive clinical findings of Expanded Access (EA) SPMS patients at Brigham and Women&#8217;s Hospital treated
with intranasal foralumab for up to 1 year. As the only fully human engineered human anti-CD3 mAb in clinical development, Foralumab has
significant potential advantages such as a shorter treatment duration and reduced immunogenicity. We believe that oral or intranasal administration
of Foralumab has the potential to reduce inflammation while minimizing the toxicity and related side effects. To date, Foralumab has been
studied in one Phase 1 and two Phase 2a clinical trials conducted by Novimmune in 68 patients dosed by the intravenous route of administration.
In these trials, Foralumab was observed to be safe and well-tolerated and produced immunologic effects consistent with potential clinical
benefit while demonstrating mild to moderate infusion related reactions, or IRRs. With completion of the intravenous dosing for Phase
2a trial in Crohn&#8217;s Disease, Foralumab&#8217;s ability to modulate T-cell response enables potential extension into a wide range
of other autoimmune and inflammatory diseases, such as Graft versus Host Disease (GvHD), ulcerative colitis (UC), multiple sclerosis(MS),
type-1 diabetes (T1D), inflammatory bowel disease (IBD), psoriasis (PSA) and rheumatoid arthritis (RA).</p><div>
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</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><div>

</div><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">Foralumab
is being developed as both an immunosuppressive and immunomodulatory agent, with therapeutic benefits of rendering T-cells unable to
orchestrate an immune response and induction of immune tolerance via maintenance of regulatory T-cells. There is further potential for
Foralumab to be combined with the Company&#8217;s TZLS-501, a fully human anti-IL-6R mAB in development to target autoimmune and inflammatory
diseases.</span></p><div>

</div><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><div>

</div><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
November 2016, Tiziana announced new data for oral efficacy in humanized mouse models with Foralumab, a major milestone and a potential
breakthrough for the treatment of NASH and autoimmune disease. This unique oral technology stimulates the natural gut immune system and
potentially provides a therapeutic effect in inflammatory and autoimmune diseases with greatly reduced toxicity. Positive therapeutic
effects with Foralumab were consistently demonstrated in animal studies conducted by Prof. Kevan Herold (Yale University) and Prof. Howard
Weiner (Harvard University).</span></p><div>

</div><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><div>

</div><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">On
16 April, 2018, the Group entered into an exclusive license agreement with The Brigham and Women&#8217;s Hospital, Inc. relating to a
novel formulation of Foralumab dosed in a medical device for nasal administration. An investigational new drug application (IND) for
the first-in-human evaluation of the nasal administration of Foralumab in healthy volunteers for progressive multiple sclerosis indication
was filed in the second quarter of 2018. Subsequent to IND approval, a single-site, double-blind, placebo-controlled, dose-ranging Phase
1 trial with nasally administered Foralumab at 10, 50 and 250 &#181;g per day, consecutively for 5 days to evaluate biomarkers of immunomodulation
of clinical responses was initiated in November 2018. The trial conducted at the Brigham and Women&#8217;s Hospital, Harvard Medical
School, Boston, MA, in healthy volunteers. 18 subjects received Foralumab treatment and 9 patients received placebo. The study was completed
in September 2019. Phase 1 clinical data demonstrated that nasally administered Foralumab, was well-tolerated and no drug-related safety
issues were reported at any of the doses. No drug-related changes were observed in vital signs among subjects at predose, during treatment
and at discharge. Nasally administered Foralumab at the 50 &#181;g dose suppressed cytotoxic CD8+ as well as perforin-secreting CD8+
cells, which have been implicated in neurodegeneration in multiple sclerosis (MS). Treatment at 50 &#181;g stimulated production of
anti-inflammatory cytokine IL-10 and suppressed production of pro-inflammatory cytokine IFN-&#947;. Taken together, the treatment showed
significant positive effects on the biomarkers for activation of mucosal immunity, which are capable of inducing site-targeted immunomodulation
to elicit anti-inflammatory effects. .&#160;Systemic levels of Foralumab were below the lower quantitation limit of 8 ng/mL suggesting
that nasally administered Foralumab appears to exert its effects via nasal epithelium utilizing local and lymphatic immune systems directly.
These data support other clinical and pre-clinical studies showing that this route of administration is capable of inducing site-targeted
immunomodulation and anti-inflammatory effects. Furthermore, these pharmacodynamic data point to a clinical dose range that Tiziana intends
to test in further clinical development among MS patients.</span></p><div>

</div><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><div>

</div><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">On
September&#160;9, 2019, the FDA granted approval to initiate the Phase 1 clinical trials to evaluate the safety and pharmacokinetics
of a novel enteric-coated capsule formulation of oral Foralumab at 1.25, 2.5 and 5.0 mg/day as a single ascending dose study. The study
was completed in December 2019 at Brigham and Women&#8217;s Hospital (Boston, MA USA). A total of 12 subjects were enrolled; 9 received
the single dose of foralumab and 3 received placebo. The median age (range) for the oral foralumab subjects was 23 (21 &#8211; 55) years,
and for the placebo subjects it was 34 (27 &#8211; 51). Of the foralumab subjects, 6 were male and 3 were female. All 3 of the placebo
subjects were female. No subjects discontinued the study. Formulated Foralumab powder blend encapsulated in enteric-coated capsule was
well-tolerated at all doses tested and there were no drug-related safety issues observed even at the highest dose of 5 mg in this trial.</span></p><div>

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</div><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">Tiziana
initiated a Phase 1b clinical trial in Crohn&#8217;s disease patients to evaluate oral capsules of foralumab, a fully human&#160;anti-CD3
monoclonal antibody. The revised protocol allowed for the study of a broader patient population and a shorter dosing period. These protocol
amendments or revisions were intended to expedite patient enrollment with study completion targeted for the fourth quarter of 2022.&#160;This
study was the first multiple-dose study with orally administered enteric-coated capsules of foralumab in patients with Crohn&#8217;s
disease. Due to the refocus of the company after the first six months of 2022, this study has been withdrawn.</span></p><div>

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</div><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
collaborative clinical trial was initiated on November 2, 2020 in&#160;Brazil&#160;investigating nasally administered Foralumab, either
alone or in combination with orally administered dexamethasone (&#8220;Dexa&#8221;) in COVID-19 patients. The clinical study was completed
in collaboration with scientific teams at the&#160;Harvard Medical School&#160;(Boston, USA), and INTRIALS, a full-service Latin American
CRO based in&#160;S&#227;o Paulo, Brazil.&#160;The objectives of the trial were to assess safety of the treatment and to evaluate if
progression of the diseases is delayed with nasally administered 100mcg/day Foralumab (50mcg/nostril). This study enrolled 39 patients
randomized in three cohorts: cohort 1, control with no treatment (n=16); cohort 2; nasally administered Foralumab plus 3 days of priming
with orally administered 6 mg Dexamethasone (n=11) and cohort 3; nasally administered Foralumab (n=12). The Foralumab treatment regimen
was once a day dosing for 10 consecutive days. The trial was completed in January 2021. There were no significant differences between
cohort 2 and 3. All treatments were well-tolerated. There were no grade 3 or 4 severe adverse events (&#8220;SAEs&#8221;) in any of the
cohorts<i>.</i>&#160;The CT scans of the lungs showed the improvement was approximately double that shown in patients treated with Foralumab
as compared to those in the control group. &#160; The results of the study were published in the&#160;peer-reviewed journal,&#160;<i>Frontiers
in Immunology</i>&#160;entitled &#8220;Nasal Administration of Anti-CD3 Monoclonal Antibody (Foralumab) Reduces Lung Inflammation and
Blood Inflammatory Biomarkers in Mild to Moderate COVID-19 Patients: A Pilot Study&#8221; in&#160;August 2021. This program has been
temporarily paused to pursue the short-term focus on clinical development of intranasal foralumab administration for treatment of SPMS
patients.</span></p><div>

</div><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><div>

</div><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">On
September 2, 2021 the Company and Precision BioSciences Inc announced an exclusive license agreement to explore Foralumab as an agent
to induce tolerance of allogeneic CAR T cells to potentially improve the clinical outcome of CAR T cell therapy. Precision&#8217;s approach
to manufacturing produces CAR T cells that are virtually CD3-negative. Foralumab will be used as a lymphodepletion or tolerizing agent,
either alone or in combination with other co-stimulatory molecules, to improve the long-term survival of CAR T cells in cancer treatment.
Tiziana has completed manufacture of foralumab solution for injection to be used by Precision Biosciences.</span></p><div>

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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: #FEFEFE"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">On
May 25, 2021 the Company announced that&#160;the first expanded access (EA) patient with secondary progressive multiple sclerosis (SPMS)
was dosed with nasally administered Foralumab at the&#160;Brigham and Women&#8217;s Hospital&#160;(BWH),&#160;Harvard Medical School,&#160;Boston,
MA.&#160;Nasal Foralumab 50 mcg (25 mcg/nostril) was administered in 3-week cycles, with 3 times/week dosing for the first 2 weeks followed
by 1 week of rest period. This first-ever clinical study in SPMS patients, under an Individual Patient Expanded Access IND, was to continue
for six months to evaluate routine safety, tolerability, and neurological behaviors. The study also examined microglial activation, by&#160;positron
emission tomography (PET), immunological and neurodegenerative markers to assess clinical responses following the dosing regimen</span></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: #FEFEFE"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">On
March 10, 2022, the Company reported positive clinical data in the first EA SPMS patient following completion of six months of treatment
with intranasally administered foralumab, at the Brigham and Women&#8217;s Hospital (BWH),&#160;Harvard University,&#160;Boston, MA.&#160;In
addition to being well-tolerated, both biological and clinical improvements were seen in this patient using Tiziana&#8217;s novel immunotherapy
technology, which, importantly overcame the challenge of delivering this antibody across the blood-brain barrier to affect immunomodulation
in the brain using nasal administration.</span></p><div>

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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: #FEFEFE"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Foralumab
was given to an EA SPMS patient intranasally into each nostril on a regimen of M-W-F for two weeks followed by one week off therapy for
a period of six months. This regimen was well-tolerated with associated beneficial clinical and biomarker changes. Importantly, the PET
imaging data indicated inhibition of microglial cell activation observed at 3 months following treatment initiation and was sustained
at 6 months after treatment start (see Table 1). The reduction in microglial activation was seen in all parts of the brain.</span></p><div>

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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: #FEFEFE"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Table
1. Percent Reduction* in Activated Microglial Cells (AMCs) PET Signal After Starting Intranasal Foralumab as Compared to Baseline, in
Whole Brain and Selected Brain Regions</b></span></p><div>

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

</div><table cellpadding="0" cellspacing="0" style="border-collapse: collapse; width: 100%; font: 10pt Times New Roman, Times, Serif">
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    <td colspan="2" style="font-weight: bold; text-align: center; border-bottom: Black 1.5pt solid">CEREBELLUM</td><td style="padding-bottom: 1.5pt; font-weight: bold">&#160;</td></tr>
  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="width: 40%; text-align: justify; padding-left: 0.75pt">3 MONTHS</td><td style="width: 1%">&#160;</td>
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    <td style="width: 1%; text-align: left">&#160;</td><td style="width: 9%; text-align: right">-23</td><td style="width: 1%; text-align: left">%</td><td style="width: 1%">&#160;</td>
    <td style="width: 1%; text-align: left">&#160;</td><td style="width: 9%; text-align: right">-20</td><td style="width: 1%; text-align: left">%</td><td style="width: 1%">&#160;</td>
    <td style="width: 1%; text-align: left">&#160;</td><td style="width: 9%; text-align: right">-25</td><td style="width: 1%; text-align: left">%</td><td style="width: 1%">&#160;</td>
    <td style="width: 1%; text-align: left">&#160;</td><td style="width: 9%; text-align: right">-22</td><td style="width: 1%; text-align: left">%</td></tr>
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    <td style="text-align: justify; padding-left: 0.75pt">&#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>
    <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>
  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="text-align: justify; padding-left: 0.75pt">6 MONTHS</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">-38</td><td style="text-align: left">%</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">-38</td><td style="text-align: left">%</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">-50</td><td style="text-align: left">%</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">-36</td><td style="text-align: left">%</td><td>&#160;</td>
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</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">*</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Percent reduction is based
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: #FEFEFE"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p><div>

</div><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">Consistent
with clinical and PET observations, intranasally administered foralumab also downregulated serum levels of pro-inflammatory cytokines,
including interferon-gamma (IFN-g), interleukin (IL-18), IL-1&#946; and IL-6, which are associated with multiple sclerosis pathogenesis
and progression. Clinical evaluation showed improvement in Timed 25-Foot Walk Test (T25FW), 9-Hole&#160;Peg Test&#160;(9HPT) and Symbol
Digit Modality Test (SDMT). Other published PET studies have shown an increase in activated microglial cells (AMCs) in patients with
secondary progressive MS (SPMS), and the increase in AMCs associated with higher scores on the Expanded Disability Status Scale (EDSS),
a widely-used scale to measure disability<sup>1,2</sup>. Several FDA-approved drugs, such as TYSABRI<sup>&#174;</sup>, MAYZENT<sup>&#174;</sup>&#160;and
ZEPOSIA<sup>&#174;</sup>&#160;have been shown to suppress microglial activation and exert neuroprotective effects in the central nervous
system (CNS) in animal studies but longitudinal assessment of drug effects on microglial activation in exclusive cohorts of SPMS patients
are lacking.</span></p><div>

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

</div><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">Prior
to treatment, this patient had continued to experience worsening disease progression despite several MS therapies, including B cell depletion.
The patient&#8217;s gait and limb strength had been deteriorating over the prior two years. The patient then started on intranasal foralumab,
which stabilized his disease course. Tiziana also received FDA authorization to continue treating this patient for an additional 6 months
to determine if 12 months of consistent treatment maintains clinical stabilization and provides sustained clinical benefits.</span></p><div>

</div><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><div>

</div><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">On
January 20, 2022, FDA approved enrollment of a second EA SPMS patient for treatment with intranasal foralumab.</span></p><div>

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

</div><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
data were presented in a virtual Key Opinion Leader (KOL) event hosted by Tiziana on&#160;March 14<sup>th</sup>, 2022, entitled &#8220;Foralumab
Clinical Update in Multiple Sclerosis; A Landmark Study with Intranasal Immunotherapy&#8221; featuring four Key Opinion Leaders and a
live Q&amp;A session. The company plans to continue treatment of EA SPMS patients at Brigham and Women&#8217;s Hospital and elsewhere
and continue evaluation of foralumab treatment.</span></p><div>

</div><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><div>

</div><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">On
April 5, 2022, Tiziana announced that FDA granted permission to enroll up to eight additional (SPMS) patients in Intermediate Size Patient
Population in the EAP with intranasal foralumab. As part of the original treatment plan, the foralumab dose will remain 50 mcg three
times a week (MWF), which is the same dose administered previously to the first two SPMS patients. The dosing regimen in this IND also
has a provision for dose escalation up to 100 mcg three times a week (MWF) as an option to improve clinical benefit, if needed.</span></p><div>

</div><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><div>

</div><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">Data
from a Secondary Progressive Multiple Sclerosis patient treated with intranasal foralumab were presented on&#160;June 2, 2022&#160;at
the consortium of multiple sclerosis centers (CMSC) 2022 annual meeting. Dr.&#160;Tanuja Chitnis, MD, Professor of Neurology and the
Principal investigator of the clinical study at the at the Brigham and Women&#8217;s Hospital (BWH),&#160;Boston, MA., presented a poster
discussing clinical data from a patient with SPMS, who was treated with intranasal foralumab for six months.</span></p><div>

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

</div><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">On
June 8, 2022, Tiziana announced positive clinical results for the second patient (EA2) in the non-active SPMS Expanded Access (EA) Program
following three months of dosing with intranasal foralumab. These results confirm the previously reported data, from the first non-active
SPMS patient (EA1) that after three months of treatment, intranasal foralumab. was well-tolerated and improved clinical and PET imaging
analyses. The second patient was diagnosed with SPMS in 2014. Since then, the disease has been progressive, resulting in an accumulation
of disability. Patient EA2 started ocrelizumab in 2018 and stopped this treatment in 2021. During this time EA2&#8217;s non-active SPMS
progressed as measured by EDSS worsening from 3.5 in 2018 to 6.0 in 2021. At this point in time EA2 needed a cane to walk 100 meters.
Patient EA2 was subsequently enrolled in the intranasal foralumab expanded access program. On&#160;September 2022, 8 months after starting
treatment with intranasal foralumab, EA2 was able to walk 100 meters without a cane or need to rest. This improved the EDSS from 6.0
to 5.5. EA2&#8217;s pyramidal score remained stable during this time. In&#160;December 2022, 11 months after starting treatment with
intranasal foralumab, EA2 was able to walk 200 meters without a cane or need to rest, resulting in further improvement in EDSS from 5.5
to 5.0. EA2&#8217;s pyramidal score continued to remain stable. Lastly preliminary reading of EA2&#8217;s 11-month PET Scan (December
2022) demonstrated improvement in microglial activation over baseline.</span></p><div>

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</div><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">On&#160;September
20, 2022, Tiziana announced that the second patient (&#8220;EA2&#8221;) with non-active secondary progressive multiple sclerosis (SPMS)
receiving intranasal foralumab had shown additional clinical improvements as measured by the Expanded Disability Status Scale (EDSS),
a standard clinical assessment.</span></p><div>

</div><p style="text-align: justify; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 22.5pt; background-color: #FEFEFE"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p><div>

</div><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">On
October 12, 2022, Tiziana announced that it planned to submit an Investigational New Drug Application (IND) for a Phase 1 Trial of intranasal
foralumab in Alzheimer's disease patients after receiving an affirmative written response from the FDA on a Pre-Investigational New Drug
Application (PIND). Tiziana plans on filing the IND for Alzheimer&#8217;s disease by the third quarter of 2023 upon the completion of
requested toxicology studies, then starting its Phase 1 program by the end of 2023.<br/>
<br/></span></p><div>

</div><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">On&#160;November
2, 2022, Tiziana announced the completion of enrollment of the first patient cohort in its Intermediate Size Patient Population Expanded
Access Program to evaluate foralumab in non-active SPMS patients.<br/>
<br/></span></p><div>

</div><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">On&#160;November
10, 2022, Tiziana announced its near-term focus on developing intranasal foralumab for inflammatory diseases of the Central Nervous System
(CNS) such as non-active SPMS, Alzheimer&#8217;s disease and amyotrophic lateral sclerosis (ALS).</span></p><div>

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

</div><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">During
2022, Tiziana completed compatibility, stability and characterization studies of foralumab nasal solution in unit dose devices for nasal
administration. Compatibility, stability and characterization studies of foralumab intranasal solution in multi dose device for intranasal
administration will be completed in Q1 2023.</span></p><div>

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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">We are evaluating administrations
of Foralumab to delay onset and progression of T1D in at-risk individuals. T1D is characterized as a chronic and progressive autoimmune
disease leading to the destruction of insulin-producing &#946;-cells of the pancreas. Teplizumab (Provention Bio), a humanized Fc-mutated
anti-CD3 monoclonal antibody that alters the function of the T-lymphocytes that mediate the destruction of the insulin-producing &#946;-cell
is seeking FDA approval. The Company believes that Foralumab, a fully human anti-CD3 mAb, would have a better safety profile and clinical
benefit than Teplizumab based on Foralumab&#8217;s fully human protein sequence and binding affinity for CD3e compared to Teplizumab.
cGMP manufacturing of Foralumab solution for subcutaneous injection was initiated in April 2022 and IND submission is anticipated in 2023.
This program has been temporarily paused to pursue the short-term focus on clinical development of intranasal foralumab administration
for treatment of SPMS patients.</p><div>
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</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: #FEFEFE"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p><div>

</div><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
2022, Tiziana initiated five Good Laboratory Practice (GLP) safety toxicology studies of foralumab administered intranasally and subcutaneously
in HuGEMM CD3 transgenic mice. The five studies consisted of three intranasal toxicology studies of 14 days, 13 weeks and 26 weeks dosing
duration and two subcutaneous safety toxicology studies of 14 days and 28 days dosing duration. On&#160;December 15, 2022&#160;the Company
announced that it had successfully completed the 13-week toxicology trial and that intranasal foralumab was well-tolerated.</span></p><div>

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

</div><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, on August 18, 2020 the United States Patent and Trademark Office, or USPTO, granted us a patent on use and methods of treatment
of Crohn&#8217;s disease with Foralumab, its proprietary fully human monoclonal antibody, and all other anti-CD3 mAbs.&#160;The CD3 (cluster
of differentiation 3) is a protein complex on T-cells, which is important for the regulation of the immune system. The patent was published
by the USPTO on September 1, 2020 as Patent No.&#160;10,759,858.&#160;Recently, we also announced the issuance of the first-ever patent
on oral administration of anti-CD3 mAbs for treatment of human diseases (Patent No.&#160;10,688,186). We believe the grant of this additional
composition-of-matter and use patent further strengthens our intellectual property, consisting of proprietary technologies on oral and
nasal administration of Foralumab and other anti-CD3 mAbs for the treatment of human diseases.</span></p><div>

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

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

</div><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">On
July 16, 2020, we&#160;announced that we had submitted a patent application on the potential use of Foralumab, a fully human anti-CD3
mAbs, to improve success of chimeric antigen receptor T-cell, or CAR-T, therapy for cancer and other human diseases. The patent application
conveys inventions related lymphodepletion to improving CAR-T expansion and/or survival using anti-CD-3 mAbs administered either alone
or in combination with other co-stimulatory molecules, such as an anti-IL-6R mAb, an anti-CD28 mAb or specific inhibitors of signaling
pathways of phosphatidylinositol 3-kinase (PI3K), protein kinase B (AKT), or mammalian target of rapamycin (mTOR).</span></p><div>

</div><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><div>

</div><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">On
July 31, 2020, we announced that we had submitted a patent application for the potential use of nasally administered Foralumab, a fully
human anti-CD3 mAb, for the treatment of COVID-19 either alone or in combination with other anti-viral drugs. Recent clinical studies
implied that a combination of anti-inflammatory and anti-viral drugs may be more effective to treat patients at different stages of COVID-19
disease.</span></p><div>

</div><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><div>

</div><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 developing a fully human mAb targeting the IL-6R (TZLS-501) for which the intellectual property was licensed from Novimmune in January
2017. This fully human mAb has a novel mechanism of action, binding to both the membrane-bound and soluble forms of the IL-6R as well
as depleting circulating levels of the IL-6 in the blood. Excessive production of IL-6 is regarded as a key driver of acute inflammation
resulting from infection with viral agents such as Coronaviruses and of chronic inflammation, associated with autoimmune diseases such
as multiple myeloma, oncology indications and rheumatoid arthritis, and we believe that TZLS-501 may have potential therapeutic value
for these indications.</span></p><div>

</div><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><div>

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</div><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><div>

</div><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
preclinical studies, TZLS-501 demonstrated the potential for overcoming the limitations of other IL-6 blocking pathway drugs. Compared
to tocilizumab and sarilumab, while binding to the membrane-bound IL-6R complex, TZLS-501 has been observed to have a higher affinity
for the soluble IL-6 receptor from antibody binding studies conducted in cell culture. TZLS-501 also demonstrated the potential to block
or reduce IL-6 signaling in mouse models of inflammation. The soluble form of IL-6 has been implicated to have a larger role in disease
progression compared to the membrane- bound form (Kallen, K.J. (2002). &#8220;The role of trans-signaling via the agonistic soluble IL-6
receptor in human diseases.&#8221; Biochimica et Biophysica Acta. 1592 (3): 323&#8211;343.)</span></p><div>

</div><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><div>

</div><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
Company is developing TZLS--501 for treatment of SSc-ILD. Tocilizumab (Actemra&#174;, Roche) a humanized interleukin-6 (IL-6) receptor
mAb antagonist. was approved by the FDA as a subcutaneous injection for slowing the rate of decline in pulmonary function in adult patients
with systemic sclerosis-associated interstitial lung disease (SSc-ILD), a debilitating condition with limited treatment options. Actemra&#174;
is the first biologic therapy approved by the FDA for the treatment of the disease.</span></p><div>

</div><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><div>

</div><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">On
April 9, 2020 The Company announced that it had developed investigational new technology to treat COVID-19 infections, consisting of
direct delivery of anti-IL-6 receptor (anti-IL-6R) monoclonal antibodies (mAbs) into the lungs using a handheld inhaler or nebulizer
for treatment of patients infected with COVID-19 (SARS-CoV-2)&#160;coronavirus.&#160;On June 29, 2020 the Company announced that it was
advancing GMP manufacturing of TZLS-501 with STC Biologics concurrently with the development of inhalation technology using a hand-held
nebulizer with Sciarra Laboratories and safety toxicology studies in Cynomolgus monkeys with ITR Canada Laboratories. GMP batches were
initiated in January 2021 and completed in March 2021. Safety inhalation toxicology studies were initiated in November 2020 and completed
in March 2021. Technological assessment of nebulizers for inhalation treatment of patients was initiated in September 2020 and completed
in February 2021. An additional 240L cGMP batch of TZLS-501 drug substance was manufactured using an improved downstream process to support
future development activities in June 2022. An IND for a Phase 1 Clinical Trial in Healthy Subjects for treatment of interstitial lung
disease associated with systemic sclerosis (SSc ILD) was filed in December 2022. This program has been temporarily paused to pursue the
Company&#8217;s short-term focus on clinical development of intranasal foralumab administration for treatment of SPMS patients.</span></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 13.5pt; background-color: #FEFEFE"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p><div>

</div><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 developing Milciclib, for which we in-licensed the intellectual property from Nerviano Medical Sciences S.r.l., or Nerviano, in January
2015, as a potential treatment for pan KRAS mutations in NSCLC patients.</span></p><div>

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

</div><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
date, Milciclib has been studied in a total of eight completed Phase 1 and 2 clinical trials in 316 patients.</span></p><div>

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

</div><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">Cumulative
Patient Exposure in Completed Milciclib Clinical Studies:</span></p><div>

</div><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><div>

</div><table cellpadding="0" cellspacing="0" style="border-collapse: collapse; width: 100%; font: 10pt Times New Roman, Times, Serif">
  <tr style="vertical-align: bottom">
    <td style="font-weight: bold; border-bottom: Black 1.5pt solid">Clinical Study</td><td style="font-weight: bold; padding-bottom: 1.5pt">&#160;</td>
    <td style="font-weight: bold; text-align: center; border-bottom: Black 1.5pt solid">Drug</td><td style="font-weight: bold; padding-bottom: 1.5pt">&#160;</td>
    <td style="font-weight: bold; text-align: center; border-bottom: Black 1.5pt solid">Indication</td><td style="font-weight: bold; padding-bottom: 1.5pt">&#160;</td>
    <td colspan="2" style="font-weight: bold; text-align: center; border-bottom: Black 1.5pt solid">Number of <br/> Patients&#160;Treated</td><td style="padding-bottom: 1.5pt; font-weight: bold">&#160;</td></tr>
  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="width: 30%">CDKO-125a-001 Phase 1</td><td style="width: 1%">&#160;</td>
    <td style="width: 28%; text-align: center">Milciclib</td><td style="width: 1%">&#160;</td>
    <td style="width: 28%; text-align: center">Solid tumors</td><td style="width: 1%">&#160;</td>
    <td style="width: 1%; text-align: left">&#160;</td><td style="width: 9%; text-align: right">37</td><td style="width: 1%; text-align: left">&#160;</td></tr>
  <tr style="vertical-align: bottom; ">
    <td style="text-align: left">CDKO-125a-002 Phase 1 / Phase 2</td><td>&#160;</td>
    <td style="text-align: center">Milciclib</td><td>&#160;</td>
    <td style="text-align: center">Malignant glioma (Phase 1) <br/> Glioblastoma (Phase 2)</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">62</td><td style="text-align: left">&#160;</td></tr>
  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td>CDKO-125a-003 Phase 1</td><td>&#160;</td>
    <td style="text-align: center">Milciclib</td><td>&#160;</td>
    <td style="text-align: center">Solid tumors</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">30</td><td style="text-align: left">&#160;</td></tr>
  <tr style="vertical-align: bottom; ">
    <td>CDKO-125a-004 Phase 1</td><td>&#160;</td>
    <td style="text-align: center">Milciclib + gemcitabine</td><td>&#160;</td>
    <td style="text-align: center">Solid tumors</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">16</td><td style="text-align: left">&#160;</td></tr>
  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td>CDKO-125a-005/-0061/-0071 Phase 2</td><td>&#160;</td>
    <td style="text-align: center">Milciclib</td><td>&#160;</td>
    <td style="text-align: center">Malignant Pleural <br/> Mesothelioma&#160;(-005) <br/> Thymic carcinoma and malignant thymoma (-0061
    and -0071)</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">140</td><td style="text-align: left">&#160;</td></tr>
  <tr style="vertical-align: bottom; ">
    <td style="padding-bottom: 1.5pt">CDKO-125a-010 Phase 2</td><td style="padding-bottom: 1.5pt">&#160;</td>
    <td style="text-align: center; padding-bottom: 1.5pt">Milciclib</td><td style="padding-bottom: 1.5pt">&#160;</td>
    <td style="text-align: center; padding-bottom: 1.5pt">HCC monotherapy</td><td style="padding-bottom: 1.5pt">&#160;</td>
    <td style="border-bottom: Black 1.5pt solid; text-align: left">&#160;</td><td style="border-bottom: Black 1.5pt solid; text-align: right">31</td><td style="padding-bottom: 1.5pt; text-align: left">&#160;</td></tr>
  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td>&#160;</td><td>&#160;</td>
    <td style="text-align: center">&#160;</td><td style="font-weight: bold">&#160;</td>
    <td style="font-weight: bold; text-align: center">Total Patients Exposed</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">316</td><td style="font-weight: bold; text-align: left">&#160;</td></tr>
  </table><div>


</div><p style="margin: 0">&#160;</p><div>

</div><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">Source:
Development Safety Update Report No. 8, February 28, 2019, Tiziana Life Sciences PLC; Investigator Brochure, Version 14, 2019. <b>&#160;
</b>&#160;</span></p><div>


</div><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">&#160;</span></p><div>

</div><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
these trials, Milciclib was observed to be well-tolerated and showed initial signals of anti-tumor action. Prior to in-licensing, Milciclib
was granted orphan designation by the European Commission and by the U.S. Food and Drug Administration (&#8220;FDA&#8221;) for the treatment
of malignant thymoma and an aggressive form of thymic carcinoma in patients previously treated with chemotherapy. In two Phase 2a trials,
CDKO-125a-006 and CDKO125a-007, Milciclib showed signs of slowing disease progression and acceptable safety.</span></p><div>

</div><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><div>

</div><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;In
the first half of 2017, the Group initiated a Phase 2a trial (CDKO-125a-010) of Milciclib to explore safety, tolerability and antitumor
activity of milciclib as a single therapy in Sorafenib-resistant patients with unresectable or metastatic HCC and good liver function..
Typically, this population of patients have an advanced form of the disease with poor prognosis and an average overall survival expectancy
of 3-5 months. The compound was administered as home-based treatment at the dose of 100 mg/day for 4 consecutive days a week in a 4-week
cycle (4 days on/3 days off x q4 wks) for a total of 24 weeks. The Phase 2a trial was completed in June 2019 with clinical safety result
reported in July 2019 and efficacy results reported in September 2019. The drug was well tolerated and the trial met clinical endpoints.</span></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-align: justify; text-indent: 0.25in; background-color: #FEFEFE"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p><div>

</div><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
overexpression of CDKs and dysregulation in pRB pathway (regulates transcription factors critical for cell cycle progression) are prominently
associated with tumor cell resistance to certain chemotherapeutic drugs, inhibition of multiple CDKs is an appealing approach to improve
clinical responses in cancer patient&#8217;s refractory to existing treatment options. A Phase 1 dose-escalation&#160;study of Milciclib
in combination with gemcitabine in patients with refractory solid tumors exhibited clinical activity in patients including those refractory
to gemcitabine. Milciclib shows inhibitory effects against multiple cell lines with mutationally active G12D (non-small cell lung carcinoma),
G13D (colorectal cancer), G12V(pancreatic cancer), and G12C (pancreatic cancer<b>&#160;</b>The Company also intends to evaluate milciclib
in combination with gemcitabine for treatment of pan KRAS mutations in NSCLC patients. cGMP manufacturing of milciclib capsules was completed
in January 2022 and IND filing was completed on December 15, 2022. This program has been temporarily paused to pursue the short-term
focus on clinical development of intranasal foralumab administration for treatment of SPMS patients.</span></p><div>

</div><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><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"></p><div>

</div><!-- Field: Page; Sequence: 83; Value: 1 --><div>
    </div><div style="margin-top: 12pt; margin-bottom: 6pt; border-bottom: Black 1.5pt solid"><p style="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><!-- Field: Sequence; Type: Arabic; Name: PageNo -->78<!-- Field: /Sequence --></p></div><div>
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</div><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><div>

</div><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 inception in March 2014, we have devoted substantially all our resources to conducting preclinical studies and clinical trials, organizing
and staffing our company, business planning, raising capital and establishing our intellectual property portfolio. We do not have any
products approved for sale and have not generated any revenue from product sales. We have funded our operations to date primarily with
proceeds from the sale of ordinary shares. Through December 31, 2022, we had received net cash proceeds of $118.3m million from sales
of our ordinary shares, issuance of convertible loans, short term loans and warrants.</span></p><div>

</div><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><div>

</div><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 inception, we have incurred operating losses. Our net loss after taxation was $12.1 million for the year ended December 31, 2022,
$23.4 million for the year ended December 31, 2021 and $26.1m for the year ended December 31, 2020 respectively. As of December 31, 2022,
we had cash and cash equivalents of $18.1 million.</span></p><div>

</div><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><div>

</div><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 to continue to incur significant expenses for the foreseeable future as we advance our product candidates through preclinical
and clinical development and seek regulatory approval and pursue commercialization of any approved product candidates. In addition, if
we obtain marketing approval for any of our product candidates, we expect to incur significant commercialization expenses related to
product manufacturing, marketing, sales and distribution.</span></p><div>

</div><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><div>

</div><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>Trend
information</b></span></p><div>

</div><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><div>

</div><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>Recent
developments</i></b></span></p><div>

</div><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"><b><i>&#160;</i></b></span></p><div>

</div><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>Legal
proceedings</b></span></p><div>

</div><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"><b>&#160;</b></span></p><div>

</div><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">From
time to time, we may be a party to litigation or subject to claims incident to the ordinary course of business. Although the results
of litigation and claims cannot be predicted with certainty, we currently believe that the final outcome of these ordinary course matters
will not have a material adverse effect on our business. Regardless of the outcome, litigation can have an adverse impact on us because
of defense and settlement costs, diversion of management resources and other factors. We are not currently a party to any material legal
proceedings.</span></p><div>

</div><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><div>

</div><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>Foreign
currency translations</b></span></p><div>

</div><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"><b>&#160;</b></span></p><div>

</div><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">Items
included in the financial statements are measured using the currency of the primary economic environment in which the entity operates
(the functional currency). The consolidated financial statements are presented in U.S. dollars, which is our presentation currency.</span></p><div>

</div><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><div>

</div><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">Foreign
currency transactions are translated into the functional currency using exchange rates prevailing at the dates of the transactions. Foreign
exchange gains and losses resulting from the settlement of foreign currency transactions and from the translation at year-end exchange
rates of monetary assets and liabilities denominated in foreign currencies are recognized in the income statement.</span></p><div>

</div><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><div>

</div><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
financial statements of overseas subsidiary undertakings are translated into U.S. dollars on the following basis:</span></p><div>

</div><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><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="vertical-align: top">
    <td style="width: 48px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
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  <tr style="vertical-align: top">
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    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="vertical-align: top">
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p><div>

</div><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">Exchange
differences arising from the translation of the net investment in foreign entities, borrowings and other currency instruments designated
as hedges of such investments, are taken to equity (and recognized in the statement of comprehensive income) on consolidation.</span></p><div>

</div><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><div>

</div><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>Components
of Our Results of Operations</b></span></p><div>

</div><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><div>

</div><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>Revenues</i></b></span></p><div>

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

</div><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
date, we have not generated any revenue from product sales and do not expect to generate any revenue from the sale of products in the
near future. If our development efforts for our product candidates are successful and result in regulatory approval, we may generate
revenue in the future from product sales. Any ad hoc sublicensing revenues have been treated as other income.</span></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.2in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.2in"></p><div>

</div><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>Operating
Expenses</i></b></span></p><div>

</div><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><div>

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

</div><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"><i>&#160;</i></span></p><div>

</div><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">R&amp;D
expenses consist primarily of costs incurred in connection with the R&amp;D of our product candidates and are expensed as incurred. These
expenses consist of:</span></p><div>

</div><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><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="vertical-align: top">
    <td style="width: 48px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">expenses incurred under
    agreements with CROs, CMOs, as well as investigative sites and consultants that conduct our clinical trials, preclinical studies
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  <tr style="vertical-align: top">
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td></tr>
  <tr style="vertical-align: top">
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></p><div>


</div><!-- Field: Page; Sequence: 84; Value: 1 --><div>
    </div><div style="margin-top: 12pt; margin-bottom: 6pt; border-bottom: Black 1.5pt solid"><p style="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><!-- Field: Sequence; Type: Arabic; Name: PageNo -->79<!-- Field: /Sequence --></p></div><div>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;&#160;</span></p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
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    <td>&#160;</td>
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  <tr style="vertical-align: top">
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">We recognize external development
costs based on an evaluation of the progress to completion of specific tasks using information provided to us by our service providers.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Our direct R&amp;D expenses
are tracked on a program-by-program basis for our product candidates and consist primarily of external costs, such as fees paid to outside
consultants, CROs and CMOs in connection with our preclinical development, manufacturing and clinical development activities. Our direct
R&amp;D expenses by program also include fees incurred under our license agreements. We do not allocate employee costs or facility expenses,
including depreciation or other indirect costs, to specific programs because these costs are deployed across multiple programs and, as
such, are not separately classified. We use internal resources primarily to oversee the R&amp;D as well as for managing our preclinical
development, process development, manufacturing and clinical development activities. These employees work across multiple programs and,
therefore, we do not track their costs by program.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">The table below summarizes
our R&amp;D expenses incurred by program:</p><div>

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

</div><table cellpadding="0" cellspacing="0" style="border-collapse: collapse; width: 100%; font: 10pt Times New Roman, Times, Serif">
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    <td>Direct research and development expense by program:</td><td>&#160;</td>
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    <td style="width: 52%">Foralumab</td><td style="width: 1%">&#160;</td>
    <td style="width: 1%; text-align: left">$</td><td style="width: 9%; text-align: right">8,962</td><td style="width: 1%; text-align: left">&#160;</td><td style="width: 1%">&#160;</td>
    <td style="width: 1%; text-align: left">$</td><td style="width: 9%; text-align: right">3,372</td><td style="width: 1%; text-align: left">&#160;</td><td style="width: 1%">&#160;</td>
    <td style="width: 1%; text-align: left">$</td><td style="width: 9%; text-align: right">1,346</td><td style="width: 1%; text-align: left">&#160;</td><td style="width: 1%">&#160;</td>
    <td style="width: 1%; text-align: left">$</td><td style="width: 9%; text-align: right">1,750</td><td style="width: 1%; text-align: left">&#160;</td></tr>
  <tr style="vertical-align: bottom; ">
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    <td style="text-align: left">&#160;</td><td style="text-align: right">111</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">1,175</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">364</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">1,916</td><td style="text-align: left">&#160;</td></tr>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">R&amp;D activities are central
to our business model. Product candidates in later stages of clinical development generally have higher development costs than those
in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials and related
product manufacturing expenses. As a result, we expect that our R&amp;D expenses will increase substantially over the next several years
as we increase personnel costs and prepare for regulatory filings related to our product candidates. We also expect to incur additional
expenses related to milestone, royalty payments and maintenance fees payable to third parties with whom we have entered into license
agreements to acquire the rights related to our product candidates.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">The successful development
and commercialization of our product candidates is highly uncertain. At this time, we cannot reasonably estimate or know the nature,
timing and costs of the efforts that will be necessary to complete the preclinical and clinical development of any of our product candidates
or when, if ever, material net cash inflows may commence from any of our product candidates. This uncertainty is due to the numerous
risks and uncertainties associated with development and commercialization, including the uncertainty of:</p><div>

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

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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in"></p><div>

</div><!-- Field: Page; Sequence: 85; Value: 1 --><div>
    </div><div style="margin-top: 12pt; margin-bottom: 6pt; border-bottom: Black 1.5pt solid"><p style="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><!-- Field: Sequence; Type: Arabic; Name: PageNo -->80<!-- Field: /Sequence --></p></div><div>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">We may never succeed in achieving
regulatory approval for any of our product candidates. We may obtain unexpected results from our clinical trials. We may elect to discontinue,
delay or modify clinical trials.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><i>General and Administrative Expenses</i></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">General and administrative
expenses consist primarily of salaries, related benefits, travel and share-based compensation expense for personnel in executive, finance
and administrative functions. General and administrative expenses also include professional fees for legal, consulting, accounting and
audit services.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">We anticipate that our general
and administrative expenses will increase in the future as we increase our headcount to support our continued research activities and
development of our product candidates. We also anticipate that we will incur increased accounting, audit, legal, regulatory, compliance,
director and officer insurance costs, as well as investor and public relations expenses associated with being a public company.&#160;</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><i>Impairment of an asset</i></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">This is an extraordinary
expense item for 2020 and includes the expenses for the impairment of a non-current asset.&#160;</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><i>Disposal of Intellectual Property</i></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">This is an extraordinary
expense item for 2020 and includes the expenses related to the disposal of intellectual property during the year.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><i>Other Income (Expense)</i></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Other expense consists of
interest on a convertible loan note and income received from a partnership agreement.</p><div>

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

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

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">The tax income for a period
represents the total of current taxation and deferred taxation. The charges in respect of current taxation are based on the estimated
taxable profit for the relevant year. Taxable profit for the year is based on the profit as shown in the income statement, as adjusted
for items of income or expenditure which are not deductible or chargeable for tax purposes. The current tax liability for the year is
calculated using tax rates which have either been enacted or substantively enacted at the relevant balance sheet date.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Under UK tax legislation,
small and medium entity R&amp;D relief allows us to claim back up to 14.5% of our surrenderable losses as a tax cash credit.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"></p><div>

</div><!-- Field: Page; Sequence: 86; Value: 1 --><div>
    </div><div style="margin-top: 12pt; margin-bottom: 6pt; border-bottom: Black 1.5pt solid"><p style="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><!-- Field: Sequence; Type: Arabic; Name: PageNo -->81<!-- Field: /Sequence --></p></div><div>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><b>A. Results of Operations</b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">The results of operations
that follow reflect the historic periods under review and should not be taken as indicative of future performance.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>Comparison of Years Ended December 31, 2022
and 2021</b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">The following tables summarizes
our results of operations for the years ended December 31, 2022 and 2021:</p><div>

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

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><i>Research and Development Expenses</i></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Research and development
activities were $13.0 million for the year ended December 31, 2022 compared to $13.2 million for the year ended December 31, 2021 a decrease
of $0.3 million. The decrease in cost is a result of focused expenditure of anti-IL-6R monoclonal antibodies (mAbs) compounds and the
manufacturing of Foralumab and less spending on Milciclib.&#160;</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><i>General and Administrative Expenses</i></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in"><i>&#160;</i></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Operating expenses were $1.6
million for the year ended December 31, 2022 as compared $13.3 million for the year ended December 31, 2021, a decrease of $11.7 million.
The decrease in operating expenses is a result of a decrease in option related expenses of $6.3mm due to options forfeitures and a decrease
in options outstanding during the year, a saving of $2.4m in labor costs due to a reduced headcount in 2022, a reduction in legal costs
of $1.5m due to a one off reorganization in 2021, a savings in insurance of $0.5m due to more favorable market conditions for D&amp;O,
$1.3m net gain due to favorable foreign exchange movements and other general savings of $0.3m.</p><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><i>Realization Bonus Expense</i></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">A realization bonus of $13.2
million became payable during the year ended December 31, 2020 to the chairman of the board. This became payable upon the Company raising
funds in excess of $28m (&#163;20m), which it successfully raised in August 2020. As the bonus was not settled until November 2021,
interest of $0.9m was accrued on the amount due in the year to December 31, 2021. No further realization bonus was paid during year ended
December 31, 2022.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><i>Other income/(expense)</i></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">There was finance expense
during the year of $0.8 million for the year ended December 31, 2022. This charge related to the change in fair value of the company&#8217;s
investment in Accustem Sciences Inc as the share price as at December 31, 2022 was $1.35 per share compared to the investment price of
$2 per share.. No further charges were incurred in the year ended December 31, 2021.</p><div>

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

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

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><i>Income Tax Credit</i></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Income tax credits of $3.2
million were recognized for the year ended December 31, 2021. No income tax credit was recognized for the year ended December 31, 2022
as the claim for 2020 is currently under review by HMRC, the company is awaiting the results of this review before proceeding with a
claim for year ended December 31, 2022.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>Comparison of Years Ended December 31, 2021
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">The following tables summarizes
our results of operations for the years ended December 31, 2021 and 2020:</p><div>

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

</div><table cellpadding="0" cellspacing="0" style="border-collapse: collapse; width: 100%; font: 10pt Times New Roman, Times, Serif">
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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    <td style="border-bottom: Black 4pt double; text-align: left">$</td><td style="border-bottom: Black 4pt double; text-align: right">(4,499</td><td style="padding-bottom: 4pt; text-align: left">)</td></tr>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in"><b>&#160;</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><i>Research and Development Expenses</i></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Research and development
activities were $13.2 million for the year ended December 31, 2021 compared to $6.0 million for the year ended December 31, 2020 an increase
of $7.2 million. The increase in cost is a result of the development of anti-IL-6R monoclonal antibodies (mAbs) compounds and the manufacturing
of Foralumab.&#160;</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><i>General and Administrative Expenses</i></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Operating expenses were $13.3
million for the year ended December 31, 2021 as compared $11.2 million for the year ended December 31, 2020, an increase of $2.1 million.
The increase in cost is a result of the additional fair value charges of $3.5m relating to modification of existing options and the issuance
of additional options, and additional compliance, professional fees and legal costs of $1.5m due to increased activity in the Company
and the corporate reorganization and establishment of a new Bermudan parent.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><i>Realization Bonus Expense</i></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">A realization bonus of $13.2
million became payable during the year ended December 31, 2020 to the chairman of the board. This became payable upon the Company raising
funds in excess of $28m (&#163;20m), which it successfully raised in August 2020. As the bonus was not settled until November 2021,
interest of $0.9m was accrued on the amount due in the year to December 31, 2021.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><i>Impairment of asset</i></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">There was an asset impairment
charge of $0.3 million for the year ended December 31, 2020. This charge related to the impairment of the Company&#8217;s investment
in SharDNA SPA. No further charges were incurred in the year ended December 31, 2021.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><i>Disposal of Intellectual Property</i></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">There was a gain of $2.7m
arising on the disposal of the StemPrintER intellectual property in the year ended December 31, 2020. No further disposals were incurred
in the year ended December 31, 2021.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in"></p><div>

</div><!-- Field: Page; Sequence: 88; Value: 1 --><div>
    </div><div style="margin-top: 12pt; margin-bottom: 6pt; border-bottom: Black 1.5pt solid"><p style="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><!-- Field: Sequence; Type: Arabic; Name: PageNo -->83<!-- Field: /Sequence --></p></div><div>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in"><b>&#160;</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><i>Income Tax Credit</i></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Income tax credits of $3.2
million and $2.2 million are recognized for the years ended December 31, 2021 and 2020, respectively. The credits are obtained at a rate
of 14.5% of 230% of our qualifying research and development expenditure. The increase in the provision is due primarily to an increase
in qualifying research and development expenditure incurred in the year ending December 31, 2021.<i>&#160;</i></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><b>B. Liquidity and Capital Resources</b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Since our inception, we have
not generated any revenue and have incurred operating losses and negative cash flows from our operations. We have funded our operations
to date primarily with proceeds from the sale of ordinary shares, American Depository Shares, or ADSs, and convertible loan notes.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">As of December 31, 2022,
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&#160;</p><div>

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

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">The following table summarizes
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"></p><div>

</div><table cellpadding="0" cellspacing="0" style="border-collapse: collapse; width: 100%; font: 10pt Times New Roman, Times, Serif">
  <tr style="vertical-align: bottom">
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  <tr style="vertical-align: bottom">
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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="border-bottom: Black 4pt double; text-align: left">$</td><td style="border-bottom: Black 4pt double; text-align: right">(21,655</td><td style="padding-bottom: 4pt; text-align: left">)</td><td style="padding-bottom: 4pt">&#160;</td>
    <td style="border-bottom: Black 4pt double; text-align: left">$</td><td style="border-bottom: Black 4pt double; text-align: right">(63,888</td><td style="padding-bottom: 4pt; text-align: left">)</td></tr>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><i>Net Cash Used in Operating Activities</i></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Our use of cash in each of
the years ended December 31, 2022, and 2021, resulted primarily from our net losses, adjusted for non-cash charges and changes in components
of working capital. Net cash used in operating activities of $19.6 million during the year ended December 31, 2022 decreased by $2.1
million compared to the year ended December 31, 2021.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Our use of cash in each of
the years ended December 31, 2021, and 2020, resulted primarily from our net losses, adjusted for non-cash charges and changes in components
of working capital. Net cash used in operating activities of $21.8 million during the year ended December 31, 2021 increased by $10.5
million compared to the year ended December 31, 2020&#160;</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><i>Net Cash Used in Investing Activities</i></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;During the year ended
December 31, 2022, we used $4 million of cash in investing activities. The company spent $2.7m investing in a related party, Accustem
Sciences Inc, where we purchased 1,337,970 shares for $2 a share, and $1.3m on a share buyback scheme.&#160;&#160;</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">During the year ended December
31, 2021, we used $0.02 million of cash in investing activities for the purchases of property and equipment offset by a finance lease
receivable.&#160;&#160;&#160;</p><div>

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

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

</div><!-- Field: Page; Sequence: 89; Value: 1 --><div>
    </div><div style="margin-top: 12pt; margin-bottom: 6pt; border-bottom: Black 1.5pt solid"><p style="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><!-- Field: Sequence; Type: Arabic; Name: PageNo -->84<!-- Field: /Sequence --></p></div><div>
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    </div><!-- Field: /Page --><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><i>Net Cash (used in)/ Provided by Financing Activities</i></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">During the year ended December
31, 2022 $0.01 million was used in the repayment of lease expenses. During the year ended December 31, 2021, net cash provided by financing
activities was $0.01 million consisting of net cash proceeds the exercise of warrants.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">During the years ended December
31, 2021 and 2020, net cash provided by financing activities was $0.1 million and $75.3 million, respectively, consisting of net cash
proceeds from our sale and issuance of ordinary shares and ADS&#8217;s, convertible loan notes and the exercise of options and warrants.</p><div>

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

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

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">We expect our expenses to
increase substantially in connection with our ongoing activities, particularly as we advance the preclinical activities, manufacturing
and clinical trials of our product candidates and as we:</p><div>

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

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="vertical-align: top">
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
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  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
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    <td style="width: 0.5in">&#160;</td>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
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    <td style="width: 0.5in">&#160;</td>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"></p><div>

</div><!-- Field: Page; Sequence: 90; Value: 1 --><div>
    </div><div style="margin-top: 12pt; margin-bottom: 6pt; border-bottom: Black 1.5pt solid"><p style="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><!-- Field: Sequence; Type: Arabic; Name: PageNo -->85<!-- Field: /Sequence --></p></div><div>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">We believe that our existing
cash, will enable us to fund our operating expenses and capital expenditure requirements for the immediate future. We have based these
estimates on assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than we expect. If we
receive regulatory approval for our other product candidates, we expect to incur significant commercialization expenses related to product
manufacturing, sales, marketing and distribution.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Because of the numerous risks
and uncertainties associated with research, development and commercialization of pharmaceutical product candidates, we are unable to
estimate the exact amount of our working capital requirements. Our future funding requirements will depend on and could increase significantly
as a result of many factors, including:</p><div>

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

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="vertical-align: top">
    <td style="width: 0.5in">&#160;</td>
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the scope, progress, outcome
    and costs of our preclinical development activities, clinical trials and other research and development activities;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="vertical-align: top">
    <td style="width: 0.5in">&#160;</td>
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    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the costs, timing, receipt
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  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
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    <td style="width: 0.5in">&#160;</td>
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the costs of future activities,
    including product sales, marketing, manufacturing and distribution, for any of our product candidates for which we receive marketing
    approval;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
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    <td style="width: 0.5in">&#160;</td>
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the revenue, if any, received
    from commercial sale of our products, should any of our product candidates receive marketing approval;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="vertical-align: top">
    <td style="width: 0.5in">&#160;</td>
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the costs and timing of
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  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="vertical-align: top">
    <td style="width: 0.5in">&#160;</td>
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the costs of preparing,
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  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="vertical-align: top">
    <td style="width: 0.5in">&#160;</td>
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
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  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Until such time, if ever,
that we can generate product revenue sufficient to achieve profitability, we expect to finance our cash needs through equity offerings.
To the extent that we raise additional capital through the sale of equity, your ownership interest will be diluted. If we raise additional
funds through other third-party funding, collaboration agreements, strategic alliances, licensing arrangements or marketing and distribution
arrangements, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates
or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity financings when
needed, we may be required to delay, limit, reduce or terminate our product development or future commercialization efforts or grant
rights to develop and market products or product candidates that we would otherwise prefer to develop and market ourselves.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><b>C. Research and Development Expenses, Patents and Licenses, etc.</b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">See &#8220;Item 4.B.&#8212;Intellectual
Property,&#8221; &#8220;Item 4.B.&#8212;Research and Development,&#8221; and &#8220;Item 5. Operating and Financial Review and Prospects.&#8221;</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><b>D. Trend Information</b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">See &#8220;Item 5. Operating and Financial Review
and Prospects&#8212;Trend Information.&#8221;</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in"></p><div>

</div><!-- Field: Page; Sequence: 91; Value: 1 --><div>
    </div><div style="margin-top: 12pt; margin-bottom: 6pt; border-bottom: Black 1.5pt solid"><p style="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><!-- Field: Sequence; Type: Arabic; Name: PageNo -->86<!-- Field: /Sequence --></p></div><div>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><b>E. Off-Balance Sheet Arrangements</b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">We did not have during the periods presented,
and we do not currently have, any off-balance sheet arrangements, as defined in the rules and regulations of the SEC.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><b>F. Tabular Disclosure of Contractual Obligations</b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">The following table summarizes our contractual
commitments and obligations as of December 31, 2022 and 2021.</p><div>

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

</div><table cellpadding="0" cellspacing="0" style="border-collapse: collapse; width: 100%; font: 10pt Times New Roman, Times, Serif">
  <tr style="vertical-align: bottom">
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    <td colspan="14">&#160;</td><td>&#160;</td></tr>
  <tr style="vertical-align: bottom">
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    <td style="text-align: left">$</td><td style="text-align: right">-</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">$</td><td style="text-align: right">&#160;&#160;&#160;&#160;-</td><td style="text-align: left">&#160;</td><td>&#160;</td>
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  <tr style="vertical-align: bottom; ">
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="border-collapse: collapse; width: 100%; font: 10pt Times New Roman, Times, Serif">
  <tr style="vertical-align: bottom">
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  <tr style="vertical-align: bottom">
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="padding-bottom: 4pt">Total</td><td style="padding-bottom: 4pt">&#160;</td>
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    <td style="border-bottom: Black 4pt double; text-align: left">$</td><td style="border-bottom: Black 4pt double; text-align: right">-</td><td style="padding-bottom: 4pt; text-align: left">&#160;</td><td style="padding-bottom: 4pt">&#160;</td>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Please refer to &#8220;Item
4.B. Business Overview&#8221; and &#8220;Item 10.C. Material Contracts&#8221; for further details.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><b>G. Safe Harbor</b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">This Annual Report on Form&#160;20-F&#160;contains
forward-looking statements within the meaning of Section&#160;27A of the Securities Act and Section&#160;21E of the Exchange Act and
as defined in the Private Securities Litigation Reform Act of 1995.&#160;See the section titled &#8220;Cautionary Statement Regarding
Forward-Looking Statements&#8221;.</p><div>

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

</div><div><a id="a_008"></a></div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><b>ITEM 6: DIRECTORS, SENIOR MANAGEMENT AND EMPLOYEES</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: -10.25pt"><b>&#160;</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><b>A. Directors and Senior Management</b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">The following table sets forth
information regarding our directors as of April 24, 2023.</p><div>

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

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="vertical-align: bottom">
    <td style="border-bottom: black 1.5pt solid"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Name</b></span></td>
    <td>&#160;</td>
    <td style="border-bottom: black 1.5pt solid; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Age</b></span></td>
    <td>&#160;</td>
    <td style="border-bottom: black 1.5pt solid"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Position</b></span></td></tr>
  <tr style="vertical-align: bottom; background-color: #CCEEFF">
    <td style="width: 35%"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Gabriele Marco Antonio Cerrone MBA&#160;(2)</span></td>
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    <td style="width: 1%">&#160;</td>
    <td style="width: 55%"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Executive Chairman and acting Chief
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  <tr style="vertical-align: bottom; ">
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Willy Simon&#160;(1,2,3)</span></td>
    <td>&#160;</td>
    <td style="text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">71</span></td>
    <td>&#160;</td>
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  <tr style="vertical-align: bottom; background-color: #CCEEFF">
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">John Brancaccio (1), (3)</span></td>
    <td>&#160;</td>
    <td style="text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">75</span></td>
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  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">(1)</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Remuneration Committee
    member</span></td></tr>
  <tr style="vertical-align: top">
    <td>&#160;</td>
    <td style="text-align: justify">&#160;</td></tr>
  <tr style="vertical-align: top">
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  <tr style="vertical-align: top">
    <td>&#160;</td>
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  <tr style="vertical-align: top">
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  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in"></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">The following table sets forth
information regarding our senior managers as of April 24, 2023:</p><div>

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

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="vertical-align: bottom; ">
    <td style="width: 51%; border-bottom: black 1.5pt solid"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Name</b></span></td>
    <td style="width: 1%">&#160;</td>
    <td style="width: 48%; border-bottom: black 1.5pt solid"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Position</b></span></td></tr>
  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Matthew Davis</span></td>
    <td>&#160;</td>
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Chief Medical Officer and Acting Chief Scientific Officer</span></td></tr>
  <tr style="vertical-align: bottom; ">
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Keeren Shah</span></td>
    <td>&#160;</td>
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Chief Financial Officer</span></td></tr>
  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Jules S. Jacob</span></td>
    <td>&#160;</td>
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Executive Director, CMC &amp; Non-Clinical Development</span></td></tr>
  <tr style="vertical-align: bottom; ">
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Dr. Vaseem A. Palejwala</span></td>
    <td>&#160;</td>
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Senior Director, Clinical operations</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>Gabriele Marco Antonio Cerrone &#8211; <i>Executive
Chairman</i></b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Mr. Gabriele Marco Antonio
Cerrone, is the Founder of the company and has been its Executive Chairman since April 2014. Mr. Cerrone has founded ten biotechnology
companies in oncology, infectious diseases and molecular diagnostics, and has listed seven of these companies on Nasdaq two to the Main
Market and AIM Market in London. Mr. Cerrone co-founded Cardiff Oncology, Inc., an oncology company and served as its Co-Chairman; he
was a co-founder and served as Chairman of both Synergy Pharmaceuticals, Inc. and Callisto Pharmaceuticals, Inc. and was a Director of
and led the restructuring of Siga Technologies, Inc. Mr. Cerrone also co-founded FermaVir Pharmaceuticals, Inc. and served as Chairman
of the Board until its merger in September 2007 with Inhibitex, Inc. Mr. Cerrone served as a director of Inhibitex, Inc. until its US$2.5bn
sale to Bristol Myers Squibb Co in 2012. Mr. Cerrone is the Executive Chairman and Founder of Tiziana Life Sciences Ltd, an oncology
focused therapeutics company; Co-Founder of Rasna Therapeutics Inc., a company focused on the development of therapeutics for leukaemias;
Co-Founder of Hepion Pharmaceuticals, Inc.; Executive Chairman and Co-Founder of Gensignia Life Sciences, Inc., a molecular diagnostics
company focused on oncology using microRNA technology; Non-Executive Chairman and Founder of Accustem Sciences Limited; and founder of
BioVitas Capital Ltd. Mr. Cerrone graduated from New York University&#8217;s Stern School of Business with a master&#8217;s degree in
business administration (MBA).</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>Willy Simon &#8211; <i>Non-Executive Director</i></b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Willy Jules Simon has served
as a Non-Executive Director of the company since November 2015. He is a banker and worked at Kredietbank N.V. and Citibank London before
serving as an executive member of the Board of Generale Bank NL from 1997 to 1999 and as the chief executive of Fortis Investment Management
from 1999 to 2002. He acted as chairman of Bank Oyens &amp; van Eeghen from 2002 to 2004. He was chairman of AIM-traded Velox3 plc (formerly
24/7 Gaming Group Holdings plc) until 2014 and had been a director of Playlogic Entertainment Inc., a Nasdaq OTC listed company. Willy
Simon has been the chairman of Bever Holdings, a company listed in Amsterdam, since 2006 and Chairman of Ducat Maritime since 2015. He
is also a non-executive director of OKYO Pharma Ltd.&#160;</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>John Brancaccio &#8211; <i>Non-Executive Director</i></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><b><i>&#160;</i></b></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">John Brancaccio, a retired
CPA, has served as a director of our company since July 2020. From April 2004 until May 2017, Mr. Brancaccio was the Chief Financial Officer
of Accelerated Technologies, Inc., an incubator for medical device companies. Mr. Brancaccio served as a director of Callisto Pharmaceuticals,
Inc. from April 2004 until its merger with Synergy Pharmaceuticals, Inc. in January 2013 and was a director of Tamir Biotechnology, Inc.
(formerly Alfacell Corporation) until 2019, as well as a director of Hepion Pharmaceuticals, Inc. since December 2013, Rasna Therapeutics,
Inc. since September 2016, Cardiff Oncology, Inc. from December 2005 until June 2022 and Okyo Pharma Ltd since June 2020. Mr. Brancaccio
served as a director of Synergy from July 2008 until April 2019.</p><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>Keeren Shah &#8211; <i>Chief Financial Officer</i></b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Keeren Shah serves as our
Chief Financial Officer. Ms. Shah currently also serves as the CFO of Accustem Sciences Inc, OKYO Pharma Ltd and Rasna Therapeutics Inc.,
having previously served as the Group Financial Controller for these businesses from June 2016 to July 2020. Prior to joining the Company,
Ms. Shah spent 10 years at Visa, Inc. as a Senior Leader in its finance team where she was responsible for key financial controller activities,
financial planning and analysis, and core processes as well as leading and participating in key transformation programmes and Visa Inc.&#8217;s
initial public offering. Before joining Visa, Ms. Shah has also held a variety of finance positions at other leading companies including
Arthur Andersen and BBC Worldwide. She holds a Bachelor of arts with honours in Economics and is a member of the Chartered Institute
of Management Accountants.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>Matthew W Davis - <i>Chief Medical Officer
and Acting Chief Scientific Officer</i></b></p><div>

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

</div><p style="text-align: justify; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; ">Dr. Davis has extensive experience in new
drug application, or NDA, and biologic license application, or BLA, FDA approvals and device clearances. Notable approved brands that
Dr. Davis has worked on include Lidoderm&#174;, Sculptra&#174;, Colcrys&#174; and most recently QWO&#174;. Dr. Davis previously served as
Chief Scientific Officer and Chief Medical Officer at Endo Pharmaceuticals where he restructured the R&amp;D department and collaborated
to obtain BLA approval for QWO&#174;. Additionally, Dr. Davis was Chief Medical Officer for Lupin Inc. and URL Pharma, Inc. where he spearheaded
three NDA approvals and was the inventor on all 17 Orange Book listed patents for Colcrys&#174;. He also was on the executive team that
sold URL Pharma to Takeda Pharmaceutical Company for approximately $800M combined with over $1B in performance-based contingent earn out
payments.</p><div>

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

</div><p style="text-align: justify; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; ">Dr. Davis matriculated to the University of
Pennsylvania as an undergraduate. He received his Pharmacy Degree from Temple University and his Medical Degree from the Medical College
of Pennsylvania. Dr. Davis undertook his surgical training at Brown University and his Urology training at Washington Hospital Center.</p><div>

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

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"></p><div>

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    </div><!-- Field: /Page --><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>Jules S. Jacob &#8211; <i>Executive Director,
CMC&#160;&amp; Non-Clinical Development</i></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><b><i>&#160;</i></b></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Mr. Jules Jacob has served
as Senior Director (2017-2021_ and Executive Director of CMC and Non-Clinical Development of the company since January 2022. He has over
25 years of drug development experience. Previously, Mr. Jacob was senior director of product development at Aprecia Pharmaceuticals Company,
a drug delivery technology platform company, from March 2009 to July 2017, where he led the development of Spritam&#174;, the first FDA-approved
dosage form manufactured using 3-dimensional printing, and other 505(b)(2) pipeline products. Mr. Jacob was director of formulation development
at Panacos Pharmaceuticals Inc., a drug company focused on human immunodeficiency virus, or HIV, and other major human viral diseases,
from March 2007 to December 2008, where he worked on the development of first-in-class maturation inhibitors for the treatment of HIV.
Mr. Jacob was a founding scientist, director of R&amp;D and director of technology development at Spherics, Inc., a pharmaceutical company
that engaged in developing and manufacturing oral pharmaceutical products for CNS conditions, GI disorders, and cancer, from February
2000 to February 2007. Mr. Jacob worked on the development of bioadhesive dosage forms for treatment of CNS disorders, through the 505(b)(2)
regulatory pathway at Spherics Inc. Mr. Jacob completed his undergraduate degree and graduate education in biological and medical sciences
at Brown University and has an active visiting faculty appointment in the Department of Molecular Pharmacology, Physiology and Biotechnology
at Brown University.</p><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">

</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>Dr. Vaseem A. Palejwala &#8211; <i>Senior Director,
Clinical Operations</i></b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Dr. Palejwala has served as
Director, Non-Clinical Studies of the company since January 2017; Director (2018-2021) and Senior Director, Clinical Operations since
2022. He has 23 years of experience in drug discovery and development. From January 2015 to January 2017, Dr. Palejwala served as director
of discovery and preclinical research, and from December 2012 to December 2014 served as associate director of discovery and preclinical
research, at Synergy Pharmaceuticals Inc. where he actively contributed to establishing GI tract-related preclinical animal models for
testing the efficacy and validating the mechanism of action for both plecanatide and dolcanatide. Dr. Palejwala also actively participated
in preparation of the nonclinical pharmacology section of the NDA for Trulance&#174;. From 2001 to 2012, Dr. Palejwala served as discovery
scientist/manager at Sanofi S.A., <i>a </i>multinational pharmaceutical company, where he advanced both small molecule and biologic programs
in immunology, inflammation, oncology, CNS and metabolic disorders and also contributed to establishing and managing high-throughput gene
expression profiling platform capabilities. Dr. Palejwala holds a degree in microbiology and chemistry from Bombay University, as well
as a master of science degree in microbiology and a Ph.D. in microbiology from the Maharaja Sayajirao University of Baroda.</p><div>

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

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

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">There are no family relationships
among any of our executive officers or directors.</p><div>

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

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>B.</b></span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Compensation</b></span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><b>Total Compensation for the Executive Chairman and Non-Executive
Directors</b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">The table below sets out
the total remuneration received by the Executive Chairman and the Non-Executive Directors for the year ended December 31, 2022.</p><div>

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

</div><table cellpadding="0" cellspacing="0" style="border-collapse: collapse; width: 100%; font: 10pt Times New Roman, Times, Serif">
  <tr style="vertical-align: bottom">
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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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">-</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">-</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">-</td><td style="text-align: left">&#160;</td><td>&#160;</td>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">(1)</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Represents the fair value
    of incentive stock options granted during the year to December 31, 2022 using an appropriate valuation model for computing stock-based
    compensation expense as of the date of grant.</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"></p><div>

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    </div><div style="margin-top: 12pt; margin-bottom: 6pt; border-bottom: Black 1.5pt solid"><p style="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><!-- Field: Sequence; Type: Arabic; Name: PageNo -->89<!-- Field: /Sequence --></p></div><div>
    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
    </div><!-- Field: /Page --><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><b>Narrative Disclosure to the Compensation table</b></p><div>

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

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

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">On June 9, 2016 we entered
into an agreement with our Executive Chairman, Gabriele Cerrone. Under the agreement, Mr Cerrone was to hold office as Chairman for &#163;80,000
per annum. The agreement was to expire no earlier than 24 April 2018 and was to continue thereafter until terminated by either party
giving written notice of 12 months. Mr Cerrone was also eligible to receive an annual bonus of up to 50% of his base salary, such bonus
amount to be determined at the discretion of the Board of Directors.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Additionally, Mr Cerrone
was also eligible to receive two realization bonuses as follows:</p><div>

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

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.5in">&#160;</td>
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">(a)</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">in the event that, either:
    (i) the Group raises, in one or a series of transactions, new equity capital in excess of &#163;20,000,000 (after expenses); or
    (ii) there is a sale, in one or a series of transactions, of all or substantially all of the assets (calculated on the basis of book
    values) of the Group Companies (or a licence of the same on an exclusive or non-exclusive basis), where the Enterprise Value equals
    or exceeds &#163;150,000,000; or (iii) there is a change of control where the Enterprise Value equals or exceeds &#163;150,000,000,
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  <tr style="vertical-align: top">
    <td>&#160;</td>
    <td>&#160;</td>
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  <tr style="vertical-align: top">
    <td>&#160;</td>
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    this Agreement, either: (i) there is a sale, in one or a series of transactions, of all or substantially all of the assets ( calculated
    on the basis of book values) of the Group ( or a licence of the same on an exclusive or non-exclusive basis ), where the Enterprise
    Value equals or exceeds &#163;300,000,000; or (ii) there is either a change of control where the Enterprise Value equals or exceeds
    &#163;300,000,000, the Chairman will be entitled to receive an additional Realization Bonus in the amount equal to the Enterprise
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  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">The Enterprise Value means:
(i) in the case of a change of control resulting in consideration payable to the Group (for example, on a sale of its assets or licensing
transaction), the total cash and non-cash consideration received by the Group; or (ii) in the case of a change of control resulting in
consideration payable to the shareholders of the ordinary shares in the issued share capital of the Group from time to time, the total
cash and non-cash consideration payable to the Shareholders.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">The first realization bonus
was satisfied on 5 August 2020, and the Chairman was unconditionally entitled to the immediate delivery of 4,763,995 new ordinary shares
credited as fully paid in lieu of a cash payment. The number of shares to be issued was fixed. Due to the delayed delivery of shares,
additional shares were granted in lieu of interest.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">On October 9, 2020, we entered
into an amended agreement with Mr Cerrone, increasing his base salary to &#163;240,000 per annum. All other terms and conditions remained
the same.</p><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">On 21 October 2021, we entered
into a new agreement which superseded the original consultancy agreement dated June 9, 2016 and the amended agreement dated October 9,
2020. The duration of the consultancy agreement was fixed until December 31, 2028 and the fee remained at &#163;240,000 per annum. All
terms regarding the second realization bonus remained the same.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">On 14 March, 2023, we granted
Mr Cerrone a long-term realisation bonus on the basis that were the Company to be sold, during the currency of his directorship or in
the period of 6 years thereafter, for a price at, or in excess of, US$1,000,000,000 that Mr Cerrone receive a bonus equal to 6.5% of the
enterprise value of the Company (and not just the excess over US$1,000,0000,000), such bonus to be in addition to the current realization
bonus contained in Mr Cerrone&#8217;s consultancy agreement dated December, 21 2022 but on the basis that were the US$1,000,000,000 threshold
to be hit, the Company would be entitled to offset any payment due under the realisation bonus contained in the December, 21 2022 Consultancy
Agreement against any amount then due under this new realisation bonus. The terms of the award to make appropriate provision for any "spin-off"
of assets and for the eventuality that the Company be sold for non-cash consideration. In addition, it should be a clear condition that
Mr Cerrone be responsible for all tax liabilities in connection with any payment of the award.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in"><i>Non -Executive Director remuneration</i></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&#160;</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">The remuneration of our non-executive
directors is determined by our board as a whole, based on independent compensation reviews. We intend to enter into service contracts
with our directors for their services or amend and restate any prior service contracts in place prior to, or as soon as practicable, following
the filing of this registration statement.</p><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">

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

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

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    </div><div style="margin-top: 12pt; margin-bottom: 6pt; border-bottom: Black 1.5pt solid"><p style="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><!-- Field: Sequence; Type: Arabic; Name: PageNo -->90<!-- Field: /Sequence --></p></div><div>
    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
    </div><!-- Field: /Page --><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><b>Compensation of Executive Directors</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">The table below sets the remuneration
of each of the Executive Directors for the financial year ended December 31, 2022.</p><div>

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

</div><table cellpadding="0" cellspacing="0" style="border-collapse: collapse; width: 100%; font: 10pt Times New Roman, Times, Serif">
  <tr style="vertical-align: bottom">
    <td style="font-weight: bold; border-bottom: Black 1.5pt solid">Name</td><td style="font-weight: bold; padding-bottom: 1.5pt">&#160;</td>
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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    <td style="width: 22%; text-align: center">Executive Director</td><td style="width: 1%">&#160;</td>
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    <td style="text-align: left">&#160;</td><td style="text-align: right">-</td><td style="text-align: left">&#160;</td><td>&#160;</td>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">

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

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">(1)</span></td>
    <td style="text-align: justify"><p style="margin: 0pt 0; font: 10pt Times New Roman, Times, Serif">Represents the fair value of incentive stock options granted during
the year to December 31, 2022 using an appropriate valuation model for computing stock-based compensation expense as of the date of grant.</p></td></tr>
  <tr style="vertical-align: top">
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">(2)</span></td>
    <td style="text-align: justify"><p style="margin: 0pt 0; font: 10pt Times New Roman, Times, Serif">Dr. Kunwar Shailubhai resigned from the company on August 1, 2022.</p></td></tr>
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    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">(3)</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Dr. Adams passed away on
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  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><b>Narrative Disclosure to the Compensation table</b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in"><i>Dr. Kunwar Shailubhai</i></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">We entered into an employment
agreement with Dr. Kunwar Shailubhai in May 2017. This agreement entitles Dr. Shailubhai to receive an initial annual base salary of
$600,000 per year. Dr. Shailubhai is eligible to receive an annual bonus of up to 35% of his base salary, such bonus amount to be determined
in the company&#8217;s sole discretion. Dr. Shailubhai is also entitled to the same fringe benefits as we provide to our other executives
from time to time and is eligible to receive employee share incentives. The vesting of any unvested employee share incentives held by
Dr. Shailubhai will accelerate in the event his employment is terminated without cause (as such term is defined in his employment agreement),
or if he resigns for good reason (as such term is defined in his employment agreement) and, in each case, such termination is upon the
consummation of or within 12 months following a change of control of the company. If Dr. Shailubhai&#8217;s employment with the company
is terminated without cause, or if he resigns for good reason, Dr. Shailubhai will also be entitled to receive severance equal to continuation
of his base salary as then currently in effect for 12 months following his date of termination and will be eligible for reimbursement
for medical coverage premiums for up to the same period. Dr. Shailubhai, his spouse and eligible dependents are entitled to stay on our
health insurance plans for a period of 12 months following his termination for any reason. Dr. Shailubhai&#8217;s severance benefits
are conditioned on, among other things, his execution of our standard separation agreement and a general release of claims in our favor.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Dr. Shailubhai resigned from
his position on our board and his employment terminated on August 1, 2022.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><b>Outstanding Equity Awards at Fiscal Year-End</b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">The following table provides
information regarding all outstanding equity awards for our directors, executive officers, and non-executive directors, as of December
31, 2022:</p><div>

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

</div><table cellpadding="0" cellspacing="0" style="border-collapse: collapse; width: 100%; font: 10pt Times New Roman, Times, Serif">
  <tr style="vertical-align: bottom">
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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    <td style="text-align: center">06/05/2020</td><td>&#160;</td>
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  <tr style="vertical-align: bottom; ">
    <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: center">&#160;</td><td>&#160;</td>
    <td style="text-align: center">&#160;</td></tr>
  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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    <td style="text-align: center">25/08/2020</td><td>&#160;</td>
    <td style="text-align: center">24/08/2030</td></tr>
  <tr style="vertical-align: bottom; ">
    <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><td>&#160;</td>
    <td>&#160;</td><td>&#160;</td>
    <td>&#160;</td></tr>
  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="text-align: left">John Brancaccio</td><td>&#160;</td>
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    <td style="text-align: left">&#160;</td><td style="text-align: right">2.95</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: center">25/08/2020</td><td>&#160;</td>
    <td style="text-align: center">24/08/2030</td></tr>
  </table><div>


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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>The Tiziana Life Sciences Ltd (formerly Tiziana
Life Sciences plc) Employee Share Option Plan with Non-Employee Sub-Plan and US Sub-Plan </b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&#160;</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">The Tiziana Life Sciences
Ltd (formerly Tiziana Life Sciences plc) Employee Share Option Plan with Non-Employee Sub-Plan and US Sub-Plan, or the 2016 Plan,
was adopted by the Board on March 23, 2016 and approved by shareholders on June 30, 2016 and allows for the grant of options to eligible
service providers. The material terms of the 2016 Plan are summarized below. This plan closed to new entrants on October 21, 2021 and
has been superseded by the Tiziana Life Sciences Ltd 2021 Equity Incentive Plan.</p><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">

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

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

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    </div><div style="margin-top: 12pt; margin-bottom: 6pt; border-bottom: Black 1.5pt solid"><p style="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><!-- Field: Sequence; Type: Arabic; Name: PageNo -->91<!-- Field: /Sequence --></p></div><div>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><i>Eligibility and Administration</i></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in"><i>&#160;</i></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Prior to October 21, 2021,
our employees, consultants and directors, and employees and consultants of our subsidiaries were eligible to receive options under the
2016 Plan. The 2016 Plan was administered by our board of directors, which may delegate its duties and responsibilities to one or more
committees of our directors and/or officers (referred to collectively as the plan administrator below), subject to the limitations imposed
under the 2016 Plan, stock exchange rules and other applicable laws. The plan administrator has the authority to take all actions and
make all determinations under the 2016 Plan, to interpret the 2016 Plan and option agreements and to adopt, amend and repeal rules for
the administration of the 2016 Plan as it deems advisable. The plan administrator also had the authority to determine which eligible service
providers receive options, to grant options and to set the terms and conditions of all options granted under the 2016 Plan, including
any vesting and vesting acceleration provisions, subject to the conditions and limitations in the 2016 Plan.</p><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">

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

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in"><i>&#160;</i></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">The 2016 Plan provided for
the grant of options. All options granted under the 2016 Plan were set forth in option agreements, which will detail the terms and conditions
of the options.</p><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Options provide for the purchase
of our ordinary shares in the future at an exercise price set on the grant date. The plan administrator will determine the number of
shares covered by each option, the exercise price of each option and the conditions and limitations applicable to the exercise of each
option</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">If a holder of options dies,
options may be exercised by the personal representative with 12 months following death in respect of all or such proportion of the option
as the plan administrator may specify to take account of the extent to which any exercise conditions have been achieved at the relevant
date. If a holder of options leaves as a good leaver or the plan administrator allows, options may be exercised within 90 days in respect
of all or such proportion of the option as the plan administrator may specify to take account of the extent to which any exercise conditions
have been achieved at the relevant date.</p><div>

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

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

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">The plan administrator may
specify one or more appropriate exercise conditions that must be satisfied before options may be exercised.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><i>Change of Control and Variation of Share Capital</i></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">In the event of a change
of control, the plan administrator may specify whether all or a proportion of options will be exercisable to take account of the extent
to which any exercise conditions have been achieved at the relevant date. Alternatively, holders of options may agree to accept an offer
to exchange options for options to acquire shares in an acquiring company.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">If there is a variation of
our ordinary shares the plan administrator may adjust the number of shares under options and/or the exercise price.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in"></p><div>

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    </div><div style="margin-top: 12pt; margin-bottom: 6pt; border-bottom: Black 1.5pt solid"><p style="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><!-- Field: Sequence; Type: Arabic; Name: PageNo -->92<!-- Field: /Sequence --></p></div><div>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><i>Plan Amendment and Termination</i></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Our board of directors may
amend the 2016 Plan at any time; however, the provisions governing eligibility requirements, equity dilution, the basis for determining
the rights of holders of options and the adjustment of options cannot be altered to the advantage of existing or new holders of options
without the prior approval of our shareholders in general meeting. No options may be granted under the 2016 Plan after the tenth anniversary
of the date of adoption by our board of directors.</p><div>

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

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

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Options granted under the
2016 Plan are generally non-transferrable, except on death. With regard to tax withholding and exercise price obligations arising in
connection with the exercise of options under the 2016 Plan, the plan administrator may, in its discretion, accept cash, wire transfer
or cheque,<i>&#160;</i></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><i>Non-Employee Sub-Plan </i></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Under the Non-Employee Sub-Plan,
options may be granted to advisers, consultants and non-executive directors on terms comparable to those described above.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 14.2pt">&#160;</p><div>

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

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">The US Sub-Plan permits the
grant of options to employees, directors and consultants who are US residents and US taxpayers, including potentially tax efficient Incentive
Stock Options (as defined in Section 422 of the Internal Revenue Code of 1986, as amended). A maximum of 9,233,392 ordinary shares may
be issued under the US Sub-Plan (which number shall be the maximum number that may be granted as Incentive Stock Options). <i>&#160;</i></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><b>The Tiziana Life Sciences Ltd 2021 Equity Incentive Plan </b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; text-indent: 0.5in; text-align: justify; margin: 0pt 0">On October&#160;20, 2021,
Tiziana adopted the Tiziana Life Sciences Ltd 2021 Equity Incentive Plan (the &#8220;Plan&#8221;) which operates over common shares in
Tiziana. The purpose of the Plan is to assist the Company and its Subsidiaries in attracting and retaining valued Employees, Consultants
and Non-Employee Directors by offering them a greater stake in the Company&#8217;s success and a closer identity with it, and to encourage
ownership of the Company&#8217;s shares by such Employees, Consultants and Non-Employee Directors. Any employee, director or consultant
of Tiziana Life Sciences Ltd or any of its subsidiaries is eligible to receive Awards under the Plan. The Plan will be administered by
the Compensation Committee of the Board (the&#160;&#8220;<span style="text-decoration:underline">Compensation Committee</span>&#8221;). Awards granted to nonemployee members
of the Board will be administered by the full Board.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">The Plan was approved by
the shareholders of the Company, no new awards will be granted under the Tiziana Life Sciences plc Employee Share Option Plan with Non-Employee
Sub-Plan and US Sub-Plan with California Supplement, as amended and/or restated from time to time (collectively, the &#8220;Prior Equity
Plan&#8221;).</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Subject to adjustment as
provided in the Plan, the maximum number of shares that may be issued pursuant to Awards under the Plan is 15,000,000 shares (the &#8220;<span style="text-decoration:underline">Cap</span>&#8221;).
The Cap will be increased by the number of shares corresponding (as determined by the Compensation Committee) to the securities underlying
the portion of an award granted under the 2016 Plan that is cancelled, terminated or forfeited or lapses, in any case, on or after the
effective date of the Plan. No more than 15,000,000 shares issued under the Plan may be issued pursuant to the exercise of incentive
stock options.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Under the Plan, awards may
be in the form of options, share appreciation rights, restricted stock, restricted stock units, performance stock, performance stock
units, and other share-based awards. Each Award will be evidenced by an Award agreement containing the terms and conditions applicable
to such Award.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><i>Change of Control and Variation of Share Capital</i></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">A Change in Control shall
not, in and of itself, accelerate the vesting, settlement or exercisability of outstanding awards, unless otherwise specified.</p><div>

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

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

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Transferability of Restricted
Stock shall be prohibited or restricted in the manner and to the extent prescribed in the applicable Award Agreement. Such restrictions
may include, without limitation, rights of repurchase or first refusal in the Company or provisions subjecting the Restricted Stock to
a continuing substantial risk of forfeiture in the hands of any transferee.</p><div>

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

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

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">The UK Supplemental plan
shall apply to any Award granted to a Participant who is resident in the United Kingdom for tax purposes at the time the Award is granted
or on the occurrence of any taxable event in respect of the Award and to any Participant who is not resident in the United Kingdom at
such time(s) but who is granted the Award in respect of duties performed in the United Kingdom (a &#8220;UK Participant&#8221;).</p><div>

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

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

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><i>Additional Terms for UK Participants</i></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><i>Employer National Insurance
Contributions Indemnity.&#160;</i>In the case of any Award to a UK Participant in the form of Options, Restricted Stock, Restricted Stock
Units, Performance Stock, Performance Stock Units or Other Share-Based Award, if required by the Board, it shall be a condition of such
Award that the UK Participant irrevocably agrees that the Company and/or any applicable Subsidiary may recover from the UK Participant
the whole or any part of any employer National Insurance Contributions, Apprenticeship Levy or other social security contributions for
which the Company and/or any applicable Subsidiary is liable to account in respect of the Award, in each case to the extent permitted
by applicable law, and/or that the UK Participant shall enter into such election (using a form approved by HM Revenue &amp; Customs)
as may be required for the whole or any part of such taxes to be transferred to the UK Participant.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><i>Date of Termination.&#160;</i>For
the purposes of the Plan (and the corresponding provisions in any Award Agreement) the termination of employment of a UK Participant
for Cause or as the result of the UK Participant&#8217;s resignation shall be deemed to occur on the earlier of (i) the date on which
the UK Participant&#8217;s employment terminates, and (ii) the date on which the UK Participant gives or receives notice of the termination
of employment.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 49.6pt; text-align: justify; text-indent: -49.6pt">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><i>Bankruptcy. </i>Unless
otherwise provided in an Award Agreement, the unvested portion of a Participant&#8217;s Award shall be immediately forfeited with no
compensation or other payment due to the Participant upon the Participant (i) being declared bankrupt, (ii) making an application for
an interim order or any proposal for a voluntary arrangement within Part VIII of the Insolvency Act 1988, or (iii) proposing any form
of compromise with his creditors or any class of creditors.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><i>Tax Election.&#160;</i>In
the case of an Award to a UK Participant in the form of Options, Restricted Stock, Restricted Stock Units, Performance Stock, Performance
Stock Units or Other Share-Based Award, unless the Board determines otherwise, it shall be a condition of the Award that the UK Participant
enters into a joint tax election with his or her employer pursuant to Section 431(1) of the Income Tax (Earnings and Pensions) Act 2003
in respect of any Shares acquired pursuant to such Award, such election to be made no later than 14 days following the date on which
such Shares are acquired.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><i>Relationship to Employment
Contract. </i>The rights of a UK Participant under the terms of his or her office or employment with the Company or any Subsidiary shall
not be affected by the Plan, this Supplement or any Award Agreement. The value of any benefit realized by a UK Participant in respect
of an Award shall not be taken into account in determining any pension or similar entitlement.21</p><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><i>Limitation on Claims</i>.
A UK Participant shall have no right to compensation or damages on account of any loss in respect of an Award where the loss arises (or
is claimed to arise), in whole or in part, from termination of office or employment with, or notice to terminate office or employment
given by or to, the Company or any Subsidiary. This exclusion of liability shall apply however termination of office or employment, or
the giving of notice, is caused, and however compensation or damages are claimed. A UK Participant shall have no right to compensation
or damages from the Company or any Subsidiary on account of any loss in respect of an Award where the loss arises (or is claimed to arise),
in whole or in part, from any Change in Control, any company ceasing to be a Subsidiary or the transfer or any business from the Company
or any Subsidiary to any other person</p><div>

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

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

</div><!-- Field: Page; Sequence: 99; Value: 1 --><div>
    </div><div style="margin-top: 12pt; margin-bottom: 6pt; border-bottom: Black 1.5pt solid"><p style="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><!-- Field: Sequence; Type: Arabic; Name: PageNo -->94<!-- Field: /Sequence --></p></div><div>
    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
    </div><!-- Field: /Page --><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><b>C. Board Practices</b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><b>Corporate Governance Practices</b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">We are a &#8220;foreign private
issuer,&#8221; as defined by the SEC. As a result, in accordance with Nasdaq listing requirements, we may rely on home country governance
requirements and certain exemptions thereunder rather than complying with NASDAQ corporate governance standards. While we voluntarily
follow most Nasdaq corporate governance rules, we may choose to take advantage of the following limited exemptions:</p><div>

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

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.5in">&#160;</td>
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Exemption from filing quarterly
    reports on Form 10-Q containing unaudited financial and other specified information or current reports on Form 8-K upon the occurrence
    of specified significant events.</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: -0.2in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
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    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Exemption from Section
    16 rules requiring insiders to file public reports of their stock ownership and trading activities and liability for insiders who
    profit from trades in a short period of time, which will provide less data in this regard than shareholders of U.S. companies that
    are subject to the Exchange Act.</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: -0.2in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.5in">&#160;</td>
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Exemption from the Nasdaq
    requirement requiring disclosure of any waivers of the code of business conduct and ethics for directors and officers.</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: -0.2in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
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    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Exemption from the requirement
    that our board have a compensation committee that is composed entirely of independent directors with a written charter addressing
    the committee&#8217;s purpose and responsibilities.</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: -0.2in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.5in">&#160;</td>
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Exemption from the requirement to have independent
    director oversight of director nominations.</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">In connection with the migration
to Bermuda, Tiziana adopted a Code of Business Conduct and Ethics which covers a broad range of matters including the handling of conflicts
of interest, compliance issues and other corporate policies such as insider trading and equal opportunity and non-discrimination standards.
Tiziana&#8217;s Code of Business Conduct and Ethics applies to all directors, executive officers and employees of Tiziana. Tiziana publishes
its Code of Business Conduct and Ethics on its website (www.tizianalifesciences.com).</p><div>

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

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.5in">&#160;</td>
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">We do not follow Nasdaq
    Rule 5620(c) regarding quorum requirements applicable to meetings of shareholders. Such quorum requirements are not required under
    English law. In accordance with generally accepted business practice, our Bye-laws will provide alternative quorum requirements that
    are generally applicable to meetings of shareholders.</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
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    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">We do not follow Nasdaq
    Rule 5605(b)(2), which requires that independent directors regularly meet in executive sessions where only independent directors
    are present. Our independent directors may choose to meet in executive sessions at their discretion.</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Although we may rely on certain
home country corporate governance practices, we must comply with Nasdaq&#8217;s Notification of Noncompliance requirement (Nasdaq Rule
5625) and the Voting Rights requirement (Nasdaq Rule 5640). Further, we must have an audit committee that satisfies Nasdaq Rule 5605(c)(3),
which addresses audit committee responsibilities and authority and requires that the audit committee consist of members who meet the
independence requirements of Nasdaq Rule 5605(c)(2)(A)(ii).</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">We intend to take all actions
necessary for us to maintain compliance as a foreign private issuer under the applicable corporate governance requirements of the Sarbanes-Oxley
Act, the rules adopted by the SEC and Nasdaq listing rules. Accordingly, our shareholders will not have the same protections afforded
to shareholders of companies that are subject to all of the corporate governance requirements of Nasdaq. For an overview of our corporate
governance principles, see the following section titled &#8220;Description of Bye-laws and Memorandum of Association&#8221;</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>Description of Bye-laws and Memorandum of
Association</b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">The following description
includes a summary of specified provisions of our memorandum of association and our Bye-laws. This description is qualified by reference
to our memorandum of association and our Bye-laws which are incorporated by reference as exhibits to this annual report.</p><div>

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

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

</div><!-- Field: Page; Sequence: 100; Value: 1 --><div>
    </div><div style="margin-top: 12pt; margin-bottom: 6pt; border-bottom: Black 1.5pt solid"><p style="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><!-- Field: Sequence; Type: Arabic; Name: PageNo -->95<!-- Field: /Sequence --></p></div><div>
    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

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

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Our Bye-laws do not provide
shareholders with pro rata preemptive rights to subscribe for any newly issued common shares. Additionally, the Companies Act does not
provide shareholders with a statutory preemptive right.</p><div>

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

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

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Our board of directors may
exercise all of the powers to purchase for cancellation or acquire our shares as treasury shares in accordance with the Companies Act.
On a reacquisition of shares, such shares may be cancelled (in which event, our issued but not our authorized capital will be diminished
accordingly) or held as treasury shares. Such purchases may only be effected out of the capital paid up on the purchased shares or out
of the funds otherwise available for dividend or distribution or out of the proceeds of a fresh issue of shares made for the purpose.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>Alteration of Share Capital</b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">We may, if authorized by
a resolution of our shareholders, increase, divide, consolidate, subdivide, change the currency denomination of, diminish or otherwise
alter or reduce the share capital in any manner permitted by the Companies Act.</p><div>

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

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

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">If at any time we have more
than one class of shares, the rights attaching to any class, unless otherwise provided for by the terms of issue of the relevant class,
may be varied with the sanction of a resolution passed by a majority of the votes cast at a general meeting of the relevant class of
shareholders at which a quorum consisting of at least two persons holding or representing one-third of the issued shares of the relevant
class is present. Our Amended and Restated Bye-laws specify that the creation or issue of shares ranking equally with existing shares
will not, unless expressly provided by the terms of issue of existing shares, vary the rights attached to existing shares. In addition,
the creation or issue of preference shares ranking prior to common shares will not be deemed to vary the rights attached to common shares
or, subject to the terms of any other series of preference shares, to vary the rights attached to any other series of preference shares.</p><div>

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

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

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Our board of directors may
in its absolute discretion and without assigning any reason refuse to register the transfer of a share which is not fully paid. Our board
of directors may also refuse to recognize an instrument of transfer of a share unless it is accompanied by the relevant share certificate
and such other evidence of the transferor&#8217;s right to make the transfer as our board of directors shall reasonably require. The
board shall refuse to register a transfer unless all applicable consents, authorizations and permissions of any governmental body or
agency in Bermuda have been obtained. Subject to these restrictions, a holder of common shares may transfer the title to all or any of
its common shares by completing a form of transfer in the form set out in our Bye-laws (or as near thereto as circumstances admit) or
in such other common form as the board may accept. The instrument of transfer must be signed by the transferor and transferee, although
in the case of a fully paid share our board of directors may accept the instrument signed only by the transferor.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Notwithstanding anything
to the contrary in the Amended and Restated Bye-laws, our shares may be transferred without a written instrument if transferred by an
appointed agent and in any form or manner which is in accordance with the rules or regulations of an appointed stock exchange (which
includes the Nasdaq Capital Market) on which the shares are listed or admitted to trading.</p><div>

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

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

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

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

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">An annual general meeting
will be held each year in accordance with the requirements of the Companies Act and our Bye-laws at such time and place as our board
of directors appoints. Our board of directors or the chairman may also, whenever in its judgment it is necessary, convene general meetings
other than annual general meetings which are called special general meetings. Bermuda law and the Bye-laws provide that a special general
meeting must be called upon the request of shareholders holding not less than one-tenth of the paid-up capital of the Company carrying
the right to vote at general meetings. Any annual general meeting and special general meeting must be called by, respectively, not less
than twenty-one (21) days and five (5) days&#8217; prior notice in writing. A notice of meeting must include the place, day and time
of the meeting and, in the case of an annual general meeting, that the election of directors will take place thereat and any other business
to be conducted at the meeting, and, in the case of a special general meeting, the general nature of the business to be considered at
the meeting. This notice requirement is subject to the ability to hold such meetings on shorter notice if such notice is agreed: (i)
in the case of an annual general meeting by all of the shareholders entitled to attend and vote at such meeting; or (ii) in the case
of a special general meeting by a majority in number of the shareholders entitled to attend and vote at the meeting holding not less
than 95% in nominal value of the shares entitled to vote at such meeting. A shareholder may appoint a proxy to attend and vote at the
general meeting by providing notice in writing to us at our registered office or at such other place or in such manner as specified in
the notice of the general meeting.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">The chairman, if present,
and if not, the chief executive officer, if present, and if not, the president, if present, and if not, any person appointed by our board
of directors will act as chairman of the meeting. In their absence and if no one is appointed by our board of directors as chairman of
such meeting, a chairman of the meeting will be appointed or elected by those present at the meeting and entitled to vote.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>Board and Shareholder Ability to Call Special
Meetings</b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Our Bye-laws provide that
(a) the president or the chairman of the Company (if any) or any two Directors or any Director and the Secretary or the Board may convene
a special general meeting whenever in their judgment such a meeting is necessary and (b) the board of directors must convene a special
general meeting at the request of shareholders holding not less than one-tenth of the paid-up share capital of the Company with the right
to vote at general meetings.</p><div>

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

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

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Our Bye-laws provide that
at any general meeting of shareholders, At any general meeting two or more persons present throughout the meeting and representing in
person or by proxy in excess of 331/3% of the total voting rights of all issued and outstanding shares in the Company shall form a quorum
for the transaction of business.</p><div>

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

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

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Subject to any restrictions
for the time being lawfully attached to any class of shares, every shareholder who is present in person or by proxy at a general meeting
shall be entitled to one vote on a show of hands and be entitled to one vote for every share of which he is a holder on a vote taken
by poll, and any question proposed for the consideration of the shareholders at any general meeting shall be decided by the affirmative
votes of a majority of the votes cast in accordance with the Bye-laws, and in the case of an equality of votes, the resolution will fail.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>Shareholder Action by Written Consent</b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">The Bye-laws provide that
no action required to be taken or which may be taken at any general meeting of Members may be taken without a meeting, and the power
of Members to consent in writing, without a meeting, to the taking of any action is specifically denied.</p><div>

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

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

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>Access to Books and Records and Dissemination
of Information</b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Members of the general public
have a right to inspect the public documents of a company available at the office of the Registrar of Companies in Bermuda. These documents
include the company&#8217;s memorandum of association, including its objects and powers, and certain alterations to the memorandum of
association. The shareholders have the additional right to inspect the bye-laws of the company, minutes of general meetings and the company&#8217;s
audited financial statements, which must be presented to the annual general meeting. The register of members of a company is also open
to inspection by shareholders and by members of the general public without charge. The register of members is required to be open for
inspection for not less than two hours in any business day (subject to the ability of a company to close the register of members for
not more than thirty days in a year). A company is required to maintain its share register in Bermuda but may, subject to the provisions
of the Companies Act, establish a branch register outside of Bermuda. A company is required to keep at its registered office a register
of directors and officers that is open for inspection for not less than two hours in any business day by members of the public without
charge. A company is also required to file with the Registrar of Companies in Bermuda a list of its directors to be maintained on a register,
which register will be available for public inspection subject to such conditions as the Registrar may impose and on payment of such
fee as may be prescribed. Bermuda law does not, however, provide a general right for shareholders to inspect or obtain copies of any
other corporate records.</p><div>

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

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

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Our Amended and Restated
Bye-laws provide that shareholders entitled to vote for the election of directors may, at any special general meeting convened and held
in accordance with the Amended and Restated Bye-laws, remove a director only with cause, by the affirmative vote of shareholders holding
at least a majority of the total voting rights of all shareholders having the right to vote at such meeting, provided that the notice
of any such meeting convened for the purpose of removing a director must contain a statement of the intention so to do and be served
on such director not less than 14 days before the meeting and at such meeting the director will be entitled to be heard on the motion
for such director&#8217;s removal.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>Proceedings of Board of Directors</b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Our Bye-laws provide that
our business is to be managed and conducted by our board of directors. Bermuda law permits individual and corporate directors and there
is no requirement in the Bye-laws or Bermuda law that directors hold any of our shares. There is also no requirement in the Bye-laws
or Bermuda law that our directors must retire at a certain age.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">The remuneration of our directors
is determined by the board of directors from time to time at a duly authorized meeting. Our directors may also be paid all travel, hotel
and other expenses properly incurred by them in connection with our business or their duties as directors.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Provided a director discloses
a direct or indirect interest in any contract or arrangement or proposed contract or arrangement with us as required by Bermuda law,
such director is entitled to vote in respect of any such contract or arrangement in which he or she is interested and/or be counted in
the quorum for the meeting at which such contract or arrangement is to be voted on.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 63.35pt; text-align: justify; text-indent: -27.35pt">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 63.35pt; text-align: justify; text-indent: -27.35pt"></p><div>

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    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 63.35pt; text-align: justify; text-indent: -27.35pt">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>Amalgamations, Mergers and Business Combinations</b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">The amalgamation or merger
of a Bermuda company with another company or corporation (other than certain affiliated companies) requires the amalgamation or merger
agreement to be approved by the company&#8217;s board of directors and by its shareholders. Unless the company&#8217;s bye-laws provide
otherwise, the approval of 75% of the shareholders voting at such meeting is required to approve the amalgamation or merger agreement,
and the quorum for such meeting must be two persons holding or representing more than one-third of the issued shares of the company.
The Amended and Restated Bye-laws provide that an amalgamation, consolidation or a merger (other than with a wholly owned subsidiary
or as described below) that has been approved by the board must only be approved by a majority of the votes cast at a general meeting
of the shareholders at which the quorum shall be two or more persons present in person and representing in person or by proxy in excess
of 50% of all issued and outstanding common voting shares. Any other amalgamation or merger or other business combination (as defined
in the Amended and Restated Bye-laws) not approved by our board must be approved by the holders of not less than 66 2/3% of all votes
attaching to all shares then in issue entitling the holder to attend and vote on the resolution.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><i>Dissenter&#8217;s Rights</i></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Under Bermuda law, in the
event of an amalgamation or merger of a Bermuda company with another company or corporation, including a public Bermuda company, a shareholder
of the Bermuda company who did not vote in favor of the amalgamation or merger and is not satisfied that fair value has been offered
for such shareholder&#8217;s shares may, within one month of notice of the shareholders meeting, apply to the Supreme Court of Bermuda
to appraise the fair value of those shares. These approval rights did not apply to the Business Combination because the Company was not
a party to any amalgamation or merger contemplated by the Business Combination.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>Limitations on Director Liability and Indemnification
of Directors and Officers</b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Section 98 of the Companies
Act provides generally that a Bermuda company may indemnify its directors, officers and auditors against any liability which by virtue
of any rule of law would otherwise be imposed on them in respect of any negligence, default, breach of duty or breach of trust, except
in cases where such liability arises from fraud or dishonesty of which such director, officer or auditor may be guilty in relation to
the company. Section 98 further provides that a Bermuda company may indemnify its directors, officers and auditors against any liability
incurred by them in defending any proceedings, whether civil or criminal, in which judgment is awarded in their favor or in which they
are acquitted or granted relief by the Supreme Court of Bermuda pursuant to section 281 of the Companies Act.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">The Bye-laws provide that
the directors, resident representative, secretary and other officers acting in relation to any of the affairs of the Company or any subsidiary
thereof and the liquidator or trustees (if any) acting in relation to any of the affairs of the Company or any subsidiary thereof and
every one of them shall be indemnified and secured harmless out of the assets of the Company from and against all actions, costs, charges,
losses, damages and expenses which they or any of them shall or may incur or sustain by or by reason of any act done, concurred in or
omitted in or about the execution of their duty, or supposed duty, or in their respective offices or trusts, and no indemnified party
shall be answerable to the acts, receipts, neglects or defaults of the others of them or for joining in any receipts for the sake of
conformity, or for any bankers or other persons with whom any moneys or effects belonging to the Company shall or may be lodged or deposited
for safe custody, or for insufficiency or deficiency of any security upon which any moneys of or belonging to the Company shall be placed
out on or invested, or for any other loss, misfortune or damage which may happen in the execution of their respective offices or trusts,
or in relation thereto, provided that this indemnity shall not extend to any matter in respect of any fraud or dishonesty in relation
to the Company which may attach to any of the indemnified parties. We may also enter into an indemnification agreement with any director
or officer of the Company.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">In addition, the Bye-laws
provide that the Company may (i) purchase and maintain insurance for the benefit of any director or officer against any liability incurred
by such person under the Companies Act in his or her capacity as a director or officer of the Company or indemnifying such director or
officer in respect of any loss arising or liability attaching to him or her by virtue of any rule of law in respect of any negligence,
default, breach of duty or breach of trust of which the director or officer may be guilty in relation to the Company or any of its subsidiaries
and (ii) advance moneys to a director or officer for the costs, charges and expenses incurred by the director or officer in defending
any civil or criminal proceedings against him or her, on condition that the director or officer shall repay the advance if any allegation
of fraud or dishonesty in relation to the Company is proved against him or her.</p><div>

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

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

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    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>Class Actions and Derivative Suits</b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Class actions and derivative
actions are generally not available to shareholders under Bermuda law. The Bermuda courts, however, would ordinarily be expected to permit
a shareholder to commence an action in the name of a company to remedy a wrong to the company where the act complained of is alleged
to be beyond the corporate power of the company or illegal, or would result in the violation of the company&#8217;s memorandum of association
or bye-laws. Furthermore, consideration would be given by a Bermuda court to acts that are alleged to constitute a fraud against the
minority shareholders or, for instance, where an act requires the approval of a greater percentage of the company&#8217;s shareholders
than that which actually approved it.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">When the affairs of a company
are being conducted in a manner which is oppressive or prejudicial to the interests of some part of the shareholders, one or more shareholders
may apply to the Supreme Court of Bermuda, which may make such order as it sees fit, including an order regulating the conduct of the
company&#8217;s affairs in the future or ordering the purchase of the shares of any shareholders by other shareholders or by the company.&#160;</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>Amendment of Memorandum of Association and
Bye-laws</b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Bermuda law provides that
the memorandum of association of a company may be amended by a resolution passed at a general meeting of shareholders. Our Amended and
Restated Bye-laws provide that no bye-law shall be rescinded, altered or amended, and no new bye-law shall be made, unless it shall have
been approved by a resolution of our board of directors and by a resolution of our shareholders.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Under Bermuda law, the holders
of an aggregate of not less than 20% in par value of the company&#8217;s issued share capital or any class thereof have the right to
apply to the Supreme Court of Bermuda for an annulment of any amendment of the memorandum of association adopted by shareholders at any
general meeting, other than an amendment which alters or reduces a company&#8217;s share capital as provided in the Companies Act. Where
such an application is made, the amendment becomes effective only to the extent that it is confirmed by the Bermuda court. An application
for an annulment of an amendment of the memorandum of association must be made within 21 days after the date on which the resolution
altering the company&#8217;s memorandum of association is passed and may be made on behalf of persons entitled to make the application
by one or more of their number as they may appoint in writing for the purpose. No application may be made by shareholders voting in favor
of the amendment.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>Capitalization of Profits and Reserves</b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Pursuant to our Bye-laws,
our board of directors may (i) capitalize any part of the amount of our share premium or other reserve accounts or any amount credited
to our profit and loss account or otherwise available for distribution by applying such sum in paying up unissued shares to be allotted
as fully paid bonus shares pro-rata (except in connection with the conversion of shares) to the shareholders; or (ii) capitalize any
sum standing to the credit of a reserve account or sums otherwise available for dividend or distribution by paying up in full, partly
paid or nil paid shares of those shareholders who would have been entitled to such sums if they were distributed by way of dividend or
distribution.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>Certain Provisions of Bermuda Law</b></p><div>

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

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

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">In accordance with Bermuda
law, share certificates are only issued in the names of companies, partnerships or individuals. In the case of a shareholder acting in
a special capacity (for example as a trustee), certificates may, at the request of the shareholder, record the capacity in which the
shareholder is acting. Notwithstanding such recording of any special capacity, we are not bound to investigate or see to the execution
of any such trust.</p><div>

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

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

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Under the Companies Act,
only those persons who agree to become members of a Bermuda company and whose names are entered on the register of members of such company
are deemed members. A Bermuda company is not bound to see to the execution of any trust, whether express, implied or constructive, to
which any of its shares are subject and whether or not the company had notice of such trust. Accordingly, persons holding shares through
a trustee, nominee or depository will not be recognized as members of a Bermuda company under Bermuda law and may only have the benefit
of rights attaching to the shares or remedies conferred by law on members through or with the assistance of the trustee, nominee or depository.</p><div>

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

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

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    </div><!-- Field: /Page --><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>Composition of Our Board of Directors</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><b>&#160;</b></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Our board of directors is
currently composed of three members. Our board of directors has determined that, of our four directors, none have a relationship that
would interfere with the exercise of independent judgment in carrying out the responsibilities of two of the directors, Mr. John Brancaccio
and Mr. Simon, and that each of these directors is &#8220;independent&#8221; as that term is defined under Nasdaq rules.</p><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">In accordance with our Articles,
at the first general meeting which is held after the date of adoption of the Bye-laws for the purpose of electing Directors, the Class
I Directors shall be elected for a three year term of office, the Class II Directors shall be elected for a two year term of office and
the Class III Directors shall be elected for a one year term of office. At each succeeding annual general meeting, successors to the
class of Directors whose term expires at that annual general meeting shall be elected for a three-year term. If the number of Directors
is changed, any increase or decrease shall be apportioned among the classes so as to maintain the number of Directors in each class as
nearly equal as possible, and any Director of any class elected to fill a vacancy shall hold office for a term that shall coincide with
the remaining term of the other Directors of that class, but in no case shall a decrease in the number of Directors shorten the term
of any Director then in office. A Director shall hold office until the annual general meeting for the year in which his term expires.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">The Class of the members
of the Board of Directors is as follows:</p><div>

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

</div><table cellpadding="0" cellspacing="0" style="border-collapse: collapse; width: 100%; font: 10pt Times New Roman, Times, Serif">
  <tr style="vertical-align: bottom; ">
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    <td style="border-bottom: Black 1.5pt solid; width: 11%; font-weight: bold; text-align: center">Year&#160;Current<br/> Term Began</td><td style="width: 1%; font-weight: bold; padding-bottom: 1.5pt">&#160;</td>
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="text-align: left">Gabriele Cerrone</td><td>&#160;</td>
    <td style="text-align: center">I</td><td>&#160;</td>
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    <td style="text-align: right">2024</td></tr>
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    <td style="text-align: left">John Brancaccio</td><td>&#160;</td>
    <td style="text-align: center">II</td><td>&#160;</td>
    <td style="text-align: right">2021</td><td>&#160;</td>
    <td style="text-align: right">2023</td></tr>
  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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  </table><div>


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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>Committees of Our Board of Directors</b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Our board of directors has
three standing committees: an audit committee, a remuneration committee and a nominating committee.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"></p><div>

</div><!-- Field: Page; Sequence: 106; Value: 1 --><div>
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    </div><!-- Field: /Page --><div>

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

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

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">The audit committee, which
consists of, Mr. Brancaccio and Mr. Simon, assists the board of directors in overseeing our accounting and financial reporting processes.
Mr. Brancaccio serves as chairman of the audit committee. The audit committee consists exclusively of members of our board who are financially
literate, and Mr. Simon is considered an &#8220;audit committee financial expert&#8221; as defined by applicable SEC rules and has the
requisite financial sophistication as defined under the applicable Nasdaq rules and regulations.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Our board has determined
that all of the members of the audit committee satisfy the &#8220;independence&#8221; requirements set forth in Rule 10A-3 under the
Exchange Act. The audit committee will be governed by a charter that complies with Nasdaq rules.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">The audit committee&#8217;s
responsibilities include:</p><div>

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

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.5in">&#160;</td>
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
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  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: -0.25in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.5in">&#160;</td>
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the appointment, compensation,
    retention and oversight of any accounting firm engaged for the purpose of preparing or issuing an audit report or performing other
    audit services;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: -0.25in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.5in">&#160;</td>
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">pre-approving the audit
    services and non-audit services to be provided by our independent auditor before the auditor is engaged to render such services;</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.5in">&#160;</td>
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">evaluating the independent
    auditor&#8217;s qualifications, performance and independence, and presenting its conclusions to the full board of directors on at
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  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: -0.25in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.5in">&#160;</td>
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">reviewing and discussing
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: -0.25in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
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    <td style="width: 0.5in">&#160;</td>
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">reviewing, approving or
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  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: -0.25in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
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    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the appointment, compensation,
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center; text-indent: 0.5in">&#160;</p><div>

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

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">The remuneration committee
consists of Mr. Brancaccio and Mr. Simon. Mr. Simon serves as chairman of the remuneration committee. Under SEC and Nasdaq rules, there
are heightened independence standards for members of the remuneration committee, including a prohibition against the receipt of any compensation
from us other than standard board member fees.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">The remuneration committee&#8217;s
responsibilities include:</p><div>

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

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
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    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">identifying, reviewing
    and proposing policies relevant to the compensation and benefits of our directors and executive officers;</span></td></tr>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: -0.25in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.5in">&#160;</td>
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: -0.25in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.5in">&#160;</td>
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">overseeing and administering
    our employee share option scheme or equity incentive plans in operation from time to time.</span></td></tr>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: -0.25in">&#160;&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center; text-indent: 0.5in"></p><div>

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    </div><div style="border-bottom: Black 1.5pt solid; margin-top: 12pt; margin-bottom: 6pt"><p style="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><!-- Field: Sequence; Type: Arabic; Name: PageNo -->102<!-- Field: /Sequence --></p></div><div>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

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

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

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">The nominating committee
consists of Mr. Cerrone and Mr. Simon. Mr. Simon serves as chairman of the nominating committee. The nominating committee&#8217;s responsibilities
include:</p><div>

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

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
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    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
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  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: -0.25in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.5in">&#160;</td>
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: -0.25in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.5in">&#160;</td>
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">assessing the functioning
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  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: -0.25in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.5in">&#160;</td>
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
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  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: -0.25in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">None of our non-employee
directors have any service contracts with Tiziana Life Sciences Ltd or any of our subsidiaries that provide for benefits upon termination
of employment.</p><div>

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

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center; text-indent: 0.5in"></p><div>

</div><table cellpadding="0" cellspacing="0" style="border-collapse: collapse; width: 100%; font: 10pt Times New Roman, Times, Serif">
  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="text-align: left">Country of Principal Executive Offices</td>
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  <tr style="vertical-align: bottom; ">
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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  <tr style="vertical-align: bottom; ">
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center; text-indent: 0.5in"><span><b>&#160;</b></span></p><div>

</div><table cellpadding="0" cellspacing="0" style="border-collapse: collapse; width: 100%; font: 10pt Times New Roman, Times, Serif">
  <tr style="vertical-align: bottom">
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  <tr style="vertical-align: bottom; ">
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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  <tr style="vertical-align: bottom; ">
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="padding-right: 0pt; text-align: left; padding-left: 0pt; text-indent: 0pt">Underrepresented Individual in Home Country Jurisdiction</td><td style="padding-right: 0pt; padding-left: 0pt; text-indent: 0pt">&#160;</td>
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  <tr style="vertical-align: bottom; ">
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><b>D. Employees</b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">As of December 31, 2022,
we had 9 full time employees. Three of our employees were engaged in research and development and six employees were engaged in management,
administration and finance. Five are located in England and four are located in the United States. None of our employees are members
of labor unions. None of our employees are covered by a collective bargaining agreement.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><b>Insurance and Indemnification</b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">To the extent permitted by
the Companies Act, we are empowered to indemnify our directors against any liability they incur by reason of their directorship. We maintain
directors&#8217; and officers&#8217; insurance to insure such persons against certain liabilities. We expect to enter into a deed of
indemnity with each of our directors and executive officers prior to, or as soon as practicable, following the filing of this registration
statement.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">In addition to such indemnification,
we provide our directors and executive officers with directors&#8217; and officers&#8217; liability insurance.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Insofar as indemnification
of liabilities arising under the Securities Act may be permitted to our board of directors, executive officers, or persons controlling
us pursuant to the foregoing provisions, we have been informed that, in the opinion of the SEC, such indemnification is against public
policy as expressed in the Securities Act and is therefore unenforceable.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: -9.8pt"><b>&#160;</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><b>E. Share Ownership</b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">See &#8220;Item 7. Major
Shareholders and Related Party Transactions.&#8221;</p><div>

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

</div><p style="margin: 0"></p><div>

</div><!-- Field: Page; Sequence: 108; Value: 1 --><div>
    </div><div style="margin-top: 12pt; margin-bottom: 6pt; border-bottom: Black 1.5pt solid"><p style="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><!-- Field: Sequence; Type: Arabic; Name: PageNo -->103<!-- Field: /Sequence --></p></div><div>
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</div><p style="margin: 0">&#160;&#160;</p><div>

</div><div><a id="a_009"></a></div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><b>ITEM 7: MAJOR SHAREHOLDERS AND RELATED PARTY
TRANSACTIONS</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: -10.25pt"><b>&#160;</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><b>A. Major Shareholders</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">The following table sets forth
information relating to the beneficial ownership of our ordinary shares as of April 24, 2023 by:</p><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">

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

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.5in">&#160;</td>
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  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: -22.5pt">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
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  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center; text-indent: 0.5in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">The number of ordinary shares
beneficially owned by each entity, person, board member, or executive officer is determined in accordance with the rules of the SEC,
and the information is not necessarily indicative of beneficial ownership for any other purpose. Under such rules, beneficial ownership
includes any ordinary shares over which the individual has sole or shared voting power or investment power as well as any ordinary shares
that the individual has the right to acquire within 60 days of April 24, 2023 through the exercise of any option, warrant or other right.
Except as otherwise indicated, and subject to applicable community property laws, the persons named in the table have sole voting and
investment power with respect to all ordinary shares held by that person.</p><div>

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

</div><table cellpadding="0" cellspacing="0" style="border-collapse: collapse; width: 100%; font: 10pt Times New Roman, Times, Serif">
  <tr style="vertical-align: bottom">
    <td>&#160;</td><td style="font-weight: bold; padding-bottom: 1.5pt">&#160;</td>
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  <tr style="vertical-align: bottom">
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  <tr style="vertical-align: bottom; ">
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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  <tr style="vertical-align: bottom; ">
    <td style="text-align: left">John Brancaccio</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">-</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">-</td><td style="text-align: left">&#160;</td></tr>
  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td>&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">-</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">-</td><td style="text-align: left">&#160;</td></tr>
  <tr style="vertical-align: bottom; ">
    <td style="text-align: left"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">All directors and executive officers as a group (3 persons)<sup>(2)</sup></span></td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">39,814,273</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">38.58</td><td style="text-align: left">&#160;</td></tr>
  </table><div>


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

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">*</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Indicates beneficial ownership
    of less than 1% of the total outstanding ordinary shares.</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">(1)</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Mr. Gabriele Cerrone is
    the ultimate beneficial owner of ordinary shares through Planwise Group Limited and Panetta Partners Limited.</span></td></tr>
  <tr style="vertical-align: top">
    <td>&#160;</td>
    <td style="text-align: justify">&#160;</td></tr>
  <tr style="vertical-align: top">
    <td>&#160;</td>
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Includes 915,388 stock options which are currently
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  <tr style="vertical-align: top">
    <td>&#160;</td>
    <td style="text-align: justify">&#160;</td></tr>
  <tr style="vertical-align: top">
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">(2)</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Includes of 915,388 stock
    options which are currently exercisable or exercisable within 60 days of April 24, 2023</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&#160;</p><div>


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    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
    </div><!-- Field: /Page --><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><b>B. Related Party Transactions</b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">The following is a description
of related party transactions we have entered into since January 1, 2020, with the beneficial owners of 5% or more of our ordinary shares,
which are our only voting securities, and senior management and members of our board of directors.</p><div>

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

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

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">We have entered into deeds
of indemnity with each of our directors.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>Related Person Transaction Policy</b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Our board of directors has
adopted a written related person transaction policy, effective as of November 9, 2018, the date on which our registration statement on
Form F-1 was declared effective. This policy covers, any transaction or proposed transactions between us and a related person that are
material to us or the related person, including without limitation, purchases of goods or services by or from the related person or entities
in which the related person has a material interest, indebtedness, guarantees of indebtedness and employment by us of a related person.
In reviewing and approving any such transactions, our audit and risk committee is tasked to consider all relevant facts and circumstances,
including, but not limited to, whether the transaction is on terms comparable to those that could be obtained in an arm&#8217;s length
transaction and the extent of the related person&#8217;s interest in the transaction.</p><div>

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

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: -10.25pt">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">We have entered into a
consultancy agreement with our Acting Chief Executive Officer, and director agreements with our remaining board members. For further
details on these agreements, see Item 6 entitled &#8220;Directors, Senior Management and Employees.&#8221;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: -10.25pt"><b>&#160;</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">We have entered into certain
related party transactions as disclosed in Note 8 and Note 23 to the Consolidated Financial Statements in Item 18 of this report.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><b>C. Interests of Experts and Counsel</b></p><div>

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

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

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

</div><div><a id="a_010"></a></div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><b>ITEM 8: FINANCIAL INFORMATION</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: -10.25pt"><b>&#160;</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><b>A. Consolidated Statements and Other Financial Information</b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">See &#8220;Item 18. Financial
Statements&#8221;.</p><div>

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

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Except as disclosed in this
paragraph, there are no governmental, legal or arbitration proceedings (including any such proceedings which are pending or threatened
of which the Company is aware), which may have, or have had during the 12 months prior to the date of this registration statement, a significant
effect on the Company&#8217;s and/or our financial position or profitability. In addition to the proceedings set out in this section,
the Company is involved in other legal proceedings and claims in the ordinary course of business.</p><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><b>B. Significant Changes</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&#160;</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">See Note 25 of our consolidated
financial statements at the end of this Annual Report for a description of the significant changes since December 31, 2022.</p><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">

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


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    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
    </div><!-- Field: /Page --><div>

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

</div><div><a id="a_011"></a></div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><b>ITEM 9: THE LISTING</b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><b>A. Listing Details</b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Our common shares are listed
on The Nasdaq Capital Market under the symbol &#8220;TLSA.&#8221;</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><b>B. Plan of Distribution</b></p><div>

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

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

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><b>C. Markets</b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Our common shares are listed on the Nasdaq Capital Market under the
symbol &#8220;TLSA.&#8221;</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><b>D. Selling Shareholders</b></p><div>

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

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

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><b>E. Dilution</b></p><div>

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

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

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><b>F. Expenses of the Issue</b></p><div>

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

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

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

</div><div><a id="a_012"></a></div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><b>ITEM 10: ADDITIONAL INFORMATION</b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><b>A. Share Capital</b></p><div>

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

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

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><b>B. Memorandum of Association and Bye-laws</b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">We incorporate by reference
into this Annual Report the description of our memorandum of association and Bye-laws contained in Form 8-K filed with the SEC on October
21, 2021.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><b>C. Material Contracts</b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Except as otherwise disclosed
in this Annual Report (including the exhibits hereto), we are not currently, and have not been in the last two years, party to any material
contract, other than contracts entered into in the ordinary course of business.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><b>D. Exchange Controls</b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">The permission of the Bermuda
Monetary Authority is required, under the provisions of the Exchange Control Act 1972 of Bermuda and related regulations, for all issuances
and transfers of shares (which includes our common shares) of Bermuda companies to or from a non-resident of Bermuda for exchange control
purposes, other than in cases where the Bermuda Monetary Authority has granted a general permission. The Bermuda Monetary Authority,
in its notice to the public dated June 1, 2005, has granted a general permission for the issue and subsequent transfer of any securities
of a Bermuda company from and/or to a non-resident of Bermuda for exchange control purposes for so long as any &#8220;Equity Securities&#8221;
of the company (which include our common shares) are listed on an &#8220;Appointed Stock Exchange&#8221; (which include Nasdaq). In granting
the general permission the Bermuda Monetary Authority accepts no responsibility for our financial soundness or the correctness of any
of the statements made or opinions expressed in this annual report.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Although the Company is incorporated
in Bermuda, as an exempted company it is classified as a non-resident of Bermuda for exchange control purposes by the Bermuda Monetary
Authority. Other than transferring Bermuda Dollars out of Bermuda, there are no restrictions on the Company&#8217;s ability to transfer
funds into and out of Bermuda or to pay dividends in currency other than Bermuda Dollars to non-residents of Bermuda who are holders
of our common shares</p><div>

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


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    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
    </div><!-- Field: /Page --><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><b>E. Taxation</b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><b>Material U.S. Federal Income Tax Considerations for U.S. Holders</b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>U.S. Federal Income Tax Considerations for
U.S. Holders</b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">The following discussion
describes the material U.S. federal income tax consequences relating to the ownership and disposition of our Common shares by U.S. Holders.
This discussion applies to U.S. Holders that purchase our Common shares pursuant to this offering and hold such Common shares as capital
assets for tax purposes. This discussion is based on the Internal Revenue Code, U.S. Treasury regulations promulgated thereunder and
administrative and judicial interpretations thereof, and the income tax treaty between the United Kingdom and the United States, or the
Treaty, all as in effect on the date hereof and all of which are subject to change, possibly with retroactive effect. This discussion
does not address all of the U.S. federal income tax consequences 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 (such as certain financial institutions,
insurance companies, dealers or traders in securities or other persons that generally mark their securities to market for U.S. federal
income tax purposes, tax-exempt entities or governmental organizations, retirement plans, regulated investment companies, real estate
investment trusts, grantor trusts, brokers, dealers or traders in securities, commodities, currencies or notional principal contracts,
certain former citizens or long-term residents of the United States, persons who hold our Common shares as part of a &#8220;straddle,&#8221;
&#8220;hedge,&#8221; &#8220;conversion transaction,&#8221; &#8220;synthetic security&#8221; or integrated investment, persons that have
a &#8220;functional currency&#8221; other than the U.S. dollar, persons who are subject to the tax accounting rules of Section 451(b)
of the Internal Revenue Code, persons that own directly, indirectly or through attribution 10% or more (by vote or value) of our equity,
corporations that accumulate earnings to avoid U.S. federal income tax, partnerships and other pass-through entities, and investors in
such pass-through entities). This discussion does not address any U.S. state or local or non-U.S. tax consequences or any U.S. federal
estate, gift or alternative minimum tax consequences.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">As used in this discussion,
the term &#8220;U.S. Holder&#8221; means a beneficial owner of our Common shares that is, for U.S. federal income tax purposes, (1) an
individual who is a citizen or resident of the United States, (2) a corporation (or entity treated 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,
(3) an estate the income of which is subject to U.S. federal income tax regardless of its source or (4) a trust (x) with respect to which
a court within the United States is able to exercise primary supervision over its administration and one or more United States persons
have the authority to control all of its substantial decisions or (y) that has elected under applicable U.S. Treasury regulations to
be treated as a domestic trust for U.S. federal income tax purposes.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">If an entity treated as a
partnership for U.S. federal income tax purposes holds our Common shares, the U.S. federal income tax consequences relating to an investment
in such Common shares will depend upon the status and activities of such entity and the particular partner. Any such entity and a partner
in any such entity should consult its own tax advisor regarding the U.S. federal income tax consequences applicable to it (and, as applicable,
its partners) of the purchase, ownership and disposition of our Common shares.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">We have not sought, nor will
we seek, a ruling from the IRS with respect to the matters discussed below. There can be no assurance that the IRS will not take a different
position concerning the tax consequences of the purchase, ownership or disposition of the Common shares or that any such position would
not be sustained. Persons considering an investment in our Common shares should consult their own tax advisors as to the particular tax
consequences applicable to them relating to the purchase, ownership and disposition of our Common shares, including the applicability
of U.S. federal, state and local tax laws and non-U.S. tax laws.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><b><i>Passive Foreign Investment Company Rules</i></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">In general, a corporation
organized outside the United States will be treated as a PFIC for any taxable year in which either (1) at least 75% of its gross income
is &#8220;passive income,&#8221; or the PFIC income test, or (2) on average at least 50% of its assets, determined on a quarterly basis,
are assets that produce passive income or are held for the production of passive income, or the PFIC asset test. Passive income for this
purpose generally includes, among other things, dividends, interest, royalties, rents, and gains from the sale or exchange of property
that give rise to passive income. Assets that produce or are held for the production of passive income generally include cash, even if
held as working capital or raised in a public offering, marketable securities, and other assets that may produce passive income. Generally,
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.</p><div>

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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Although PFIC status is determined
on an annual basis and generally cannot be determined until the end of the taxable year, based on the nature of our current and expected
income and the current and expected value and composition of our assets, we believe we were a PFIC for our 2017 tax year and we expect
to be a PFIC for our current taxable year. There can be no assurance that we will not be a PFIC in future taxable years. Even if we determine
that we are not a PFIC for a taxable year, there can be no assurance that the IRS will agree with our conclusion and that the IRS would
not successfully challenge our position. Because of the uncertainties involved in establishing our PFIC status, our U.S. counsel expresses
no opinion regarding our PFIC status, and also expresses no opinion with respect to our predictions or past determinations regarding
our PFIC status.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">If we are a PFIC in any taxable
year during which a U.S. Holder owns our Common shares, the U.S. Holder could be liable for additional taxes and interest charges under
the &#8220;PFIC excess distribution regime&#8221; upon (1) a distribution paid during a taxable year that is greater than 125% of the
average annual distributions paid in the three preceding taxable years, or, if shorter, the U.S. Holder&#8217;s holding period for our
Common shares, and (2) any gain recognized on a sale, exchange or other disposition, including, under certain circumstances, a pledge,
of our Common shares, whether or not we continue to be a PFIC. Under the PFIC excess distribution regime, the tax on such distribution
or gain would be determined by allocating the distribution or gain ratably over the U.S. Holder&#8217;s holding period for our Common
shares. The amount allocated to the current taxable year (<i>i.e</i>., the year in which the distribution occurs or the gain is recognized)
and any year prior to the first taxable year in which we are a PFIC will be taxed as ordinary income earned in the current taxable year.
The amount allocated to other taxable years will be taxed at the highest marginal rates in effect for individuals or corporations, as
applicable, to ordinary income for each such taxable year, and an interest charge, generally applicable to underpayments of tax, will
be added to the tax.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">If we are a PFIC for any
year during which a U.S. Holder holds our Common shares, we must generally continue to be treated as a PFIC by that U.S. Holder for all
succeeding years during which the U.S. Holder holds such Common shares, unless we cease to meet the requirements for PFIC status and
the U.S. Holder makes a &#8220;deemed sale&#8221; election with respect to our Common shares. If the election is made, the U.S. Holder
will be deemed to sell our Common shares it holds at their fair market value on the last day of the last taxable year in which we qualified
as a PFIC, and any gain recognized from such deemed sale would be taxed under the PFIC excess distribution regime. After the deemed sale
election, the U.S. Holder&#8217;s Common shares would not be treated as shares of a PFIC unless we subsequently become a PFIC.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">If we are a PFIC for any
taxable year during which a U.S. Holder holds our Common shares and one of our non-United States subsidiaries is also a PFIC (<i>i.e</i>.,
a lower-tier PFIC), such U.S. Holder would be treated as owning a proportionate amount (by value) of the shares of the lower-tier PFIC
and would be taxed under the PFIC excess distribution regime on distributions by the lower-tier PFIC and on gain from the disposition
of shares of the lower-tier PFIC even though such U.S. Holder would not receive the proceeds of those distributions or dispositions.
Any of our non-United States subsidiaries that have elected to be disregarded as entities separate from us or as partnerships for U.S.
federal income tax purposes would not be corporations under U.S. federal income tax law and accordingly, cannot be classified as lower-tier
PFICs. However, a non-United States subsidiary that has not made the election may be classified as a lower-tier PFIC if we are a PFIC
during your holding period and the subsidiary meets the PFIC income test or PFIC asset test.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">If we are a PFIC, a U.S.
Holder will not be subject to tax under the PFIC excess distribution regime on distributions or gain recognized on our Common shares
if a valid &#8220;mark-to-market&#8221; election is made by the U.S. Holder for our Common shares. An electing U.S. Holder generally
would take into account as ordinary income each year, the excess of the fair market value of our Common shares held at the end of such
taxable year over the adjusted tax basis of such Common shares. The U.S. Holder would also take into account, as an ordinary loss each
year, the excess of the adjusted tax basis of such Common shares over their fair market value at the end of the taxable year, but only
to the extent of the excess of amounts previously included in income over ordinary losses deducted as a result of the mark-to-market
election. The U.S. Holder&#8217;s tax basis in our Common shares would be adjusted annually to reflect any income or loss recognized
as a result of the mark-to-market election. Any gain from a sale, exchange or other disposition of our Common shares in any taxable year
in which we are a PFIC would be treated as ordinary income and any loss from such sale, exchange or other disposition would be treated
first as ordinary loss (to the extent of any net mark-to-market gains previously included in income) and thereafter as capital loss.
If, after having been a PFIC for a taxable year, we cease to be classified as a PFIC because we no longer meet the PFIC income or PFIC
asset test, the U.S. Holder would not be required to take into account any latent gain or loss in the manner described above and any
gain or loss recognized on the sale or exchange of the Common shares would be classified as a capital gain or loss.</p><div>

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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">A mark-to-market election
is available to a U.S. Holder only for &#8220;marketable stock.&#8221; 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 U.S. Treasury regulations. A class
of stock is regularly traded 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.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Our Common shares will be
marketable stock as long as they remain listed on Nasdaq and are regularly traded. A mark-to-market election will not apply to the Common
shares 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 of our non-U.S. subsidiaries. Accordingly, a U.S. Holder may continue to
be subject to tax under the PFIC excess distribution regime with respect to any lower-tier PFICs notwithstanding the U.S. Holder&#8217;s
mark-to-market election for our Common shares.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">The tax consequences that
would apply if we are a PFIC would also be different from those described above if a U.S. Holder were able to make a valid QEF election.
As we do not expect to provide U.S. Holders with the information necessary for a U.S. Holder to make a QEF election, prospective investors
should assume that a QEF election will not be available.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><b>The U.S. federal income
tax rules relating to PFICs are very complex. Prospective U.S. investors are strongly urged to consult their own tax advisors with respect
to the impact of PFIC status on the purchase, ownership and disposition of our </b>Common shares<b>, the consequences to them of an investment
in a PFIC, any elections available with respect to the </b>Common shares <b>and the IRS information reporting obligations with respect
to the purchase, ownership and disposition of </b>Common shares <b>of a PFIC.</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

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

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Subject to the discussion
above under &#8220;&#8212; Passive Foreign Investment Company Rules,&#8221; a U.S. Holder that receives a distribution with respect to
our Common shares generally will be required to include the gross amount of such distribution in gross income as a dividend when actually
or constructively received by the U.S. Holder 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). To the extent a distribution received by a U.S. Holder
is not a dividend because it exceeds the U.S. Holder&#8217;s pro rata share of our current and accumulated earnings and profits, it will
be treated first as a tax-free return of capital and reduce (but not below zero) the adjusted tax basis of the U.S. Holder&#8217;s Common
shares. To the extent the distribution exceeds the adjusted tax basis of the U.S. Holder&#8217;s Common shares, the remainder will be
taxed as capital gain. Because we may not account for our earnings and profits in accordance with U.S. federal income tax principles,
U.S. Holders should expect all distributions to be reported to them as dividends. The amount of a dividend will include any amounts withheld
by the company in respect of United Kingdom taxes.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Distributions on our Common
shares that are treated as dividends generally will constitute income from sources outside the United States for foreign tax credit purposes
and generally will constitute passive category income. Subject to applicable limitations, some of which vary depending upon the U.S.
Holder&#8217;s particular circumstances, any United Kingdom income taxes withheld from dividends on Common shares at a rate not exceeding
the rate provided by the Treaty will be creditable against the U.S. Holder&#8217;s U.S. federal income tax liability. The rules governing
foreign tax credits are complex and U.S. Holders should consult their tax advisers regarding the creditability of foreign taxes in their
particular circumstances. In lieu of claiming a foreign tax credit, U.S. Holders may, at their election, deduct foreign taxes, including
any United Kingdom income tax, in computing their taxable income, subject to generally applicable limitations under U.S. law. An election
to deduct foreign taxes instead of claiming foreign tax credits applies to all foreign taxes paid or accrued in the taxable year. The
amount of any dividend income paid in a currency other than the U.S. dollar will be the U.S. dollar amount calculated by reference to
the exchange rate in effect on the date of actual or constructive receipt, regardless of whether the payment is in fact converted into
U.S. dollars at that time. If the dividend is converted into U.S. dollars on the date of receipt, a U.S. holder should not be required
to recognize foreign currency gain or loss in respect of the dividend amount. A U.S. Holder may have foreign currency gain or loss if
the dividend is converted into U.S. dollars after the date of receipt.</p><div>

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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Distributions paid on our
Common shares will not be eligible for the &#8220;dividends received&#8221; deduction generally allowed to corporate shareholders with
respect to dividends received from U.S. corporations under the Internal Revenue Code. Dividends paid by a &#8220;qualified foreign corporation&#8217;&#8217;
to non-corporate U.S. Holders are eligible for taxation at a reduced capital gains rate rather than the marginal tax rates generally
applicable to ordinary income provided that a holding period requirement (more than 60 days of ownership, without protection from the
risk of loss, during the 121-day period beginning 60 days before the ex-dividend date) and certain other requirements are met. Each U.S.
Holder is advised to consult its tax advisors regarding the availability of the reduced tax rate on dividends to its particular circumstances.
However, if we are a PFIC for the taxable year in which the dividend is paid or the preceding taxable year (see discussion above under
&#8220;&#8212; Passive Foreign Investment Company Rules&#8217;&#8217;), we will not be treated as a qualified foreign corporation, and
therefore the reduced capital gains tax rate described above will not apply.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">A non-United States corporation
(other than a corporation that is classified as 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 with respect to any dividend it pays on Common shares that are readily
tradable on an established securities market in the United States.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">The amount of any dividend
income that is paid in Pounds Sterling will be the U.S. dollar amount calculated by reference to the exchange rate in effect on the date
of receipt, regardless of whether the payment is in fact converted into U.S. dollars. If the dividend is converted into U.S. dollars
on the date of receipt (actual or constructive), a U.S. Holder should not be required to recognize foreign currency gain or loss in respect
of the dividend income. A U.S. Holder may have foreign currency gain or loss if the dividend is converted into U.S. dollars after the
date of receipt (actual or constructive).</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>Sale, Exchange or Other Taxable Disposition
of Our </i></b>Common shares</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Subject to the discussion
above under &#8220;&#8212; Passive Foreign Investment Company Rules,&#8221; a U.S. Holder generally will recognize capital gain or loss
for U.S. federal income tax purposes upon the sale, exchange or other disposition of our Common shares in an amount equal to the difference,
if any, between the amount realized (<i>i.e</i>., the amount of cash plus the fair market value of any property received) on the sale,
exchange or other disposition and such U.S. Holder&#8217;s adjusted tax basis in the Common shares. Such capital gain or loss generally
will be long-term capital gain taxable at a reduced rate for non-corporate U.S. Holders or long-term capital loss if, on the date of
sale, exchange or other disposition, the Common shares were held by the U.S. Holder for more than one year. Any capital gain of a non-corporate
U.S. Holder that is not long-term capital gain is taxed at ordinary income rates. The deductibility of capital losses is subject to limitations.
Any gain or loss recognized from the sale or other disposition of our Common shares will generally be gain or loss from sources within
the United States for U.S. foreign tax credit purposes.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>




</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in"></p><div>

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

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Certain U.S. Holders that
are individuals, estates or trusts and whose income exceeds certain thresholds generally are subject to a 3.8% tax on all or a portion
of their net investment income, which may include their gross dividend income and net gains from the disposition of our Common shares.
If you are a U.S. Holder that is an individual, estate or trust, you are encouraged to consult your tax advisors regarding the applicability
of this Medicare tax to your income and gains in respect of your investment in our Common shares.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>Information Reporting and Backup Withholding</i></b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">U.S. Holders may be required
to file certain U.S. information reporting returns with the IRS with respect to an investment in our Common shares, including, among others,
IRS Form 8938 (Statement of Specified Foreign Financial Assets). In addition, each U.S. Holder who is a shareholder of a PFIC must file
an annual report containing certain information. U.S. Holders paying more than $100,000 for our Common shares may be required to file
IRS Form 926 (Return by a U.S. Transferor of Property to a Foreign Corporation) reporting this payment. Substantial penalties and other
adverse circumstances may be imposed upon a U.S. Holder that fails to comply with the required information reporting.</p><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">

</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Dividends on and proceeds
from the sale or other disposition of our Common shares generally have to be reported to the IRS unless the U.S. Holder establishes a
basis for exemption. Backup withholding may apply to amounts subject to reporting if the holder (1) fails to provide an accurate U.S.
taxpayer identification number or otherwise establish a basis for exemption, or (2) is described in certain other categories of persons.
However, U.S. Holders that are corporations generally are excluded from these information reporting and backup withholding tax rules.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Backup withholding is not
an additional tax. Any amounts withheld under the backup withholding rules generally will be allowed as a refund or a credit against
a U.S. Holder&#8217;s U.S. federal income tax liability if the required information is furnished by the U.S. Holder on a timely basis
to the IRS.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">U.S. Holders should consult
their own tax advisors regarding the backup withholding tax and information reporting rules.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><b>EACH PROSPECTIVE INVESTOR
IS URGED TO CONSULT ITS OWN TAX ADVISOR ABOUT THE TAX CONSEQUENCES TO IT OF AN INVESTMENT IN OUR </b>COMMON SHARES <b>IN LIGHT OF THE
INVESTOR&#8217;S OWN CIRCUMSTANCES. IN ADDITION, SIGNIFICANT CHANGES IN U.S. FEDERAL INCOME TAX LAWS WERE RECENTLY ENACTED. PROSPECTIVE
INVESTORS SHOULD ALSO CONSULT WITH THEIR TAX ADVISORS WITH RESPECT TO SUCH CHANGES IN U.S. TAX LAW AS WELL AS POTENTIAL CONFORMING CHANGES
IN STATE TAX LAWS.</b></p><div>

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

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

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Under present Bermuda law,
no Bermuda withholding tax on dividends or other distributions, or any Bermuda tax computed on profits or income or on any capital asset,
gain or appreciation will be payable by us or applicable to our operations, and there is no Bermuda tax in the nature of estate duty
or inheritance tax applicable to our shares, debentures or other obligations held by non-residents of Bermuda.</p><div>

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

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

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">We have obtained an assurance
from the Minister of Finance of Bermuda under the Exempted Undertakings Tax Protection Act 1966 that, in the event that any legislation
is enacted in Bermuda imposing any tax computed on profits or income, or computed on any capital asset, gain or appreciation or any tax
in the nature of estate duty or inheritance tax, such tax shall not, until March 31,2035, be applicable to us or to any of our operations
or to our shares, debentures or other obligations except insofar as such tax applies to persons ordinarily resident in Bermuda or is
payable by us in respect of real property owned or leased by us in Bermuda.</p><div>

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

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

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Shareholders should seek
advice from their tax advisor to determine the taxation to which they may be subject based on the shareholder&#8217;s circumstances.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"></p><div>

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    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
    </div><!-- Field: /Page --><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><b>F. Dividends and Paying Agents</b></p><div>

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

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

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><b>G. Statements by Experts</b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Not applicable</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><b>H. Documents on Display</b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">We are subject to the informational
requirements of the Exchange Act. Accordingly, we are required to file reports and other information with the SEC, including annual reports
on Form 20-F and reports on Form 6-K. You may inspect and copy reports and other information filed with the SEC at the public reference
facilities of the SEC located at 100 F Street, N.E., Washington, D.C. 20549. You may also obtain copies of the documents at prescribed
rates by writing to the Public Reference Section of the SEC at 100 F Street, N.E., Washington, DC 20549. Please call the SEC at 1-800-SEC-0330
for further information on the public reference room. The SEC also maintains a website at http://www.sec.gov from which certain filings
may be accessed.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">We also make available on
our website, free of charge, our Annual Report and the text of our reports on Form 6-K, including any amendments to these reports, as
well as certain other SEC filings, as soon as reasonably practicable after they are electronically filed with or furnished to the SEC.
Our website address is &#8220;www.tizianalifesciences.com.&#8221; The information contained on our website is not incorporated by reference
in this Annual Report.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Members of the general public
have a right to inspect the public documents of a company available at the office of the Registrar of Companies in Bermuda. These documents
include the company&#8217;s memorandum of association, including its objects and powers, and certain alterations to the memorandum of
association. The shareholders have the additional right to inspect the bye-laws of the company, minutes of general meetings and the company&#8217;s
audited financial statements, which must be presented to the annual general meeting. The register of members of a company is also open
to inspection by shareholders and by members of the general public without charge. The register of members is required to be open for
inspection for not less than two hours in any business day (subject to the ability of a company to close the register of members for
not more than thirty days in a year). A company is required to maintain its share register in Bermuda but may, subject to the provisions
of the Companies Act, establish a branch register outside of Bermuda. A company is required to keep at its registered office a register
of directors and officers that is open for inspection for not less than two hours in any business day by members of the public without
charge. A company is also required to file with the Registrar of Companies in Bermuda a list of its directors to be maintained on a register,
which register will be available for public inspection subject to such conditions as the Registrar may impose and on payment of such
fee as may be prescribed. Bermuda law does not, however, provide a general right for shareholders to inspect or obtain copies of any
other corporate records.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><b>I. Subsidiary Information</b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">For information on our subsidiaries,
see &#8220;Item 4C. Organizational Structure.&#8221;</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in"></p><div>

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    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
    </div><!-- Field: /Page --><div>

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

</div><div><a id="a_013"></a></div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><b>ITEM 11: QUANTITATIVE AND QUALITATIVE DISCLOSURES
ABOUT MARKET RISK</b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">We are exposed to market
risks in the ordinary course of our business, which are principally limited to interest rate fluctuations and foreign currency exchange
rate fluctuations. We maintain significant amounts of cash and cash equivalents that are in excess of federally insured limits in various
currencies, placed with one or more financial institutions for varying periods according to expected liquidity requirements.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><i>Interest Rate Risk</i></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Our exposure to interest
rate sensitivity is impacted by changes in the underlying U.S. and U.K. bank interest rates. Our surplus cash and cash equivalents have
been invested in interest-bearing savings and money market accounts from time to time. We have not entered into investments for trading
or speculative purposes. Due to the conservative nature of our investment portfolio, which is predicated on capital preservation of investments
with short-term maturities, we do not believe an immediate one percentage point change in interest rates would have a material effect
on the fair market value of our portfolio, and therefore we do not expect our operating results or cash flows to be significantly affected
by changes in market interest rates.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><i>Foreign Currency Exchange Risk</i></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">We maintain our consolidated
financial statements in the functional currency US Dollar. Monetary assets and liabilities denominated in currencies other than the functional
currency are translated into the functional currency at rates of exchange prevailing at the balance sheet dates. Non-monetary assets
and liabilities denominated in foreign currencies are translated into the functional currency at the exchange rates prevailing at the
date of the transaction. Exchange gains or losses arising from foreign currency transactions are included in the determination of net
income (loss) for the respective periods.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">The currencies of our subsidiaries
are generally their functional currencies, In translating the financial statements of those subsidiaries or branches whose functional
currency is other than the U.S. dollar, assets and liabilities are converted into U.S. dollars using the rates of exchange in effect
at the balance sheet dates, and revenues and expenses are converted using the average foreign exchange rates for the period. Translation
adjustments are not included in determining net income (loss) but are included in foreign exchange adjustment to accumulate other comprehensive
loss, a component of shareholders&#8217; equity.</p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">We do not currently engage
in currency hedging activities in order to reduce our currency exposure, but we may begin to do so in the future. Instruments that may
be used to hedge future risks may include foreign currency forward and swap contracts. These instruments may be used to selectively manage
risks, but there can be no assurance that we will be fully protected against material foreign currency fluctuations.</p><div>

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

</div><div><a id="a_014"></a></div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><b>ITEM 12: DESCRIPTION OF SECURITIES OTHER THAN
EQUITY SECURITIES</b></p><div>

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><b>A. Debt Securities</b></p><div>

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

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

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><b>B. Warrants and Rights</b></p><div>

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

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

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><b>C. Other Securities</b></p><div>

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

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

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><b>D. American Depositary Shares</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; ">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; ">Not
applicable.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p><div>


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    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
    </div><!-- Field: /Page --><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p><div>

</div><div><a id="a_015"></a></div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><b>PART II</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in"><b>&#160;</b></p><div>

</div><div><a id="a_016"></a></div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><b>ITEM 13: DEFAULTS, DIVIDEND ARREARAGES AN DELINQUENCIES</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">None.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in"><b>&#160;</b></p><div>

</div><div><a id="a_017"></a></div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><b>ITEM 14: MATERIAL MODIF</b>IC<b>ATIONS TO THE
RIGHTS OF SECURITY HOLDERS AND USE OF PROCEEDS</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">None.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in"><b>&#160;</b></p><div>

</div><div><a id="a_018"></a></div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><b>ITEM 15: CONTROLS AND PROCEDURES</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in"><b>&#160;</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in"><i>Evaluation of Disclosure Controls and Procedures</i></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><b>Disclosure Controls and Procedures</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&#160;</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">The Company&#8217;s management,
with the participation of the Company&#8217;s Chief Executive Officer and Finance Director, have evaluated the effectiveness of the Company&#8217;s
disclosure controls and procedures (as defined in Rules&#160;13a-15(e) and&#160;15d-15(e) under the Securities Exchange Act of&#160;1934,
as amended (the&#160;&#8220;Exchange Act&#8221;)) as of&#160;December 31, 2022. Based on that evaluation, the Company&#8217;s Chief Executive
Officer and the Company&#8217;s Finance Director have concluded that as of&#160;December 31, 2022, due to the existence of the material
weaknesses in the Company&#8217;s internal control over financial reporting described below, the Company&#8217;s disclosure controls and
procedures were not effective.</p><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">

</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><b>Management&#8217;s Annual Report on Internal Control over Financial
Reporting</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.75in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">The Company&#8217;s management
is responsible for establishing and maintaining adequate internal controls over financial reporting as defined in Rules&#160;13a-15(f)
and&#160;15d-15(f) under the Exchange Act. The Company&#8217;s internal control over financial reporting is a process designed to provide
reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes
in accordance with International Financial Reporting Standards (IFRS) as issued by the International Accounting Standards Board (IASB),
and IFRIC interpretations as applicable to companies reporting under IFRS.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.75in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Because of their inherent
limitations, internal controls over financial reporting may not prevent or detect misstatements. Also, 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.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Under the supervision and
with the participation of management, the Company&#8217;s Chief Executive Officer and the Company&#8217;s Finance Director, the Company
conducted an evaluation of the effectiveness of its internal control over financial over financial reporting based on the framework described
in Internal Control-Integrated Framework issued by the Commission of Sponsoring Organizations of the Treadway Commission, as revised in&#160;2013.
Based on that evaluation, management has concluded that the Company did not maintain effective internal control over financial reporting
as of the period ended&#160;December 31, 2022&#160;due to the existence of the material weaknesses in internal control over financial
reporting described below.</p><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">

</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="text-decoration:underline">Material Weaknesses</span></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">A deficiency in internal
control over financial reporting exists when the design or operation of a control does not allow management or employees, in the normal
course of performing their assigned functions, to prevent or detect misstatements on a timely basis. A material weakness is a deficiency,
or a combination of deficiencies, in internal controls over financial reporting, such that there is a reasonable possibility that a material
misstatement of the Company&#8217;s annual or interim financial statements will not be prevented or detected on a timely basis.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p><div>

</div><!-- Field: Page; Sequence: 119; Value: 1 --><div>
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    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
    </div><!-- Field: /Page --><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Management has determined
that the Company did not maintain effective internal control over financial reporting as of the period ended&#160;December 31, 2022&#160;due
to the existence of the following material weaknesses identified by management. The material weaknesses identified below did not result
in a material misstatement of our consolidated financial statements, and management believes that our consolidated financial statements
present fairly the consolidated financial position, results of operations and cash flows for the periods covered. However, management
recognizes that the failure of the internal control over financial reporting to operate effectively as described below could have resulted
in a material misstatement which may not have been detected by our controls:</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="text-decoration:underline">Control Environment</span></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">The Company did not maintain
an effective control environment. The control environment, which is the responsibility of senior management, sets the tone of the organization,
influences the control consciousness of its people, and is the foundation for all other components of internal control over financial
reporting. Our control environment was ineffective because:</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.5in; text-align: justify">&#160;</td>
    <td style="width: 0.25in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">We did not timely develop
    and communicate an employee handbook for employees to consult in the event an issue arises</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="text-decoration:underline">Remediation efforts</span></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Management intends to remediate
this item in the following manner:</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.5in; text-align: justify">&#160;</td>
    <td style="width: 0.25in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">i.</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Develop and maintain an
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  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">We intend to complete the
remediation of the material weaknesses discussed above as soon as practicable, but we can give no assurance that we will be able to do
so. Designing and implementing effective disclosure controls and procedures is a continuous effort that requires us to anticipate and
react to changes in our business and the economic and regulatory environments and to devote significant resources to maintain a financial
reporting system that adequately satisfies our reporting obligations. The remedial measures that we have taken and intend to take may
not fully address the material weaknesses that we have identified, and material weaknesses in our disclosure controls and procedures
may be identified in the future. Should we discover such conditions, we intend to remediate them as soon as practicable. We are committed
to taking appropriate steps for remediation, as needed.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&#160;</p><div>

</div><div><a id="a_019"></a></div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><b>ITEM 16A: AUDIT COMMITTEE FINANCIAL EXPERT</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">The members of our audit
committee are Mr John Brancaccio and Mr. Willy Simon. Mr. John Brancaccio is the chair of the audit committee. Each of our audit committee
members satisfies the independence requirements of Rule 5605(a)(2) of the Nasdaq Stock Market Marketplace Rules and the independence
requirements of Rule 10A-3(b)(1) under the Exchange Act. Our board of directors has determined that Mr. John Brancaccio is an &#8220;audit
committee financial expert&#8221; as defined in Item 16A of Form 20-F.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in"><b>&#160;</b></p><div>

</div><div><a id="a_020"></a></div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><b>ITEM 16B: CODE OF ETHICS</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Our Code of Business Conduct
and Ethics is applicable to all of our employees, officers and directors and is available on our website at https://www.tizianalifesciences.com.
Our Code of Business Conduct and Ethics provides that our directors and officers are expected to avoid any action, position or interest
that conflicts with the interests of our company or gives the appearance of a conflict. Our directors and officers have an obligation
under our Code of Business Conduct and Ethics to advance our company&#8217;s interests when the opportunity to do so arises. We expect
that any amendment to this code, or any waivers of its requirements, will be disclosed on our website. Information contained on, or that
can be accessed through, our website is not incorporated by reference into this Annual Report, and you should not consider information
on our website to be part of this Annual Report.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in"><b>&#160;</b></p><div>

</div><div><a id="a_021"></a></div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><b>ITEM 16C: PRINCIPAL ACCOUNTANT FEES AND SERVICES</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in"><b>&#160;</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">The following table sets
forth, for each of the years indicated, the aggregate fees billed to us for services rendered by PKF and Mazars, our independent registered
public accounting firm.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="border-collapse: collapse; width: 100%; font: 10pt Times New Roman, Times, Serif">
  <tr style="vertical-align: bottom">
    <td>&#160;</td><td style="font-weight: bold; padding-bottom: 1.5pt">&#160;</td>
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  <tr style="vertical-align: bottom">
    <td>&#160;</td><td style="font-weight: bold; padding-bottom: 1.5pt">&#160;</td>
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  <tr style="vertical-align: bottom">
    <td>&#160;</td><td>&#160;</td>
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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  <tr style="vertical-align: bottom; ">
    <td style="text-align: left; padding-bottom: 1.5pt">Other assurance services</td><td style="padding-bottom: 1.5pt">&#160;</td>
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    <td style="border-bottom: Black 1.5pt solid; text-align: left">&#160;</td><td style="border-bottom: Black 1.5pt solid; text-align: right">32</td><td style="padding-bottom: 1.5pt; text-align: left">&#160;</td></tr>
  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <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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    <td style="font-weight: bold; padding-bottom: 4pt">Total</td><td style="font-weight: bold; padding-bottom: 4pt">&#160;</td>
    <td style="border-bottom: Black 4pt double; font-weight: bold; text-align: left">&#160;</td><td style="border-bottom: Black 4pt double; font-weight: bold; text-align: right">325</td><td style="padding-bottom: 4pt; font-weight: bold; text-align: left">&#160;</td><td style="font-weight: bold; padding-bottom: 4pt">&#160;</td>
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  </table><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&#160;</p><div>


</div><!-- Field: Page; Sequence: 120; Value: 1 --><div>
    </div><div style="margin-top: 12pt; margin-bottom: 6pt; border-bottom: Black 1.5pt solid"><p style="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><!-- Field: Sequence; Type: Arabic; Name: PageNo -->115<!-- Field: /Sequence --></p></div><div>
    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
    </div><!-- Field: /Page --><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&#160;</p><div>

</div><div><a id="a_022"></a></div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><b>ITEM 16D: EXEMPTIONS FROM THE LISTING STANDARDS
FOR AUDIT COMMITTEES</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">Not applicable.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in"><b>&#160;</b></p><div>

</div><div><a id="a_023"></a></div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><b>ITEM 16E: PURCHASES OF EQUITY SECURITIES BY
THE ISSUER AND AFFILIATED PURCHASERS</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">During the year ended December 31, 2022, we purchased
1,683,544 of our common shares at an average price of $0.78 (excluding fees).</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in"><b>&#160;</b></p><div>

</div><div><a id="a_024"></a></div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><b>ITEM 16F: CHANGE IN REGISTRANTS CERTIFYING
ACCOUNTANT</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">None.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&#160;</p><div>

</div><div><a id="a_025"></a></div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><b>ITEM 16G: CORPORATE GOVERNANCE</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">The Sarbanes-Oxley Act of
2002, as well as related rules subsequently implemented by the SEC, requires foreign private issuers, including our company, to comply
with various corporate governance practices. In addition, Nasdaq rules provide that foreign private issuers may follow home country practice
in lieu of the Nasdaq corporate governance standards, subject to certain exceptions and except to the extent that such exemptions would
be contrary to U.S. federal securities laws. The home country practices followed by our company in lieu of Nasdaq rules are described
below:</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.5in">&#160;</td>
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">We do not follow Nasdaq&#8217;s
    quorum requirements applicable to meetings of shareholders. Such quorum requirements are not required under Bermuda law. In accordance
    with generally accepted business practice, our Bye-laws provide alternative quorum requirements that are generally applicable to
    meetings of shareholders.</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.5in">&#160;</td>
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">We do not follow Nasdaq&#8217;s
    requirements that non-management directors meet on a regular basis without management present. Our board of directors may choose
    to meet in executive session at their discretion.</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 0.5in">&#160;</td>
    <td style="width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">We do not follow Nasdaq&#8217;s
    requirements to seek shareholder approval for the implementation of certain equity compensation plans, the issuances of ordinary
    shares under such plans, or in connection with certain private placements of equity securities. In accordance with Bermuda &#160;law,
    we are not required to seek shareholder approval to allot ordinary shares in connection with applicable employee equity compensation
    plans. We will follow Bermuda. law with respect to any requirement to obtain shareholder approval prior to any private placements
    of equity securities.</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">We intend to take all actions
necessary for us to maintain compliance as a foreign private issuer under the applicable corporate governance requirements of the Sarbanes-Oxley
Act of 2002, the rules adopted by the SEC and Nasdaq&#8217;s listing standards.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Because we are a foreign
private issuer, our directors and senior management are not subject to short-swing profit and insider trading reporting obligations under
Section 16 of the U.S. Securities Exchange Act of 1934, as amended, or Exchange Act. They are, however, subject to the obligations to
report changes in share ownership under Section 13 of the Exchange Act and related SEC rules.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&#160;</p><div>

</div><div><a id="a_026"></a></div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><b>ITEM 16H: MINE SAFETY DISCLOSURE</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">Not applicable.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&#160;</p><div>

</div><div><a id="a_027"></a></div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><b>ITEM 16I: DISCLOSURE REGARDING FOREIGN JURISDICTIONS
THAT PREVENT INSPECTIONS</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">Not applicable.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&#160;</p><div>


</div><!-- Field: Page; Sequence: 121; Value: 1 --><div>
    </div><div style="margin-top: 12pt; margin-bottom: 6pt; border-bottom: Black 1.5pt solid"><p style="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><!-- Field: Sequence; Type: Arabic; Name: PageNo -->116<!-- Field: /Sequence --></p></div><div>
    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
    </div><!-- Field: /Page --><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&#160;</p><div>

</div><div><a id="a_028"></a></div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><b>PART III</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in"><b>&#160;</b></p><div>

</div><div><a id="a_029"></a></div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><b>ITEM 17: FINANCIAL STATEMENTS</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">We have elected to furnish financial statements
and related information specified in Item 18.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in"><b>&#160;</b></p><div>

</div><div><a id="a_030"></a></div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><b>ITEM 18: FINANCIAL STATEMENTS</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">See the Financial Statements beginning on page
F-1.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&#160;</p><div>

</div><div><a id="a_031"></a></div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><b>ITEM 19: EXHIBITS</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in"><b>&#160;</b></p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="vertical-align: top">
    <td style="border-bottom: black 1.5pt solid; width: 9%"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Exhibit
    No.</span></td>
    <td style="width: 1%">&#160;</td>
    <td style="border-bottom: black 1.5pt solid; width: 90%; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Description</span></td></tr>
  <tr style="vertical-align: top">
    <td>&#160;</td>
    <td>&#160;</td>
    <td style="text-align: justify">&#160;</td></tr>
  <tr style="vertical-align: top; background-color: rgb(204,238,255)">
    <td>2.1</td>
    <td>&#160;</td>
    <td style="text-align: justify"><a href="http://www.sec.gov/Archives/edgar/data/1723069/000121390021053952/ea149115-8k12b_tizianalife.htm">Description of registrant&#8217;s securities (incorporated by reference to Form 8-K filed on October 21, 2021).</a></td></tr>
  <tr style="vertical-align: top; ">
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">3.2</span></td>
    <td>&#160;</td>
    <td style="text-align: justify"><a href="http://www.sec.gov/Archives/edgar/data/1723069/000121390021053952/ea149115ex3-1_tizianalife.htm"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Memorandum
    of Association of Tiziana Life Sciences Ltd, adopted as of October 20, 2021 (incorporated by reference to Exhibit 3.1 to Form 8-K12B
    filed on October 21, 2021).</span></a></td></tr>
  <tr style="vertical-align: top; background-color: rgb(204,238,255)">
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">3.3</span></td>
    <td>&#160;</td>
    <td style="text-align: justify"><a href="http://www.sec.gov/Archives/edgar/data/1723069/000121390021053952/ea149115ex3-2_tizianalife.htm"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Amended
    and restated bye-laws of Tiziana Life Sciences Ltd, adopted as of October 20, 2021 (incorporated by reference to Exhibit 3.2 to Form
    8-K12B filed on October 21, 2021).</span></a></td></tr>
  <tr style="vertical-align: top; ">
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">4.1</span></td>
    <td>&#160;</td>
    <td style="text-align: justify"><a href="http://www.sec.gov/Archives/edgar/data/1723069/000121390018011631/ff12018a1ex10-1_tiziana.htm"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">License
    Agreement relating to Milciclib between Nerviano Medical Services S.r.l. and Tiziana Life Sciences PLC, dated January 2015
    (incorporated by reference to Exhibit 10.1 to Amendment No. 1 to Form F-1 filed on August 23, 2018).</span></a></td></tr>
  <tr style="vertical-align: top; background-color: rgb(204,238,255)">
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">4.2</span></td>
    <td>&#160;</td>
    <td style="text-align: justify"><a href="http://www.sec.gov/Archives/edgar/data/1723069/000121390018011631/ff12018a1ex10-2_tiziana.htm"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">License
    and Sublicence Agreement relating to CD3 (NI-0401) between Novimmune SA and Tiziana Life Sciences PLC, dated December 2014. incorporated
    by reference to Exhibit 10.2 to Amendment No. 1 to Form F-1 filed on August 23, 2018).</span></a></td></tr>
  <tr style="vertical-align: top; ">
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">4.3</span></td>
    <td>&#160;</td>
    <td style="text-align: justify"><a href="http://www.sec.gov/Archives/edgar/data/1723069/000121390018011631/ff12018a1ex10-3_tiziana.htm"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">License
    and Sublicence Agreement relating to IL-6r (NI-1201) between Novimmune SA and Tiziana Life Sciences PLC, dated December 2016. (incorporated
    by reference to Exhibit 10.3 to Amendment No. 1 to Form F-1 filed on August 23, 2018).</span></a></td></tr>
  <tr style="vertical-align: top; background-color: rgb(204,238,255)">
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">4.4</span></td>
    <td>&#160;</td>
    <td style="text-align: justify"><a href="http://www.sec.gov/Archives/edgar/data/1723069/000121390018011631/ff12018a1ex10-4_tiziana.htm"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">License
    Agreement relating to a novel formulation of Foralumab in a medical device for nasal administration between The Brigham and Women&#8217;s
    Hospital, Inc. and Tiziana Life Sciences plc, dated April 2018. (incorporated by reference to Exhibit 10.4 to Amendment No. 1 to
    Form F-1 filed on August 23, 2018).</span></a></td></tr>
  <tr style="vertical-align: top; ">
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">4.5*</span></td>
    <td>&#160;</td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><a href="f20f2022ex4-5_tizianalife.htm">Annual Lease for 14-15 Conduit Street, London W1S 2XJ United Kingdom</a></span></td></tr>
  <tr style="vertical-align: top; background-color: rgb(204,238,255)">
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">4.7*</span></td>
    <td>&#160;</td>
    <td style="text-align: justify"><p style="margin: 0pt 0"> <a href="f20f2022ex4-7_tizianalife.htm">Lease agreement for 601 New Britain Road, Suite 102, Doylestown Old Easton Road, Doylestown, Pennsylvania, 18901, United States, dated August 29, 2022.</a></p></td></tr>
  <tr style="vertical-align: top; ">
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">4.8</span></td>
    <td>&#160;</td>
    <td style="text-align: justify"><a href="http://www.sec.gov/Archives/edgar/data/1723069/000121390019005736/f20f2018ex4-7_tizianalife.htm"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Tiziana
    Life Sciences plc Employee Share Option Plan, with Non-Employee Sub-Plan and US Sub-Plan, adopted by the Board on 23 March 2016 and
    approved by shareholders on June 30, 2016. (Incorporated by reference to Exhibit 4.7 to Form 20-F filed on April 4, 2019).</span></a></td></tr>
  <tr style="vertical-align: top; background-color: rgb(204,238,255)">
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">4.9</span></td>
    <td>&#160;</td>
    <td style="text-align: justify"><p style="margin: 0pt 0; font: 10pt Times New Roman, Times, Serif"><a href="http://www.sec.gov/Archives/edgar/data/1723069/000121390019014612/ff12019ex10-9_tiziana.htm">Amended and Restated Service Agreement dated July 11, 2019, between the Registrant and Dr. Kunwar Shailubhai (incorporated by reference to Exhibit 10.9 to Amendment No. 2 to Form F-1 filed on September 20, 2019)</a></p></td></tr>
  <tr style="vertical-align: top; ">
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">4.10</span></td>
    <td>&#160;</td>
    <td style="text-align: justify"><a href="http://www.sec.gov/Archives/edgar/data/1723069/000121390018011631/ff12018a1ex10-10_tiziana.htm"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Form
    of Deed of Indemnity for board members. (Incorporated by reference to Exhibit 10.10 to Amendment No. 1 to Form F-1 filed on August
    23, 2018).</span></a></td></tr>
  <tr style="vertical-align: top; background-color: rgb(204,238,255)">
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">4.12</span></td>
    <td>&#160;</td>
    <td style="text-align: justify"><a href="http://www.sec.gov/Archives/edgar/data/1723069/000121390021053952/ea149115ex10-3_tizianalife.htm"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Tiziana
    Life Sciences Ltd 2021 Equity Incentive Plan (incorporated by reference to Exhibit 10.3 to Form 8-K12B filed on October 21, 2021).</span></a></td></tr>
  <tr style="vertical-align: top; ">
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">8.1</span></td>
    <td>&#160;</td>
    <td style="text-align: justify"><p style="margin: 0pt 0; font: 10pt Times New Roman, Times, Serif"><a href="http://www.sec.gov/Archives/edgar/data/1723069/000121390022028645/f20f2021ex8-1_tizianalife.htm">List of Subsidiaries. (Incorporated by reference to Exhibit 8.1 to Form 20-F filed on May 23, 2022).</a></p></td></tr>
  <tr style="vertical-align: top; background-color: rgb(204,238,255)">
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">12.1*</span></td>
    <td>&#160;</td>
    <td style="text-align: justify"><a href="f20f2022ex12-1_tizianalife.htm"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Certification by the Principal Executive Officer pursuant to Securities Exchange Act Rules 13a-14(a) and 15d-14(a) as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.</span></a></td></tr>
  <tr style="vertical-align: top; ">
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">12.2*</span></td>
    <td>&#160;</td>
    <td style="text-align: justify"><a href="f20f2022ex12-2_tizianalife.htm"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Certification by the Principal Financial Officer pursuant to Securities Exchange Act Rules 13a-14(a) and 15d-14(a) as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.</span></a></td></tr>
  <tr style="vertical-align: top; background-color: rgb(204,238,255)">
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">13.1*</span></td>
    <td>&#160;</td>
    <td style="text-align: justify"><a href="f20f2022ex13-1_tizianalife.htm"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Certification by the Principal Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.</span></a></td></tr>
  <tr style="vertical-align: top; ">
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">13.2*</span></td>
    <td>&#160;</td>
    <td style="text-align: justify"><a href="f20f2022ex13-2_tizianalife.htm"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Certification by the Principal Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.</span></a></td></tr>
  <tr style="vertical-align: top; background-color: rgb(204,238,255)">
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">15.1</span></td>
    <td>&#160;</td>
    <td style="text-align: justify"><p style="margin: 0pt 0; font: 10pt Times New Roman, Times, Serif"><a href="http://www.sec.gov/Archives/edgar/data/1723069/000121390022028645/f20f2021ex15-1_tizianalife.htm">Consent of Mazars LLP (Incorporated by reference to Exhibit 15.1 to Form 20-F filed on May 23, 2022).</a></p></td></tr>
  <tr style="vertical-align: top; ">
    <td><p style="margin: 0pt 0; font: 10pt Times New Roman, Times, Serif">15.2*</p></td>
    <td>&#160;</td>
    <td style="text-align: justify"><p style="margin: 0pt 0; font: 10pt Times New Roman, Times, Serif"><a href="f20f2022ex15-2_tizianalife.htm">Consent of PKF Littlejohn.</a></p></td></tr>
  <tr style="vertical-align: top; background-color: rgb(204,238,255)">
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">101.INS</span></td>
    <td>&#160;</td>
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  <tr style="vertical-align: top; ">
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    <td>&#160;</td>
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Inline XBRL Taxonomy Extension Schema Document.</span></td></tr>
  <tr style="vertical-align: top; background-color: rgb(204,238,255)">
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">101.CAL</span></td>
    <td>&#160;</td>
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Inline XBRL Taxonomy Extension Calculation Linkbase
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  <tr style="vertical-align: top; ">
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    <td>&#160;</td>
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Inline XBRL Taxonomy Extension Definition Linkbase
    Document.</span></td></tr>
  <tr style="vertical-align: top; background-color: rgb(204,238,255)">
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">101.LAB</span></td>
    <td>&#160;</td>
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Inline XBRL Taxonomy Extension Label Linkbase Document.</span></td></tr>
  <tr style="vertical-align: top; ">
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    <td>&#160;</td>
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Inline XBRL Taxonomy Extension Presentation Linkbase
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  <tr style="vertical-align: top; background-color: rgb(204,238,255)">
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    <td>&#160;</td>
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Cover Page Interactive Data File (formatted as Inline
    XBRL and contained in Exhibit 101).</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in"><b>&#160;</b></p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="vertical-align: top">
    <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">*</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Filed Herewith</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&#160;</p><div>


</div><!-- Field: Page; Sequence: 122; Value: 1 --><div>
    </div><div style="margin-top: 12pt; margin-bottom: 6pt; border-bottom: Black 1.5pt solid"><p style="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><!-- Field: Sequence; Type: Arabic; Name: PageNo -->117<!-- Field: /Sequence --></p></div><div>
    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
    </div><!-- Field: /Page --><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><b>SIGNATURES</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in"><b>&#160;</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">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
registration statement on its behalf.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="vertical-align: top">
    <td>&#160;</td>
    <td colspan="2"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt; font-variant: small-caps"><b>Tiziana Life
Sciences Ltd</b></span><b> </b></td></tr>
  <tr style="vertical-align: top">
    <td style="width: 60%">&#160;</td>
    <td style="width: 4%">&#160;</td>
    <td style="width: 36%">&#160;</td></tr>
  <tr style="vertical-align: top">
    <td>&#160;</td>
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">By:&#160;</span></td>
    <td style="border-bottom: black 1.5pt solid"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">/s/ Gabriele
    Cerrone&#160;</span></td></tr>
  <tr style="vertical-align: top">
    <td>&#160;</td>
    <td>&#160;</td>
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Gabriele Cerrone</span></td></tr>
  <tr style="vertical-align: top">
    <td>&#160;</td>
    <td>&#160;</td>
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><i>Acting Chief Executive Officer</i></span></td></tr>
  <tr style="vertical-align: top">
    <td>&#160;</td>
    <td>&#160;</td>
    <td>&#160;</td></tr>
  <tr style="vertical-align: top">
    <td>&#160;</td>
    <td>&#160;</td>
    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Date: April 26, 2023</span></td></tr>
  </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&#160;</p><div>


</div><!-- Field: Page; Sequence: 123; Value: 1 --><div>
    </div><div style="margin-top: 12pt; margin-bottom: 6pt; border-bottom: Black 1.5pt solid"><p style="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><!-- Field: Sequence; Type: Arabic; Name: PageNo -->118<!-- Field: /Sequence --></p></div><div>
    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
    </div><!-- Field: /Page --><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">INDEX TO CONSOLIDATED FINANCIAL STATEMENTS</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><b>TIZIANA LIFE SCIENCES LTD</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse"> <tr style="vertical-align: top; background-color: #CCEEFF"> <td style="width: 90%; padding-left: 9pt; text-indent: -9pt"><a href="#f_001"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Report of Independent Registered Public Accounting Firm (PKF Littlejohn, London, United Kingdom, PCAOB ID <ix:nonNumeric contextRef="c0" name="dei:AuditorFirmId">2814</ix:nonNumeric>)</span></a></td> <td style="width: 1%">&#160;</td> <td style="vertical-align: bottom; width: 9%; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">F-2</span></td></tr> <tr style="vertical-align: top; "> <td style="padding-left: 9pt; text-indent: -9pt"><a href="#f_002"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Consolidated Balance Sheets</span></a></td> <td>&#160;</td> <td style="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="vertical-align: top; background-color: #CCEEFF"> <td style="padding-left: 9pt; text-indent: -9pt"><a href="#f_003"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Consolidated Statements of Operations and Comprehensive Loss</span></a></td> <td>&#160;</td> <td style="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="vertical-align: top; "> <td style="padding-left: 9pt; text-indent: -9pt"><a href="#f_004"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Consolidated Statements of Shareholders&#8217; Equity</span></a></td> <td>&#160;</td> <td style="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="vertical-align: top; background-color: #CCEEFF"> <td style="padding-left: 9pt; text-indent: -9pt"><a href="#f_005"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Consolidated Statements of Cash Flows</span></a></td> <td>&#160;</td> <td style="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="vertical-align: top; "> <td style="padding-left: 9pt; text-indent: -9pt"><a href="#f_006"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Notes to Consolidated Financial Statements</span></a></td> <td>&#160;</td> <td style="vertical-align: bottom; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">F-7</span></td></tr> </table><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><i>Consolidated Financial Statements and Notes
to Financial Statements to be provided under separate cover.</i></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&#160;</p><div>


</div><!-- Field: Page; Sequence: 124; Options: NewSection; Value: 1 --><div>
    </div><div style="margin-top: 12pt; margin-bottom: 6pt; border-bottom: Black 1.5pt solid"><p style="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt">F-<!-- Field: Sequence; Type: Arabic; Name: PageNo -->1<!-- Field: /Sequence --></p></div><div>
    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
    </div><!-- Field: /Page --><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&#160;</p><div>

</div><div><a id="f_001"></a></div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><i>REPORT OF INDEPENDENT REGISTERED
PUBLIC ACCOUNTING FIRM</i></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><i>Opinion on the Consolidated Financial Statements</i></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><i>&#160;</i></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">We have audited the accompanying Consolidated
Statements of financial position of Tiziana Life Sciences Limited its subsidiaries (the &#8220;Group&#8221;) as of December 31, 2022 and
the related Consolidated Statements of comprehensive income, Consolidated Statements of cash flow and Consolidated Statements of changes
in equity for the year ended December 31, 2022 and the related notes (collectively referred to as the &#8220;consolidated financial statements&#8221;).
In our opinion, the consolidated financial statements referred to above present fairly, in all material respects, the financial position
of the Group as of December 31, 2022and the results of its operations and its cash flows for the year ended December 31, 2022 in conformity
with International Financial Reporting Standards as issued by the International Accounting Standards Board.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Basis for opinion</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">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.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">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. The Company is not required to have, nor were we
engaged to perform, an audit of its internal control over financial reporting. As part of our audits, we are required to obtain an understanding
of internal control over financial reporting, but not for the purpose of expressing an opinion on the effectiveness of the Company&#8217;s
internal control over financial reporting. Accordingly, we express no such opinion.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">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.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><ix:nonNumeric contextRef="c0" name="dei:AuditorName">PKF Littlejohn LLP</ix:nonNumeric></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">We have served as the Group&#8217;s auditor since 2022.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><ix:nonNumeric contextRef="c0" name="dei:AuditorLocation">London, England</ix:nonNumeric></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p><div>

</div><p style="margin: 0pt 0; font: 10pt Times New Roman, Times, Serif">April 26, 2023</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></p><div>

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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"></p><div>

</div><div><a id="f_002"></a></div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><i>TIZIANA LIFE SCIENCES LTD</i></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><b>Consolidated Balance Sheets</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">(In thousands)</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&#160;</p><div>


</div><table cellpadding="0" cellspacing="0" style="border-collapse: collapse; width: 100%; font: 10pt Times New Roman, Times, Serif">
  <tr style="vertical-align: bottom">
    <td>&#160;</td><td style="padding-bottom: 1.5pt">&#160;</td>
    <td>&#160;</td><td style="padding-bottom: 1.5pt">&#160;</td><td style="font-weight: bold; padding-bottom: 1.5pt">&#160;</td>
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    <td>&#160;</td><td style="padding-bottom: 1.5pt">&#160;</td>
    <td>&#160;</td><td style="padding-bottom: 1.5pt">&#160;</td><td style="font-weight: bold; padding-bottom: 1.5pt">&#160;</td>
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  <tr style="vertical-align: bottom">
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    <td>&#160;</td><td>&#160;</td><td>&#160;</td>
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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  <tr style="vertical-align: bottom; ">
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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  <tr style="vertical-align: bottom; ">
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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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">&#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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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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    <td style="text-align: center">18</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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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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  <tr style="vertical-align: bottom; ">
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&#160;&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">The accompanying notes are an integral part of
these consolidated financial statements.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&#160;</p><div>


</div><!-- Field: Page; Sequence: 126; Value: 1 --><div>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&#160;</p><div>

</div><div><a id="f_003"></a></div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><i>TIZIANA LIFE SCIENCES LTD</i></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><b>Consolidated Statements of Operations and Comprehensive
Loss</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">(In thousands, except loss per share)</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="border-collapse: collapse; width: 100%; font: 10pt Times New Roman, Times, Serif">
  <tr style="vertical-align: bottom">
    <td style="text-align: center">&#160;</td><td style="padding-bottom: 1.5pt">&#160;</td>
    <td style="text-align: center">&#160;</td><td style="padding-bottom: 1.5pt">&#160;</td><td style="font-weight: bold; padding-bottom: 1.5pt">&#160;</td>
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="text-align: left; padding-bottom: 1.5pt">Gain from disposal of intellectual property</td><td style="padding-bottom: 1.5pt">&#160;</td>
    <td style="padding-bottom: 1.5pt; text-align: center">&#160;</td><td style="padding-bottom: 1.5pt; text-align: left">&#160;</td><td style="padding-bottom: 1.5pt">&#160;</td>
    <td style="border-bottom: Black 1.5pt solid; text-align: left">&#160;</td><td style="border-bottom: Black 1.5pt solid; text-align: right"><div style="-sec-ix-hidden: hidden-fact-5">-</div></td><td style="padding-bottom: 1.5pt; text-align: left">&#160;</td><td style="padding-bottom: 1.5pt">&#160;</td>
    <td style="border-bottom: Black 1.5pt solid; text-align: left">&#160;</td><td style="border-bottom: Black 1.5pt solid; text-align: right"><div style="-sec-ix-hidden: hidden-fact-6">-</div></td><td style="padding-bottom: 1.5pt; text-align: left">&#160;</td><td style="padding-bottom: 1.5pt">&#160;</td>
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  <tr style="vertical-align: bottom; ">
    <td style="text-align: left; padding-left: 9pt">Total operating expenses</td><td>&#160;</td>
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td>&#160;</td><td>&#160;</td>
    <td style="text-align: center">&#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></tr>
  <tr style="vertical-align: bottom; ">
    <td style="text-align: left">Loss from operations</td><td>&#160;</td>
    <td style="text-align: center">&#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)">
    <td>&#160;</td><td>&#160;</td>
    <td style="text-align: center">&#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></tr>
  <tr style="vertical-align: bottom; ">
    <td style="text-align: left">Other income/(expense):</td><td>&#160;</td>
    <td style="text-align: center">&#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></tr>
  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="text-align: left">Finance Income/(expense)</td><td>&#160;</td>
    <td style="text-align: center">9</td><td style="text-align: left">&#160;</td><td>&#160;</td>
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  <tr style="vertical-align: bottom; ">
    <td style="text-align: left; padding-bottom: 1.5pt">Other income/(losses)</td><td style="padding-bottom: 1.5pt">&#160;</td>
    <td style="padding-bottom: 1.5pt; text-align: center">4</td><td style="padding-bottom: 1.5pt; text-align: left">&#160;</td><td style="padding-bottom: 1.5pt">&#160;</td>
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    <td style="border-bottom: Black 1.5pt solid; text-align: left">&#160;</td><td style="border-bottom: Black 1.5pt solid; text-align: right"><ix:nonFraction contextRef="c4" decimals="-3" format="ixt:num-dot-decimal" name="tlsa:OtherIncomelosses" scale="3" unitRef="usd">893</ix:nonFraction></td><td style="padding-bottom: 1.5pt; text-align: left">&#160;</td><td style="padding-bottom: 1.5pt">&#160;</td>
    <td style="border-bottom: Black 1.5pt solid; text-align: left">&#160;</td><td style="border-bottom: Black 1.5pt solid; text-align: right">-</td><td style="padding-bottom: 1.5pt; text-align: left">&#160;</td></tr>
  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="text-align: left">Total other income/(expense)</td><td>&#160;</td>
    <td style="text-align: center">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
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  <tr style="vertical-align: bottom; ">
    <td>&#160;</td><td>&#160;</td>
    <td style="text-align: center">&#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></tr>
  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="text-align: left; padding-bottom: 4pt">Loss from operations before income taxes</td><td style="padding-bottom: 4pt">&#160;</td>
    <td style="padding-bottom: 4pt; text-align: center">&#160;</td><td style="padding-bottom: 4pt; text-align: left">&#160;</td><td style="padding-bottom: 4pt">&#160;</td>
    <td style="border-bottom: Black 4pt double; text-align: left">&#160;</td><td style="border-bottom: Black 4pt double; text-align: right">(<ix:nonFraction contextRef="c0" decimals="-3" format="ixt:num-dot-decimal" name="ifrs-full:ProfitLossBeforeTax" scale="3" sign="-" unitRef="usd">15,397</ix:nonFraction></td><td style="padding-bottom: 4pt; text-align: left">)</td><td style="padding-bottom: 4pt">&#160;</td>
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  <tr style="vertical-align: bottom; ">
    <td>&#160;</td><td>&#160;</td>
    <td style="text-align: center">&#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></tr>
  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="text-align: left; padding-bottom: 1.5pt">Income tax credit</td><td style="padding-bottom: 1.5pt">&#160;</td>
    <td style="padding-bottom: 1.5pt; text-align: center">&#160;</td><td style="padding-bottom: 1.5pt; text-align: left">&#160;</td><td style="padding-bottom: 1.5pt">&#160;</td>
    <td style="border-bottom: Black 1.5pt solid; text-align: left">&#160;</td><td style="border-bottom: Black 1.5pt solid; text-align: right"><div style="-sec-ix-hidden: hidden-fact-7">-</div></td><td style="padding-bottom: 1.5pt; text-align: left">&#160;</td><td style="padding-bottom: 1.5pt">&#160;</td>
    <td style="border-bottom: Black 1.5pt solid; text-align: left">&#160;</td><td style="border-bottom: Black 1.5pt solid; text-align: right"><ix:nonFraction contextRef="c4" decimals="-3" format="ixt:num-dot-decimal" name="tlsa:IncomeTaxSCredit" scale="3" sign="-" unitRef="usd">3,240</ix:nonFraction></td><td style="padding-bottom: 1.5pt; text-align: left">&#160;</td><td style="padding-bottom: 1.5pt">&#160;</td>
    <td style="border-bottom: Black 1.5pt solid; text-align: left">&#160;</td><td style="border-bottom: Black 1.5pt solid; text-align: right"><ix:nonFraction contextRef="c5" decimals="-3" format="ixt:num-dot-decimal" name="tlsa:IncomeTaxSCredit" scale="3" sign="-" unitRef="usd">2,207</ix:nonFraction></td><td style="padding-bottom: 1.5pt; text-align: left">&#160;</td></tr>
  <tr style="vertical-align: bottom; ">
    <td>&#160;</td><td>&#160;</td>
    <td style="text-align: center">&#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></tr>
  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="text-align: left; padding-bottom: 4pt">Loss for the year</td><td style="padding-bottom: 4pt">&#160;</td>
    <td style="padding-bottom: 4pt; text-align: center">&#160;</td><td style="padding-bottom: 4pt; text-align: left">&#160;</td><td style="padding-bottom: 4pt">&#160;</td>
    <td style="border-bottom: Black 4pt double; text-align: left">&#160;</td><td style="border-bottom: Black 4pt double; text-align: right">(<ix:nonFraction contextRef="c0" decimals="-3" format="ixt:num-dot-decimal" name="ifrs-full:ProfitLoss" scale="3" sign="-" unitRef="usd">15,397</ix:nonFraction></td><td style="padding-bottom: 4pt; text-align: left">)</td><td style="padding-bottom: 4pt">&#160;</td>
    <td style="border-bottom: Black 4pt double; text-align: left">&#160;</td><td style="border-bottom: Black 4pt double; text-align: right">(<ix:nonFraction contextRef="c4" decimals="-3" format="ixt:num-dot-decimal" name="ifrs-full:ProfitLoss" scale="3" sign="-" unitRef="usd">23,417</ix:nonFraction></td><td style="padding-bottom: 4pt; text-align: left">)</td><td style="padding-bottom: 4pt">&#160;</td>
    <td style="border-bottom: Black 4pt double; text-align: left">&#160;</td><td style="border-bottom: Black 4pt double; text-align: right">(<ix:nonFraction contextRef="c5" decimals="-3" format="ixt:num-dot-decimal" name="ifrs-full:ProfitLoss" scale="3" sign="-" unitRef="usd">26,131</ix:nonFraction></td><td style="padding-bottom: 4pt; text-align: left">)</td></tr>
  <tr style="vertical-align: bottom; ">
    <td>&#160;</td><td>&#160;</td>
    <td style="text-align: center">&#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></tr>
  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="text-align: left">Other Comprehensive loss:</td><td>&#160;</td>
    <td style="text-align: center">&#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></tr>
  <tr style="vertical-align: bottom; ">
    <td style="text-align: left; padding-bottom: 1.5pt">Gain/(Loss) on currency translation</td><td style="padding-bottom: 1.5pt">&#160;</td>
    <td style="padding-bottom: 1.5pt; text-align: center">&#160;</td><td style="padding-bottom: 1.5pt; text-align: left">&#160;</td><td style="padding-bottom: 1.5pt">&#160;</td>
    <td style="border-bottom: Black 1.5pt solid; text-align: left">&#160;</td><td style="border-bottom: Black 1.5pt solid; text-align: right">(<ix:nonFraction contextRef="c0" decimals="-3" format="ixt:num-dot-decimal" name="ifrs-full:OtherComprehensiveIncomeNetOfTaxExchangeDifferencesOnTranslation" scale="3" sign="-" unitRef="usd">3,582</ix:nonFraction></td><td style="padding-bottom: 1.5pt; text-align: left">)</td><td style="padding-bottom: 1.5pt">&#160;</td>
    <td style="border-bottom: Black 1.5pt solid; text-align: left">&#160;</td><td style="border-bottom: Black 1.5pt solid; text-align: right">(<ix:nonFraction contextRef="c4" decimals="-3" format="ixt:num-dot-decimal" name="ifrs-full:OtherComprehensiveIncomeNetOfTaxExchangeDifferencesOnTranslation" scale="3" sign="-" unitRef="usd">4,478</ix:nonFraction></td><td style="padding-bottom: 1.5pt; text-align: left">)</td><td style="padding-bottom: 1.5pt">&#160;</td>
    <td style="border-bottom: Black 1.5pt solid; text-align: left">&#160;</td><td style="border-bottom: Black 1.5pt solid; text-align: right"><ix:nonFraction contextRef="c5" decimals="-3" format="ixt:num-dot-decimal" name="ifrs-full:OtherComprehensiveIncomeNetOfTaxExchangeDifferencesOnTranslation" scale="3" unitRef="usd">3,474</ix:nonFraction></td><td style="padding-bottom: 1.5pt; text-align: left">&#160;</td></tr>
  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td>&#160;</td><td>&#160;</td>
    <td style="text-align: center">&#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></tr>
  <tr style="vertical-align: bottom; ">
    <td style="text-align: left; padding-bottom: 4pt">Comprehensive loss</td><td style="padding-bottom: 4pt">&#160;</td>
    <td style="padding-bottom: 4pt; text-align: center">&#160;</td><td style="padding-bottom: 4pt; text-align: left">&#160;</td><td style="padding-bottom: 4pt">&#160;</td>
    <td style="border-bottom: Black 4pt double; text-align: left">&#160;</td><td style="border-bottom: Black 4pt double; text-align: right">(<ix:nonFraction contextRef="c0" decimals="-3" format="ixt:num-dot-decimal" name="ifrs-full:ComprehensiveIncome" scale="3" sign="-" unitRef="usd">18,979</ix:nonFraction></td><td style="padding-bottom: 4pt; text-align: left">)</td><td style="padding-bottom: 4pt">&#160;</td>
    <td style="border-bottom: Black 4pt double; text-align: left">&#160;</td><td style="border-bottom: Black 4pt double; text-align: right">(<ix:nonFraction contextRef="c4" decimals="-3" format="ixt:num-dot-decimal" name="ifrs-full:ComprehensiveIncome" scale="3" sign="-" unitRef="usd">27,895</ix:nonFraction></td><td style="padding-bottom: 4pt; text-align: left">)</td><td style="padding-bottom: 4pt">&#160;</td>
    <td style="border-bottom: Black 4pt double; text-align: left">&#160;</td><td style="border-bottom: Black 4pt double; text-align: right">(<ix:nonFraction contextRef="c5" decimals="-3" format="ixt:num-dot-decimal" name="ifrs-full:ComprehensiveIncome" scale="3" sign="-" unitRef="usd">22,657</ix:nonFraction></td><td style="padding-bottom: 4pt; text-align: left">)</td></tr>
  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td>&#160;</td><td>&#160;</td>
    <td style="text-align: center">&#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></tr>
  <tr style="vertical-align: bottom; ">
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  </table><div>


</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">The accompanying notes are an integral part of
these consolidated financial statements.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&#160;</p><div>


</div><!-- Field: Page; Sequence: 127; Value: 1 --><div>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&#160;</p><div>

</div><div><a id="f_004"></a></div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><i>TIZIANA LIFE SCIENCES LTD</i></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><b>Consolidated Statements of Shareholders&#8217;
Equity</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">(In thousands)</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="border-collapse: collapse; width: 100%; font: 10pt Times New Roman, Times, Serif">
  <tr style="vertical-align: bottom">
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    <td colspan="2" style="text-align: center">$</td><td style="text-align: center">&#160;</td><td style="text-align: center">&#160;</td>
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    <td colspan="2" style="text-align: center">$</td><td style="text-align: center">&#160;</td><td style="text-align: center">&#160;</td>
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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  <tr style="vertical-align: bottom; ">
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  <tr style="vertical-align: bottom; ">
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  <tr style="vertical-align: bottom; ">
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    <td style="text-align: left">&#160;</td><td style="text-align: right"><div style="-sec-ix-hidden: hidden-fact-37">&#160;</div></td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><div style="-sec-ix-hidden: hidden-fact-38">&#160;</div></td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><div style="-sec-ix-hidden: hidden-fact-39">&#160;</div></td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><div style="-sec-ix-hidden: hidden-fact-40">&#160;</div></td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><div style="-sec-ix-hidden: hidden-fact-41">&#160;</div></td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><div style="-sec-ix-hidden: hidden-fact-42">&#160;</div></td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><div style="-sec-ix-hidden: hidden-fact-43">&#160;</div></td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><div style="-sec-ix-hidden: hidden-fact-44">&#160;</div></td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><div style="-sec-ix-hidden: hidden-fact-45">&#160;</div></td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><div style="-sec-ix-hidden: hidden-fact-46">&#160;</div></td><td style="text-align: left">&#160;</td></tr>
  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="text-indent: -0.125in; padding-left: 0.125in; text-align: left">Loss for the period</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><div style="-sec-ix-hidden: hidden-fact-47">-</div></td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><div style="-sec-ix-hidden: hidden-fact-48">-</div></td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><div style="-sec-ix-hidden: hidden-fact-49">-</div></td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><div style="-sec-ix-hidden: hidden-fact-50">-</div></td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><div style="-sec-ix-hidden: hidden-fact-51">-</div></td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><div style="-sec-ix-hidden: hidden-fact-52">-</div></td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">(<ix:nonFraction contextRef="c22" decimals="-3" format="ixt:num-dot-decimal" name="tlsa:ProfitLoss1" scale="3" unitRef="usd">23,417</ix:nonFraction></td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><div style="-sec-ix-hidden: hidden-fact-53">-</div></td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><div style="-sec-ix-hidden: hidden-fact-54">-</div></td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">(<ix:nonFraction contextRef="c4" decimals="-3" format="ixt:num-dot-decimal" name="tlsa:ProfitLoss1" scale="3" sign="-" unitRef="usd">23,417</ix:nonFraction></td><td style="text-align: left">)</td></tr>
  <tr style="vertical-align: bottom; ">
    <td style="text-indent: -0.125in; padding-left: 0.125in">Translation</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><div style="-sec-ix-hidden: hidden-fact-55">-</div></td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><div style="-sec-ix-hidden: hidden-fact-56">-</div></td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><div style="-sec-ix-hidden: hidden-fact-57">-</div></td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><div style="-sec-ix-hidden: hidden-fact-58">-</div></td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><div style="-sec-ix-hidden: hidden-fact-59">-</div></td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><div style="-sec-ix-hidden: hidden-fact-60">&#160;</div></td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><div style="-sec-ix-hidden: hidden-fact-61">-</div></td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><div style="-sec-ix-hidden: hidden-fact-62">-</div></td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">(<ix:nonFraction contextRef="c24" decimals="-3" format="ixt:num-dot-decimal" name="tlsa:OtherComprehensiveIncomeNetOfTaxExchangeDifferencesOnTranslation1" scale="3" sign="-" unitRef="usd">4,478</ix:nonFraction></td><td style="text-align: left">)</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">(<ix:nonFraction contextRef="c4" decimals="-3" format="ixt:num-dot-decimal" name="tlsa:OtherComprehensiveIncomeNetOfTaxExchangeDifferencesOnTranslation1" scale="3" sign="-" unitRef="usd">4,478</ix:nonFraction></td><td style="text-align: left">)</td></tr>
  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="text-indent: -0.125in; padding-left: 0.125in; text-align: left">Total comprehensive loss</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><div style="-sec-ix-hidden: hidden-fact-63">-</div></td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><div style="-sec-ix-hidden: hidden-fact-64">-</div></td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><div style="-sec-ix-hidden: hidden-fact-65">-</div></td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><div style="-sec-ix-hidden: hidden-fact-66">-</div></td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><div style="-sec-ix-hidden: hidden-fact-67">-</div></td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><div style="-sec-ix-hidden: hidden-fact-68">-</div></td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">(<ix:nonFraction contextRef="c22" decimals="-3" format="ixt:num-dot-decimal" name="tlsa:ComprehensiveIncome1" scale="3" unitRef="usd">23,417</ix:nonFraction></td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><div style="-sec-ix-hidden: hidden-fact-69">-</div></td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">(<ix:nonFraction contextRef="c24" decimals="-3" format="ixt:num-dot-decimal" name="tlsa:ComprehensiveIncome1" scale="3" sign="-" unitRef="usd">4,478</ix:nonFraction></td><td style="text-align: left">)</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">(<ix:nonFraction contextRef="c4" decimals="-3" format="ixt:num-dot-decimal" name="tlsa:ComprehensiveIncome1" scale="3" unitRef="usd">27,895</ix:nonFraction></td><td style="text-align: left">&#160;</td></tr>
  <tr style="vertical-align: bottom; ">
    <td style="text-indent: -0.125in; padding-left: 0.125in; font-weight: bold">Balance at 31 December 2021</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"><ix:nonFraction contextRef="c25" decimals="-3" format="ixt:num-dot-decimal" name="ifrs-full:Equity" scale="3" unitRef="usd">102</ix:nonFraction></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"><ix:nonFraction contextRef="c26" decimals="-3" format="ixt:num-dot-decimal" name="ifrs-full:Equity" scale="3" unitRef="usd">15,596</ix:nonFraction></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"><ix:nonFraction contextRef="c27" decimals="-3" format="ixt:num-dot-decimal" name="ifrs-full:Equity" scale="3" unitRef="usd">13,797</ix:nonFraction></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"><ix:nonFraction contextRef="c28" decimals="-3" format="ixt:num-dot-decimal" name="ifrs-full:Equity" scale="3" unitRef="usd">697</ix:nonFraction></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"><ix:nonFraction contextRef="c29" decimals="-3" format="ixt:num-dot-decimal" name="ifrs-full:Equity" scale="3" unitRef="usd">118,697</ix:nonFraction></td><td style="font-weight: bold; text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><div style="-sec-ix-hidden: hidden-fact-70">-</div></td><td style="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">(<ix:nonFraction contextRef="c31" decimals="-3" format="ixt:num-dot-decimal" name="ifrs-full:Equity" scale="3" sign="-" unitRef="usd">108,063</ix:nonFraction></td><td style="font-weight: bold; text-align: left">)</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"><div style="-sec-ix-hidden: hidden-fact-71">-</div></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"><ix:nonFraction contextRef="c33" decimals="-3" format="ixt:num-dot-decimal" name="ifrs-full:Equity" scale="3" unitRef="usd">454</ix:nonFraction></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"><ix:nonFraction contextRef="c3" decimals="-3" format="ixt:num-dot-decimal" name="ifrs-full:Equity" scale="3" unitRef="usd">41,280</ix:nonFraction></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="text-indent: -0.125in; padding-left: 0.125in">Treasury Shares</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><div style="-sec-ix-hidden: hidden-fact-72">-</div></td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><div style="-sec-ix-hidden: hidden-fact-73">-</div></td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><div style="-sec-ix-hidden: hidden-fact-74">-</div></td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><div style="-sec-ix-hidden: hidden-fact-75">-</div></td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><div style="-sec-ix-hidden: hidden-fact-76">-</div></td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">(<ix:nonFraction contextRef="c39" decimals="-3" format="ixt:num-dot-decimal" name="ifrs-full:IssueOfEquity" scale="3" sign="-" unitRef="usd">1,320</ix:nonFraction></td><td style="text-align: left">)</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><div style="-sec-ix-hidden: hidden-fact-77">-</div></td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><div style="-sec-ix-hidden: hidden-fact-78">-</div></td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><div style="-sec-ix-hidden: hidden-fact-79">-</div></td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">(<ix:nonFraction contextRef="c0" decimals="-3" format="ixt:num-dot-decimal" name="ifrs-full:IssueOfEquity" scale="3" sign="-" unitRef="usd">1,320</ix:nonFraction></td><td style="text-align: left">)</td></tr>
  <tr style="vertical-align: bottom; ">
    <td style="text-indent: -0.125in; padding-left: 0.125in; text-align: left">Share based payment charge (options)</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><div style="-sec-ix-hidden: hidden-fact-80">-</div></td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><div style="-sec-ix-hidden: hidden-fact-81">-</div></td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><ix:nonFraction contextRef="c36" decimals="-3" format="ixt:num-dot-decimal" name="tlsa:ShareBasedPaymentoptions" scale="3" unitRef="usd">1,811</ix:nonFraction></td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><div style="-sec-ix-hidden: hidden-fact-82">-</div></td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><div style="-sec-ix-hidden: hidden-fact-83">-</div></td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><div style="-sec-ix-hidden: hidden-fact-84">-</div></td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><div style="-sec-ix-hidden: hidden-fact-85">-</div></td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><div style="-sec-ix-hidden: hidden-fact-86">-</div></td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><div style="-sec-ix-hidden: hidden-fact-87">-</div></td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><ix:nonFraction contextRef="c0" decimals="-3" format="ixt:num-dot-decimal" name="tlsa:ShareBasedPaymentoptions" scale="3" unitRef="usd">1,811</ix:nonFraction></td><td style="text-align: left">&#160;</td></tr>
  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="text-indent: -0.125in; padding-left: 0.125in; text-align: left">Options forfeited/cancelled in the year</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><div style="-sec-ix-hidden: hidden-fact-88">-</div></td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><div style="-sec-ix-hidden: hidden-fact-89">-</div></td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">(<ix:nonFraction contextRef="c36" decimals="-3" format="ixt:num-dot-decimal" name="tlsa:OptionsForfeitedcancelled" scale="3" sign="-" unitRef="usd">3,221</ix:nonFraction></td><td style="text-align: left">)</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><div style="-sec-ix-hidden: hidden-fact-90">-</div></td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><div style="-sec-ix-hidden: hidden-fact-91">-</div></td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><div style="-sec-ix-hidden: hidden-fact-92">-</div></td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><div style="-sec-ix-hidden: hidden-fact-93">-</div></td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><div style="-sec-ix-hidden: hidden-fact-94">-</div></td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><div style="-sec-ix-hidden: hidden-fact-95">-</div></td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">(<ix:nonFraction contextRef="c0" decimals="-3" format="ixt:num-dot-decimal" name="tlsa:OptionsForfeitedcancelled" scale="3" sign="-" unitRef="usd">3,221</ix:nonFraction></td><td style="text-align: left">)</td></tr>
  <tr style="vertical-align: bottom; ">
    <td style="text-indent: -0.125in; padding-left: 0.125in; text-align: left">Reclass of FV for options forfeited/Cancelled</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><div style="-sec-ix-hidden: hidden-fact-96">-</div></td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><div style="-sec-ix-hidden: hidden-fact-97">-</div></td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">(<ix:nonFraction contextRef="c36" decimals="-3" format="ixt:num-dot-decimal" name="ifrs-full:IncreaseDecreaseThroughExerciseOfOptions" scale="3" sign="-" unitRef="usd">7,197</ix:nonFraction></td><td style="text-align: left">)</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><div style="-sec-ix-hidden: hidden-fact-98">-</div></td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><div style="-sec-ix-hidden: hidden-fact-99">-</div></td><td style="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"><div style="-sec-ix-hidden: hidden-fact-100">-</div></td><td style="font-weight: bold; text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><ix:nonFraction contextRef="c40" decimals="-3" format="ixt:num-dot-decimal" name="ifrs-full:IncreaseDecreaseThroughExerciseOfOptions" scale="3" unitRef="usd">7,197</ix:nonFraction></td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><div style="-sec-ix-hidden: hidden-fact-101">-</div></td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><div style="-sec-ix-hidden: hidden-fact-102">-</div></td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><div style="-sec-ix-hidden: hidden-fact-103">-</div></td><td style="text-align: left">&#160;</td></tr>
  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="text-indent: -0.125in; padding-left: 0.125in; text-align: left">Total transactions with owners</td><td>&#160;</td>
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    <td style="text-align: left">&#160;</td><td style="text-align: right"><div style="-sec-ix-hidden: hidden-fact-105">-</div></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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  <tr style="vertical-align: bottom; ">
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">The accompanying notes are an integral part of
these consolidated financial statements.</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&#160;</p><div>


</div><!-- Field: Page; Sequence: 128; Value: 1 --><div>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&#160;</p><div>

</div><div><a id="f_005"></a></div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><i>TIZIANA LIFE SCIENCES LTD</i></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><b>Consolidated Statements of Cash Flows</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">(In thousands)</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&#160;</p><div>

</div><table cellpadding="0" cellspacing="0" style="border-collapse: collapse; width: 100%; font: 10pt Times New Roman, Times, Serif">
  <tr style="vertical-align: bottom">
    <td style="text-align: center">&#160;</td><td style="font-weight: bold; padding-bottom: 1.5pt">&#160;</td>
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  <tr style="vertical-align: bottom">
    <td>&#160;</td><td style="font-weight: bold; padding-bottom: 1.5pt">&#160;</td>
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  <tr style="vertical-align: bottom">
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    <td colspan="2" style="text-align: right">&#160;</td><td>&#160;</td><td>&#160;</td>
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  <tr style="vertical-align: bottom; ">
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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  <tr style="vertical-align: bottom; ">
    <td style="text-align: left">Share based payment &#8211; warrants</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><div style="-sec-ix-hidden: hidden-fact-146">-</div></td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><div style="-sec-ix-hidden: hidden-fact-147">-</div></td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><ix:nonFraction contextRef="c5" decimals="-3" format="ixt:num-dot-decimal" name="tlsa:AdjustmentsForSharebasedPaymentsWarrants" scale="3" unitRef="usd">26</ix:nonFraction></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">Fair value loss on investment</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><ix:nonFraction contextRef="c0" decimals="-3" format="ixt:num-dot-decimal" name="tlsa:FVLossOnInvestment" scale="3" unitRef="usd">869</ix:nonFraction></td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><div style="-sec-ix-hidden: hidden-fact-148">-</div></td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><div style="-sec-ix-hidden: hidden-fact-149">-</div></td><td style="text-align: left">&#160;</td></tr>
  <tr style="vertical-align: bottom; ">
    <td style="text-align: left">Loss on disposal of asset</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><ix:nonFraction contextRef="c0" decimals="-3" format="ixt:num-dot-decimal" name="tlsa:LossOnDisposalOfAsset" scale="3" unitRef="usd">129</ix:nonFraction></td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><div style="-sec-ix-hidden: hidden-fact-150">-</div></td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><div style="-sec-ix-hidden: hidden-fact-151">-</div></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">Bonus to be settled in equity</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><div style="-sec-ix-hidden: hidden-fact-152">-</div></td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><ix:nonFraction contextRef="c4" decimals="-3" format="ixt:num-dot-decimal" name="tlsa:BonusToBeSettledInEquity" scale="3" unitRef="usd">855</ix:nonFraction></td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><ix:nonFraction contextRef="c5" decimals="-3" format="ixt:num-dot-decimal" name="tlsa:BonusToBeSettledInEquity" scale="3" unitRef="usd">13,503</ix:nonFraction></td><td style="text-align: left">&#160;</td></tr>
  <tr style="vertical-align: bottom; ">
    <td>Depreciation</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><ix:nonFraction contextRef="c0" decimals="-3" format="ixt:num-dot-decimal" name="ifrs-full:AdjustmentsForDepreciationExpense" scale="3" unitRef="usd">1</ix:nonFraction></td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><ix:nonFraction contextRef="c4" decimals="-3" format="ixt:num-dot-decimal" name="ifrs-full:AdjustmentsForDepreciationExpense" scale="3" unitRef="usd">8</ix:nonFraction></td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><ix:nonFraction contextRef="c5" decimals="-3" format="ixt:num-dot-decimal" name="ifrs-full:AdjustmentsForDepreciationExpense" scale="3" unitRef="usd">5</ix:nonFraction></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">(Gain)/ loss on foreign exchange</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">(<ix:nonFraction contextRef="c0" decimals="-3" format="ixt:num-dot-decimal" name="ifrs-full:GainsLossesOnExchangeDifferencesOnTranslationRecognisedInProfitOrLoss" scale="3" unitRef="usd">3,183</ix:nonFraction></td><td style="text-align: left">)</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">(<ix:nonFraction contextRef="c4" decimals="-3" format="ixt:num-dot-decimal" name="ifrs-full:GainsLossesOnExchangeDifferencesOnTranslationRecognisedInProfitOrLoss" scale="3" unitRef="usd">1,899</ix:nonFraction></td><td style="text-align: left">)</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><ix:nonFraction contextRef="c5" decimals="-3" format="ixt:num-dot-decimal" name="ifrs-full:GainsLossesOnExchangeDifferencesOnTranslationRecognisedInProfitOrLoss" scale="3" sign="-" unitRef="usd">237</ix:nonFraction></td><td style="text-align: left">&#160;</td></tr>
  <tr style="vertical-align: bottom; ">
    <td style="text-align: left">Options forfeited during the year</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">(<ix:nonFraction contextRef="c0" decimals="-3" format="ixt:num-dot-decimal" name="tlsa:OptionsForfeitedDuringTheYear" scale="3" unitRef="usd">3,221</ix:nonFraction></td><td style="text-align: left">)</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><div style="-sec-ix-hidden: hidden-fact-153">-</div></td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><div style="-sec-ix-hidden: hidden-fact-154">-</div></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">Depreciation of right-of-use asset</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><ix:nonFraction contextRef="c0" decimals="-3" format="ixt:num-dot-decimal" name="tlsa:DepreciationOfRightofuseAsset" scale="3" unitRef="usd">50</ix:nonFraction></td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><ix:nonFraction contextRef="c4" decimals="-3" format="ixt:num-dot-decimal" name="tlsa:DepreciationOfRightofuseAsset" scale="3" unitRef="usd">133</ix:nonFraction></td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><ix:nonFraction contextRef="c5" decimals="-3" format="ixt:num-dot-decimal" name="tlsa:DepreciationOfRightofuseAsset" scale="3" unitRef="usd">86</ix:nonFraction></td><td style="text-align: left">&#160;</td></tr>
  <tr style="vertical-align: bottom; ">
    <td style="text-align: left">(Gain)/loss on disposal of right of use asset</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><div style="-sec-ix-hidden: hidden-fact-155">-</div></td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">(<ix:nonFraction contextRef="c4" decimals="-3" format="ixt:num-dot-decimal" name="ifrs-full:ProfitsLossesOnDisposalOfInvestmentsAndChangesInValueOfInvestments" scale="3" unitRef="usd">28</ix:nonFraction></td><td style="text-align: left">)</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><div style="-sec-ix-hidden: hidden-fact-156">-</div></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">Proceeds from finance lease reclassified as an investing activity</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><div style="-sec-ix-hidden: hidden-fact-157">-</div></td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">(<ix:nonFraction contextRef="c4" decimals="-3" format="ixt:num-dot-decimal" name="tlsa:ProceedsFromSaleAndCollectionOfFinanceReceivable" scale="3" sign="-" unitRef="usd">152</ix:nonFraction></td><td style="text-align: left">)</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><div style="-sec-ix-hidden: hidden-fact-158">-</div></td><td style="text-align: left">&#160;</td></tr>
  <tr style="vertical-align: bottom; ">
    <td style="text-align: left">Cash inflow from taxation</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><ix:nonFraction contextRef="c0" decimals="-3" format="ixt:num-dot-decimal" name="ifrs-full:IncomeTaxesPaidRefundClassifiedAsOperatingActivities" scale="3" sign="-" unitRef="usd">490</ix:nonFraction></td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><ix:nonFraction contextRef="c4" decimals="-3" format="ixt:num-dot-decimal" name="ifrs-full:IncomeTaxesPaidRefundClassifiedAsOperatingActivities" scale="3" sign="-" unitRef="usd">1,415</ix:nonFraction></td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><div style="-sec-ix-hidden: hidden-fact-159">-</div></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">Impairment of SharDNA SPA</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><div style="-sec-ix-hidden: hidden-fact-160">-</div></td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><div style="-sec-ix-hidden: hidden-fact-161">-</div></td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><ix:nonFraction contextRef="c5" decimals="-3" format="ixt:num-dot-decimal" name="tlsa:ImpairmentCharges" scale="3" unitRef="usd">296</ix:nonFraction></td><td style="text-align: left">&#160;</td></tr>
  <tr style="vertical-align: bottom; ">
    <td style="text-align: left">Gain from disposal of intellectual property</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><div style="-sec-ix-hidden: hidden-fact-162">-</div></td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><div style="-sec-ix-hidden: hidden-fact-163">-</div></td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">(<ix:nonFraction contextRef="c5" decimals="-3" format="ixt:num-dot-decimal" name="tlsa:CapitalDistribution" scale="3" unitRef="usd">2,663</ix:nonFraction>)</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; padding-left: 9pt">Net (increase) in related party receivables</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">(<ix:nonFraction contextRef="c0" decimals="-3" format="ixt:num-dot-decimal" name="tlsa:NetIncreaseInRelatedPartyReceivables" scale="3" unitRef="usd">1,158</ix:nonFraction></td><td style="text-align: left">)</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">(<ix:nonFraction contextRef="c4" decimals="-3" format="ixt:num-dot-decimal" name="tlsa:NetIncreaseInRelatedPartyReceivables" scale="3" unitRef="usd">88</ix:nonFraction></td><td style="text-align: left">)</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">(<ix:nonFraction contextRef="c5" decimals="-3" format="ixt:num-dot-decimal" name="tlsa:NetIncreaseInRelatedPartyReceivables" scale="3" unitRef="usd">31</ix:nonFraction></td><td style="text-align: left">)</td></tr>
  <tr style="vertical-align: bottom; ">
    <td style="text-align: left; padding-left: 9pt">Net (decrease)/increase in related party payables</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">(<ix:nonFraction contextRef="c0" decimals="-3" format="ixt:num-dot-decimal" name="tlsa:NetIncreaseInRelatedPartyPayables" scale="3" sign="-" unitRef="usd">1,355</ix:nonFraction></td><td style="text-align: left">)</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">(<ix:nonFraction contextRef="c4" decimals="-3" format="ixt:num-dot-decimal" name="tlsa:NetIncreaseInRelatedPartyPayables" scale="3" sign="-" unitRef="usd">685</ix:nonFraction></td><td style="text-align: left">)</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><ix:nonFraction contextRef="c5" decimals="-3" format="ixt:num-dot-decimal" name="tlsa:NetIncreaseInRelatedPartyPayables" scale="3" unitRef="usd">1,145</ix:nonFraction></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; padding-left: 9pt">Net (increase)/decrease in operating assets/other receivables</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><ix:nonFraction contextRef="c0" decimals="-3" format="ixt:num-dot-decimal" name="ifrs-full:AdjustmentsForDecreaseIncreaseInOtherOperatingReceivables" scale="3" unitRef="usd">1,002</ix:nonFraction></td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><ix:nonFraction contextRef="c4" decimals="-3" format="ixt:num-dot-decimal" name="ifrs-full:AdjustmentsForDecreaseIncreaseInOtherOperatingReceivables" scale="3" unitRef="usd">516</ix:nonFraction></td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">(<ix:nonFraction contextRef="c5" decimals="-3" format="ixt:num-dot-decimal" name="ifrs-full:AdjustmentsForDecreaseIncreaseInOtherOperatingReceivables" scale="3" sign="-" unitRef="usd">437</ix:nonFraction>)</td><td style="text-align: left">&#160;</td></tr>
  <tr style="vertical-align: bottom; ">
    <td style="text-align: left; padding-left: 9pt">Net increase/(decrease) in operating liabilities /other liabilities</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><ix:nonFraction contextRef="c0" decimals="-3" format="ixt:num-dot-decimal" name="ifrs-full:AdjustmentsForIncreaseDecreaseInOtherLiabilities" scale="3" unitRef="usd">347</ix:nonFraction></td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">(<ix:nonFraction contextRef="c4" decimals="-3" format="ixt:num-dot-decimal" name="ifrs-full:AdjustmentsForIncreaseDecreaseInOtherLiabilities" scale="3" sign="-" unitRef="usd">516</ix:nonFraction></td><td style="text-align: left">)</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">(<ix:nonFraction contextRef="c5" decimals="-3" format="ixt:num-dot-decimal" name="ifrs-full:AdjustmentsForIncreaseDecreaseInOtherLiabilities" scale="3" sign="-" unitRef="usd">972</ix:nonFraction></td><td style="text-align: left">)</td></tr>
  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="text-align: left; padding-left: 9pt">Net cash used in operating activities</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">(<ix:nonFraction contextRef="c0" decimals="-3" format="ixt:num-dot-decimal" name="ifrs-full:CashFlowsFromUsedInOperatingActivities" scale="3" sign="-" unitRef="usd">19,615</ix:nonFraction></td><td style="text-align: left">)</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">(<ix:nonFraction contextRef="c4" decimals="-3" format="ixt:num-dot-decimal" name="ifrs-full:CashFlowsFromUsedInOperatingActivities" scale="3" sign="-" unitRef="usd">21,762</ix:nonFraction></td><td style="text-align: left">)</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">(<ix:nonFraction contextRef="c5" decimals="-3" format="ixt:num-dot-decimal" name="ifrs-full:CashFlowsFromUsedInOperatingActivities" scale="3" sign="-" unitRef="usd">11,335</ix:nonFraction></td><td style="text-align: left">)</td></tr>
  <tr style="vertical-align: bottom; ">
    <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><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>
  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="font-weight: bold; text-align: left">CASH FLOWS FROM INVESTING ACTIVITIES</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></tr>
  <tr style="vertical-align: bottom; ">
    <td>Purchase of PPE</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><div style="-sec-ix-hidden: hidden-fact-164">-</div></td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">(<ix:nonFraction contextRef="c4" decimals="-3" format="ixt:num-dot-decimal" name="ifrs-full:PurchaseOfPropertyPlantAndEquipmentClassifiedAsInvestingActivities" scale="3" unitRef="usd">22</ix:nonFraction></td><td style="text-align: left">)</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">(<ix:nonFraction contextRef="c5" decimals="-3" format="ixt:num-dot-decimal" name="ifrs-full:PurchaseOfPropertyPlantAndEquipmentClassifiedAsInvestingActivities" scale="3" unitRef="usd">3</ix:nonFraction></td><td style="text-align: left">)</td></tr>
  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="text-align: left">Purchase of Act D</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><div style="-sec-ix-hidden: hidden-fact-165">-</div></td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><div style="-sec-ix-hidden: hidden-fact-166">-</div></td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">(<ix:nonFraction contextRef="c5" decimals="-3" format="ixt:num-dot-decimal" name="tlsa:PurchaseOfActD" scale="3" unitRef="usd">120</ix:nonFraction></td><td style="text-align: left">)</td></tr>
  <tr style="vertical-align: bottom; ">
    <td style="text-align: left; padding-left: 9pt">Proceeds from finance lease</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><div style="-sec-ix-hidden: hidden-fact-167">-</div></td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><ix:nonFraction contextRef="c4" decimals="-3" format="ixt:num-dot-decimal" name="tlsa:ProceedsFromFinanceLease" scale="3" unitRef="usd">152</ix:nonFraction></td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><div style="-sec-ix-hidden: hidden-fact-168">-</div></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; padding-left: 9pt">Investment in Related Party</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">(<ix:nonFraction contextRef="c0" decimals="-3" format="ixt:num-dot-decimal" name="tlsa:InvestmentInRelatedParty" scale="3" unitRef="usd">2,676</ix:nonFraction></td><td style="text-align: left">)</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><div style="-sec-ix-hidden: hidden-fact-169">-</div></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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  <tr style="vertical-align: bottom; ">
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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  <tr style="vertical-align: bottom; ">
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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">(<ix:nonFraction contextRef="c0" decimals="-3" format="ixt:num-dot-decimal" name="ifrs-full:CashFlowsFromUsedInFinancingActivities" scale="3" sign="-" unitRef="usd">55</ix:nonFraction></td><td style="text-align: left">)</td><td>&#160;</td>
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  <tr style="vertical-align: bottom; ">
    <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><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>
  <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">(<ix:nonFraction contextRef="c0" decimals="-3" format="ixt:num-dot-decimal" name="ifrs-full:IncreaseDecreaseInCashAndCashEquivalentsBeforeEffectOfExchangeRateChanges" scale="3" sign="-" unitRef="usd">23,666</ix:nonFraction></td><td style="text-align: left">)</td><td>&#160;</td>
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  <tr style="vertical-align: bottom; ">
    <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><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>
  <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"><ix:nonFraction contextRef="c3" decimals="-3" format="ixt:num-dot-decimal" name="ifrs-full:CashAndCashEquivalents" scale="3" unitRef="usd">42,186</ix:nonFraction></td><td style="text-align: left">&#160;</td><td>&#160;</td>
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  <tr style="vertical-align: bottom; ">
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    <td style="text-align: left">&#160;</td><td style="text-align: right">(<ix:nonFraction contextRef="c0" decimals="-3" format="ixt:num-dot-decimal" name="ifrs-full:EffectOfExchangeRateChangesOnCashAndCashEquivalents" scale="3" sign="-" unitRef="usd">398</ix:nonFraction></td><td style="text-align: left">)</td><td>&#160;</td>
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="text-align: left">Cash and cash equivalent, end of year</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><ix:nonFraction contextRef="c2" decimals="-3" format="ixt:num-dot-decimal" name="ifrs-full:CashAndCashEquivalents" scale="3" unitRef="usd">18,122</ix:nonFraction></td><td style="text-align: left">&#160;</td><td>&#160;</td>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&#160;</p><div>


</div><!-- Field: Page; Sequence: 129; Value: 1 --><div>
    </div><div style="margin-top: 12pt; margin-bottom: 6pt; border-bottom: Black 1.5pt solid"><p style="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt">F-<!-- Field: Sequence; Type: Arabic; Name: PageNo -->6<!-- Field: /Sequence --></p></div><div>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&#160;</p><div>

</div><div><a id="f_006"></a></div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><b>TIZIANA LIFE SCIENCES LTD</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><b>Notes to Consolidated Financial Statements</b></p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&#160;</p><div>

</div><ix:nonNumeric contextRef="c0" continuedAt="tlsa_DisclosureOfGeneralInformationAboutFinancialStatementsAndOrganization-c0_cont_1" escape="true" name="tlsa:DisclosureOfGeneralInformationAboutFinancialStatementsAndOrganization"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>1. GENERAL INFORMATION</b></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:nonNumeric><div>

</div><div>

</div><ix:continuation continuedAt="tlsa_DisclosureOfGeneralInformationAboutFinancialStatementsAndOrganization-c0_cont_2" id="tlsa_DisclosureOfGeneralInformationAboutFinancialStatementsAndOrganization-c0_cont_1"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Tiziana Life Sciences Ltd,
(the &#8220;company&#8221;) is a public limited company incorporated in Bermuda and at the year end is quoted on the NASDAQ Capital Market
(NASDAQ: TLSA). The previous parent, Tiziana Life Sciences PLC, delisted from the main market of the London Stock Exchange (LSE: TILS)
on October 21, 2021. The address of its registered office is given on page 1. The principal activities of the Company and its subsidiaries
(the Group) are that of a clinical stage biotechnology company that specializes in the development of transformative therapies for neurodegenerative
and lung diseases . Our clinical pipeline includes drug assets for Secondary Progressive Multiple Sclerosis, ALS. Alzheimer's, Crohn's
Disease and KRAS+ NSCLC.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p></ix:continuation><div>

</div><div>

</div><ix:continuation id="tlsa_DisclosureOfGeneralInformationAboutFinancialStatementsAndOrganization-c0_cont_2"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">The functional currency for
the Company is also US dollars ($) indicative of the primary economic environment in which the Company operates. These consolidated financial
statements are presented in thousands of dollars ($&#8217;000) which is the presentational currency of the Company.</p></ix:continuation><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><ix:nonNumeric contextRef="c0" continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_1" escape="true" name="ifrs-full:DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>2. ACCOUNTING POLICIES</b></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:nonNumeric><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_2" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_1"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">The principal accounting
policies applied in the preparation of these consolidated financial statements are set out below. These policies have been applied consistently
to all the years presented unless otherwise stated.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_3" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_2"><ix:nonNumeric contextRef="c0" continuedAt="tlsa_TheDisclosureOfBasisOfPreparation-c0_cont_1" escape="true" name="tlsa:TheDisclosureOfBasisOfPreparation"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>Basis of preparation</b></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:nonNumeric></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_4" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_3"><ix:continuation continuedAt="tlsa_TheDisclosureOfBasisOfPreparation-c0_cont_2" id="tlsa_TheDisclosureOfBasisOfPreparation-c0_cont_1"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">The consolidated financial
statements of the Group have been prepared in accordance with International Financial Reporting Standards (IFRS) as issued by the International
Accounting Standards Board (IASB), and International Financial Reporting Interpretations Committee IFRIC interpretations as applicable
to companies reporting under IFRS. These accounts have been prepared under the historical cost convention except for the following items:</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_5" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_4"><ix:continuation continuedAt="tlsa_TheDisclosureOfBasisOfPreparation-c0_cont_3" id="tlsa_TheDisclosureOfBasisOfPreparation-c0_cont_2"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt" width="100%"><tr style="vertical-align: top">
<td style="width: 0.5in"></td><td style="width: 0.25in">-</td><td style="text-align: justify">Financial instruments &#8211; fair value
                                            through profit or loss</td></tr></table><p style="margin-top: 0; margin-bottom: 0">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_6" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_5"><ix:continuation id="tlsa_TheDisclosureOfBasisOfPreparation-c0_cont_3"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt" width="100%"><tr style="vertical-align: top">
<td style="width: 0.5in"></td><td style="width: 0.25in">-</td><td style="text-align: justify">Financial instruments &#8211; fair value
                                            through other comprehensive income</td></tr></table><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_7" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_6"><ix:nonNumeric contextRef="c0" continuedAt="tlsa_DescriptionOfAccountingPolicyForGoingConcern-c0_cont_1" escape="true" name="tlsa:DescriptionOfAccountingPolicyForGoingConcern"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>Going Concern</b></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:nonNumeric></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_8" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_7"><ix:continuation continuedAt="tlsa_DescriptionOfAccountingPolicyForGoingConcern-c0_cont_2" id="tlsa_DescriptionOfAccountingPolicyForGoingConcern-c0_cont_1"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">The Group incurred losses
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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_9" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_8"><ix:continuation continuedAt="tlsa_DescriptionOfAccountingPolicyForGoingConcern-c0_cont_3" id="tlsa_DescriptionOfAccountingPolicyForGoingConcern-c0_cont_2"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">The Group is in the early
stages of developing its business focusing on the discovery and development of novel molecules that treat human disease in oncology and
immunology. As the Group is pre-revenue, the Directors expect the Group to incur further losses and to require significant capital expenditure
in continuing to develop clinical stage development therapeutic candidates in both oncology and immunology. The Group has successfully
funded clinical trials to date and going forward will need to continue to secure additional investment to fund the clinical trials.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation></ix:continuation><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_10" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_9"><ix:continuation id="tlsa_DescriptionOfAccountingPolicyForGoingConcern-c0_cont_3"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">The Directors have prepared
cash flow projections that include the costs associated with the continued clinical trials and additional investment to fund that operation.&#160;
Based on those projections, the directors conclude that the company will be able to meet its liabilities as they fall due until at least
April 2024, with a cash surplus of approximately $<ix:nonFraction contextRef="c0" decimals="-6" format="ixt:num-dot-decimal" name="tlsa:CashSurplus" scale="6" unitRef="usd">1</ix:nonFraction>m projected at this date. Accordingly, the Directors believe it appropriate that the
consolidated financial statements have been prepared on a going concern basis.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">

</p></ix:continuation></ix:continuation><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_11" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_10"><ix:nonNumeric contextRef="c0" continuedAt="_DisclosureOfChangesInAccountingPoliciesExplanatory-c0_cont_1" escape="true" name="ifrs-full:DisclosureOfChangesInAccountingPoliciesExplanatory"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>New and Revised Standards</i></b></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:nonNumeric></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_12" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_11"><ix:continuation continuedAt="_DisclosureOfChangesInAccountingPoliciesExplanatory-c0_cont_2" id="_DisclosureOfChangesInAccountingPoliciesExplanatory-c0_cont_1"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>Standards in effect in 2022</i></b></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_13" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_12"><ix:continuation id="_DisclosureOfChangesInAccountingPoliciesExplanatory-c0_cont_2"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">There are no new IFRS standards,
amendments to standards or interpretations that are mandatory for the financial year beginning on January 1, 2022, that are relevant
to the Group and that have had any impact in the year to December 31, 2022. New standards, amendments to standards and interpretations
that are not yet effective, which have been deemed by the Group as currently not relevant and are not listed here.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>


</div><!-- Field: Page; Sequence: 130; Value: 1 --><div>
    </div><div style="margin-top: 12pt; margin-bottom: 6pt; border-bottom: Black 1.5pt solid"><p style="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt">F-<!-- Field: Sequence; Type: Arabic; Name: PageNo -->7<!-- Field: /Sequence --></p></div><div>
    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_14" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_13"><ix:nonNumeric contextRef="c0" continuedAt="tlsa_DescriptionOfAccountingPolicyForBasisofConsolidation-c0_cont_1" escape="true" name="tlsa:DescriptionOfAccountingPolicyForBasisofConsolidation"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>Basis of consolidation</b></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:nonNumeric></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_15" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_14"><ix:continuation continuedAt="tlsa_DescriptionOfAccountingPolicyForBasisofConsolidation-c0_cont_2" id="tlsa_DescriptionOfAccountingPolicyForBasisofConsolidation-c0_cont_1"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Subsidiary undertakings are
all entities over which the Group exercises control. The Group has control when it can demonstrate all of the following: (a) power over
the investee; (b) exposure, or rights, to variable returns from its involvement with the investee; and (c) the ability to use its power
over the investee to affect the amount of the investor&#8217;s return.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_16" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_15"><ix:continuation id="tlsa_DescriptionOfAccountingPolicyForBasisofConsolidation-c0_cont_2"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">The existence and effect
of both current voting rights and potential voting rights that are currently exercisable or convertible are considered when assessing
whether control of an entity is exercised. Subsidiaries are consolidated from the date at which the Group obtains control and are de-consolidated
from the date at which control ceases.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_17" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_16"><ix:nonNumeric contextRef="c0" continuedAt="_DescriptionOfAccountingPolicyForBusinessCombinationsExplanatory-c0_cont_1" escape="true" name="ifrs-full:DescriptionOfAccountingPolicyForBusinessCombinationsExplanatory"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>Business combination</b></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:nonNumeric></ix:continuation><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_18" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_17"><ix:continuation continuedAt="_DescriptionOfAccountingPolicyForBusinessCombinationsExplanatory-c0_cont_2" id="_DescriptionOfAccountingPolicyForBusinessCombinationsExplanatory-c0_cont_1"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">The Group undertook a group
reorganisation exercise during the year to December 31, 2021. As part of this process, Tiziana Life Sciences Ltd (a Bermudan entity) was
inserted above Tiziana Life Sciences Limited (formerly Tiziana Life Sciences Plc) in the Group&#8217;s structure. As both entities were
under common control of Planwise Ltd, the transaction does not constitute a business combination under IFRS 3 &#8216;Business combinations&#8217;
and instead has been accounted for as a group reorganization, using the pooling of interest method. This results in assets and liabilities
being measured at their carrying amount in Tiziana Life Sciences Limited (formerly Tiziana Life Sciences Plc) but share capital being
that of Tiziana Life Sciences Ltd (a Bermudan entity). Merger accounting has been used to account for this transaction (See note 15 for
details).</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">

</p></ix:continuation></ix:continuation><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_19" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_18"><ix:continuation continuedAt="_DescriptionOfAccountingPolicyForBusinessCombinationsExplanatory-c0_cont_3" id="_DescriptionOfAccountingPolicyForBusinessCombinationsExplanatory-c0_cont_2"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">On 21 October 2021, Tiziana
Life Sciences Ltd. (the &#8216;Company&#8217;) acquired the entire shareholding of the former Tiziana Life Sciences Plc and its related
subsidiaries, by a way of a share for share exchange with Tiziana Life Sciences Ltd becoming the Group&#8217;s immediate parent company.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_20" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_19"><ix:continuation id="_DescriptionOfAccountingPolicyForBusinessCombinationsExplanatory-c0_cont_3"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">On 21 October 2021, the Company
was admitted for listing on the NASDAQ Capital Market Exchange and the former Tiziana Life Sciences Plc was delisted from the London
Stock Exchange.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_21" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_20"><ix:nonNumeric contextRef="c0" continuedAt="_DescriptionOfAccountingPolicyForSegmentReportingExplanatory-c0_cont_1" escape="true" name="ifrs-full:DescriptionOfAccountingPolicyForSegmentReportingExplanatory"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>Segment reporting</b></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:nonNumeric></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_22" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_21"><ix:continuation id="_DescriptionOfAccountingPolicyForSegmentReportingExplanatory-c0_cont_1"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Operating segments are reported
in a manner consistent with the internal reporting provided to the Board. The Board considers there to be only <ix:nonFraction contextRef="c0" decimals="0" format="ixt-sec:numwordsen" name="tlsa:NumberOfSegment" scale="0" unitRef="pure">one</ix:nonFraction> operating segment
being the research and development of biotechnological and pharmaceutical products.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>


</div><!-- Field: Page; Sequence: 131; Value: 1 --><div>
    </div><div style="margin-top: 12pt; margin-bottom: 6pt; border-bottom: Black 1.5pt solid"><p style="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt">F-<!-- Field: Sequence; Type: Arabic; Name: PageNo -->8<!-- Field: /Sequence --></p></div><div>
    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
    </div><!-- Field: /Page --><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_23" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_22"><ix:nonNumeric contextRef="c0" continuedAt="_DescriptionOfAccountingPolicyForTaxesOtherThanIncomeTaxExplanatory-c0_cont_1" escape="true" name="ifrs-full:DescriptionOfAccountingPolicyForTaxesOtherThanIncomeTaxExplanatory"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>Taxation</b></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:nonNumeric></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_24" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_23"><ix:continuation continuedAt="_DescriptionOfAccountingPolicyForTaxesOtherThanIncomeTaxExplanatory-c0_cont_2" id="_DescriptionOfAccountingPolicyForTaxesOtherThanIncomeTaxExplanatory-c0_cont_1"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">The tax expense for the year
represents the total of current taxation and deferred taxation. The charge in respect of current taxation is based on the estimated taxable
profit for the year. Current tax is provided at amounts expected to be paid (or recovered) using the tax rates and laws that have been
enacted or substantively enacted by the balance sheet date.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_25" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_24"><ix:continuation continuedAt="_DescriptionOfAccountingPolicyForTaxesOtherThanIncomeTaxExplanatory-c0_cont_3" id="_DescriptionOfAccountingPolicyForTaxesOtherThanIncomeTaxExplanatory-c0_cont_2"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Deferred tax is provided
in full, using the liability method, on temporary differences arising between the tax bases of assets and liabilities and their carrying
amounts in the consolidated financial statements. Deferred tax is determined using tax rates (and laws) that have been enacted or substantially
enacted by the balance sheet date and expected to apply when the related deferred tax is realized, or the deferred liability is settled.
Deferred tax assets are recognized to the extent that it is probable that the future taxable profit will be available against which the
temporary differences can be utilized.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_26" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_25"><ix:continuation id="_DescriptionOfAccountingPolicyForTaxesOtherThanIncomeTaxExplanatory-c0_cont_3"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Research and Development
tax credits are provided for in the year that the costs are incurred. These are estimated based on eligible research and development
expenditure. Any differences that are rebated are recognized in the following year, when the cash is received from the UK tax authorities.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_27" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_26"><ix:nonNumeric contextRef="c0" continuedAt="_DescriptionOfAccountingPolicyForForeignCurrencyTranslationExplanatory-c0_cont_1" escape="true" name="ifrs-full:DescriptionOfAccountingPolicyForForeignCurrencyTranslationExplanatory"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>Foreign currency translation</b></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:nonNumeric></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_28" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_27"><ix:continuation continuedAt="_DescriptionOfAccountingPolicyForForeignCurrencyTranslationExplanatory-c0_cont_2" id="_DescriptionOfAccountingPolicyForForeignCurrencyTranslationExplanatory-c0_cont_1"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Items included in the financial
statements of each of the Group&#8217;s entities are measured using the currency of the primary economic environment in which the entity
operates (the functional currency). The consolidated financial statements are presented in US dollars, which is the Group&#8217;s presentational
currency.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_29" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_28"><ix:continuation continuedAt="_DescriptionOfAccountingPolicyForForeignCurrencyTranslationExplanatory-c0_cont_3" id="_DescriptionOfAccountingPolicyForForeignCurrencyTranslationExplanatory-c0_cont_2"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Foreign currency transactions
are translated into the functional currency using exchange rates prevailing at the dates of the transactions. Foreign exchange gains
and losses resulting from the settlement of foreign currency transactions and from the translation at year-end exchange rates of monetary
assets and liabilities denominated in foreign currencies are recognized in the Consolidated statements of operations and comprehensive
loss.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_30" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_29"><ix:continuation continuedAt="_DescriptionOfAccountingPolicyForForeignCurrencyTranslationExplanatory-c0_cont_4" id="_DescriptionOfAccountingPolicyForForeignCurrencyTranslationExplanatory-c0_cont_3"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">The financial statements
of overseas subsidiary undertakings are translated into US dollars on the following basis:</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_31" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_30"><ix:continuation continuedAt="_DescriptionOfAccountingPolicyForForeignCurrencyTranslationExplanatory-c0_cont_5" id="_DescriptionOfAccountingPolicyForForeignCurrencyTranslationExplanatory-c0_cont_4"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 48px">&#160;</td>
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    <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Assets and liabilities at the rate of exchange ruling
    at the year-end date.</span></td></tr>
  <tr style="vertical-align: top">
    <td>&#160;</td>
    <td>&#160;</td>
    <td>&#160;</td></tr>
  <tr style="vertical-align: top">
    <td>&#160;</td>
    <td><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; text-align: justify">&#160;</p></ix:continuation></ix:continuation><div>
</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_32" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_31"><ix:continuation id="_DescriptionOfAccountingPolicyForForeignCurrencyTranslationExplanatory-c0_cont_5"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Exchange differences arising
from the translation of the net investment in foreign entities, borrowings and other currency instruments designated as hedges of such
investments, are taken to equity (and recognized in the Consolidated statements of operations and comprehensive loss) on consolidation.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_33" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_32"><ix:nonNumeric contextRef="c0" continuedAt="tlsa_DescriptionOfAccountingPolicyForLicenseFees-c0_cont_1" escape="true" name="tlsa:DescriptionOfAccountingPolicyForLicenseFees"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>License fees</b></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:nonNumeric></ix:continuation><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_34" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_33"><ix:continuation id="tlsa_DescriptionOfAccountingPolicyForLicenseFees-c0_cont_1"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Payments made which provide
the right to perform research are carefully evaluated to determine whether such payments are to fund research or acquire an asset. &#8220;License
fees expenses&#8221; are recognized as incurred.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">

</p></ix:continuation></ix:continuation><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_35" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_34"><ix:nonNumeric contextRef="c0" continuedAt="_DescriptionOfAccountingPolicyForResearchAndDevelopmentExpenseExplanatory-c0_cont_1" escape="true" name="ifrs-full:DescriptionOfAccountingPolicyForResearchAndDevelopmentExpenseExplanatory"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>Research and development</b></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:nonNumeric></ix:continuation><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_36" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_35"><ix:continuation id="_DescriptionOfAccountingPolicyForResearchAndDevelopmentExpenseExplanatory-c0_cont_1"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">All
on-going research and development expenditure is currently expensed in the period in which it is incurred. Due to the regulatory environment
inherent in the development of the Group&#8217;s products, the criteria for development costs to be recognized as an asset, as set out
in IAS 38 &#8216;Intangible Assets&#8217;, are not met until a product has been granted regulatory approval and it is probable that future
economic benefit will flow to the Group. The Group currently has no qualifying expenditure.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_37" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_36"><ix:nonNumeric contextRef="c0" continuedAt="_DescriptionOfAccountingPolicyForFairValueMeasurementExplanatory-c0_cont_1" escape="true" name="ifrs-full:DescriptionOfAccountingPolicyForFairValueMeasurementExplanatory"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>Fair Value Measurement</b></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>&#160;</b></p></ix:nonNumeric></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_38" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_37"><ix:continuation continuedAt="_DescriptionOfAccountingPolicyForFairValueMeasurementExplanatory-c0_cont_2" id="_DescriptionOfAccountingPolicyForFairValueMeasurementExplanatory-c0_cont_1"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Management have assessed the
categorisation of the fair value measurements using the IFRS 13 fair value hierarchy. Categorisation within the hierarchy has been determined
on the basis of the lowest level of input that is significant to the fair value measurement of the relevant asset as follows;</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_39" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_38"><ix:continuation continuedAt="_DescriptionOfAccountingPolicyForFairValueMeasurementExplanatory-c0_cont_3" id="_DescriptionOfAccountingPolicyForFairValueMeasurementExplanatory-c0_cont_2"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Level 1 - valued using quoted prices in active
markets for identical assets</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_40" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_39"><ix:continuation continuedAt="_DescriptionOfAccountingPolicyForFairValueMeasurementExplanatory-c0_cont_4" id="_DescriptionOfAccountingPolicyForFairValueMeasurementExplanatory-c0_cont_3"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Level 2 - valued by reference to valuation techniques
using observable inputs other than quoted prices included within Level 1;</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_41" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_40"><ix:continuation id="_DescriptionOfAccountingPolicyForFairValueMeasurementExplanatory-c0_cont_4"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Level 3 - valued by reference to valuation techniques
using inputs that are not based on observable market data.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>


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    </div><div style="margin-top: 12pt; margin-bottom: 6pt; border-bottom: Black 1.5pt solid"><p style="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt">F-<!-- Field: Sequence; Type: Arabic; Name: PageNo -->9<!-- Field: /Sequence --></p></div><div>
    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
    </div><!-- Field: /Page --><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_42" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_41"><ix:nonNumeric contextRef="c0" continuedAt="_DescriptionOfAccountingPolicyForFinancialInstrumentsExplanatory-c0_cont_1" escape="true" name="ifrs-full:DescriptionOfAccountingPolicyForFinancialInstrumentsExplanatory"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>Financial instruments</b></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:nonNumeric></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_43" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_42"><ix:continuation continuedAt="_DescriptionOfAccountingPolicyForFinancialInstrumentsExplanatory-c0_cont_2" id="_DescriptionOfAccountingPolicyForFinancialInstrumentsExplanatory-c0_cont_1"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">The Group classifies a financial
instrument, or its component parts, as a financial liability, a financial asset or an equity instrument in accordance with the substance
of the contractual arrangement and the definitions of a financial liability, a financial asset and an equity instrument.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_44" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_43"><ix:continuation continuedAt="_DescriptionOfAccountingPolicyForFinancialInstrumentsExplanatory-c0_cont_3" id="_DescriptionOfAccountingPolicyForFinancialInstrumentsExplanatory-c0_cont_2"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">The Group evaluates the terms
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separately as financial assets, financial liabilities or equity instruments.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_45" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_44"><ix:continuation continuedAt="_DescriptionOfAccountingPolicyForFinancialInstrumentsExplanatory-c0_cont_4" id="_DescriptionOfAccountingPolicyForFinancialInstrumentsExplanatory-c0_cont_3"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">A financial instrument is
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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_46" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_45"><ix:continuation continuedAt="_DescriptionOfAccountingPolicyForFinancialInstrumentsExplanatory-c0_cont_5" id="_DescriptionOfAccountingPolicyForFinancialInstrumentsExplanatory-c0_cont_4"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">(a) Financial assets, initial
recognition and measurement and subsequent measurement</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation></ix:continuation><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_47" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_46"><ix:continuation continuedAt="_DescriptionOfAccountingPolicyForFinancialInstrumentsExplanatory-c0_cont_6" id="_DescriptionOfAccountingPolicyForFinancialInstrumentsExplanatory-c0_cont_5"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">All financial assets not recorded
at fair value through profit or loss, such as receivables and deposits, are recognized initially at fair value plus transaction costs.
Financial assets carried at fair value through profit or loss (FVTPL) are initially recognized at fair value, and transaction costs are
expensed in the consolidated statements of operations and comprehensive loss. The measurement of financial assets depends on their classification.
Financial assets such as receivables and deposits are subsequently measured at amortized cost using the effective interest method, less
loss allowance. The Group holds an investment in Accustem Inc.as a financial assets at fair value through profit or loss or fair value
through other comprehensive income.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">

</p></ix:continuation></ix:continuation><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_48" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_47"><ix:continuation continuedAt="_DescriptionOfAccountingPolicyForFinancialInstrumentsExplanatory-c0_cont_7" id="_DescriptionOfAccountingPolicyForFinancialInstrumentsExplanatory-c0_cont_6"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">(b) Financial liabilities,
initial recognition and measurement and subsequent measurement</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_49" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_48"><ix:continuation continuedAt="_DescriptionOfAccountingPolicyForFinancialInstrumentsExplanatory-c0_cont_8" id="_DescriptionOfAccountingPolicyForFinancialInstrumentsExplanatory-c0_cont_7"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Financial liabilities are
classified as measured at amortized cost or FVTPL.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_50" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_49"><ix:continuation continuedAt="_DescriptionOfAccountingPolicyForFinancialInstrumentsExplanatory-c0_cont_9" id="_DescriptionOfAccountingPolicyForFinancialInstrumentsExplanatory-c0_cont_8"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">A financial liability is
classified as at FVTPL if it is a derivative. Financial liabilities at FVTPL are measured at fair value and net gains and losses, including
any interest expense, are recognized in profit or loss. Other financial liabilities are subsequently measured at amortized cost using
the effective interest method. Interest expense and foreign exchange gains and losses are recognized in profit or loss. Any gain or loss
on derecognition is also recognized in profit or loss.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_51" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_50"><ix:continuation id="_DescriptionOfAccountingPolicyForFinancialInstrumentsExplanatory-c0_cont_9"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">The Group&#8217;s financial
liabilities include trade and other payables.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_52" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_51"><ix:nonNumeric contextRef="c0" continuedAt="tlsa_WarrantsPolicyTextBlock-c0_cont_1" escape="true" name="tlsa:WarrantsPolicyTextBlock"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b><i>Warrants</i></b></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:nonNumeric></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_53" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_52"><ix:continuation continuedAt="tlsa_WarrantsPolicyTextBlock-c0_cont_2" id="tlsa_WarrantsPolicyTextBlock-c0_cont_1"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Warrants are issued by the
Group in return for services and as part of a financing transaction.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><i>&#160;</i></p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_54" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_53"><ix:continuation continuedAt="tlsa_WarrantsPolicyTextBlock-c0_cont_3" id="tlsa_WarrantsPolicyTextBlock-c0_cont_2"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><i>Warrants issued in return for services.</i></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_55" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_54"><ix:continuation continuedAt="tlsa_WarrantsPolicyTextBlock-c0_cont_4" id="tlsa_WarrantsPolicyTextBlock-c0_cont_3"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">These warrants fall within
the scope of IFRS 2. The Company recognises that the fair value at the date of grant of these warrants should be expensed to the Statement
of Income and recognised over the life of the service for which the warrant was provided. These warrants have been valued by reference
to the equity instruments granted as they are all tied to Convertible loan notes. The measurement date is therefore the date that the
Convertible loan note was entered into.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><i>&#160;</i></p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_56" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_55"><ix:continuation continuedAt="tlsa_WarrantsPolicyTextBlock-c0_cont_5" id="tlsa_WarrantsPolicyTextBlock-c0_cont_4"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><i>Warrants issued as part of a financing transaction.</i></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_57" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_56"><ix:continuation id="tlsa_WarrantsPolicyTextBlock-c0_cont_5"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Warrants issued as part of
a financing transaction fall outside the scope of IFRS 2. These are classified as equity instruments because a fixed amount of cash is
exchanged for a fixed amount of equity. The fair value is recognised within equity and is not remeasured.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>


</div><!-- Field: Page; Sequence: 133; Value: 1 --><div>
    </div><div style="margin-top: 12pt; margin-bottom: 6pt; border-bottom: Black 1.5pt solid"><p style="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt">F-<!-- Field: Sequence; Type: Arabic; Name: PageNo -->10<!-- Field: /Sequence --></p></div><div>
    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
    </div><!-- Field: /Page --><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_58" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_57"><ix:nonNumeric contextRef="c0" continuedAt="_DescriptionOfAccountingPolicyForIssuedCapitalExplanatory-c0_cont_1" escape="true" name="ifrs-full:DescriptionOfAccountingPolicyForIssuedCapitalExplanatory"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>Share capital</b></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:nonNumeric></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_59" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_58"><ix:continuation id="_DescriptionOfAccountingPolicyForIssuedCapitalExplanatory-c0_cont_1"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Ordinary shares of the Company
are classified as equity.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_60" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_59"><ix:nonNumeric contextRef="c0" continuedAt="_DescriptionOfAccountingPolicyForPropertyPlantAndEquipmentExplanatory-c0_cont_1" escape="true" name="ifrs-full:DescriptionOfAccountingPolicyForPropertyPlantAndEquipmentExplanatory"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>Property, plant and equipment</b></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:nonNumeric></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_61" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_60"><ix:continuation continuedAt="_DescriptionOfAccountingPolicyForPropertyPlantAndEquipmentExplanatory-c0_cont_2" id="_DescriptionOfAccountingPolicyForPropertyPlantAndEquipmentExplanatory-c0_cont_1"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><b>(i</b>) Recognition and
measurement</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_62" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_61"><ix:continuation continuedAt="_DescriptionOfAccountingPolicyForPropertyPlantAndEquipmentExplanatory-c0_cont_3" id="_DescriptionOfAccountingPolicyForPropertyPlantAndEquipmentExplanatory-c0_cont_2"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Items of property, plant
and equipment are measured at cost less accumulated depreciation and accumulated impairment losses. Costs include expenditures that are
directly attributable to the acquisition of the asset. Purchased software that is integral to the functionality of the related equipment
is capitalised as part of that equipment.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_63" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_62"><ix:continuation continuedAt="_DescriptionOfAccountingPolicyForPropertyPlantAndEquipmentExplanatory-c0_cont_4" id="_DescriptionOfAccountingPolicyForPropertyPlantAndEquipmentExplanatory-c0_cont_3"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">When parts of an item of
property, plant and equipment have different useful lives, they are accounted for as separate items (major components) of property, plant
and equipment.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_64" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_63"><ix:continuation continuedAt="_DescriptionOfAccountingPolicyForPropertyPlantAndEquipmentExplanatory-c0_cont_5" id="_DescriptionOfAccountingPolicyForPropertyPlantAndEquipmentExplanatory-c0_cont_4"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Gains and losses on disposal
of an item of property, plant and equipment are determined by comparing the proceeds from disposal with the carrying amount of property,
plant and equipment, and are recognised in profit or loss.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_65" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_64"><ix:continuation continuedAt="_DescriptionOfAccountingPolicyForPropertyPlantAndEquipmentExplanatory-c0_cont_6" id="_DescriptionOfAccountingPolicyForPropertyPlantAndEquipmentExplanatory-c0_cont_5"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">(ii) Depreciation</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_66" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_65"><ix:continuation continuedAt="_DescriptionOfAccountingPolicyForPropertyPlantAndEquipmentExplanatory-c0_cont_7" id="_DescriptionOfAccountingPolicyForPropertyPlantAndEquipmentExplanatory-c0_cont_6"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Depreciation is calculated
on the depreciable amount, which is the cost of an asset, or other amount substituted for cost, less its residual value.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_67" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_66"><ix:continuation continuedAt="_DescriptionOfAccountingPolicyForPropertyPlantAndEquipmentExplanatory-c0_cont_8" id="_DescriptionOfAccountingPolicyForPropertyPlantAndEquipmentExplanatory-c0_cont_7"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Depreciation is recognised
in consolidated statements of operations and comprehensive loss on a straight-line basis over the estimated useful life of each part
of an item of property, plant and equipment. Leased assets are depreciated over the shorter of the lease term and their useful lives
unless it is reasonably certain that the Group will obtain ownership by the end of the lease term in which case they are depreciated
over their useful lives.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_68" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_67"><ix:continuation continuedAt="_DescriptionOfAccountingPolicyForPropertyPlantAndEquipmentExplanatory-c0_cont_9" id="_DescriptionOfAccountingPolicyForPropertyPlantAndEquipmentExplanatory-c0_cont_8"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">The estimated useful lives
for the current period and the comparative period are as follows.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_69" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_68"><ix:nonNumeric contextRef="c0" escape="true" name="tlsa:DisclosureOfDetailedInformationAboutEstimatedUsefulLives"><ix:continuation continuedAt="_DescriptionOfAccountingPolicyForPropertyPlantAndEquipmentExplanatory-c0_cont_10" id="_DescriptionOfAccountingPolicyForPropertyPlantAndEquipmentExplanatory-c0_cont_9"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_70" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_69"><ix:continuation id="_DescriptionOfAccountingPolicyForPropertyPlantAndEquipmentExplanatory-c0_cont_10"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Depreciation methods, useful
lives and residual values are reviewed at each reporting date. Depreciation is allocated to the operating expenses line of the Consolidated
statements of operations and comprehensive loss.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_71" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_70"><ix:nonNumeric contextRef="c0" continuedAt="_DescriptionOfAccountingPolicyForImpairmentOfAssetsExplanatory-c0_cont_1" escape="true" name="ifrs-full:DescriptionOfAccountingPolicyForImpairmentOfAssetsExplanatory"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>Impairment</b></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:nonNumeric></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_72" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_71"><ix:continuation continuedAt="_DescriptionOfAccountingPolicyForImpairmentOfAssetsExplanatory-c0_cont_2" id="_DescriptionOfAccountingPolicyForImpairmentOfAssetsExplanatory-c0_cont_1"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Impairment of financial assets
measured at amortised cost</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_73" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_72"><ix:continuation continuedAt="_DescriptionOfAccountingPolicyForImpairmentOfAssetsExplanatory-c0_cont_3" id="_DescriptionOfAccountingPolicyForImpairmentOfAssetsExplanatory-c0_cont_2"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">At each reporting date the
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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_74" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_73"><ix:continuation continuedAt="_DescriptionOfAccountingPolicyForImpairmentOfAssetsExplanatory-c0_cont_4" id="_DescriptionOfAccountingPolicyForImpairmentOfAssetsExplanatory-c0_cont_3"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">In establishing the appropriate
amount of loss allowance to be recognised, the Group applies either the general approach or the simplified approach, depending on the
nature of the underlying group of financial assets.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_75" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_74"><ix:continuation continuedAt="_DescriptionOfAccountingPolicyForImpairmentOfAssetsExplanatory-c0_cont_5" id="_DescriptionOfAccountingPolicyForImpairmentOfAssetsExplanatory-c0_cont_4"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><i>General approach</i></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_76" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_75"><ix:continuation continuedAt="_DescriptionOfAccountingPolicyForImpairmentOfAssetsExplanatory-c0_cont_6" id="_DescriptionOfAccountingPolicyForImpairmentOfAssetsExplanatory-c0_cont_5"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">The general approach is applied
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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_77" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_76"><ix:continuation continuedAt="_DescriptionOfAccountingPolicyForImpairmentOfAssetsExplanatory-c0_cont_7" id="_DescriptionOfAccountingPolicyForImpairmentOfAssetsExplanatory-c0_cont_6"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Under the general approach
the Group recognises a loss allowance for a financial asset at an amount equal to the 12-month expected credit losses, unless the credit
risk on the financial asset has increased significantly since initial recognition, in which case a loss allowance is recognised at an
amount equal to the lifetime expected credit losses.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>


</div><!-- Field: Page; Sequence: 134; Value: 1 --><div>
    </div><div style="margin-top: 12pt; margin-bottom: 6pt; border-bottom: Black 1.5pt solid"><p style="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt">F-<!-- Field: Sequence; Type: Arabic; Name: PageNo -->11<!-- Field: /Sequence --></p></div><div>
    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
    </div><!-- Field: /Page --><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_78" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_77"><ix:continuation continuedAt="_DescriptionOfAccountingPolicyForImpairmentOfAssetsExplanatory-c0_cont_8" id="_DescriptionOfAccountingPolicyForImpairmentOfAssetsExplanatory-c0_cont_7"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><i>Simplified approach</i></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_79" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_78"><ix:continuation continuedAt="_DescriptionOfAccountingPolicyForImpairmentOfAssetsExplanatory-c0_cont_9" id="_DescriptionOfAccountingPolicyForImpairmentOfAssetsExplanatory-c0_cont_8"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">The simplified approach is
applied to the impairment assessment of trade receivables.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_80" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_79"><ix:continuation continuedAt="_DescriptionOfAccountingPolicyForImpairmentOfAssetsExplanatory-c0_cont_10" id="_DescriptionOfAccountingPolicyForImpairmentOfAssetsExplanatory-c0_cont_9"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Under the simplified approach
the Group always recognises a loss allowance for a financial asset at an amount equal to the lifetime expected credit losses.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_81" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_80"><ix:continuation continuedAt="_DescriptionOfAccountingPolicyForImpairmentOfAssetsExplanatory-c0_cont_11" id="_DescriptionOfAccountingPolicyForImpairmentOfAssetsExplanatory-c0_cont_10"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><i>Impairment of non-financial assets</i></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_82" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_81"><ix:continuation continuedAt="_DescriptionOfAccountingPolicyForImpairmentOfAssetsExplanatory-c0_cont_12" id="_DescriptionOfAccountingPolicyForImpairmentOfAssetsExplanatory-c0_cont_11"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Non-financial assets are
tested for impairment whenever events or changes in circumstances indicate that the carrying amount may not be recoverable.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_83" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_82"><ix:continuation id="_DescriptionOfAccountingPolicyForImpairmentOfAssetsExplanatory-c0_cont_12"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Non-financial assets are
impaired when carrying amounts exceed recoverable amounts. The recoverable amount is measured as the higher of fair value less cost of
disposal and value in use. The value in use is calculated as being net projected cash flows based on financial forecasts discounted back
to present value at a pre-tax discount rate.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_84" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_83"><ix:nonNumeric contextRef="c0" continuedAt="_DescriptionOfAccountingPolicyForContingentLiabilitiesAndContingentAssetsExplanatory-c0_cont_1" escape="true" name="ifrs-full:DescriptionOfAccountingPolicyForContingentLiabilitiesAndContingentAssetsExplanatory"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>Contingent Liabilities</b></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>&#160;</b></p></ix:nonNumeric></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_85" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_84"><ix:continuation id="_DescriptionOfAccountingPolicyForContingentLiabilitiesAndContingentAssetsExplanatory-c0_cont_1"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">The Company is required to
make judgments about contingent liabilities including the probability of pending and potential future litigation outcomes that, by their
nature, are dependent on future events that are inherently uncertain. In making its determination of possible scenarios, management considers
the evaluation of outside counsel knowledgeable about each matter, as well as known outcomes in case law.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_86" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_85"><ix:nonNumeric contextRef="c0" continuedAt="_DescriptionOfAccountingPolicyForLeasesExplanatory-c0_cont_1" escape="true" name="ifrs-full:DescriptionOfAccountingPolicyForLeasesExplanatory"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>Leases</b></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:nonNumeric></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_87" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_86"><ix:continuation continuedAt="_DescriptionOfAccountingPolicyForLeasesExplanatory-c0_cont_2" id="_DescriptionOfAccountingPolicyForLeasesExplanatory-c0_cont_1"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">All leases are accounted
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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_88" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_87"><ix:continuation continuedAt="_DescriptionOfAccountingPolicyForLeasesExplanatory-c0_cont_3" id="_DescriptionOfAccountingPolicyForLeasesExplanatory-c0_cont_2"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
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    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Leases of low value assets;
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  </table><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p></ix:continuation></ix:continuation><div>
</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_89" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_88"><ix:continuation continuedAt="_DescriptionOfAccountingPolicyForLeasesExplanatory-c0_cont_4" id="_DescriptionOfAccountingPolicyForLeasesExplanatory-c0_cont_3"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
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  </table><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p></ix:continuation></ix:continuation><div>
</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_90" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_89"><ix:continuation continuedAt="_DescriptionOfAccountingPolicyForLeasesExplanatory-c0_cont_5" id="_DescriptionOfAccountingPolicyForLeasesExplanatory-c0_cont_4"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">The Group has leases for
its offices. Each lease is reflected on the consolidated balance sheet as a right-of-use asset and a lease liability. The Group does
not have any leases of low value assets. Variable lease payments which do not depend on an index or a rate (such as lease payments based
on a percentage of Group sales) are excluded from the initial measurement of the lease liability and asset. The Group classifies its
right-of-use assets in a consistent manner to its property, plant and equipment (see Note 21).</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_91" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_90"><ix:continuation continuedAt="_DescriptionOfAccountingPolicyForLeasesExplanatory-c0_cont_6" id="_DescriptionOfAccountingPolicyForLeasesExplanatory-c0_cont_5"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">For leases over office buildings
and factory premises the Group must keep those properties in a good state of repair and return the properties in their original condition
at the end of the lease. The expected costs of returning to original condition are considered negligible.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_92" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_91"><ix:continuation continuedAt="_DescriptionOfAccountingPolicyForLeasesExplanatory-c0_cont_7" id="_DescriptionOfAccountingPolicyForLeasesExplanatory-c0_cont_6"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">At lease commencement date,
the Group recognises a right-of-use asset and a lease liability in its consolidated balance sheets. The right-of-use asset is measured
at cost, which is made up of the initial measurement of the lease liability, any initial direct costs incurred by the Group, an estimate
of any costs to dismantle and remove the asset at the end of the lease, and any lease payments made in advance of the lease commencement
date (net of any incentives received).</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_93" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_92"><ix:continuation continuedAt="_DescriptionOfAccountingPolicyForLeasesExplanatory-c0_cont_8" id="_DescriptionOfAccountingPolicyForLeasesExplanatory-c0_cont_7"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">At the commencement date,
the Group measures the lease liability at the present value of the lease payments unpaid at that date, discounted using the Group&#8217;s
incremental borrowing rate because as the lease contracts are negotiated with third parties it is not possible to determine the interest
rate that is implicit in the lease. The incremental borrowing rate is the estimated rate that the Group would have to pay to borrow the
same amount over a similar term, and with similar security to obtain an asset of equivalent value. This rate is adjusted should the lessee
entity have a different risk profile to that of the Group.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_94" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_93"><ix:continuation continuedAt="_DescriptionOfAccountingPolicyForLeasesExplanatory-c0_cont_9" id="_DescriptionOfAccountingPolicyForLeasesExplanatory-c0_cont_8"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">The Group depreciates the
right-of-use asset on a straight-line basis from the lease commencement date to the earlier of the end of the useful life of the right-of-use
asset or the end of the lease term. The Group also assesses the right-of-use asset for impairment when such indicators exist.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>


</div><!-- Field: Page; Sequence: 135; Value: 1 --><div>
    </div><div style="margin-top: 12pt; margin-bottom: 6pt; border-bottom: Black 1.5pt solid"><p style="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt">F-<!-- Field: Sequence; Type: Arabic; Name: PageNo -->12<!-- Field: /Sequence --></p></div><div>
    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
    </div><!-- Field: /Page --><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_95" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_94"><ix:continuation continuedAt="_DescriptionOfAccountingPolicyForLeasesExplanatory-c0_cont_10" id="_DescriptionOfAccountingPolicyForLeasesExplanatory-c0_cont_9"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Lease payments included in
the measurement of the lease liability are made up of fixed payments (including in substance fixed), variable payments based on an index
or rate, amounts expected to be payable under a residual value guarantee and payments arising from options reasonably certain to be exercised.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_96" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_95"><ix:continuation continuedAt="_DescriptionOfAccountingPolicyForLeasesExplanatory-c0_cont_11" id="_DescriptionOfAccountingPolicyForLeasesExplanatory-c0_cont_10"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Subsequent to initial measurement,
the liability will be reduced by lease payments that are allocated between repayments of principal and finance costs. The finance cost
is the amount that produces a constant periodic rate of interest on the remaining balance of the lease liability.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_97" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_96"><ix:continuation id="_DescriptionOfAccountingPolicyForLeasesExplanatory-c0_cont_11"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Short term leases exempt
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</div><div>

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</div><div>

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requires assumptions to be made regarding future events and market conditions. These assumptions include the future volatility of the
Company&#8217;s share price. These assumptions are then applied to a recognised valuation model in order to calculate the fair value
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</div><div>

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</div><div>

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a charge is made to the Consolidated statements of operations and comprehensive loss for all share-based payments including share options
based upon the fair value of the instrument used. A corresponding credit is made to an equity reserve, in the case of options/warrants
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</div><div>

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vesting conditions apply, the expense is allocated over the vesting period, based on the best available estimate of the number of share
options/warrants expected to vest. Non market vesting conditions are included in assumptions about the number of options/warrants that
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</div><div>

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is made to the expense or share issue cost recognised in prior periods if fewer share options ultimately are exercised than originally
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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_104" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_103"><ix:continuation continuedAt="_DescriptionOfAccountingPolicyForSharebasedPaymentTransactionsExplanatory-c0_cont_7" id="_DescriptionOfAccountingPolicyForSharebasedPaymentTransactionsExplanatory-c0_cont_6"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Upon exercise of share options/warrants,
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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_105" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_104"><ix:continuation continuedAt="_DescriptionOfAccountingPolicyForSharebasedPaymentTransactionsExplanatory-c0_cont_8" id="_DescriptionOfAccountingPolicyForSharebasedPaymentTransactionsExplanatory-c0_cont_7"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Where share options are cancelled,
this is treated as an acceleration of the vesting period of the options. The amount that otherwise would have been recognised for services
received over the remainder of the vesting period is recognised immediately within the Consolidated statements of operations and comprehensive
loss.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_106" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_105"><ix:continuation id="_DescriptionOfAccountingPolicyForSharebasedPaymentTransactionsExplanatory-c0_cont_8"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">All goods and services received
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</div><div>


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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_108" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_107"><ix:continuation id="tlsa_SubLicenseIncomePolicyTextBlock-c0_cont_1"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">In September 2021 the Company
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with the contract for the grant of an exclusive license to use foralumab as a lymphodepletion agent in conjunction with Precision Biosciences,
Inc&#8217;s allogeneic CAR T therapeutics for the treatment of cancers. Sublicense income is included in other income on the consolidated
statements of operations and comprehensive loss.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_109" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_108"><ix:nonNumeric contextRef="c0" continuedAt="_DescriptionOfAccountingPolicyForIntangibleAssetsOtherThanGoodwillExplanatory-c0_cont_1" escape="true" name="ifrs-full:DescriptionOfAccountingPolicyForIntangibleAssetsOtherThanGoodwillExplanatory"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>Other intangible assets</b></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>&#160;</b></p></ix:nonNumeric></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_110" id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_109"><ix:continuation continuedAt="_DescriptionOfAccountingPolicyForIntangibleAssetsOtherThanGoodwillExplanatory-c0_cont_2" id="_DescriptionOfAccountingPolicyForIntangibleAssetsOtherThanGoodwillExplanatory-c0_cont_1"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Other intangible assets that
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</div><div>

</div><ix:continuation id="_DisclosureOfSummaryOfSignificantAccountingPoliciesExplanatory-c0_cont_110"><ix:continuation id="_DescriptionOfAccountingPolicyForIntangibleAssetsOtherThanGoodwillExplanatory-c0_cont_2"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">At each balance sheet date
non-financial assets are assessed to determine whether there is an indication that the asset or the asset&#8217;s cash generating unit
may be impaired. If there is such an indication the recoverable amount of the asset or asset&#8217;s cash generating unit is compared
to the carrying amount.</p></ix:continuation></ix:continuation><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

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</div><div>

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information in accordance with generally accepted accounting practice, in the case of the Group being International Financial Reporting
Standards as issued by the IASB, requires the directors to make estimates and judgements that affect the reported amount of assets, liabilities,
income and expenditure and the disclosures made in the consolidated financial statements. Such estimates and judgements must be continually
evaluated based on historical experience and other factors, including expectations of future events.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p></ix:continuation><div>

</div><div>

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to be critical accounting estimates:</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation><div>

</div><div>

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</div><div>

</div><ix:continuation continuedAt="_DescriptionOfNatureAndAmountOfChangeInAccountingEstimate-c0_cont_5" id="_DescriptionOfNatureAndAmountOfChangeInAccountingEstimate-c0_cont_4"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">The Group accounts for share-based
payment transactions for employees in accordance with IFRS 2 Share-based Payment, which requires the measurement of the cost of employee
services received in exchange for the options on our ordinary shares, based on the fair value of the award on the grant date.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p></ix:continuation><div>

</div><div>

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Black-Scholes-Merton option pricing model as the most appropriate method for determining the estimated fair value of our share-based
awards without market conditions. For performance-based options that include vesting conditions relating to the market performance of
our ordinary shares, a Monte Carlo pricing model was used in order to reflect the valuation impact of price hurdles that have to be met
as conditions to vesting.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p></ix:continuation><div>

</div><div>

</div><ix:continuation id="_DescriptionOfNatureAndAmountOfChangeInAccountingEstimate-c0_cont_6"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">The Company makes estimates
as to the useful life of an option award, the expected price volatility of the underlying share, risk free interest rate for the term
of the award and correlations and volatilities of the shares of peer group companies. The Company also makes estimates as to the vesting
period for awards that have performance &#8211; based criteria.</p></ix:continuation><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p><div>


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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p><div>

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</div><div>

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</div><div>

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  </table><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p></ix:nonNumeric></ix:continuation><div>


</div><div>

</div><ix:continuation id="_DisclosureOfOtherOperatingIncomeExplanatory-c0_cont_3"><p style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-right: 0; margin-bottom: 0pt; text-align: justify">Sublicense income has been
classified as other income as the counterparty is not considered a customer but an entity we are collaborating with.</p></ix:continuation><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p><div>

</div><ix:nonNumeric contextRef="c0" continuedAt="_DisclosureOfProfitLossFromOperatingActivitiesExplanatory-c0_cont_1" escape="true" name="ifrs-full:DisclosureOfProfitLossFromOperatingActivitiesExplanatory"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>5. OPERATING LOSS</b></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:nonNumeric><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfProfitLossFromOperatingActivitiesExplanatory-c0_cont_2" id="_DisclosureOfProfitLossFromOperatingActivitiesExplanatory-c0_cont_1"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">The Group&#8217;s operating
losses are stated after charging/(crediting) the following:</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfProfitLossFromOperatingActivitiesExplanatory-c0_cont_3" id="_DisclosureOfProfitLossFromOperatingActivitiesExplanatory-c0_cont_2"><ix:nonNumeric contextRef="c0" escape="true" name="tlsa:DisclosureOfDetailedInformationAboutOperatingLoss"><table cellpadding="0" cellspacing="0" style="border-collapse: collapse; width: 100%; font: 10pt Times New Roman, Times, Serif">
  <tr style="vertical-align: bottom">
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  <tr style="vertical-align: bottom">
    <td>&#160;</td><td style="font-weight: bold; padding-bottom: 1.5pt">&#160;</td>
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="width: 64%; text-align: left">License fee</td><td style="width: 1%">&#160;</td>
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  <tr style="vertical-align: bottom; ">
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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"><div style="-sec-ix-hidden: hidden-fact-188">-</div></td><td style="text-align: left">&#160;</td><td>&#160;</td>
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  <tr style="vertical-align: bottom; ">
    <td style="text-align: left">Depreciation of Property, plant and equipment</td><td>&#160;</td>
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="text-align: left">Depreciation (Right-of-use asset)</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><ix:nonFraction contextRef="c0" decimals="-3" format="ixt:num-dot-decimal" name="ifrs-full:DepreciationRightofuseAssets" scale="3" unitRef="usd">50</ix:nonFraction></td><td style="text-align: left">&#160;</td><td>&#160;</td>
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  <tr style="vertical-align: bottom; ">
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    <td style="text-align: left">&#160;</td><td style="text-align: right">(<ix:nonFraction contextRef="c0" decimals="-3" format="ixt:num-dot-decimal" name="tlsa:ForeignExchangegainlosses" scale="3" sign="-" unitRef="usd">3,183</ix:nonFraction></td><td style="text-align: left">)</td><td>&#160;</td>
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  </table><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:nonNumeric></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfProfitLossFromOperatingActivitiesExplanatory-c0_cont_4" id="_DisclosureOfProfitLossFromOperatingActivitiesExplanatory-c0_cont_3"><p style="font: 10pt Times New Roman, Times, Serif; text-indent: 0.5in; margin: 0pt 0; text-align: justify">License fees relating to
2020 were waived in 2021 as a result of negotiations by the Group.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation><div>

</div><div>

</div><ix:continuation id="_DisclosureOfProfitLossFromOperatingActivitiesExplanatory-c0_cont_4"><p style="font: 10pt Times New Roman, Times, Serif; text-indent: 0.5in; margin: 0pt 0; text-align: justify">A realization bonus of $<ix:nonFraction contextRef="c5" decimals="-5" format="ixt:num-dot-decimal" name="ifrs-full:BenefitsPaidOrPayable" scale="6" unitRef="usd">13.5</ix:nonFraction>
million became payable during the year ended December 31, 2020 to the chairman of the board upon the Company raising funds in excess
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was accrued on the amount due in the year to December 31, 2021. No realization bonus is accounted for in year ended December 31, 2022.</p></ix:continuation><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><ix:nonNumeric contextRef="c0" continuedAt="tlsa_DescriptionOfSegmentReportingExplanatory-c0_cont_1" escape="true" name="tlsa:DescriptionOfSegmentReportingExplanatory"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>6. SEGMENTAL REPORTING</b></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:nonNumeric><div>

</div><div>

</div><ix:continuation id="tlsa_DescriptionOfSegmentReportingExplanatory-c0_cont_1"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">During the year under review
Management identified the Group&#8217;s only operating segment as the research and development of biotechnological and pharmaceutical
products. This one segment is monitored and strategic decisions are made based upon it and other non-financial data collated from industry
intelligence. The form of financial reporting reported to the Board is consistent with those presented in the annual consolidated financial
statements.</p></ix:continuation><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p><div>


</div><!-- Field: Page; Sequence: 138; Value: 1 --><div>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p><div>

</div><ix:nonNumeric contextRef="c0" continuedAt="_DisclosureOfInformationAboutEmployeesExplanatory-c0_cont_1" escape="true" name="ifrs-full:DisclosureOfInformationAboutEmployeesExplanatory"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>7. EMPLOYEES</b></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>&#160;</b></p></ix:nonNumeric><div>

</div><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p><div>

</div><ix:continuation id="_DisclosureOfInformationAboutEmployeesExplanatory-c0_cont_1"><ix:nonNumeric contextRef="c0" escape="true" name="tlsa:DisclosureOfDetailedInformationAboutEmployeesExplanatory"><table cellpadding="0" cellspacing="0" style="border-collapse: collapse; width: 100%; font: 10pt Times New Roman, Times, Serif">
  <tr style="vertical-align: bottom">
    <td>&#160;</td><td style="font-weight: bold; padding-bottom: 1.5pt">&#160;</td>
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  <tr style="vertical-align: bottom">
    <td>&#160;</td><td style="font-weight: bold; padding-bottom: 1.5pt">&#160;</td>
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="text-align: left">Staff costs comprised:</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></tr>
  <tr style="vertical-align: bottom; ">
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    <td style="width: 1%; text-align: left">&#160;</td><td style="width: 9%; text-align: right"><ix:nonFraction contextRef="c0" decimals="-3" format="ixt:num-dot-decimal" name="ifrs-full:DirectorsRemunerationExpense" scale="3" unitRef="usd">554</ix:nonFraction></td><td style="width: 1%; text-align: left">&#160;</td><td style="width: 1%">&#160;</td>
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="text-align: left; text-indent: -9pt; padding-left: 9pt">Employees&#8217; wages, salaries and bonus</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><ix:nonFraction contextRef="c0" decimals="-3" format="ixt:num-dot-decimal" name="ifrs-full:WagesAndSalaries" scale="3" unitRef="usd">2,014</ix:nonFraction></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"><ix:nonFraction contextRef="c5" decimals="-3" format="ixt:num-dot-decimal" name="ifrs-full:WagesAndSalaries" scale="3" unitRef="usd">1,058</ix:nonFraction></td><td style="text-align: left">&#160;</td></tr>
  <tr style="vertical-align: bottom; ">
    <td style="text-align: left; text-indent: -9pt; padding-left: 9pt">Social security costs</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><ix:nonFraction contextRef="c0" decimals="-3" format="ixt:num-dot-decimal" name="ifrs-full:SocialSecurityContributions" scale="3" unitRef="usd">135</ix:nonFraction></td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><ix:nonFraction contextRef="c4" decimals="-3" format="ixt:num-dot-decimal" name="ifrs-full:SocialSecurityContributions" scale="3" unitRef="usd">176</ix:nonFraction></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)">
    <td style="text-align: left; text-indent: -9pt; padding-left: 9pt">Recruitment fees</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><ix:nonFraction contextRef="c0" decimals="-3" format="ixt:num-dot-decimal" name="tlsa:RecruitmentFees" scale="3" unitRef="usd">197</ix:nonFraction></td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><ix:nonFraction contextRef="c4" decimals="-3" format="ixt:num-dot-decimal" name="tlsa:RecruitmentFees" scale="3" unitRef="usd">242</ix:nonFraction></td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><ix:nonFraction contextRef="c5" decimals="-3" format="ixt:num-dot-decimal" name="tlsa:RecruitmentFees" scale="3" unitRef="usd">17</ix:nonFraction></td><td style="text-align: left">&#160;</td></tr>
  <tr style="vertical-align: bottom; ">
    <td style="text-align: left; padding-bottom: 1.5pt; text-indent: -9pt; padding-left: 9pt">Share based payment charge</td><td style="padding-bottom: 1.5pt">&#160;</td>
    <td style="border-bottom: Black 1.5pt solid; text-align: left">&#160;</td><td style="border-bottom: Black 1.5pt solid; text-align: right">(<ix:nonFraction contextRef="c0" decimals="-3" format="ixt:num-dot-decimal" name="ifrs-full:ExpenseFromSharebasedPaymentTransactionsWithEmployees" scale="3" sign="-" unitRef="usd">1,410</ix:nonFraction></td><td style="padding-bottom: 1.5pt; text-align: left">)</td><td style="padding-bottom: 1.5pt">&#160;</td>
    <td style="border-bottom: Black 1.5pt solid; text-align: left">&#160;</td><td style="border-bottom: Black 1.5pt solid; text-align: right"><ix:nonFraction contextRef="c4" decimals="-3" format="ixt:num-dot-decimal" name="ifrs-full:ExpenseFromSharebasedPaymentTransactionsWithEmployees" scale="3" unitRef="usd">5,173</ix:nonFraction></td><td style="padding-bottom: 1.5pt; text-align: left">&#160;</td><td style="padding-bottom: 1.5pt">&#160;</td>
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  </table></ix:nonNumeric></ix:continuation><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>&#160;&#160;</b></p><div>

</div><ix:nonNumeric contextRef="c0" continuedAt="_DisclosureOfInformationAboutKeyManagementPersonnelExplanatory-c0_cont_1" escape="true" name="ifrs-full:DisclosureOfInformationAboutKeyManagementPersonnelExplanatory"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>8. REMUNERATION OF KEY MANAGEMENT PERSONNEL</b></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>&#160;</b></p></ix:nonNumeric><div>

</div><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p><div>

</div><ix:continuation continuedAt="_DisclosureOfInformationAboutKeyManagementPersonnelExplanatory-c0_cont_2" id="_DisclosureOfInformationAboutKeyManagementPersonnelExplanatory-c0_cont_1"><ix:nonNumeric contextRef="c0" continuedAt="tlsa_DisclosureOfDetailedInformationAboutRemunerationOfKeyManagementPersonnelTextBlock-c0_cont_1" escape="true" name="tlsa:DisclosureOfDetailedInformationAboutRemunerationOfKeyManagementPersonnelTextBlock"><table cellpadding="0" cellspacing="0" style="border-collapse: collapse; width: 100%; font: 10pt Times New Roman, Times, Serif">
  <tr style="vertical-align: bottom">
    <td style="font-weight: bold; border-bottom: Black 1.5pt solid">$&#8217;000</td><td style="font-weight: bold; padding-bottom: 1.5pt">&#160;</td>
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  <tr style="vertical-align: bottom">
    <td>&#160;</td><td style="font-weight: bold; padding-bottom: 1.5pt">&#160;</td>
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  <tr style="vertical-align: bottom">
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  <tr style="vertical-align: bottom; ">
    <td style="text-align: left; text-indent: -9pt; padding-left: 9pt">Willy Simon</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"><div style="-sec-ix-hidden: hidden-fact-194">&#160;</div></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)">
    <td style="text-align: left; text-indent: -9pt; padding-left: 9pt">Gregor MacRae</td><td>&#160;</td>
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    <td style="text-align: left">&#160;</td><td style="text-align: right"><div style="-sec-ix-hidden: hidden-fact-198">-</div></td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><div style="-sec-ix-hidden: hidden-fact-199">-</div></td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><div style="-sec-ix-hidden: hidden-fact-200">-</div></td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><div style="-sec-ix-hidden: hidden-fact-201">-</div></td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><div style="-sec-ix-hidden: hidden-fact-202">-</div></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"><div style="-sec-ix-hidden: hidden-fact-205">-</div></td><td style="text-align: left">&#160;</td><td>&#160;</td>
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  <tr style="vertical-align: bottom; ">
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    <td style="text-align: left">&#160;</td><td style="text-align: right"><div style="-sec-ix-hidden: hidden-fact-209">-</div></td><td style="text-align: left">&#160;</td><td>&#160;</td>
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</div><ix:continuation continuedAt="_DisclosureOfInformationAboutKeyManagementPersonnelExplanatory-c0_cont_3" id="_DisclosureOfInformationAboutKeyManagementPersonnelExplanatory-c0_cont_2"><ix:continuation id="tlsa_DisclosureOfDetailedInformationAboutRemunerationOfKeyManagementPersonnelTextBlock-c0_cont_1"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%"> <tr style="vertical-align: top"> <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">(1)</span></td> <td style="text-align: justify"><ix:nonNumeric contextRef="c0" name="tlsa:GabrieleCerronesBonusDescription"><ix:footnote id="ix_0_footnote" xml:lang="en-US"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Gabriele Cerrone&#8217;s 2021 bonus is the interest charged on his 2020 bonus due to delayed issuance of shares; his 2020 bonus includes a $13.2m realization bonus.</span></ix:footnote></ix:nonNumeric></td></tr> </table><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p></ix:continuation></ix:continuation><div>
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</div><!-- Field: Page; Sequence: 139; Options: NewSection; Value: 16 --><div>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p><div>

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</div><div>

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</div><div>

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  <tr style="vertical-align: bottom; ">
    <td style="text-align: left; padding-bottom: 1.5pt">T Adams</td><td style="padding-bottom: 1.5pt">&#160;</td>
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="padding-bottom: 4pt">&#160;</td><td style="padding-bottom: 4pt">&#160;</td>
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  </table><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:nonNumeric></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfInformationAboutKeyManagementPersonnelExplanatory-c0_cont_7" id="_DisclosureOfInformationAboutKeyManagementPersonnelExplanatory-c0_cont_6"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Key management personnel
of the Group are comprised of directors and officers of the Company.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfInformationAboutKeyManagementPersonnelExplanatory-c0_cont_8" id="_DisclosureOfInformationAboutKeyManagementPersonnelExplanatory-c0_cont_7"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">No share options were exercised
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December 2020 for an intrinsic gain of $<ix:nonFraction contextRef="c5" decimals="-5" format="ixt:num-dot-decimal" name="tlsa:intrinsicGain" scale="6" unitRef="usd">4.1</ix:nonFraction>m.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation><div>

</div><div>

</div><ix:continuation id="_DisclosureOfInformationAboutKeyManagementPersonnelExplanatory-c0_cont_8"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">The Company made payments
totaling approximately $<ix:nonFraction contextRef="c0" decimals="0" format="ixt:num-dot-decimal" name="ifrs-full:PostemploymentBenefitExpenseDefinedContributionPlans" scale="0" unitRef="usd">32</ix:nonFraction>K, $<ix:nonFraction contextRef="c4" decimals="-3" format="ixt:num-dot-decimal" name="ifrs-full:PostemploymentBenefitExpenseDefinedContributionPlans" scale="3" unitRef="usd">24</ix:nonFraction>K, and $<ix:nonFraction contextRef="c5" decimals="-3" format="ixt:num-dot-decimal" name="ifrs-full:PostemploymentBenefitExpenseDefinedContributionPlans" scale="3" unitRef="usd">10</ix:nonFraction>K to defined contribution pension schemes on behalf of directors or employees during 2022,
2021, and 2020, respectively.</p></ix:continuation><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><ix:nonNumeric contextRef="c0" continuedAt="_DisclosureOfFinanceCostExplanatory-c0_cont_1" escape="true" name="ifrs-full:DisclosureOfFinanceCostExplanatory"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;<b>9. FINANCE COSTS</b></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&#160;</p></ix:nonNumeric><div>

</div><div>

</div><ix:continuation id="_DisclosureOfFinanceCostExplanatory-c0_cont_1"><ix:nonNumeric contextRef="c0" escape="true" name="tlsa:DisclosureDetailedInformationAboutOfFinanceCostTableTextBlock"><table cellpadding="0" cellspacing="0" style="border-collapse: collapse; width: 100%; font: 10pt Times New Roman, Times, Serif">
  <tr style="vertical-align: bottom">
    <td>&#160;</td><td style="font-weight: bold; padding-bottom: 1.5pt">&#160;</td>
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  <tr style="vertical-align: bottom">
    <td>&#160;</td><td style="font-weight: bold; padding-bottom: 1.5pt">&#160;</td>
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  <tr style="vertical-align: bottom">
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    <td colspan="2" style="padding-bottom: 1.5pt">&#160;</td><td style="padding-bottom: 1.5pt">&#160;</td><td style="padding-bottom: 1.5pt">&#160;</td>
    <td colspan="2" style="padding-bottom: 1.5pt">&#160;</td><td style="padding-bottom: 1.5pt">&#160;</td><td style="padding-bottom: 1.5pt">&#160;</td>
    <td colspan="2" style="padding-bottom: 1.5pt">&#160;</td><td style="padding-bottom: 1.5pt">&#160;</td></tr>
  <tr style="vertical-align: bottom">
    <td style="padding-bottom: 1.5pt"><span style="text-decoration:underline">Finance Income</span></td><td style="padding-bottom: 1.5pt">&#160;</td>
    <td colspan="2" style="text-align: right">&#160;</td><td style="padding-bottom: 1.5pt">&#160;</td><td style="padding-bottom: 1.5pt">&#160;</td>
    <td colspan="2" style="text-align: right">&#160;</td><td style="padding-bottom: 1.5pt">&#160;</td><td style="padding-bottom: 1.5pt">&#160;</td>
    <td colspan="2" style="text-align: right">&#160;</td><td style="padding-bottom: 1.5pt">&#160;</td></tr>
  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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    <td style="width: 1%; border-bottom: Black 1.5pt solid; text-align: left">&#160;</td><td style="width: 9%; border-bottom: Black 1.5pt solid; text-align: right"><div style="-sec-ix-hidden: hidden-fact-241">-</div></td><td style="width: 1%; padding-bottom: 1.5pt; text-align: left">&#160;</td><td style="width: 1%; padding-bottom: 1.5pt">&#160;</td>
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  <tr style="vertical-align: bottom; ">
    <td style="text-align: left">Total finance income</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><div style="-sec-ix-hidden: hidden-fact-243">-</div></td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><div style="-sec-ix-hidden: hidden-fact-244">-</div></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)">
    <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><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>
  <tr style="vertical-align: bottom; ">
    <td style="text-decoration: underline; text-align: left">Finance Expense</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></tr>
  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="text-align: left">Finance charge accrued on convertible loan notes</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><div style="-sec-ix-hidden: hidden-fact-245">-</div></td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><ix:nonFraction contextRef="c4" decimals="-3" format="ixt:num-dot-decimal" name="tlsa:FinanceChargeAccruedOnConvertibleLoanNotes" scale="3" unitRef="usd">163</ix:nonFraction></td><td style="text-align: left">&#160;</td><td>&#160;</td>
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  <tr style="vertical-align: bottom; ">
    <td style="text-align: left; padding-bottom: 1.5pt">Interest expense on lease liabilities</td><td style="padding-bottom: 1.5pt">&#160;</td>
    <td style="border-bottom: Black 1.5pt solid; text-align: left">&#160;</td><td style="border-bottom: Black 1.5pt solid; text-align: right"><ix:nonFraction contextRef="c0" decimals="-3" format="ixt:num-dot-decimal" name="ifrs-full:InterestExpenseOnLeaseLiabilities" scale="3" unitRef="usd">7</ix:nonFraction></td><td style="padding-bottom: 1.5pt; text-align: left">&#160;</td><td style="padding-bottom: 1.5pt">&#160;</td>
    <td style="border-bottom: Black 1.5pt solid; text-align: left">&#160;</td><td style="border-bottom: Black 1.5pt solid; text-align: right"><ix:nonFraction contextRef="c4" decimals="-3" format="ixt:num-dot-decimal" name="ifrs-full:InterestExpenseOnLeaseLiabilities" scale="3" unitRef="usd">13</ix:nonFraction></td><td style="padding-bottom: 1.5pt; text-align: left">&#160;</td><td style="padding-bottom: 1.5pt">&#160;</td>
    <td style="border-bottom: Black 1.5pt solid; text-align: left">&#160;</td><td style="border-bottom: Black 1.5pt solid; text-align: right"><ix:nonFraction contextRef="c5" decimals="-3" format="ixt:num-dot-decimal" name="ifrs-full:InterestExpenseOnLeaseLiabilities" scale="3" unitRef="usd">17</ix:nonFraction></td><td style="padding-bottom: 1.5pt; text-align: left">&#160;</td></tr>
  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="font-weight: bold; text-align: left; padding-bottom: 4pt">Total finance expenses</td><td style="padding-bottom: 4pt">&#160;</td>
    <td style="border-bottom: Black 4pt double; text-align: left">&#160;</td><td style="border-bottom: Black 4pt double; text-align: right"><ix:nonFraction contextRef="c0" decimals="-3" format="ixt:num-dot-decimal" name="tlsa:FinanceExpense" scale="3" unitRef="usd">7</ix:nonFraction></td><td style="padding-bottom: 4pt; text-align: left">&#160;</td><td style="padding-bottom: 4pt">&#160;</td>
    <td style="border-bottom: Black 4pt double; text-align: left">&#160;</td><td style="border-bottom: Black 4pt double; text-align: right"><ix:nonFraction contextRef="c4" decimals="-3" format="ixt:num-dot-decimal" name="tlsa:FinanceExpense" scale="3" unitRef="usd">176</ix:nonFraction></td><td style="padding-bottom: 4pt; text-align: left">&#160;</td><td style="padding-bottom: 4pt">&#160;</td>
    <td style="border-bottom: Black 4pt double; text-align: left">&#160;</td><td style="border-bottom: Black 4pt double; text-align: right"><ix:nonFraction contextRef="c5" decimals="-3" format="ixt:num-dot-decimal" name="tlsa:FinanceExpense" scale="3" unitRef="usd">320</ix:nonFraction></td><td style="padding-bottom: 4pt; text-align: left">&#160;</td></tr>
  <tr style="vertical-align: bottom; ">
    <td style="text-indent: -0.125in; padding-left: 0.125in; font-weight: bold; text-align: left; padding-bottom: 4pt">Net finance expense
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    <td style="border-bottom: Black 4pt double; text-align: left">&#160;</td><td style="border-bottom: Black 4pt double; text-align: right"><ix:nonFraction contextRef="c0" decimals="-3" format="ixt:num-dot-decimal" name="tlsa:NetFinanceExpenseRecognizedInStatementOfComprehensiveIncome" scale="3" unitRef="usd">7</ix:nonFraction></td><td style="padding-bottom: 4pt; text-align: left">&#160;</td><td style="padding-bottom: 4pt">&#160;</td>
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  </table></ix:nonNumeric></ix:continuation><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"></p><div>

</div><!-- Field: Page; Sequence: 140; Value: 16 --><div>
    </div><div style="margin-top: 12pt; margin-bottom: 6pt; border-bottom: Black 1.5pt solid"><p style="font-size: 10pt; text-align: center; margin-top: 0pt; margin-bottom: 0pt">F-<!-- Field: Sequence; Type: Arabic; Name: PageNo -->17<!-- Field: /Sequence --></p></div><div>
    </div><div style="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><p style="margin: 0pt">&#160;</p></div><div>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p><div>

</div><ix:nonNumeric contextRef="c0" continuedAt="_DisclosureOfIncomeTaxExplanatory-c0_cont_1" escape="true" name="ifrs-full:DisclosureOfIncomeTaxExplanatory"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>10. TAXATION </b></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>&#160;</b></p></ix:nonNumeric><div>
</div><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p><div>

</div><ix:continuation continuedAt="_DisclosureOfIncomeTaxExplanatory-c0_cont_2" id="_DisclosureOfIncomeTaxExplanatory-c0_cont_1"><ix:nonNumeric contextRef="c0" escape="true" name="tlsa:DisclosureOfDetailedInformationAboutIncomeTaxExpenseBenefitTableTextBlock"><table cellpadding="0" cellspacing="0" style="border-collapse: collapse; width: 100%; font: 10pt Times New Roman, Times, Serif">
  <tr style="vertical-align: bottom">
    <td>&#160;</td><td style="font-weight: bold; padding-bottom: 1.5pt">&#160;</td>
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  <tr style="vertical-align: bottom">
    <td>&#160;</td><td style="font-weight: bold; padding-bottom: 1.5pt">&#160;</td>
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  <tr style="vertical-align: bottom">
    <td style="font-weight: bold"><span style="text-decoration:underline">Group</span></td><td style="padding-bottom: 1.5pt">&#160;</td>
    <td colspan="2">&#160;</td><td style="padding-bottom: 1.5pt">&#160;</td><td style="padding-bottom: 1.5pt">&#160;</td>
    <td colspan="2">&#160;</td><td style="padding-bottom: 1.5pt">&#160;</td><td style="padding-bottom: 1.5pt">&#160;</td>
    <td colspan="2">&#160;</td><td style="padding-bottom: 1.5pt">&#160;</td></tr>
  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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  <tr style="vertical-align: bottom; ">
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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  <tr style="vertical-align: bottom; ">
    <td style="text-indent: -9pt; padding-left: 9pt">&#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">&#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>
  <tr style="vertical-align: bottom; ">
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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  <tr style="vertical-align: bottom; ">
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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  <tr style="vertical-align: bottom; ">
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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  <tr style="vertical-align: bottom; ">
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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  <tr style="vertical-align: bottom; ">
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="text-align: left; text-indent: -9pt; padding-left: 9pt">Consolidation adjustment in relation to foreign exchange movements</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><div style="-sec-ix-hidden: hidden-fact-255">-</div></td><td style="text-align: left">&#160;</td><td>&#160;</td>
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  <tr style="vertical-align: bottom; ">
    <td style="padding-bottom: 1.5pt; text-indent: -9pt; padding-left: 9pt">&#160;</td><td style="padding-bottom: 1.5pt">&#160;</td>
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  </table><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:nonNumeric></ix:continuation><div>


</div><div>

</div><ix:continuation continuedAt="_DisclosureOfIncomeTaxExplanatory-c0_cont_3" id="_DisclosureOfIncomeTaxExplanatory-c0_cont_2"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">The Research and Development
claim has been calculated in accordance with the R&amp;D tax relief available to small and medium sized entities, whereby the entity
is able to claim a cash tax credit (if loss making), worth up to <ix:nonFraction contextRef="c0" decimals="3" format="ixt:num-dot-decimal" name="tlsa:MaximumPercentageOfSurrenderableLosses" scale="-2" unitRef="pure">14.5</ix:nonFraction>% of the surrenderable losses.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfIncomeTaxExplanatory-c0_cont_4" id="_DisclosureOfIncomeTaxExplanatory-c0_cont_3"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">The adjustments due to prior
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R&amp;D tax relief can be claimed.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfIncomeTaxExplanatory-c0_cont_5" id="_DisclosureOfIncomeTaxExplanatory-c0_cont_4"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">No deferred tax asset has
been recognized in respect of trading losses carried forward because of uncertainty as to when these losses will be recoverable.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation><div>

</div><ix:continuation id="_DisclosureOfIncomeTaxExplanatory-c0_cont_5"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">The amount of tax losses for
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">

</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><ix:nonNumeric contextRef="c0" continuedAt="_DisclosureOfEarningsPerShareExplanatory-c0_cont_1" escape="true" name="ifrs-full:DisclosureOfEarningsPerShareExplanatory"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>11. LOSS PER SHARE</b></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:nonNumeric><div>

</div><ix:continuation continuedAt="_DisclosureOfEarningsPerShareExplanatory-c0_cont_2" id="_DisclosureOfEarningsPerShareExplanatory-c0_cont_1"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Basic loss per share is calculated
by dividing the loss attributable to equity holders of the Company by the weighted average number of ordinary shares in issue during the
year.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">

</p></ix:continuation><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><ix:continuation continuedAt="_DisclosureOfEarningsPerShareExplanatory-c0_cont_3" id="_DisclosureOfEarningsPerShareExplanatory-c0_cont_2"><ix:nonNumeric contextRef="c0" escape="true" name="tlsa:DisclosureOfDetailedInformationAboutOfEarningsPerShareTableTextBlock"><table cellpadding="0" cellspacing="0" style="border-collapse: collapse; width: 100%; font: 10pt Times New Roman, Times, Serif">
  <tr style="vertical-align: bottom">
    <td>&#160;</td><td style="font-weight: bold; padding-bottom: 1.5pt">&#160;</td>
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  <tr style="vertical-align: bottom">
    <td>&#160;</td><td style="font-weight: bold; padding-bottom: 1.5pt">&#160;</td>
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  <tr style="vertical-align: bottom">
    <td>&#160;</td><td>&#160;</td>
    <td colspan="2">&#160;</td><td>&#160;</td><td>&#160;</td>
    <td colspan="2">&#160;</td><td>&#160;</td><td>&#160;</td>
    <td colspan="2">&#160;</td><td>&#160;</td></tr>
  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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</div><div>

</div><ix:continuation id="_DisclosureOfEarningsPerShareExplanatory-c0_cont_3"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">As the Group is reporting
a loss from continuing operations for the year then, in accordance with IAS 33, share options, warrants and convertible loan notes are
not considered dilutive because the exercise of the share options would have an anti-dilutive effect. The basic and diluted earnings
per share as presented on the face of the income statement are therefore identical. All earnings per share figures presented above arise
from continuing and total operations and therefore no earnings per share for discontinued operations are presented. The weighted average
number of ordinary shares in issuance is stated as net excluding Treasury shares.</p></ix:continuation><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&#160;</p><div>


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    </div><div style="margin-top: 12pt; margin-bottom: 6pt; border-bottom: Black 1.5pt solid"><p style="font-size: 10pt; text-align: center; margin-top: 0pt; margin-bottom: 0pt">F-<!-- Field: Sequence; Type: Arabic; Name: PageNo -->18<!-- Field: /Sequence --></p></div><div>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&#160;</p><div>

</div><ix:nonNumeric contextRef="c0" continuedAt="_DisclosureOfTradeAndOtherReceivablesExplanatory-c0_cont_1" escape="true" name="ifrs-full:DisclosureOfTradeAndOtherReceivablesExplanatory"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><b>12. OTHER RECEIVABLES</b></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:nonNumeric><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfTradeAndOtherReceivablesExplanatory-c0_cont_2" id="_DisclosureOfTradeAndOtherReceivablesExplanatory-c0_cont_1"><ix:nonNumeric contextRef="c0" escape="true" name="tlsa:DisclosureOfDetailedInformationAboutOtherReceivablesTableTextBlock"><table cellpadding="0" cellspacing="0" style="border-collapse: collapse; width: 100%; font: 10pt Times New Roman, Times, Serif">
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  <tr style="vertical-align: bottom">
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  <tr style="vertical-align: bottom">
    <td style="text-indent: 0in">&#160;</td><td>&#160;</td>
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="text-indent: 0in; width: 76%; text-align: left">VAT Receivable</td><td style="width: 1%">&#160;</td>
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  <tr style="vertical-align: bottom; ">
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</div><div>

</div><ix:continuation id="_DisclosureOfTradeAndOtherReceivablesExplanatory-c0_cont_2"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">There are no differences
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></p><div>




</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&#160;</p><div>

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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfShareCapitalReservesAndOtherEquityInterestExplanatory-c0_cont_2" id="_DisclosureOfShareCapitalReservesAndOtherEquityInterestExplanatory-c0_cont_1"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="text-decoration:underline">Group</span></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p></ix:continuation><div>

</div><div>

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acquired the entire shareholding of Tiziana Life Sciences Plc and its subsidiaries through a share for share exchange transaction. On
this date Tiziana Life Sciences Ltd became the Group&#8217;s parent company. This transaction does not constitute a business combination
under IFRS 3 &#8220;Business combinations&#8221; and has been accounted for as a group reorganization. Merger accounting has been applied
to account for the insertion of the new company. Due to a share consolidation, the effect of this was a decrease in share capital of
the Company with an offset posted to the merger reserve. As a common control transaction, the Group has elected to present the comparative
information as if this transaction had occurred before the start of the comparative period. The share capital arising on the share for
share exchange has been presented as share capital in the comparative period.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfShareCapitalReservesAndOtherEquityInterestExplanatory-c0_cont_4" id="_DisclosureOfShareCapitalReservesAndOtherEquityInterestExplanatory-c0_cont_3"><ix:nonNumeric contextRef="c0" escape="true" name="tlsa:DisclosureShareCapitalArisingForShareExchangetextBlock"><table cellpadding="0" cellspacing="0" style="border-collapse: collapse; width: 100%; font: 10pt Times New Roman, Times, Serif">
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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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  <tr style="vertical-align: bottom; ">
    <td style="padding-left: 0.125in; text-indent: -0.125in; text-align: left">Shares issued pursuant to share for share exchange and
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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  <tr style="vertical-align: bottom; ">
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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  <tr style="vertical-align: bottom; ">
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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  <tr style="vertical-align: bottom; ">
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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  <tr style="vertical-align: bottom; ">
    <td style="padding-left: 0.125in; text-indent: -0.125in">&#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></tr>
  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="padding-left: 0.125in; text-indent: -0.125in">Shares issued in the period:</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></tr>
  <tr style="vertical-align: bottom; ">
    <td style="padding-left: 0.125in; text-indent: -0.125in">&#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>
    <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)">
    <td style="padding-left: 0.125in; text-indent: -0.125in; font-weight: bold">At 31 December 2022</td><td>&#160;</td>
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  </table><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:nonNumeric></ix:continuation><div>



</div><div>

</div><ix:continuation continuedAt="_DisclosureOfShareCapitalReservesAndOtherEquityInterestExplanatory-c0_cont_5" id="_DisclosureOfShareCapitalReservesAndOtherEquityInterestExplanatory-c0_cont_4"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="text-decoration:underline">Ordinary Shares</span></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation><div>

</div><ix:continuation id="_DisclosureOfShareCapitalReservesAndOtherEquityInterestExplanatory-c0_cont_5"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Ordinary shares have a par
value of $<ix:nonFraction contextRef="c2" decimals="3" format="ixt:num-dot-decimal" name="ifrs-full:ParValuePerShare" scale="0" unitRef="usdPershares">0.001</ix:nonFraction>. They entitle the holder to participate in dividends, and to share in the proceeds of winding up the company in proportion
to the number of and amounts paid on the shares held. On a show of hands every holder of ordinary shares present at a meeting in person
or by proxy, is entitled to one vote, and upon a poll each share is entitled to one vote. Ordinary shares include <ix:nonFraction contextRef="c2" decimals="0" format="ixt:num-dot-decimal" name="ifrs-full:SharesInEntityHeldByEntityOrByItsSubsidiariesOrAssociates" scale="0" unitRef="shares">1,683,544</ix:nonFraction> of shares
that are held in treasury which the Company has purchased pursuant to a share buyback but which are not cancelled upon delivery back to
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voting rights and do not rank for dividends or return of capital whilst held in treasury.</p></ix:continuation><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">

</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"></p><div>

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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p><div>

</div><ix:nonNumeric contextRef="c0" continuedAt="_DisclosureOfSharebasedPaymentArrangementsExplanatory-c0_cont_1" escape="true" name="ifrs-full:DisclosureOfSharebasedPaymentArrangementsExplanatory"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>14. SHARE BASED PAYMENTS</b></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p></ix:nonNumeric><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSharebasedPaymentArrangementsExplanatory-c0_cont_2" id="_DisclosureOfSharebasedPaymentArrangementsExplanatory-c0_cont_1"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="text-decoration:underline">Group and Company Options</span></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSharebasedPaymentArrangementsExplanatory-c0_cont_3" id="_DisclosureOfSharebasedPaymentArrangementsExplanatory-c0_cont_2"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">The Company operates share-based
payment arrangements to remunerate directors and key employees in the form of a share option scheme. The exercise price of the option
is normally equal to the market price of an ordinary share in the Company at the date of grant. The Company is currently operating two
plans (Tiziana Life Sciences PLC) Share Option Plan which is closed for any new issuances and the Tiziana Life Sciences Ltd 2021 Equity
Incentive Plan.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation><div>

</div><div>

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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSharebasedPaymentArrangementsExplanatory-c0_cont_5" id="_DisclosureOfSharebasedPaymentArrangementsExplanatory-c0_cont_4"><ix:nonNumeric contextRef="c0" escape="true" name="ifrs-full:DisclosureOfNumberAndWeightedAverageExercisePricesOfShareOptionsExplanatory"><table cellpadding="0" cellspacing="0" style="border-collapse: collapse; width: 100%; font: 10pt Times New Roman, Times, Serif">
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  <tr style="vertical-align: bottom">
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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSharebasedPaymentArrangementsExplanatory-c0_cont_6" id="_DisclosureOfSharebasedPaymentArrangementsExplanatory-c0_cont_5"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">No options were exercised
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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSharebasedPaymentArrangementsExplanatory-c0_cont_7" id="_DisclosureOfSharebasedPaymentArrangementsExplanatory-c0_cont_6"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">The total outstanding fair
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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSharebasedPaymentArrangementsExplanatory-c0_cont_8" id="_DisclosureOfSharebasedPaymentArrangementsExplanatory-c0_cont_7"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Under the Tiziana Life Sciences
PLC Share Option Plan, the total expense recognized for the year ending 31 December 2022 arising from share &#8211; based payment transactions
under the Tiziana Life Sciences PLC Share Option Plan is ($<ix:nonFraction contextRef="c81" decimals="-3" format="ixt:num-dot-decimal" name="ifrs-full:ExpenseFromSharebasedPaymentTransactionsWithPartiesOtherThanEmployees" scale="3" unitRef="usd">1,479</ix:nonFraction>k) of which $<ix:nonFraction contextRef="c0" decimals="-3" format="ixt:num-dot-decimal" name="ifrs-full:ExpenseFromSharebasedPaymentTransactionsWithPartiesOtherThanEmployees" scale="3" unitRef="usd">3,221</ix:nonFraction>k was forfeiture during the year (2021 $<ix:nonFraction contextRef="c4" decimals="-3" format="ixt:num-dot-decimal" name="ifrs-full:ExpenseFromSharebasedPaymentTransactionsWithPartiesOtherThanEmployees" scale="3" unitRef="usd">5,173</ix:nonFraction>k, 2020:
$<ix:nonFraction contextRef="c5" decimals="-3" format="ixt:num-dot-decimal" name="ifrs-full:ExpenseFromSharebasedPaymentTransactionsWithPartiesOtherThanEmployees" scale="3" unitRef="usd">5,105</ix:nonFraction>k).</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSharebasedPaymentArrangementsExplanatory-c0_cont_9" id="_DisclosureOfSharebasedPaymentArrangementsExplanatory-c0_cont_8"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Share options outstanding
at the end of the year have the following expiry dates and exercise prices:</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSharebasedPaymentArrangementsExplanatory-c0_cont_10" id="_DisclosureOfSharebasedPaymentArrangementsExplanatory-c0_cont_9"><ix:nonNumeric contextRef="c0" continuedAt="tlsa_ScheduleOfOutstandingFairValueChargeOfTheShareOptionInstrumentsTableTextBlock-c0_cont_1" escape="true" name="tlsa:ScheduleOfOutstandingFairValueChargeOfTheShareOptionInstrumentsTableTextBlock"><table cellpadding="0" cellspacing="0" style="border-collapse: collapse; width: 100%; font: 10pt Times New Roman, Times, Serif">
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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSharebasedPaymentArrangementsExplanatory-c0_cont_11" id="_DisclosureOfSharebasedPaymentArrangementsExplanatory-c0_cont_10"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><i>Fair value of options granted</i></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSharebasedPaymentArrangementsExplanatory-c0_cont_12" id="_DisclosureOfSharebasedPaymentArrangementsExplanatory-c0_cont_11"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">The Directors have used the
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applying the assumptions below.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSharebasedPaymentArrangementsExplanatory-c0_cont_13" id="_DisclosureOfSharebasedPaymentArrangementsExplanatory-c0_cont_12"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Historical volatility is
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</div><div>


</div><!-- Field: Page; Sequence: 143; Value: 16 --><div>
    </div><div style="margin-top: 12pt; margin-bottom: 6pt; border-bottom: Black 1.5pt solid"><p style="font-size: 10pt; text-align: center; margin-top: 0pt; margin-bottom: 0pt">F-<!-- Field: Sequence; Type: Arabic; Name: PageNo -->20<!-- Field: /Sequence --></p></div><div>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><ix:continuation continuedAt="_DisclosureOfSharebasedPaymentArrangementsExplanatory-c0_cont_14" id="_DisclosureOfSharebasedPaymentArrangementsExplanatory-c0_cont_13"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">The Company has estimated
a forfeiture rate of zero.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSharebasedPaymentArrangementsExplanatory-c0_cont_15" id="_DisclosureOfSharebasedPaymentArrangementsExplanatory-c0_cont_14"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">The model inputs for options
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</div><div>

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  <tr style="vertical-align: bottom">
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    <td style="white-space: nowrap; text-align: center">&#160;</td>
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    <td style="white-space: nowrap; text-align: center">&#160;</td>
    <td style="white-space: nowrap; text-align: center">&#160;</td>
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    <td style="white-space: nowrap; text-align: center">&#160;</td></tr>
  <tr style="vertical-align: bottom">
    <td style="white-space: nowrap">&#160;</td>
    <td style="white-space: nowrap">&#160;</td>
    <td colspan="2" style="white-space: nowrap">&#160;</td>
    <td style="white-space: nowrap">&#160;</td>
    <td style="white-space: nowrap">&#160;</td>
    <td colspan="2" style="white-space: nowrap">&#160;</td>
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  <tr style="background-color: #CCEEFF">
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    <td style="white-space: nowrap; vertical-align: bottom">&#160;</td>
    <td style="white-space: nowrap; vertical-align: bottom">&#160;</td>
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    <td style="white-space: nowrap; vertical-align: bottom">&#160;</td>
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  <tr>
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    <td style="white-space: nowrap; vertical-align: bottom">&#160;</td>
    <td style="white-space: nowrap; vertical-align: bottom">&#160;</td>
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    <td style="white-space: nowrap; vertical-align: bottom">&#160;</td>
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  <tr style="vertical-align: bottom; background-color: #CCEEFF">
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    <td style="white-space: nowrap">&#160;</td>
    <td style="white-space: nowrap">&#160;</td>
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    <td style="white-space: nowrap">&#160;</td>
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    <td style="white-space: nowrap">&#160;</td>
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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSharebasedPaymentArrangementsExplanatory-c0_cont_17" id="_DisclosureOfSharebasedPaymentArrangementsExplanatory-c0_cont_16"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">For the options issued in
August 2020 with a market condition attached, the Directors have used the Monte Carlo simulation to estimate the fair value of these
options. The Company uses the following methods to determine its underlying assumptions:</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSharebasedPaymentArrangementsExplanatory-c0_cont_18" id="_DisclosureOfSharebasedPaymentArrangementsExplanatory-c0_cont_17"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <tr style="vertical-align: top">
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  </table><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p></ix:continuation><div>
</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSharebasedPaymentArrangementsExplanatory-c0_cont_19" id="_DisclosureOfSharebasedPaymentArrangementsExplanatory-c0_cont_18"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%"> <tr style="vertical-align: top"> <td style="width: 48px">&#160;</td> <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td> <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the expected term of the award is <ix:nonNumeric contextRef="c57" format="ixt-sec:duryear" name="tlsa:ExpectedTermOfAwards">4</ix:nonNumeric> years and is based on managements&#8217; assessment of when the market condition is likely to be achieved; and</span></td></tr> </table><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p></ix:continuation><div>
</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSharebasedPaymentArrangementsExplanatory-c0_cont_20" id="_DisclosureOfSharebasedPaymentArrangementsExplanatory-c0_cont_19"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSharebasedPaymentArrangementsExplanatory-c0_cont_21" id="_DisclosureOfSharebasedPaymentArrangementsExplanatory-c0_cont_20"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><i>Modification of share &#8211; based payments.</i></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation><div>

</div><div>

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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSharebasedPaymentArrangementsExplanatory-c0_cont_23" id="_DisclosureOfSharebasedPaymentArrangementsExplanatory-c0_cont_22"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">The fair value of the modified
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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSharebasedPaymentArrangementsExplanatory-c0_cont_24" id="_DisclosureOfSharebasedPaymentArrangementsExplanatory-c0_cont_23"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">The fair value of the modified
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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSharebasedPaymentArrangementsExplanatory-c0_cont_25" id="_DisclosureOfSharebasedPaymentArrangementsExplanatory-c0_cont_24"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="text-decoration:underline">Tiziana Life Sciences Ltd 2021 Equity Incentive
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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSharebasedPaymentArrangementsExplanatory-c0_cont_26" id="_DisclosureOfSharebasedPaymentArrangementsExplanatory-c0_cont_25"><ix:nonNumeric contextRef="c0" escape="true" name="tlsa:ScheduleOfEquityIncentivePlanTableTextBlock"><table cellpadding="0" cellspacing="0" style="border-collapse: collapse; width: 100%; font: 10pt Times New Roman, Times, Serif">
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</div><div>

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</div><ix:continuation continuedAt="_DisclosureOfSharebasedPaymentArrangementsExplanatory-c0_cont_27" id="_DisclosureOfSharebasedPaymentArrangementsExplanatory-c0_cont_26"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">The model inputs for options
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</div><div>

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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSharebasedPaymentArrangementsExplanatory-c0_cont_29" id="_DisclosureOfSharebasedPaymentArrangementsExplanatory-c0_cont_28"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">During the year ending 31
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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSharebasedPaymentArrangementsExplanatory-c0_cont_30" id="_DisclosureOfSharebasedPaymentArrangementsExplanatory-c0_cont_29"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">The total outstanding fair
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</div><div>

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</div><div>

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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSharebasedPaymentArrangementsExplanatory-c0_cont_34" id="_DisclosureOfSharebasedPaymentArrangementsExplanatory-c0_cont_33"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="text-decoration:underline">Group and Company Warrants</span></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSharebasedPaymentArrangementsExplanatory-c0_cont_35" id="_DisclosureOfSharebasedPaymentArrangementsExplanatory-c0_cont_34"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">No warrants were issued in
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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSharebasedPaymentArrangementsExplanatory-c0_cont_36" id="_DisclosureOfSharebasedPaymentArrangementsExplanatory-c0_cont_35"><ix:continuation id="tlsa_ScheduleOfModelInputsForOptionsGrantedUnderTheBlackScholesValuationModelTableTextBlock-c0_cont_2"><table cellpadding="0" cellspacing="0" style="border-collapse: collapse; width: 100%; font: 10pt Times New Roman, Times, Serif">
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfSharebasedPaymentArrangementsExplanatory-c0_cont_37" id="_DisclosureOfSharebasedPaymentArrangementsExplanatory-c0_cont_36"><ix:nonNumeric contextRef="c0" escape="true" name="tlsa:ScheduleOfEstimatedTheFairValueOfWarrantsUsingTextBlock"><table cellpadding="0" cellspacing="0" style="border-collapse: collapse; width: 100%; font: 10pt Times New Roman, Times, Serif">
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  <tr style="vertical-align: bottom">
    <td>&#160;</td><td>&#160;</td>
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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  <tr style="vertical-align: bottom; ">
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    <td style="text-align: left">&#160;</td><td style="text-align: right"><div style="-sec-ix-hidden: hidden-fact-290">-</div></td><td style="text-align: left">&#160;</td><td>&#160;</td>
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    <td>&#160;</td><td>&#160;</td>
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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</div><div>

</div><ix:continuation id="_DisclosureOfSharebasedPaymentArrangementsExplanatory-c0_cont_37"><p style="text-align: justify; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">No share-based payment charges
relating to warrants were recorded during 2022 or 2021. Approximately $<ix:nonFraction contextRef="c5" decimals="-3" format="ixt:num-dot-decimal" name="tlsa:SharebasedPaymentCharge" scale="3" unitRef="usd">26</ix:nonFraction>K of share-based payment charges are included in the consolidated
statement of operations and comprehensive loss for the year ended December 31, 2020.</p></ix:continuation><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></p><div>

</div><!-- Field: Page; Sequence: 145; Value: 16 --><div>
    </div><div style="margin-top: 12pt; margin-bottom: 6pt; border-bottom: Black 1.5pt solid"><p style="font-size: 10pt; text-align: center; margin-top: 0pt; margin-bottom: 0pt">F-<!-- Field: Sequence; Type: Arabic; Name: PageNo -->22<!-- Field: /Sequence --></p></div><div>
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p><div>

</div><ix:nonNumeric contextRef="c0" continuedAt="tlsa_DisclosureOfReservesTextBlock-c0_cont_1" escape="true" name="tlsa:DisclosureOfReservesTextBlock"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>15. RESERVES</b></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:nonNumeric><div>

</div><div>

</div><ix:continuation continuedAt="tlsa_DisclosureOfReservesTextBlock-c0_cont_2" id="tlsa_DisclosureOfReservesTextBlock-c0_cont_1"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">The share-based payment reserve
for warrants represents the cost to issue warrants in the future based on their grant date fair value.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="tlsa_DisclosureOfReservesTextBlock-c0_cont_3" id="tlsa_DisclosureOfReservesTextBlock-c0_cont_2"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">The share-based payment reserve
for options represents the cost to issue share-based compensation, primarily share options, based on their grant date fair value.&#160;</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="tlsa_DisclosureOfReservesTextBlock-c0_cont_4" id="tlsa_DisclosureOfReservesTextBlock-c0_cont_3"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Retained earnings represent
the cumulative profits/(losses) of the entity which have not been distributed to shareholders. This reserve has been credited as part
of the capital reduction exercise described below.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="tlsa_DisclosureOfReservesTextBlock-c0_cont_5" id="tlsa_DisclosureOfReservesTextBlock-c0_cont_4"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">The translation reserve represents
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</div><div>

</div><ix:continuation id="tlsa_DisclosureOfReservesTextBlock-c0_cont_5"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">The merger reserve arises
on consolidation as a result of the share for share exchange transaction that took place this year described in note 13. It represents
the difference between the share capital issued and the aggregate carrying value of assets and liabilities and other reserves of the
previous parent on the merger date.</p></ix:continuation><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p><div>

</div><ix:nonNumeric contextRef="c0" continuedAt="_DisclosureOfFinancialInstrumentsExplanatory-c0_cont_1" escape="true" name="ifrs-full:DisclosureOfFinancialInstrumentsExplanatory"><p style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: left"><b>16. FINANCIAL INSTRUMENTS</b></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:nonNumeric><div>

</div><div>

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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfFinancialInstrumentsExplanatory-c0_cont_3" id="_DisclosureOfFinancialInstrumentsExplanatory-c0_cont_2"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>Market risk</b></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfFinancialInstrumentsExplanatory-c0_cont_4" id="_DisclosureOfFinancialInstrumentsExplanatory-c0_cont_3"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Market risk encompasses three
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value interest rate risk are considered along with those for managing cash flow interest rate risk and are set out in the subsection
entitled &#8220;interest rate risk&#8221; below. The Directors do not consider the Group&#8217;s exposure to price risk to be significant.
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</div><div>


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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

</div><ix:continuation continuedAt="_DisclosureOfFinancialInstrumentsExplanatory-c0_cont_5" id="_DisclosureOfFinancialInstrumentsExplanatory-c0_cont_4"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>Credit risk</b></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfFinancialInstrumentsExplanatory-c0_cont_6" id="_DisclosureOfFinancialInstrumentsExplanatory-c0_cont_5"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Credit risk is managed on
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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfFinancialInstrumentsExplanatory-c0_cont_7" id="_DisclosureOfFinancialInstrumentsExplanatory-c0_cont_6"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><b>Liquidity risk</b></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfFinancialInstrumentsExplanatory-c0_cont_8" id="_DisclosureOfFinancialInstrumentsExplanatory-c0_cont_7"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">The Group&#8217;s policy
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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfFinancialInstrumentsExplanatory-c0_cont_9" id="_DisclosureOfFinancialInstrumentsExplanatory-c0_cont_8"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">The table below summarizes
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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfFinancialInstrumentsExplanatory-c0_cont_10" id="_DisclosureOfFinancialInstrumentsExplanatory-c0_cont_9"><ix:nonNumeric contextRef="c0" continuedAt="tlsa_ScheduleOfFinancialLiabilitiesBasedOnContractualUndiscountedPaymentsTableTextBlock-c0_cont_1" escape="true" name="tlsa:ScheduleOfFinancialLiabilitiesBasedOnContractualUndiscountedPaymentsTableTextBlock"><table cellpadding="0" cellspacing="0" style="border-collapse: collapse; width: 100%; font: 10pt Times New Roman, Times, Serif">
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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfFinancialInstrumentsExplanatory-c0_cont_11" id="_DisclosureOfFinancialInstrumentsExplanatory-c0_cont_10"><ix:continuation id="tlsa_ScheduleOfFinancialLiabilitiesBasedOnContractualUndiscountedPaymentsTableTextBlock-c0_cont_1"><table cellpadding="0" cellspacing="0" style="border-collapse: collapse; width: 100%; font: 10pt Times New Roman, Times, Serif">
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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfFinancialInstrumentsExplanatory-c0_cont_12" id="_DisclosureOfFinancialInstrumentsExplanatory-c0_cont_11"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>Interest rate risk</b></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfFinancialInstrumentsExplanatory-c0_cont_13" id="_DisclosureOfFinancialInstrumentsExplanatory-c0_cont_12"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">The Group has limited exposure
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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfFinancialInstrumentsExplanatory-c0_cont_14" id="_DisclosureOfFinancialInstrumentsExplanatory-c0_cont_13"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">The Directors do not consider
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equity position as of year-end for either the year ended 31 December 2022 or 31 December 2021.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p></ix:continuation><div>

</div><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"></p><div>

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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p><div>

</div><ix:continuation continuedAt="_DisclosureOfFinancialInstrumentsExplanatory-c0_cont_15" id="_DisclosureOfFinancialInstrumentsExplanatory-c0_cont_14"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>Foreign currency risk</b></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfFinancialInstrumentsExplanatory-c0_cont_16" id="_DisclosureOfFinancialInstrumentsExplanatory-c0_cont_15"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">The Group operates internationally
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are denominated in US Dollars, with a small amount denominated in Pound Sterling. It therefore is exposed to some foreign exchange risk
arising from exposure to various currencies primarily the Pound Sterling. The Group monitors currency exchange rates and makes judgments
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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfFinancialInstrumentsExplanatory-c0_cont_17" id="_DisclosureOfFinancialInstrumentsExplanatory-c0_cont_16"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><i>Sensitivity analysis </i></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfFinancialInstrumentsExplanatory-c0_cont_18" id="_DisclosureOfFinancialInstrumentsExplanatory-c0_cont_17"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">A reasonably possible strengthening
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financial instruments denominated in a foreign currency and affected equity and profit and loss by the amounts shown below. This analysis
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</div><div>

</div><ix:continuation id="_DisclosureOfFinancialInstrumentsExplanatory-c0_cont_18"><ix:nonNumeric contextRef="c0" escape="true" name="tlsa:ScheduleOfMeasurementOfTheFinancialInstrumentsTextBlock"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
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</div><div>

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payments for warrants, convertible loan note reserve, and all other equity reserves attributable to the equity holders of the parent
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</div><div>

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</div><div>

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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>


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</div><div>

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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

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</div><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p><div>

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</div><ix:continuation id="tlsa_InvestmentInRelatedPartyTextBlock-c0_cont_2"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">During the year the company
purchased One Million Three Hundred Thirty Seven Thousand Nine Hundred Seventy (<ix:nonFraction contextRef="c0" decimals="0" format="ixt:num-dot-decimal" name="tlsa:CommonStockShares" scale="0" sign="-" unitRef="shares">1,337,970</ix:nonFraction>) shares of the Accustem Sciences Inc's Common
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Level 1per IFRS 13 fair value hierarchy. Accustem Sciences Inc is listed on the OTC markets and is run by a separate management team which
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">

</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p><div>

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of its own shares through purchases on the NASDAQ stock exchange during the year ended December 31, 2022. The amount paid to acquire
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p><div>

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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfRelatedPartyExplanatory-c0_cont_2" id="_DisclosureOfRelatedPartyExplanatory-c0_cont_1"><p style="font: 10pt Times New Roman, Times, Serif; text-indent: 0.5in; margin: 0pt 0; text-align: justify">The ultimate controlling
party of the Group is Planwise Group Ltd.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation><div>

</div><ix:continuation continuedAt="_DisclosureOfRelatedPartyExplanatory-c0_cont_3" id="_DisclosureOfRelatedPartyExplanatory-c0_cont_2"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Rasna Therapeutics Inc is
a related party as the entity is controlled by a person that has significant influence over the Group. Rasna is also party to a Shared
Services agreement&#160;with&#160;Tiziana&#160;whereby Rasna is charged for shared services such as the payroll and rent. During 2022,
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</p></ix:continuation><div>
</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&#160;</p><div>

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</div><div>

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Life Sciences Ltd in respect of this agreement. The total charged under the shared services agreement in the year ending 31 December 2022
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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfRelatedPartyExplanatory-c0_cont_6" id="_DisclosureOfRelatedPartyExplanatory-c0_cont_5"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">In August 2022, the Group
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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfRelatedPartyExplanatory-c0_cont_7" id="_DisclosureOfRelatedPartyExplanatory-c0_cont_6"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Gensignia Lifesciences Inc
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</div><div>

</div><ix:continuation id="_DisclosureOfRelatedPartyExplanatory-c0_cont_7"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Accustem Sciences Inc is
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p><div>

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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;&#160;</p><div>

</div><ix:nonNumeric contextRef="c0" continuedAt="_DisclosureOfLeasesExplanatory-c0_cont_1" escape="true" name="ifrs-full:DisclosureOfLeasesExplanatory"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><b>22. LEASES</b></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:nonNumeric><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfLeasesExplanatory-c0_cont_2" id="_DisclosureOfLeasesExplanatory-c0_cont_1"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">All leases are accounted for by recognising a
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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfLeasesExplanatory-c0_cont_3" id="_DisclosureOfLeasesExplanatory-c0_cont_2"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
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  <tr style="vertical-align: top">
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  <tr style="vertical-align: top">
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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfLeasesExplanatory-c0_cont_4" id="_DisclosureOfLeasesExplanatory-c0_cont_3"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">The Group has leases for
its offices. Each lease is reflected on the balance sheet as a right-of-use asset and a lease liability. The Group does not have leases
of low value assets. Variable lease payments which do not depend on an index or a rate (such as lease payments based on a percentage
of Group sales) are excluded from the initial measurement of the lease liability and asset. The Group classifies its right-of-use assets
in a consistent manner to its property, plant and equipment.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfLeasesExplanatory-c0_cont_5" id="_DisclosureOfLeasesExplanatory-c0_cont_4"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">For leases over office buildings
and factory premises the Group must keep those properties in a good state of repair and return the properties in their original condition
at the end of the lease.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</p></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfLeasesExplanatory-c0_cont_6" id="_DisclosureOfLeasesExplanatory-c0_cont_5"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">During the course of 2022,
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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfLeasesExplanatory-c0_cont_7" id="_DisclosureOfLeasesExplanatory-c0_cont_6"><ix:nonNumeric contextRef="c0" continuedAt="tlsa_DisclosureOfQuantitativeInformationAboutRightofuseAssetsTableTextBlock-c0_cont_1" escape="true" name="tlsa:DisclosureOfQuantitativeInformationAboutRightofuseAssetsTableTextBlock"><table cellpadding="0" cellspacing="0" style="border-collapse: collapse; width: 100%; font: 10pt Times New Roman, Times, Serif">
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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfLeasesExplanatory-c0_cont_8" id="_DisclosureOfLeasesExplanatory-c0_cont_7"><ix:continuation id="tlsa_DisclosureOfQuantitativeInformationAboutRightofuseAssetsTableTextBlock-c0_cont_1"><table cellpadding="0" cellspacing="0" style="border-collapse: collapse; width: 100%; font: 10pt Times New Roman, Times, Serif">
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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfLeasesExplanatory-c0_cont_9" id="_DisclosureOfLeasesExplanatory-c0_cont_8"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in; text-align: justify">Lease liabilities are presented
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</div><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p><div>

</div><ix:continuation continuedAt="_DisclosureOfLeasesExplanatory-c0_cont_10" id="_DisclosureOfLeasesExplanatory-c0_cont_9"><ix:nonNumeric contextRef="c0" escape="true" name="ifrs-full:DisclosureOfFinancialAssetsExplanatory"><table cellpadding="0" cellspacing="0" style="border-collapse: collapse; width: 100%; font: 10pt Times New Roman, Times, Serif">
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  <tr style="vertical-align: bottom">
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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfLeasesExplanatory-c0_cont_11" id="_DisclosureOfLeasesExplanatory-c0_cont_10"><p style="font: 10pt Times New Roman, Times, Serif; text-indent: 0.5in; margin: 0pt 0; text-align: justify">The lease liabilities are
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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfLeasesExplanatory-c0_cont_12" id="_DisclosureOfLeasesExplanatory-c0_cont_11"><ix:nonNumeric contextRef="c0" escape="true" name="tlsa:DisclosureOfFutureMinimumLeasePayments"><table cellpadding="0" cellspacing="0" style="border-collapse: collapse; width: 100%; font: 10pt Times New Roman, Times, Serif">
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</div><div>

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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></p><div>


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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfCommitmentsExplanatory-c0_cont_2" id="_DisclosureOfCommitmentsExplanatory-c0_cont_1"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">The Group&#8217;s main financial
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and development and the length of time required to reach commercialisation of the products of this research and development, pre-clinical,
clinical and commercial milestone obligations are not detailed until there is a reasonable certainty that the obligation will become
payable.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfCommitmentsExplanatory-c0_cont_3" id="_DisclosureOfCommitmentsExplanatory-c0_cont_2"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfCommitmentsExplanatory-c0_cont_4" id="_DisclosureOfCommitmentsExplanatory-c0_cont_3"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">We are obligated to pay Nerviano
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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfCommitmentsExplanatory-c0_cont_5" id="_DisclosureOfCommitmentsExplanatory-c0_cont_4"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse"> <tr style="vertical-align: top"> <td style="width: 48px">&#160;</td> <td style="width: 24px"><ix:nonNumeric contextRef="c0" continuedAt="tlsa_FinancialCommitmentsDescription-c0_cont_1" name="tlsa:FinancialCommitmentsDescription"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">(a)</span></ix:nonNumeric></td> <td style="text-align: justify"><p style="margin: 0pt 0; font: 10pt Times New Roman, Times, Serif"><ix:continuation continuedAt="tlsa_FinancialCommitmentsDescription-c0_cont_2" id="tlsa_FinancialCommitmentsDescription-c0_cont_1">$1,000,000 upon initiation of the first Phase II clinical trial, this
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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfCommitmentsExplanatory-c0_cont_6" id="_DisclosureOfCommitmentsExplanatory-c0_cont_5"><ix:continuation continuedAt="tlsa_FinancialCommitmentsDescription-c0_cont_3" id="tlsa_FinancialCommitmentsDescription-c0_cont_2"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
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    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">$4,000,000 upon FPD of
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  </table><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p></ix:continuation></ix:continuation><div>
</div><div>

</div><ix:continuation continuedAt="_DisclosureOfCommitmentsExplanatory-c0_cont_7" id="_DisclosureOfCommitmentsExplanatory-c0_cont_6"><ix:continuation continuedAt="tlsa_FinancialCommitmentsDescription-c0_cont_4" id="tlsa_FinancialCommitmentsDescription-c0_cont_3"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="vertical-align: top">
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trial</p></td></tr>
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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfCommitmentsExplanatory-c0_cont_8" id="_DisclosureOfCommitmentsExplanatory-c0_cont_7"><ix:continuation id="tlsa_FinancialCommitmentsDescription-c0_cont_4"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
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    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Upon the first NDA equivalent
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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfCommitmentsExplanatory-c0_cont_9" id="_DisclosureOfCommitmentsExplanatory-c0_cont_8"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%"> <tr style="vertical-align: top"> <td style="width: 48px">&#160;</td> <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td> <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Foralumab project &#8211; Future payments relate to the achievement of clinical milestones or the payment of royalties. Diligence obligations are payable to BMS/Medarex should the project continue to commercialisation. $<ix:nonFraction contextRef="c0" decimals="0" format="ixt:num-dot-decimal" name="tlsa:AccruedOfDiligenceObligations" scale="0" unitRef="usd">750,000</ix:nonFraction> has been recoded as other income in respect of diligence obligations due to Medarex for 2021.</span></td></tr> </table><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p></ix:continuation><div>
</div><div>

</div><ix:continuation continuedAt="_DisclosureOfCommitmentsExplanatory-c0_cont_10" id="_DisclosureOfCommitmentsExplanatory-c0_cont_9"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">We are obligated to pay BMS
the following additional amounts in respect of the first licensed product or service which achieves the stated development milestones:</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p></ix:continuation><div>

</div><div>

</div><ix:continuation continuedAt="_DisclosureOfCommitmentsExplanatory-c0_cont_11" id="_DisclosureOfCommitmentsExplanatory-c0_cont_10"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse"> <tr style="vertical-align: top"> <td style="width: 48px">&#160;</td> <td style="width: 24px"><ix:nonNumeric contextRef="c0" continuedAt="tlsa_DevelopmentMilestonesDescription-c0_cont_1" name="tlsa:DevelopmentMilestonesDescription"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">(a)</span></ix:nonNumeric></td> <td style="text-align: justify"><p style="margin: 0pt 0; font: 10pt Times New Roman, Times, Serif"><ix:continuation continuedAt="tlsa_DevelopmentMilestonesDescription-c0_cont_2" id="tlsa_DevelopmentMilestonesDescription-c0_cont_1">$300,000 upon enrollment of first patient in a Phase I human clinical
trial of the first Phase II Clinical trial, this is currently being negotiated with BMS.</ix:continuation></p></td></tr> </table><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p></ix:continuation><div>
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</div><ix:continuation continuedAt="_DisclosureOfCommitmentsExplanatory-c0_cont_12" id="_DisclosureOfCommitmentsExplanatory-c0_cont_11"><ix:continuation continuedAt="tlsa_DevelopmentMilestonesDescription-c0_cont_3" id="tlsa_DevelopmentMilestonesDescription-c0_cont_2"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="vertical-align: top">
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</div><div>

</div><ix:continuation continuedAt="_DisclosureOfCommitmentsExplanatory-c0_cont_13" id="_DisclosureOfCommitmentsExplanatory-c0_cont_12"><ix:continuation continuedAt="tlsa_DevelopmentMilestonesDescription-c0_cont_4" id="tlsa_DevelopmentMilestonesDescription-c0_cont_3"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
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</div><div>

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</div><ix:continuation continuedAt="_DisclosureOfCommitmentsExplanatory-c0_cont_18" id="_DisclosureOfCommitmentsExplanatory-c0_cont_17"><ix:continuation continuedAt="tlsa_DevelopmentMilestonesDescription-c0_cont_9" id="tlsa_DevelopmentMilestonesDescription-c0_cont_8"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
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</div><ix:continuation id="_DisclosureOfCommitmentsExplanatory-c0_cont_19"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%"> <tr style="vertical-align: top"> <td style="width: 48px">&#160;</td> <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td> <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">ACT D - Tiziana will need to make milestone payments of up to $<ix:nonFraction contextRef="c0" decimals="-3" format="ixt:num-dot-decimal" name="tlsa:MilestonePayments" scale="3" unitRef="usd">630</ix:nonFraction>k depending on the issuance of a US patent from any US patent application in Transferred IP relating to nanoparticle formulations of Act D and upon the successful completion of a Phase II clinical efficacy trial.</span></td></tr> </table></ix:continuation><div>
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</div><div>

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Contingencies arising in the ordinary course of business, for which no security has been given, are not expected to result in any material
financial loss.</p></ix:continuation><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p><div>

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announced the grant of <ix:nonFraction contextRef="c139" decimals="0" format="ixt:num-dot-decimal" name="tlsa:GrantShareOptions" scale="0" unitRef="shares">857,500</ix:nonFraction> share options to directors and members of senior management.</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p></ix:continuation><div>

</div><div>

</div><ix:continuation id="_DisclosureOfEventsAfterReportingPeriodExplanatory-c0_cont_2"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">In August 2022, the Group issued a short-term credit facility to Okyo Pharma, a related party, for $<ix:nonFraction contextRef="c129" decimals="0" format="ixt:num-dot-decimal" name="ifrs-full:OtherShorttermEmployeeBenefits" scale="0" unitRef="usd">2,000</ix:nonFraction>k in
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</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">

</p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center">F-28</p><div>

</div><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"></p><div>

</div><!-- Field: Rule-Page --><div style="margin-top: 0pt; margin-bottom: 0pt; width: 100%"><div style="font-size: 1pt; border-top: Black 1.5pt solid">&#160;</div></div><!-- Field: /Rule-Page --><div>

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{"company-data": {"conformed-name": "Tiziana Life Sciences Ltd", "cik": "0001723069", "assigned-sic": "2834", "irs-number": "000000000", "state-of-incorporation": "D0", "fiscal-year-end": "1231"}, "filing-values": {"form-type": "20-F", "act": "34", "file-number": "001-38723", "film-number": "23848984"}, "business-address": {"street1": "3RD FLOOR, 11-12 ST. JAMES'S SQUARE", "city": "LONDON, ENGLAND", "state": "X0", "zip": "SW1Y 4LB", "phone": "0044(0) 207-495-2379"}, "mail-address": {"street1": "3RD FLOOR, 11-12 ST. JAMES'S SQUARE", "city": "LONDON, ENGLAND", "state": "X0", "zip": "SW1Y 4LB"}, "former-company": {"former-conformed-name": "Tiziana Life Sciences plc", "date-changed": "20171116"}}
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
20-F
REGISTRATION ST
ATEMENT
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
,
2022
OR
☐
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the transition period from                    
to
OR
☐
SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
Commission
file number:
Tiziana
L
ife Sciences Ltd
(Exact name of Registrant as specified in its
charter and translation of Registrant's name into English)
Bermuda
(Jurisdiction of incorporation or organization)
Clarendon House
,
2 Church Street,
Hamilton HM
11
,
Bermuda
(Address of principal executive offices)
Keeren Shah
Chief Financial Officer
14-15 Conduit Street
,
LondonW1S
2XJ
United
Kingdom
+44
20 7495 2379
(Name, Telephone, E-mail and/or Facsimile number
and Address of Company Contact Person)
Copies to:
Ed Lukins
Orrick, Herrington & Sutcliffe (UK)
LLP
107 Cheapside
London EC2V 6DN
United Kingdom
Jeffrey Fessler
Sheppard, Mullin, Richter & Hampton LLP
30 Rockefeller Plaza
New York, NY 10112-0015
(212) 653 8700
Securities registered or to be registered pursuant
to Section 12(b) of the Act:
Title of each class
Name of each exchange on which registered
Common Shares
NASDAQ Capital Market
(*) Not for trading, but only in connection with the listing of
the American Depositary Shares
Securities registered or to be registered pursuant
to Section 12(g) of the Act:
None
Securities for which there is a reporting obligation
pursuant to Section 15(d) of the Act:
None
Number
of outstanding shares of each of the issuer's classes of capital or common stock as of December 31, 2022:
102,272,614
common shares.
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
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 and posted on its corporate Web site, if any, every Interactive Data
File required to be submitted and posted 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, or a non-accelerated filer, smaller reporting
company, or an emerging growth company. See definitions of "large accelerated filer, "accelerated filer", "smaller
reporting company", and "emerging growth company" in Rule 12b-2 of the Exchange Act. (Check one):
Large accelerated filer ☐
Accelerated filer ☐
Non-accelerated filer
☒
Smaller reporting company ☒
Emerging growth company
☒
If
an emerging growth company that prepares its financial statements in accordance with U.S. GAAP, indicate by checkmark 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 Exchange 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 the 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
Item 1
Identity of Directors,
    Senior Management and Advisers
1
Item 2
Offer Statistics and Expected Timetable
1
Item 3
Key Information
1
Item 4
Information on the Company
36
Item 4A
Unresolved Staff Comments
73
Item 5
Operating and Financial Review and
    Prospects
73
Item 6
Directors, Senior Management and Employees
87
Item 7
Major Shareholders and Related Party
    Transactions
104
Item 8
Financial Information
105
Item 9
The Offer and Listing
106
Item 10
Additional Information
106
Item 11
Quantitative and Qualitative Disclosures
    About Market Risk
113
Item 12
Description of Securities Other than
    Equity Securities
113
PART
    II
Item 13
Defaults, Dividend Arrearages and
    Delinquencies
114
Item 14
Material Modifications to the Rights
    of Security Holders and Use of Proceeds
114
Item 15
Controls and Procedures
114
Item 16A
Audit Committee Financial Expert
115
Item 16B
Code of Ethics
115
Item 16C
Principal Accountant Fees and Services
115
Item 16D
Exemptions From the Listing Standards
    for Audit Committees
116
Item 16E
Purchases of Equity Securities by
    the Issuer and Affiliated Purchasers
116
Item 16F
Change in Registrant's Certifying
    Accountant
116
Item 16G
Corporate Governance
116
Item 16H
Mine Safety Disclosure
116
Item 16I
Disclosure Regarding Foreign Jurisdictions
    that Prevent Inspections
116
PART
    III
Item 17
Financial Statements
117
Item 18
Financial Statements
117
Item 19
Exhibits
117
i
INTRODUCTION
In this Annual Report on
the Form 20-F references to "Tiziana," "Tiziana Life Sciences plc," "the company," "we,"
"us" and "our" refer to Tiziana Life Sciences Ltd, Bermuda and its wholly owned subsidiaries, Tiziana Life Sciences
Ltd (formerly Tiziana Life Sciences plc), Tiziana Therapeutics Inc., Tiziana Pharma Limited and Longevia Genomics S.r.l.
Solely for convenience, the
trademarks, service marks and trade names in this registration statement may be referred to without the ® and ™ symbols, but
such references should not be construed as any indicator that their respective owners will not assert, to the fullest extent under applicable
law, their rights thereto. This annual report contains additional trademarks, service marks and trade names of others, which are the
property of their respective owners. We do not intend to use or display other companies' trademarks, service marks and trade names
to imply a relationship with, or endorsement or sponsorship of us by, any other companies.
In this annual report, unless
otherwise stated, all references to "U.S. dollars" or "US$" or "$" or "cents" are to
the currency of the United States of America, and all references to "Pounds Sterling" or "Sterling" or "£"
or "pence" are to the currency of the United Kingdom.
In this annual report, any
reference to any provision of any legislation shall include any amendment, modification, re-enactment or extension thereof. Words importing
the singular shall include the plural and vice versa, and words importing the masculine gender shall include the feminine or neutral
gender.
ii
Presentation
of Financial Information
This annual report includes
our audited consolidated financial statements as of and for the years ended December 31, 2022 and 2021, which are prepared in accordance
with International Financial Reporting Standards, or IFRS, as issued by the International Accounting Standards Board, or IASB. None of
our financial statements were prepared in accordance with generally accepted accounting principles in the United States.
Our financial information
is presented in United States dollars. For the convenience of the reader, in this prospectus, unless otherwise indicated, translations
from Pounds Sterling into U.S. dollars were made at the rate of £1.00 to $1.2225, which was the noon buying rate of the Federal
Reserve Bank of New York on March 24, 2023. Such U.S. dollar amounts are not necessarily indicative of the amounts of U.S. dollars that
could actually have been purchased upon exchange of Pounds Sterling at the dates indicated.
We have made rounding adjustments
to some of the figures included in this prospectus. Accordingly, numerical figures shown as totals in some tables may not be an arithmetic
aggregation of the figures that preceded them.
iii
CAUTIONARY
STATEMENT REGARDING FORWARD-LOOKING STATEMENTS
This Annual Report contains
forward-looking statements that involve substantial risks and uncertainties. All statements contained in this Annual Report, other than
statements of historical fact, including statements regarding our strategy, future operations, future financial position, future revenues,
projected costs, prospects, plans and objectives of management, are forward-looking statements. The words "may," "might,"
"will," "could," "would," "should," "expect," "intend," "plan,"
"objective," "anticipate," "believe," "estimate," "predict," "potential,"
"continue" and "ongoing," or the negative of these terms, or other comparable terminology intended to identify
statements about the future. These statements involve known and unknown risks, uncertainties and other important factors that may cause
our actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied
by these forward-looking statements. The forward-looking statements and opinions contained in this registration statement are based upon
information available to us as of the date of this registration statement and, while we believe such information forms a reasonable basis
for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted
an exhaustive inquiry into, or review of, all potentially available relevant information. Forward-looking statements include statements
about:
●
the development of Foralumab,
    anti-IL6R monoclonal antibody (TZLS-501), Milciclib, and any of our other product candidates, including statements regarding the
    timing of initiation, completion and the outcome of clinical studies or trials and related preparatory work, the period during which
    the results of the trials will become available and our research and development programs;
●
our ability to obtain and
    maintain regulatory approval of our product candidates, including Foralumab, anti-IL6R monoclonal antibody (TZLS-501), Milciclib,
    in the indications for which we plan to develop them, and any related restrictions, limitations or warnings in the label of an approved
    drug or therapy;
●
our plans to research,
    develop, manufacture and commercialize our product candidates;
●
the timing of our regulatory
    filings for our product candidates;
●
the size and growth potential
    of the markets for our product candidates;
●
our ability to raise additional
    capital;
●
our commercialization,
    marketing and manufacturing capabilities and strategy;
●
our expectations regarding
    our ability to obtain and maintain intellectual property protection;
●
our ability to attract
    and retain qualified employees and key personnel;
●
our ability to contract
    with third-party suppliers and manufacturers and their ability to perform adequately;
●
our estimates regarding
    future revenue, expenses and needs for additional financing; and
●
regulatory developments
    in the United States, European Union and foreign countries.
You should refer to the section
titled "Risk Factors" for a discussion of important factors that may cause our actual results to differ materially from those
expressed or implied by our forward-looking statements. As a result of these factors, we cannot assure you that the forward-looking statements
in this registration statement will prove to be accurate.
Furthermore, if our forward-looking
statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking
statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our
objectives and plans in any specified time frame, or at all. We undertake no obligation to publicly update any forward-looking statements,
whether as a result of new information, future events or otherwise, except as required by law.
You should read this Annual
Report and the documents that we have filed as exhibits to this Annual Report completely and with the understanding that our actual future
results may be materially different from what we expect. We qualify all of our forward-looking statements by these cautionary statements.
iv
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. Selected Financial Data
The following table summarizes
our consolidated financial data as of the dates and for the periods indicated. The consolidated financial statement data as of December
31, 2022 and 2021 and for the years ended December 31, 2022, 2021 and 2020 have been derived from our consolidated financial statements,
as presented at the end of this Annual Report, which have been prepared in accordance with IFRS, as issued by the IASB, and audited in
accordance with the standards of the Public Company Accounting Oversight Board (United States). The consolidated financial statement data
as of December 31, 2019 and 2018 and for the years ended December 31, 2019 and 2018 have been derived from our consolidated financial
statements, which are not presented herein, which have also been prepared in accordance with IFRS as issued by the IASB.
Our functional and presentational currency is the U.S. dollar.
1
Our historical results are
not necessarily indicative of the results that may be expected in the future. The following selected consolidated financial data should
be read in conjunction with our audited consolidated financial statements included at the end of this Annual Report and the related notes
and Item 5, "Operating and Financial Review and Prospects" below.
Consolidated Statement of Operations and Comprehensive Loss Data:
Years Ended December 31,
2022
2021
2020
2019
2018
(in thousands except share and per share data)
Operating expenses:
Research and development
$
(12,955
)
$
(13,208
)
$
(5,993
)
$
(3,714
)
$
(5,510
)
General and administrative
(1,631
)
(13,311
)
(11,203
)
(6,207
)
(4,357
)
Realization bonus
-
(855
)
(13,214
)
-
-
Impairment of asset
-
-
(279
)
-
-
Disposal of Intellectual Property
-
-
2,663
-
-
Total operating expenses
(14,586
)
(27,374
)
(28,026
)
(9,921
)
(9,867
)
Loss from operations
(14,586
)
(27,374
)
(28,026
)
(9,921
)
(9,867
)
Other income (expense), net
(811
)
717
(312
)
(91
)
(12
)
Tax provision
-
3,240
2,207
689
1,945
Net loss attributable to ordinary shareholders
(15,397
)
(23,417
)
(26,131
)
(9,323
)
(7,934
)
Other comprehensive loss:
Foreign currency translation adjustment
(3,582
)
(4, 478
)
3,474
(27
)
(21
Total comprehensive loss
(18,979
)
(27,895
)
(22,657
)
(9,350
)
(7,955
)
Basic and diluted net loss per ordinary share
(0.15
)
(0.24
)
(0.16
)
(0.07
)
(0.06
)
Consolidated Balance Sheet Data:
As of December 31,
2022
2021
2020
2019
2018
(in thousands except share and per share data)
Cash and cash equivalents
$
18,122
$
42,186
$
65,824
$
200
$
5,304
Working capital
17,619
41,133
62,196
(5,846
)
513
Total assets
26,477
48,826
70,656
2,378
6,920
Total shareholders' equity/(deficit)
19,571
41,280
62,386
(5,514
)
519
We define working capital
as current assets less current liabilities.
B. Capitalization and Indebtedness
Not applicable.
C. Reasons for the Offer and Use of Proceeds
Not applicable.
2
D. Risk Factors
Our business has significant risks.
You should consider carefully the risks described below, together with the other information contained in this Annual Report, including
our financial statements and the related notes. If any of the following risks occur, our business, financial condition, results of operations
and future growth prospects could be materially and adversely affected. This Annual Report also contains forward-looking statements that
involve risks and uncertainties. Our results could materially differ from those anticipated in these forward-looking statements, as a
result of certain factors including the risks described below and elsewhere in this Annual Report and our other SEC filings. See "Cautionary
Statement Regarding Forward-Looking Statements" above.
Risks Related to the Development of our Product Candidates
If we encounter substantial delays in clinical
trials of our product candidates, we may be unable to obtain required regulatory approvals, and therefore will be unable to commercialize
our product candidates on a timely basis or at all.
Before obtaining marketing
approval from regulatory authorities for the sale of our product candidates, we must conduct extensive clinical trials to demonstrate
the safety and utility of the product candidates. Clinical testing is expensive, time-consuming and uncertain as to outcome. We cannot
guarantee that any clinical trials will be conducted as planned or completed on schedule, if at all, as a failure of one or more clinical
trials can occur at any stage of testing. Events that may prevent successful or timely completion of clinical development include:
●
delays in reaching a consensus
    with the U.S. Food and Drug Administration, or FDA, European Medicines Agency, or EMA, or other regulatory authorities on trial design;
●
delays in reaching agreement
    on acceptable terms with prospective contract research organizations, or CROs, and clinical trial sites;
●
delays in execution of development due to financial
    instability of our CROs, CMOs and CDMOs
●
delays in opening clinical
    trial sites or obtaining required institutional review board or independent ethics committee approval at each clinical trial site;
●
delays in recruiting suitable
    patients to participate in our future clinical trials;
●
imposition of a clinical
    hold by regulatory authorities as a result of a serious adverse event or after an inspection of our clinical trial operations or
    clinical trial sites;
●
failure by us, any CROs
    we engage or any other third parties to adhere to clinical trial requirements;
●
failure to perform in accordance
    with good clinical practice, or GCP, or applicable regulatory guidelines in Europe and other international markets;
●
delays in the testing,
    validation, manufacturing and delivery of our product candidates to the clinical trial sites, including delays by third parties with
    whom we have contracted to perform certain of those functions;
●
delays in having patients
    complete participation in a clinical trial or return for post-treatment follow-up;
●
clinical trial sites or
    patients dropping out of a clinical trial;
●
selection of clinical endpoints
    that require prolonged periods of clinical observation or analysis of the resulting data;
●
occurrence of serious adverse
    events associated with the product candidate that are viewed to outweigh its potential benefits;
●
occurrence of serious adverse
    events in clinical trials of the same class of agents conducted by other sponsors; and
●
changes in regulatory requirements
    and guidance that require amending or submitting new clinical protocols.
Any inability to successfully
complete preclinical and clinical development could result in additional costs to us or impair our ability to generate revenues from
product sales, regulatory and commercialization milestones and royalties. In addition, if we make manufacturing or formulation changes
to our product candidates, we may need to conduct additional studies to bridge our modified product candidates to earlier versions. Clinical
trial delays also could shorten any periods during which we may have the exclusive right to commercialize our product candidates or allow
our competitors to bring products to market before we do, which could impair our ability to successfully commercialize our product candidates
and may harm our business, financial condition, results of operations and prospects.
3
We may fail to demonstrate the safety and
therapeutic utility of our product candidates to the satisfaction of applicable regulatory authorities, which would prevent or delay
regulatory approval and commercialization.
Before obtaining regulatory
approvals for the commercial sale of our product candidates, we must demonstrate through lengthy, complex and expensive preclinical testing
and clinical trials that our product candidates are both safe and effective for use in each target indication. Clinical testing is expensive
and can take many years to complete, and its outcome is inherently uncertain. Most product candidates that commence clinical trials are
never approved as products. If the results of our registrational trial or future pivotal trials for our other product candidates do not
demonstrate therapeutic utility of our product candidates, or if there are safety concerns or serious adverse events associated with
our product candidates, we may:
●
be delayed in obtaining
    marketing approval for our product candidates, if at all;
●
obtain approval for indications
    or patient populations that are not as broad as intended or desired;
●
obtain approval with labeling
    that includes significant use or distribution restrictions or safety warnings;
●
be subject to additional
    post-marketing testing requirements;
●
be subject to changes in
    the way the product is administered;
●
be required to perform
    additional clinical trials to support approval or be subject to additional post-marketing testing requirements;
●
have regulatory authorities
    withdraw or suspend their approval of the product or impose restrictions on its distribution in the form of a modified risk evaluation
    and mitigation strategy, or REMS;
●
be subject to the addition
    of labeling statements, such as warnings or contraindications; or
●
be sued or experience damage
    to our reputation.
Success in preclinical studies or clinical
trials may not be indicative of results in future clinical trials.
Success in preclinical testing
and early clinical trials does not ensure that later clinical trials will generate the same results or otherwise provide adequate data
to demonstrate the effectiveness and safety of our product candidate. Frequently, product candidates that have shown promising results
in early clinical trials have subsequently suffered significant setbacks in later clinical trials. To date, some of our clinical trials
have involved small patient populations and because of the small sample size in such trials, the interim results of these clinical trials
may be subject to substantial variability and may not be indicative of either future interim results or final results. 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.  In addition, there is a high failure rate for drugs and
biologic products proceeding through clinical trials. In fact, many companies in the pharmaceutical and biotechnology industries have
suffered significant setbacks in late-stage clinical trials even after achieving promising results in preclinical testing and earlier-stage
clinical trials. Moreover, data obtained from preclinical and clinical activities is subject to varying interpretations, which may delay,
limit or prevent regulatory approval. In addition, we may experience regulatory delays or rejections as a result of many factors, including
due to changes in regulatory policy during the period of our product candidate development. Any such delays could negatively impact our
business, financial condition, results of operations and prospects.
We depend on enrollment of patients in
our clinical trials for our product candidates and may find it difficult to enroll patients in our clinical trials, which could delay
or prevent us from proceeding with clinical trials of our product candidates and could materially adversely affect our R&D efforts
and business, financial condition and results of operations.
Identifying and qualifying
patients to participate in clinical trials of our product candidates is critical to our success. The timing of our clinical trials depends
on our ability to recruit patients to participate, and to see those patients through the completion of required follow-up periods. If,
for any reason, patients are unwilling to enroll in our clinical trials, then the timeline for recruiting patients, conducting studies
and obtaining regulatory approvals for our product candidates may be delayed. These delays could result in increased costs, delays in
advancing our product candidates, delays in testing the effectiveness of our product candidates or termination of clinical trials altogether.
4
Our current product candidates
are being developed to treat oncology and immune diseases of high unmet medical need. However, we may not be able to initiate or continue
clinical trials if we cannot enroll a sufficient number of eligible patients to participate in the clinical trials required by the FDA,
EMA or other regulatory authorities. As a result, we may not be able to identify, recruit and enroll a sufficient number of patients,
or those with required or desired characteristics, to complete our clinical trials in a timely manner. Patient enrollment can be affected
by many factors, including:
●
size of the patient population
    and process for identifying patients;
●
eligibility and exclusion
    criteria for our clinical trials;
●
perceived risks and benefits
    of our product candidates;
●
severity of the disease
    under investigation;
●
proximity and availability
    of clinical trial sites for prospective patients;
●
competition with other
    clinical trials for product candidates competing in the same therapeutic areas as our product candidates;
●
ability to obtain and maintain
    patient consent;
●
patient drop-outs prior
    to completion of clinical trials;
●
patient referral practices
    of physicians; and
●
ability to monitor patients
    adequately during and after treatment.
Our ability to successfully
initiate, enroll and complete clinical trials in any foreign country is subject to numerous risks unique to conducting business in foreign
countries, including:
●
difficulty in establishing
    or managing relationships with CROs and physicians;
●
different standards for
    the conduct of clinical trials;
●
absence in some countries
    of established groups with sufficient regulatory expertise for review of certain treatment protocols;
●
inability to locate qualified
    local consultants, physicians and partners; and
●
the potential burden of
    complying with a variety of foreign laws, medical standards and regulatory requirements, including the regulation of pharmaceutical
    and biotechnology products and treatment.
If we have difficulty enrolling
a sufficient number of patients or finding additional clinical trial sites to conduct our clinical trials as planned, we may need to
delay, limit or terminate ongoing or planned clinical trials, any of which could have an adverse effect on our business, financial condition,
results of operations and prospects.
Our product candidates and the process
for administering our product candidates may cause undesirable side effects or have other properties that could delay or prevent their
regulatory approval, limit their commercial potential or result in significant negative consequences following any potential marketing
approval.
During the conduct of clinical
trials, patients report changes in their health, including illnesses, injuries and discomforts, to their study doctor. Often, it is not
possible to determine whether the product candidate being studied caused these conditions. Regulatory authorities may draw different
conclusions or require additional testing to confirm these determinations. For Milciclib, the most frequent drug-related side effects
reported across studies, at all doses tested, were gastrointestinal, or GI, adverse events (nausea and diarrhea, followed by less frequent
vomiting), neurological effects (mainly tremor, then ataxia, dizziness and dysgeusia), skin disorders and asthenia, fatigue, headache
and anorexia. For Foralumab, the most frequent drug-related side effects reported following intravenous administration were infusion
related reactions, or IRR, including fever, headaches, chills, nausea, vomiting diarrhea and hypotension considered the result of cytokine
release also known as cytokine release syndrome, or CRS. Other adverse events included reactivation of Epstein-Barr virus (clinically
silent); moderate lymphocytopenia, abnormalities in liver function tests. Since most of these changes are related to the infusion route
of administration and dosage level, such systemic toxicities are not anticipated when administered orally or nasally due to what we assume
will be minimal systemic absorption.
In addition, it is possible
that as we test our product candidates in larger, longer and more extensive clinical programs, or as use of these product candidates
becomes more widespread if they receive regulatory approval, illnesses, injuries, discomforts and other adverse events that were observed
in earlier trials, as well as conditions that did not occur or went undetected in previous trials, will be reported by patients. Many
times, side effects are only detectable after investigational products are tested in large-scale, Phase 3 clinical trials or, in some
cases, after they are made available to patients on a commercial scale after approval. If additional clinical experience indicates that
our product candidates cause serious or life-threatening side effects, the development of our product candidates may fail or be delayed,
or, if the product candidate has received regulatory approval, such approval may be revoked, which would harm our business, prospects,
operating results and financial condition.
5
If in the future we are unable
to demonstrate that such adverse events were caused by the administration process or related procedures, the FDA, EMA or other regulatory
authorities could order us to cease further development of, or deny approval of, our product candidates for any or all targeted indications.
Even if we are able to demonstrate that any serious adverse events are not product-related, such occurrences could affect patient recruitment
or the ability of enrolled patients to complete the clinical trial. Moreover, if we elect or are required to delay, suspend or terminate
any clinical trial of any of our product candidates, the commercial prospects of such product candidate may be harmed and our ability
to generate product revenues from such product candidate may be delayed or eliminated. Any of these occurrences may harm our ability
to develop other product candidates, and may harm our business, financial condition and prospects.
Additionally, if we or others
later identify undesirable side effects caused by any of our product candidates, several potentially significant negative consequences
could result, including:
●
regulatory authorities
    may suspend or withdraw approvals of such product candidate;
●
regulatory authorities
    may require additional warnings on the label;
●
we may be required to change
    the way a product candidate is administered or conduct additional clinical trials;
●
we could be sued and held
    liable for harm caused to patients; and
●
our reputation may suffer.
Any of these events could
prevent us from achieving or maintaining market acceptance of our product candidates.
Any contamination in our manufacturing
process, shortages of raw materials or failure of any of our key suppliers to deliver necessary components could result in delays in
our clinical development or marketing schedules.
Given the nature of biologics
and NCE manufacturing, there is a risk of contamination. Any contamination could adversely affect our ability to produce product candidates
on schedule and could, therefore, harm our results of operations and cause reputational damage. In addition, some of the raw materials
required in our manufacturing process are derived from biologic sources and are difficult to procure and may be subject to contamination
or recall. A material shortage, contamination, recall or restriction on the use of biologically derived substances in the manufacture
of our product candidates could adversely impact or disrupt the commercial manufacturing or the production of clinical material, which
could adversely affect our development timelines and our business, financial condition, results of operations and prospects.
Risks Related to Our Financial Position and
Need for Capital
We have incurred net losses in every year
since our inception. We anticipate that we will continue to incur losses for the foreseeable future and may never achieve or maintain
profitability.
We are a clinical stage biotechnology
company with a limited operating history. Since our inception in May 2013, we have incurred significant net losses. Our net losses were
$15.4 million, $23.4 million and $26.1 million for the years ended December 31, 2022, 2021 and 2020, respectively. As of December 31,
2022, we had an accumulated loss of $116 million. We have devoted substantially all of our efforts to research and development of our
product candidates, including clinical development of our lead product candidates, Foralumab and Milciclib, as well as to building out
our management team and infrastructure. We expect that it could be several years, if ever, before we have a commercialized product candidate.
We expect to continue to incur significant expenses and increasing operating losses for the foreseeable future. These net losses will
adversely impact our shareholders' equity and net assets and may fluctuate significantly from quarter to quarter and year to year.
We anticipate that our expenses will increase substantially if, and as, we:
●
continue research and development of Foralumab, including the initiation
of a clinical trial with nasally administered Foralumab in patients with secondary progressive multiple sclerosis (SPMS), develop
a program for intranasal administration of Foralumab for the treatment or prevention of Type 1 Diabetes (TID), investigate intranasal
foralumab for the treatment of Long COVID, study intranasal foralumab in patients with mild to moderate Alzheimer's Disease and
potentially study intranasal foralumab in rare Orphan pediatric diseases when funding becomes available.
●
initiate a Phase 2 trial
    for Milciclib in combination with gemcitabine in patients with KRAS-mutated (mut) non-small cell lung cancer (NSCLC) after failure
    of standard-of-care (SoC) therapy.
●
cGMP manufacturing of anti-IL6R mAb drug substance and drug product
for treatment Interstitial lung disease associated with systemic sclerosis (SSc-ILD) is complete. An IND to conduct a Phase 1 clinical
trial was submitted in December 2021
●
manufacture our product
    candidates in accordance with current good manufacturing practices, or cGMP, for clinical trials or potential commercial sales;
6
●
establish
    a sales, marketing and distribution infrastructure to commercialize any product candidate for which we may obtain marketing approval;
●
develop, maintain, expand
    and protect our intellectual property portfolio;
●
identify, assess, and acquire
    or in-license other product candidates and technologies;
●
secure, maintain or obtain
    freedom to operate for any in-licensed technologies and products;
●
address any competing technological
    and market developments; and
●
expand our operations in
    the United States and Europe.
We may never succeed in any
or all of these activities and, even if we do, we may never generate revenues that are significant or large enough to achieve profitability.
If we do achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis. Our failure to
become and remain profitable would decrease the value of our company and could impair our ability to raise capital, maintain our R&D
efforts, expand our business or continue our operations.
We need substantial additional funding
to complete the development of our product candidates, which may not be available on acceptable terms, if at all. Failure to obtain this
necessary capital when needed may force us to delay, limit or terminate certain of our product development, research operations or future
commercialization efforts, if any.
Our operations have consumed
substantial amounts of cash since inception, and we expect our expenses to increase in connection with our ongoing activities, particularly
as we continue the R&D of, initiate further clinical trials of and seek marketing approval for, our product candidates. In addition,
if we obtain marketing approval for our product candidates, we expect to incur significant expenses related to product sales, marketing,
manufacturing and distribution. Furthermore, we expect to incur additional costs associated with operating as a public company listed
on the Nasdaq in the United States. Our future capital requirements will depend on many factors, including:
●
the scope, progress, results
    and costs of laboratory testing, manufacturing, preclinical and clinical development for our current and future product candidates;
●
the costs, timing and outcome
    of regulatory review of our product candidates;
●
the extent to which we
    acquire or in-license and develop other product candidates and technologies;
●
our ability to establish
    and maintain collaborations and license agreements on favorable terms, if at all;
●
the costs, timing and outcome
    of potential future commercialization activities, including manufacturing, marketing, sales and distribution for our product candidates
    for which we receive marketing approval;
●
the costs of developing,
    maintaining and enforcing our intellectual property rights and defending intellectual property-related claims; and
●
the sales price and availability
    of adequate third-party coverage and reimbursement for our product candidates, if and when approved.
Developing product candidates
and conducting preclinical studies and clinical trials is a time-consuming, expensive and uncertain process that takes years to complete,
and we may never generate the necessary data or results required to obtain marketing approval and achieve product sales. In addition,
our product candidates, if approved, may not achieve commercial success. Our product revenues, if any, will be derived from or based
on sales of product candidates that may not be commercially available for many years, if at all. Accordingly, we will need to continue
to rely on additional financing to achieve our business objectives. Adequate additional financing may not be available to us on acceptable
terms, if at all. To the extent that additional capital is raised through the issuance of equity or equity-linked securities, the issuance
of those securities could result in substantial dilution for our current shareholders and the terms of any future issuance may include
liquidation or other preferences that adversely affect the rights of our current shareholders. Debt financing, if available, may involve
covenants restricting our operations or our ability to incur additional debt. Any debt or additional equity financing that we raise may
contain terms that are not favorable to us or our shareholders. If we raise additional funds through collaboration and licensing arrangements
with third parties, it may be necessary to relinquish some rights to our technologies or our product candidates or grant licenses on
terms that are not favorable to us. Furthermore, the potential issuance of additional securities in the future, whether equity or debt,
by us, or the possibility of such issuance, may cause the market price of our Common shares, to decline and existing shareholders may
not agree with our financing plans or the terms of such financings.
If we are unable to obtain
adequate funding on a timely basis, we may be required to significantly curtail, delay or discontinue our R&D programs of our product
candidates or any future commercialization efforts, be unable to expand our operations or be unable to otherwise capitalize on our business
opportunities, as desired, which could harm our business and potentially cause us to discontinue operations.
7
Our limited operating history and no history
of commercializing pharmaceutical products may make it difficult to evaluate the success of our business to date and to assess the prospects
for our future viability.
Since our inception, we have
devoted substantially all of our resources to developing Foralumab and Milciclib, and our other product candidates, building our intellectual
property portfolio and providing general and administrative support for these operations. Although our R&D efforts to date have resulted
in a pipeline of product candidates, we have not yet demonstrated our ability to successfully complete Phase 3 or other pivotal clinical
trials, obtain regulatory approvals, or commercialize any of our product candidates. In addition, given our limited operating history,
we may encounter unforeseen expenses, difficulties, complications, delays and other known and unknown factors in achieving our business
objectives.
Additionally, we are not
profitable and have incurred losses in each year since our inception, and we expect that our financial condition and operating results
may continue to fluctuate significantly from quarter to quarter and year to year due to a variety of factors, many of which are beyond
our control. Consequently, any predictions you make about our future success or viability may not be as accurate as they could be if
we had a longer operating history.
Risks Related to Our Reliance on Third Parties
We rely, and expect to continue to rely,
on third parties to conduct our preclinical studies and clinical trials. If these third parties do not successfully carry out their contractual
duties or meet expected deadlines, we may not be able to obtain regulatory approval for or commercialize our product candidates.
We have relied upon and plan
to continue to rely upon third parties, including independent clinical investigators and third-party CROs, to conduct our preclinical
studies and clinical trials and to monitor and manage data for our ongoing preclinical and clinical programs. In engaging these third
parties, we typically have to, and expect to have to, negotiate budgets and contracts, which may result in delays to our development
timelines and increases costs. Additionally, there is a limited number of qualified third-party service providers that specialize or
have the expertise required to achieve our business objectives, and so it may be challenging to find alternative investigators or CROs,
or do so on commercially reasonable terms. We rely on these parties for execution of our preclinical studies and clinical trials, and
control only certain aspects of their activities. Nevertheless, we are responsible for ensuring that each of our preclinical studies
and clinical trials is conducted in accordance with the applicable protocol and legal, regulatory and scientific standards, and our reliance
on these third parties does not relieve us of our regulatory responsibilities. We and our third-party contractors and CROs are required
to comply with GCP requirements, which are regulations and guidelines enforced by the FDA, the Competent Authorities of the Member States
of the European Economic Area and comparable foreign regulatory authorities for all of our product candidates in clinical development.
Regulatory authorities enforce these GCP requirements through periodic inspections of trial sponsors, principal investigators and clinical
trial sites. If we fail to exercise adequate oversight over any of our CROs or if we or any of our CROs fail to comply with applicable
GCP requirements, the clinical data generated in our clinical trials may be deemed unreliable and the FDA, EMA or other regulatory authorities
may require us to perform additional clinical trials before approving our marketing applications. We cannot assure you that upon a regulatory
inspection of us or our CROs or other third parties performing services in connection with our clinical trials, such regulatory authority
will determine that any of our clinical trials complies with GCP regulations. In addition, our clinical trials must be conducted with
product produced under applicable cGMP regulations. Our failure to comply with these regulations may require us to repeat clinical trials,
which would delay the regulatory approval process.
Further, these investigators
and CROs are not our employees and we will not be able to control, other than by contract, the amount of resources, including time, which
they devote to our product candidates and clinical trials. If independent investigators or CROs fail to devote sufficient resources to
the development of our product candidates, or if their performance is substandard, it may delay or compromise the prospects for approval
and commercialization of our product candidates. These investigators and CROs may also have relationships with other commercial entities,
including our competitors, for whom they may also be conducting clinical studies or other drug development activities, which could affect
their performance on our behalf. In addition, the use of third-party service providers requires us to disclose our proprietary information
to these parties, which increases the risk that a competitor will discover them or that this information will be misappropriated or disclosed.
If any of our relationships
with these third-party CROs terminate, we may not be able to enter into arrangements with alternative CROs or to do so on commercially
reasonable terms. If CROs do not successfully carry out their contractual duties or obligations or 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, regulatory requirements or for other reasons, our clinical trials may be extended, delayed or terminated and we may not be
able to obtain regulatory approval for or successfully commercialize our product candidates. As a result, our results of operations and
commercial prospects would be harmed, our costs could increase and our ability to generate revenues could be delayed.
Repeating clinical trials
or switching or engaging additional CROs involves additional cost and requires our management's time and focus. In addition, there
is a natural transition period when a clinical trial has to be repeated or when a new CRO commences work. As a result, delays could occur,
which could materially impact our ability to meet our desired clinical development timelines.
8
Our reliance on third parties requires
us to share our trade secrets, which increases the possibility that a competitor will discover them or that our trade secrets will be
misappropriated or disclosed.
We have engaged contract
manufacturing organizations, or CMOs, to cGMP manufacture Foralumab (TZLS-401) drug product, Milciclib (TZLS-201) and anti-Interleukin
6 Receptor monoclonal antibody (anti-IL6R mAb, TZLS-501) drug substance and drug product and to perform quality testing, and because
we collaborate with various organizations and academic institutions for the advancement of our platforms, we must, at times, share our
proprietary technology and confidential information, including trade secrets, with them. We seek to protect our proprietary technology,
in part, by entering into confidentiality agreements and, if applicable, material transfer agreements, collaborative research agreements,
consulting agreements or other similar agreements with our collaborators, advisors, employees and consultants prior to beginning research
or disclosing proprietary information. These agreements typically limit the rights of the third parties to use or disclose our confidential
information. Despite the contractual provisions employed when working with third parties, the need to share trade secrets and other confidential
information increases the risk that such trade secrets become known by our competitors, are inadvertently incorporated into the technology
of others or are disclosed or used in violation of these agreements. Given that our proprietary position is based, in part, on our know-how
and trade secrets, a competitor's discovery of our proprietary technology and confidential information or other unauthorized use
or disclosure of such technology or information would impair our competitive position and may have an adverse effect on our business,
financial condition, results of operations and prospects.
Despite our efforts to protect
our trade secrets, our competitors may discover our trade secrets, either through breach of these agreements, independent development
or publication of information including our trade secrets by third parties. A competitor's discovery of our trade secrets would
impair our competitive position and have an adverse impact on our business, financial condition, results of operations and prospects.
We utilize, and expect to continue to utilize,
third parties to conduct our product manufacturing for the foreseeable future, and these third parties may not perform satisfactorily.
We currently rely on CMOs
for the manufacturing of clinical batches and intend to continue to rely on third parties to manufacture our preclinical study and clinical
trial product supplies. If our current CMOs, or any future third-party manufacturers, do not successfully carry out their contractual
duties, meet expected deadlines or manufacture our product candidates in accordance with regulatory requirements, or if there are disagreements
between us and our CMOs or any future third-party manufacturers, we will not be able to complete, or may be delayed in completing, the
preclinical studies required to support future investigational new drug, or IND, submissions and the clinical trials required for approval
of our product candidates.
In addition to our current
CMOs, we may rely on additional third parties to manufacture ingredients of our product candidates in the future and to perform quality
testing, and reliance on these third parties entails risks to which we would not be subject if we manufactured the product candidates
ourselves, including:
●
reduced control for certain
    aspects of manufacturing activities;
●
termination or nonrenewal
    of manufacturing and service agreements with third parties in a manner or at a time that is costly or damaging to us; and
●
disruptions to the operations
    of our third-party manufacturers and service providers caused by conditions unrelated to our business or operations, including the
    bankruptcy of the manufacturer or service provider.
Any of these events could
lead to clinical trial delays or failure to obtain regulatory approval or impact our ability to successfully commercialize any of our
product candidates. Some of these events could be the basis for FDA, EMA or other regulatory authority action, including injunction,
recall, seizure or total or partial suspension of product manufacture.
To the extent we rely on a third-party
manufacturing facility for commercial supply, that third party will be subject to significant regulatory oversight with respect to manufacturing
our product candidates.
The preparation of therapeutics
for clinical trials or commercial sale is subject to extensive regulation. Components of a finished therapeutic product approved for
commercial sale or used in late-stage clinical trials must be manufactured in accordance with cGMP requirements. These regulations govern
manufacturing processes and procedures, including record keeping, and the implementation and operation of quality systems to control
and assure the quality of investigational products and products approved for sale. Poor control of production processes can lead to the
introduction of outside agents or other contaminants, or to inadvertent changes in the properties or stability of a product candidate
that may not be detectable in final product testing. To the extent that we utilize third-party facilities for commercial supply, the
third party's facilities and quality systems must pass an inspection for compliance with the applicable regulations as a condition
of regulatory approval. In addition, the regulatory authorities may, at any time, audit or inspect the third-party manufacturing facility
or the associated quality systems for compliance with the regulations applicable to the activities being conducted. If, for example,
these facilities do not pass a plant inspection, the FDA will not approve the applicable NDA or biologics license application, or BLA.
9
We do not directly control
the manufacturing of, and are completely dependent on, our CMOs for compliance with cGMP requirements. If our CMOs cannot successfully
manufacture material that conforms to our specifications and the strict regulatory requirements of the FDA, EMA or other regulatory authorities,
they will not be able to secure and/or maintain regulatory approval for their manufacturing facilities. In addition, we have no direct
control over the ability of our CMOs to maintain adequate quality control, quality assurance and qualified personnel. Furthermore, all
of our CMOs are engaged with other companies to supply and/or manufacture materials or products for such companies, which exposes our
CMOs to regulatory risks for the production of such materials and products. As a result, failure to meet the regulatory requirements
for the production of those materials and products may generally affect the regulatory clearance of our CMOs' facilities. Our failure,
or the failure of third parties, to comply with applicable regulations could result in sanctions being imposed on us, including clinical
holds, fines, injunctions, civil penalties, delays, suspension or withdrawal of approvals, license revocation, seizures or recalls of
product candidates or products, operating restrictions and criminal prosecutions, any of which could significantly and adversely affect
supplies of our products and product candidates.
Our potential future dependence
upon others for the manufacture of our product candidates may adversely affect our future profit margins and our ability to commercialize
any products that receive regulatory approval on a timely and competitive basis.
Risks Related to Commercialization of Our
Product Candidates
We currently have no marketing and sales
force. If we are unable to establish effective sales, marketing and distribution capabilities or enter into agreements with third parties
to market, sell and distribute our product candidates that may be approved, we may not be successful in commercializing our product candidates
if and when approved, and we may be unable to generate any product revenue.
We currently do not have
a marketing or sales team for the marketing, sales and distribution of any of our product candidates. In order to commercialize any of
our product candidates that may be approved, we intend to build, on a territory-by-territory basis, marketing, sales, distribution, managerial
and other non-technical capabilities or make arrangements with third parties to perform these services. These efforts will require significant
capital expenditures, management resources and time, and we face competition in search for qualified personnel or third parties to assist
with marketing, sales and distribution of any of our product candidates. We may not be successful in building these capabilities.
There are risks involved
with both establishing our own sales, marketing and distribution capabilities and entering into arrangements with third parties to perform
these services. For example, recruiting and training a sales force is expensive and time consuming and could delay any product launch.
If the commercial launch of a product candidate for which we recruit a sales force and establish marketing and/or distribution capabilities
is delayed or does not occur for any reason, we would have prematurely or unnecessarily incurred these commercialization expenses. This
may be costly, and our investment would be lost if we cannot retain or reposition our sales and marketing personnel.
Factors that may inhibit
our efforts to commercialize our product candidates on our own include:
●
our inability to recruit,
    train and retain adequate numbers of effective sales and marketing personnel;
●
the inability of sales
    personnel to obtain access to physicians or persuade adequate numbers of physicians to prescribe any future product that we may develop;
●
the lack of complementary
    treatments to be offered by sales personnel, which may put us at a competitive disadvantage relative to companies with more extensive
    product lines; and
●
unforeseen costs and expenses
    associated with creating an independent sales and marketing organization.
If we enter into arrangements
with third parties to perform sales, marketing and distribution services, our product revenue or the profitability to us from these revenue
streams is likely to be lower than if we were to market and sell any product candidates that we develop ourselves. In addition, we may
not be successful in entering into arrangements with third parties to sell and market  our product candidates or may be unable to
do so on terms that are favorable to us. We likely will have little control over such third parties and any of them may fail to devote
the necessary resources and attention to sell and market our product candidates effectively. If we do not establish sales and marketing
capabilities successfully, either on our own or in collaboration with third parties, we may not be successful in commercializing our
product candidates.
We face significant competition in an environment
of rapid technological change and the possibility that our competitors may achieve regulatory approval before us or develop therapies
that are more advanced or effective than ours.
The biotechnology and pharmaceutical
industries are characterized by rapidly changing technologies, significant competition and a strong emphasis on intellectual property.
We face substantial competition from many different sources, including large and specialty pharmaceutical and biotechnology companies,
academic research institutions, government agencies and public and private research institutions.
New developments, including
the development of other pharmaceutical technologies and methods of treating disease, occur in the pharmaceutical and life sciences industries
at a rapid pace. Developments by competitors may render our product candidates obsolete or noncompetitive. We anticipate that we will
face intense and increasing competition as new treatments enter the market and advanced technologies become available.
10
Many of our potential competitors,
alone or with their strategic partners, have substantially greater financial, technical and other resources, such as larger R&D,
clinical, sales and marketing and manufacturing organizations. These third parties also compete with us in recruiting and retaining qualified
scientific and management personnel, establishing clinical trial sites and patient registration for clinical trials, as well as in acquiring
technologies complementary to, or necessary for, the development of our products. In addition, mergers and acquisitions in the biotechnology
and pharmaceutical industries may result in even more resources being concentrated among a smaller number of competitors. Our commercial
opportunity could be reduced or eliminated if competitors develop and commercialize products that are safer, more effective, have fewer
or less severe side effects, are more convenient or are less expensive than any product candidate that we may develop. Competitors also
may obtain FDA, EMA or other regulatory approval for their products more rapidly or earlier than we may obtain approval for ours, which
could result in our competitors establishing a strong market position before we are able to enter the market. Additionally, technologies
developed by our competitors may render our product candidates uneconomical or obsolete, and we may not be successful in marketing our
product candidates against competitors.
In addition, as a result
of the expiration or successful challenge of our patent rights, we could face more litigation with respect to the validity and/or scope
of patents relating to our competitors' products. The availability of our competitors' products could limit the demand, and
the price we are able to charge, for any product candidate that we may develop and commercialize.
The market opportunities for our product
candidates may be smaller than we anticipate.
We focus our R&D efforts
on treatments for cancer and autoimmune disease. Our understanding of both the number of people who have these diseases, as well as the
subset of people with these diseases who have the potential to benefit from treatment with our product candidates, is based on estimates.
These estimates may prove to be incorrect and new studies may reduce the estimated incidence or prevalence of these diseases. The number
of patients in the United States, the European Union and elsewhere may turn out to be lower than expected, may not be otherwise amenable
to treatment with our product candidates or patients may become increasingly difficult to identify and access, all of which would adversely
affect our business, financial condition, results of operations and prospects.
Further, there are several
factors that could contribute to making the actual number of patients who receive our potential products, if and when approved, less
than the potentially addressable market. These include, for example, the lack of widespread availability of, and limited reimbursement
for, new therapies in many underdeveloped markets.
The future commercial success of our product
candidates will depend upon the degree of each product candidates' market acceptance by physicians, patients, third-party payors
and others in the medical community.
Our product candidates are
at varying stages of development, and we may never have a product that is commercially successful. To date, we have no product authorized
for marketing. Due to the inherent risk in the development of pharmaceutical products, we may never successfully complete development
and commercialization of any of our product candidates. Even with the requisite approvals from the FDA, EMA and other regulatory authorities
internationally, the commercial success of our product candidates will depend, in part, on the acceptance of physicians, patients and
third-party payors of our product candidates as medically necessary, cost-effective and safe. Any product that we commercialize may not
gain acceptance by physicians, patients, third-party payors and others in the medical community. If these products do not achieve an
adequate level of acceptance, we may not generate significant product revenue and may not become profitable. Even if some product candidates
achieve market acceptance, the market may not prove to be large enough to allow us to generate significant revenues. The degree of market
acceptance of our product candidates, if approved for commercial sale, will depend on several factors, including:
●
the effectiveness and safety
    of our product candidates as demonstrated in clinical trials;
●
the potential and perceived
    advantages of our product candidates over alternative treatments;
●
the availability and cost
    of treatment relative to alternative treatments;
●
changes in the standard
    of care for the targeted indications for any product candidate;
●
the willingness of physicians
    to prescribe, and the target patient population to try, new therapies;
●
the prevalence and severity
    of any side effects;
●
product labeling or product
    insert requirements of the FDA, EMA or other regulatory authorities, including any limitations or warnings contained in a product's
    approved labeling;
●
the timing of market introduction
    of competitive products;
●
sales, distribution and
    marketing support;
●
publicity concerning our
    product candidates or competing products and treatments;
●
potential product liability
    claims;
●
any restrictions on the
    use of our products together with other medications; and
●
favorable third-party payor
    coverage and adequate reimbursement.
11
Even if a potential product
displays favorable clinical properties and safety profile in preclinical studies and clinical trials, market acceptance of the product
will not be fully known until after it is launched.
The insurance coverage and reimbursement
status of newly approved products is uncertain. Failure to obtain or maintain adequate coverage and reimbursement for our product candidates,
if approved, could limit our ability to market those products.
We expect that coverage and
adequate reimbursement by government and private payors will be essential for most patients to be able to afford these treatments. Accordingly,
sales of our product candidates will depend substantially, both domestically and abroad, on the extent to which the costs of our product
candidates will be paid by health maintenance, managed care, pharmacy benefit and similar healthcare management organizations, or will
be reimbursed by government authorities, private health coverage insurers and other third-party payors. Coverage and reimbursement by
a third-party payor may depend upon several factors, including the third-party payor's determination that use of a product is:
●
a covered benefit under
    our health plan;
●
safe, effective and medically
    necessary;
●
appropriate for the specific
    patient;
●
cost-effective; and
●
neither experimental nor
    investigational.
Obtaining coverage and reimbursement
for a product from third-party payors is a time-consuming and costly process that could require us to provide to the payor supporting
scientific, clinical and cost-effectiveness data. We may not be able to provide data sufficient to gain acceptance with respect to coverage
and reimbursement. If coverage and reimbursement are not available, or are available only at limited levels, we may not be able to successfully
commercialize our product candidates. Even if coverage is provided, the approved reimbursement amount may not be adequate to realize
a sufficient return on our investment.
There is significant uncertainty
related to third-party coverage and reimbursement of newly approved products. In the United States, third-party payors, including government
payors such as the Medicare and Medicaid programs, play an important role in determining the extent to which new drugs and biologics
will be covered and reimbursed. The Medicare and Medicaid programs increasingly are used as models for how private payors develop their
coverage and reimbursement policies. However, no uniform policy of coverage and reimbursement exists among third-party payors. Therefore,
coverage and reimbursement for products can differ significantly from payor to payor. One payor's determination to provide coverage
for a product does not assure that other payors will also provide coverage, and adequate reimbursement. It is difficult to predict what
the Centers for Medicare and Medicaid Services, or CMS will decide with respect to coverage and reimbursement for fundamentally novel
products such as ours, as there is no body of established practices and precedents for these types of products. Moreover, reimbursement
agencies in the European Union may be more conservative than the CMS. For example, several cancer drugs have been approved for reimbursement
in the United States and have not been approved for reimbursement in certain European Union, or EU, member states, or Member States.
It is difficult to predict what third-party payors will decide with respect to the coverage and reimbursement for our product candidates.
Also, the containment of
healthcare costs has become a priority of federal, state and foreign governments, and the prices of drugs have been a focus in this effort.
The U.S. government, state legislatures, and foreign governments have shown significant interest in implementing cost-containment programs
to limit the growth of government-paid healthcare costs, including price controls, restrictions on reimbursement and requirements for
substitution of generic products for branded prescription drugs. For example, in the United States, the Patient Protection and Affordable
Care Act of 2010 (as amended by the Health Care and Education Reconciliation Act of 2010), or the PPACA, contains provisions that may
reduce the profitability of products, including, for example, increased rebates for products sold to Medicaid programs, extension of
Medicaid rebates to Medicaid managed care plans, mandatory discounts for certain Medicare Part D beneficiaries and annual fees based
on pharmaceutical companies' share of sales to federal health care programs. Further, there has been heightened governmental scrutiny
over the manner in which manufacturers set prices for their marketed products, which has resulted in several recent congressional inquiries
and proposed federal and state legislation designed to, among other things, bring more transparency to product pricing, contain the cost
of drugs, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies
for products.
Outside the United States,
international operations generally are subject to extensive government price controls and other market regulations and increasing emphasis
on cost-containment initiatives in the European Union, Canada and other countries may put pricing pressure on us. In many countries,
the prices of medical products are subject to varying price control mechanisms as part of national health systems. In general, the prices
of medicines under such systems are substantially lower than in the United States. Other countries allow companies to fix their own prices
for medical products but monitor and control company profits. Additional foreign price controls or other changes in pricing regulation
could restrict the amount that we are able to charge for our product candidates. Accordingly, in markets outside the United States, the
reimbursement for our product candidates may be reduced compared with the United States and may be insufficient to generate commercially
reasonable product revenues.
In addition, there can be
considerable pressure by governments and other stakeholders on prices and reimbursement levels, including as part of cost containment
measures. Political, economic and regulatory developments may further complicate pricing negotiations, and pricing negotiations may continue
after reimbursement has been obtained. Reference pricing used by various Member States and parallel distribution, or arbitrage between
low-priced and high-priced Member States, can further reduce prices. To obtain reimbursement or pricing approval in some countries, we
may be required to conduct a clinical trial that compares the cost-effectiveness of our product candidates 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.
12
Moreover, increasing efforts
by government and third-party payors in the United States and abroad to cap or reduce healthcare costs may cause such organizations to
limit both coverage and the level of reimbursement for new products approved and, as a result, they may not cover or provide adequate
payment for our product candidates.
Payors increasingly are considering
new metrics as the basis for reimbursement rates, such as average sales price, average manufacturer price and actual acquisition cost.
The existing data for reimbursement based on some of these metrics is relatively limited, although certain states have begun to survey
acquisition cost data for the purpose of setting Medicaid reimbursement rates, and CMS has begun making pharmacy National Average Drug
Acquisition Cost and National Average Retail Price data publicly available on at least a monthly basis. Therefore, it may be difficult
to project the impact of these evolving reimbursement metrics on the willingness of payors to cover product candidates that we or our
partners are able to commercialize. We expect to experience pricing pressures in connection with the sale of any of our product candidates
due to the trend toward managed healthcare, the increasing influence of health maintenance organizations and additional legislative changes.
The downward pressure on healthcare costs in general, particularly prescription drugs and surgical procedures and other treatments, has
become intense. As a result, increasingly high barriers are being erected to the entry of new products such as ours.
Risks Related to Our Intellectual Property
Our rights to develop and commercialize
our product candidates are subject to the terms and conditions of licenses granted to us by others. If we fail to comply with our obligations
under our existing and any future intellectual property licenses with third parties, we could lose license rights that are important
to the business.
We are heavily reliant upon
licenses and sublicenses from Nerviano, Lonza and Novimmune to certain patent rights and proprietary technology that are important or
necessary to the development of our technology and product candidates, including the patents and know-how relating to manufacture. These
and other licenses may not provide exclusive rights to use such intellectual property and technology or may not provide exclusive rights
to use such intellectual property and technology in all relevant fields of use and in all territories in which we may wish to develop
or commercialize our technology and product candidates in the future. As a result, we may not be able to prevent competitors from developing
and commercializing competitive products, including in territories covered by our licenses.
In some circumstances, we
may not have the right to control the preparation, filing and prosecution of patent applications, or to maintain the patents, covering
technology that we license from third parties. If our licensors fail to maintain such patents or patent applications, or lose rights
to those patents or patent applications, the rights we have licensed may be reduced or eliminated and our right to develop and commercialize
any of our product candidates that are the subject of such licensed rights could be adversely affected. In addition to the foregoing,
the risks associated with patent rights that we license from third parties will also apply to patent rights we may own in the future.
Licenses to additional third-party
technology and materials that may be required for our development programs, including additional technology and materials owned by any
of our current licensors, may not be available in the future or may not be available on commercially reasonable terms, or at all, which
could have an adverse effect on our business and financial condition.
If we are unable to obtain and maintain
patent protection for our current product candidates, any future product candidates we may develop and our technology, or if the scope
of the patent protection obtained is not sufficiently broad, our competitors could develop and commercialize products and technology
similar or identical to ours.
Our success depends, in large
part, on our ability to seek, obtain and maintain patent protection in the United States and other countries with respect to our product
candidates and to future innovation related to our manufacturing technology. Our licensors have sought, and we intend to seek to protect
our proprietary position by filing patent applications in the United States, the United Kingdom and elsewhere, related to certain technologies
and our product candidates that are important to our business. Our current patent portfolio contains a limited number of patent applications,
all of which are in-licensed from third parties and relate to either composition of matter, formulation, method of use or process of
manufacturing Foralumab, Milciclib and a fully human anti-interleukin-6 receptor, or IL-6r, mAb. However, the risks associated with patent
rights generally apply to patent rights that we in-license now or in the future, as well as patent rights that we may own in the future.
Moreover, the risks apply with respect to patent rights and other intellectual property applicable to our product candidates, as well
as to any intellectual property rights that we may acquire in the future related to future product candidates, if any. Tiziana was granted
a new patent by USPTO in June 2020 covering lyophilized formulation of Foralumab..
The patent prosecution process
is expensive, time-consuming, and complex, and we may not be able to file, prosecute, maintain, enforce or license all necessary or desirable
patent applications at a reasonable cost or in a timely manner.
In some cases, the work of
certain academic researchers in the oncology and immunology fields has entered the public domain, which we believe precludes our ability
to obtain patent protection for certain inventions relating to such work.
Consequently, we will not
be able to assert any such patents to prevent others from using our technology for, and developing and marketing competing products to
treat, these indications. It is also possible that we will fail to identify patentable aspects of our R&D output before it is too
late to obtain patent protection.
13
Our existing license agreements
impose, and we expect that future license agreements will impose, various due diligence, development and commercialization timelines,
insurance, milestone payments, royalties, and other obligations on us. See the description in the section titled "Business-Collaboration
and License Agreements" herein. If we fail to comply with our obligations under these agreements, or we are subject to a bankruptcy,
or, in some cases, under other circumstances, the licensor may have the right to terminate the license, in which event we would not be
able to market product candidates covered by the license. In addition, certain of these license agreements are not assignable by us without
the consent of the respective licensor, which may have an adverse effect on our ability to engage in certain transactions.
The patent position of biotechnology
and pharmaceutical companies generally is highly uncertain, involves complex legal and factual questions and has, in recent years, been
the subject of much litigation. As a result, the issuance, scope, validity, enforceability and commercial value of any patent rights
are highly uncertain. Our licensed patent applications may not result in patents being issued which protect our technology or product
candidates, effectively prevent others from commercializing competitive technologies and product candidates or otherwise provide any
competitive advantage. In fact, patent applications may not issue as patents at all. Even assuming patents issue from patent applications
in which we have rights, changes in either the patent laws or interpretation of the patent laws in the United States and other countries
may diminish the value of our patents or narrow the scope of our patent protection.
Other parties have developed
technologies that may be related or competitive to our own and such parties may have filed or may file patent applications, or may have
received or may receive patents, claiming inventions that may overlap or conflict with those claimed in our own patent applications or
issued patents. We may not be aware of all third-party intellectual property rights potentially relating to our current and future product
candidates.
Publications of discoveries
in the scientific literature often lag behind the actual discoveries, and patent applications in the United States and in other jurisdictions
are typically not published until 18 months after filing, or, in some cases, not at all. Therefore, we cannot know with certainty whether
the inventors of our licensed patents and applications were the first to make the inventions claimed in those patents or pending patent
applications, or that they were the first to file for patent protection of such inventions. Similarly, should we own any patents or patent
applications in the future, we may not be certain that we were the first to file for patent protection for the inventions claimed in
such patents or patent applications. As a result, the issuance, scope, validity and commercial value of our patent rights cannot be predicted
with any certainty.
The degree of patent protection
we require to successfully compete in the marketplace may be unavailable or severely limited in some cases and may not adequately protect
our rights or permit us to gain or keep any competitive advantage. We cannot provide any assurances that any of our licensed patents
have, or that any of our pending licensed patent applications that mature into issued patents will include, claims with a scope sufficient
to protect our product candidates or otherwise provide any competitive advantage. In addition, the laws of foreign countries may not
protect our rights to the same extent as the laws of the United States. Furthermore, patents have a limited lifespan. In the United States,
the natural expiration of a patent is generally 20 years after it is filed. Various extensions may be available; however, the life of
a patent, and the protection it affords, is limited. 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 licensed patent portfolio may not provide us with adequate and continuing patent protection sufficient to exclude others
from commercializing products similar to our product candidates, including "highly similar," or biosimilar, versions of such
products. In addition, the intellectual property portfolio licensed to us by Nerviano and Novimmune may be used by them or licensed to
third parties, and such third parties may have certain enforcement rights. Thus, patents licensed to us could be put at risk of being
invalidated or interpreted narrowly in litigation filed by or against our licensors or another licensee or in administrative proceedings
brought by or against our licensors or another licensee in response to such litigation or for other reasons.
Even if we acquire patent
protection that we expect should enable us to maintain some competitive advantage, third parties, including competitors, may challenge
the validity, enforceability or scope thereof, which may result in such patents being narrowed, invalidated or held unenforceable. In
litigation, a competitor could claim that our patents, if issued, are not valid for several reasons. If a court agrees, we would lose
our rights to those challenged patents.
The issuance of a patent
is not conclusive as to its inventorship, scope, validity or enforceability and our licensed patents may be challenged in courts or patent
offices in the United States and abroad. For example, we may be subject to a third-party submission of prior art to the USPTO challenging
the validity of one or more claims of our licensed patents. Such submissions may also be made prior to a patent's issuance, precluding
the granting of a patent based on one of our pending licensed patent applications. We may become involved in opposition, derivation,
re-examination, inter partes review, post-grant review or interference proceedings challenging the patent rights of others from whom
we have obtained licenses to such rights. Competitors may claim that they invented the inventions claimed in our licensed issued patents
or patent applications prior to the inventors of such patents or applications. A competitor who can establish an earlier filing or invention
date may also claim that we are infringing their patents and that we therefore cannot practice our technology as claimed under our licensed
patents, if issued. Competitors may also contest our licensed patents, if issued, by showing that the invention was not patent-eligible,
was not novel, was obvious or that the patent claims failed any other requirement for patentability.
An adverse determination
by former employees or consultants asserting ownership rights to our patents may result in loss of exclusivity or freedom to operate
or in patent claims being narrowed, invalidated or held unenforceable, in whole or in part, which could limit our ability to stop others
from using or commercializing similar technology and therapeutics, without payment to us, or could limit the duration of the patent protection
covering our technology and product candidates. Such challenges may also result in our inability to manufacture or commercialize our
product candidates without infringing third-party patent rights. In addition, if the breadth or strength of protection provided by our
patents and patent applications is threatened, it could dissuade companies from collaborating with us to license, develop or commercialize
current or future product candidates.
14
Even if they are unchallenged,
our licensed patents and pending patent applications, if issued, may not provide us with any meaningful protection or prevent competitors
from designing around our patent claims to circumvent our licensed patents by developing similar or alternative technologies or therapeutics
in a non-infringing manner. For example, a third party may develop a competitive therapeutic that provides benefits similar to one or
more of our product candidates but that uses a different antibody or molecular active ingredient that falls outside the scope of our
patent protection. If the patent protection provided by the patents and patent applications we hold or pursue with respect to our product
candidates is not sufficiently broad to impede such competition, our ability to successfully commercialize our product candidates could
be negatively affected, which would harm our business.
Our intellectual property licenses with
third parties 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 to our licensors.
We currently depend, and
will continue to depend, on our license agreements whereby we obtain rights in certain patents and patent applications owned by them.
Further development and commercialization of our current product candidates may, and development of any future product candidates will,
require us to enter into additional license or collaboration agreements. The agreements under which we currently 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 an adverse effect on our business, financial condition, results of operations and prospects.
If any of our licenses or
material relationships or any in-licenses upon which our licenses are based are terminated or breached, we may:
●
lose our rights to develop
    and market our product candidates;
●
lose patent protection
    for our product candidates;
●
experience significant
    delays in the development or commercialization of our product candidates;
●
not be able to obtain any
    other licenses on acceptable terms, if at all; or
●
incur liability for damages.
In addition, a third party
may in the future bring claims that our performance under our license agreements, including our sponsoring of clinical trials, interferes
with such third party's rights under its agreement with one of our licensors. If any such claim were successful, it may adversely
affect our rights and ability to advance our product candidates as clinical candidates or subject us to liability for monetary damages,
any of which would have an adverse effect on our business, financial condition, results of operations and prospects.
These risks apply to any
agreements that we may enter into in the future for our current or any future product candidates. If we experience any of the foregoing,
it could have a negative impact on our business, financial condition, results or operations and prospects.
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 license rights that are important to our business.
We have entered into license
agreements with third parties and may need to obtain additional licenses from one or more of these same third parties or from others
to advance our research or allow commercialization of our product candidates. It is possible that we may be unable to obtain additional
licenses at a reasonable cost or on reasonable terms, if at all. In that event, we may be required to expend significant time and resources
to redesign our product candidates or the methods for manufacturing them or to develop or license replacement technology, all of which
may not be feasible on a technical or commercial basis. If we are unable to do so, we may be unable to develop or commercialize our product
candidates, which would harm our business. We cannot provide any assurances that third-party patents or other intellectual property rights
do not exist which might be enforced against our current product candidates or future product candidates, resulting in either an injunction
prohibiting our manufacture or sales, or, with respect to our sales, an obligation on our part to pay royalties and/or other forms of
compensation to third parties.
15
In each of our existing license
agreements, and we expect in our future agreements, patent prosecution of our licensed technology is controlled solely by the licensor,
and we may be required to reimburse the licensor for their costs of patent prosecution. If our licensors fail to obtain and maintain
patent or other protection for the proprietary intellectual property we license from them, we could lose our rights to the intellectual
property, or our exclusivity with respect to those rights, and our competitors could market competing products using the intellectual
property. Our license agreements with Nerviano and Novimmune also require us to meet development thresholds to maintain each license,
including establishing a set timeline for developing and commercializing product candidates. 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
    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 pursuant to our collaborative development relationships;
●
our diligence obligations
    under the license agreements and what activities satisfy those diligence obligations;
●
the inventorship or 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.
If disputes over intellectual
property that we have licensed prevent or impair our ability to maintain our current licensing arrangements on acceptable terms, we may
be unable to successfully develop and commercialize our product candidates.
We may not be successful in obtaining or
maintaining necessary rights to our product candidates through acquisitions and in-licenses.
We currently have certain
rights to the intellectual property, through licenses from third parties, to develop our product candidates. Because our programs may
require the use of additional proprietary rights held by these or other third parties, the growth of our business likely will depend,
in part, on our ability to acquire, in-license or use these proprietary rights. We may be unable to acquire or in-license any compositions,
methods of use, processes or other intellectual property rights from third parties that we identify as necessary for our product candidates.
The licensing or acquisition of third-party intellectual property rights is a competitive area, and several more established companies
may pursue strategies to license or acquire third-party intellectual property rights that we may consider attractive. These established
companies may have a competitive advantage over us due to their size, capital resources and greater clinical development and commercialization
capabilities. In addition, companies that perceive us to be a competitor may be unwilling to assign or license rights to us. We also
may be unable to license or acquire third-party intellectual property rights on terms that would allow us to make an appropriate return
on our investment.
We may collaborate with non-profit
and academic institutions to accelerate our preclinical R&D under written agreements with these institutions. These institutions
may provide us with an option to negotiate a license to any of the institution's rights in technology resulting from the collaboration.
Regardless of such option, we may be unable to negotiate a license within the specified timeframe or under terms that are acceptable
to us. If we are unable to do so, the institution may offer the intellectual property rights to other parties, potentially blocking our
ability to pursue our program.
If we are unable to successfully
obtain rights to required third-party intellectual property or maintain the existing intellectual property rights we have, we may have
to abandon development of our product candidates and our business, financial condition, results of operations and prospects could suffer.
Moreover, to the extent that we seek to develop other product candidates in the future, we will likely require acquisition or in-license
of additional proprietary rights held by third parties.
Obtaining and maintaining our patent protection
depends on compliance with various procedural, document submission, fee payment and other requirements imposed by government patent agencies,
and our patent protection could be reduced or eliminated as a result of non-compliance with these requirements.
Periodic maintenance fees,
renewal fees, annuity fees and various other government fees on patents and/or applications will be due to be paid to the USPTO and various
government patent agencies outside of the United States over the lifetime of our licensed patents and/or applications and any patent
rights we may own in the future. We rely on our outside counsel or our licensing partners to pay these fees due to non-U.S. patent agencies.
The USPTO and various non-U.S. government patent agencies require compliance with several procedural, documentary, fee payment and other
similar provisions during the patent application process. We employ reputable law firms and other professionals to help us comply and
we are also dependent on our licensors to take the necessary action to comply with these requirements with respect to our licensed intellectual
property. In many cases, an inadvertent lapse can be cured by payment of a late fee or by other means in accordance with the applicable
rules. There are situations, however, in which non-compliance can result in abandonment or lapse of the patent or patent application,
resulting in partial or complete loss of patent rights in the relevant jurisdiction. In such an event, potential competitors might be
able to enter the market and this circumstance could have an adverse effect on our business.
16
We may not be able to protect our intellectual
property rights throughout the world.
Filing, prosecuting and defending
patents on product candidates in all countries throughout the world would be prohibitively expensive, and our intellectual property rights
in some countries outside the United States could be less extensive than those in the United States. In some cases, we may not be able
to obtain patent protection for certain licensed technology outside the United States. In addition, the laws of some foreign countries
do not protect intellectual property rights to the same extent as federal and state laws in the United States, even in jurisdictions
where we do pursue patent protection. Consequently, we may not be able to prevent third parties from practicing our inventions in all
countries outside the United States, even in jurisdictions where we do pursue patent protection or from selling or importing products
made using our inventions in and into the United States or other jurisdictions.
Competitors may use our technologies
in jurisdictions where we have not pursued and obtained patent protection to develop their own products and, further, may export otherwise
infringing products to territories where we have patent protection, but enforcement is not as strong as that in the United States. These
products may compete with our product candidates, and our patents or other intellectual property rights may not be effective or sufficient
to prevent them from competing.
Many companies have encountered
significant problems in protecting and defending intellectual property rights in foreign jurisdictions. The legal systems of certain
countries, particularly certain developing countries, do not favor the enforcement of patents, trade secrets and other intellectual property
protection, particularly those relating to biotechnology products, which could make it difficult for us to stop the infringement of our
patents, if pursued and obtained, or marketing of competing products in violation of our proprietary rights generally. Moreover, many
countries have compulsory licensing laws under which a patent owner may be compelled to grant licenses to third parties. Many countries
limit the enforceability of patents against government agencies or government contractors. In these countries, the patent owner may have
limited remedies, which could materially diminish the value of such patent. If we or any of our licensors is forced to grant a license
to third parties with respect to any patents relevant to our business, our competitive position may be impaired, and our business and
results of operations may be adversely affected.
In addition, 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, could put our patents at risk of being invalidated or interpreted narrowly and our patent applications at risk
of not issuing and could provoke third parties to assert claims against us. We may not prevail in any lawsuits that we initiate, and
the damages or other remedies awarded, if any, may not be commercially meaningful. Accordingly, our efforts to enforce our intellectual
property rights around the world may be inadequate to obtain a significant commercial advantage from the intellectual property that we
develop or license.
We may not be able to protect our trade
secrets in court.
In addition to the protection
afforded by patents, we rely on trade secret protection and confidentiality agreements to protect proprietary know-how that is not patentable
or that we elect not to patent, processes for which patents are difficult to enforce and any other elements of our product candidate
discovery and development processes that involve proprietary know-how, information or technology that is not covered by patents. However,
trade secrets can be difficult to protect and some courts inside and outside the United States are less willing or unwilling to protect
trade secrets. We seek to protect our proprietary technology and processes, in part, by entering into confidentiality agreements with
our employees, consultants, scientific advisors and contractors. However, we may not be able to prevent the unauthorized disclosure or
use of our technical know-how or other trade secrets by the parties to these agreements, despite the existence generally of confidentiality
agreements and other contractual restrictions.
Monitoring unauthorized uses
and disclosures is difficult and we do not know whether the steps we have taken to protect our proprietary technologies will be effective.
If any of the collaborators, scientific advisors, employees and consultants who are parties to these agreements breach or violate the
terms of any of these agreements, we may not have adequate remedies for any such breach or violation. As a result, we could lose our
trade secrets.
We cannot guarantee that
we have entered into such agreements with each party that may have or have had access to our trade secrets or proprietary technology
and processes. We also seek to preserve the integrity and confidentiality of our data and trade secrets 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, agreements and security measures, they may still 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. Competitors could purchase our product candidates and attempt
to replicate some or all of the competitive advantages we derive from our development efforts, willfully infringe our intellectual property
rights, design around our protected technology or develop their own competitive technologies that fall outside of our intellectual property
rights. If any of our trade secrets were to be lawfully obtained or independently developed by a competitor, we would have no right to
prevent them, or those to whom they communicate such trade secrets, from using that technology or information to compete with us. If
our trade secrets are not adequately protected so as to protect our market against competitors' therapeutics, our competitive position
could be adversely affected, as could our business.
17
Third parties may initiate legal proceedings
alleging that we are infringing their intellectual property rights.
Our commercial success depends
upon our ability and the ability of our future collaborators to develop, manufacture, market and sell our product candidates and use
our proprietary technologies without infringing the proprietary rights and intellectual property of third parties. The biotechnology
and pharmaceutical industries are characterized by extensive and complex litigation regarding patents and other intellectual property
rights. We may in the future become party to, or be threatened with, adversarial proceedings or litigation regarding intellectual property
rights with respect to our product candidates and technology, including interference proceedings, post grant review and inter partes
review before the USPTO. Our competitors or other third parties may assert infringement claims against us, alleging that our therapeutics,
manufacturing methods, formulations or administration methods are covered by their patents. Given the vast number of patents in our field
of technology, we cannot be certain or guarantee that we do not infringe existing patents or that we will not infringe patents that may
be granted in the future. Since this area is competitive and of strong interest to pharmaceutical and biotechnology companies, there
will likely be additional patent applications filed and additional patents granted in the future, as well as additional R&D programs
expected in the future. Furthermore, because patent applications can take many years to issue, may be confidential for 18 months or more
after filing and can be revised before issuance, there may be applications now pending which may later result in issued patents that
may be infringed by the manufacture, use, sale or importation of our product candidates and we may or may not be aware of such patents.
If a patent holder believes the manufacture, use, sale or importation of one of our product candidates infringes its patent, the patent
holder may sue us even if we have licensed other patent protection for our technology. Moreover, we may face patent infringement claims
from non-practicing entities that have no relevant product revenue and against whom our licensed patent portfolio may therefore have
no deterrent effect.
It is also possible that
we have failed to identify relevant third-party patents or applications. For example, applications filed before November 29, 2000 and
certain applications filed after that date that will not be filed outside the United States may remain confidential until patents issue.
Moreover, it is difficult for industry participants, including us, to identify all third-party patent rights that may be relevant to
our product candidates and technologies because patent searching is imperfect due to differences in terminology among patents, incomplete
databases and the difficulty in assessing the meaning of patent claims. We may fail to identify relevant patents or patent applications
or may identify pending patent applications of potential interest but incorrectly predict the likelihood that such patent applications
may issue with claims of relevance to our technology. In addition, we may be unaware of one or more issued patents that would be infringed
by the manufacture, sale or use of a current or future product candidate, or we may incorrectly conclude that a third-party patent is
invalid, unenforceable or not infringed by our activities. Additionally, pending patent applications that have been published can, subject
to certain limitations, be later amended in a manner that could cover our technologies, our product candidates or the use of our product
candidates.
Third parties may assert
infringement claims against us based on existing patents or patents that may be granted in the future, regardless of their merit. There
is a risk that third parties may choose to engage in litigation with us to enforce or to otherwise assert their patent or other intellectual
property rights against us. Even if we believe such claims are without merit, a court of competent jurisdiction could hold that these
third-party patents are valid, enforceable and infringed, which could adversely affect our ability to commercialize our product candidates.
In order to successfully challenge the validity of any such U.S. patent in federal court, we would need to overcome a presumption of
validity. As this burden is a high one requiring us to present clear and convincing evidence as to the invalidity of any such U.S. patent
claim, there is no assurance that a court of competent jurisdiction would invalidate the claims of any such U.S. patent. Similarly, there
is no assurance that a court of competent jurisdiction would find that product candidates or our technology did not infringe a third-party
patent.
Patent and other types of
intellectual property litigation can involve complex factual and legal questions, and their outcome is uncertain. If we are found or
believe there is a risk that we may be found, to infringe a third party's valid and enforceable intellectual property rights, we
could be required or may choose to obtain a license from such third party to continue developing, manufacturing and marketing our product
candidates and technology. However, we may not be able to obtain any required license on commercially reasonable terms or at all. Even
if we were able to obtain a license, it could be non-exclusive, thereby giving our competitors and other third parties access to the
same technologies licensed to us, and it could require us to make substantial licensing and royalty payments. We could be forced, including
by court order, to cease developing, manufacturing and commercializing the infringing technology or product candidate. In addition, we
could be found liable for monetary damages, including treble damages and attorneys' fees, if we are found to have willfully infringed
a patent or other intellectual property right. A finding of infringement could prevent us from manufacturing and commercializing our
product candidates or force us to cease some or all of our business operations, which could harm our business. Claims that we have misappropriated
the confidential information or trade secrets of third parties could have a similar negative impact on our business, financial condition,
results of operations and prospects.
Intellectual property litigation could
cause us to spend substantial resources and distract our personnel from their normal responsibilities.
Litigation or other legal
proceedings relating to intellectual property claims, with or without merit, are unpredictable and generally expensive and time-consuming.
Competitors may infringe our patents or the patents of our licensing partners, should such patents issue, or we may be required to defend
against claims of infringement. To counter infringement or unauthorized use claims or to defend against claims of infringement can be
expensive and time consuming. Even if resolved in our favor, litigation or other legal proceedings relating to intellectual property
claims may cause us to incur significant expenses and could distract our technical and management personnel from their normal responsibilities.
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. In addition, there
could be public announcements of the results of hearings, motions or other interim proceedings or developments and if securities analysts
or investors perceive these results to be negative, it could have a substantial adverse effect on us. Such litigation or proceedings
could substantially increase our operating losses and reduce the resources available for development activities or any future sales,
marketing or distribution activities.
18
We may not have sufficient
financial or other resources to adequately conduct such litigation or proceedings. Some of our competitors may be able to sustain the
costs of such litigation or proceedings more effectively than we can because of their greater financial resources and more mature and
developed intellectual property portfolios.
Accordingly, despite our
efforts, we may not be able to prevent third parties from infringing, misappropriating or successfully challenging our intellectual property
rights. Uncertainties resulting from the initiation and continuation of patent litigation or other proceedings could have a negative
impact on our ability to compete in the marketplace.
We may be subject to claims asserting that
our employees, consultants or advisors have wrongfully used or disclosed alleged trade secrets of their current or former employers or
claims asserting ownership of what we regard as our own intellectual property.
Certain of our employees,
consultants or advisors are currently, or were previously, employed at universities or other biotechnology or pharmaceutical companies,
including our competitors or potential competitors, as well as our academic partners. Although we try to ensure that our employees, consultants
and advisors do not use the proprietary information or know-how of others in their work for us, we may be subject to claims that these
individuals or we have used or disclosed intellectual property, including trade secrets or other proprietary information, of any such
individual's current or former employer. Litigation may be necessary to defend against these claims. If we fail in defending any
such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights. An inability to incorporate such
technologies or features would harm our business and may prevent us from successfully obtaining necessary regulatory approvals and commercializing
our product candidates. In addition, we may lose personnel as a result of such claims, and any such litigation or the threat thereof
may adversely affect our ability to hire employees or contract with independent contractors. A loss of key personnel or their work product
could hamper or prevent our ability to obtain necessary regulatory approvals and commercialize our product candidates, which would have
an adverse effect on our business, results of operations and financial condition. Even if we are successful in defending against such
claims, litigation could result in substantial costs and be a distraction to management.
In addition, while it is
our policy to require our employees and contractors who may be involved in the conception or development of intellectual property to
execute agreements assigning such intellectual property to us, we may be unsuccessful in executing such an agreement with each party
who, in fact, conceives or develops intellectual property that we regard as our own. Moreover, even when we obtain agreements assigning
intellectual property to us, the assignment of intellectual property rights may not be self-executing or the assignment agreements may
be breached, and we may be forced to bring claims against third parties, or defend claims that they may bring against us, to determine
the ownership of what we regard as our intellectual property. Furthermore, individuals executing agreements with us may have pre-existing
or competing obligations to a third party, such as an academic institution, and thus an agreement with us may be ineffective in perfecting
ownership of inventions developed by that individual. Disputes about the ownership of intellectual property that we may own may have
an adverse effect on our business.
Changes in U.S. patent law could diminish
the value of patents in general, thereby impairing our ability to protect our product candidates.
Recent patent reform legislation
could increase the uncertainties and costs surrounding the prosecution of patent applications and the enforcement or defense of issued
patents. On September 16, 2011, the Leahy-Smith America Invents Act, or the Leahy-Smith Act, was signed into law. The Leahy-Smith Act
includes several significant changes to U.S. patent law. These include provisions that affect the way patent applications are prosecuted
and also may affect patent litigation. These also include provisions that switched the United States from a "first-to-invent"
system to a "first-to-file" system, allow third-party submission of prior art to the USPTO during patent prosecution and
set forth additional procedures to attack the validity of a patent through various post-grant proceedings administered by the USPTO.
Under a first-to-file system, assuming the other requirements for patentability are met, the first inventor to file a patent application
generally will be entitled to the patent on an invention regardless of whether another inventor had made the invention earlier. The USPTO
developed new regulations and procedures to govern administration of the Leahy-Smith Act, and many of the substantive changes to patent
law associated with the Leahy-Smith Act, and in particular, the first-to-file provisions, only became effective on March 16, 2013.
Accordingly, it is not clear
what, if any, impact the Leahy-Smith Act will have on the operation of our business. However, the Leahy-Smith Act and its implementation
could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our
issued patents, all of which could have a negative impact effect on our business, financial condition, results of operations and prospects.
Additionally, the U.S. Supreme
Court has ruled on several patent cases in recent years, 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 with regard to our ability to obtain
patents in the future, the combination of new federal legislation, federal court decisions, and guidance from the USPTO has created uncertainty
with respect to the value of patents, once obtained. Depending on the decisions by the U.S. Congress, federal courts, and the USPTO,
the laws and regulations governing patents could change in unpredictable ways that would weaken our ability to obtain new patents or
enforce our existing patents and patents we might obtain in the future.
19
If our trademarks and trade names are not
adequately protected, then we may not be able to build name recognition in our markets of interest.
We do not currently have
any registered trademarks and we have not filed any trademark applications to date. Any trademark applications in the United States,
Europe and in other foreign jurisdictions where we may file may not be allowed or may subsequently be opposed. Once filed and registered,
our trademarks or trade names may be challenged, infringed, circumvented or declared generic or determined to be infringing on other
marks. As a means to enforce our trademark rights and prevent infringement, we may be required to file trademark claims against third
parties or initiate trademark opposition proceedings. This can be expensive and time-consuming, particularly for a company of our size.
We may not be able to protect our rights to these trademarks and trade names, which we need to build name recognition among potential
partners or customers in our markets of interest. At times, competitors may adopt trade names or trademarks similar to ours, thereby
impeding our ability to build brand identity and possibly leading to market confusion. In addition, there could be potential trade name
or trademark infringement claims brought by owners of other registered trademarks or trademarks that incorporate variations of our registered
or unregistered trademarks or trade names. Over the long term, if we are unable to establish name recognition based on our trademarks
and trade names, then we may not be able to compete effectively and our business may be adversely affected. Our efforts to enforce or
protect our proprietary rights related to trademarks, trade secrets, domain names, copyrights or other intellectual property may be ineffective
and could result in substantial costs and diversion of resources.
Intellectual property rights and regulatory
exclusivity rights do not necessarily address all potential threats
.
The degree of future protection
afforded by our intellectual property rights is uncertain because intellectual property rights have limitations and may not adequately
protect our business or permit us to maintain our competitive advantage. For example:
●
others may be able to make
    products that are similar to our product candidates but that are not covered by the claims of the patents that we license or may
    own in the future;
●
we, or our license partners
    or future collaborators, might not have been the first to make the inventions covered by the issued patent or pending patent applications
    that we license or may own in the future;
●
we, or our license partners
    or future collaborators, might not have been the first to file patent applications covering certain of our or their inventions;
●
others may independently
    develop similar or alternative technologies or duplicate any of our technologies without infringing our owned or licensed intellectual
    property rights;
●
others may circumvent our
    regulatory exclusivities, such as by pursuing approval of a competitive product candidate via the traditional approval pathway based
    on their own clinical data, rather than relying on the abbreviated pathway provided for biosimilar applicants;
●
it is possible that our
    pending licensed patent applications or those that we may own in the future will not lead to issued patents;
●
issued patents that we
    hold rights to now or in the future may be held invalid or unenforceable, including as a result of legal challenges by our competitors;
●
others may have access
    to the same intellectual property rights licensed to us on a non-exclusive basis;
●
our competitors might conduct
    R&D activities in countries where we do not have patent rights and then use the information learned from such activities to develop
    competitive products for sale in our major commercial markets;
●
we may not develop additional
    proprietary technologies that are patentable;
●
the patents or other intellectual
    property rights of others may have an adverse effect on our business; or
●
we may choose not to file
    a patent for certain trade secrets or know-how, and a third party may subsequently file a patent covering such intellectual property.
Should any of these events
occur, they could significantly harm our business, financial condition, results of operations and prospects.
20
Risks Related to Government Regulation
Even if we complete the necessary clinical
trials, we cannot predict when, or if, we will obtain regulatory approval to commercialize our product candidates and the approval may
be for a narrower indication than we seek.
We cannot commercialize a
product candidate until the appropriate regulatory authorities have reviewed and approved the product candidate. The FDA must review
and approve any new pharmaceutical product before it can be marketed and sold in the United States. The FDA regulatory review and approval
process, which includes evaluation of preclinical studies and clinical trials of a product candidate and proposed labeling, as well as
the evaluation of the manufacturing process and manufacturers' facilities, all of which is lengthy, expensive and uncertain. To
obtain approval, we must, among other things, demonstrate with substantial evidence from well-controlled clinical trials that the product
candidate is both safe and effective for each indication where approval is sought. Even if our product candidates meet the FDA's
safety and effectiveness endpoints in clinical trials, the FDA may not complete their review processes in a timely manner, or we may
not be able to obtain regulatory approval. The FDA has substantial discretion in the review and approval process and may refuse to file
our application for substantive review or may determine after review of our data that our application is insufficient to allow approval
of our product candidates. The FDA may require that we conduct additional preclinical studies, clinical trials or manufacturing validation
studies and submit that data before it will reconsider our application. Additional delays may result if an FDA Advisory Committee or
other regulatory authority recommends non-approval or restrictions on approval. In addition, we may experience delays or rejections based
upon additional government regulation from future legislation or administrative action, or changes in regulatory authority policy during
the period of product development, clinical trials and the review process.
The FDA, EMA or other regulatory
authorities also may approve a product candidate for more limited indications than requested or may impose significant limitations in
the form of narrow indications, warnings or a REMS. These regulatory authorities may require precautions or contraindications with respect
to conditions of use or may grant approval subject to the performance of costly post-marketing clinical trials. In addition, the FDA,
EMA or other regulatory authorities may not approve the labeling claims that are necessary or desirable for the successful commercialization
of our product candidates. Any of the foregoing scenarios could harm the commercial prospects for our product candidates and negatively
impact our business, financial condition, results of operations and prospects.
Delays in obtaining regulatory approval
of our manufacturing process and facility or disruptions in our manufacturing process may delay or disrupt our product development and
commercialization efforts.
We do not currently operate
manufacturing facilities for clinical or commercial production of our product candidates. Before we can begin to commercially manufacture
our product candidates, whether in a third-party facility or in our own facility, if and when established, we must obtain regulatory
approval from the FDA for our manufacturing process and facility. A manufacturing authorization must also be obtained from the appropriate
European Union regulatory authorities and from other foreign regulatory authorities, as applicable. In order to obtain approval, we will
need to ensure that all of our processes, methods and equipment are compliant with cGMP, and perform extensive audits of vendors, contract
laboratories and suppliers. If any of our vendors, contract laboratories or suppliers are found to be non-compliant with cGMP, we may
experience delays or disruptions in manufacturing while we work with these third parties to remedy the violation or while we work to
identify suitable replacement vendors. The cGMP requirements govern quality control of the manufacturing process and documentation policies
and procedures. In complying with cGMP, we will be obligated to expend time, money and effort in production, record keeping and quality
assurance to confirm that the product meets applicable specifications and other requirements. If we fail to comply with these requirements,
we would be subject to possible regulatory action and may not be permitted to sell any product candidate that we may develop.
If we or our third-party
manufacturers fail to comply with applicable cGMP regulations, the FDA, EMA and other regulatory authorities can impose regulatory sanctions
including, among other things, refusal to approve a pending application for a new product candidate or suspension or revocation of a
pre-existing approval. Such an occurrence may cause our business, financial condition, results of operations and prospects to be harmed.
Additionally, if the supply
of our products from our third-party manufacturers to us is interrupted for any reason, including due to regulatory requirements or actions
(including recalls), adverse financial developments at or affecting the supplier, failure by the supplier to comply with cGMPs, contamination,
business interruptions or labor shortages or disputes, there could be a significant disruption in commercial supply of our products.
We do not currently have a backup manufacturer of our product candidate supply for clinical trials or commercial sale. An alternative
manufacturer would need to be qualified through a supplement to its regulatory filing, which could result in further delays. The regulatory
authorities also may require additional clinical trials if a new manufacturer is relied upon for commercial production. Switching manufacturers
may involve substantial costs and could result in a delay in our desired clinical and commercial timelines.
21
If our competitors are able to obtain orphan
drug exclusivity for products that constitute the same drug and treat the same indications as our product candidates, we may not be able
to have competing products approved by applicable regulatory authorities for a significant period of time. In addition, even if we obtain
orphan drug exclusivity for any of our products, such exclusivity may not protect us from competition.
Regulatory authorities in
some jurisdictions, including the United States and the European Union, may designate products for relatively small patient populations
as orphan drugs. Under the Orphan Drug Act of 1983, the FDA may designate a product candidate as an orphan drug if it is intended to
treat a rare disease or condition, which is generally defined as having a patient population of fewer than 200,000 individuals in the
United States, or a patient population greater than 200,000 in the United States where there is no reasonable expectation that the cost
of developing the drug will be recovered from sales in the United States. In the United States, orphan drug designation entitles a party
to financial incentives such as opportunities for grant funding towards clinical trial costs, tax advantages and user-fee waivers. In
the European Union, the EMA's Committee for Orphan Medicinal Products grants orphan drug designation to promote the development
of products that are intended for the diagnosis, prevention or treatment of a life-threatening or chronically debilitating condition
affecting not more than five in 10,000 persons in the European Union. Additionally, orphan drug designation is granted for products intended
for the diagnosis, prevention or treatment of a life-threatening, seriously debilitating or serious and chronic condition and when, without
incentives, it is unlikely that sales of the drug in the European Union would be sufficient to justify the necessary investment in developing
the drug or biologic product. In Europe, orphan drug designation entitles a party to a number of incentives, such as protocol assistance
and scientific advice specifically for designated orphan medicines, and potential fee reductions depending on the status of the sponsor.
The designation as an orphan
product does not guarantee that any regulatory agency will accelerate regulatory review of, or ultimately approve, that product candidate,
nor does it limit the ability of any regulatory agency to grant orphan drug designation to product candidates of other companies that
treat the same indications as our product candidates prior to our product candidates receiving exclusive marketing approval.
Generally, if a product candidate
with an orphan drug designation receives the first marketing approval for the indication for which it has such designation, the product
is entitled to a period of marketing exclusivity, which precludes the FDA or the EMA from approving another marketing application for
a product that constitutes the same drug treating the same indication for that marketing exclusivity period, except in limited circumstances.
If another sponsor receives such approval before we do (regardless of our orphan drug designation), we will be precluded from receiving
marketing approval for our product for the applicable exclusivity period. The applicable period is seven years in the United States and
ten years in the European Union. The exclusivity period in the European Union can be reduced to six years if a product no longer meets
the criteria for orphan drug designation or if the product is sufficiently profitable so that market exclusivity is no longer justified.
Orphan drug exclusivity may be revoked if any regulatory agency determines that the request for designation was materially defective
or if the manufacturer is unable to assure sufficient quantity of the product to meet the needs of patients with the rare disease or
condition.
Even if we obtain orphan
drug exclusivity for a product candidate, that exclusivity may not effectively protect the product candidate from competition because
different drugs can be approved for the same condition. In the United States, even after an orphan drug is approved, the FDA may subsequently
approve another drug for the same condition if the FDA concludes that the latter drug is not the same drug or is clinically superior
in that it is shown to be safer, more effective or makes a major contribution to patient care. In the European Union, marketing authorization
may be granted to a similar medicinal product for the same orphan indication if:
●
the second applicant can
    establish in its application that its medicinal product, although similar to the orphan medicinal product already authorized, is
    safer, more effective or otherwise clinically superior;
●
the holder of the marketing
    authorization for the original orphan medicinal product consents to a second orphan medicinal product application; or
●
the holder of the marketing
    authorization for the original orphan medicinal product cannot supply sufficient quantities of orphan medicinal product.
Even if we obtain regulatory approval for
a product candidate, our product candidates will remain subject to regulatory oversight.
Even if we obtain regulatory
approval for our product candidates, they will be subject to ongoing regulatory requirements for manufacturing, labeling, packaging,
storage, advertising, promotion, sampling, record-keeping and submission of safety and other post-market information. Any regulatory
approvals that we receive for our product candidates may also be subject to limitations on the approved indicated uses for which the
product may be marketed or to the conditions of approval, or contain requirements for potentially costly post-marketing testing, including
Phase 4 clinical trials, and surveillance to monitor the quality, safety and clinical effectiveness of the product.
Some of our product candidates
are classified as biologics in the United States, and therefore, can only be sold if we obtain a BLA from the FDA. The holder of an approved
BLA also must submit new or supplemental applications and obtain FDA approval for certain changes to the approved product, product labeling
or manufacturing process. In addition, the holder of a BLA must comply with the FDA's advertising and promotion requirements, such
as those related to the prohibition on promoting products for uses or in patient populations that are not described in the product's
approved labeling (known as "off-label use"). Advertising and promotional materials must comply with FDA rules and are subject
to FDA review, in addition to other potentially applicable federal and state laws.
22
In addition, product manufacturers
and their facilities are subject to payment of user fees and continual review and periodic inspections by the FDA and other regulatory
authorities for compliance with cGMP requirements and adherence to commitments made in the BLA or foreign marketing application. If we,
or a regulatory authority, discover previously unknown problems with a product, such as adverse events of unanticipated severity or frequency,
or problems with the facility where the product is manufactured or if a regulatory authority disagrees with the promotion, marketing
or labeling of that product (in addition to our being obligated as holder of a BLA to monitor and report adverse events and any failure
of a product to meet the BLA specifications), a regulatory authority may impose restrictions relative to that product, the manufacturing
facility or us, including requiring recall or withdrawal of the product from the market or suspension of manufacturing.
If we fail to comply with
applicable regulatory requirements following approval of our product candidates, a regulatory or enforcement authority may:
●
issue a warning letter
    asserting that we are in violation of the law;
●
seek an injunction or impose
    administrative, civil or criminal penalties or monetary fines;
●
suspend or withdraw regulatory
    approval;
●
suspend any ongoing clinical
    trials;
●
refuse to approve a pending
    BLA or comparable foreign marketing application (or any supplements thereto) submitted by us or our strategic partners;
●
restrict the marketing
    or manufacturing of the product;
●
seize or detain the product
    or otherwise require the withdrawal of the product from the market;
●
refuse to permit the import
    or export of the product; or
●
refuse to allow us to enter
    into supply contracts, including government contracts.
Any government investigation
of alleged violations of law could require us to expend significant time and resources in response and could generate negative publicity.
The occurrence of any event or penalty described above may inhibit our ability to commercialize our product candidates and adversely
affect our business, financial condition, results of operations and prospects.
In addition, the FDA's
policies, and those of the EMA and other regulatory authorities, may change and additional government regulations may be enacted that
could prevent, limit or delay regulatory approval of our product candidates. We cannot predict the likelihood, nature or extent of government
regulation that may arise from future legislation or administrative action, either in the United States or abroad. If we are slow or
unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we are not able to maintain
regulatory compliance, we may lose any marketing approval that we may have obtained and we may not achieve or sustain profitability,
which would negatively impact our business, financial condition, results of operations and prospects.
Even if we obtain and maintain approval
for our product candidates in a major pharmaceutical market such as the United States, we may never obtain approval for our product candidates
in other major markets.
In order to market any products
in a country or territory, we must establish and comply with numerous and varying regulatory requirements of such countries or territories
regarding safety and effectiveness. Clinical trials conducted in one country may not be accepted by regulatory authorities in other countries,
and regulatory approval in one country does not mean that regulatory approval will be obtained in any other country. Approval procedures
vary among countries and can involve additional product testing and validation and additional administrative review periods. Seeking
regulatory approvals in all major markets could result in significant delays, difficulties and costs for us and may require additional
preclinical studies or clinical trials, which would be costly and time consuming. Regulatory requirements can vary widely from country
to country and could delay or prevent the introduction of our product candidates in those countries. For example, in many jurisdictions
outside of the United States, a product candidate must be approved for reimbursement before it can be approved for sale in that jurisdiction.
In some cases, the price that we intend to charge for our products would also be subject to approval. Satisfying these and other regulatory
requirements is costly, time consuming, uncertain and subject to unanticipated delays. In addition, our failure to obtain regulatory
approval in any country may delay or have negative effects on the process for regulatory approval in other countries. We currently do
not have any product candidates approved for sale in any jurisdiction, whether in the United States, Europe or any other 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, our target market will be reduced and our ability
to realize the full market potential of our product candidates will be compromised.
23
We may seek a conditional marketing authorization
in Europe for some or all of our current product candidates, but we may not be able to obtain or maintain such designation.
As part of its marketing
authorization process, the EMA may grant marketing authorizations for certain categories of medicinal products on the basis of less complete
data than is normally required, when doing so may meet unmet medical needs of patients and serve the interest of public health. In such
cases, it is possible for the Committee for Medicinal Products for Human Use, or CHMP, to recommend the granting of a marketing authorization,
subject to certain specific obligations to be reviewed annually, which is referred to as a conditional marketing authorization.
This may apply to medicinal
products for human use that fall under the jurisdiction of the EMA, including those that aim at the treatment, the prevention, or the
medical diagnosis of seriously debilitating or life-threatening diseases and those designated as orphan medicinal products.
A conditional marketing authorization
may be granted when the CHMP finds that, although comprehensive clinical data referring to the safety and therapeutic utility of the
medicinal product have not been supplied, all the following requirements are met:
●
the risk-benefit balance
    of the medicinal product is positive;
●
it is likely that the applicant
    will be in a position to provide the comprehensive clinical data;
●
unmet medical needs will
    be fulfilled; and
●
the benefit to public health
    of the immediate availability on the market of the medicinal product concerned outweighs the risk inherent in the fact that additional
    data is still required.
The granting of a conditional
marketing authorization is restricted to situations in which only the clinical part of the application is not yet fully complete. Incomplete
preclinical or quality data may only be accepted if duly justified and only in the case of a product intended to be used in emergency
situations in response to public health threats. Conditional marketing authorizations are valid for one year, on a renewable basis. The
holder will be required to complete ongoing trials or to conduct new trials with a view to confirming that the benefit-risk balance is
positive. In addition, specific obligations may be imposed in relation to the collection of pharmacovigilance data.
Granting a conditional marketing
authorization allows medicines to reach patients with unmet medical needs earlier than might otherwise be the case and will ensure that
additional data on a product is generated, submitted, assessed and acted upon.
Healthcare legislative reform measures
may have a negative impact on our business and results of operations.
In the United States and
some foreign jurisdictions, there have been, and continue to be, several legislative and regulatory changes and proposed changes regarding
the healthcare system that could prevent or delay marketing approval of our product candidates, restrict or regulate post-approval activities
and affect our ability to profitably sell any product candidates for which we obtain marketing approval.
In the United States, the
Medicare Prescription Drug, Improvement, and Modernization Act of 2003, or the MMA, changed the way Medicare covers and pays for pharmaceutical
products. The MMA expanded Medicare coverage for outpatient drug purchases by adding a new Medicare Part D program and introduced a new
reimbursement methodology based on average sales prices for Medicare Part B physician-administered drugs. In addition, the MMA authorized
Medicare Part D prescription drug plans to limit the number of drugs that will be covered in any therapeutic class in their formularies.
The MMA's cost reduction initiatives and other provisions could decrease the coverage and price that we receive for any approved
products. While the MMA applies 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 the MMA
may result in a similar reduction in payments from private payors. Similar regulations or reimbursement policies may be enacted in international
markets, which could similarly impact our business.
More recently, in March 2010,
the PPACA (as amended by the Health Care and Education Reconciliation Act of 2010) was passed, which substantially changes the way healthcare
is financed by both the government and private insurers, and significantly impacts the U.S. pharmaceutical industry. The PPACA, among
other things: (i) addresses a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated
for drugs that are inhaled, infused, instilled, implanted or injected; (ii) increases the minimum Medicaid rebates owed by manufacturers
under the Medicaid Drug Rebate Program and extends the rebate program to individuals enrolled in Medicaid managed care organizations;
(iii) establishes annual fees and taxes on manufacturers of certain branded prescription drugs; (iv) expands the availability of lower
pricing under the 340B drug pricing program by adding new entities to the program; and (v) establishes a new Medicare Part D coverage
gap discount program, in which manufacturers must agree to offer 50% point-of-sale discounts off negotiated prices of applicable brand
drugs to eligible beneficiaries during their coverage gap period, as a condition for the manufacturer's outpatient drugs to be
covered under Medicare Part D. Additionally, in the United States, the Biologics Price Competition and Innovation Act of 2009 created
an abbreviated approval pathway for biologic products that are demonstrated to be biosimilar or "interchangeable" with an
FDA-approved biologic product. This new pathway could allow competitors to reference data from biologic products already approved after
12 years from the time of approval. This could expose us to potential competition by lower-cost biosimilars even if we commercialize
a product candidate faster than our competitors. Moreover, the creation of this abbreviated approval pathway does not preclude or delay
a third party from pursuing approval of a competitive product candidate via the traditional approval pathway based on their own clinical
trial data.
24
Additional changes that may
affect our business include those governing enrollments in federal healthcare programs, reimbursement changes, rules regarding prescription
drug benefits under the health insurance exchanges and fraud and abuse and enforcement. Continued implementation of the PPACA and the
passage of additional laws and regulations may result in the expansion of new programs such as Medicare payment for performance initiatives,
and may impact existing government healthcare programs, such as by improving the physician quality reporting system and feedback program.
For each state that does
not choose to expand its Medicaid program, there likely will be fewer insured patients overall, which could impact the sales, business
and financial condition of manufacturers of branded prescription drugs. Where patients receive insurance coverage under any of the new
options made available through the PPACA, manufacturers may be required to pay Medicaid rebates on that resulting drug utilization. The
U.S. federal government also has announced delays in the implementation of key provisions of the PPACA. The implications of these delays
for our and our potential partners' business and financial condition, if any, are not yet clear.
In addition, there have been
judicial and congressional challenges to certain aspects of the PPACA, and we expect the current administration and Congress will likely
continue to seek legislative and regulatory changes, including repeal and replacement of certain provisions of the PPACA. In January
2017, President Trump signed an Executive Order directing federal agencies with authorities and responsibilities under the PPACA to waive,
defer, grant exemptions from, or delay the implementation of any provision of the PPACA that would impose a fiscal or regulatory burden
on states, individuals, healthcare providers, health insurers, or manufacturers of pharmaceuticals or medical devices. More recently,
the U.S. House of Representatives passed legislation known as the American Health Care Act of 2017, and Senate Republicans have released
a draft bill known as the Better Care Reconciliation Act of 2017, each of which would repeal certain aspects of the PPACA if ultimately
enacted. The prospects for enactment of these legislative initiatives remain uncertain. Further, Congress also could consider other legislation
to replace elements of the PPACA. We cannot know how efforts to repeal and replace the PPACA or any future healthcare reform legislation
will impact our business.
We expect that the PPACA,
as well as other healthcare reform measures that may be adopted in the future, may result in more rigorous coverage criteria and in additional
downward pressure on the price that we receive for any approved product. Any reduction in reimbursement from Medicare or other government
programs may result in a similar reduction in payments from private payors. The implementation of cost containment measures or other
healthcare reforms may prevent us from being able to generate revenue, attain profitability, or commercialize our products.
We expect that additional
state and federal healthcare reform measures will be adopted in the future, any of which could limit the amounts that federal and state
governments will pay for healthcare products and services, which could result in reduced demand for our product candidates or additional
pricing pressures.
We are subject to governmental regulation
and other legal obligations related to privacy, data protection and data security. Our actual or perceived failure to comply with such
obligations could harm our business.
We are subject to diverse
laws and regulations relating to data privacy and security in the UK and EU, including the EU and UK GDPR. New global privacy rules are
being enacted and existing ones are being updated and strengthened. We are likely to be required to expend capital and other resources
to ensure ongoing compliance with these laws and regulations.
The EU and UK GDPR applies
extraterritorially and implements stringent operational requirements for controllers and processors of personal data. For example, the
EU and UK GDPR: (i) require detailed disclosures to data subjects; (ii) require disclosure of the legal basis on which personal data is
processed; (iii) make it harder to obtain valid consent for processing; (iv) require the appointment of a data protection officers where
sensitive personal data (i.e. health data) is processed on a large scale; (v) provide more robust rights for data subjects; (vi) introduce
mandatory data breach notification through the EU and in the UK; (vii) impose additional obligations when contracting with service providers;
and (viii) require an appropriate privacy governance framework to be implemented including policies, procedures, training and data audit.
The EU GDPR permits Member State derogations for certain issues and, accordingly, we are also subject to EU national laws relating to
the processing of certain data such as genetic data, biometric data and data concerning health. Complying with these numerous, complex
and often changing regulations is expensive and difficult. Failure by us, or our partners or service providers, to comply with the EU
and/or UK GDPR could result in regulatory investigations, enforcement notices and/ or fines of up to the higher of 20,000,000 Euros/17,500,000
GBP or up to 4% of our total worldwide annual turnover. In addition to the foregoing, any breach of privacy laws or data security laws,
particularly those resulting in any security incident or breach involving the misappropriation, loss or other unauthorized use or disclosure
of sensitive or confidential patient or consumer information, could have a material adverse effect on our business, reputation and financial
condition.
25
As a data controller, we are
accountable for any third-party data service providers we engage to process personal data on our behalf. We attempt to address the associated
risks by performing security assessments, detailed due diligence and regularly performing privacy and security reviews of its vendors
and requiring all such third-party providers with data access to sign agreements, including business associate agreements, and where required
under EU or UK law, obligating them to only process data according to our instructions and to take sufficient security measures to protect
such data. There is no assurance that these contractual measures and our own privacy and security-related safeguards will protect us from
the risks associated with the third-party processing, storage and transmission of such information. Any violation of data or security
laws by our third-party processors could have a material adverse effect on our business and result in the fines and penalties outlined
above. We are also subject to evolving European privacy laws on electronic marketing and cookies. The EU is in the process of replacing
the e-Privacy Directive (2002/58/EC) with a new set of rules taking the form of a regulation, which will be directly implemented in the
laws of each Member State. The draft e-Privacy Regulation imposes strict opt-in marketing rules with limited exceptions for business-to-business
communications, alters rules on third-party cookies, web beacons and similar technology and significantly increases fining powers to the
same levels as GDPR (i.e. the greater of 20,000,000 Euros or 4% of total global annual revenue). While the e-Privacy Regulation was originally
intended to be adopted on May 25, 2018 (alongside the GDPR), it is still going through the European legislative process and commentators
do not expect it to be enacted before mid to end 2023 and would not come into force before mid to end 2025. The UK is also updating its
data protection law via the Data Protection and Digital Information Bill that is currently being considered by the UK Parliament. This
is expected to be passed at the end of 2023 and will modify certain aspects of the UK GDPR and Data Protection Act 2018. These proposed
changes will require us to modify certain aspects of our data protection compliance program.
We are subject to the U.K. Bribery Act,
the U.S. Foreign Corrupt Practices Act and other anti-corruption laws, as well as export control laws, import and customs laws, trade
and economic sanctions laws and other laws governing our operations.
Our operations are subject
to anti-corruption laws, including the U.K. Bribery Act 2010, or the U.K. Bribery Act, the U.S. Foreign Corrupt Practices Act of 1977,
or the FCPA, the U.S. domestic bribery statute contained in 18 §201, the U.S. Travel Act, and other anti-corruption laws that apply
in countries where we do business. The U.K. Bribery Act, the FCPA and these other laws generally prohibit us and our employees and intermediaries
from authorizing, promising, offering, or providing, directly or indirectly, improper or prohibited payments, or anything else of value,
to government officials or other persons to obtain or retain business or gain some other business advantage. Under the U.K. Bribery Act,
we may also be liable for failing to prevent a person associated with us from committing a bribery offense. We and our commercial partners
operate in a number of jurisdictions that pose a high risk of potential U.K. Bribery Act or FCPA violations, and we participate in collaborations
and relationships with third parties whose corrupt or illegal activities could potentially subject us to liability under the U.K. Bribery
Act, FCPA or local anti-corruption laws, even if we do not explicitly authorize or have actual knowledge of such activities. In addition,
we cannot predict the nature, scope or effect of future regulatory requirements to which our international operations might be subject
or the manner in which existing laws might be administered or interpreted.
We are also subject to other
laws and regulations governing our international operations, including regulations administered by the governments of the United Kingdom
and the United States, and authorities in the European Union, including applicable export control regulations, economic sanctions and
embargoes on certain countries and persons, anti-money laundering laws, import and customs requirements and currency exchange regulations,
collectively referred to as the Trade Control laws.
There is no assurance that
we will be completely effective in ensuring our compliance with all applicable anti-corruption laws, including the U.K. Bribery Act,
the FCPA or other legal requirements, including Trade Control laws. If we are not in compliance with the U.K. Bribery Act, the FCPA and
other anti-corruption laws or Trade Control laws, we may be subject to criminal and civil penalties, disgorgement and other sanctions
and remedial measures, and legal expenses, which could have an adverse impact on our business, financial condition, results of operations
and liquidity. Likewise, any investigation of any potential violations of the U.K. Bribery Act, the FCPA, other anti-corruption laws
or Trade Control laws by United Kingdom, United States or other authorities could also have an adverse impact on our reputation, our
business, results of operations and financial condition.
Our relationships with customers, physicians
and third-party payors will be subject, directly or indirectly, to federal and state healthcare fraud and abuse laws, false claims laws,
health information privacy and security laws and other healthcare laws and regulations. If we are found in violation of these laws and
regulations, we may be required to pay a penalty or be suspended from participation in federal or state healthcare programs, which may
adversely affect our business, financial condition and results of operations.
If we obtain FDA approval
for our product candidates and begin commercializing them in the United States, our operations will be directly, or indirectly through
our prescribers, customers and purchasers, subject to various federal and state fraud and abuse laws and regulations, including, without
limitation, the federal Anti-Kickback Statute, the federal civil and criminal laws and Physician Payments Sunshine Act of 2010 and regulations.
These laws will impact, among other things, our proposed sales, marketing and educational programs. In addition, we may be subject to
patient privacy laws by both the U.S. federal government and the states in which we conduct our business. The laws that will affect our
operations include, but are not limited to:
●
the federal Anti-Kickback
    Statute, which prohibits, among other things, persons or entities from knowingly and willfully soliciting, receiving, offering or
    paying any remuneration (including any kickback, bribe or rebate), directly or indirectly, overtly or covertly, in cash or in kind,
    in return for either the referral of an individual, or the purchase, leasing, furnishing or arranging for the purchase, lease or
    order of a good, facility, item or service reimbursable under a federal healthcare program, such as the Medicare and Medicaid programs.
    This statute has been interpreted to apply to arrangements between pharmaceutical manufacturers on the one hand, and prescribers,
    purchasers and formulary managers on the other. The PPACA amended the intent requirement of the federal Anti-Kickback Statute, such
    that a person or entity no longer needs to have actual knowledge of this statute or specific intent to violate it;
●
federal civil and criminal
    false claims laws and civil monetary penalty laws which prohibit, among other things, individuals or entities from knowingly presenting,
    or causing to be presented, claims for payment or approval from Medicare, Medicaid or other government payors that are false or fraudulent.
    The PPACA provides, and recent government cases against pharmaceutical and medical device manufacturers support the view that federal
    Anti-Kickback Statute violations and certain marketing practices, including off-label promotion, may implicate the False Claims Act
    of 1863;
26
●
the federal Health Insurance
    Portability and Accountability Act of 1996, or HIPAA, which created new federal criminal statutes that prohibit, among other things,
    a person from knowingly and willfully executing a scheme or from making false or fraudulent statements to defraud any healthcare
    benefit program, regardless of the payor (e.g., public or private);
●
HIPAA (as amended by the
    Health Information Technology for Economic and Clinical Health Act of 2009), and their implementing regulations, which impose certain
    requirements relating to the privacy, security and transmission of individually identifiable health information without appropriate
    authorization by entities subject to the rule, such as health plans, health care clearinghouses and health care providers, and their
    respective business associates that perform certain functions or activities that involve the use or disclosure of protected health
    information on their behalf;
●
federal transparency laws,
    including the federal Physician Payment Sunshine Act, that require certain manufacturers of drugs, devices, biologics and medical
    supplies for which payment is available under Medicare, Medicaid or the Children's Health Insurance Program, with specific
    exceptions, to report annually to the CMS information related to: (i) payments or other "transfers of value" made to
    physicians and teaching hospitals and (ii) ownership and investment interests held by physicians and their immediate family members;
●
federal consumer protection
    and unfair competition laws, which broadly regulate marketplace activities and activities that potentially harm consumers; and
●
state and foreign law equivalents
    of each of the above federal laws, state and local laws that 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 governing
    the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways
    and may not have the same effect, thus complicating compliance efforts.
Efforts to ensure that our
business arrangements with third parties will comply with applicable healthcare laws and regulations will involve substantial costs.
Because of the breadth of these laws and the narrowness of the statutory exceptions and safe harbors available, it is possible that some
of our business activities could be subject to challenge under one or more of such laws. It is possible that governmental authorities
will conclude that our business practices may not comply with current or future statutes, regulations or case law involving applicable
fraud and abuse or other healthcare laws and regulations. If our operations are found to be in violation of any of these laws or any
other governmental regulations that may apply to us, we may be subject to significant criminal, civil and administrative sanctions including
monetary penalties, damages, fines, disgorgement, individual imprisonment, and exclusion from participation in government funded healthcare
programs, such as Medicare and Medicaid, additional reporting requirements and oversight if we become subject to a corporate integrity
agreement or similar agreement to resolve allegations of non-compliance with these laws, reputational harm, and we may be required to
curtail or restructure our operations, any of which could adversely affect our ability to operate our business and our results of operations.
The risk of our being found
in violation of these laws is increased by the fact that many of them have not been fully interpreted by the regulatory authorities or
the courts, and their provisions are open to a variety of interpretations. Any action against us for violation of these laws, even if
we successfully defend against it, could cause us to incur significant legal expenses and divert our management's attention from
the operation of our business. The shifting compliance environment and the need to build and maintain robust and expandable systems to
comply with multiple jurisdictions with different compliance and/or reporting requirements increases the possibility that a healthcare
company may run afoul of one or more of the requirements.
If we fail to comply with environmental,
health and safety laws and regulations, we could become subject to fines or penalties or incur substantial costs.
We are subject to numerous
environmental, health and safety laws and regulations, including those governing laboratory procedures and the generation, handling,
use, storage, treatment, manufacture, transportation and disposal of, and exposure to, hazardous materials and wastes, as well as laws
and regulations relating to occupational health and safety. We contract with third parties that conduct operations on our behalf that
involve the use of hazardous and flammable materials, including chemicals and biologic materials. Our contractors also produce and dispose
of hazardous waste products. We cannot eliminate the risk of contamination or injury from these materials. In the event of contamination
or injury resulting from our contractors' use of hazardous materials, we could be held liable for any resulting damages and any
liability could exceed our resources, and our clinical trials or regulatory approvals could be suspended. We also could incur significant
costs associated with civil or criminal fines and penalties. Our third-party contractors may not carry specific biological or hazardous
waste insurance coverage, and their property, casualty and general liability insurance policies specifically exclude coverage for damages
and fines arising from biological or hazardous waste exposure or contamination.
Although we maintain workers'
compensation insurance for certain costs and expenses, we may incur due to injuries to our employees resulting from the use of hazardous
materials or other work-related injuries, this insurance may not provide adequate coverage against potential liabilities. We do not maintain
insurance for toxic tort claims that may be asserted against us in connection with our storage or disposal of biologic, hazardous or
radioactive materials.
27
In addition, we may incur
substantial costs in order to comply with current or future environmental, health and safety laws and regulations, which have tended
to become more stringent over time. These current or future laws and regulations may impair our research, development or production efforts.
Failure to comply with these laws and regulations also may result in substantial fines, penalties or other sanctions or liabilities,
which could adversely affect our business, financial condition, results of operations and prospects.
Risks Related to our Business Operations
We may not be successful in our efforts
to identify or discover additional product candidates and may fail to capitalize on programs or product candidates that may be a greater
commercial opportunity or for which there is a greater likelihood of success.
The success of our business
depends upon our ability to identify, develop and commercialize product candidates. Research programs to identify new product candidates
require substantial technical, financial and human resources. Although a substantial amount of our efforts will focus on the continued
preclinical and clinical testing and potential approval of our product candidates, a key element of our long-term growth strategy is
to develop and market additional products and product candidates. However, we may fail to identify other potential product candidates
for clinical development for several reasons. For example, our research may be unsuccessful in identifying potential product candidates
or our potential product candidates may be shown to have harmful side effects, may be commercially impracticable to manufacture or may
have other characteristics that may make the products unmarketable or unlikely to receive marketing approval.
Additionally, because we
have limited resources, we may forego or delay pursuit of opportunities with certain programs or product candidates or for indications
that later prove to have greater commercial potential. Our spending on current and future R&D programs may not yield any commercially
viable products. If we do not accurately evaluate the commercial potential for a particular product candidate, we may relinquish valuable
rights to that product candidate through strategic collaboration, licensing or other arrangements in cases in which it would have been
more advantageous for us to retain sole development and commercialization rights to such product candidate. Alternatively, we may allocate
internal resources to a product candidate in a therapeutic area in which it would have been more advantageous to enter into a partnering
arrangement.
Our long-term growth strategy
to develop and market additional products and product candidates is heavily dependent on precise, accurate and reliable scientific data
to identify, select and develop promising pharmaceutical product candidates and products. Our business decisions may therefore be adversely
influenced by improper or fraudulent scientific data sourced from third parties. Any irregularities in the scientific data used by us
to determine our focus in R&D of product candidates and products could have a material adverse effect on our business, prospects,
financial condition and results of operations.
If any of these events occur,
we may be forced to abandon our development efforts with respect to a particular product candidate or fail to develop a potentially successful
product candidate, which could have a negative impact on our business, financial condition, results of operations and prospects.
Our future success depends on our ability
to retain key employees, consultants and advisors and to recruit, retain and motivate qualified personnel.
Our ability to compete in
the highly competitive biotechnology and pharmaceutical industries depends upon our ability to attract and retain highly qualified managerial,
scientific and medical personnel. While we have entered into employment agreements with each of our executive officers, any of them could
leave our employment at any time. We currently do not have "key person" insurance on any of our employees. The loss of the
services of one or more of our current employees might impede the achievement of our research, development and commercialization objectives.
Recruiting and retaining
other qualified employees, consultants and advisors for our business, including scientific and technical personnel, also will be critical
to our success. We may not be able to attract and retain personnel on acceptable terms given the competition among numerous pharmaceutical
and biotechnology companies and academic institutions for individuals with similar skill sets. In addition, failure to succeed in preclinical
studies or clinical trials or applications for marketing approval may make it more challenging to recruit and retain qualified personnel.
The inability to recruit, or loss of services of certain executives, key employees, consultants or advisors, may impede the progress
of our research, development and commercialization objectives and have an adverse effect on our business, financial condition, results
of operations and prospects.
28
If we are unable to manage expected growth
in the scale and complexity of our operations, our performance may suffer
.
At December 31, 2022, we
had 3 full-time employees, who were engaged in R&D activities. If we are successful in executing our business strategy, we will need
to expand our managerial, operational, financial and other systems and resources to manage our operations, continue our R&D activities
and, in the longer term, build a commercial infrastructure to support commercialization of any of our product candidates that are approved
for sale. Future growth would impose significant added responsibilities on members of management and, to a potentially significant extent,
divert our management and business development resources away from their current uses. It is likely that our management, finance, development
personnel, systems and facilities currently in place may not be adequate to support this future growth. Our need to effectively manage
our operations, growth and any future product candidates requires that we continue to develop more robust business processes and improve
our systems and procedures in each of these areas, to attract and retain sufficient numbers of talented employees and to expand the group
of contractors we use.
We may be unable to successfully
implement these tasks on a larger scale and, accordingly, may not achieve our research, development and growth goals.
Our employees, principal investigators,
consultants and commercial partners may engage in misconduct or other improper activities, including non-compliance with regulatory standards
and requirements and insider trading, which could have a material adverse impact on our business.
We are exposed to the risk
of fraud or other misconduct by our employees, principal investigators, consultants and commercial partners. Misconduct by these parties
could include intentional failures to: comply with FDA or EMA regulations or the regulations applicable in other jurisdictions, provide
accurate information to the FDA, EMA and other regulatory authorities, comply with healthcare fraud and abuse laws and regulations in
the United States and abroad, report financial information or data accurately or disclose unauthorized activities to us. 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. These laws and regulations restrict or prohibit a wide range
of pricing, discounting, marketing and promotion, sales commission, customer incentive programs and other business arrangements. Such
misconduct also could involve the improper use of information obtained in the course of clinical trials or interactions with the FDA,
EMA or other regulatory authorities, which could result in regulatory sanctions and cause serious harm to our reputation. Additionally,
we are subject to the risk that a person could allege fraud or other misconduct, even in none occurred. We have adopted a code of conduct
applicable to all of our employees, but it is not always possible to identify and deter employee misconduct, and the precautions we take
to detect and prevent these activities may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from
government investigations or other actions or lawsuits stemming from a failure to comply with these laws or regulations. If any such
actions are instituted against us, and we are not successful in defending ourselves or asserting our rights, those actions could have
a significant impact on our business, financial condition, results of operations and prospects, including the imposition of significant
criminal, civil and administrative sanctions, such as monetary penalties, damages, fines, disgorgement, individual imprisonment, and
exclusion from participation in government funded healthcare programs, such as Medicare and Medicaid, additional reporting requirements
and oversight if we become subject to a corporate integrity agreement or similar agreement to resolve allegations of non-compliance with
these laws, reputational harm, and we may be required to curtail or restructure our operations. We are also subject to the data privacy
regime in the EU, which imposes obligations and restrictions on the collection and use of personal data relating to individuals located
in the EU and includes the General Data Protection Regulation, or the GDPR, and any national laws implementing or supplementing the GDPR.
If we do not comply with our obligations under the EU privacy regime, we could be exposed to significant fines and we may be the subject
of litigation and/or adverse publicity, which could have a material adverse effect on our reputation and business.
Product liability lawsuits against us could
cause us to incur substantial liabilities and could limit commercialization of any product candidate that we may develop.
We face an inherent risk
of product liability exposure related to the testing of our current and future product candidates in clinical trials and may face an
even greater risk if we commercialize any product candidate that we may develop. For example, we may be sued if our current or future
product candidates cause or are perceived to cause injury or are found to be otherwise unsuitable during clinical testing, manufacturing,
marketing or sale. Any such product liability claims may include allegations of defects in manufacturing, defects in design, a failure
to warn of dangers inherent in the product, negligence, strict liability or a breach of warranties. Claims could also be asserted under
state consumer protection acts. If we cannot successfully defend ourselves against product liability claims, we could incur substantial
liabilities. Regardless of merit or eventual outcome, liability claims may result in:
●
decreased demand for any
    product candidate that we may develop;
●
loss of revenue;
29
●
substantial monetary awards
    to trial participants or patients;
●
significant time and costs
    to defend the related litigation;
●
withdrawal of clinical
    trial participants;
●
the inability to commercialize
    any product candidates that we may develop; or
●
injury to our reputation
    and significant negative media attention.
Although we maintain product
liability insurance coverage, such insurance may not be adequate to cover all liabilities that we may incur. We anticipate that we will
need to increase our insurance coverage each time we commence a clinical trial and if we successfully commercialize any product candidate.
Insurance coverage is increasingly expensive. We may not be able to maintain insurance coverage at a reasonable cost or in an amount
adequate to satisfy any liability that may arise.
A pandemic, epidemic or outbreak of an
infectious disease, such as COVID-19, may materially and adversely affect our business and operations.
The outbreak of COVID-19
originated in Wuhan, China, in December 2019 and has since spread to multiple countries, including the United States and several European
countries. On March 11, 2020, the World Health Organization declared the outbreak a pandemic. The COVID-19 pandemic is affecting the
United States and global economies and may affect our operations and those of third parties on which we rely, including by causing disruptions
in the supply of our product candidates and the conduct of future clinical trials. Disruptions caused by the COVID-19 pandemic may increase
the likelihood that we encounter such difficulties or delays in initiating, enrolling, conducting or completing our planned and ongoing
preclinical studies and clinical trials, as applicable.
In addition, the COVID-19
pandemic may affect the operations of the FDA and other health authorities, which could result in delays of reviews and approvals, including
with respect to our product candidates. Additionally, while the potential economic impact brought by, and the duration of the COVID-19
pandemic is difficult to assess or predict, the impact of the COVID-19 pandemic on the global financial markets may reduce our ability
to access capital, which could negatively impact our short-term and long-term liquidity. The ultimate impact of the COVID-19 pandemic
is highly uncertain and subject to change. We do not yet know the full extent of potential delays or impacts on our business, financing
or clinical trial activities or on healthcare systems or the global economy as a whole. However, these effects could have a material
impact on our liquidity, capital resources, operations and business and those of the third parties on which we rely.
Exchange rate fluctuations may materially
affect our results of operations and financial condition.
Owing to the international
scope of our operations, fluctuations in exchange rates, particularly between Pounds Sterling and the U.S. dollar, may adversely affect
us. Although we are based in the United Kingdom, we may source R&D, manufacturing, consulting and other services from the United States
and the European Union. Further, potential future revenue may be derived from abroad, particularly from the United States. As a result,
our business and the potential value of our Common shares may be affected by fluctuations in foreign exchange rates not only between the
Pounds Sterling and the U.S. dollar, but also the euro, which may have a significant impact on our results of operations and cash flows
from period to period. Currently, we do not have any exchange rate hedging arrangements in place.
Our internal computer systems, or those
of our collaborators or other contractors or consultants, may fail or suffer security breaches, which could result in a material disruption
of our product development programs.
Our internal computer systems
and those of our current and any future collaborators and other contractors or consultants are vulnerable to damage from computer viruses,
unauthorized access, natural disasters, terrorism, war and telecommunication and electrical failures. While we have not experienced any
such material system failure, accident or security breach to date, if such an event were to occur and cause interruptions in our operations,
it could result in a material disruption of our development programs and our business operations, whether due to a loss of our trade
secrets or other proprietary information or other similar disruptions. For example, the loss of clinical trial data from completed or
future 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 were to result in a loss of, or damage to, our data or applications, or
inappropriate disclosure of confidential or proprietary information, we could incur liability, our competitive position could be harmed,
and the further development and commercialization of our product candidates could be delayed.
30
Risks Related to the Ownership of Our Securities
The prices of our common shares may be
volatile and fluctuate substantially, which could result in substantial losses for holders of our common shares.
The market prices of our common
shares on the Nasdaq Capital Market may be volatile and fluctuate substantially. The stock market in general and the market for smaller
pharmaceutical and biotechnology companies in particular have experienced extreme volatility that has often been unrelated to the operating
performance of particular companies. As a result of this volatility, holders our common shares may not be able to sell their common shares
at or above the price at which they were purchased. The market price for the common shares may be influenced by many factors, including:
●
the success of competitive
    products or technologies;
●
results of clinical trials
    of Foralumab, anti-IL6R mAb (TZLS-501), Milciclib and any other future product candidate that we develop;
●
results of clinical trials
    of product candidates of our competitors;
●
changes or developments
    in laws or regulations applicable to Foralumab, anti-IL6R mAb (TZLS-501), Milciclib and any other future product candidates that
    we develop;
●
our entry into, and
    the success of, any collaboration agreements with third parties;
●
developments or disputes
    concerning patent applications, issued patents or other proprietary rights;
●
the recruitment or departure
    of key personnel;
●
the level of expenses related
    to any of our product candidates or clinical development programs;
●
the results of our efforts
    to discover, develop, acquire or in-license additional product candidates, products or technologies;
●
actual or anticipated changes
    in estimates as to financial results, development timelines or recommendations by securities analysts;
●
variations in our financial
    results or those of companies that are perceived to be similar to us;
●
market conditions in the
    biotechnology and pharmaceutical sectors;
●
general economic, industry
    and market conditions;
●
the trading volume of our common shares on the Nasdaq Capital Market;
and
●
the other factors described
    in this "Risk Factors" section.
Our common shares
may be delisted from The Nasdaq Capital Market if we fail to comply with continued listing standards.
If we fail to
meet any of the continued listing standards of The Nasdaq Capital Market, our common shares could be delisted from The Nasdaq Capital
Market. These continued listing standards include specifically enumerated criteria, such as:
●
a $1.00 minimum closing bid price;
●
stockholders' equity of $2.5 million;
●
500,000 shares of publicly-held common stock with a market value of at least $1 million;
●
300 round-lot stockholders; and
●
compliance with Nasdaq's corporate governance requirements, as well as additional or more stringent criteria that may be applied in the exercise of Nasdaq's discretionary authority.
On June 14, 2022, we received a written notice (the "Notice")
from the Nasdaq Stock Market LLC ("Nasdaq") notifying us that were not in compliance with Nasdaq Listing Rule 5550(a)(2) (the
"Rule"), as the minimum bid price of the Company's common shares has been below $1.00 per share for 30 consecutive business
days. On December 13, 2022, Nasdaq notified us that we were eligible for an additional 180 calendar day period, or until June 12, 2023
,
to regain compliance.
On April 21, 2023, we received notice from
Nasdaq that we had regained compliance with the minimum bid price requirement for continued listing on The Nasdaq Capital Market.
If we fail to
comply with Nasdaq's continued listing standards, we may be delisted and our common shares will trade, if at all, only on the over-the-counter
market, such as the OTC Bulletin Board or OTCQX market, and then only if one or more registered broker-dealer market makers comply with
quotation requirements. In addition, delisting of our common shares could depress our stock price, substantially limit liquidity of our
common shares and materially adversely affect our ability to raise capital on terms acceptable to us, or at all. Finally, delisting of
our common shares could result in our common shares becoming a "penny stock" under the Exchange Act.
Because we are a
foreign corporation, you may not have the same rights as a shareholder in a U.S. corporation.
We
are a Bermuda exempted company. Our Memorandum of Association and Bye-laws and the Companies Act 1981 of Bermuda (the "
Companies
Act
") govern our affairs Bermudan 1981 While many provisions of the Companies Act resemble provisions of the corporation laws
of a number of states in the United States, Bermuda law may not as clearly establish your rights and the fiduciary responsibilities of
our directors as do statutes and judicial precedent in some U.S. jurisdictions. In addition, apart from three non-executive directors,
our directors and officers are not resident in the United States and all or substantially all of our assets are located outside of the
United States. As a result, investors may have more difficulty in protecting their interests and enforcing judgments in the face of actions
by our management, directors or controlling shareholders than would shareholders of a corporation incorporated in a U.S. jurisdiction.
In addition, you should not
assume that courts in the country in which we are incorporated or where our assets are located would enforce judgments of U.S. courts
obtained in actions against us based upon the civil liability provisions of applicable U.S. federal and state securities laws or would
enforce, in original actions, liabilities against us based on those laws.
Shareholders of Bermuda exempted
companies such as the Company also have no general rights under Bermuda law to inspect corporate records and accounts other than rights
to review the Company's memorandum of association and bye-laws, financial statements, minutes of the shareholder meetings and the
shareholder register. This could make it more difficult for you to obtain the information needed to establish any facts necessary for
a shareholder motion or to solicit proxies from other shareholders in connection with a proxy contest.
As
a result of all of the above, public shareholders might have more difficulty in protecting their interests in the face of actions taken
by management, members of the board of directors or controlling shareholders than they would as public shareholders of a U.S. company.
31
U.S. persons who own our securities may
have more difficulty in protecting their interests than U.S. persons who are shareholders of a U.S. corporation.
The Companies Act, which
applies to the Company, differs in some material respects from laws generally applicable to U.S. corporations and their shareholders.
These differences include, but are not limited to, the manner in which directors must disclose transactions in which they have an interest,
the rights of shareholders to bring class action and derivative lawsuits, the scope of indemnification available to directors and officers
and provisions relating to amalgamations, mergers and acquisitions and takeovers. Holders of our common shares may therefore have more
difficulty protecting their interests than would shareholders of a corporation incorporated in a jurisdiction within the U.S.
Generally, the duties of
directors and officers of a Bermuda company are owed to the company and not, in the absence of special circumstances, to the shareholders
as individuals. Shareholders of Bermuda companies typically do not have rights to take action against directors or officers of the company
and may only do so in limited circumstances. Class actions and derivative actions are typically not available to shareholders under Bermuda
law. The Bermuda courts, however, would ordinarily be expected to permit a shareholder to commence an action in the name of a company
to remedy a wrong to the company where the act complained of is alleged to be beyond the corporate power of the company or illegal, or
would result in the violation of the company's memorandum of association or bye-laws.
Certain Other Bermuda Law Considerations
.
All Bermuda "exempted
companies" are exempt from certain Bermuda laws restricting the percentage of share capital that may be held by non-Bermudians.
However, exempted companies may not participate in certain business transactions, including (1) the acquisition or holding of land in
Bermuda except that required for their business and held by way of lease or tenancy for a term not exceeding 50 years or, with the consent
of the Minister of Economic Development (the "Minister") granted in his discretion by way of lease or tenancy for a term
not exceeding 21 years in order to provide accommodation or recreational facilities for officers and employees of the Company, (2) the
taking of mortgages on land in Bermuda to secure an amount in excess of $50,000 without the consent of the Minister, (3) the acquisition
of any bonds or debentures secured by any land in Bermuda, other than certain types of Bermuda government securities or securities issued
by Bermuda public authorities or (4) the carrying on of business of any kind in Bermuda, except in furtherance of business carried on
outside Bermuda or under license granted by the Minister.
All Bermuda companies must
comply with the provisions of the Companies Act regulating the payment of dividends and making distributions from contributed surplus.
A company may not declare or pay a dividend, or make a distribution out of contributed surplus, if there are reasonable grounds for believing
that: (a) the company is, or would after the payment be, unable to pay its liabilities as they become due; or (b) the realizable value
of the company's assets would thereby be less than its liabilities.
Bermuda Exchange Control
Regulation
. The permission of the Bermuda Monetary Authority is required, under the provisions of the Exchange Control Act 1972 of
Bermuda and related regulations, for all issuances and transfers of shares (which includes our common shares) of Bermuda companies to
or from a non-resident of Bermuda for exchange control purposes, other than in cases where the Bermuda Monetary Authority has granted
a general permission. The Bermuda Monetary Authority, in its notice to the public dated June 1, 2005, has granted a general permission
for the issue and subsequent transfer of any securities of a Bermuda company from and/or to a non-resident of Bermuda for exchange control
purposes for so long as any "Equity Securities" of the company (which include our common shares) are listed on an "Appointed
Stock Exchange" (which include Nasdaq). In granting the general permission the Bermuda Monetary Authority accepts no responsibility
for our financial soundness or the correctness of any of the statements made or opinions expressed in this annual report.
Although the Company is incorporated
in Bermuda, as an exempted company, the Company is classified as a non-resident of Bermuda for exchange control purposes by the Bermuda
Monetary Authority. Other than transferring Bermuda Dollars out of Bermuda, there are no restrictions on the Company's ability
to transfer funds into and out of Bermuda or to pay dividends in currency other than Bermuda Dollars to nonresidents of Bermuda who are
holders of our common shares.
If we engage in future acquisitions or
strategic partnerships, this may increase our capital requirements, dilute our shareholders, cause us to incur debt or assume contingent
liabilities and subject us to other risks.
We intend to continue to
evaluate various acquisitions and strategic partnerships, including licensing or acquiring complementary drugs, intellectual property
rights, technologies or businesses. Any potential acquisition or strategic partnership may entail numerous risks, including:
●
increased operating expenses
    and cash requirements;
●
the assumption of additional
    indebtedness or contingent liabilities;
●
assimilation of operations,
    intellectual property and drugs of an acquired company, including difficulties associated with integrating new personnel;
32
●
the diversion of our management's
    attention from our existing drug programs and initiatives in pursuing such a strategic partnership, merger or acquisition;
●
retention of key employees,
    the loss of key personnel and uncertainties in our ability to maintain key business relationships;
●
risks and uncertainties
    associated with the other party to such a transaction, including the prospects of that party and their existing drugs or drug candidates
    and regulatory approvals; and
●
our inability to generate
    revenue from acquired technology and/or drugs sufficient to meet our objectives in undertaking the acquisition or even to offset
    the associated acquisition and maintenance costs.
As an FPI, we are
exempt from a number of rules under the U.S. securities laws and are permitted to file less information with the SEC than U.S. public
companies
.
We are an FPI, as defined
in the SEC rules and regulations and, consequently, we are not subject to all of the disclosure requirements applicable to companies
organized within the United States. For example, we are exempt from certain rules under the Exchange Act, that regulate disclosure obligations
and procedural requirements related to the solicitation of proxies, consents or authorizations applicable to a security registered under
the Exchange Act. In addition, our officers and directors are exempt from the reporting and "short-swing" profit recovery
provisions of Section 16 of the Exchange Act and related rules with respect to their purchases and sales of our securities. Moreover,
we are not required to file periodic reports and financial statements with the SEC as frequently or as promptly as U.S. public companies.
Accordingly, there may be less publicly available information concerning our company than there is for U.S. public companies.
As an FPI, we will file an
annual report on Form 20-F within four months of the close of each fiscal year ended December 31 and reports on Form 6-K relating to
certain material events promptly after we publicly announce these events. However, because of the above exemptions for FPIs, our common
shareholders will not be afforded the same protections or information generally available to investors holding shares in public companies
organized in the United States.
While we are an FPI, we are not subject
to certain Nasdaq corporate governance rules applicable to U.S. listed companies.
We are entitled to rely on
a provision in Nasdaq's corporate governance rules that allows us to follow our home country corporate law and the Companies Act
with regard to certain aspects of corporate governance. This allows us to follow certain corporate governance practices that differ in
significant respects from the corporate governance requirements applicable to U.S. companies listed on Nasdaq.
For example, we are exempt
from Nasdaq regulations that require a listed U.S. company to (i) have a majority of the board of directors consist of independent directors,
(ii) require non-management directors to meet on a regular basis without management present and (iii) promptly disclose any waivers of
the code for directors or executive officers that should address certain specified items.
In accordance with our Nasdaq
listing, our audit committee is required to comply with the provisions of Section 301 of the Sarbanes-Oxley Act and Rule 10A-3 of the
Exchange Act, both of which are also applicable to Nasdaq-listed U.S. companies. Because we are an FPI, however, our audit committee
is not subject to additional Nasdaq requirements applicable to listed U.S. companies, including an affirmative determination that all
members of the audit committee are "independent," using more stringent criteria than those applicable to us as an FPI. Furthermore,
Nasdaq's corporate governance rules require listed U.S. companies to, among other things, seek shareholder approval for the implementation
of certain equity compensation plans and issuances of ordinary shares, which we are not required to follow as an FPI.
We may lose our FPI status, which would
then require us to comply with the Exchange Act's domestic reporting regime and cause us to incur significant legal, accounting
and other expenses.
As an FPI, we are not required
to comply with all of the periodic disclosure and current reporting requirements of the Exchange Act applicable to U.S. domestic issuers.
In order to maintain our current status as an FPI, either (a) a majority of our Common shares must be either directly or indirectly owned
of record by non-residents of the United States or (b)(i) a majority of our executive officers or directors cannot be U.S. citizens or
residents, (ii) more than 50% of our assets must be located outside the United States and (iii) our business must be administered principally
outside the United States. If we lose our status as an FPI, we would be required to comply with the Exchange Act reporting and other
requirements applicable to U.S. domestic issuers, which are more detailed and extensive than the requirements for FPIs. We may also be
required to make changes in our corporate governance practices in accordance with various SEC and Nasdaq rules. The regulatory and compliance
costs to us under U.S. securities laws if we are required to comply with the reporting requirements applicable to a U.S. domestic issuer
may be significantly higher than the cost we would incur as an FPI. As a result, we expect that a loss of FPI status would increase our
legal and financial compliance costs and is likely to make some activities highly time consuming and costly. We also expect that if we
were required to comply with the rules and regulations applicable to U.S. domestic issuers, it would make it more difficult and expensive
for us to obtain director and officer liability insurance, and we may be required to accept reduced coverage or incur substantially higher
costs to obtain coverage. These rules and regulations could also make it more difficult for us to attract and retain qualified members
of our board of directors.
33
We are an emerging growth company within
the meaning of the Securities Act of 1933 and will take advantage of certain reduced reporting requirements.
We are an EGC, as defined
in the JOBS Act. For as long as we continue to be an EGC, we may take advantage of exemptions from various reporting requirements that
are applicable to other public companies that are not EGCs, including not being required to comply with the auditor attestation requirements
of Section 404 of the Sarbanes-Oxley Act, or Section 404, exemptions from the requirements of holding a nonbinding advisory vote on executive
compensation and shareholder approval of any golden parachute payments not previously approved. As an EGC, we are required to report
only two years of financial results and selected financial data compared to three and five years, respectively, for comparable data reported
by other public companies. We may take advantage of these exemptions until we are no longer an EGC. We could be an EGC for up to five
years, although circumstances could cause us to lose that status earlier, including if the aggregate market value of our common shares
held by non-affiliates exceeds $700 million as of any June 30 (the end of our second fiscal quarter) before that time, in which case
we would no longer be an EGC as of the following December 31 (our fiscal year-end). We cannot predict if investors will find our common
shares less attractive because we may rely on these exemptions. If some investors find our common shares less attractive as a result,
there may be a less active trading market for our common shares and the price of our common shares may be more volatile in the event
that we decide to make an offering of our common shares.
If we fail to establish and maintain proper
internal controls, our ability to produce accurate financial statements or comply with applicable regulations could be impaired.
Section 404(a) of the Sarbanes-Oxley
Act, or Section 404(a), requires that beginning with our second annual report following our IPO, management assess and report annually
on the effectiveness of our internal control over financial reporting and identify any material weaknesses in our internal control over
financial reporting. Although Section 404(b) of the Sarbanes-Oxley Act, or Section 404(b), requires our independent registered public
accounting firm to issue an annual report that addresses the effectiveness of our internal control over financial reporting, we have
opted to rely on the exemptions provided in the JOBS Act, and consequently will not be required to comply with SEC rules that implement
Section 404(b) until such time as we are no longer an EGC.
Pursuant to Section 404,
we will be required to furnish a report by our senior management on our internal control over financial reporting. However, while we
remain an EGC, we will not be required to include an attestation report on internal control over financial reporting issued by our independent
registered public accounting firm. To prepare for eventual compliance with Section 404, once we no longer qualify as an EGC, we will
be engaged in a process to document and evaluate our internal control over financial reporting, which is both costly and challenging.
In this regard, we will need
to continue to dedicate internal resources, potentially engage outside consultants and adopt a detailed work plan to assess and document
the adequacy of internal control over financial reporting, continue steps to improve control processes as appropriate, validate through
testing that controls are functioning as documented and implement a continuous reporting and improvement process for internal control
over financial reporting. Despite our efforts, there is a risk that we will not be able to conclude, within the prescribed timeframe
or at all, that our internal control over financial reporting is effective as required by Section 404. If we identify one or more material
weaknesses, it could result in an adverse reaction in the financial markets due to a loss of confidence in the reliability of our financial
statements.
Our 10% or more
stockholders and management own a significant percentage of our stock and are able to exercise significant influence over matters subject
to stockholder approval.
As of the date of this annual
report, our executive officers, directors and 10% or more stockholders, together with their respective affiliates, owned approximately
42.03% of our outstanding securities. Accordingly, this group of security holders will be able to exert a significant degree of influence
over our management and affairs and over matters requiring security holder approval, including the election of our Board of Directors,
future issuances of our securities, declaration of dividends and approval of other significant corporate transactions. As a result, if
these shareholders were to choose to act together, they would be able to exert significant influence over matters submitted to our shareholders
for approval, as well as our management and affairs. For example, these persons, if they choose to act together, would exercise sufficient
voting power to influence the election of directors and approve any merger, consolidation or sale of all or substantially all of our
assets. This concentration of ownership control may:
●
delay, defer or prevent
    a change in control;
●
entrench our management
    and board of directors; or
●
impede a merger, consolidation,
    takeover or other business combination involving us that other shareholders may desire.
Claims of U.S. civil liabilities may not
be enforceable against us.
We are incorporated under
Bermudan law. The United States and Bermuda do not currently have a treaty providing for recognition and enforcement of judgments in civil
and commercial matters. Consequently, a final judgment for payment given by a court in the United States, whether or not predicated solely
upon U.S. securities laws, would not automatically be recognized or enforceable in Bermuda. In addition, uncertainty exists as to whether
the courts of Bermuda would entertain original actions brought in Bermuda against us or our directors or senior management predicated
upon the securities laws of the United States or any state in the United States. Any final and conclusive monetary judgment for a definite
sum obtained against us in U.S. courts would be treated by the courts of Bermuda as a cause of action in itself and sued upon as a debt
at common law so that no retrial of the issues would be necessary, provided that certain requirements are met. The courts of Bermuda will
not automatically accept that the foreign court had jurisdiction and was properly seized of the matter. For a Bermuda court to enforce
or recognize a foreign judgment either at common law or under the Judgments (Reciprocal Enforcement) Act 1958 of Bermuda, the foreign
court must have had jurisdiction according to Bermuda Conflict of Law principles. Whether these requirements are met in respect of a judgment
based upon the civil liability provisions of the U.S. securities laws, including whether the award of monetary damages under such laws
would constitute a penalty, is an issue for the court making such decision. If a Bermuda court gives judgment for the sum payable under
a U.S. judgment, the Bermuda judgment will be enforceable by methods generally available for this purpose. These methods generally permit
the Bermuda court discretion to prescribe the manner of enforcement.
34
In addition, U.S. investors
may not be able to enforce against us or our senior management, certain of our board of directors or certain experts named herein (who
are residents of countries other than the United States) any judgments obtained in U.S. courts in civil and commercial matters, including
judgments under the U.S. federal securities laws.
If we are a passive foreign investment
company, there could be adverse U.S. federal income tax consequences to U.S. holders.
Under the Internal Revenue
Code of 1986, as amended, or the Code, we will be a PFIC for any taxable year in which (1) 75% or more of our gross income consists of
passive income or (2) 50% or more of the average quarterly value of our assets consists of assets that produce, or are held for the production
of, passive income. For purposes of these tests, passive income includes dividends, interest, gains from the sale or exchange of investment
property and certain rents and royalties. In addition, for purposes of the above calculations, a non-U.S. corporation that directly or
indirectly owns at least 25% by value of the shares of another corporation is treated as if it held its proportionate share of the assets
and received directly its proportionate share of the income of such other corporation. If we are a PFIC for any taxable year during which
a U.S. Holder (as defined below under "Material Income Tax Considerations-Material U.S. Federal Income Tax Considerations for U.S.
Holders") holds our shares, the U.S. Holder may be subject to adverse tax consequences regardless of whether we continue to qualify
as a PFIC, including ineligibility for any preferred tax rates on capital gains or on actual or deemed dividends, interest charges on
certain taxes treated as deferred, and additional reporting requirements.
We believe that we were a
PFIC for our taxable year ended December 31, 2022 but cannot provide any assurances regarding our PFIC status for any past, current or
future taxable years. The determination of whether we are a PFIC is a fact-intensive determination made on an annual basis applying principles
and methodologies which in some circumstances are unclear and subject to varying interpretation. In particular, the characterization
of our assets as active or passive may depend in part on our current and intended future business plans, which are subject to change.
In addition, for our current and future taxable years, the total value of our assets for PFIC testing purposes may be determined in part
by reference to the market price of our common shares from time to time, which may fluctuate considerably. Under the income test, our
status as a PFIC depends on the composition of our income which will depend on the transactions we enter into in the future and our corporate
structure. The composition of our income and assets may also be affected by how, and how quickly, we spend the cash we raise in any offering.
In certain circumstances,
a U.S. Holder of shares in a PFIC may alleviate some of the adverse tax consequences described above by making a qualified electing fund,
or QEF, election to include in income its pro rata share of the corporation's income on a current basis. However, a U.S. Holder
may make a QEF election with respect to our common shares only if we agree to furnish such U.S. Holder annually with a PFIC annual information
statement as specified in the applicable U.S. Treasury Regulations. We currently do not intend to prepare or provide the information
that would enable U.S. Holders to make a QEF election if we are treated as a PFIC for any taxable year, and prospective investors should
assume that a QEF election will not be available.
For further discussion of
the PFIC rules and the adverse U.S. federal income tax consequences in the event we are classified as a PFIC, see the section of this
report entitled "Material Income Tax Considerations-Material U.S. Federal Income Considerations For U.S. Holders."
We may be unable to use net operating loss
and tax credit carryforwards and certain built-in losses to reduce future tax payments or benefit from favorable U.K. tax legislation.
As a U.K. tax resident trading
entity, we are subject to U.K. corporate taxation. Due to the nature of our business, we have generated losses since inception. As of
December 31, 2022, we had cumulative carryforward tax losses of $60.0 million.  Subject to any relevant restrictions, we expect
these to be available to carry forward and offset against future operating profits. As a company that carries out extensive research and
development activities, we benefit from the U.K. research and development tax credit regime for small and medium-sized companies, whereby
we are able to surrender the trading losses that arise from our qualifying research and development activities for a payable tax credit
of up to 33.35% of eligible research and development expenditures. Qualifying expenditures largely comprise employment costs for research
staff, consumables and certain internal overhead costs incurred as part of research projects. Certain subcontracted qualifying research
expenditures are eligible for a cash rebate of up to 21.67%. The majority of our pipeline research, clinical trials management and manufacturing
development activities are eligible for inclusion within these tax credit cash rebate claims. Our ability to continue to claim payable
research and development tax credits in the future may be limited because we may no longer qualify as a small or medium-sized company.
35
We may benefit in the future
from the United Kingdom's "patent box" regime, which allows certain profits attributable to revenues from patented
products to be taxed at an effective rate of 10%. We are the exclusive licensee or owner of several patent applications which, if issued,
would cover our product candidates, and accordingly, future upfront fees, milestone fees, product revenues and royalties could be taxed
at this tax rate. When taken in combination with the enhanced relief available on our research and development expenditures, we expect
a long-term lower rate of corporation tax to apply to us. If, however, there are unexpected adverse changes to the U.K. research and
development tax credit regime or the "patent box" regime, or for any reason we are unable to qualify for such advantageous
tax legislation, or we are unable to use net operating loss and tax credit
Changes and uncertainties in the tax system
in the countries in which we have operations could materially adversely affect our financial condition and results of operations, and
reduce net returns to our shareholders.
Our tax position could be
adversely impacted by changes in tax rates, tax laws, tax practice, tax treaties or tax regulations or changes in the interpretation
thereof by the tax authorities in the United Kingdom, the United States and other jurisdictions as well as being affected by certain
changes currently proposed by the Organization for Economic Co-operation and Development and their action plan on Base Erosion and Profit
Shifting. Such changes may become more likely as a result of recent economic trends in the jurisdictions in which we operate, particularly
if such trends continue.
Our actual effective tax
rate may vary from our expectation and that variance may be material. A number of factors may increase our future effective tax rates,
including: (1) the jurisdictions in which profits are determined to be earned and taxed; (2) the resolution of issues arising from any
future tax audits with various tax authorities; (3) changes in the valuation of our deferred tax assets and liabilities; (4) increases
in expenses not deductible for tax purposes, including transaction costs and impairments of goodwill in connection with acquisitions;
(5) changes in the taxation of share-based compensation; (6) changes in tax laws or the interpretation of such tax laws, and changes
in generally accepted accounting principles; and (7) challenges to the transfer pricing policies related to our structure.
A tax authority may disagree
with tax positions that we have taken, which could result in increased tax liabilities. For example, Her Majesty's Revenue&
Customs, or HMRC, the U.S. Internal Revenue Service, or IRS, or another tax authority could challenge our allocation of income by tax
jurisdiction and the amounts paid between our affiliated companies pursuant to our intercompany arrangements and transfer pricing policies,
including methodologies for valuing developed technology and amounts paid with respect to our intellectual property development. Similarly,
a tax authority could assert that we are subject to tax in a jurisdiction where we believe we have not established a taxable connection,
often referred to as a "permanent establishment" under international tax treaties, and such an assertion, if successful,
could increase our expected tax liability in one or more jurisdictions.
A tax authority may take
the position that material income tax liabilities, interest and penalties are payable by us, for example where there has been a technical
violation of contradictory laws and regulations that are relatively new and have not been subject to extensive review or interpretation,
in which case we expect that we might contest such assessment. High-profile companies can be particularly vulnerable to aggressive application
of unclear requirements. Many companies must negotiate their tax bills with tax inspectors who may demand higher taxes than applicable
law appears to provide. Contesting such an assessment may be lengthy and costly and if we were unsuccessful in disputing the assessment,
the implications could increase our anticipated effective tax rate, where applicable.
ITEM 4: INFORMATION ON THE COMPANY
A. History and Development of the Company
We were originally incorporated
under the laws of England and Wales on February 11, 1998, with the goal of leveraging the expertise of our management team as well as
Napoleone Ferrara, M.D., Arun Sanyal, M.D., Howard Weiner, M.D. and Kevan Herold, M.D., and to acquire and exploit certain intellectual
property in biotechnology. We subsequently changed our name to Tiziana Life Sciences plc in April 2014 as a result of the acquisition
of Tiziana Pharma Limited in April 2014. On August 20, 2021 we announced that we had formally commenced a strategic plan to change our
corporate structure by establishing Tiziana Life Sciences Ltd, a Bermuda-incorporated company, to become the ultimate parent company of
the Tiziana Group. The reorganization was performed under a scheme of arrangement under Part 26 of the UK Companies Act 2006 and became
effective on October 20, 2021, at which point all shareholders became shareholders in the new Bermuda company.
Our registered office is
located at Clarendon House, 2 Church Street, Hamilton HM 11, Bermuda and our telephone number is +44 20 7495 2379.
The SEC maintains an Internet
site that contains reports, proxy and information statements, and other information regarding issuers, such as we, that file electronically,
with the SEC at www.sec.gov. Our website address is www.tizianalifesciences.com. The reference to our website is an inactive
textual reference only and the information contained in, or that can be accessed through, our website is not a part of this annual report.
Our agent for service of
process in the United States is Tiziana Therapeutics, Inc, 5 Penn Plaza, 19
th
Floor, Suite 1954, New York, NY 10001.
36
B. Business Overview
Overview
We are a biotechnology company
that specializes in the developing transformative therapies for neurodegenerative and lung diseases. Our clinical pipeline includes drug
assets for Secondary Progressive Multiple Sclerosis, ALS. Alzheimer's, Crohn's Disease and KRAS+ NSCLC. Tiziana is led by a team of highly
qualified executives with extensive drug development and commercialization experience.. Our mission is to bring breakthrough therapies
to patients with the aim of treating Secondary Progressive Multiple Sclerosis, ALS, Alzheimer's, and other CNS indications. Crohn's Disease,
lung diseases and optimizing health outcomes.. We are developing transformational formulation technologies, enabling to switch from
traditional routes to alternative routes of immunotherapy to facilitate local site of action. For example, nasal, oral and inhalation
administrations to target neurodegenerative and lung diseases. We believe, if we succeed in these alternative routes of immunotherapies
that has the potential to change the way immunotherapies are currently conducted.
We employ a lean and virtual
research and development, or R&D, model using highly experienced teams of experts for each business function to maximize value accretion
by focusing resources on the drug discovery and development processes.
We are developing Foralumab,
for which we in-licensed the intellectual property from Novimmune SA, or Novimmune, in December 2014, as a potential treatment for neurodegenerative
diseases such as Secondary Progressive Multiple Sclerosis (SPMS), Crohn's disease and delayed onset of Type I Diabetes (T1D). On
November 10, 2022, Tiziana announced a short-term focus on administration of intranasal foralumab for treatment of neurodegenerative diseases,
especially SPMS, based on positive clinical findings of Expanded Access (EA) SPMS patients at Brigham and Women's Hospital treated
with intranasal foralumab for up to 1 year. As the only fully human engineered human anti-CD3 mAb in clinical development, Foralumab has
significant potential advantages such as a shorter treatment duration and reduced immunogenicity. We believe that oral or intranasal administration
of Foralumab has the potential to reduce inflammation while minimizing the toxicity and related side effects. To date, Foralumab has been
studied in one Phase 1 and two Phase 2a clinical trials conducted by Novimmune in 68 patients dosed by the intravenous route of administration.
In these trials, Foralumab was observed to be safe and well-tolerated and produced immunologic effects consistent with potential clinical
benefit while demonstrating mild to moderate infusion related reactions, or IRRs. With completion of the intravenous dosing for Phase
2a trial in Crohn's Disease, Foralumab's ability to modulate T-cell response enables potential extension into a wide range
of other autoimmune and inflammatory diseases, such as Graft versus Host Disease (GvHD), ulcerative colitis (UC), multiple sclerosis(MS),
type-1 diabetes (T1D), inflammatory bowel disease (IBD), psoriasis (PSA) and rheumatoid arthritis (RA).
Foralumab is being developed
as both an immunosuppressive and immunomodulatory agent, with therapeutic benefits of rendering T-cells unable to orchestrate an immune
response and induction of immune tolerance via maintenance of regulatory T-cells. There is further potential for Foralumab to be combined
with the Company's TZLS-501, a fully human anti-IL-6R mAB in development to target autoimmune and inflammatory diseases.
In November 2016, Tiziana
announced new data for oral efficacy in humanized mouse models with Foralumab, a major milestone and a potential breakthrough for the
treatment of NASH and autoimmune disease. This unique oral technology stimulates the natural gut immune system and potentially provides
a therapeutic effect in inflammatory and autoimmune diseases with greatly reduced toxicity. Positive therapeutic effects with Foralumab
were consistently demonstrated in animal studies conducted by Prof. Kevan Herold (Yale University) and Prof. Howard Weiner (Harvard University).
On 16 April, 2018, the Group
entered into an exclusive license agreement with The Brigham and Women's Hospital, Inc. relating to a novel formulation of Foralumab
dosed in a medical device for nasal administration. An investigational new drug application (IND) for the first-in-human evaluation of
the nasal administration of Foralumab in healthy volunteers for progressive multiple sclerosis indication was filed in the second quarter
of 2018. Subsequent to IND approval, a single-site, double-blind, placebo-controlled, dose-ranging Phase 1 trial with nasally administered
Foralumab at 10, 50 and 250 µg per day, consecutively for 5 days to evaluate biomarkers of immunomodulation of clinical responses
was initiated in November 2018. The trial conducted at the Brigham and Women's Hospital, Harvard Medical School, Boston, MA, in
healthy volunteers. 18 subjects received Foralumab treatment and 9 patients received placebo. The study was completed in September 2019.
Phase 1 clinical data demonstrated that nasally administered Foralumab, was well-tolerated and no drug-related safety issues were reported
at any of the doses. No drug-related changes were observed in vital signs among subjects at predose, during treatment and at discharge.
Nasally administered Foralumab at the 50 µg dose suppressed cytotoxic CD8+ as well as perforin-secreting CD8+ cells, which have
been implicated in neurodegeneration in multiple sclerosis (MS). Treatment at 50 µg stimulated production of anti-inflammatory
cytokine IL-10 and suppressed production of pro-inflammatory cytokine IFN-γ. Taken together, the treatment showed significant positive
effects on the biomarkers for activation of mucosal immunity, which are capable of inducing site-targeted immunomodulation to elicit
anti-inflammatory effects. . Systemic levels of Foralumab were below the lower quantitation limit of 8 ng/mL suggesting that nasally
administered Foralumab appears to exert its effects via nasal epithelium utilizing local and lymphatic immune systems directly. These
data support other clinical and pre-clinical studies showing that this route of administration is capable of inducing site-targeted immunomodulation
and anti-inflammatory effects. Furthermore, these pharmacodynamic data point to a clinical dose range that Tiziana intends to test in
further clinical development among MS patients.
37
On September 9, 2019,
the FDA granted approval to initiate the Phase 1 clinical trials to evaluate the safety and pharmacokinetics of a novel enteric-coated
capsule formulation of oral Foralumab at 1.25, 2.5 and 5.0 mg/day as a single ascending dose study. The study was completed in December
2019 at Brigham and Women's Hospital (Boston, MA USA). A total of 12 subjects were enrolled; 9 received the single dose of foralumab
and 3 received placebo. The median age (range) for the oral foralumab subjects was 23 (21 – 55) years, and for the placebo subjects
it was 34 (27 – 51). Of the foralumab subjects, 6 were male and 3 were female. All 3 of the placebo subjects were female. No subjects
discontinued the study. Formulated Foralumab powder blend encapsulated in enteric-coated capsule was well-tolerated at all doses tested
and there were no drug-related safety issues observed even at the highest dose of 5 mg in this trial.
Tiziana initiated a Phase
1b clinical trial in Crohn's disease patients to evaluate oral capsules of foralumab, a fully human anti-CD3 monoclonal antibody.
The revised protocol allowed for the study of a broader patient population and a shorter dosing period. These protocol amendments or
revisions were intended to expedite patient enrollment with study completion targeted for the fourth quarter of 2022. This study
was the first multiple-dose study with orally administered enteric-coated capsules of foralumab in patients with Crohn's disease.
Due to the refocus of the company after the first six months of 2022, this study was withdrawn.
A collaborative clinical
trial was initiated on November 2, 2020 in Brazil investigating nasally administered Foralumab, either alone or in combination
with orally administered dexamethasone ("Dexa") in COVID-19 patients. The clinical study was completed in collaboration with
scientific teams at the Harvard Medical School (Boston, USA), and INTRIALS, a full-service Latin American CRO based in São
Paulo, Brazil. The objectives of the trial were to assess safety of the treatment and to evaluate if progression of the diseases
is delayed with nasally administered 100mcg/day Foralumab (50mcg/nostril). This study enrolled 39 patients randomized in three cohorts:
cohort 1, control with no treatment (n=16); cohort 2; nasally administered Foralumab plus 3 days of priming with orally administered
6 mg Dexamethasone (n=11) and cohort 3; nasally administered Foralumab (n=12). The Foralumab treatment regimen was once a day dosing
for 10 consecutive days. The trial was completed in January 2021. There were no significant differences between cohort 2 and 3. All treatments
were well-tolerated. There were no grade 3 or 4 severe adverse events ("SAEs") in any of the cohorts
.
The CT
scans of the lungs showed the improvement was approximately double that shown in patients treated with Foralumab as compared to those
in the control group.   The results of the study were published in the peer-reviewed journal,
Frontiers in Immunology
entitled
"Nasal Administration of Anti-CD3 Monoclonal Antibody (Foralumab) Reduces Lung Inflammation and Blood Inflammatory Biomarkers in
Mild to Moderate COVID-19 Patients: A Pilot Study" in August 2021. This program has been temporarily paused to pursue the
short term focus on clinical development of intranasal foralumab administration for treatment of SPMS patients.
On September 2, 2021 the
Company and Precision BioSciences Inc announced an exclusive license agreement to explore Foralumab as an agent to induce tolerance of
allogeneic CAR T cells to potentially improve the clinical outcome of CAR T cell therapy. Precision's approach to manufacturing
produces CAR T cells that are virtually CD3-negative. Foralumab will be used as a lymphodepletion or tolerizing agent, either alone or
in combination with other co-stimulatory molecules, to improve the long-term survival of CAR T cells in cancer treatment. Tiziana has
completed manufacturing of foralumab solution for injection to be used by Precision Biosciences.
On
May 25, 2021 the Company announced that the first expanded access (EA) patient with secondary progressive multiple sclerosis (SPMS)
was dosed with nasally administered Foralumab at the Brigham and Women's Hospital (BWH), Harvard Medical School, Boston,
MA. Nasal Foralumab 50 mcg (25 mcg/nostril) was administered in 3-week cycles, with 3 times/week dosing for the first 2 weeks followed
by 1 week of rest period. This first-ever clinical study in SPMS patients, under an Individual Patient Expanded Access IND, was to continue
for six months to evaluate routine safety, tolerability, and neurological behaviors. The study also examined microglial activation, by positron
emission tomography (PET), immunological and neurodegenerative markers to assess clinical responses following the dosing regimen
On
March 10, 2022, the Company reported positive clinical data in the first EA SPMS patient following completion of six months of treatment
with intranasally administered foralumab, at the Brigham and Women's Hospital (BWH), Harvard University, Boston, MA. In
addition to being well-tolerated, both biological and clinical improvements were seen in this patient using Tiziana's novel immunotherapy
technology, which, importantly overcame the challenge of effecting immunomodulation in the brain using nasal administration.
Foralumab
was given to an EA SPMS patient intranasally into each nostril on a regimen of M-W-F for two weeks followed by one week off therapy for
a period of six months. This regimen was well-tolerated with associated beneficial clinical and biomarker changes. Importantly, the PET
imaging data indicated inhibition of microglial cell activation observed at 3 months following treatment initiation and was sustained
at 6 months after treatment start (see Table 1). The reduction in microglial activation was seen in all parts of the brain.
38
Table 1. Percent
Reduction* in Activated Microglial Cells (AMCs) PET Signal After Starting Intranasal Foralumab as Compared to Baseline, in Whole Brain
and Selected Brain Regions
WHOLE
BRAIN
CEREBRAL
CORTEX
THALAMUS
WHITE
MATTER
CEREBELLUM
3 MONTHS
-23
%
-23
%
-20
%
-25
%
-22
%
6 MONTHS
-38
%
-38
%
-50
%
-36
%
-38
%
*
Percent reduction is based
    on changes from baseline in SUVR-1, a surrogate index for PET binding potential. SUVR=Standardized Uptake Value Ratio, calculated
    with reference to a pseudo reference region in cerebral white matter that showed minimal change in PET SUV, across time points.
Consistent with clinical
and PET observations, intranasally administered foralumab also downregulated serum levels of pro-inflammatory cytokines, including interferon-gamma
(IFN-g), interleukin (IL-18), IL-1β and IL-6, which are associated with multiple sclerosis pathogenesis and progression. Clinical
evaluation showed improvement in Timed 25-Foot Walk Test (T25FW), 9-Hole Peg Test (9HPT) and Symbol Digit Modality Test (SDMT).
Other published PET studies have shown an increase in activated microglial cells (AMCs) in patients with secondary progressive MS (SPMS),
and the increase in AMCs associated with higher scores on the Expanded Disability Status Scale (EDSS), a widely-used scale to measure
disability
1,2
. Several FDA-approved drugs, such as TYSABRI
®
, MAYZENT
®
and ZEPOSIA
®
have
been shown to suppress microglial activation and exert neuroprotective effects in the central nervous system (CNS) in animal studies
but longitudinal assessment of drug effects on microglial activation in exclusive cohorts of SPMS patients are lacking.
Prior to treatment, this
patient had continued to experience worsening disease progression despite several MS therapies, including B cell depletion. The patient's
gait and limb strength had been deteriorating over the prior two years. The patient then started on intranasal foralumab, which stabilized
his disease course. Tiziana also received FDA authorization to continue treating this patient for an additional 6 months to determine
if 12 months of consistent treatment maintains clinical stabilization and provides sustained clinical benefits.
On January 20, 2022, FDA
approved enrollment of a second EA SPMS patient for treatment with intranasal foralumab.
These data were presented
in a virtual Key Opinion Leader (KOL) event hosted by Tiziana on March 14
th
, 2022, entitled "Foralumab Clinical
Update in Multiple Sclerosis; A Landmark Study with Intranasal Immunotherapy" featuring four Key Opinion Leaders and a live Q&A
session. The company plans to continue treatment of EA SPMS patients at Brigham and Women's Hospital and elsewhere and continue
evaluation of foralumab treatment.
On April 5, 2022, Tiziana
announced that FDA granted permission to enroll up to eight additional (SPMS) patients in the Intermediate Size Patient Population EAP
with intranasal foralumab. As part of the original treatment plan, the foralumab dose will remain 50 mcg three times a week (MWF), which
is the same dose administered previously to the first two SPMS patients. The dosing regimen in this IND also has a provision for dose
escalation up to 100 mcg three times a week (MWF) as an option to improve clinical benefit, if needed.
Data from a Secondary Progressive
Multiple Sclerosis patient treated with intranasal foralumab were presented on June 2, 2022 at the consortium of multiple sclerosis
centers (CMSC) 2022 annual meeting. Dr. Tanuja Chitnis, MD, Professor of Neurology and the Principal investigator of the clinical
study at the at the Brigham and Women's Hospital (BWH), Boston, MA., presented a poster discussing clinical data from a patient
with SPMS, who was treated with intranasal foralumab for six months.
On June 8, 2022, Tiziana
announced positive clinical results for the second patient (EA2) in the non-active SPMS Expanded Access (EA) Program following three
months of dosing with intranasal foralumab. These results confirm the previously reported data, from the first non-active SPMS patient
(EA1) that after three months of treatment, intranasal foralumab. was well-tolerated and improved clinical and PET imaging analyses.
The second patient was diagnosed with SPMS in 2014. Since then, the disease has been progressive, resulting in an accumulation of disability.
Patient EA2 started ocrelizumab in 2018 and stopped this treatment in 2021. During this time EA2's non-active SPMS progressed as
measured by EDSS worsening from 3.5 in 2018 to 6.0 in 2021. At this point in time EA2 needed a cane to walk 100 meters. Patient EA2 was
subsequently enrolled in the intranasal foralumab expanded access program. On September 2022, 8 months after starting treatment
with intranasal foralumab, EA2 was able to walk 100 meters without a cane or need to rest. This improved the EDSS from 6.0 to 5.5. EA2's
pyramidal score remained stable during this time. In December 2022, 11 months after starting treatment with intranasal foralumab,
EA2 was able to walk 200 meters without a cane or need to rest, resulting in further improvement in EDSS from 5.5 to 5.0. EA2's
pyramidal score continued to remain stable. Lastly preliminary reading of EA2's 11-month PET Scan (December 2022) demonstrated
improvement in microglial activation over baseline.
39
On September 20, 2022,
Tiziana announced that the second patient ("EA2") with non-active secondary progressive multiple sclerosis (SPMS) receiving
intranasal foralumab had shown additional clinical improvements as measured by the Expanded Disability Status Scale (EDSS), a standard
clinical assessment.
On October 12, 2022, Tiziana
announced that it planned to submit an Investigational New Drug Application (IND) for a Phase 1 Trial of intranasal foralumab in Alzheimer's
disease patients after receiving an affirmative written response from the FDA on a Pre-Investigational New Drug Application (PIND). Tiziana
plans on filing the IND for Alzheimer's disease by the third quarter of 2023 upon the completion of requested toxicology studies,
then starting its Phase 1 program by the end of 2023.
On November 2, 2022,
Tiziana announced the completion of enrollment of the first patient cohort in its Intermediate Size Patient Population Expanded Access
Program to evaluate foralumab in non-active SPMS patients.
On November 10, 2022,
Tiziana announced its near-term focus on developing intranasal foralumab for inflammatory diseases of the Central Nervous System (CNS)
such as non-active SPMS, Alzheimer's disease and amyotrophic lateral sclerosis (ALS).
During 2022, Tiziana completed
compatibility, stability and characterization studies of foralumab nasal solution in unit dose devices for nasal administration.
We are evaluating administrations
of Foralumab to delay onset and progression of T1D in at-risk individuals. T1D is characterized as a chronic and progressive autoimmune
disease leading to the destruction of insulin-producing β-cells of the pancreas. Teplizumab (Provention Bio), a humanized Fc-mutated
anti-CD3 monoclonal antibody that alters the function of the T-lymphocytes that mediate the destruction of the insulin-producing β-cell
is seeking FDA approval. The Company believes that Foralumab, a fully human anti-CD3 mAb, would have a better safety profile and clinical
benefit than Teplizumab based on Foralumab's fully human protein sequence and binding affinity for CD3e compared to Teplizumab.
cGMP manufacturing of Foralumab solution for subcutaneous injection was initiated in April 2022 and IND submission is anticipated in 2023.
This program has been temporarily paused to pursue the short-term focus on clinical development of intranasal foralumab administration
for treatment of SPMS patients.
In 2022, Tiziana initiated
five Good Laboratory Practice (GLP) safety toxicology studies of foralumab administered intranasally and subcutaneously in HuGEMM CD3
transgenic mice. The five studies consisted of three intranasal toxicology studies of 14 days, 13 weeks and 26 weeks dosing duration
and two subcutaneous safety toxicology studies of 14 days and 28 days dosing duration. On December 15, 2022 the Company announced
that it had successfully completed the 13-week toxicology trial and that intranasal foralumab was well-tolerated.
In addition, on August 18,
2020 the United States Patent and Trademark Office, or USPTO, granted us a patent on use and methods of treatment of Crohn's disease
with Foralumab, its proprietary fully human monoclonal antibody, and all other anti-CD3 mAbs. The CD3 (cluster of differentiation
3) is a protein complex on T-cells, which is important for the regulation of the immune system. The patent was published by the USPTO
on September 1, 2020 as Patent No. 10,759,858. Recently, we also announced the issuance of the first-ever patent on oral administration
of anti-CD3 mAbs for treatment of human diseases (Patent No. 10,688,186). We believe the grant of this additional composition-of-matter
and use patent further strengthens our intellectual property, consisting of proprietary technologies on oral and nasal administration
of Foralumab and other anti-CD3 mAbs for the treatment of human diseases.
40
On July 16, 2020, we announced
that we had submitted a patent application on the potential use of Foralumab, a fully human anti-CD3 mAbs, to improve success of chimeric
antigen receptor T-cell, or CAR-T, therapy for cancer and other human diseases. The patent application conveys inventions related lymphodepletion
to improving CAR-T expansion and/or survival using anti-CD-3 mAbs administered either alone or in combination with other co-stimulatory
molecules, such as an anti-IL-6R mAb, an anti-CD28 mAb or specific inhibitors of signaling pathways of phosphatidylinositol 3-kinase
(PI3K), protein kinase B (AKT), or mammalian target of rapamycin (mTOR).
On July 31, 2020, we announced
that we had submitted a patent application for the potential use of nasally administered Foralumab, a fully human anti-CD3 mAb, for the
treatment of COVID-19 either alone or in combination with other anti-viral drugs. Recent clinical studies implied that a combination
of anti-inflammatory and anti-viral drugs may be more effective to treat patients at different stages of COVID-19 disease.
We are accelerating development
of a fully human mAb targeting the IL-6R (TZLS-501) for which the intellectual property was licensed from Novimmune in January 2017.
This fully human mAb has a novel mechanism of action, binding to both the membrane-bound and soluble forms of the IL-6R as well as depleting
circulating levels of the IL-6 in the blood. Excessive production of IL-6 is regarded as a key driver of acute inflammation resulting
from infection with viral agents such as Coronaviruses and of chronic inflammation, associated with autoimmune diseases such as multiple
myeloma, oncology indications and rheumatoid arthritis, and we believe that TZLS-501 may have potential therapeutic value for these indications.
In preclinical studies, TZLS-501
demonstrated the potential for overcoming the limitations of other IL-6 blocking pathway drugs. Compared to tocilizumab and sarilumab,
while binding to the membrane-bound IL-6R complex, TZLS-501 has been observed to have a higher affinity for the soluble IL-6 receptor
from antibody binding studies conducted in cell culture. TZLS-501 also demonstrated the potential to block or reduce IL-6 signaling in
mouse models of inflammation. The soluble form of IL-6 has been implicated to have a larger role in disease progression compared to the
membrane- bound form (Kallen, K.J. (2002). "The role of trans-signaling via the agonistic soluble IL-6 receptor in human diseases."
Biochimica et Biophysica Acta. 1592 (3): 323–343.)
The Company is advancing development
of TZLS-501 for treatment of Interstitial lung disease associated with systemic sclerosis (SSc-ILD). Tocilizumab (Actemra®, Roche)
a humanized interleukin-6 (IL-6) receptor mAb antagonist. was approved by the FDA as a subcutaneous injection for slowing the rate of
decline in pulmonary function in adult patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD), a debilitating
condition with limited treatment options. Actemra® is the first biologic therapy approved by the FDA for the treatment of the disease.
On April 9, 2020 The Company
announced that it had developed investigational new technology to treat COVID-19 infections, consisting of direct delivery of anti-IL-6
receptor (anti-IL-6R) monoclonal antibodies (mAbs) into the lungs using a handheld inhaler or nebulizer for treatment of patients infected
with COVID-19 (SARS-CoV-2) coronavirus. On June 29, 2020 the Company announced that it was advancing GMP manufacturing of TZLS-501
with STC Biologics concurrently with the development of inhalation technology using a hand-held nebulizer with Sciarra Laboratories and
safety toxicology studies in Cynomolgus monkeys with ITR Canada Laboratories. GMP batches were initiated in January 2021 and completed
in March 2021. Safety inhalation toxicology studies were initiated in November 2020 and completed in March 2021. Technological assessment
of nebulizers for inhalation treatment of patients was initiated in September 2020 and completed in February 2021. An additional 240L
cGMP batch of TZLS-501 drug substance was manufactured using an improved downstream process to support future development activities.
An IND for a Phase 1 Clinical Trial in Healthy Subjects for treatment of interstitial lung disease associated with systemic sclerosis
(SSc ILD) was filed in December 2021. This program has been temporarily paused to pursue the Company's short term focus on clinical
development of intranasal foralumab administration for treatment of SPMS patients.
We are developing Milciclib,
for which we in-licensed the intellectual property from Nerviano Medical Sciences S.r.l., or Nerviano, in January 2015, as a potential
treatment for pan KRAS mutations in NSCLC patients.
To date, Milciclib has been
studied in a total of eight completed Phase 1 and 2 clinical trials in 316 patients. In these trials, Milciclib was observed to be well-tolerated
and showed initial signals of anti-tumor action. Prior to in-licensing, Milciclib was granted orphan designation by the European Commission
and by the U.S. Food and Drug Administration ("FDA") for the treatment of malignant thymoma and an aggressive form of thymic
carcinoma in patients previously treated with chemotherapy. In two Phase 2a trials, CDKO-125a-006 and CDKO125a-007, Milciclib showed
signs of slowing disease progression and acceptable safety.
41
In the first half of 2017,
the Group initiated a Phase 2a trial (CDKO-125a-010) of Milciclib to explore safety, tolerability and antitumor activity of milciclib
as a single therapy in Sorafenib-resistant patients with unresectable or metastatic HCC and good liver function.. Typically, this population
of patients have an advanced form of the disease with poor prognosis and an average overall survival expectancy of 3-5 months. The compound
was administered as home-based treatment at the dose of 100 mg/day for 4 consecutive days a week in a 4-week cycle (4 days on/3 days
off x q4 wks) for a total of 24 weeks.
The Phase 2a trial was completed
in June 2019 with clinical safety result reported in July 2019 and efficacy results reported in September 2019.
Since overexpression of CDKs
and dysregulation in pRB pathway (regulates transcription factors critical for cell cycle progression) are prominently associated with
tumor cell resistance to certain chemotherapeutic drugs, inhibition of multiple CDKs is an appealing approach to improve clinical responses
in cancer patient's refractory to existing treatment options. A Phase 1 dose-escalation study of Milciclib in combination
with gemcitabine in patients with refractory solid tumors exhibited clinical activity in patients including those refractory to gemcitabine.
Milciclib shows inhibitory effects against multiple cell lines with mutationally active G12D (non-small cell lung carcinoma), G13D (colorectal
cancer), G12V(pancreatic cancer), and G12C (pancreatic cancer
The Company also intends to evaluate milciclib in combination
with gemcitabine for treatment of pan KRAS mutations in NSCLC patients. cGMP manufacturing of milciclib capsules was completed in January
2022 and IND filing was completed on December 15, 2022. This program has been temporarily paused to pursue the short-term focus on clinical
development of intranasal foralumab administration for treatment of SPMS patients.
Our Competitive Strengths
Our mission is to design
and deliver next generation therapeutics and diagnostics for oncology and immune diseases of high unmet medical need by combining deep
understanding of disease biology with clinical development expertise. We believe the following strengths will allow us to continue to
pursue this mission:
●
Advanced, novel pipeline
.
    We have an advanced pipeline of novel and proprietary drug candidates, including antibodies and small molecules, to address high
    unmet medical needs in the inflammation, autoimmune and oncology markets with significant commercial potential.
●
Proprietary technology
.
    Our proprietary technology enables the development of alternative routes of administration of antibodies, including oral delivery.
    We believe that oral and nasal routes of delivery will alleviate the significant time and cost burden associated with other routes
    of administration, including intravenous delivery.
●
Broad and engaged
    network of experts.
Our strong relationships with key opinion leaders contribute to our clinical development efforts and
    position us well to support our products, if approved. Dr. Napoleone Ferrara, Dr. Arun Sanyal, Dr. Kevan Herold, and Dr. Howard Weiner
    are among   the thought leaders on our scientific advisory committee.
●
Specialized expertise
    and focus on oncology and inflammation
. Our management team, including Dr. Matthew Davis, Jules Jacob, and Dr. Vaseem Palejwala,
    has considerable experience translating technologies from bench to market, and managing the global administration of clinical trials.
●
Strong intellectual
    property and know-how
. We believe our proprietary intellectual property portfolio, in-licensed from Nerviano and Novimmune,
    provides us with a substantial competitive advantage for the commercial development of small molecule NCEs, and biologics, as well
    as expanded possibilities for new development programs in the future. We have retained the worldwide development and commercialization
    rights to all of our product candidates. We have submitted additional patent applications to further strengthen our intellectual
    property.
●
Lean research and
    development model, designed to maximize value
. We employ a lean and virtual R&D model using highly experienced teams
    of experts for each business function to maximize value accretion by focusing resources on the drug discovery and development processes.
42
Our Strategy
Our goal is to become a leading
biotechnology company focused on developing and delivering therapies and related diagnostics in both oncology and immunology. The key
elements of our strategy to achieve this goal are to:
●
Advance the clinical development of intranasally-administered
Foralumab for treatment of neurodegenerative diseases, particularly SPMS, and potentially including Alzheimer's Disease, ALS and
intracerebral hemorrhage (hemorrhagic stroke). Tiziana will continue to supply foralumab for intranasal treatment of up to 10 EA patients
at Brigham and Women's Hospital and plans to initiate a multisite Phase 2 trial for treatment of SPMS patients in Q3 2023.
The following programs have been paused temporarily to focus Tiziana's
clinical development efforts on intranasal foralumab for treatment of SPMS and other neurodegenerative disease.
●
Development of our product
candidate, TZLS-501, a fully human mAb targeting the IL-6 receptor (a biological mAb which may control the proteins involved in cell
signaling relevant to many inflammatory diseases and cancers), for treatment of inflammatory and oncology indications especially SSc-ILD.
Additional cGMP manufacturing and IND-enabling GLP safety toxicology studies in Cynomolgus monkeys, have been completed evaluation/qualification
of hand-held nebulizers for pulmonary administration of TZLS-501 for SSc-ILD treatment have been completed
●
Clinical
                                            development and obtain regulatory approval for our lead oncology product candidate, Milciclib,
                                            as a combination therapy for the treatment of refractory solid tumors (being cancers which
                                            are non-responsive or become resistant to treatment), especially NSCLC. An IND was filed
                                            on December 15, 2022.
The following activities
will continue to be pursued aggressively:
●
Continue development of platform drug delivery technologies that provide competitive advantage over existing approved products, e.g. inhalation delivery, nasal delivery and enteric delivery of mAbs.
●
Continue relationship with Precision Biosciences to improve CAR-T therapy using foralumab immunomodulation to enhance survival of CAR-T cells
●
Continue to leverage relationships
    with key opinion leaders to promote clinical trial success and enhance future commercialization.
●
Opportunistically identify
    and acquire or in-license complimentary product and technology candidates.
●
Seek orphan drug, fast
    track or breakthrough designation for our product candidates where warranted.
Our Product Candidates
Our product candidate pipeline
is set forth below:
DEVELOPMENT PIPELINE
43
Foralumab (TZLS-401 formerly known as NI-0401)
We believe Foralumab is
the only fully human anti-CD3 mAb in clinical development, in contrast to the previous non-human or humanized anti-CD3 mAbs.
Foralumab targets the CD3 epsilon (CD3ε) receptor, which is a recognized approach for modulating T-Cell response and
achieving immunosuppression. We believe Foralumab could have broad application to autoimmune and inflammatory diseases, such as
inflammatory bowel disease such as MS, Crohn's disease type-1 diabetes (T1D) psoriasis and rheumatoid arthritis, where
modulation of a T-cell response is desirable. In July 2017, we announced publication of a research article in, Clinical Immunology,
entitled: "Oral treatment with Foralumab, a fully human anti-CD3 mAb, prevents skin xenograft rejection in humanized
mice." We believe this is the first-ever published report demonstrating the potential of oral therapy with Foralumab for
inflammatory diseases and is based on the landmark discovery by Prof. Howard Weiner of Harvard University, one of our Scientific
Advisory Committee members.
On April 16, 2018, the Group
entered into an exclusive license agreement with The Brigham and Women's Hospital, Inc. relating to a novel formulation of Foralumab
dosed in a medical device for nasal administration. An investigational new drug application (IND) for the first-in-human evaluation of
the nasal administration of Foralumab in healthy volunteers for progressive multiple sclerosis indication was filed in the second quarter
of 2018. Subsequent to IND approval, a single-site, double-blind, placebo-controlled, dose-ranging Phase 1 trial with nasally administered
Foralumab at 10, 50 and 250 µg per day, consecutively for 5 days to evaluate biomarkers of immunomodulation of clinical responses
was initiated in November 2018. The trial conducted at the Brigham and Women's Hospital, Harvard Medical School, Boston, MA, in
healthy volunteers. 18 subjects received Foralumab treatment and 9 patients received placebo. The study was completed in September 2019.
Phase 1 clinical data demonstrated that nasally administered Foralumab, was well-tolerated and no drug-related safety issues were reported
at any of the doses. No drug-related changes were observed in vital signs among subjects at predose, during treatment and at discharge.
The mean blood pressure (BP) during the 5 days of treatment were; Cohort A (10 µg/d):124/73, Cohort B (50 µg/d): 119/67 and
Cohort C (250 µg/d):113/65 compared to placebo:118/67). Heart rates, respiratory rates and oral temperatures were unchanged among
the 3 cohorts compared to the placebo. Nasally administered Foralumab at the 50 µg dose suppressed cytotoxic CD8+ as well as perforin
secreting CD8+ cells, which have been implicated in neurodegeneration in multiple sclerosis (MS). Treatment at 50 mg stimulated production
of anti-inflammatory cytokine IL-10 and suppressed production of pro-inflammatory cytokine IFN-γ. Taken together, the treatment
showed significant positive effects on the biomarkers for activation of mucosal immunity, which are capable of inducing site-targeted
immunomodulation to elicit anti-inflammatory effects. Based on the results we intend to conduct a Phase 2 trial in secondary progressive
MS (SPMS) patients starting in Q3 2023.
An enteric-coated capsule
formulation using a proprietary and novel technology has been developed for oral administration of Foralumab. cGMP manufacturing of clinical
trial materials for a Phase 1 study has been completed and an IND was submitted in March 2019.
On September 9, 2019,
the FDA granted approval to initiate the Phase 1 clinical trial to evaluate the safety and pharmacokinetics of a novel enteric-coated
capsule formulation of oral Foralumab at 1.25, 2.5 and 5.0 mg/day as a single ascending dose study. The study was completed in December
2019 at Brigham and Women's Hospital (Boston, MA USA). A total of 12 subjects were enrolled; 9 received the single dose of foralumab
and 3 received placebo. The median age (range) for the oral foralumab subjects was 23 (21 – 55) years, and for the placebo subjects
it was 34 (27 – 51). Of the foralumab subjects, 6 were male and 3 were female. All 3 of the placebo subjects were female. No subjects
discontinued the study. Formulated Foralumab powder blend encapsulated in enteric-coated capsules was well-tolerated at all doses tested
and there were no drug-related safety issues observed even at the highest dose of 5 mg in this trial.
Tiziana initiated a Phase
1b clinical trial in Crohn's disease patients to evaluate oral capsules of foralumab, a fully human anti-CD3 monoclonal antibody.
The revised protocol allowed for the study of a broader patient population and a shorter dosing period. These protocol amendments or
revisions were intended to expedite patient enrollment with study completion targeted for the fourth quarter of 2022. This study
was to be the first multiple-dose study with orally administered enteric-coated capsules of foralumab in patients with Crohn's
disease. Due to the refocus of the company subsequent to the first six months of 2022, this study has been withdrawn to focus
on nasal administration studies for SPMS indication
A collaborative clinical
study was initiated on November 2, 2020, investigating nasally administered Foralumab either alone or in combination with orally administered
dexamethasone in COVID-19 patients in Brazil. In view of the importance and urgency, scientific teams at the Harvard Medical School,
Santa Casa de Misericórdia de Santos Hospital (Jabaquara, Santos, Brazil) and at our company closely collaborated to facilitate
initiation of this study in expedited time frames. The clinical trial was coordinated by the team at INTRIALS, a leading, full-service
Latin America Clinical Research Organization, (CRO) based in Sao Paulo City, Brazil. The trial was completed in January 2021. This trial,
the first-ever trial on nasal administration of Foralumab for treatment of COVID-19, is of enormous significance because the underlying
scientific approach is to modulate immune system, which is dysregulated and crippled to protect against the virus The results of the
trial were All treatments were well-tolerated. There were no grade 3 or 4 severe adverse events ("SAEs") in any of the cohorts
.
The
CT scans of the lungs showed the improvement was approximately double that shown in patients treated with Foralumab as compared to those
in the control group.   The results of the study were published in the peer-reviewed journal,
Frontiers in Immunology
entitled
"Nasal Administration of Anti-CD3 Monoclonal Antibody (Foralumab) Reduces Lung Inflammation and Blood Inflammatory Biomarkers in Mild
to Moderate COVID-19 Patients: A Pilot Study" in August 2021. The study served as "proof of concept" that nasal
administration of foralumab could be used to treat systemic inflammatory response related to COVID infection and could be used for treatment
of other systemic inflammatory diseases. The Company has refocused development of Foralumab for treatment of Crohn's disease (oral
treatment) and progressive MS (nasal treatment) utilizing site specific delivery technologies to limit systemic exposure of foralumab
which achieving local delivery to inflamed tissue. Further development has been paused because of the Company's refocus on administration
of nasal foralumab for SPMS and other neurodegenerative diseases.
44
Multiple Sclerosis
MS is an inflammatory-mediated
demyelinating disease of the human central nervous system. The disease develops in young adults with a complex predisposing genetic trait
and most likely involves an environmental insult such as a viral infection to trigger the disease. The activation of CD4+ autoreactive
T cells and their differentiation are crucial initial steps in the progression of this disease. The therapeutic use of monoclonal antibodies
was initially viewed with great skepticism owing to the high rates of sensitization against mouse proteins, their pharmacokinetic properties,
and the difficulties in their production. However, most of these problems have been overcome, and monoclonal antibodies are now among
the most promising therapies for MS.
The innate immune system
plays a central role in the chronic central nervous system inflammation that drives neurological disability in progressive forms of multiple
sclerosis, for which there are few effective treatments. The mucosal immune system is a unique tolerogenic organ that provides a physiological
approach for the induction of regulatory T cells. Nasal administration of CD3-specific antibody ameliorates disease in a progressive
animal model of multiple sclerosis. This effect is IL-10-dependent and is mediated by the induction of regulatory T cells that share
a similar transcriptional profile to Tr1 regulatory cells and that suppress the astrocyte inflammatory transcriptional program. Treatment
results in an attenuated inflammatory milieu in the central nervous system decreased microglia activation, reduced recruitment of peripheral
monocytes, stabilization of the blood-brain barrier, less neurodegeneration, and decreased accumulation of neurologic disability (Mayo, 2016).
Patients with non-active secondary progressive MS, demonstrate increased microglial activation that drives disease progression. These
nonclinical findings suggest foralumab may be a new therapeutic approach for the treatment of progressive forms of multiple sclerosis.
Based on this work, we hypothesize that nasal foralumab will slow disability accumulation and microglial activation measured by PET imaging
in non-active secondary progressive multiple sclerosis. Two patients with non-active SPMS have been treated for 12 or more months with
a suggestion of clinical improvement and no clinically significant adverse events.
Binding of foralumab to the
T-cell receptor complex, through the nasal, results in suppression of effector T-cells involved in various inflammatory and autoimmune
diseases along with a reduction in inflammatory cytokines and increase in Tregs anti inflammatory cytokines resulting in site-targeted
immunomodulation.
45
Autoimmune and Inflammatory Diseases
Autoimmune diseases are primarily
due to a malfunction when the immune system attacks certain cells in the body as foreign invaders. This can result in irreparable damage
to critical organs and tissues eventually resulting in autoimmune diseases.
In humans, CD3-epsilon is
encoded by the CD3ε gene on Chromosome 11. The CD3ε molecule, along with four other membrane-bound polypeptides (CD3-gamma,
-delta, -zeta, and -eta) form the CD3 complex, which is associated with the T-cell receptor. Upon antigen bindings, the CD3 complex sends
signals through the cell membrane to the cytoplasm inside the T-cell. This leads to activation of the T-cell that rapidly divides to
produce new T-cells sensitized to fight the particular antigen to which the TCR was exposed. While T-cell activation is critical for
the human immune system to properly fight bacterial, viral or parasitic infections, abnormal T-cell induction can cause and worsen numerous
human diseases, including T-cell lymphoma and leukemia, human malignancies, autoimmune disorders, cardiovascular disease and transplant
rejection.
Our Solution
We believe Foralumab is the
only fully human anti-CD3 mAb in clinical development. Since the discovery of the hybridoma technology, a method to generate large quantities
of a single (monoclonal) antibody, the production and manufacture of mAbs has become widely available showing promise in several autoimmune
and inflammatory disease clinical trials and therapeutic utility in animal models. The first murine anti-CD3 mAb (IgG2a) was developed
and approved by the FDA in 1985 under the name of muromonab, OKT3, (Ortho Kung T3; Orthoclone®) to treat allograft rejection in kidney,
liver and heart transplantation by exerting its potent immunosuppressive effects, mainly due to depletion of T-cells in tissues and thereby
preventing rejection of the allografts. Subsequently, OKT3 was administered in clinical trials to patients with MS, T1D, inflammatory
bowel disease, rheumatoid arthritis and NASH. Although showing promise to alleviate the disease process, the mAb being of murine origin
and extremely immunogenic in humans, was associated with a wide range of side effects that included the typical Cytokine Release Syndrome
(CRS) or flu-like syndrome, limiting its clinical development. The side effect profile of OKT3 is a consequence of T-cell activation
resulting in the release of numerous cytokines into the systemic circulation. These shortcomings of the murine OKT3 led to the development
of a new generation of anti-CD3 mAbs using genetic engineering of the mAb structure, as depicted below.
Foralumab dosed intravenously
has been observed to alter T-cell function via antigenic modulation, that is, removal of the CD3/TCR complex from the T-cell surface.
Modulation has two therapeutic benefits:
●
It transiently renders
    the T-cells incapable of recognizing an antigen and thus unable to orchestrate an immune response such as an allograft rejection;
    and
●
It has a favorable long-term
    effect on generation and maintenance of regulatory T-cells, a specialized subset of T-cells that promote immunological tolerance.
46
In comparison with the two
other anti-CD3 mAbs evaluated in patients with T1D (otelixizumab and teplizumab), Foralumab, being fully human, was less mitogenic (capable
of causing cell division), therefore allowing re-treatment, and to have a better risk/benefit profile. As such, Foralumab was previously
developed by Novimmune as an intravenous formulation for the treatment of autoimmune indications: Crohn's disease and in renal
allograft recipients.
Further, recent data from
studies conducted in the laboratories of our Scientific Advisory Committee members, Prof. Howard Weiner of Harvard University and Prof.
Kevan Herold of Yale University, suggest that oral administration of Foralumab has the potential for therapeutic utility while minimizing
toxicity associated with intravenous administration, such as Cytokine Release Syndrome (CRS). Importantly, recent clinical studies conducted
by Prof. Yaron Ilan with oral administration of anti-CD3 (OKT3; murine mAb) in HCV infected patients (non-respondents) and in NASH patients
suggested that the treatment was well-tolerated and produced immunologic effects consistent with potential clinical benefits.
In addition, increasing appreciation
for the gut-liver cross-talk and of its role in the initiation of NASH-associated inflammation and fibrogenesis has led to the understanding
that systemic inflammatory processes can be alleviated by modulating the gut immune system, without inducing generalized immunosuppression.
This has been achieved in multiple approaches, including oral administration of fatty liver-derived proteins, anti-CD3 antibodies, TNF,
fusion protein, anti-lipopolysaccharide antibodies, glucosylceramide, delayed-release mercaptopurine and soy-derived extracts. Several
of these compounds were shown to be effective in patients with NASH.
Orally administered OKT3
was evaluated in a Phase 2 trial in 36 patients with NASH and type 2 diabetes and was found to be well tolerated. Increases in regulatory
T-cell markers consistent with induction of regulatory T-cells was observed as well as increases in other anti-inflammatory markers.
Although not powered sufficiently to evaluate efficacy endpoints, positive trends were observed including lowering of liver enzymes and
lowering of glucose levels (Lalazar et.al, J. Clin. Immunol. (2015) 34 (4):399-407).
More recent animal studies
conducted separately by Prof. Howard Weiner and Prof. Kevan Herold demonstrated therapeutic utility of orally administered Foralumab
for immune-inflammatory diseases. Our strategy is to build on these findings to develop orally administered Foralumab for the treatment
of Crohn's disease and other autoimmune diseases. We believe Foralumab may also be combined with our other product candidate, TZLS-501,
a fully human anti-IL-6R mAb, for the treatment of rheumatoid arthritis and other diseases.
On April 16, 2018, the Group
entered into an exclusive license agreement with The Brigham and Women's Hospital, Inc. relating to a novel formulation of Foralumab
dosed in a medical device for nasal administration. An investigational new drug application (IND) for the first-in-human evaluation of
the nasal administration of Foralumab in healthy volunteers for progressive multiple sclerosis indication was filed in the second quarter
of 2018. Subsequent to IND approval, a single-site, double-blind, placebo-controlled, dose-ranging Phase 1 trial with nasally administered
Foralumab at 10, 50 and 250 µg per day, consecutively for 5 days to evaluate biomarkers of immunomodulation of clinical responses
was initiated in November 2018. The trial conducted at the Brigham and Women's Hospital, Harvard Medical School, Boston, MA, in
healthy volunteers. 18 subjects received Foralumab treatment and 9 patients received placebo. The study was completed in September 2019.
Phase 1 clinical data demonstrated that nasally administered Foralumab, was well-tolerated and no drug-related safety issues were reported
at any of the doses. No drug-related changes were observed in vital signs among subjects at Predose, during treatment and at discharge.
The mean blood pressure (BP) during the 5 days of treatment were; Cohort A (10 µg/d):124/73, Cohort B (50 µg/d): 119/67 and
Cohort C (250 µg/d):113/65 compared to placebo:118/67). Heart rates, respiratory rates and oral temperatures were unchanged among
the 3 cohorts compared to the placebo. Nasally administered Foralumab at the 50µg dose suppressed cytotoxic CD8+ as well as perforin
secreting CD8+ cells, which have been implicated in neurodegeneration in multiple sclerosis (MS). Treatment at 50 µg stimulated
production of anti-inflammatory cytokine IL-10 and suppressed production of pro-inflammatory cytokine IFN-γ. Taken together, the
treatment showed significant positive effects on the biomarkers for activation of mucosal immunity, which are capable of inducing site-targeted
immunomodulation to elicit anti-inflammatory effects.
An enteric-coated capsule
formulation using a proprietary and novel technology has been developed for oral administration of Foralumab. cGMP manufacturing of clinical
trial materials for a Phase 1 study has been completed and an IND was submitted in March 2019.
47
On September 9, 2019,
the FDA granted approval to initiate the Phase I clinical trials to evaluate the safety and pharmacokinetics of oral Foralumab at 1.25,
2.5 and 5.0 mg/day as a single ascending dose study. The study was completed in December 2019 at Brigham and Women's Hospital (Boston,
MA USA). Formulated Foralumab powder blend encapsulated in enteric-coated capsule was well-tolerated at all doses tested and there were
no drug-related safety issues observed even at the highest dose of 5 mg in this trial.
Tiziana initiated a Phase
1b clinical trial in Crohn's disease patients to evaluate oral capsules of foralumab, a fully human anti-CD3 monoclonal antibody.
The revised protocol allowed for the study of a broader patient population and a shorter dosing period. These protocol amendments or
revisions were intended to expedite patient enrollment with study completion targeted for the fourth quarter of 2022. This study
was the first multiple-dose study with orally administered enteric-coated capsules of foralumab in patients with Crohn's disease.
Due to the refocus of the company subsequent to the first six months of 2022, this study has been withdrawn.
Clinical Development Plan
Phase 1a Clinical
Trial for Oral Foralumab in Healthy Volunteers
This Phase 1a trial, conducted
at the Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA, was a single-site, double-blind, placebo-controlled,
single ascending dose ("SAD") study in healthy subjects in which Foralumab was orally administered at 1.25, 2.5 and 5.0 mg
per dose as enteric-coated capsules. The primary endpoint of the Phase 1 study is safety and tolerability of Foralumab in humans. Each
cohort comprised of 4 subjects, of whom 3 received Foralumab treatment and 1 received a placebo capsule. All subjects completed the trial
without any safety concerns at any of the doses.
Phase 1 Clinical
Trial of Nasally-Administered Foralumab for Treatment of Secondary Progressive Multiple Sclerosis
This Phase 1 trial, conducted
at the Brigham and Women's Hospital, Harvard Medical School, Boston, MA, was a single-site, double-blind, placebo-controlled, dose-ranging
study with nasally administered Foralumab at 10, 50 and 250 µg per day, consecutively for 5 days in healthy volunteers for the
treatment of progressive multiple sclerosis (pMS). 18 subjects received Foralumab treatment and 9 patients received placebo. All nasal
doses were well tolerated. Biomarker analysis showed significant positive immune effects, that were most prominent in the 50 µg
cohort with minimal immunomodulatory effects at the 10 µg and 250 µg doses.  Prominent results included:
●
Treatment was well-tolerated
    and no drug-related safety issues were reported at any of the doses.
48
●
No drug-related changes
    were observed in vital signs among subjects at predose, during treatment and at discharge. The mean blood pressure (BP) during the
    5 days of treatment were; Cohort A (10 µg/d):124/73, Cohort B (50 µg/d): 119/67 and Cohort C (250 µg/d):113/65
    compared to placebo:118/67). Heart rates, respiratory rates and oral temperatures were unchanged among the 3 cohorts compared to
    the placebo.
●
Nasally administered Foralumab
    at the 50 µg dose suppressed cytotoxic CD8+ as well as perforin secreting CD8+ cells, which have been implicated in neurodegeneration
    in multiple sclerosis (MS).
●
Treatment at 50
m
g
    stimulated production of anti-inflammatory cytokine IL-10 and suppressed  production of pro-inflammatory cytokine IFN-γ.
●
Taken together, these results
    suggest stimulation of Tregs that are needed to provide clinical benefits
Treatment of Expanded
Access SPMS Patients at Brigham and Women's Hospital (Boston) with Nasally-Administered Foralumab
On
May 25, 2021 the Company announced that the first expanded access (EA) patient with secondary progressive multiple sclerosis (SPMS)
was dosed with nasally administered Foralumab at the Brigham and Women's Hospital (BWH), Harvard Medical School, Boston,
MA. Nasal Foralumab 50 mcg (25 mcg/nostril) was administered in 3-week cycles, with 3 times/week dosing for the first 2 weeks followed
by 1 week of rest period. This first-ever clinical study in SPMS patients, under an Individual Patient Expanded Access IND, was to continue
for six months to evaluate routine safety, tolerability, and neurological behaviors. The study also examined microglial activation, by positron
emission tomography (PET), immunological and neurodegenerative markers to assess clinical responses following the dosing regimen
On
March 10, 2022, the Company reported positive clinical data in the first SPMS EA patient following completion of six months of treatment
with intranasally administered foralumab, at the Brigham and Women's Hospital (BWH), Harvard University, Boston, MA. In
addition to being well-tolerated, both biological and clinical improvements were seen in this patient using Tiziana's novel immunotherapy
technology, which, importantly effected immunomodulation in the brain using nasal administration.
Foralumab
was given to an SPMS patient intranasally into each nostril on a regimen of M-W-F for two weeks followed by one week off therapy for
a period of six months. This regimen was well-tolerated with associated beneficial clinical and biomarker changes. Importantly, the PET
imaging data indicated inhibition of microglial cell activation observed at 3 months following treatment initiation and was sustained
at 6 months after treatment start (see Table 1). The reduction in microglial activation was seen in all parts of brain.
Table 1. Percent Reduction* in Activated
Microglial Cells (AMCs) PET Signal After Starting Intranasal Foralumab as Compared to Baseline, in Whole Brain and Selected Brain Regions
WHOLE
BRAIN
CEREBRAL
CORTEX
THALAMUS
WHITE
MATTER
CEREBELLUM
3 MONTHS
-23
%
-23
%
-20
%
-25
%
-22
%
6 MONTHS
-38
%
-38
%
-50
%
-36
%
-38
%
*
Percent reduction is based
    on changes from baseline in SUVR-1, a surrogate index for PET binding potential. SUVR=Standardized Uptake Value Ratio, calculated
    with reference to a pseudo reference region in cerebral white matter that showed minimal change in PET SUV, across time points.
49
Consistent
with clinical and PET observations, intranasally administered foralumab also downregulated serum levels of pro-inflammatory cytokines,
including interferon-gamma (IFN-g), interleukin (IL-18), IL-1β and IL-6, which are associated with multiple sclerosis pathogenesis
and progression. Clinical evaluation showed improvement in Timed 25-Foot Walk Test (T25FW), 9-Hole Peg Test (9HPT) and Symbol
Digit Modality Test (SDMT). Other published PET studies have shown an increase in activated microglial cells (AMCs) in patients with
secondary progressive MS (SPMS), and the increase in AMCs associated with higher scores on the Expanded Disability Status Scale (EDSS),
a widely-used scale to measure disability
1,2
. Several FDA-approved drugs, such as TYSABRI
®
, MAYZENT
®
and
ZEPOSIA
®
have been shown to suppress microglial activation and exert neuroprotective effects in the central nervous
system (CNS) in animal studies but longitudinal assessment of drug effects on microglial activation in exclusive cohorts of SPMS patients
are lacking.
Prior
to treatment, this patient had continued to experience worsening disease progression despite several MS therapies, including B cell depletion.
The patient's gait and limb strength had been deteriorating over the prior two years. The patient then started on intranasal foralumab,
which stabilized his disease course. Tiziana also received FDA authorization to continue treating this patient for an additional 6 months
to determine if 12 months of consistent treatment maintains clinical stabilization and provides sustained clinical benefits.
On
January 20, 2022, FDA allowed enrollment of a second EA SPMS patient for treatment with intranasal foralumab.
These data were presented
in a virtual Key Opinion Leader (KOL) event hosted by Tiziana on March 14
th
, 2022, entitled "Foralumab Clinical
Update in Multiple Sclerosis; A Landmark Study with Intranasal Immunotherapy" featuring four Key Opinion Leaders and a live Q&A
session. The company plans to continue treatment of EA SPMS patients at Brigham and Women's Hospital and elsewhere and continue
evaluation of foralumab treatment.
On April 5, 2022, Tiziana
announced that FDA granted permission to enroll up to eight additional (SPMS) Intermediate Size Patient Population EAP with intranasal
foralumab. As part of the original treatment plan, the foralumab dose will remain 50 mcg three times a week (MWF), which is the same
dose administered previously to the first two SPMS patients. The dosing regimen in this IND also has a provision for dose escalation
up to 100 mcg three times a week (MWF) as an option to improve clinical benefit, if needed.
Data from a Secondary Progressive
Multiple Sclerosis patient treated with intranasal foralumab were presented on June 2, 2022 at the consortium of multiple sclerosis
centers (CMSC) 2022 annual meeting. Dr. Tanuja Chitnis, MD, Professor of Neurology and the Principal investigator of the clinical
study at the at the Brigham and Women's Hospital (BWH), Boston, MA., presented a poster discussing clinical data from a patient
with SPMS, who was treated with intranasal foralumab for six months.
On June 8, 2022, Tiziana
announced positive clinical results for the second patient (EA2) in the non-active SPMS Expanded Access (EA) Program following three
months of dosing with intranasal foralumab. These results confirm the previously reported data, from the first non-active SPMS patient
(EA1) that after three months of treatment, intranasal foralumab. was well-tolerated and improved clinical and PET imaging analyses.
The second patient was diagnosed with SPMS in 2014. Since then, the disease has been progressive, resulting in an accumulation of disability.
Patient EA2 started ocrelizumab in 2018 and stopped this treatment in 2021. During this time EA2's non-active SPMS progressed as
measured by EDSS worsening from 3.5 in 2018 to 6.0 in 2021. At this point in time EA2 needed a cane to walk 100 meters. Patient EA2 was
subsequently enrolled in the intranasal foralumab expanded access program. On September 2022, 8 months after starting treatment
with intranasal foralumab, EA2 was able to walk 100 meters without a cane or need to rest. This improved the EDSS from 6.0 to 5.5. EA2's
pyramidal score remained stable during this time. In December 2022, 11 months after starting treatment with intranasal foralumab,
EA2 was able to walk 200 meters without a cane or need to rest, resulting in further improvement in EDSS from 5.5 to 5.0. EA2's
pyramidal score continued to remain stable. Lastly preliminary reading of EA2's 11-month PET Scan (December 2022) demonstrated
improvement in microglial activation over baseline.
50
On September
20, 2022, Tiziana announced that the second patient ("EA2") with non-active secondary progressive multiple sclerosis (SPMS)
receiving intranasal foralumab had shown additional clinical improvements as measured by the Expanded Disability Status Scale (EDSS),
a standard clinical assessment.
On October 12, 2022, Tiziana
announced that it planned to submit an Investigational New Drug Application (IND) for a Phase 1 Trial of intranasal foralumab in Alzheimer's
disease patients after receiving an affirmative written response from the FDA on a Pre-Investigational New Drug Application (PIND). Tiziana
plans on filing the IND for Alzheimer's disease by the third quarter of 2023 upon the completion of requested toxicology studies,
then starting its Phase 1 program by the end of 2023.
On November 2, 2022,
Tiziana announced the completion of enrollment of the first patient cohort in its Intermediate Size Patient Population Expanded Access
Program to evaluate foralumab in non-active SPMS patients.
On November 10, 2022,
Tiziana announced its near-term focus on developing intranasal foralumab for inflammatory diseases of the Central Nervous System (CNS)
such as non-active SPMS, Alzheimer's disease and amyotrophic lateral sclerosis (ALS).
The company plans
to continue treatment of EA SPMS patients at Brigham and Women's Hospital and continue evaluation of foralumab treatment.
Phase 2a Clinical
Trial of Nasally-Administered Foralumab for Treatment of Secondary Progressive Multiple Sclerosis
A multisite Phase 2a study
evaluating intranasal foralumab for treatment of SPMS is anticipated to start in Q3 2023 by holding the first investigator's meeting.
This is a double-blinded, placebo-controlled study of two (2) doses of foralumab nasal solution (50 µg and 100 µg) delivered
intranasally compared to placebo, administered in non-active secondary progressive MS patients who are continuing to deteriorate despite
standard of care therapy.
Earlier Phase
1 and 2 Studies Conducted by Novimmune with Intravenous Administration of Foralumab
Intravenous Foralumab has
been studied in a total of three Phase 1 and Phase 2 clinical trials conducted by Novimmune. A total of 68 patients were exposed to Foralumab:
Study NI-0401-01:
a Phase 1/2a randomized, double-blind, placebo-controlled and dose escalation study NI-0401-01 in subjects with moderate to severe active
CD. The study was completed and 33 subjects were exposed to Foralumab. The study NI-0401-01 was designed to assess tolerability of Foralumab
and was not powered to evaluate efficacy parameters included the proportion of patients achieving, clinical response and change from
baseline of Crohn's Disease Endoscopy Index of Severity. A trend, although not statistically significant, was seen when analyzing
the clinical response and endoscopic response. Single and repeat intravenous doses of 0.05, 0.1, 0.5, 1.0, 2.0 and 10.0 mg Foralumab
were administered to subjects and serum pharmacokinetics evaluated for up to five days. Limited pharmacokinetic data was collected, however
it was observed that at doses over 1.0 mg, severe infusion related reactions (IRRs) were observed that led to discontinuation of the
2 and 10 mg groups. Therefore, the 1.0 mg dose was considered the MTD in this study. CD3 modulation on CD4 positive and CD8 positive
T cells was related to Foralumab dose. There was a dose response for the reduction of peripheral T-cell (CD2 positive) count. The main
adverse events were infusion related reactions related to the route of administration of the drug.
51
Study
NI-0401-02:
an open-label, dose titration, multicenter Phase 1 study of Foralumab for the treatment of subjects with biopsy-proven
acute cellular renal allograft rejection (BpACR). The study was completed and 11 subjects were exposed to Foralumab. Patients were dosed
with 1.0 mg, 1.5 mg, 2.0 mg and 2.5 mg of Foralumab daily for five days and most were pre-treated with methylprednisolone. The data from
study NI-0401-02 has confirmed the dose response in terms of CD3 modulation and reduction of peripheral T-cell count. A CD3 modulation
of up to 90% was achieved at study NI-0401-02 day five with a daily dose of 2.5 mg during the 5 days of treatment period. Although there
was no dose-response relationship, treatment with foralumab seems to be globally effective to reverse protocol defined acute cellular
rejection and in the mormalization of serum creatinine levels, a primary efficacy objective. The main adverse events were infusion related
reactions in patients that were not premedication with prednisolone.
Study
NI-0401-03:
a Phase 2a study with an open label dose escalation phase followed by a double-blind phase to assess safety and efficacy
of Foralumab in subjects with moderate to severe active CD. The study NI-0401-03 was completed and 24 subjects were exposed to Foralumab.
74% of patients had achieved a clinical response at week 2 and 87% of patients at week 4. At weeks 6, 8 and 12 the proportion of patients
with a clinical response decreased to 75%, 70% and 67%, respectively. 30% of patients had achieved clinical remission at week 2, 42%
by weeks 4, 38% by week 6, 43% at week 8 and 46% at week 12. Treatment failures were 12.5%. There was a reduction in the mean Crohn's
Disease Activity Index (CDAI) scores in all treatment cohorts and an overall improvement in the Crohn's Disease Endoscopic Index
of Severity (CDEIS) scores across all treatment groups following 5 daily doses of Foralumab treatment. Pharmacokinetic evaluations were
performed, and no dose-response relationship was established due to variability between patients. The observed half-life of Foralumab
was approximately 180 hours. A rapid and almost complete disappearance of CD45 positive lymphocytes, CD3 positive T-cells, CD3 positive
and CD4 positive helper T-cells and CD3 positive and CD8 positive cytotoxic T-cells from the circulation was observed was observed within
24 hours of infusion for all dose cohorts. The lowest unit dose in the study NI-0401-03 was equivalent to the 1 mg daily unit dose that
was the maximum tolerated dose in study NI-0401-01. Pre-medication with prednisolone reduced the severity and frequency of infusion related
reactions.
In two Phase 2a trials conducted
by Novimmune, patients with Crohn's disease and renal allograft rejection in kidney transplants demonstrated Foralumab's immunomodulatory
activity in humans. We have decided not to pursue evaluation of intravenous Foralumab in Crohn's Disease because we believe the
market for this disease is saturated by other FDA approved drugs. Further, while intravenous administration of antibodies has been widely
used, side effects from the intravenous administration still are prevalent as well as patient compliant issues come into play. We intend
to move forward with an oral formulation of Foralumab for treatment of Crohn's disease at a later date.
Two
of Novimmune's clinical trials were in patients with Crohn's disease and the third clinical trial was conducted in patients
undergoing kidney transplantation and suffering with renal allograft rejection. Sixty-eight subjects with active Crohn's disease
and 11 subjects with acute cellular renal allograft rejection were treated with Foralumab. The route of administration of Foralumab in
these studies was via intravenous administration.
In
these trials, it was observed that:
●
The short-term tolerability
    profile of Foralumab was very similar to those reported with other anti CD3 antibodies and no new emerging concerns have been identified.
●
Total daily doses of up
    to 1mg (~ 500 µg/m2) per patient were generally well tolerated without corticosteroid premedication. The most common adverse
    events following exposure to Foralumab were IRRs, which occurred in all patients treated with the compound. In the majority of cases,
    these symptoms were mild (66%) in intensity and were reported following the first two infusions of the 5-infusion treatment course.
    The number of affected patients and the severity of symptoms tended to increase with increasing dose level, or DL.
52
●
A clear reduction of CRS
    and its associated IRRs were observed with steroid pre-medication. All patients who received pre-medication with steroids had mild
    or no IRRs, and CRS was reduced. Only one patient who did not receive steroid pre-medication had significant levels of CRS, in particularly
    IL-6.
●
Usage of steroid pre-medication
    allows the administration of higher doses.
●
Both the magnitude and
    duration of CD3 modulation increased in a dose related manner.
●
No anti-drug antibodies
    were detected.
Prior
Clinical Experience
Oral
anti-CD3 antibodies, as opposed to the narrow therapeutic window of its intravenous counterpart, have been shown to impact the gut immune
system and mesenteric lymph nodes, thereby promoting regulatory T-cells activity, without inducing immunosuppression. The treatment alleviated
experimental autoimmune encephalitis and T1D mellitus, which was associated with regulatory T-cells induction. Orally and nasally administered
anti-CD3 suppressed autoantibody production in a mouse lupus model. Oral anti-CD3 yielded reduced pancreatic hyperplasia, hepatic fat
accumulation and muscle inflammation in a leptin-deficient model of NASH and diabetes.
Pharmacology
Summary (In Vitro Studies)
The
key conclusions arising from the non-clinical studies of Foralumab by Novimmune are:
●
Foralumab is a specific
    anti-CD3 epsilon mAb, as it binds to human T-cells and the recombinant human CD3 epsilon chain, and can be displaced by another specific
    anti-CD3 epsilon mAb, muromonab CD3.
●
When bound to its target,
    Foralumab triggers calcium flux into the cell and modulates the CD3/TCR complex causing its' transient removal from the cell
    surface.
●
The combination of the
    two-point mutations introduced into the Fc portion (the constant region of the antibody that has limited structural variability and
    is responsible for adverse side effects) of Foralumab, resulting in the abrogation of the binding to Fc gamma receptors, and C1q,
    consequently eliminates T-cell proliferation and the release of numerous cytokines including TNF, and interferon gamma, or IFNγ
in vitro
.
●
Foralumab does not cross
    react with CD3 molecules expressed by T-cells of other species including baboon,
Rhesus
monkey,
Cynomolgus
monkey,
    rabbit, dog, rat and mouse. As a consequence, options for the most relevant species selection for pharmacology and toxicology assessment
    of Foralumab are limited. Novimmune addressed this limitation by studying LCD3 transgenic mice. This transgenic mouse line expresses
    the human as well as the mouse CD3 epsilon chain on the surface of their T-cells.
●
Using a transgenic line
    of mice expressing both human and mouse CD3 molecules (1:1 ratio) at the surface of T-cell (LCD3
),
following a single intravenous
    injection, Foralumab dose dependently:
●
Modifies
                                            human CD3 epsilon expression; that is, more than 80% of the cell surface protein was removed
                                            within 24 hours when given at a saturating dose. This modulation was transient as receptor
                                            expression levels returned to baseline values within 7 days of dosing.
●
Caused
                                            a reduction of 70-80% in the number of circulating T-cells when given at a saturating dose.
                                            The maximal effect was observed at hour 6 post dose. Cell counts returned to baseline levels
                                            within 3.5 days.
●
Demonstrated
                                            a half-life of 1.4 and 1.7 days for doses of 5 and 200 µg per mouse, respectively.
                                            This seemingly short half-life is similar to that observed in vivo for other anti-CD3 mAbs
                                            and reflects internalization of Foralumab by the human CD3 molecule on the T-cells of these
                                            transgenic mice. It was therefore expected that Foralumab will be internalized by human T-cells
                                            in patients and consequently have a half-life comparable to other therapeutic anti-CD3 mAbs.
53
Safety
Toxicology Studies
Tiziana
conducted Intranasal and Subcutaneous Safety Toxicology Studies in HuGEMM Transgenic Mice Expressing human CD3 and mouse CD3 molecules.
Study
700656 14 Days Intranasal Dosing Duration/7 days Recovery
Three
times/week intranasal dosing of 1, 10 and 50 µg foralumab /animal
●
There
                                            were no test item related mortalities during the course of the study.
●
The
                                            three times weekly intranasal instillation of Foralumab at doses of up to 50 µg of
                                            Foralumab/animal were well tolerated. There were no foralumab related changes in clinical
                                            signs, body weights, hematology or clinical pathology.
●
Intranasal
                                            instillation of a high dose (50 µg) of Foralumab promoted a neat depletion of the mCD3/hCD3
                                            coexpressing T lymphocyte compartment, including the mCD3
+
hCD3
+
mCD4
+
and mCD3
+
hCD3
+
mCD8
+
subsets.
Study
700800 13 Weeks Dosing Duration/8 weeks Recovery
Three
times/week intranasal dosing of 1, 10 and 50 µg foralumab /animal
●
There
                                            were no test item related mortalities during the course of the study.
●
There
                                            were no foralumab related changes in clinical signs, body weights, hematology or clinical
                                            pathology.
●
Intranasal
                                            instillation of foralumab to mouse three times weekly for 13 weeks was well tolerated at
                                            dose levels up to 50 μg/dose and did not produce foralumab-related macroscopic or microscopic
                                            pathology findings
●
The no-observed-adverse-effect level (NOAEL) is considered to be 50
μg/animal (equivalent to a 10 mg dose administered to a 60 kg adult human).
Study
700657 26 Weeks Dosing Duration/12 weeks Recovery
Three
times/week intranasal dosing of 1, 10 and 50 µg foralumab /animal
●
Study
                                            in progress. Dosing initiated on December 5 2022
Study 700680 14 Days Subcutaneous
Dosing Duration/7 days Recovery
Once
daily subcutaneous dosing of 5, 15 and 50 µg foralumab /animal
●
There
                                            was no evidence of local (subcutaneous injection site) or systemic toxicity.
●
The
                                            administration at 50 µg/animal of Foralumab promoted a neat reduction of the mCD45
+
mCD3/hCD3
                                            co-expressing T lymphocyte compartment, especially in the mCD3
+
hCD3
+
mCD8
+
subset. Meanwhile, the number of mCD45
+
mCD3
+
hCD3
-
cells increased including the mCD3
+
hCD3
-
mCD4
+
and mCD3
+
hCD3
-
mCD8
+
subsets
●
The
                                            no observable adverse effect level (NOAEL) was determined to be 50 µg/animal based
                                            on parameters monitored on the study.
Study
700681 28 Days Subcutaneoous Dosing Duration/28 days Recovery
Three
times/week intranasal dosing of 1, 10 and 50 µg foralumab /animal
●
The
                                            three times weekly (Day 1, 3 and 5 of the week) administration of Foralumab for 4 consecutive
                                            weeks by subcutaneous injection at doses of 5, 15 and 50 µg/animal/dose to HuGEMM mice
                                            was well-tolerated.
●
There
                                            was no evidence of local (subcutaneous injection site) or systemic toxicity.
●
The
                                            administration of Foralumab promoted the decrease of mCD3/hCD3 co-expressing T cells and
                                            subsets in a dose-independent manner.
●
The
                                            no observable adverse effect level (NOAEL) was determined to be 50 µg/animal/dose based
                                            on parameters monitored on the study.
54
Milciclib
(TZLS-201)
Milciclib
is an orally bioavailable, small molecule broad spectrum inhibitor of CDKs (CDKs): 1, 2, 4, 5 and 7 and Src family kinases. CDKs are
a family of highly conserved enzymes that are involved in regulating the cell cycle, which is a series of events that takes place in
cells leading to division and duplication of its DNA to produce two daughter cells. Src family kinases regulate cell growth and potential
transformation of normal cells to cancer cells. A novel feature of Milciclib is its ability to reduce microRNAs, miR-221 and miR-222,
that silence gene expression. miR-221 and miR-222 promote the formation of blood vessels (angiogenesis) that are important for spread
of cancer cells (metastasis). Levels of these microRNAs are consistently increased in HCC patients and may contribute towards resistance
to treatment with Sorafenib. As a result, we are investigating Milciclib both as a monotherapy and plan a combination treatment with
Sorafenib. To date, Milciclib has been studied in a total of eight completed and ongoing Phase 1 and Phase 2 clinical trials in 316 patients.
In these trials, Milciclib was observed to be well-tolerated and showed initial signals of anti-tumor action. A Phase 2a trial (CDKO-125a-010)
for Milciclib as a single therapy in patients with HCC was completed in June 2019.
Hepatocellular
Cancer
Tiziana
plans to conduct a Phase 2 study combination therapy of milciclib and gemcitabine in Non-Small Cell Lung Cancer (NSCLC) patients with
a broad-spectrum of KRAS mutations (except G12C mutation) after failure of at least one line of standard-of-care (SoC) therapy. NSCLC
is the most common type of lung cancer, occurring in approximately 80% of patients. Due to the asymptomatic nature of early disease,
many patients are diagnosed with later stages of disease, and typically have short overall survival. In the United States, at initial
diagnosis of NSCLC, approximately 55% of patients have distant metastases with a 5-year survival rate of 7%, despite the recent development
of novel anticancer therapies and regimens. The results of clinical trials with sotorasib (Lumakras™) demonstrated that selective
targeting of a single KRAS mutation is a promising therapeutic strategy. Although there is a clear benefit to target KRAS directly, KRAS
represents a challenging molecular target due to the lack of suitable drug pockets where a small molecule can bind. An alternative approach
is to target downstream signaling pathways. The rationale for evaluation of milciclib in combination with gemcitabine is suggested by
preclinical studies conducted on a non-small cell lung xenograft model that demonstrated the efficacy of milciclib in terms of antitumor
activity, both as a single agent and in combination with gemcitabine, at well tolerated doses. Given that gemcitabine is used for treatment
of both pancreatic cancer (for which gemcitabine is the standard therapy) and NSCLC (for which gemcitabine is used in combination with
cisplatin), an evaluation of the feasibility of the combination of milciclib and gemcitabine is considered appropriate in view of future
uses in these diseases. In addition, the 2 compounds showed non-overlapping toxicities when administered as single agents, providing
an additional rationale for their evaluation in combined treatment in the clinical setting.
Furthermore,
in the Phase 1 CDKO-125a-004 study, 16 patients were treated with milciclib at 3 dose levels administered once daily for 7 days, followed
by 7 days off treatment in a 4-week cycle and with a fixed dose of gemcitabine administered intravenously on Days 1, 8, and 15 in a 4-week
cycle1, Overall, the combination was well tolerated and showed clinical benefit with 1 PR and 10 patients with SD. The PR was documented
in a patient with NSCLC whose disease was refractory to gemcitabine.
Clinical
Data
Milciclib
has been studied in a total of eight completed Phase 1 and Phase 2 clinical trials in approximately 316 patients. Milciclib was observed
to be well tolerated by patients with thymoma in Phase 1 and Phase 2 clinical trials.
55
Phase
1 Development
Milciclib
has been investigated in each of the below, open-label, multi-center, non-randomized, dose-escalation Phase 1 clinical trials.
Trial
Patient
    Population
Treatment Schedule / Dosing
Key
    Findings
CDKO-125a-001
Advanced/metastatic
        solid tumors
37
    patients
1st
        Schedule: Orally, once daily
for
    7 consecutive days every 14 days in a 2-week cycle at escalating doses of 50, 100, 150, 200 and 300 mg
2nd
    Schedule: Orally, once daily for 4 consecutive days a week for 3 weeks in a 4-week cycle at escalating doses of 150, 180 and 200
    mg
Pharmacokinetics:
Comparable
    plasma pharmacokinetic parameters between the two schedules were observed.
The
    exposure to Milciclib increased with the dose and there was a 3-fold accumulation in the daily systemic exposure after repeated dosing,
    in good agreement with expectations on the basis of the half-life of the compound (24-43 h).
Clinical
    observations:
No
    objective responses were achieved on 1st schedule; Disease stabilizations, defined as cancer disease that is neither increasing nor
    decreasing in extent or severity, was observed in 6 of 14 evaluable patients (42.9%).
A
    partial response, or PR, was achieved in 2 out of 14 evaluable patients (14.3%) on 2nd schedule; Disease stabilization (no change
    in extent or severity of disease state) was reported in 3 patients (21.4%), all treated at 180 mg/day DL, including a stabilization
    lasting 31 weeks in a patient with pancreatic cancer and stable disease, or SD, lasting 29 weeks in a patient with carcinoid.
56
Trial
Patient
    Population
Treatment Schedule / Dosing
Key
    Findings
CDKO-125a-002
Recurrent
        malignant glioma 28 patients (Phase 1)
34
    patients (Phase 2)
Escalating
        oral doses of 18, 36, 54 and 72 mg/m2 once a day for 14 consecutive days followed by 7 days of rest in a 3-week cycle
54
    mg/m2 (RP2D)
Pharmacokinetics:
Results
    indicated that the pharmacokinetics of Milciclib was dose-independent in the dose range 18
–
    72 mg/m2.
Systemic exposure values
    of Milciclib maleate accumulated by a factor of 3
Clinical
        observations:
Phase
    1: No evidence of clinical effect was observed in all the 28 treated patients. However 5 patients seemed to have benefitted from
    therapy with SD observed (no change in extent or severity of cancer).
Phase
    2: One out of 34 patients achieved the primary endpoint. PFS at 6 months or PFS-6 rate was 2.9%. No complete response, or CR (disappearance
    of all signs of cancer in response to treatment) or PR (decrease in tumor size or extent of cancer in the body) were reported. 4
    patients showed SD as best overall response (11.8%). Prolonged SD (≥ 6 months) was observed in one patient whose SD lasted for
    24.9 months.
Safety:
34
    patients were enrolled and treated: 29 patients of non-Enzyme Inducing Anti-Epileptic Drugs, or non-EIAED, population and 5 of EIAEDs
    population. The primary clinical endpoint was not met. Only one patient (non-EIAEDs) achieved the study primary endpoint out of 34
    treated patients. PFS-6 rate evaluated in the treated patients was 2.9% (95% CI, 0.07-15.33). No CR or PR was reported; 4 patients
    in the treated patients showed SD as best overall response on treatment (11.8%). Prolonged SDs (≥6 months) was observed in one
    patient whose SD lasted for 24.9 months. Median OS in treated patients was 7.03 months (95% CI, 5.72-10.58). The exploration of the
    role play by potential prognostic factors, such as Karnofsky Performance Scale (≥90 vs. <90), age (<40 vs. ≥40)
    and interval between initial diagnosis and current recurrence (≥52 weeks vs. <52 weeks) indicated a better survival outcome
    for patients whose interval between initial diagnosis and current recurrence was (≥52 weeks). Given the non-comparative nature
    of the study, it cannot be said whether the treatment played any role in this result.
The
    influence of other factors cannot be excluded but was not apparent in the current sample.
57
Trial
Patient
    Population
Treatment Schedule / Dosing
Key
    Findings
CDKO-125a-003
Advanced/metastatic
        solid tumors
30
    patients
1st
        Schedule: Orally, once daily for 21 consecutive days followed by 7 days of rest in a 4-week cycle at escalating doses of 16 and
        24 mg/m2
2nd
    Schedule: Orally, once daily for 14 consecutive days followed by 7 days of rest in a 3-week cycle at escalating doses of 24, 48,
    54 and 72 mg/m2
Pharmacokinetics:
No
    differences in the pharmacokinetics were observed between the two schedules after both single and repeated dosing.
The
    systemic exposure to Milciclib (amount of Milciclib available systemically in the patient) increased with dose in terms of both Cmax
    (maximum concentration of Milciclib in plasma) and daily Area Under the Plasma Drug Concentration, or AUC, vs Time Curve, a measure
    of drug bioavailability without deviations from dose-proportionality (plasma concentration changes in a linear relationship to amount
    of drug dosed).
After
        repeated administrations, Milciclib Cmax and AUC accumulated by a factor of 2-4, independent of the dose-level.
Clinical
        observations:
No
    objective (measurable) responses were achieved. SDs were reported in 5 out of 16 evaluable patients (31.3%), starting from the dose
    of 48 mg/m2/day. One disease stabilization maintained for 12 cycles (10.5 months) at 48 mg/m2/day, was achieved in a parotid gland
    patient.
CDKO-125a-004
Advanced/metastatic
        solid tumors
16
    patients
Orally administered at
    45, 60 and 80 mg/m2 once daily for 7 days on / 7 days off (Days 1 to 7 and 15 to 21) in a 4-week cycle in combination with fixed
    dose of IV gemcitabine (1000 mg/m2/day) on Days 1, 8, 15 over 30 minutes every 4 weeks
Pharmacokinetics:
Pharmacokinetic
    parameters (Cmax, AUC) of Milciclib after Milciclib maleate/ gemcitabine combination were consistent with those previously observed
    after Milciclib maleate administration as single agent, suggesting no influence of gemcitabine on the pharmacokinetics of the compound.
Clinical
    observations:
One
    PR in 14 evaluable patients (7.1%) and one SD in 10 patients (71.4%).
Disease
    stabilizations lasting z 6 months were recorded in 4 cases (28.6%) in thyroid, prostatic, pancreatic carcinoma and peritoneal mesothelioma,
    in 2 of them lasting 13.4 months (peritoneal mesothelioma) and 14.3 months (prostate cancer).
The
    PR and 3 of the 4 long lasting disease stabilizations were obtained at the recommended Phase 2 dose (RP2D) of 80 mg/m2/day plus 1000
    mg/m2/day gemcitabine, supporting development of combination therapies with Milciclib in advanced cancer patients.
Results
    of trial CDKO-125a-004 were published: S. Aspeslagh et.al. Cancer Chemother. Pharmacol (2017) 79: 1257-1265
58
Phase
2 Development
Trial
Patient
    Population
Treatment Schedule / Dosing
Key
    Findings
CDKO-125a-005
Malignant
        pleural mesothelioma
38
    patients
150 mg/day orally administered
    for 7 consecutive days every 14 days in 2-week cycles
Pharmacokinetics:
Plasma
    levels of Milciclib were comparable to those previously obtained in the Phase 1 study CDK0-125a-001 at the same dosage and with the
    same schedule, confirming the reliability of the pharmacokinetic profile of the compound.
Clinical
    observations:
No
    objective responses were reported; prolonged SDs were observed in 2 patients, lasting 8.9 months and 8.7 months, respectively.
CDKO-125a-006
Trial
    cutoff: 1/9/2017
Malignant B3 thymoma / thymic carcinoma 72 patients
Single
        agent (flat dose)
150
    mg once daily 7days on/7days off q2wks
Clinical
        Observations:
Treatment
    with Milciclib met the primary endpoint of PFS at 3 months (PFS-3). 56 of 72 treated patients had median PFS of 5.78 months with
    upper and lower 95% confidence limits of 3.48 months and 7.89 months, respectively. The secondary endpoint, OS, was also met in this
    trial. 36 of 72 patients (50%) had median OS of 24.44 months with upper and lower 95% confidence limits of 22.05 and 54.55 months,
    respectively. Five patients from this study are continuing treatment with Milciclib.
CDKO-125a-007
Trial
    cutoff: 1/9/2017
Malignant B3 thymoma / thymic carcinoma 30 patients
Single agent (flat dose) 150 mg once daily 7days on/7days
    off q2wks
Clinical
        Observations:
Treatment
    with Milciclib met the primary endpoint of PFS-3. 18 of 30 patients had median PFS of 5.65 months with upper and lower 95% confidence
    limits of 3.94 months and 17.45 months, respectively. The secondary endpoint, OS, was met in this trial. 18 of 30 treated patients
    (54.5%) had OS of 48 months. Upper and lower 95% confidence limits could not be calculated because the median survival probability
    was not reached.
59
Trial
Patient
    Population
Treatment Schedule / Dosing
Key
    Findings
CDKO-125a-010
Recurrent or metastatic unresectable
    HCC
Single
                           agent (flat dose)
100
    mg once daily
4days
    on/3days off x 4 wks q4 wks
The
                           trial successfully met the primary endpoint that oral treatment with Milciclib was well tolerated with manageable
                           toxicities and no recorded drug related deaths.
●  The
    secondary endpoints for clinical activity assessment were based on the independent radiological review using the modified Response
    Evaluation Criteria in Solid Tumors (mRECIST)
●  Positive
    demonstrated clinical activity included:
1.   50%
    (14 out of 28) evaluable patients completed 6-month duration of the trial.
2.   64%
    (9 out of 14) patients requested and were approved by their respective ethical committees to continue the treatment.
3.   Both
    median time to progression (TTP) and progression free survival (PFS) were 5.9 months (95% Confidence Interval ("CI")
    1.5-6.7 months) out of the 6-months duration of the trial.
4.   Approximately
    57% of evaluable patients showed 'Stable Disease' (SD; met at least once in an 8-week interval) and 3.6% patients showed
    'Partial Response' (PR).
5.   Approximately
    61% of patients showed 'Clinical Benefit Rate' defined as CBR=CR+PR+SD (with CR representing Complete Remission).
6.   Five
    patients on compassionate use continued the treatment for a total of 9, 9, 11, 13 and 16 months, respectively. Two patients continuing
    the treatment have reached 16 months.
Source:
Milciclib Investigators Brochure version 14
Safety
Overall,
Milciclib has indicated a similar pattern of toxicity across studies. Consistent with preclinical findings, the safety profile of the
compound in humans is characterized by a dose-limiting neurological toxicity and, to a lesser extent, by GI toxicity. Asthenia (weakness)
and fatigue have also been observed, as well as effects on liver, especially with prolonged schedules of administration. Mild/moderate
tremors are a common finding, reported also at recommended Phase 2 doses (RP2Ds) (only one case of grade 3), whereas ataxia (loss of
muscle control and balance) was observed primarily during the first dose-escalation study (one case of grade 3 ataxia occurred also at
the RP2D in the combination study CDKO-125a-004 and one in CDKO-125a-006 trial). Both tremor and ataxia were generally reversible in
all cases in up to 7-9 days, upon drug discontinuation or dose reduction in some cases. Grade 1-2 dizziness was also reported, with only
one grade 3 occurrence, overall. Mild dysgeusia (disorder of sense of taste) is another event that was reported across studies, as well
as headache and anorexia (loss of appetite). Grade 3 myasthenia (muscle weakness) was also reported in two patients. Nausea and/or vomiting
and/or diarrhea were mostly of grade 1-2 in severity and were manageable with appropriate therapy. Diarrhea was occasionally severe,
leading to dehydration in several instances. Skin disorders were also reported across studies; the events were mainly of grade 1-2 in
severity except for one case of grade 3 rash maculopapular and one case grade 3 of erythema multiforme. Hematological toxicity was mainly
represented by lymphocytes (white blood cells) decrease and, to a lesser extent by all the other hematological parameters. Severe thrombocytopenia
(decrease in number of platelets in blood) was sporadically observed, especially at the highest doses tested and in combination with
gemcitabine. Effects on liver were dose-dependent and mainly represented by transient transaminase elevation (with bilirubin slightly
less affected). ALT/AST (liver enzymes measured to monitor liver damage) elevations were usually mild using the 7 days on / 7 days off
schedule (even if prolonged transaminases (liver enzymes) were occasionally observed). The more prolonged administrations were associated
with a more frequent and pronounced effect on liver function tests. Asymptomatic grade 3-4 lipase (a pancreatic enzyme that breaks down
fats, measured to monitor pancreatic function) elevations were sometimes reported, without clinical manifestation. No important effects
on renal function were noted.
60
Monitoring
of visual function was performed through visual acuity, funduscopy (ophthalmic examination of the back of the eye) and, in a subset of
studies, electroretinography examinations, or ERG. Overall, no clinically relevant abnormalities for these parameters emerged during
treatment across studies, except for ERG worsening, compared to baseline, observed in three patients, who for this reason discontinued
study treatment as per protocol, and one case of retinal detachment reported as a serious event in one patient (CDKO-125a-006 trial)
and assessed as probably related to Milciclib maleate.
Our
interim review in trial CDKD-125A-010, as noted above, found Milciclib to be well-tolerated with no drug-related serious adverse events
in 6 patients with unresectable or metastatic HCC who had concluded a first cycle of treatment with Milciclib.
Preclinical
Data
The
pharmacokinetics of Milciclib were investigated in mouse, rat, dog and monkey models after single intravenous and oral administration
of the compound. Since the compound is intended for the oral administration route, the pharmacokinetics were further characterized after
single and repeated oral administrations. These preclinical studies were performed with Milciclib formulated as maleate or mono/di/tri-hydrochloride
salt. Following intravenous administration, Milciclib was characterized by a moderate clearance in mice, rats and monkeys and a high
clearance in dogs. The volume of distribution was higher than the total body water in all tested species, suggesting an extensive tissue
distribution. Following oral administration to rats and monkeys, Milciclib crossed the blood-brain barrier and distributed in the brain.
In all species, Milciclib plasma levels increased largely in direct proportion with the dose.
Preclinical
toxicology studies conducted with Milciclib have shown that the hemolymphopoietic system, the GI tract and the male reproductive organs
are the major target organs considered related to the pharmacological activity of the compound in all species. The effects on the hemolymphopoietic
system and GI tract were reversible after drug withdrawal. Reversibility could not be demonstrated in the male reproductive organs at
the end of the 2-3-week recovery period because of the longtime of maturation of the seminiferous epithelium. Additional toxicities,
that are considered not related to the mechanism of action of the compound, were Central Nervous System, or CNS, ocular and renal toxicities.
In addition, hemorrhages in different organs were observed in dogs and monkeys. Clinical signs of CNS toxicity were observed at high
doses given as single or repeated administrations in all species.
61
Anti-IL6R
Fully Human mAb TZLS-501 (formerly known as NI-1201)
TZLS-501
is a fully human mAb targeting the IL-6R. We licensed the intellectual property from Novimmune in January 2017. This fully human mAb
has a novel mechanism of action, binding to both the membrane-bound and soluble forms of the IL-6R and depleting circulating levels of
the IL-6 in the blood. An excessive production of IL-6 is regarded as a key driver of chronic inflammation, associated with autoimmune
diseases such as multiple myeloma, oncology indications and rheumatoid arthritis, and we believe that TZLS-501 may have potential therapeutic
value for these indications.
In
preclinical studies, TZLS-501 demonstrated the potential for overcoming the limitations of other IL-6 blocking pathway drugs. Compared
to tocilizumab and sarilumab, while binding to the membrane-bound IL-6R complex, TZLS-501 has been observed to have a higher affinity
for the soluble IL-6 receptor from antibody binding studies conducted in cell culture. TZLS-501 also demonstrated the potential to block
or reduce IL-6 signaling in mouse models of inflammation. The soluble form of IL-6 has been implicated to have a larger role in disease
progression compared to the membrane- bound form (Kallen, K.J. (2002). "The role of transsignaling via the agonistic soluble IL-6
receptor in human diseases." Biochimica et Biophysica Acta. 1592 (3): 323–343.).
Originally
TZLS-501 clinical development was intended or treatment of "cytokine storm"-induced lung damage in COVID-19 patients by aerosol
delivery to lung, however, with the increasing number of effective therapies and vaccines now available for COVID patients the Company
decided to refocus TZLS-501 development for SSc-ILD indication.
On
April 9, 2020 The Company announced that it had developed investigational new technology to treat COVID-19 infections, consisting of
direct delivery of anti-IL-6 receptor (anti-IL-6R) monoclonal antibodies (mAbs) into the lungs using a handheld inhaler or nebulizer
for treatment of patients infected with COVID-19 (SARS-CoV-2) coronavirus. On June 29, 2020 the Company announced that it was
advancing GMP manufacturing of TZLS-501 with STC Biologics concurrently with the development of inhalation technology using a hand-held
nebulizer with Sciarra Laboratories and safety toxicology studies in Cynomolgus monkeys with ITR Canada Laboratories. GMP batches were
initiated in January 2021 and completed in March 2021. Safety inhalation toxicology studies were initiated in November 2020 and completed
in March 2021. Technological assessment of nebulizers for inhalation treatment of patients was initiated in September 2020 and completed
in February 2021.
An
additional 250L cGMP batch of TZLS-501 drug substance was manufactured using an improved downstream process to support future development
activities. An IND for a Phase 1 Clinical Trial in Healthy Subjects for treatment of interstitial lung disease associated with systemic
sclerosis (SSc ILD) was filed in December 2021. This program has been temporarily paused to pursue the Company's short-term focus
on clinical development of intranasal foralumab administration for treatment of SPMS patients
Competition
The
biotechnology and pharmaceutical industries are characterized by rapidly changing technologies, significant competition and a strong
emphasis on intellectual property. We face substantial competition from many different sources, including large and specialty pharmaceutical
and biotechnology companies, academic research institutions, government agencies and public and private research institutions.
We
are aware of a number of companies focused on developing therapies in various indications. Any advances made by a competitor may be used
to develop therapies that could compete against any of our product candidates.
For
our specific product candidates, the main competitors include:
●
We believe that Foralumab
    is currently the only fully human anti-CD3 mAb in clinical development for treatment of Crohn's disease, progressive MS and
    other autoimmune and inflammatory diseases.
Many
of our potential competitors, alone or with their strategic partners, have substantially greater financial, technical and other resources
than we do, such as larger R&D, clinical, marketing and manufacturing organizations. Mergers and acquisitions in the biotechnology
and pharmaceutical industries may result in even more resources being concentrated among a smaller number of competitors. Our commercial
opportunity could be reduced or eliminated if competitors develop and commercialize products that are safer, more effective, have fewer
or less severe side effects, are more convenient or are less expensive than any products that we may develop. Competitors also may obtain
FDA or other regulatory approval for their products more rapidly than we may obtain approval for ours, which could result in our competitors
establishing a strong market position before we are able to enter the market. Additionally, technologies developed by our competitors
may render our potential product candidates uneconomical or obsolete, and we may not be successful in marketing our product candidates
against competitors.
62
Intellectual
Property
We
strive to protect and enhance the proprietary technologies, inventions and improvements that we believe are important to our business,
including seeking, maintaining and defending patent rights, whether developed internally or licensed from third parties. Our policy is
to seek to protect our proprietary position by, among other methods, pursuing and obtaining patent protection in the United States and
in jurisdictions outside of the United States related to our proprietary technology, inventions, improvements, platforms and our product
candidates that are important to the development and implementation of our business.
As of April 24, 2023, our
intellectual property portfolio was made up as follows:
63
We
have rights to a patent family that discloses the Milciclib compound, methods of using the compound, and processes for making the compound
licensed from Nerviano Medical Sciences S.R.L. (which is further described below). This patent family includes six granted U.S. patents,
one granted European patent, and one granted Eurasian patent. This patent family also includes granted patents in Africa (African Intellectual
Property Organization, African Regional Intellectual Property Organization), Algeria, Argentina, Australia, Brazil, Barbados, Bosnia
& Herzegovina, Canada, Colombia, Costa Rica, Croatia, Cuba, Ecuador, Georgia, Iceland, India, Indonesia, Israel, Japan, Korea, Kosovo,
Malaysia, Mexico, Mongolia, Montenegro, New Zealand, Nicaragua, Norway, Pakistan, Philippines, Serbia, Singapore, South Africa, Sri Lanka,
Taiwan, Thailand, Trinidad & Tobago, Tunisia, Ukraine, Uzbekistan, and Vietnam. Applications are also pending in the U.S., Egypt,
and Venezuela. The patents in this family will expire in April 2024, excluding any patent term adjustment and patent term extension in
the U.S. and similar regulatory extensions available in several other jurisdictions, such as Europe.
64
We
also have rights to a patent family which covers related entities, such as salts and crystal forms, of Milciclib, and methods of using
the salts and crystal forms licensed from Nerviano Medical Sciences S.R.L. This patent family comprises one granted U.S. patent and one
granted patent in each of Europe, China, Japan, and Hong Kong. The patents in this family will expire in April 2030, excluding any patent
term adjustment and patent term extension in the U.S. and several other jurisdictions, such as Europe.
In
addition, we have rights to five patent families which cover methods of using Milciclib in the treatment of multiple indications licensed
from Nerviano Medical Sciences S.R.L. These patent families comprise five granted U.S. patents, and granted patents in Europe, China,
Hong Kong, and Japan, and one pending patent application in Europe. The patents in these families will expire between February 2027 and
March 2030, excluding any patent term adjustment and patent term extension in the U.S. and similar regulatory extensions available in
several other jurisdictions, such as Europe.
Among
the above five patent families, two families also cover combination therapies of Milciclib with cytotoxic agents. These families comprise
two granted U.S. patents, and granted patents in Europe, China, Hong Kong, and Japan. The patents in these families will expire between
November 2029 and March 2030, excluding any patent term adjustment and patent term extension in the U.S. and similar regulatory extensions
available in several other jurisdictions, such as Europe.
One
family of the above five patent families also covers combination therapies of Milciclib with therapeutic antibodies. This patent family
includes one granted U.S. patent, and granted patents in Europe, China, and Japan. The patents in this family will expire in February
2027, excluding any patent term adjustment and patent term extension in the U.S. and similar regulatory extensions available in several
other jurisdictions, such as Europe.
In
addition, we have rights to a patent family which covers methods of using Milciclib together with a second anti-cancer agent in the treatment
of cancer. This patent family includes granted patents in the U.S. and Japan and pending applications in the U.S., Europe, Canada, Japan,
and Hong Kong. The patent and patent applications in this family, if issued as patents, will expire in November 2038, excluding any patent
term adjustment and patent term extension in the U.S. and similar regulatory extensions available in several other jurisdictions, such
as Europe.
We
also have rights to a U.S. provisional application which covers enteric-coated pharmaceutical formulations comprising Milciclib. The
patent applications in this family, if issued as patents, will expire in March 2043, excluding any patent term adjustment and patent
term extension in the U.S. and similar regulatory extensions available in several other jurisdictions, such as Europe.
We
also have rights to a PCT application that discloses method of treating KRAS mutated cancers by administering Milciclib and a chemotherapy.
Any patents issued in this family will expire in August 2042, excluding any patent term adjustment and patent term extensions available
in the U.S and several other jurisdictions.
We
have rights to a patent family that discloses methods of using Foralumab, licensed from NovImmune S.A. (which is further described below).
This patent family includes one granted European patent and one granted Eurasian patent. This patent family also includes granted patents
in Australia, Canada, China, Hong Kong, Israel, Japan, Mexico, Norway, Singapore, South Africa, and Ukraine. The patents in this family
will expire in April 2025, excluding any patent term extensions available in several jurisdictions, such as Europe.
We
also have rights to a patent family that discloses the Foralumab compound and methods of using the compound also licensed from NovImmune
S.A. This patent family comprises four granted U.S. patents one granted European patent, and one granted Eurasian patent. This patent
family also includes granted patents in Australia, Brazil, Canada, China, Hong Kong, India, Israel, Japan, Mexico, Republic of Korea,
Singapore, South Africa, and Ukraine. An application is pending in the U.S. The patents in this family will expire in June 2025, excluding
any patent term adjustment in the U.S. and patent term extensions available in the U.S. and several other jurisdictions, such as Europe.
In
addition, we have rights to a patent family that discloses combination therapies of Foralumab with IL-6 or IL-6R antibodies licensed
from NovImmune S.A. This patent family has one pending U.S. application. Once issued, the patents in this family will expire in January
2032, excluding any patent term adjustment and patent term extensions available in the U.S.
65
We
have rights to a patent family that discloses formulations of Foralumab and dosing regimens for treating various disorders. This patent
family has an issued patent in the U.S., issued patents in China and Japan, and applications pending in the U.S, Australia, Canada, China,
Europe, Israel, Hong Kong, and Japan. The patents in this family will expire in August 2037, excluding any patent term adjustment and
patent term extensions available in the U.S and several other jurisdictions.
We
have rights to a patent family that discloses methods of using Foralumab for treating central nervous system (CNS) disorders, licensed
from Brigham and Women's Hospital, Inc. (which is further described below). This patent family has applications pending in Canada,
Europe, Japan, and the United States that, if issued as patents, will expire in June 2038, excluding any patent term adjustment and patent
term extensions available in the U.S and several other jurisdictions.
We
have rights to a PCT application that discloses methods of using Foralumab for microglial activation, which is co-owned with Brigham
and Women's Hospital Inc. The patent applications in this family, if issued as patents, will expire in 2042, excluding any patent
term adjustment and patent term extensions available in the U.S and several other jurisdictions.
We
have rights to a patent family that discloses methods of using Foralumab for treating gastrointestinal, autoimmune, and inflammatory
disorders. This family has pending applications in the U.S., Europe, Australia, Canada, China, Hong Kong, and Japan. The applications
in this family, if issued as patents, will expire in October 2039, excluding any patent term adjustment and patent term extensions that
may be available.
We
also have rights to a patent family that discloses methods of using Foralumab in the treatment of coronavirus. This family has pending
applications in the U.S., Australia, Canada, China, Europe, Israel and Japan. The patent applications in this family, if issued as patents,
will expire in 2041, excluding any patent term adjustment and patent term extensions available in the U.S and several other jurisdictions.
We
also have rights to a patent family that discloses methods of using Foralumab to enhance cell adoptive therapies. This family has pending
applications in the U.S., Australia, Canada, China, Europe, Israel and Japan. The patent applications in this family, if issued as patents,
will expire in 2041, excluding any patent term adjustment and patent term extensions available in the U.S and several other jurisdictions.
We
also have rights to a PCT application that discloses methods of administering Foralumab subcutaneously for the treatment of various diseases.
Any patents issued in this family will expire in April 2042, excluding any patent term adjustment and patent term extensions available
in the U.S and several other jurisdictions.
We
also have rights to a U.S. provisional application that discloses nasal formulations of Foralumab for the treatment of various diseases.
Any patents issued in this family will expire in 2043, excluding any patent term adjustment and patent term extensions available in the
U.S and several other jurisdictions.
We
have rights to a patent family that discloses methods of using TZLS-501 to treat various disorders, licensed from NovImmune S.A. This
patent family includes five granted U.S. patents, one granted European patent, and granted patents in Australia, Canada, China, India,
Israel, Japan, and Mexico. Applications are pending in U.S. and Japan. The patents in this family will expire in May 2029, excluding
any patent term extensions available in several jurisdictions, such as Europe.
We
have rights to a second patent family that discloses methods of using TZLS-501 to treat coronavirus alone and in combination with Actinomycin
D. This patent family includes pending applications in the U.S., Australia, Canada, China, Europe, Israel, and Japan. The patent applications
in this family, if issued as patents, will expire in March 2041, excluding any patent term extensions available in several jurisdictions.
We
also have rights to two patent families related to Actinomycin D (ActD). The first family covers the use of ActD in the treatment of
acute myeloid leukemia, and includes granted patents in the U.S., Australia, Canada, Japan, and Europe. The patents in this family will
expire in September 2036, excluding any patent term adjustment and patent term extension in the U.S. and similar regulatory extensions
available in several other jurisdictions, such as Europe.
66
The
second ActD family covers nanoparticle formulations of ActD and the use of the same in the treatment of acute myeloid leukemia and myelodysplastic
syndrome. In this family, there are granted patents in the U.S. and Japan and pending applications in the U.S., Europe, Australia, Canada,
and Japan. The patents and patent applications in this family, if issued as patents, will expire in September 2037, excluding any patent
term adjustment and patent term extension in the U.S. and similar regulatory extensions available in several other jurisdictions, such
as Europe.
Individual
patents extend for varying periods depending on the date of filing of the patent application or the date of patent issuance and the legal
term of patents in the countries in which they are obtained. Generally, patents issued for regularly filed applications in the United
States are granted a term of 20 years from the earliest effective non-provisional filing date. In addition, in certain instances, a patent
term can be extended to recapture a portion of the USPTO delay in issuing the patent as well as a portion of the term effectively lost
as a result of the FDA regulatory review period. However, as to the FDA component, the restoration period cannot be longer than five
years and the total patent term including the restoration period must not exceed 14 years following FDA approval. The duration of foreign
patents varies in accordance with provisions of applicable local law, but typically is also 20 years from the earliest effective filing
date. However, the actual protection afforded by a patent varies on a product by product basis, from country to country and depends upon
many factors, including the type of patent, the scope of its coverage, the availability of regulatory-related extensions, the availability
of legal remedies in a particular country and the validity and enforceability of the patent.
Furthermore,
we rely upon trade secrets and know-how and continuing technological innovation to develop and maintain our competitive position. We
seek to protect our proprietary information, in part, using confidentiality agreements with our collaborators, employees and consultants
and invention assignment agreements with our employees. We also have confidentiality agreements or invention assignment agreements with
our collaborators and selected consultants. These agreements are designed to protect our proprietary information and, in the case of
the invention assignment agreements, to grant us ownership of technologies that are developed through a relationship with a third party.
These agreements 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. To the extent that our collaborators, employees and consultants use intellectual
property owned by others in their work for us, disputes may arise as to the rights in related or resulting know-how and inventions.
Our
commercial success will also depend in part on not infringing upon the proprietary rights of third parties. It is uncertain whether the
issuance of any third-party patent would require us to alter our development or commercial strategies, or our product candidates or processes,
obtain licenses or cease certain activities. Our breach of any license agreements or failure to obtain a license to proprietary rights
that we may require to develop or commercialize our future product candidates may have an adverse impact on us. If third parties have
prepared and filed patent applications prior to March 16, 2013 in the United States that also claim technology to which we have rights,
we may have to participate in interference proceedings in the USPTO, to determine priority of invention. For more information, see "Risk
Factors—Risks Related to Our Intellectual Property."
67
Material
Agreements
Nerviano
Agreement
In
January 2015, we entered into an agreement with Nerviano, or the Nerviano Agreement, pursuant to which we obtained a worldwide, exclusive
license to patents owned or controlled by Nerviano, or the Nerviano License to develop and commercialize products and services incorporating
Milciclib as an active ingredient, and any product or service controlled or owned by Nerviano that is used to diagnose or assess responsiveness
to Milciclib therapy or dosage. The Nerviano License confers the right on us grant sub-licenses, and otherwise to employ third party
manufacturers and distributors to produce and sell licensed products and services.
Each
party to the Nerviano Agreement agreed to a development plan, or the Nerviano Development Plan, approved by a joint development committee,
or the JDC. The JDC is comprised of at least two members of each party, meets at least twice a year and endeavors to make decisions by
consensus, save that where there is a disagreement with respect to any aspect of the licensed products or services we shall have a deciding
vote.
Under
the Nerviano Development Plan, we (or, as the case may be, our sub-licensee(s)) are obliged to use commercially reasonable efforts to
develop and commercialize a licensed product or service in at least one therapeutic indication that arises out of the Nerviano Development
Plan, and Nerviano is obliged to use commercially reasonable efforts to manufacture such product(s) or service(s). Pursuant to the Nerviano
Development Plan, we have sole responsibility for costs for further clinical development and Nerviano is obliged to perform Phase 2 studies
of licensed products and services, save that the amounts to be invoiced by Nerviano to us for Phase 2 studies shall be commercially reasonable
and not be greater than a low-double-digit percentage in excess than amounts estimated to be invoiced by another reputable clinical research
organization.
During
the term of the Nerviano Development Plan, or the Nerviano Exclusivity Period, we and our affiliates may not, directly or indirectly,
develop, make, use, sell, offer for sale or import any small molecule compound or other biological or chemical molecule other than Milciclib
that directly binds to, with an affinity indicated by an IC50 of 100nM or less, and modulates the following specified pharmacological
targets hit by Milciclib: Cdk-2, Cdc-4 and Cdc6.
Upon
entry into the Nerviano Agreement, we paid an upfront, non-refundable initial license fee of $3,500,000 to Nerviano. We issued 4,233,616
of ordinary shares, fully paid with a nominal value of three pence each, or the Consideration Shares, to Nerviano at an issue price of
50.5 pence (equivalent to an aggregate value of £2,137,976.08).
Nerviano
granted us an option, or the Nerviano Option, to buy-back all the Consideration Shares for a de minimis aggregate consideration exercisable
on written notice at any time after the earlier of:
(i)
an unsuccessful Phase 2
    trial for HCC or breast cancer with a licensed product or service and the concomitant decision of the company, our affiliates or
    sub-licensees to discontinue development of a licensed product or service;
(ii)
the fifth anniversary of
    the Nerviano Agreement, (provided that if on such date a Phase 2 trial has commenced but has not been completed our ability to exercise
    the Nerviano Option shall be delayed until the outcome of the Phase 2 trial has become clear); or
(iii)
our abandonment of any licensed product or service
    for bona fide scientific reasons.
68
The
Nerviano Option cannot be exercised if any of the following events (each, a Release Event), occurs:
(i)
a successful completion
    of a Phase 2 trial for HCC or breast cancer with a licensed product or service, where such successful conclusion renders the licensed
    product or service eligible for entry into a Phase 3 trial with no further clinical study; or
(ii)
our abandonment of the
    development of, or failure to exercise commercially reasonable efforts develop any, licensed product or service, save for where we
    have bona fide scientific reasons.
The
Nerviano Option effectively allows us to recover the Consideration Shares if it transpires that Milciclib proves to be unsuccessful in
the indications for which we licensed it or we fail to see satisfactory results in a period of 5 years from the date of the license agreement.
Prior
to a Release Event, Nerviano has agreed to not transfer, dispose of, or grant options or other rights over directly or indirectly any
interests in the Consideration Shares nor to derive any financial benefit from the Shares, but is entitled to exercise all voting rights
arising from the Consideration Shares.
Following
a Release Event, Nerviano has agreed to a 12 month lock-up, or the Nerviano Lock-Up, in respect of the Consideration Shares, subject
to customary exceptions, including the prior written consent of the company and our nominated adviser from time to time (which consent
may be approved, provided or provided subject to conditions as each may determine in its absolute discretion), acceptance of takeover
bids, share buy-backs by the company, or where required by law.
Following
the lapse of the term of the Nerviano Lock-Up, Nerviano has agreed to not directly or indirectly, transfer, sell, mortgage, charge or
otherwise dispose of more than 10% of the Consideration Shares (i.e. 423,362 ordinary shares) per calendar month, and to utilize the
company's broker from time to time to execute those transactions in respect of the legal and or beneficial ownership or any other
interest in the Consideration Shares so as to ensure an orderly market.
We
are obligated to pay Nerviano the following additional amounts in respect of the first licensed product or service which achieves the
stated development milestones:
(a)
$100,000 upon initiation,
    first patient dosed, or FPD, of the first Phase 3 registration trial in thymic carcinoma.
(b)
$4,000,000 upon FPD of
    the first Phase 3 registration trial in HCC.
(c)
$6,000,000 upon FPD of
    the first Phase 3 registration trial in breast cancer.
(d)
Upon the first NDA equivalent
    in: thymic carcinoma, $900,000; HCC, $9,000,000; breast cancer, $15,000,000.
We
are obliged to pay Nerviano a low-single-digit percentage royalty fee of the annual net sales of licensed products or services, subject
to certain royalty off-sets on a country-by-country basis and, subject to certain exclusions, a low-double-digit percentage of sub-licensing
revenues from the sale of licensed products or services for the life of the licensed patents.
During
the Nerviano Exclusivity Period, we have the right to terminate activities and funding to Nerviano after 24 months from the beginning
of the Nerviano Exclusivity Period but not prior thereto. If we exercise our termination right, we are obliged to transfer to Nerviano
all relevant data, licensed products and services and an exclusive license pertaining to the licensed product or services, and Nerviano
shall pay us a low-single-digit percentage royalty on annual net sales of licensed products and services, subject to certain exceptions.
Following
the expiry of the Nerviano Exclusivity Period, we may terminate the Nerviano Agreement at any time on 90 days' written notice,
and either party may terminate the Nerviano Agreement for material breach by the other party of any material obligation or condition
of the Nerviano Agreement by written notice, subject to a 45 day cure period for a payment breach, and a 120 day cure period for any
other breach.
69
Absent
early termination, the Nerviano Agreement shall remain in force until the later of, in all countries in which licensed products and services
are marketed pursuant to the Nerviano Agreement, (a) the expiration of the last claim in an issued, unexpired patent within the licensed
patents, subject to certain exceptions, which covers the sale of such licensed products or services, or (b) five years from the date
of first commercial sale of such licensed product or service in such country.
Novimmune
CD3 Agreement
In
December 2014, we entered into a license and sublicense agreement with Novimmune, or the Novimmune CD3 Agreement, pursuant to which we
obtained a worldwide, exclusive license to certain patents owned or controlled by Novimmune, or the Novimmune CD3 License, together with
a sublicense to certain patent licenses from Bristol-Myers Squibb Company, or BMS, or the BMS CD3 Sublicense, and any associated know-how,
biologic materials, clinical data or other technology relating to CD3 receptor mAbs and their use in order to research, develop and commercialize
products and services. The Novimmune CD3 License and BMS CD3 Sublicense both confer the right to us to grant sublicenses, and otherwise
to employ third party manufacturers and distributors to produce and sell licensed products and services, respectively.
Pursuant
to the Novimmune CD3 Agreement, Novimmune granted the BMS CD3 Sub-License to us. Novimmune effected such grant pursuant to a research
and commercialization agreement between Novimmune and BMS dated September 20, 2014, or the BMS R&C Agreement, and the agreement for
the exclusive commercial license for the CD3 licensed product (NI-0401) between Novimmune and BMS dated February 2005.
Under
the Novimmune CD3 Agreement, we have full control and authority over the research, development and commercialization of licensed products
and services, and are required to exercise commercially reasonable efforts to commercialize such licensed products and services at all
times.
Upon
our entry into the Novimmune CD3 Agreement we paid an upfront fee of $750,000 to Novimmune (to be on paid by Novimmune to BMS pursuant
to the terms of the BMS R&C Agreement), and a further upfront fee of $500,000 to Novimmune. We are required to pay Novimmune installments
of $250,000 on each of the 14 month, 26 month and 38 month anniversaries of the date of the Novimmune CD3 Agreement. For the term of
the Novimmune Agreement, we are obligated to pay to Novimmune a royalty of a low-single-digit percentage on net sales of licensed products
and services, together with any amounts owed to BMS incurred pursuant to the BMS CD3 Sub-License.
We
may terminate the Novimmune CD3 Agreement at any time on 90 days' written notice, and either party may terminate the Novimmune
CD3 Agreement by written notice for a payment breach or any other breach, subject to 45 day and 120 day cure periods, respectively. Absent
early termination, the Novimmune CD3 Agreement will continue until the later of, in all countries in which licensed products are marketed
pursuant to the Novimmune CD3 Agreement, (a) the expiration of the last claim in an issued, unexpired patent within the licensed patents
or a claim that has not been pending more than five years, subject to certain exceptions, which covers the sale of such licensed product
or service, or (b) the end of any market exclusivity period granted by the relevant governmental authority in a country that prevents
another party from marketing the same licensed product or service.
70
Novimmune
IL-6r Agreement
In
December 2016, we entered into a license and sublicense agreement with Novimmune, or the Novimmune IL-6r Agreement, pursuant to which
we obtained a worldwide, exclusive license to certain patents owned or controlled by Novimmune, or the Novimmune IL-6r License, together
with a sub-license to certain patent licenses from BMS, or the BMS IL-6r Sub-License, and any associated know-how, biologic materials,
clinical data or other technology relating to IL-6r mAbs and their use in order to research, develop, commercialize products and services.
The Novimmune IL-6r License and BMS IL-6r Sub-License both confer the right to us to grant sub-licenses, and otherwise to employ third
party manufacturers and distributors to produce and sell licensed products and services, respectively.
Pursuant
to the Novimmune IL-6r Agreement, Novimmune granted the BMS IL-6r Sub-License. Novimmune effected such grant pursuant to the BMS R&C
Agreement and the agreement for the IL-6r exclusive commercial license for the IL-6r antibody licensed product (NI-1201) between Novimmune
and BMS dated September 20, 2009, or the IL-6r Commercial License Agreement.
Under
the Novimmune IL-6r Agreement, we have full control and authority over the research, development and commercialization of licensed products
and services, and are required to exercise commercially reasonable efforts to commercialize such licensed products and services at all
times.
Upon
our entry into the Novimmune IL-6r Agreement we paid an upfront fee of $100,000 to Novimmune. For the term of the Novimmune IL-6r Agreement,
we are obligated to pay to Novimmune a royalty of a low-single-digit percentage on net sales of licensed products and services, or low-double-digit
percentage of any sub-license royalty revenue which we receive that arises from sales of licensed products and services, together with
any amounts owed to BMS incurred pursuant to the BMS IL-6r Sub-License.
The
BMS R&C Agreement and the IL-6r Commercial License Agreement were amended pursuant to an agreement between Novimmune and BMS dated
December 2016, or the Novimmune Amendment Agreement. Pursuant to the Novimmune Amendment Agreement, in the event that Novimmune (or,
as the case may be, a sublicensee) commercializes a combination product comprising NI-1201 and NI-0401, then such product shall be subject
to a single royalty.
We
may terminate the Novimmune IL-6r Agreement at any time on 90 days' written notice, and either party may terminate the Novimmune
IL-6r Agreement by written notice for a payment breach or any other breach, subject to 45 day and 120 day cure periods, respectively.
Absent early termination, the Novimmune IL-6r Agreement will continue until the later of, in all countries in which licensed products
are marketed pursuant to the Novimmune IL-6r Agreement, (a) the expiration of the last claim in an issued, unexpired patent within the
licensed patents or a claim that has not been pending more than five years, subject to certain exceptions, which covers the sale of such
licensed product or service, or (b) the end of any market exclusivity period granted by the relevant governmental authority in a country
that prevents another party from marketing the same licensed product or service.
71
Brigham
and Women's Hospital License
On
May 29, 2018, we entered into a license agreement, or the BWH License, with BWH pursuant to which we obtained a worldwide exclusive license
to a patent owned by BWH for a novel technology discovered by Dr. Howard Weiner. The patent relates to a formulation of Foralumab in
a medical device developed for nasal administration of Foralumab. The BWH License extends to any associated know-how, clinical data and
use in order to research, develop and commercialize products and services. The BWH License confers on us the right to grant sub-licenses,
and otherwise to employ third party manufacturers and distributors to sell licensed products and services.
Under
the BWH License we have full control and amnesty over the research, development and commercialization of licensed products and services
and are required to exercise commercially reasonable efforts to commercialize such licensed products and services at all times.
Upon
our entry into the BWH License we paid an upfront fee of $10,000 to BWH. We are required to pay annual maintenance fees, all ongoing
patent maintenance and prosecution costs and a low single-digit royalty on annual net sales (and a 12% royalty of non-royalty sub-license
revenues for the life of the intellectual property). We are also obliged to make certain milestone payments of: (a) US$300,000 within
60 days of first patient enrolled in a Phase 1 human clinical trial; (b) US$600,000 within 60 days of first patient enrolled in a Phase
2 human clinical trial; (c) US$1,500,000 within 60 days of first patient enrolled in a Phase 3 clinical trial; and (d) US$3,000,000 within
60 days of first commercial sale of a licensed product.
We
may terminate the BWH License at any time on 90 days' written notice, and either party may terminate the BWH License by written
notice for payment or other breach, subject to a 60 day cure period. Absent early termination the BWH License will remain in effect until
the date on which all patents and filed patent applications have expired or been abandoned.
C.
Organizational Structure
The
following table sets out details of the Company's significant subsidiaries:
Name
Principal
    activity
Registered
    address
Percentage
shareholding
Country
    of
incorporation
Tiziana Life
    Sciences Ltd
Clinical stage
    biotechnology company
107 Cheapside,
    London EC2V 6DN
100
%
England
    & Wales
Tiziana Pharma Limited
Clinical stage biotechnology
    company
107 Cheapside, London
    EC2V 6DN
100
%
England
    & Wales
Tiziana Therapeutics Inc.
Clinical stage biotechnology
    company
5
                                       Penn Plaza, Floor 19
New
    York , NY 10001
100
%
USA
Longevia Genomics S.r.l.
Biotechnology discovery
    company
Via Constantinopli 42
09100- Cagliria (CA)
100
%
Italy
D.
Property, Plant and Equipment
The
below table contains information regarding existing or planned material tangible fixed assets owned or leased by Tiziana and its subsidiaries.
We believe that suitable additional or substitute space will be available as needed to accommodate any future expansion of our operations.
Location
Tenure
Principal
    Use
Size
14-15
        Conduit Street
London
    W1S 2XJ, United
Kingdom
4-year Lease
Principal Office
821 square feet
5
        Penn Plaza
19
th
Floor
New
    York, United States
Monthly lease
Principal Office
450 square feet
601 New Britain Road
Building 100, Suite 102
Doylestown, PA, United States
Annual lease
Research & Development Centre
408 square feet
72
ITEM
4A: UNRESOLVED STAFF COMMENTS
Not
applicable.
ITEM
5: OPERATING AND FINANCIAL REVIEW AND PROSPECTS
You
should read the following discussion and analysis of our financial condition and results of operations together with "Selected
Consolidated Financial Data" and our consolidated financial statements and the related notes thereto appearing at the end of this
Annual Report. We present our consolidated financial statements in U.S. dollars and in accordance with International Financial Reporting
Standards, or IFRS, as issued by the International Accounting Standards Board, or IASB.
Some
information included in this discussion and analysis, including statements regarding industry outlook, our expectations regarding our
future performance, liquidity and capital resources and other statements regarding our plans and strategy for our business and related
financing, are forward-looking statements. These forward-looking statements are subject to numerous risks and uncertainties. You should
read the "Risk Factors" section of this Annual Report for a discussion of important factors that could cause actual results
to differ materially from the results described in or implied by the forward-looking statements contained in the following discussion
and analysis.
We
maintain our books and records in Pounds Sterling, and we prepare our financial statements in accordance with IFRS as issued by the IASB.
We report our financial results in U.S. dollars.
Overview
Introduction
to Tiziana
We
are a biotechnology company that is focused on the discovery and development of novel molecules and related diagnostics to treat high
unmet medical needs in oncology and immunology. Our lead product candidate in immunology is Foralumab (TZLS-401), which we believe is
the only fully human anti-CD3 monoclonal antibody, or mAb, in clinical development. MAbs represent a single pure antibody produced by
single clones and are an important class of human therapeutics for treating cancers and autoimmune diseases. Generation of antibodies
for use in humans developed in animals, leads to strong, immune responses limiting their effectiveness and potentially leading to severe
side effects. A process known as "humanization" removes most of the animal components of the antibody thereby lowering the
immune response from the human immune system. The entire omission of other animal material, as in fully human antibodies, is the optimal
goal to avoid incompatibility with the human immune system. Our lead product candidate in oncology is Milciclib (TZLS-201), which is
an orally bioavailable, small molecule broad spectrum inhibitor of cyclin-dependent kinases, or CDKs, and Src family kinases. CDKs are
a highly conserved family of enzymes that phosphorylate a specific group of proteins that are involved in regulating the cell cycle.
The cell cycle is a series of events that takes place in cells leading to division and duplication of its DNA to produce two daughter
cells. Src family kinases are non-receptor tyrosine kinase proteins encoded by the Src gene also involved in regulating cell growth and
potential transformation of normal cells to cancer cells. We are developing a fully human mAb targeting the IL-6R (TZLS-501) for which
the intellectual property was licensed from Novimmune in January 2017. This fully human mAb has a novel mechanism of action, binding
to both the membrane-bound and soluble forms of the IL-6R as well as depleting circulating levels of the IL-6 in the blood. Excessive
production of IL-6 is regarded as a key driver of acute inflammation resulting from infection with viral agents such as Coronaviruses
and of chronic inflammation, associated with autoimmune diseases such as multiple myeloma, oncology indications and rheumatoid arthritis,
and we believe that TZLS-501 may have potential therapeutic value for these indications.
We
employ a lean and virtual research and development, or R&D, model using highly experienced teams of experts for each business function
to maximize value accretion by focusing resources on the drug discovery and development processes. Our mission is to design and deliver
next generation therapeutics and diagnostics for oncology and immune diseases of high unmet medical need by combining deep understanding
of disease biology with clinical development expertise.
73
We are developing Foralumab,
for which we in-licensed the intellectual property from Novimmune SA, or Novimmune, in December 2014, as a potential treatment for neurodegenerative
diseases such as Secondary Progressive Multiple Sclerosis (SPMS), Crohn's disease and delayed onset of Type I Diabetes (T1D). On
November 10, 2022, Tiziana announced a short-term focus on administration of intranasal foralumab for treatment of neurodegenerative diseases,
especially SPMS, based on positive clinical findings of Expanded Access (EA) SPMS patients at Brigham and Women's Hospital treated
with intranasal foralumab for up to 1 year. As the only fully human engineered human anti-CD3 mAb in clinical development, Foralumab has
significant potential advantages such as a shorter treatment duration and reduced immunogenicity. We believe that oral or intranasal administration
of Foralumab has the potential to reduce inflammation while minimizing the toxicity and related side effects. To date, Foralumab has been
studied in one Phase 1 and two Phase 2a clinical trials conducted by Novimmune in 68 patients dosed by the intravenous route of administration.
In these trials, Foralumab was observed to be safe and well-tolerated and produced immunologic effects consistent with potential clinical
benefit while demonstrating mild to moderate infusion related reactions, or IRRs. With completion of the intravenous dosing for Phase
2a trial in Crohn's Disease, Foralumab's ability to modulate T-cell response enables potential extension into a wide range
of other autoimmune and inflammatory diseases, such as Graft versus Host Disease (GvHD), ulcerative colitis (UC), multiple sclerosis(MS),
type-1 diabetes (T1D), inflammatory bowel disease (IBD), psoriasis (PSA) and rheumatoid arthritis (RA).
Foralumab
is being developed as both an immunosuppressive and immunomodulatory agent, with therapeutic benefits of rendering T-cells unable to
orchestrate an immune response and induction of immune tolerance via maintenance of regulatory T-cells. There is further potential for
Foralumab to be combined with the Company's TZLS-501, a fully human anti-IL-6R mAB in development to target autoimmune and inflammatory
diseases.
In
November 2016, Tiziana announced new data for oral efficacy in humanized mouse models with Foralumab, a major milestone and a potential
breakthrough for the treatment of NASH and autoimmune disease. This unique oral technology stimulates the natural gut immune system and
potentially provides a therapeutic effect in inflammatory and autoimmune diseases with greatly reduced toxicity. Positive therapeutic
effects with Foralumab were consistently demonstrated in animal studies conducted by Prof. Kevan Herold (Yale University) and Prof. Howard
Weiner (Harvard University).
On
16 April, 2018, the Group entered into an exclusive license agreement with The Brigham and Women's Hospital, Inc. relating to a
novel formulation of Foralumab dosed in a medical device for nasal administration. An investigational new drug application (IND) for
the first-in-human evaluation of the nasal administration of Foralumab in healthy volunteers for progressive multiple sclerosis indication
was filed in the second quarter of 2018. Subsequent to IND approval, a single-site, double-blind, placebo-controlled, dose-ranging Phase
1 trial with nasally administered Foralumab at 10, 50 and 250 µg per day, consecutively for 5 days to evaluate biomarkers of immunomodulation
of clinical responses was initiated in November 2018. The trial conducted at the Brigham and Women's Hospital, Harvard Medical
School, Boston, MA, in healthy volunteers. 18 subjects received Foralumab treatment and 9 patients received placebo. The study was completed
in September 2019. Phase 1 clinical data demonstrated that nasally administered Foralumab, was well-tolerated and no drug-related safety
issues were reported at any of the doses. No drug-related changes were observed in vital signs among subjects at predose, during treatment
and at discharge. Nasally administered Foralumab at the 50 µg dose suppressed cytotoxic CD8+ as well as perforin-secreting CD8+
cells, which have been implicated in neurodegeneration in multiple sclerosis (MS). Treatment at 50 µg stimulated production of
anti-inflammatory cytokine IL-10 and suppressed production of pro-inflammatory cytokine IFN-γ. Taken together, the treatment showed
significant positive effects on the biomarkers for activation of mucosal immunity, which are capable of inducing site-targeted immunomodulation
to elicit anti-inflammatory effects. . Systemic levels of Foralumab were below the lower quantitation limit of 8 ng/mL suggesting
that nasally administered Foralumab appears to exert its effects via nasal epithelium utilizing local and lymphatic immune systems directly.
These data support other clinical and pre-clinical studies showing that this route of administration is capable of inducing site-targeted
immunomodulation and anti-inflammatory effects. Furthermore, these pharmacodynamic data point to a clinical dose range that Tiziana intends
to test in further clinical development among MS patients.
On
September 9, 2019, the FDA granted approval to initiate the Phase 1 clinical trials to evaluate the safety and pharmacokinetics
of a novel enteric-coated capsule formulation of oral Foralumab at 1.25, 2.5 and 5.0 mg/day as a single ascending dose study. The study
was completed in December 2019 at Brigham and Women's Hospital (Boston, MA USA). A total of 12 subjects were enrolled; 9 received
the single dose of foralumab and 3 received placebo. The median age (range) for the oral foralumab subjects was 23 (21 – 55) years,
and for the placebo subjects it was 34 (27 – 51). Of the foralumab subjects, 6 were male and 3 were female. All 3 of the placebo
subjects were female. No subjects discontinued the study. Formulated Foralumab powder blend encapsulated in enteric-coated capsule was
well-tolerated at all doses tested and there were no drug-related safety issues observed even at the highest dose of 5 mg in this trial.
74
Tiziana
initiated a Phase 1b clinical trial in Crohn's disease patients to evaluate oral capsules of foralumab, a fully human anti-CD3
monoclonal antibody. The revised protocol allowed for the study of a broader patient population and a shorter dosing period. These protocol
amendments or revisions were intended to expedite patient enrollment with study completion targeted for the fourth quarter of 2022. This
study was the first multiple-dose study with orally administered enteric-coated capsules of foralumab in patients with Crohn's
disease. Due to the refocus of the company after the first six months of 2022, this study has been withdrawn.
A
collaborative clinical trial was initiated on November 2, 2020 in Brazil investigating nasally administered Foralumab, either
alone or in combination with orally administered dexamethasone ("Dexa") in COVID-19 patients. The clinical study was completed
in collaboration with scientific teams at the Harvard Medical School (Boston, USA), and INTRIALS, a full-service Latin American
CRO based in São Paulo, Brazil. The objectives of the trial were to assess safety of the treatment and to evaluate if
progression of the diseases is delayed with nasally administered 100mcg/day Foralumab (50mcg/nostril). This study enrolled 39 patients
randomized in three cohorts: cohort 1, control with no treatment (n=16); cohort 2; nasally administered Foralumab plus 3 days of priming
with orally administered 6 mg Dexamethasone (n=11) and cohort 3; nasally administered Foralumab (n=12). The Foralumab treatment regimen
was once a day dosing for 10 consecutive days. The trial was completed in January 2021. There were no significant differences between
cohort 2 and 3. All treatments were well-tolerated. There were no grade 3 or 4 severe adverse events ("SAEs") in any of the
cohorts
.
The CT scans of the lungs showed the improvement was approximately double that shown in patients treated with Foralumab
as compared to those in the control group.   The results of the study were published in the peer-reviewed journal,
Frontiers
in Immunology
entitled "Nasal Administration of Anti-CD3 Monoclonal Antibody (Foralumab) Reduces Lung Inflammation and
Blood Inflammatory Biomarkers in Mild to Moderate COVID-19 Patients: A Pilot Study" in August 2021. This program has been
temporarily paused to pursue the short-term focus on clinical development of intranasal foralumab administration for treatment of SPMS
patients.
On
September 2, 2021 the Company and Precision BioSciences Inc announced an exclusive license agreement to explore Foralumab as an agent
to induce tolerance of allogeneic CAR T cells to potentially improve the clinical outcome of CAR T cell therapy. Precision's approach
to manufacturing produces CAR T cells that are virtually CD3-negative. Foralumab will be used as a lymphodepletion or tolerizing agent,
either alone or in combination with other co-stimulatory molecules, to improve the long-term survival of CAR T cells in cancer treatment.
Tiziana has completed manufacture of foralumab solution for injection to be used by Precision Biosciences.
On
May 25, 2021 the Company announced that the first expanded access (EA) patient with secondary progressive multiple sclerosis (SPMS)
was dosed with nasally administered Foralumab at the Brigham and Women's Hospital (BWH), Harvard Medical School, Boston,
MA. Nasal Foralumab 50 mcg (25 mcg/nostril) was administered in 3-week cycles, with 3 times/week dosing for the first 2 weeks followed
by 1 week of rest period. This first-ever clinical study in SPMS patients, under an Individual Patient Expanded Access IND, was to continue
for six months to evaluate routine safety, tolerability, and neurological behaviors. The study also examined microglial activation, by positron
emission tomography (PET), immunological and neurodegenerative markers to assess clinical responses following the dosing regimen
On
March 10, 2022, the Company reported positive clinical data in the first EA SPMS patient following completion of six months of treatment
with intranasally administered foralumab, at the Brigham and Women's Hospital (BWH), Harvard University, Boston, MA. In
addition to being well-tolerated, both biological and clinical improvements were seen in this patient using Tiziana's novel immunotherapy
technology, which, importantly overcame the challenge of delivering this antibody across the blood-brain barrier to affect immunomodulation
in the brain using nasal administration.
Foralumab
was given to an EA SPMS patient intranasally into each nostril on a regimen of M-W-F for two weeks followed by one week off therapy for
a period of six months. This regimen was well-tolerated with associated beneficial clinical and biomarker changes. Importantly, the PET
imaging data indicated inhibition of microglial cell activation observed at 3 months following treatment initiation and was sustained
at 6 months after treatment start (see Table 1). The reduction in microglial activation was seen in all parts of the brain.
75
Table
1. Percent Reduction* in Activated Microglial Cells (AMCs) PET Signal After Starting Intranasal Foralumab as Compared to Baseline, in
Whole Brain and Selected Brain Regions
WHOLE
BRAIN
CEREBRAL
CORTEX
THALAMUS
WHITE
MATTER
CEREBELLUM
3 MONTHS
-23
%
-23
%
-20
%
-25
%
-22
%
6 MONTHS
-38
%
-38
%
-50
%
-36
%
-38
%
*
Percent reduction is based
    on changes from baseline in SUVR-1, a surrogate index for PET binding potential. SUVR=Standardized Uptake Value Ratio, calculated
    with reference to a pseudo reference region in cerebral white matter that showed minimal change in PET SUV, across time points.
Consistent
with clinical and PET observations, intranasally administered foralumab also downregulated serum levels of pro-inflammatory cytokines,
including interferon-gamma (IFN-g), interleukin (IL-18), IL-1β and IL-6, which are associated with multiple sclerosis pathogenesis
and progression. Clinical evaluation showed improvement in Timed 25-Foot Walk Test (T25FW), 9-Hole Peg Test (9HPT) and Symbol
Digit Modality Test (SDMT). Other published PET studies have shown an increase in activated microglial cells (AMCs) in patients with
secondary progressive MS (SPMS), and the increase in AMCs associated with higher scores on the Expanded Disability Status Scale (EDSS),
a widely-used scale to measure disability
1,2
. Several FDA-approved drugs, such as TYSABRI
®
, MAYZENT
®
and
ZEPOSIA
®
have been shown to suppress microglial activation and exert neuroprotective effects in the central nervous
system (CNS) in animal studies but longitudinal assessment of drug effects on microglial activation in exclusive cohorts of SPMS patients
are lacking.
Prior
to treatment, this patient had continued to experience worsening disease progression despite several MS therapies, including B cell depletion.
The patient's gait and limb strength had been deteriorating over the prior two years. The patient then started on intranasal foralumab,
which stabilized his disease course. Tiziana also received FDA authorization to continue treating this patient for an additional 6 months
to determine if 12 months of consistent treatment maintains clinical stabilization and provides sustained clinical benefits.
On
January 20, 2022, FDA approved enrollment of a second EA SPMS patient for treatment with intranasal foralumab.
These
data were presented in a virtual Key Opinion Leader (KOL) event hosted by Tiziana on March 14
th
, 2022, entitled "Foralumab
Clinical Update in Multiple Sclerosis; A Landmark Study with Intranasal Immunotherapy" featuring four Key Opinion Leaders and a
live Q&A session. The company plans to continue treatment of EA SPMS patients at Brigham and Women's Hospital and elsewhere
and continue evaluation of foralumab treatment.
On
April 5, 2022, Tiziana announced that FDA granted permission to enroll up to eight additional (SPMS) patients in Intermediate Size Patient
Population in the EAP with intranasal foralumab. As part of the original treatment plan, the foralumab dose will remain 50 mcg three
times a week (MWF), which is the same dose administered previously to the first two SPMS patients. The dosing regimen in this IND also
has a provision for dose escalation up to 100 mcg three times a week (MWF) as an option to improve clinical benefit, if needed.
Data
from a Secondary Progressive Multiple Sclerosis patient treated with intranasal foralumab were presented on June 2, 2022 at
the consortium of multiple sclerosis centers (CMSC) 2022 annual meeting. Dr. Tanuja Chitnis, MD, Professor of Neurology and the
Principal investigator of the clinical study at the at the Brigham and Women's Hospital (BWH), Boston, MA., presented a poster
discussing clinical data from a patient with SPMS, who was treated with intranasal foralumab for six months.
On
June 8, 2022, Tiziana announced positive clinical results for the second patient (EA2) in the non-active SPMS Expanded Access (EA) Program
following three months of dosing with intranasal foralumab. These results confirm the previously reported data, from the first non-active
SPMS patient (EA1) that after three months of treatment, intranasal foralumab. was well-tolerated and improved clinical and PET imaging
analyses. The second patient was diagnosed with SPMS in 2014. Since then, the disease has been progressive, resulting in an accumulation
of disability. Patient EA2 started ocrelizumab in 2018 and stopped this treatment in 2021. During this time EA2's non-active SPMS
progressed as measured by EDSS worsening from 3.5 in 2018 to 6.0 in 2021. At this point in time EA2 needed a cane to walk 100 meters.
Patient EA2 was subsequently enrolled in the intranasal foralumab expanded access program. On September 2022, 8 months after starting
treatment with intranasal foralumab, EA2 was able to walk 100 meters without a cane or need to rest. This improved the EDSS from 6.0
to 5.5. EA2's pyramidal score remained stable during this time. In December 2022, 11 months after starting treatment with
intranasal foralumab, EA2 was able to walk 200 meters without a cane or need to rest, resulting in further improvement in EDSS from 5.5
to 5.0. EA2's pyramidal score continued to remain stable. Lastly preliminary reading of EA2's 11-month PET Scan (December
2022) demonstrated improvement in microglial activation over baseline.
76
On September
20, 2022, Tiziana announced that the second patient ("EA2") with non-active secondary progressive multiple sclerosis (SPMS)
receiving intranasal foralumab had shown additional clinical improvements as measured by the Expanded Disability Status Scale (EDSS),
a standard clinical assessment.
On
October 12, 2022, Tiziana announced that it planned to submit an Investigational New Drug Application (IND) for a Phase 1 Trial of intranasal
foralumab in Alzheimer's disease patients after receiving an affirmative written response from the FDA on a Pre-Investigational New Drug
Application (PIND). Tiziana plans on filing the IND for Alzheimer's disease by the third quarter of 2023 upon the completion of
requested toxicology studies, then starting its Phase 1 program by the end of 2023.
On November
2, 2022, Tiziana announced the completion of enrollment of the first patient cohort in its Intermediate Size Patient Population Expanded
Access Program to evaluate foralumab in non-active SPMS patients.
On November
10, 2022, Tiziana announced its near-term focus on developing intranasal foralumab for inflammatory diseases of the Central Nervous System
(CNS) such as non-active SPMS, Alzheimer's disease and amyotrophic lateral sclerosis (ALS).
During
2022, Tiziana completed compatibility, stability and characterization studies of foralumab nasal solution in unit dose devices for nasal
administration. Compatibility, stability and characterization studies of foralumab intranasal solution in multi dose device for intranasal
administration will be completed in Q1 2023.
We are evaluating administrations
of Foralumab to delay onset and progression of T1D in at-risk individuals. T1D is characterized as a chronic and progressive autoimmune
disease leading to the destruction of insulin-producing β-cells of the pancreas. Teplizumab (Provention Bio), a humanized Fc-mutated
anti-CD3 monoclonal antibody that alters the function of the T-lymphocytes that mediate the destruction of the insulin-producing β-cell
is seeking FDA approval. The Company believes that Foralumab, a fully human anti-CD3 mAb, would have a better safety profile and clinical
benefit than Teplizumab based on Foralumab's fully human protein sequence and binding affinity for CD3e compared to Teplizumab.
cGMP manufacturing of Foralumab solution for subcutaneous injection was initiated in April 2022 and IND submission is anticipated in 2023.
This program has been temporarily paused to pursue the short-term focus on clinical development of intranasal foralumab administration
for treatment of SPMS patients.
In
2022, Tiziana initiated five Good Laboratory Practice (GLP) safety toxicology studies of foralumab administered intranasally and subcutaneously
in HuGEMM CD3 transgenic mice. The five studies consisted of three intranasal toxicology studies of 14 days, 13 weeks and 26 weeks dosing
duration and two subcutaneous safety toxicology studies of 14 days and 28 days dosing duration. On December 15, 2022 the Company
announced that it had successfully completed the 13-week toxicology trial and that intranasal foralumab was well-tolerated.
In
addition, on August 18, 2020 the United States Patent and Trademark Office, or USPTO, granted us a patent on use and methods of treatment
of Crohn's disease with Foralumab, its proprietary fully human monoclonal antibody, and all other anti-CD3 mAbs. The CD3 (cluster
of differentiation 3) is a protein complex on T-cells, which is important for the regulation of the immune system. The patent was published
by the USPTO on September 1, 2020 as Patent No. 10,759,858. Recently, we also announced the issuance of the first-ever patent
on oral administration of anti-CD3 mAbs for treatment of human diseases (Patent No. 10,688,186). We believe the grant of this additional
composition-of-matter and use patent further strengthens our intellectual property, consisting of proprietary technologies on oral and
nasal administration of Foralumab and other anti-CD3 mAbs for the treatment of human diseases.
On
July 16, 2020, we announced that we had submitted a patent application on the potential use of Foralumab, a fully human anti-CD3
mAbs, to improve success of chimeric antigen receptor T-cell, or CAR-T, therapy for cancer and other human diseases. The patent application
conveys inventions related lymphodepletion to improving CAR-T expansion and/or survival using anti-CD-3 mAbs administered either alone
or in combination with other co-stimulatory molecules, such as an anti-IL-6R mAb, an anti-CD28 mAb or specific inhibitors of signaling
pathways of phosphatidylinositol 3-kinase (PI3K), protein kinase B (AKT), or mammalian target of rapamycin (mTOR).
On
July 31, 2020, we announced that we had submitted a patent application for the potential use of nasally administered Foralumab, a fully
human anti-CD3 mAb, for the treatment of COVID-19 either alone or in combination with other anti-viral drugs. Recent clinical studies
implied that a combination of anti-inflammatory and anti-viral drugs may be more effective to treat patients at different stages of COVID-19
disease.
We
are developing a fully human mAb targeting the IL-6R (TZLS-501) for which the intellectual property was licensed from Novimmune in January
2017. This fully human mAb has a novel mechanism of action, binding to both the membrane-bound and soluble forms of the IL-6R as well
as depleting circulating levels of the IL-6 in the blood. Excessive production of IL-6 is regarded as a key driver of acute inflammation
resulting from infection with viral agents such as Coronaviruses and of chronic inflammation, associated with autoimmune diseases such
as multiple myeloma, oncology indications and rheumatoid arthritis, and we believe that TZLS-501 may have potential therapeutic value
for these indications.
77
In
preclinical studies, TZLS-501 demonstrated the potential for overcoming the limitations of other IL-6 blocking pathway drugs. Compared
to tocilizumab and sarilumab, while binding to the membrane-bound IL-6R complex, TZLS-501 has been observed to have a higher affinity
for the soluble IL-6 receptor from antibody binding studies conducted in cell culture. TZLS-501 also demonstrated the potential to block
or reduce IL-6 signaling in mouse models of inflammation. The soluble form of IL-6 has been implicated to have a larger role in disease
progression compared to the membrane- bound form (Kallen, K.J. (2002). "The role of trans-signaling via the agonistic soluble IL-6
receptor in human diseases." Biochimica et Biophysica Acta. 1592 (3): 323–343.)
The
Company is developing TZLS--501 for treatment of SSc-ILD. Tocilizumab (Actemra®, Roche) a humanized interleukin-6 (IL-6) receptor
mAb antagonist. was approved by the FDA as a subcutaneous injection for slowing the rate of decline in pulmonary function in adult patients
with systemic sclerosis-associated interstitial lung disease (SSc-ILD), a debilitating condition with limited treatment options. Actemra®
is the first biologic therapy approved by the FDA for the treatment of the disease.
On
April 9, 2020 The Company announced that it had developed investigational new technology to treat COVID-19 infections, consisting of
direct delivery of anti-IL-6 receptor (anti-IL-6R) monoclonal antibodies (mAbs) into the lungs using a handheld inhaler or nebulizer
for treatment of patients infected with COVID-19 (SARS-CoV-2) coronavirus. On June 29, 2020 the Company announced that it was
advancing GMP manufacturing of TZLS-501 with STC Biologics concurrently with the development of inhalation technology using a hand-held
nebulizer with Sciarra Laboratories and safety toxicology studies in Cynomolgus monkeys with ITR Canada Laboratories. GMP batches were
initiated in January 2021 and completed in March 2021. Safety inhalation toxicology studies were initiated in November 2020 and completed
in March 2021. Technological assessment of nebulizers for inhalation treatment of patients was initiated in September 2020 and completed
in February 2021. An additional 240L cGMP batch of TZLS-501 drug substance was manufactured using an improved downstream process to support
future development activities in June 2022. An IND for a Phase 1 Clinical Trial in Healthy Subjects for treatment of interstitial lung
disease associated with systemic sclerosis (SSc ILD) was filed in December 2022. This program has been temporarily paused to pursue the
Company's short-term focus on clinical development of intranasal foralumab administration for treatment of SPMS patients.
We
are developing Milciclib, for which we in-licensed the intellectual property from Nerviano Medical Sciences S.r.l., or Nerviano, in January
2015, as a potential treatment for pan KRAS mutations in NSCLC patients.
To
date, Milciclib has been studied in a total of eight completed Phase 1 and 2 clinical trials in 316 patients.
Cumulative
Patient Exposure in Completed Milciclib Clinical Studies:
Clinical Study
Drug
Indication
Number of
Patients Treated
CDKO-125a-001 Phase 1
Milciclib
Solid tumors
37
CDKO-125a-002 Phase 1 / Phase 2
Milciclib
Malignant glioma (Phase 1)
Glioblastoma (Phase 2)
62
CDKO-125a-003 Phase 1
Milciclib
Solid tumors
30
CDKO-125a-004 Phase 1
Milciclib + gemcitabine
Solid tumors
16
CDKO-125a-005/-0061/-0071 Phase 2
Milciclib
Malignant Pleural
Mesothelioma (-005)
Thymic carcinoma and malignant thymoma (-0061
    and -0071)
140
CDKO-125a-010 Phase 2
Milciclib
HCC monotherapy
31
Total Patients Exposed
316
Source:
Development Safety Update Report No. 8, February 28, 2019, Tiziana Life Sciences PLC; Investigator Brochure, Version 14, 2019.
In
these trials, Milciclib was observed to be well-tolerated and showed initial signals of anti-tumor action. Prior to in-licensing, Milciclib
was granted orphan designation by the European Commission and by the U.S. Food and Drug Administration ("FDA") for the treatment
of malignant thymoma and an aggressive form of thymic carcinoma in patients previously treated with chemotherapy. In two Phase 2a trials,
CDKO-125a-006 and CDKO125a-007, Milciclib showed signs of slowing disease progression and acceptable safety.
In
the first half of 2017, the Group initiated a Phase 2a trial (CDKO-125a-010) of Milciclib to explore safety, tolerability and antitumor
activity of milciclib as a single therapy in Sorafenib-resistant patients with unresectable or metastatic HCC and good liver function..
Typically, this population of patients have an advanced form of the disease with poor prognosis and an average overall survival expectancy
of 3-5 months. The compound was administered as home-based treatment at the dose of 100 mg/day for 4 consecutive days a week in a 4-week
cycle (4 days on/3 days off x q4 wks) for a total of 24 weeks. The Phase 2a trial was completed in June 2019 with clinical safety result
reported in July 2019 and efficacy results reported in September 2019. The drug was well tolerated and the trial met clinical endpoints.
Since
overexpression of CDKs and dysregulation in pRB pathway (regulates transcription factors critical for cell cycle progression) are prominently
associated with tumor cell resistance to certain chemotherapeutic drugs, inhibition of multiple CDKs is an appealing approach to improve
clinical responses in cancer patient's refractory to existing treatment options. A Phase 1 dose-escalation study of Milciclib
in combination with gemcitabine in patients with refractory solid tumors exhibited clinical activity in patients including those refractory
to gemcitabine. Milciclib shows inhibitory effects against multiple cell lines with mutationally active G12D (non-small cell lung carcinoma),
G13D (colorectal cancer), G12V(pancreatic cancer), and G12C (pancreatic cancer
The Company also intends to evaluate milciclib
in combination with gemcitabine for treatment of pan KRAS mutations in NSCLC patients. cGMP manufacturing of milciclib capsules was completed
in January 2022 and IND filing was completed on December 15, 2022. This program has been temporarily paused to pursue the short-term
focus on clinical development of intranasal foralumab administration for treatment of SPMS patients.
78
Since
our inception in March 2014, we have devoted substantially all our resources to conducting preclinical studies and clinical trials, organizing
and staffing our company, business planning, raising capital and establishing our intellectual property portfolio. We do not have any
products approved for sale and have not generated any revenue from product sales. We have funded our operations to date primarily with
proceeds from the sale of ordinary shares. Through December 31, 2022, we had received net cash proceeds of $118.3m million from sales
of our ordinary shares, issuance of convertible loans, short term loans and warrants.
Since
our inception, we have incurred operating losses. Our net loss after taxation was $12.1 million for the year ended December 31, 2022,
$23.4 million for the year ended December 31, 2021 and $26.1m for the year ended December 31, 2020 respectively. As of December 31, 2022,
we had cash and cash equivalents of $18.1 million.
We
expect to continue to incur significant expenses for the foreseeable future as we advance our product candidates through preclinical
and clinical development and seek regulatory approval and pursue commercialization of any approved product candidates. In addition, if
we obtain marketing approval for any of our product candidates, we expect to incur significant commercialization expenses related to
product manufacturing, marketing, sales and distribution.
Trend
information
Recent
developments
Legal
proceedings
From
time to time, we may be a party to litigation or subject to claims incident to the ordinary course of business. Although the results
of litigation and claims cannot be predicted with certainty, we currently believe that the final outcome of these ordinary course matters
will not have a material adverse effect on our business. Regardless of the outcome, litigation can have an adverse impact on us because
of defense and settlement costs, diversion of management resources and other factors. We are not currently a party to any material legal
proceedings.
Foreign
currency translations
Items
included in the financial statements are measured using the currency of the primary economic environment in which the entity operates
(the functional currency). The consolidated financial statements are presented in U.S. dollars, which is our presentation currency.
Foreign
currency transactions are translated into the functional currency using exchange rates prevailing at the dates of the transactions. Foreign
exchange gains and losses resulting from the settlement of foreign currency transactions and from the translation at year-end exchange
rates of monetary assets and liabilities denominated in foreign currencies are recognized in the income statement.
The
financial statements of overseas subsidiary undertakings are translated into U.S. dollars on the following basis:
●
Assets and liabilities at the rate of exchange ruling
    at the year-end date.
●
Profit and loss account items at the average rate of
    exchange for the year.
Exchange
differences arising from the translation of the net investment in foreign entities, borrowings and other currency instruments designated
as hedges of such investments, are taken to equity (and recognized in the statement of comprehensive income) on consolidation.
Components
of Our Results of Operations
Revenues
To
date, we have not generated any revenue from product sales and do not expect to generate any revenue from the sale of products in the
near future. If our development efforts for our product candidates are successful and result in regulatory approval, we may generate
revenue in the future from product sales. Any ad hoc sublicensing revenues have been treated as other income.
Operating
Expenses
Research
and Development Expenses
R&D
expenses consist primarily of costs incurred in connection with the R&D of our product candidates and are expensed as incurred. These
expenses consist of:
●
expenses incurred under
    agreements with CROs, CMOs, as well as investigative sites and consultants that conduct our clinical trials, preclinical studies
    and other scientific development services;
●
manufacturing scale-up
    expenses and the cost of acquiring and manufacturing materials for preclinical studies and clinical trial materials;
79
●
employee-related expenses,
    including salaries, related benefits, travel and share-based compensation expense for employees engaged in R&D functions;
●
costs related to compliance with regulatory requirements;
●
facilities costs, depreciation and other expenses,
    which include rent and utilities; and
●
fees for maintaining our third-party licensing agreements.
We recognize external development
costs based on an evaluation of the progress to completion of specific tasks using information provided to us by our service providers.
Our direct R&D expenses
are tracked on a program-by-program basis for our product candidates and consist primarily of external costs, such as fees paid to outside
consultants, CROs and CMOs in connection with our preclinical development, manufacturing and clinical development activities. Our direct
R&D expenses by program also include fees incurred under our license agreements. We do not allocate employee costs or facility expenses,
including depreciation or other indirect costs, to specific programs because these costs are deployed across multiple programs and, as
such, are not separately classified. We use internal resources primarily to oversee the R&D as well as for managing our preclinical
development, process development, manufacturing and clinical development activities. These employees work across multiple programs and,
therefore, we do not track their costs by program.
The table below summarizes
our R&D expenses incurred by program:
Year ended December 31,
2022
2021
2020
2019
Direct research and development expense by program:
(in thousands)
Foralumab
$
8,962
$
3,372
$
1,346
$
1,750
Milciclib
111
1,175
364
1,916
TZLS-501
3,785
8,556
4,167
39
ACT-D
50
74
62
-
CAR-T
47
31
-
-
StemPrintER
-
-
54
9
Total direct research and development expense
$
12,955
$
13,208
$
5,993
$
3,714
Indirect research and development expense
-
-
Total research and development expense
$
12,955
$
13,208
$
5,993
$
3,714
R&D activities are central
to our business model. Product candidates in later stages of clinical development generally have higher development costs than those
in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials and related
product manufacturing expenses. As a result, we expect that our R&D expenses will increase substantially over the next several years
as we increase personnel costs and prepare for regulatory filings related to our product candidates. We also expect to incur additional
expenses related to milestone, royalty payments and maintenance fees payable to third parties with whom we have entered into license
agreements to acquire the rights related to our product candidates.
The successful development
and commercialization of our product candidates is highly uncertain. At this time, we cannot reasonably estimate or know the nature,
timing and costs of the efforts that will be necessary to complete the preclinical and clinical development of any of our product candidates
or when, if ever, material net cash inflows may commence from any of our product candidates. This uncertainty is due to the numerous
risks and uncertainties associated with development and commercialization, including the uncertainty of:
●
the scope, progress, outcome
    and costs of our preclinical development activities, clinical trials and other R&D activities;
●
establishing an appropriate
    safety profile with IND- and CTA-enabling studies;
●
successful patient enrollment
    in, and the initiation and completion of, clinical trials;
●
the timing, receipt and
    terms of any marketing approvals from applicable regulatory authorities;
●
establishing commercial
    manufacturing capabilities or making arrangements with third-party manufacturers;
●
development and timely
    delivery of commercial-grade drug formulations that can be used in our clinical trials and for commercial launch;
●
obtaining, maintaining,
    defending and enforcing patent claims and other intellectual property rights;
●
significant and changing
    government regulation;
●
launching commercial sales
    of our product candidates, if and when approved, whether alone or in collaboration with others; and
●
maintaining a continued
    acceptable safety profile of the product candidates following approval.
80
We may never succeed in achieving
regulatory approval for any of our product candidates. We may obtain unexpected results from our clinical trials. We may elect to discontinue,
delay or modify clinical trials.
General and Administrative Expenses
General and administrative
expenses consist primarily of salaries, related benefits, travel and share-based compensation expense for personnel in executive, finance
and administrative functions. General and administrative expenses also include professional fees for legal, consulting, accounting and
audit services.
We anticipate that our general
and administrative expenses will increase in the future as we increase our headcount to support our continued research activities and
development of our product candidates. We also anticipate that we will incur increased accounting, audit, legal, regulatory, compliance,
director and officer insurance costs, as well as investor and public relations expenses associated with being a public company.
Impairment of an asset
This is an extraordinary
expense item for 2020 and includes the expenses for the impairment of a non-current asset.
Disposal of Intellectual Property
This is an extraordinary
expense item for 2020 and includes the expenses related to the disposal of intellectual property during the year.
Other Income (Expense)
Other expense consists of
interest on a convertible loan note and income received from a partnership agreement.
Taxation
The tax income for a period
represents the total of current taxation and deferred taxation. The charges in respect of current taxation are based on the estimated
taxable profit for the relevant year. Taxable profit for the year is based on the profit as shown in the income statement, as adjusted
for items of income or expenditure which are not deductible or chargeable for tax purposes. The current tax liability for the year is
calculated using tax rates which have either been enacted or substantively enacted at the relevant balance sheet date.
Under UK tax legislation,
small and medium entity R&D relief allows us to claim back up to 14.5% of our surrenderable losses as a tax cash credit.
81
A. Results of Operations
The results of operations
that follow reflect the historic periods under review and should not be taken as indicative of future performance.
Comparison of Years Ended December 31, 2022
and 2021
The following tables summarizes
our results of operations for the years ended December 31, 2022 and 2021:
Year ended December 31,
2022
2021
Change
(in thousands)
Operating Expenses
Research and Development
(12,955
)
(13,208
)
253
Operating expenses
(1,638
)
(13,311
)
11,673
Realization bonus
-
(855
)
855
Total operating expenses
(14,593
)
(27,374
)
12,781
Loss from operations
(14,593
)
(27,374
)
12,781
Other income/(expense):
Finance Income/(expense)
(869
)
(176
)
(693
)
Other income
65
893
(828
)
Total other income/(expense)
(804
)
717
(1,521
)
Loss from operations before income taxes
(15,397
)
(26,657
)
11,260
Income tax credit
-
3,240
(3,240
)
Loss for the year
(15,397
)
(23,417
)
8,020
Other Comprehensive loss:
Gain/(Loss) on currency translation
(3,582
)
(4,478
)
896
Comprehensive loss
(18,979
)
(27,895
)
8,916
Research and Development Expenses
Research and development
activities were $13.0 million for the year ended December 31, 2022 compared to $13.2 million for the year ended December 31, 2021 a decrease
of $0.3 million. The decrease in cost is a result of focused expenditure of anti-IL-6R monoclonal antibodies (mAbs) compounds and the
manufacturing of Foralumab and less spending on Milciclib.
General and Administrative Expenses
Operating expenses were $1.6
million for the year ended December 31, 2022 as compared $13.3 million for the year ended December 31, 2021, a decrease of $11.7 million.
The decrease in operating expenses is a result of a decrease in option related expenses of $6.3mm due to options forfeitures and a decrease
in options outstanding during the year, a saving of $2.4m in labor costs due to a reduced headcount in 2022, a reduction in legal costs
of $1.5m due to a one off reorganization in 2021, a savings in insurance of $0.5m due to more favorable market conditions for D&O,
$1.3m net gain due to favorable foreign exchange movements and other general savings of $0.3m.
Realization Bonus Expense
A realization bonus of $13.2
million became payable during the year ended December 31, 2020 to the chairman of the board. This became payable upon the Company raising
funds in excess of $28m (£20m), which it successfully raised in August 2020. As the bonus was not settled until November 2021,
interest of $0.9m was accrued on the amount due in the year to December 31, 2021. No further realization bonus was paid during year ended
December 31, 2022.
Other income/(expense)
There was finance expense
during the year of $0.8 million for the year ended December 31, 2022. This charge related to the change in fair value of the company's
investment in Accustem Sciences Inc as the share price as at December 31, 2022 was $1.35 per share compared to the investment price of
$2 per share.. No further charges were incurred in the year ended December 31, 2021.
82
Income Tax Credit
Income tax credits of $3.2
million were recognized for the year ended December 31, 2021. No income tax credit was recognized for the year ended December 31, 2022
as the claim for 2020 is currently under review by HMRC, the company is awaiting the results of this review before proceeding with a
claim for year ended December 31, 2022.
Comparison of Years Ended December 31, 2021
and 2020
The following tables summarizes
our results of operations for the years ended December 31, 2021 and 2020:
Year Ended December 31,
2021
2020
Change
(in thousands)
Operating Expenses:
Research and development
$
(13,208
)
$
(5,993
)
$
(7,215
)
General and administrative
$
(13,311
)
$
(11,203
)
$
(2,108
)
Realization bonus
(855
)
(13,214
)
12,359
Impairment of asset
-
(279
)
279
Disposal of Intellectual Property
-
2,663
(2,663
)
Total Operating Expenses
$
(27,374
)
$
(28,026
)
$
652
Other Income/ (Expense)
717
(312
)
1,029
Tax credit
3,240
2,207
1,048
Net Loss
$
(23,417
)
$
(26,131
)
$
2,729
Other comprehensive loss:
Foreign currency translation adjustment
(4,478
)
3,474
(7,978
)
Total Comprehensive (Loss)
$
(27,895
)
$
(22,657
)
$
(4,499
)
Research and Development Expenses
Research and development
activities were $13.2 million for the year ended December 31, 2021 compared to $6.0 million for the year ended December 31, 2020 an increase
of $7.2 million. The increase in cost is a result of the development of anti-IL-6R monoclonal antibodies (mAbs) compounds and the manufacturing
of Foralumab.
General and Administrative Expenses
Operating expenses were $13.3
million for the year ended December 31, 2021 as compared $11.2 million for the year ended December 31, 2020, an increase of $2.1 million.
The increase in cost is a result of the additional fair value charges of $3.5m relating to modification of existing options and the issuance
of additional options, and additional compliance, professional fees and legal costs of $1.5m due to increased activity in the Company
and the corporate reorganization and establishment of a new Bermudan parent.
Realization Bonus Expense
A realization bonus of $13.2
million became payable during the year ended December 31, 2020 to the chairman of the board. This became payable upon the Company raising
funds in excess of $28m (£20m), which it successfully raised in August 2020. As the bonus was not settled until November 2021,
interest of $0.9m was accrued on the amount due in the year to December 31, 2021.
Impairment of asset
There was an asset impairment
charge of $0.3 million for the year ended December 31, 2020. This charge related to the impairment of the Company's investment
in SharDNA SPA. No further charges were incurred in the year ended December 31, 2021.
Disposal of Intellectual Property
There was a gain of $2.7m
arising on the disposal of the StemPrintER intellectual property in the year ended December 31, 2020. No further disposals were incurred
in the year ended December 31, 2021.
83
Income Tax Credit
Income tax credits of $3.2
million and $2.2 million are recognized for the years ended December 31, 2021 and 2020, respectively. The credits are obtained at a rate
of 14.5% of 230% of our qualifying research and development expenditure. The increase in the provision is due primarily to an increase
in qualifying research and development expenditure incurred in the year ending December 31, 2021.
B. Liquidity and Capital Resources
Since our inception, we have
not generated any revenue and have incurred operating losses and negative cash flows from our operations. We have funded our operations
to date primarily with proceeds from the sale of ordinary shares, American Depository Shares, or ADSs, and convertible loan notes.
As of December 31, 2022,
we had cash and cash equivalents of $18.1 million.
Cash Flows
The following table summarizes
our cash flows for each of the periods presented:
Year ended December 31,
2022
2021
2020
Net cash used in operating activities
$
(19,615
)
$
(21,762
)
$
(11,335
)
Net cash used in investing activities
(3,996
)
(23
)
(123
)
Net cash (used in) / provided by financing activities
(55
)
130
75,346
Effect of exchange rate changes on cash and cash equivalents
(398
)
(1,983
)
1,736
Net (decrease)/increase in cash and cash equivalents
$
(23,666
)
$
(21,655
)
$
(63,888
)
Net Cash Used in Operating Activities
Our use of cash in each of
the years ended December 31, 2022, and 2021, resulted primarily from our net losses, adjusted for non-cash charges and changes in components
of working capital. Net cash used in operating activities of $19.6 million during the year ended December 31, 2022 decreased by $2.1
million compared to the year ended December 31, 2021.
Our use of cash in each of
the years ended December 31, 2021, and 2020, resulted primarily from our net losses, adjusted for non-cash charges and changes in components
of working capital. Net cash used in operating activities of $21.8 million during the year ended December 31, 2021 increased by $10.5
million compared to the year ended December 31, 2020
Net Cash Used in Investing Activities
During the year ended
December 31, 2022, we used $4 million of cash in investing activities. The company spent $2.7m investing in a related party, Accustem
Sciences Inc, where we purchased 1,337,970 shares for $2 a share, and $1.3m on a share buyback scheme.
During the year ended December
31, 2021, we used $0.02 million of cash in investing activities for the purchases of property and equipment offset by a finance lease
receivable.
84
Net Cash (used in)/ Provided by Financing Activities
During the year ended December
31, 2022 $0.01 million was used in the repayment of lease expenses. During the year ended December 31, 2021, net cash provided by financing
activities was $0.01 million consisting of net cash proceeds the exercise of warrants.
During the years ended December
31, 2021 and 2020, net cash provided by financing activities was $0.1 million and $75.3 million, respectively, consisting of net cash
proceeds from our sale and issuance of ordinary shares and ADS's, convertible loan notes and the exercise of options and warrants.
Funding Requirements
We expect our expenses to
increase substantially in connection with our ongoing activities, particularly as we advance the preclinical activities, manufacturing
and clinical trials of our product candidates and as we:
●
seek regulatory approvals
    for any product candidates that successfully complete clinical trials;
●
establish a sales, marketing
    and distribution infrastructure in anticipation of commercializing any product candidates for which we may obtain marketing approval
    and intend to commercialize on our own or jointly;
●
hire additional clinical,
    medical and development personnel;
●
expand our infrastructure
    and facilities to accommodate our growing employee base; and
●
maintain, expand and protect
    our intellectual property portfolio.
85
We believe that our existing
cash, will enable us to fund our operating expenses and capital expenditure requirements for the immediate future. We have based these
estimates on assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than we expect. If we
receive regulatory approval for our other product candidates, we expect to incur significant commercialization expenses related to product
manufacturing, sales, marketing and distribution.
Because of the numerous risks
and uncertainties associated with research, development and commercialization of pharmaceutical product candidates, we are unable to
estimate the exact amount of our working capital requirements. Our future funding requirements will depend on and could increase significantly
as a result of many factors, including:
●
the scope, progress, outcome
    and costs of our preclinical development activities, clinical trials and other research and development activities;
●
the costs, timing, receipt
    and terms of any marketing approvals from applicable regulatory authorities;
●
the costs of future activities,
    including product sales, marketing, manufacturing and distribution, for any of our product candidates for which we receive marketing
    approval;
●
the revenue, if any, received
    from commercial sale of our products, should any of our product candidates receive marketing approval;
●
the costs and timing of
    hiring new employees to support our continued growth;
●
the costs of preparing,
    filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending intellectual
    property-related claims; and
●
the extent to which we
    acquire technologies.
Until such time, if ever,
that we can generate product revenue sufficient to achieve profitability, we expect to finance our cash needs through equity offerings.
To the extent that we raise additional capital through the sale of equity, your ownership interest will be diluted. If we raise additional
funds through other third-party funding, collaboration agreements, strategic alliances, licensing arrangements or marketing and distribution
arrangements, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates
or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity financings when
needed, we may be required to delay, limit, reduce or terminate our product development or future commercialization efforts or grant
rights to develop and market products or product candidates that we would otherwise prefer to develop and market ourselves.
C. Research and Development Expenses, Patents and Licenses, etc.
See "Item 4.B.—Intellectual
Property," "Item 4.B.—Research and Development," and "Item 5. Operating and Financial Review and Prospects."
D. Trend Information
See "Item 5. Operating and Financial Review
and Prospects—Trend Information."
86
E. Off-Balance Sheet Arrangements
We did not have during the periods presented,
and we do not currently have, any off-balance sheet arrangements, as defined in the rules and regulations of the SEC.
F. Tabular Disclosure of Contractual Obligations
The following table summarizes our contractual
commitments and obligations as of December 31, 2022 and 2021.
As at December 31, 2022
(in thousands)
Total
Less than
1 Year
Between
                                            1
and 5
Years
More than
5 Years
Borrowings
$
-
$
-
$
-
$
-
Operating lease obligations
382
139
243
-
Total
$
382
$
139
$
243
$
-
As at December 31, 2021
(in thousands)
Total
Less than
1 Year
Between
                                            1
and 5
Years
More than
5 Years
Borrowings
$
-
$
-
$
-
$
-
Operating lease obligations
24
-
-
-
Total
$
24
$
-
$
-
$
-
Please refer to "Item
4.B. Business Overview" and "Item 10.C. Material Contracts" for further details.
G. Safe Harbor
This Annual Report on Form 20-F contains
forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E of the Exchange Act and
as defined in the Private Securities Litigation Reform Act of 1995. See the section titled "Cautionary Statement Regarding
Forward-Looking Statements".
ITEM 6: DIRECTORS, SENIOR MANAGEMENT AND EMPLOYEES
A. Directors and Senior Management
The following table sets forth
information regarding our directors as of April 24, 2023.
Name
Age
Position
Gabriele Marco Antonio Cerrone MBA (2)
51
Executive Chairman and acting Chief
    Executive Officer
Willy Simon (1,2,3)
71
Non-Executive Director
John Brancaccio (1), (3)
75
Non-Executive Director
(1)
Remuneration Committee
    member
(2)
Nominating Committee member
(3)
Audit Committee member
87
The following table sets forth
information regarding our senior managers as of April 24, 2023:
Name
Position
Matthew Davis
Chief Medical Officer and Acting Chief Scientific Officer
Keeren Shah
Chief Financial Officer
Jules S. Jacob
Executive Director, CMC & Non-Clinical Development
Dr. Vaseem A. Palejwala
Senior Director, Clinical operations
Gabriele Marco Antonio Cerrone –
Executive
Chairman
Mr. Gabriele Marco Antonio
Cerrone, is the Founder of the company and has been its Executive Chairman since April 2014. Mr. Cerrone has founded ten biotechnology
companies in oncology, infectious diseases and molecular diagnostics, and has listed seven of these companies on Nasdaq two to the Main
Market and AIM Market in London. Mr. Cerrone co-founded Cardiff Oncology, Inc., an oncology company and served as its Co-Chairman; he
was a co-founder and served as Chairman of both Synergy Pharmaceuticals, Inc. and Callisto Pharmaceuticals, Inc. and was a Director of
and led the restructuring of Siga Technologies, Inc. Mr. Cerrone also co-founded FermaVir Pharmaceuticals, Inc. and served as Chairman
of the Board until its merger in September 2007 with Inhibitex, Inc. Mr. Cerrone served as a director of Inhibitex, Inc. until its US$2.5bn
sale to Bristol Myers Squibb Co in 2012. Mr. Cerrone is the Executive Chairman and Founder of Tiziana Life Sciences Ltd, an oncology
focused therapeutics company; Co-Founder of Rasna Therapeutics Inc., a company focused on the development of therapeutics for leukaemias;
Co-Founder of Hepion Pharmaceuticals, Inc.; Executive Chairman and Co-Founder of Gensignia Life Sciences, Inc., a molecular diagnostics
company focused on oncology using microRNA technology; Non-Executive Chairman and Founder of Accustem Sciences Limited; and founder of
BioVitas Capital Ltd. Mr. Cerrone graduated from New York University's Stern School of Business with a master's degree in
business administration (MBA).
Willy Simon –
Non-Executive Director
Willy Jules Simon has served
as a Non-Executive Director of the company since November 2015. He is a banker and worked at Kredietbank N.V. and Citibank London before
serving as an executive member of the Board of Generale Bank NL from 1997 to 1999 and as the chief executive of Fortis Investment Management
from 1999 to 2002. He acted as chairman of Bank Oyens & van Eeghen from 2002 to 2004. He was chairman of AIM-traded Velox3 plc (formerly
24/7 Gaming Group Holdings plc) until 2014 and had been a director of Playlogic Entertainment Inc., a Nasdaq OTC listed company. Willy
Simon has been the chairman of Bever Holdings, a company listed in Amsterdam, since 2006 and Chairman of Ducat Maritime since 2015. He
is also a non-executive director of OKYO Pharma Ltd.
John Brancaccio –
Non-Executive Director
John Brancaccio, a retired
CPA, has served as a director of our company since July 2020. From April 2004 until May 2017, Mr. Brancaccio was the Chief Financial Officer
of Accelerated Technologies, Inc., an incubator for medical device companies. Mr. Brancaccio served as a director of Callisto Pharmaceuticals,
Inc. from April 2004 until its merger with Synergy Pharmaceuticals, Inc. in January 2013 and was a director of Tamir Biotechnology, Inc.
(formerly Alfacell Corporation) until 2019, as well as a director of Hepion Pharmaceuticals, Inc. since December 2013, Rasna Therapeutics,
Inc. since September 2016, Cardiff Oncology, Inc. from December 2005 until June 2022 and Okyo Pharma Ltd since June 2020. Mr. Brancaccio
served as a director of Synergy from July 2008 until April 2019.
Keeren Shah –
Chief Financial Officer
Keeren Shah serves as our
Chief Financial Officer. Ms. Shah currently also serves as the CFO of Accustem Sciences Inc, OKYO Pharma Ltd and Rasna Therapeutics Inc.,
having previously served as the Group Financial Controller for these businesses from June 2016 to July 2020. Prior to joining the Company,
Ms. Shah spent 10 years at Visa, Inc. as a Senior Leader in its finance team where she was responsible for key financial controller activities,
financial planning and analysis, and core processes as well as leading and participating in key transformation programmes and Visa Inc.'s
initial public offering. Before joining Visa, Ms. Shah has also held a variety of finance positions at other leading companies including
Arthur Andersen and BBC Worldwide. She holds a Bachelor of arts with honours in Economics and is a member of the Chartered Institute
of Management Accountants.
Matthew W Davis -
Chief Medical Officer
and Acting Chief Scientific Officer
Dr. Davis has extensive experience in new
drug application, or NDA, and biologic license application, or BLA, FDA approvals and device clearances. Notable approved brands that
Dr. Davis has worked on include Lidoderm®, Sculptra®, Colcrys® and most recently QWO®. Dr. Davis previously served as
Chief Scientific Officer and Chief Medical Officer at Endo Pharmaceuticals where he restructured the R&D department and collaborated
to obtain BLA approval for QWO®. Additionally, Dr. Davis was Chief Medical Officer for Lupin Inc. and URL Pharma, Inc. where he spearheaded
three NDA approvals and was the inventor on all 17 Orange Book listed patents for Colcrys®. He also was on the executive team that
sold URL Pharma to Takeda Pharmaceutical Company for approximately $800M combined with over $1B in performance-based contingent earn out
payments.
Dr. Davis matriculated to the University of
Pennsylvania as an undergraduate. He received his Pharmacy Degree from Temple University and his Medical Degree from the Medical College
of Pennsylvania. Dr. Davis undertook his surgical training at Brown University and his Urology training at Washington Hospital Center.
88
Jules S. Jacob –
Executive Director,
CMC & Non-Clinical Development
Mr. Jules Jacob has served
as Senior Director (2017-2021_ and Executive Director of CMC and Non-Clinical Development of the company since January 2022. He has over
25 years of drug development experience. Previously, Mr. Jacob was senior director of product development at Aprecia Pharmaceuticals Company,
a drug delivery technology platform company, from March 2009 to July 2017, where he led the development of Spritam®, the first FDA-approved
dosage form manufactured using 3-dimensional printing, and other 505(b)(2) pipeline products. Mr. Jacob was director of formulation development
at Panacos Pharmaceuticals Inc., a drug company focused on human immunodeficiency virus, or HIV, and other major human viral diseases,
from March 2007 to December 2008, where he worked on the development of first-in-class maturation inhibitors for the treatment of HIV.
Mr. Jacob was a founding scientist, director of R&D and director of technology development at Spherics, Inc., a pharmaceutical company
that engaged in developing and manufacturing oral pharmaceutical products for CNS conditions, GI disorders, and cancer, from February
2000 to February 2007. Mr. Jacob worked on the development of bioadhesive dosage forms for treatment of CNS disorders, through the 505(b)(2)
regulatory pathway at Spherics Inc. Mr. Jacob completed his undergraduate degree and graduate education in biological and medical sciences
at Brown University and has an active visiting faculty appointment in the Department of Molecular Pharmacology, Physiology and Biotechnology
at Brown University.
Dr. Vaseem A. Palejwala –
Senior Director,
Clinical Operations
Dr. Palejwala has served as
Director, Non-Clinical Studies of the company since January 2017; Director (2018-2021) and Senior Director, Clinical Operations since
2022. He has 23 years of experience in drug discovery and development. From January 2015 to January 2017, Dr. Palejwala served as director
of discovery and preclinical research, and from December 2012 to December 2014 served as associate director of discovery and preclinical
research, at Synergy Pharmaceuticals Inc. where he actively contributed to establishing GI tract-related preclinical animal models for
testing the efficacy and validating the mechanism of action for both plecanatide and dolcanatide. Dr. Palejwala also actively participated
in preparation of the nonclinical pharmacology section of the NDA for Trulance®. From 2001 to 2012, Dr. Palejwala served as discovery
scientist/manager at Sanofi S.A.,
a
multinational pharmaceutical company, where he advanced both small molecule and biologic programs
in immunology, inflammation, oncology, CNS and metabolic disorders and also contributed to establishing and managing high-throughput gene
expression profiling platform capabilities. Dr. Palejwala holds a degree in microbiology and chemistry from Bombay University, as well
as a master of science degree in microbiology and a Ph.D. in microbiology from the Maharaja Sayajirao University of Baroda.
Family Relationships
There are no family relationships
among any of our executive officers or directors.
B.
Compensation
Total Compensation for the Executive Chairman and Non-Executive
Directors
The table below sets out
the total remuneration received by the Executive Chairman and the Non-Executive Directors for the year ended December 31, 2022.
Name
Position
Fees
earned
or paid
in cash
($000)
Bonus
earned
or paid
in cash
($000)
(2)
Options
awarded
($000)
(1)
Other
($000)
Total
($000)
Gabriele Cerrone
Executive Chairman
296
148
-
-
444
Willy Simon
Non – Executive Director
55
-
-
-
55
John Brancaccio
Non – Executive Director
55
-
-
-
55
(1)
Represents the fair value
    of incentive stock options granted during the year to December 31, 2022 using an appropriate valuation model for computing stock-based
    compensation expense as of the date of grant.
89
Narrative Disclosure to the Compensation table
Gabriele Cerrone
On June 9, 2016 we entered
into an agreement with our Executive Chairman, Gabriele Cerrone. Under the agreement, Mr Cerrone was to hold office as Chairman for £80,000
per annum. The agreement was to expire no earlier than 24 April 2018 and was to continue thereafter until terminated by either party
giving written notice of 12 months. Mr Cerrone was also eligible to receive an annual bonus of up to 50% of his base salary, such bonus
amount to be determined at the discretion of the Board of Directors.
Additionally, Mr Cerrone
was also eligible to receive two realization bonuses as follows:
(a)
in the event that, either:
    (i) the Group raises, in one or a series of transactions, new equity capital in excess of £20,000,000 (after expenses); or
    (ii) there is a sale, in one or a series of transactions, of all or substantially all of the assets (calculated on the basis of book
    values) of the Group Companies (or a licence of the same on an exclusive or non-exclusive basis), where the Enterprise Value equals
    or exceeds £150,000,000; or (iii) there is a change of control where the Enterprise Value equals or exceeds £150,000,000,
    in which case the Realisation Bonus will be the amount equal to the Enterprise Value multiplied by two and a half (2.5) per cent
(b)
In the event that, during
    this Agreement, either: (i) there is a sale, in one or a series of transactions, of all or substantially all of the assets ( calculated
    on the basis of book values) of the Group ( or a licence of the same on an exclusive or non-exclusive basis ), where the Enterprise
    Value equals or exceeds £300,000,000; or (ii) there is either a change of control where the Enterprise Value equals or exceeds
    £300,000,000, the Chairman will be entitled to receive an additional Realization Bonus in the amount equal to the Enterprise
    Value multiplied by three and a half (3.5) per cent.
The Enterprise Value means:
(i) in the case of a change of control resulting in consideration payable to the Group (for example, on a sale of its assets or licensing
transaction), the total cash and non-cash consideration received by the Group; or (ii) in the case of a change of control resulting in
consideration payable to the shareholders of the ordinary shares in the issued share capital of the Group from time to time, the total
cash and non-cash consideration payable to the Shareholders.
The first realization bonus
was satisfied on 5 August 2020, and the Chairman was unconditionally entitled to the immediate delivery of 4,763,995 new ordinary shares
credited as fully paid in lieu of a cash payment. The number of shares to be issued was fixed. Due to the delayed delivery of shares,
additional shares were granted in lieu of interest.
On October 9, 2020, we entered
into an amended agreement with Mr Cerrone, increasing his base salary to £240,000 per annum. All other terms and conditions remained
the same.
On 21 October 2021, we entered
into a new agreement which superseded the original consultancy agreement dated June 9, 2016 and the amended agreement dated October 9,
2020. The duration of the consultancy agreement was fixed until December 31, 2028 and the fee remained at £240,000 per annum. All
terms regarding the second realization bonus remained the same.
On 14 March, 2023, we granted
Mr Cerrone a long-term realisation bonus on the basis that were the Company to be sold, during the currency of his directorship or in
the period of 6 years thereafter, for a price at, or in excess of, US$1,000,000,000 that Mr Cerrone receive a bonus equal to 6.5% of the
enterprise value of the Company (and not just the excess over US$1,000,0000,000), such bonus to be in addition to the current realization
bonus contained in Mr Cerrone's consultancy agreement dated December, 21 2022 but on the basis that were the US$1,000,000,000 threshold
to be hit, the Company would be entitled to offset any payment due under the realisation bonus contained in the December, 21 2022 Consultancy
Agreement against any amount then due under this new realisation bonus. The terms of the award to make appropriate provision for any "spin-off"
of assets and for the eventuality that the Company be sold for non-cash consideration. In addition, it should be a clear condition that
Mr Cerrone be responsible for all tax liabilities in connection with any payment of the award.
Non -Executive Director remuneration
The remuneration of our non-executive
directors is determined by our board as a whole, based on independent compensation reviews. We intend to enter into service contracts
with our directors for their services or amend and restate any prior service contracts in place prior to, or as soon as practicable, following
the filing of this registration statement.
90
Compensation of Executive Directors
The table below sets the remuneration
of each of the Executive Directors for the financial year ended December 31, 2022.
Name
Position
Fees
earned or
paid in
cash
($000)
Bonus
earned or
paid in
cash
($000)
Options
awarded
($000)
(1)
Total
($000)
Kunwar Shailubhai (2)
Executive Director
379
-
-
379
Tom Adams (3)
Executive Director
-
-
-
-
(1)
Represents the fair value of incentive stock options granted during
the year to December 31, 2022 using an appropriate valuation model for computing stock-based compensation expense as of the date of grant.
(2)
Dr. Kunwar Shailubhai resigned from the company on August 1, 2022.
(3)
Dr. Adams passed away on
    January 9, 2022.
Narrative Disclosure to the Compensation table
Dr. Kunwar Shailubhai
We entered into an employment
agreement with Dr. Kunwar Shailubhai in May 2017. This agreement entitles Dr. Shailubhai to receive an initial annual base salary of
$600,000 per year. Dr. Shailubhai is eligible to receive an annual bonus of up to 35% of his base salary, such bonus amount to be determined
in the company's sole discretion. Dr. Shailubhai is also entitled to the same fringe benefits as we provide to our other executives
from time to time and is eligible to receive employee share incentives. The vesting of any unvested employee share incentives held by
Dr. Shailubhai will accelerate in the event his employment is terminated without cause (as such term is defined in his employment agreement),
or if he resigns for good reason (as such term is defined in his employment agreement) and, in each case, such termination is upon the
consummation of or within 12 months following a change of control of the company. If Dr. Shailubhai's employment with the company
is terminated without cause, or if he resigns for good reason, Dr. Shailubhai will also be entitled to receive severance equal to continuation
of his base salary as then currently in effect for 12 months following his date of termination and will be eligible for reimbursement
for medical coverage premiums for up to the same period. Dr. Shailubhai, his spouse and eligible dependents are entitled to stay on our
health insurance plans for a period of 12 months following his termination for any reason. Dr. Shailubhai's severance benefits
are conditioned on, among other things, his execution of our standard separation agreement and a general release of claims in our favor.
Dr. Shailubhai resigned from
his position on our board and his employment terminated on August 1, 2022.
Outstanding Equity Awards at Fiscal Year-End
The following table provides
information regarding all outstanding equity awards for our directors, executive officers, and non-executive directors, as of December
31, 2022:
Name
Ordinary
Shares
Underlying
Options
Exercise
Price Per
Ordinary
Share (£)
Grant Date
Expiration
Date
Gabriele Cerrone
915,388
0.70
25/06/2014
25/06/2024
1,629,702
0.70
06/05/2020
05/05/2028
Willy Simon
125,000
2.95
25/08/2020
24/08/2030
John Brancaccio
125,000
2.95
25/08/2020
24/08/2030
The Tiziana Life Sciences Ltd (formerly Tiziana
Life Sciences plc) Employee Share Option Plan with Non-Employee Sub-Plan and US Sub-Plan
The Tiziana Life Sciences
Ltd (formerly Tiziana Life Sciences plc) Employee Share Option Plan with Non-Employee Sub-Plan and US Sub-Plan, or the 2016 Plan,
was adopted by the Board on March 23, 2016 and approved by shareholders on June 30, 2016 and allows for the grant of options to eligible
service providers. The material terms of the 2016 Plan are summarized below. This plan closed to new entrants on October 21, 2021 and
has been superseded by the Tiziana Life Sciences Ltd 2021 Equity Incentive Plan.
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Eligibility and Administration
Prior to October 21, 2021,
our employees, consultants and directors, and employees and consultants of our subsidiaries were eligible to receive options under the
2016 Plan. The 2016 Plan was administered by our board of directors, which may delegate its duties and responsibilities to one or more
committees of our directors and/or officers (referred to collectively as the plan administrator below), subject to the limitations imposed
under the 2016 Plan, stock exchange rules and other applicable laws. The plan administrator has the authority to take all actions and
make all determinations under the 2016 Plan, to interpret the 2016 Plan and option agreements and to adopt, amend and repeal rules for
the administration of the 2016 Plan as it deems advisable. The plan administrator also had the authority to determine which eligible service
providers receive options, to grant options and to set the terms and conditions of all options granted under the 2016 Plan, including
any vesting and vesting acceleration provisions, subject to the conditions and limitations in the 2016 Plan.
Options
The 2016 Plan provided for
the grant of options. All options granted under the 2016 Plan were set forth in option agreements, which will detail the terms and conditions
of the options.
Options provide for the purchase
of our ordinary shares in the future at an exercise price set on the grant date. The plan administrator will determine the number of
shares covered by each option, the exercise price of each option and the conditions and limitations applicable to the exercise of each
option
If a holder of options dies,
options may be exercised by the personal representative with 12 months following death in respect of all or such proportion of the option
as the plan administrator may specify to take account of the extent to which any exercise conditions have been achieved at the relevant
date. If a holder of options leaves as a good leaver or the plan administrator allows, options may be exercised within 90 days in respect
of all or such proportion of the option as the plan administrator may specify to take account of the extent to which any exercise conditions
have been achieved at the relevant date.
Exercise Conditions
The plan administrator may
specify one or more appropriate exercise conditions that must be satisfied before options may be exercised.
Change of Control and Variation of Share Capital
In the event of a change
of control, the plan administrator may specify whether all or a proportion of options will be exercisable to take account of the extent
to which any exercise conditions have been achieved at the relevant date. Alternatively, holders of options may agree to accept an offer
to exchange options for options to acquire shares in an acquiring company.
If there is a variation of
our ordinary shares the plan administrator may adjust the number of shares under options and/or the exercise price.
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Plan Amendment and Termination
Our board of directors may
amend the 2016 Plan at any time; however, the provisions governing eligibility requirements, equity dilution, the basis for determining
the rights of holders of options and the adjustment of options cannot be altered to the advantage of existing or new holders of options
without the prior approval of our shareholders in general meeting. No options may be granted under the 2016 Plan after the tenth anniversary
of the date of adoption by our board of directors.
Transferability
Options granted under the
2016 Plan are generally non-transferrable, except on death. With regard to tax withholding and exercise price obligations arising in
connection with the exercise of options under the 2016 Plan, the plan administrator may, in its discretion, accept cash, wire transfer
or cheque,
Non-Employee Sub-Plan
Under the Non-Employee Sub-Plan,
options may be granted to advisers, consultants and non-executive directors on terms comparable to those described above.
US Sub-Plan
The US Sub-Plan permits the
grant of options to employees, directors and consultants who are US residents and US taxpayers, including potentially tax efficient Incentive
Stock Options (as defined in Section 422 of the Internal Revenue Code of 1986, as amended). A maximum of 9,233,392 ordinary shares may
be issued under the US Sub-Plan (which number shall be the maximum number that may be granted as Incentive Stock Options).
The Tiziana Life Sciences Ltd 2021 Equity Incentive Plan
On October 20, 2021,
Tiziana adopted the Tiziana Life Sciences Ltd 2021 Equity Incentive Plan (the "Plan") which operates over common shares in
Tiziana. The purpose of the Plan is to assist the Company and its Subsidiaries in attracting and retaining valued Employees, Consultants
and Non-Employee Directors by offering them a greater stake in the Company's success and a closer identity with it, and to encourage
ownership of the Company's shares by such Employees, Consultants and Non-Employee Directors. Any employee, director or consultant
of Tiziana Life Sciences Ltd or any of its subsidiaries is eligible to receive Awards under the Plan. The Plan will be administered by
the Compensation Committee of the Board (the "
Compensation Committee
"). Awards granted to nonemployee members
of the Board will be administered by the full Board.
The Plan was approved by
the shareholders of the Company, no new awards will be granted under the Tiziana Life Sciences plc Employee Share Option Plan with Non-Employee
Sub-Plan and US Sub-Plan with California Supplement, as amended and/or restated from time to time (collectively, the "Prior Equity
Plan").
Subject to adjustment as
provided in the Plan, the maximum number of shares that may be issued pursuant to Awards under the Plan is 15,000,000 shares (the "
Cap
").
The Cap will be increased by the number of shares corresponding (as determined by the Compensation Committee) to the securities underlying
the portion of an award granted under the 2016 Plan that is cancelled, terminated or forfeited or lapses, in any case, on or after the
effective date of the Plan. No more than 15,000,000 shares issued under the Plan may be issued pursuant to the exercise of incentive
stock options.
Under the Plan, awards may
be in the form of options, share appreciation rights, restricted stock, restricted stock units, performance stock, performance stock
units, and other share-based awards. Each Award will be evidenced by an Award agreement containing the terms and conditions applicable
to such Award.
Change of Control and Variation of Share Capital
A Change in Control shall
not, in and of itself, accelerate the vesting, settlement or exercisability of outstanding awards, unless otherwise specified.
Transferability
Transferability of Restricted
Stock shall be prohibited or restricted in the manner and to the extent prescribed in the applicable Award Agreement. Such restrictions
may include, without limitation, rights of repurchase or first refusal in the Company or provisions subjecting the Restricted Stock to
a continuing substantial risk of forfeiture in the hands of any transferee.
UK Supplemental Plan
The UK Supplemental plan
shall apply to any Award granted to a Participant who is resident in the United Kingdom for tax purposes at the time the Award is granted
or on the occurrence of any taxable event in respect of the Award and to any Participant who is not resident in the United Kingdom at
such time(s) but who is granted the Award in respect of duties performed in the United Kingdom (a "UK Participant").
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Additional Terms for UK Participants
Employer National Insurance
Contributions Indemnity.
In the case of any Award to a UK Participant in the form of Options, Restricted Stock, Restricted Stock
Units, Performance Stock, Performance Stock Units or Other Share-Based Award, if required by the Board, it shall be a condition of such
Award that the UK Participant irrevocably agrees that the Company and/or any applicable Subsidiary may recover from the UK Participant
the whole or any part of any employer National Insurance Contributions, Apprenticeship Levy or other social security contributions for
which the Company and/or any applicable Subsidiary is liable to account in respect of the Award, in each case to the extent permitted
by applicable law, and/or that the UK Participant shall enter into such election (using a form approved by HM Revenue & Customs)
as may be required for the whole or any part of such taxes to be transferred to the UK Participant.
Date of Termination.
For
the purposes of the Plan (and the corresponding provisions in any Award Agreement) the termination of employment of a UK Participant
for Cause or as the result of the UK Participant's resignation shall be deemed to occur on the earlier of (i) the date on which
the UK Participant's employment terminates, and (ii) the date on which the UK Participant gives or receives notice of the termination
of employment.
Bankruptcy.
Unless
otherwise provided in an Award Agreement, the unvested portion of a Participant's Award shall be immediately forfeited with no
compensation or other payment due to the Participant upon the Participant (i) being declared bankrupt, (ii) making an application for
an interim order or any proposal for a voluntary arrangement within Part VIII of the Insolvency Act 1988, or (iii) proposing any form
of compromise with his creditors or any class of creditors.
Tax Election.
In
the case of an Award to a UK Participant in the form of Options, Restricted Stock, Restricted Stock Units, Performance Stock, Performance
Stock Units or Other Share-Based Award, unless the Board determines otherwise, it shall be a condition of the Award that the UK Participant
enters into a joint tax election with his or her employer pursuant to Section 431(1) of the Income Tax (Earnings and Pensions) Act 2003
in respect of any Shares acquired pursuant to such Award, such election to be made no later than 14 days following the date on which
such Shares are acquired.
Relationship to Employment
Contract.
The rights of a UK Participant under the terms of his or her office or employment with the Company or any Subsidiary shall
not be affected by the Plan, this Supplement or any Award Agreement. The value of any benefit realized by a UK Participant in respect
of an Award shall not be taken into account in determining any pension or similar entitlement.21
Limitation on Claims
.
A UK Participant shall have no right to compensation or damages on account of any loss in respect of an Award where the loss arises (or
is claimed to arise), in whole or in part, from termination of office or employment with, or notice to terminate office or employment
given by or to, the Company or any Subsidiary. This exclusion of liability shall apply however termination of office or employment, or
the giving of notice, is caused, and however compensation or damages are claimed. A UK Participant shall have no right to compensation
or damages from the Company or any Subsidiary on account of any loss in respect of an Award where the loss arises (or is claimed to arise),
in whole or in part, from any Change in Control, any company ceasing to be a Subsidiary or the transfer or any business from the Company
or any Subsidiary to any other person
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C. Board Practices
Corporate Governance Practices
We are a "foreign private
issuer," as defined by the SEC. As a result, in accordance with Nasdaq listing requirements, we may rely on home country governance
requirements and certain exemptions thereunder rather than complying with NASDAQ corporate governance standards. While we voluntarily
follow most Nasdaq corporate governance rules, we may choose to take advantage of the following limited exemptions:
●
Exemption from filing quarterly
    reports on Form 10-Q containing unaudited financial and other specified information or current reports on Form 8-K upon the occurrence
    of specified significant events.
●
Exemption from Section
    16 rules requiring insiders to file public reports of their stock ownership and trading activities and liability for insiders who
    profit from trades in a short period of time, which will provide less data in this regard than shareholders of U.S. companies that
    are subject to the Exchange Act.
●
Exemption from the Nasdaq
    requirement requiring disclosure of any waivers of the code of business conduct and ethics for directors and officers.
●
Exemption from the requirement
    that our board have a compensation committee that is composed entirely of independent directors with a written charter addressing
    the committee's purpose and responsibilities.
●
Exemption from the requirement to have independent
    director oversight of director nominations.
In connection with the migration
to Bermuda, Tiziana adopted a Code of Business Conduct and Ethics which covers a broad range of matters including the handling of conflicts
of interest, compliance issues and other corporate policies such as insider trading and equal opportunity and non-discrimination standards.
Tiziana's Code of Business Conduct and Ethics applies to all directors, executive officers and employees of Tiziana. Tiziana publishes
its Code of Business Conduct and Ethics on its website (www.tizianalifesciences.com).
●
We do not follow Nasdaq
    Rule 5620(c) regarding quorum requirements applicable to meetings of shareholders. Such quorum requirements are not required under
    English law. In accordance with generally accepted business practice, our Bye-laws will provide alternative quorum requirements that
    are generally applicable to meetings of shareholders.
●
We do not follow Nasdaq
    Rule 5605(b)(2), which requires that independent directors regularly meet in executive sessions where only independent directors
    are present. Our independent directors may choose to meet in executive sessions at their discretion.
Although we may rely on certain
home country corporate governance practices, we must comply with Nasdaq's Notification of Noncompliance requirement (Nasdaq Rule
5625) and the Voting Rights requirement (Nasdaq Rule 5640). Further, we must have an audit committee that satisfies Nasdaq Rule 5605(c)(3),
which addresses audit committee responsibilities and authority and requires that the audit committee consist of members who meet the
independence requirements of Nasdaq Rule 5605(c)(2)(A)(ii).
We intend to take all actions
necessary for us to maintain compliance as a foreign private issuer under the applicable corporate governance requirements of the Sarbanes-Oxley
Act, the rules adopted by the SEC and Nasdaq listing rules. Accordingly, our shareholders will not have the same protections afforded
to shareholders of companies that are subject to all of the corporate governance requirements of Nasdaq. For an overview of our corporate
governance principles, see the following section titled "Description of Bye-laws and Memorandum of Association"
Description of Bye-laws and Memorandum of
Association
The following description
includes a summary of specified provisions of our memorandum of association and our Bye-laws. This description is qualified by reference
to our memorandum of association and our Bye-laws which are incorporated by reference as exhibits to this annual report.
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Preemptive Rights
Our Bye-laws do not provide
shareholders with pro rata preemptive rights to subscribe for any newly issued common shares. Additionally, the Companies Act does not
provide shareholders with a statutory preemptive right.
Repurchase of Shares
Our board of directors may
exercise all of the powers to purchase for cancellation or acquire our shares as treasury shares in accordance with the Companies Act.
On a reacquisition of shares, such shares may be cancelled (in which event, our issued but not our authorized capital will be diminished
accordingly) or held as treasury shares. Such purchases may only be effected out of the capital paid up on the purchased shares or out
of the funds otherwise available for dividend or distribution or out of the proceeds of a fresh issue of shares made for the purpose.
Alteration of Share Capital
We may, if authorized by
a resolution of our shareholders, increase, divide, consolidate, subdivide, change the currency denomination of, diminish or otherwise
alter or reduce the share capital in any manner permitted by the Companies Act.
Variation of Rights
If at any time we have more
than one class of shares, the rights attaching to any class, unless otherwise provided for by the terms of issue of the relevant class,
may be varied with the sanction of a resolution passed by a majority of the votes cast at a general meeting of the relevant class of
shareholders at which a quorum consisting of at least two persons holding or representing one-third of the issued shares of the relevant
class is present. Our Amended and Restated Bye-laws specify that the creation or issue of shares ranking equally with existing shares
will not, unless expressly provided by the terms of issue of existing shares, vary the rights attached to existing shares. In addition,
the creation or issue of preference shares ranking prior to common shares will not be deemed to vary the rights attached to common shares
or, subject to the terms of any other series of preference shares, to vary the rights attached to any other series of preference shares.
Transfer of Shares
Our board of directors may
in its absolute discretion and without assigning any reason refuse to register the transfer of a share which is not fully paid. Our board
of directors may also refuse to recognize an instrument of transfer of a share unless it is accompanied by the relevant share certificate
and such other evidence of the transferor's right to make the transfer as our board of directors shall reasonably require. The
board shall refuse to register a transfer unless all applicable consents, authorizations and permissions of any governmental body or
agency in Bermuda have been obtained. Subject to these restrictions, a holder of common shares may transfer the title to all or any of
its common shares by completing a form of transfer in the form set out in our Bye-laws (or as near thereto as circumstances admit) or
in such other common form as the board may accept. The instrument of transfer must be signed by the transferor and transferee, although
in the case of a fully paid share our board of directors may accept the instrument signed only by the transferor.
Notwithstanding anything
to the contrary in the Amended and Restated Bye-laws, our shares may be transferred without a written instrument if transferred by an
appointed agent and in any form or manner which is in accordance with the rules or regulations of an appointed stock exchange (which
includes the Nasdaq Capital Market) on which the shares are listed or admitted to trading.
96
General Meetings
An annual general meeting
will be held each year in accordance with the requirements of the Companies Act and our Bye-laws at such time and place as our board
of directors appoints. Our board of directors or the chairman may also, whenever in its judgment it is necessary, convene general meetings
other than annual general meetings which are called special general meetings. Bermuda law and the Bye-laws provide that a special general
meeting must be called upon the request of shareholders holding not less than one-tenth of the paid-up capital of the Company carrying
the right to vote at general meetings. Any annual general meeting and special general meeting must be called by, respectively, not less
than twenty-one (21) days and five (5) days' prior notice in writing. A notice of meeting must include the place, day and time
of the meeting and, in the case of an annual general meeting, that the election of directors will take place thereat and any other business
to be conducted at the meeting, and, in the case of a special general meeting, the general nature of the business to be considered at
the meeting. This notice requirement is subject to the ability to hold such meetings on shorter notice if such notice is agreed: (i)
in the case of an annual general meeting by all of the shareholders entitled to attend and vote at such meeting; or (ii) in the case
of a special general meeting by a majority in number of the shareholders entitled to attend and vote at the meeting holding not less
than 95% in nominal value of the shares entitled to vote at such meeting. A shareholder may appoint a proxy to attend and vote at the
general meeting by providing notice in writing to us at our registered office or at such other place or in such manner as specified in
the notice of the general meeting.
The chairman, if present,
and if not, the chief executive officer, if present, and if not, the president, if present, and if not, any person appointed by our board
of directors will act as chairman of the meeting. In their absence and if no one is appointed by our board of directors as chairman of
such meeting, a chairman of the meeting will be appointed or elected by those present at the meeting and entitled to vote.
Board and Shareholder Ability to Call Special
Meetings
Our Bye-laws provide that
(a) the president or the chairman of the Company (if any) or any two Directors or any Director and the Secretary or the Board may convene
a special general meeting whenever in their judgment such a meeting is necessary and (b) the board of directors must convene a special
general meeting at the request of shareholders holding not less than one-tenth of the paid-up share capital of the Company with the right
to vote at general meetings.
Shareholder Meeting Quorum
Our Bye-laws provide that
at any general meeting of shareholders, At any general meeting two or more persons present throughout the meeting and representing in
person or by proxy in excess of 331/3% of the total voting rights of all issued and outstanding shares in the Company shall form a quorum
for the transaction of business.
Voting Rights
Subject to any restrictions
for the time being lawfully attached to any class of shares, every shareholder who is present in person or by proxy at a general meeting
shall be entitled to one vote on a show of hands and be entitled to one vote for every share of which he is a holder on a vote taken
by poll, and any question proposed for the consideration of the shareholders at any general meeting shall be decided by the affirmative
votes of a majority of the votes cast in accordance with the Bye-laws, and in the case of an equality of votes, the resolution will fail.
Shareholder Action by Written Consent
The Bye-laws provide that
no action required to be taken or which may be taken at any general meeting of Members may be taken without a meeting, and the power
of Members to consent in writing, without a meeting, to the taking of any action is specifically denied.
97
Access to Books and Records and Dissemination
of Information
Members of the general public
have a right to inspect the public documents of a company available at the office of the Registrar of Companies in Bermuda. These documents
include the company's memorandum of association, including its objects and powers, and certain alterations to the memorandum of
association. The shareholders have the additional right to inspect the bye-laws of the company, minutes of general meetings and the company's
audited financial statements, which must be presented to the annual general meeting. The register of members of a company is also open
to inspection by shareholders and by members of the general public without charge. The register of members is required to be open for
inspection for not less than two hours in any business day (subject to the ability of a company to close the register of members for
not more than thirty days in a year). A company is required to maintain its share register in Bermuda but may, subject to the provisions
of the Companies Act, establish a branch register outside of Bermuda. A company is required to keep at its registered office a register
of directors and officers that is open for inspection for not less than two hours in any business day by members of the public without
charge. A company is also required to file with the Registrar of Companies in Bermuda a list of its directors to be maintained on a register,
which register will be available for public inspection subject to such conditions as the Registrar may impose and on payment of such
fee as may be prescribed. Bermuda law does not, however, provide a general right for shareholders to inspect or obtain copies of any
other corporate records.
Removal of Directors
Our Amended and Restated
Bye-laws provide that shareholders entitled to vote for the election of directors may, at any special general meeting convened and held
in accordance with the Amended and Restated Bye-laws, remove a director only with cause, by the affirmative vote of shareholders holding
at least a majority of the total voting rights of all shareholders having the right to vote at such meeting, provided that the notice
of any such meeting convened for the purpose of removing a director must contain a statement of the intention so to do and be served
on such director not less than 14 days before the meeting and at such meeting the director will be entitled to be heard on the motion
for such director's removal.
Proceedings of Board of Directors
Our Bye-laws provide that
our business is to be managed and conducted by our board of directors. Bermuda law permits individual and corporate directors and there
is no requirement in the Bye-laws or Bermuda law that directors hold any of our shares. There is also no requirement in the Bye-laws
or Bermuda law that our directors must retire at a certain age.
The remuneration of our directors
is determined by the board of directors from time to time at a duly authorized meeting. Our directors may also be paid all travel, hotel
and other expenses properly incurred by them in connection with our business or their duties as directors.
Provided a director discloses
a direct or indirect interest in any contract or arrangement or proposed contract or arrangement with us as required by Bermuda law,
such director is entitled to vote in respect of any such contract or arrangement in which he or she is interested and/or be counted in
the quorum for the meeting at which such contract or arrangement is to be voted on.
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Amalgamations, Mergers and Business Combinations
The amalgamation or merger
of a Bermuda company with another company or corporation (other than certain affiliated companies) requires the amalgamation or merger
agreement to be approved by the company's board of directors and by its shareholders. Unless the company's bye-laws provide
otherwise, the approval of 75% of the shareholders voting at such meeting is required to approve the amalgamation or merger agreement,
and the quorum for such meeting must be two persons holding or representing more than one-third of the issued shares of the company.
The Amended and Restated Bye-laws provide that an amalgamation, consolidation or a merger (other than with a wholly owned subsidiary
or as described below) that has been approved by the board must only be approved by a majority of the votes cast at a general meeting
of the shareholders at which the quorum shall be two or more persons present in person and representing in person or by proxy in excess
of 50% of all issued and outstanding common voting shares. Any other amalgamation or merger or other business combination (as defined
in the Amended and Restated Bye-laws) not approved by our board must be approved by the holders of not less than 66 2/3% of all votes
attaching to all shares then in issue entitling the holder to attend and vote on the resolution.
Dissenter's Rights
Under Bermuda law, in the
event of an amalgamation or merger of a Bermuda company with another company or corporation, including a public Bermuda company, a shareholder
of the Bermuda company who did not vote in favor of the amalgamation or merger and is not satisfied that fair value has been offered
for such shareholder's shares may, within one month of notice of the shareholders meeting, apply to the Supreme Court of Bermuda
to appraise the fair value of those shares. These approval rights did not apply to the Business Combination because the Company was not
a party to any amalgamation or merger contemplated by the Business Combination.
Limitations on Director Liability and Indemnification
of Directors and Officers
Section 98 of the Companies
Act provides generally that a Bermuda company may indemnify its directors, officers and auditors against any liability which by virtue
of any rule of law would otherwise be imposed on them in respect of any negligence, default, breach of duty or breach of trust, except
in cases where such liability arises from fraud or dishonesty of which such director, officer or auditor may be guilty in relation to
the company. Section 98 further provides that a Bermuda company may indemnify its directors, officers and auditors against any liability
incurred by them in defending any proceedings, whether civil or criminal, in which judgment is awarded in their favor or in which they
are acquitted or granted relief by the Supreme Court of Bermuda pursuant to section 281 of the Companies Act.
The Bye-laws provide that
the directors, resident representative, secretary and other officers acting in relation to any of the affairs of the Company or any subsidiary
thereof and the liquidator or trustees (if any) acting in relation to any of the affairs of the Company or any subsidiary thereof and
every one of them shall be indemnified and secured harmless out of the assets of the Company from and against all actions, costs, charges,
losses, damages and expenses which they or any of them shall or may incur or sustain by or by reason of any act done, concurred in or
omitted in or about the execution of their duty, or supposed duty, or in their respective offices or trusts, and no indemnified party
shall be answerable to the acts, receipts, neglects or defaults of the others of them or for joining in any receipts for the sake of
conformity, or for any bankers or other persons with whom any moneys or effects belonging to the Company shall or may be lodged or deposited
for safe custody, or for insufficiency or deficiency of any security upon which any moneys of or belonging to the Company shall be placed
out on or invested, or for any other loss, misfortune or damage which may happen in the execution of their respective offices or trusts,
or in relation thereto, provided that this indemnity shall not extend to any matter in respect of any fraud or dishonesty in relation
to the Company which may attach to any of the indemnified parties. We may also enter into an indemnification agreement with any director
or officer of the Company.
In addition, the Bye-laws
provide that the Company may (i) purchase and maintain insurance for the benefit of any director or officer against any liability incurred
by such person under the Companies Act in his or her capacity as a director or officer of the Company or indemnifying such director or
officer in respect of any loss arising or liability attaching to him or her by virtue of any rule of law in respect of any negligence,
default, breach of duty or breach of trust of which the director or officer may be guilty in relation to the Company or any of its subsidiaries
and (ii) advance moneys to a director or officer for the costs, charges and expenses incurred by the director or officer in defending
any civil or criminal proceedings against him or her, on condition that the director or officer shall repay the advance if any allegation
of fraud or dishonesty in relation to the Company is proved against him or her.
99
Class Actions and Derivative Suits
Class actions and derivative
actions are generally not available to shareholders under Bermuda law. The Bermuda courts, however, would ordinarily be expected to permit
a shareholder to commence an action in the name of a company to remedy a wrong to the company where the act complained of is alleged
to be beyond the corporate power of the company or illegal, or would result in the violation of the company's memorandum of association
or bye-laws. Furthermore, consideration would be given by a Bermuda court to acts that are alleged to constitute a fraud against the
minority shareholders or, for instance, where an act requires the approval of a greater percentage of the company's shareholders
than that which actually approved it.
When the affairs of a company
are being conducted in a manner which is oppressive or prejudicial to the interests of some part of the shareholders, one or more shareholders
may apply to the Supreme Court of Bermuda, which may make such order as it sees fit, including an order regulating the conduct of the
company's affairs in the future or ordering the purchase of the shares of any shareholders by other shareholders or by the company.
Amendment of Memorandum of Association and
Bye-laws
Bermuda law provides that
the memorandum of association of a company may be amended by a resolution passed at a general meeting of shareholders. Our Amended and
Restated Bye-laws provide that no bye-law shall be rescinded, altered or amended, and no new bye-law shall be made, unless it shall have
been approved by a resolution of our board of directors and by a resolution of our shareholders.
Under Bermuda law, the holders
of an aggregate of not less than 20% in par value of the company's issued share capital or any class thereof have the right to
apply to the Supreme Court of Bermuda for an annulment of any amendment of the memorandum of association adopted by shareholders at any
general meeting, other than an amendment which alters or reduces a company's share capital as provided in the Companies Act. Where
such an application is made, the amendment becomes effective only to the extent that it is confirmed by the Bermuda court. An application
for an annulment of an amendment of the memorandum of association must be made within 21 days after the date on which the resolution
altering the company's memorandum of association is passed and may be made on behalf of persons entitled to make the application
by one or more of their number as they may appoint in writing for the purpose. No application may be made by shareholders voting in favor
of the amendment.
Capitalization of Profits and Reserves
Pursuant to our Bye-laws,
our board of directors may (i) capitalize any part of the amount of our share premium or other reserve accounts or any amount credited
to our profit and loss account or otherwise available for distribution by applying such sum in paying up unissued shares to be allotted
as fully paid bonus shares pro-rata (except in connection with the conversion of shares) to the shareholders; or (ii) capitalize any
sum standing to the credit of a reserve account or sums otherwise available for dividend or distribution by paying up in full, partly
paid or nil paid shares of those shareholders who would have been entitled to such sums if they were distributed by way of dividend or
distribution.
Certain Provisions of Bermuda Law
Share Certificates
In accordance with Bermuda
law, share certificates are only issued in the names of companies, partnerships or individuals. In the case of a shareholder acting in
a special capacity (for example as a trustee), certificates may, at the request of the shareholder, record the capacity in which the
shareholder is acting. Notwithstanding such recording of any special capacity, we are not bound to investigate or see to the execution
of any such trust.
Membership
Under the Companies Act,
only those persons who agree to become members of a Bermuda company and whose names are entered on the register of members of such company
are deemed members. A Bermuda company is not bound to see to the execution of any trust, whether express, implied or constructive, to
which any of its shares are subject and whether or not the company had notice of such trust. Accordingly, persons holding shares through
a trustee, nominee or depository will not be recognized as members of a Bermuda company under Bermuda law and may only have the benefit
of rights attaching to the shares or remedies conferred by law on members through or with the assistance of the trustee, nominee or depository.
100
Composition of Our Board of Directors
Our board of directors is
currently composed of three members. Our board of directors has determined that, of our four directors, none have a relationship that
would interfere with the exercise of independent judgment in carrying out the responsibilities of two of the directors, Mr. John Brancaccio
and Mr. Simon, and that each of these directors is "independent" as that term is defined under Nasdaq rules.
In accordance with our Articles,
at the first general meeting which is held after the date of adoption of the Bye-laws for the purpose of electing Directors, the Class
I Directors shall be elected for a three year term of office, the Class II Directors shall be elected for a two year term of office and
the Class III Directors shall be elected for a one year term of office. At each succeeding annual general meeting, successors to the
class of Directors whose term expires at that annual general meeting shall be elected for a three-year term. If the number of Directors
is changed, any increase or decrease shall be apportioned among the classes so as to maintain the number of Directors in each class as
nearly equal as possible, and any Director of any class elected to fill a vacancy shall hold office for a term that shall coincide with
the remaining term of the other Directors of that class, but in no case shall a decrease in the number of Directors shorten the term
of any Director then in office. A Director shall hold office until the annual general meeting for the year in which his term expires.
The Class of the members
of the Board of Directors is as follows:
Name
Class
Year Current
Term Began
Year Current
Term Expires
Gabriele Cerrone
I
2021
2024
John Brancaccio
II
2021
2023
Willy Simon
III
2022
2023
Committees of Our Board of Directors
Our board of directors has
three standing committees: an audit committee, a remuneration committee and a nominating committee.
101
Audit Committee
The audit committee, which
consists of, Mr. Brancaccio and Mr. Simon, assists the board of directors in overseeing our accounting and financial reporting processes.
Mr. Brancaccio serves as chairman of the audit committee. The audit committee consists exclusively of members of our board who are financially
literate, and Mr. Simon is considered an "audit committee financial expert" as defined by applicable SEC rules and has the
requisite financial sophistication as defined under the applicable Nasdaq rules and regulations.
Our board has determined
that all of the members of the audit committee satisfy the "independence" requirements set forth in Rule 10A-3 under the
Exchange Act. The audit committee will be governed by a charter that complies with Nasdaq rules.
The audit committee's
responsibilities include:
●
recommending the appointment
    of the independent auditor to the general meeting of shareholders;
●
the appointment, compensation,
    retention and oversight of any accounting firm engaged for the purpose of preparing or issuing an audit report or performing other
    audit services;
●
pre-approving the audit
    services and non-audit services to be provided by our independent auditor before the auditor is engaged to render such services;
●
evaluating the independent
    auditor's qualifications, performance and independence, and presenting its conclusions to the full board of directors on at
    least an annual basis;
●
reviewing and discussing
    with management and our independent registered public accounting firm our financial statements and our financial reporting process;
●
reviewing, approving or
    ratifying any related party transactions.
●
recommending the appointment
    of the independent auditor to the general meeting of shareholders; and
●
the appointment, compensation,
    retention and oversight of any accounting firm engaged for the purpose of preparing or issuing an audit report or performing other
    audit services;
Remuneration Committee
The remuneration committee
consists of Mr. Brancaccio and Mr. Simon. Mr. Simon serves as chairman of the remuneration committee. Under SEC and Nasdaq rules, there
are heightened independence standards for members of the remuneration committee, including a prohibition against the receipt of any compensation
from us other than standard board member fees.
The remuneration committee's
responsibilities include:
●
identifying, reviewing
    and proposing policies relevant to the compensation and benefits of our directors and executive officers;
●
evaluating each executive
    officer's performance in light of such policies and reporting to the board; and
●
overseeing and administering
    our employee share option scheme or equity incentive plans in operation from time to time.
102
Nominating Committee
The nominating committee
consists of Mr. Cerrone and Mr. Simon. Mr. Simon serves as chairman of the nominating committee. The nominating committee's responsibilities
include:
●
drawing up selection criteria
    and appointment procedures for directors;
●
recommending nominees for
    election to our board of directors and its corresponding committees;
●
assessing the functioning
    of individual members of our board of directors and executive officers and reporting the results of such assessment to the board
    of directors; and
●
developing corporate governance
    guidelines.
None of our non-employee
directors have any service contracts with Tiziana Life Sciences Ltd or any of our subsidiaries that provide for benefits upon termination
of employment.
Board
Diversity Matrix (As of April 24, 2023)
Country of Principal Executive Offices
United Kingdom
Foreign Private Issuer
Yes
Disclosure Prohibited Under Home Country Law
No
Total Number of Directors
3
Female
Male
Non-Binary
Did Not Disclose Gender
Part I: Gender Identity
Directors
0
3
0
0
Part II: Demographic Background
Underrepresented Individual in Home Country Jurisdiction
0
0
0
0
LGBTQ+
0
0
0
0
D. Employees
As of December 31, 2022,
we had 9 full time employees. Three of our employees were engaged in research and development and six employees were engaged in management,
administration and finance. Five are located in England and four are located in the United States. None of our employees are members
of labor unions. None of our employees are covered by a collective bargaining agreement.
Insurance and Indemnification
To the extent permitted by
the Companies Act, we are empowered to indemnify our directors against any liability they incur by reason of their directorship. We maintain
directors' and officers' insurance to insure such persons against certain liabilities. We expect to enter into a deed of
indemnity with each of our directors and executive officers prior to, or as soon as practicable, following the filing of this registration
statement.
In addition to such indemnification,
we provide our directors and executive officers with directors' and officers' liability insurance.
Insofar as indemnification
of liabilities arising under the Securities Act may be permitted to our board of directors, executive officers, or persons controlling
us pursuant to the foregoing provisions, we have been informed that, in the opinion of the SEC, such indemnification is against public
policy as expressed in the Securities Act and is therefore unenforceable.
E. Share Ownership
See "Item 7. Major
Shareholders and Related Party Transactions."
103
ITEM 7: MAJOR SHAREHOLDERS AND RELATED PARTY
TRANSACTIONS
A. Major Shareholders
The following table sets forth
information relating to the beneficial ownership of our ordinary shares as of April 24, 2023 by:
●
each person, or group of
    affiliated persons, known by us to own beneficially 5% or more of our outstanding ordinary shares; and
●
each member of our board
    of directors and each of our executive officers.
The number of ordinary shares
beneficially owned by each entity, person, board member, or executive officer is determined in accordance with the rules of the SEC,
and the information is not necessarily indicative of beneficial ownership for any other purpose. Under such rules, beneficial ownership
includes any ordinary shares over which the individual has sole or shared voting power or investment power as well as any ordinary shares
that the individual has the right to acquire within 60 days of April 24, 2023 through the exercise of any option, warrant or other right.
Except as otherwise indicated, and subject to applicable community property laws, the persons named in the table have sole voting and
investment power with respect to all ordinary shares held by that person.
Number of Ordinary
Shares Beneficially
Owned
Name and address of beneficial owner
Shares
%
5% or Greater Shareholders:
Gabriele Cerrone
(1)
39, 806,023
38.58
Executive Officers and Directors:
Gabriele Cerrone
(1)
39,806,023
38.58
Willy Simon
8,250
*
John Brancaccio
-
-
-
-
All directors and executive officers as a group (3 persons)
(2)
39,814,273
38.58
*
Indicates beneficial ownership
    of less than 1% of the total outstanding ordinary shares.
(1)
Mr. Gabriele Cerrone is
    the ultimate beneficial owner of ordinary shares through Planwise Group Limited and Panetta Partners Limited.
Includes 915,388 stock options which are currently
    exercisable or exercisable within 60 days of April 24, 2023
(2)
Includes of 915,388 stock
    options which are currently exercisable or exercisable within 60 days of April 24, 2023
104
B. Related Party Transactions
The following is a description
of related party transactions we have entered into since January 1, 2020, with the beneficial owners of 5% or more of our ordinary shares,
which are our only voting securities, and senior management and members of our board of directors.
Indemnity Agreements
We have entered into deeds
of indemnity with each of our directors.
Related Person Transaction Policy
Our board of directors has
adopted a written related person transaction policy, effective as of November 9, 2018, the date on which our registration statement on
Form F-1 was declared effective. This policy covers, any transaction or proposed transactions between us and a related person that are
material to us or the related person, including without limitation, purchases of goods or services by or from the related person or entities
in which the related person has a material interest, indebtedness, guarantees of indebtedness and employment by us of a related person.
In reviewing and approving any such transactions, our audit and risk committee is tasked to consider all relevant facts and circumstances,
including, but not limited to, whether the transaction is on terms comparable to those that could be obtained in an arm's length
transaction and the extent of the related person's interest in the transaction.
Employment Agreements
We have entered into a
consultancy agreement with our Acting Chief Executive Officer, and director agreements with our remaining board members. For further
details on these agreements, see Item 6 entitled "Directors, Senior Management and Employees."
We have entered into certain
related party transactions as disclosed in Note 8 and Note 23 to the Consolidated Financial Statements in Item 18 of this report.
C. Interests of Experts and Counsel
Not applicable.
ITEM 8: FINANCIAL INFORMATION
A. Consolidated Statements and Other Financial Information
See "Item 18. Financial
Statements".
Legal Proceedings
Except as disclosed in this
paragraph, there are no governmental, legal or arbitration proceedings (including any such proceedings which are pending or threatened
of which the Company is aware), which may have, or have had during the 12 months prior to the date of this registration statement, a significant
effect on the Company's and/or our financial position or profitability. In addition to the proceedings set out in this section,
the Company is involved in other legal proceedings and claims in the ordinary course of business.
B. Significant Changes
See Note 25 of our consolidated
financial statements at the end of this Annual Report for a description of the significant changes since December 31, 2022.
105
ITEM 9: THE LISTING
A. Listing Details
Our common shares are listed
on The Nasdaq Capital Market under the symbol "TLSA."
B. Plan of Distribution
Not applicable.
C. Markets
Our common shares are listed on the Nasdaq Capital Market under the
symbol "TLSA."
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.
B. Memorandum of Association and Bye-laws
We incorporate by reference
into this Annual Report the description of our memorandum of association and Bye-laws contained in Form 8-K filed with the SEC on October
21, 2021.
C. Material Contracts
Except as otherwise disclosed
in this Annual Report (including the exhibits hereto), we are not currently, and have not been in the last two years, party to any material
contract, other than contracts entered into in the ordinary course of business.
D. Exchange Controls
The permission of the Bermuda
Monetary Authority is required, under the provisions of the Exchange Control Act 1972 of Bermuda and related regulations, for all issuances
and transfers of shares (which includes our common shares) of Bermuda companies to or from a non-resident of Bermuda for exchange control
purposes, other than in cases where the Bermuda Monetary Authority has granted a general permission. The Bermuda Monetary Authority,
in its notice to the public dated June 1, 2005, has granted a general permission for the issue and subsequent transfer of any securities
of a Bermuda company from and/or to a non-resident of Bermuda for exchange control purposes for so long as any "Equity Securities"
of the company (which include our common shares) are listed on an "Appointed Stock Exchange" (which include Nasdaq). In granting
the general permission the Bermuda Monetary Authority accepts no responsibility for our financial soundness or the correctness of any
of the statements made or opinions expressed in this annual report.
Although the Company is incorporated
in Bermuda, as an exempted company it is classified as a non-resident of Bermuda for exchange control purposes by the Bermuda Monetary
Authority. Other than transferring Bermuda Dollars out of Bermuda, there are no restrictions on the Company's ability to transfer
funds into and out of Bermuda or to pay dividends in currency other than Bermuda Dollars to non-residents of Bermuda who are holders
of our common shares
106
E. Taxation
Material U.S. Federal Income Tax Considerations for U.S. Holders
U.S. Federal Income Tax Considerations for
U.S. Holders
The following discussion
describes the material U.S. federal income tax consequences relating to the ownership and disposition of our Common shares by U.S. Holders.
This discussion applies to U.S. Holders that purchase our Common shares pursuant to this offering and hold such Common shares as capital
assets for tax purposes. This discussion is based on the Internal Revenue Code, U.S. Treasury regulations promulgated thereunder and
administrative and judicial interpretations thereof, and the income tax treaty between the United Kingdom and the United States, or the
Treaty, all as in effect on the date hereof and all of which are subject to change, possibly with retroactive effect. This discussion
does not address all of the U.S. federal income tax consequences 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 (such as certain financial institutions,
insurance companies, dealers or traders in securities or other persons that generally mark their securities to market for U.S. federal
income tax purposes, tax-exempt entities or governmental organizations, retirement plans, regulated investment companies, real estate
investment trusts, grantor trusts, brokers, dealers or traders in securities, commodities, currencies or notional principal contracts,
certain former citizens or long-term residents of the United States, persons who hold our Common shares as part of a "straddle,"
"hedge," "conversion transaction," "synthetic security" or integrated investment, persons that have
a "functional currency" other than the U.S. dollar, persons who are subject to the tax accounting rules of Section 451(b)
of the Internal Revenue Code, persons that own directly, indirectly or through attribution 10% or more (by vote or value) of our equity,
corporations that accumulate earnings to avoid U.S. federal income tax, partnerships and other pass-through entities, and investors in
such pass-through entities). This discussion does not address any U.S. state or local or non-U.S. tax consequences or any U.S. federal
estate, gift or alternative minimum tax consequences.
As used in this discussion,
the term "U.S. Holder" means a beneficial owner of our Common shares that is, for U.S. federal income tax purposes, (1) an
individual who is a citizen or resident of the United States, (2) a corporation (or entity treated 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,
(3) an estate the income of which is subject to U.S. federal income tax regardless of its source or (4) a trust (x) with respect to which
a court within the United States is able to exercise primary supervision over its administration and one or more United States persons
have the authority to control all of its substantial decisions or (y) that has elected under applicable U.S. Treasury regulations to
be treated as a domestic trust for U.S. federal income tax purposes.
If an entity treated as a
partnership for U.S. federal income tax purposes holds our Common shares, the U.S. federal income tax consequences relating to an investment
in such Common shares will depend upon the status and activities of such entity and the particular partner. Any such entity and a partner
in any such entity should consult its own tax advisor regarding the U.S. federal income tax consequences applicable to it (and, as applicable,
its partners) of the purchase, ownership and disposition of our Common shares.
We have not sought, nor will
we seek, a ruling from the IRS with respect to the matters discussed below. There can be no assurance that the IRS will not take a different
position concerning the tax consequences of the purchase, ownership or disposition of the Common shares or that any such position would
not be sustained. Persons considering an investment in our Common shares should consult their own tax advisors as to the particular tax
consequences applicable to them relating to the purchase, ownership and disposition of our Common shares, including the applicability
of U.S. federal, state and local tax laws and non-U.S. tax laws.
Passive Foreign Investment Company Rules
In general, a corporation
organized outside the United States will be treated as a PFIC for any taxable year in which either (1) at least 75% of its gross income
is "passive income," or the PFIC income test, or (2) on average at least 50% of its assets, determined on a quarterly basis,
are assets that produce passive income or are held for the production of passive income, or the PFIC asset test. Passive income for this
purpose generally includes, among other things, dividends, interest, royalties, rents, and gains from the sale or exchange of property
that give rise to passive income. Assets that produce or are held for the production of passive income generally include cash, even if
held as working capital or raised in a public offering, marketable securities, and other assets that may produce passive income. Generally,
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.
107
Although PFIC status is determined
on an annual basis and generally cannot be determined until the end of the taxable year, based on the nature of our current and expected
income and the current and expected value and composition of our assets, we believe we were a PFIC for our 2017 tax year and we expect
to be a PFIC for our current taxable year. There can be no assurance that we will not be a PFIC in future taxable years. Even if we determine
that we are not a PFIC for a taxable year, there can be no assurance that the IRS will agree with our conclusion and that the IRS would
not successfully challenge our position. Because of the uncertainties involved in establishing our PFIC status, our U.S. counsel expresses
no opinion regarding our PFIC status, and also expresses no opinion with respect to our predictions or past determinations regarding
our PFIC status.
If we are a PFIC in any taxable
year during which a U.S. Holder owns our Common shares, the U.S. Holder could be liable for additional taxes and interest charges under
the "PFIC excess distribution regime" upon (1) a distribution paid during a taxable year that is greater than 125% of the
average annual distributions paid in the three preceding taxable years, or, if shorter, the U.S. Holder's holding period for our
Common shares, and (2) any gain recognized on a sale, exchange or other disposition, including, under certain circumstances, a pledge,
of our Common shares, whether or not we continue to be a PFIC. Under the PFIC excess distribution regime, the tax on such distribution
or gain would be determined by allocating the distribution or gain ratably over the U.S. Holder's holding period for our Common
shares. The amount allocated to the current taxable year (
i.e
., the year in which the distribution occurs or the gain is recognized)
and any year prior to the first taxable year in which we are a PFIC will be taxed as ordinary income earned in the current taxable year.
The amount allocated to other taxable years will be taxed at the highest marginal rates in effect for individuals or corporations, as
applicable, to ordinary income for each such taxable year, and an interest charge, generally applicable to underpayments of tax, will
be added to the tax.
If we are a PFIC for any
year during which a U.S. Holder holds our Common shares, we must generally continue to be treated as a PFIC by that U.S. Holder for all
succeeding years during which the U.S. Holder holds such Common shares, unless we cease to meet the requirements for PFIC status and
the U.S. Holder makes a "deemed sale" election with respect to our Common shares. If the election is made, the U.S. Holder
will be deemed to sell our Common shares it holds at their fair market value on the last day of the last taxable year in which we qualified
as a PFIC, and any gain recognized from such deemed sale would be taxed under the PFIC excess distribution regime. After the deemed sale
election, the U.S. Holder's Common shares would not be treated as shares of a PFIC unless we subsequently become a PFIC.
If we are a PFIC for any
taxable year during which a U.S. Holder holds our Common shares and one of our non-United States subsidiaries is also a PFIC (
i.e
.,
a lower-tier PFIC), such U.S. Holder would be treated as owning a proportionate amount (by value) of the shares of the lower-tier PFIC
and would be taxed under the PFIC excess distribution regime on distributions by the lower-tier PFIC and on gain from the disposition
of shares of the lower-tier PFIC even though such U.S. Holder would not receive the proceeds of those distributions or dispositions.
Any of our non-United States subsidiaries that have elected to be disregarded as entities separate from us or as partnerships for U.S.
federal income tax purposes would not be corporations under U.S. federal income tax law and accordingly, cannot be classified as lower-tier
PFICs. However, a non-United States subsidiary that has not made the election may be classified as a lower-tier PFIC if we are a PFIC
during your holding period and the subsidiary meets the PFIC income test or PFIC asset test.
If we are a PFIC, a U.S.
Holder will not be subject to tax under the PFIC excess distribution regime on distributions or gain recognized on our Common shares
if a valid "mark-to-market" election is made by the U.S. Holder for our Common shares. An electing U.S. Holder generally
would take into account as ordinary income each year, the excess of the fair market value of our Common shares held at the end of such
taxable year over the adjusted tax basis of such Common shares. The U.S. Holder would also take into account, as an ordinary loss each
year, the excess of the adjusted tax basis of such Common shares over their fair market value at the end of the taxable year, but only
to the extent of the excess of amounts previously included in income over ordinary losses deducted as a result of the mark-to-market
election. The U.S. Holder's tax basis in our Common shares would be adjusted annually to reflect any income or loss recognized
as a result of the mark-to-market election. Any gain from a sale, exchange or other disposition of our Common shares in any taxable year
in which we are a PFIC would be treated as ordinary income and any loss from such sale, exchange or other disposition would be treated
first as ordinary loss (to the extent of any net mark-to-market gains previously included in income) and thereafter as capital loss.
If, after having been a PFIC for a taxable year, we cease to be classified as a PFIC because we no longer meet the PFIC income or PFIC
asset test, the U.S. Holder would not be required to take into account any latent gain or loss in the manner described above and any
gain or loss recognized on the sale or exchange of the Common shares would be classified as a capital gain or loss.
108
A mark-to-market election
is available to a U.S. Holder only for "marketable stock." Generally, stock will be considered marketable stock if it is
"regularly traded" on a "qualified exchange" within the meaning of applicable U.S. Treasury regulations. A class
of stock is regularly traded 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.
Our Common shares will be
marketable stock as long as they remain listed on Nasdaq and are regularly traded. A mark-to-market election will not apply to the Common
shares 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 of our non-U.S. subsidiaries. Accordingly, a U.S. Holder may continue to
be subject to tax under the PFIC excess distribution regime with respect to any lower-tier PFICs notwithstanding the U.S. Holder's
mark-to-market election for our Common shares.
The tax consequences that
would apply if we are a PFIC would also be different from those described above if a U.S. Holder were able to make a valid QEF election.
As we do not expect to provide U.S. Holders with the information necessary for a U.S. Holder to make a QEF election, prospective investors
should assume that a QEF election will not be available.
The U.S. federal income
tax rules relating to PFICs are very complex. Prospective U.S. investors are strongly urged to consult their own tax advisors with respect
to the impact of PFIC status on the purchase, ownership and disposition of our
Common shares
, the consequences to them of an investment
in a PFIC, any elections available with respect to the
Common shares
and the IRS information reporting obligations with respect
to the purchase, ownership and disposition of
Common shares
of a PFIC.
Distributions
Subject to the discussion
above under "— Passive Foreign Investment Company Rules," a U.S. Holder that receives a distribution with respect to
our Common shares generally will be required to include the gross amount of such distribution in gross income as a dividend when actually
or constructively received by the U.S. Holder 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). To the extent a distribution received by a U.S. Holder
is not a dividend because it exceeds the U.S. Holder's pro rata share of our current and accumulated earnings and profits, it will
be treated first as a tax-free return of capital and reduce (but not below zero) the adjusted tax basis of the U.S. Holder's Common
shares. To the extent the distribution exceeds the adjusted tax basis of the U.S. Holder's Common shares, the remainder will be
taxed as capital gain. Because we may not account for our earnings and profits in accordance with U.S. federal income tax principles,
U.S. Holders should expect all distributions to be reported to them as dividends. The amount of a dividend will include any amounts withheld
by the company in respect of United Kingdom taxes.
Distributions on our Common
shares that are treated as dividends generally will constitute income from sources outside the United States for foreign tax credit purposes
and generally will constitute passive category income. Subject to applicable limitations, some of which vary depending upon the U.S.
Holder's particular circumstances, any United Kingdom income taxes withheld from dividends on Common shares at a rate not exceeding
the rate provided by the Treaty will be creditable against the U.S. Holder's U.S. federal income tax liability. The rules governing
foreign tax credits are complex and U.S. Holders should consult their tax advisers regarding the creditability of foreign taxes in their
particular circumstances. In lieu of claiming a foreign tax credit, U.S. Holders may, at their election, deduct foreign taxes, including
any United Kingdom income tax, in computing their taxable income, subject to generally applicable limitations under U.S. law. An election
to deduct foreign taxes instead of claiming foreign tax credits applies to all foreign taxes paid or accrued in the taxable year. The
amount of any dividend income paid in a currency other than the U.S. dollar will be the U.S. dollar amount calculated by reference to
the exchange rate in effect on the date of actual or constructive receipt, regardless of whether the payment is in fact converted into
U.S. dollars at that time. If the dividend is converted into U.S. dollars on the date of receipt, a U.S. holder should not be required
to recognize foreign currency gain or loss in respect of the dividend amount. A U.S. Holder may have foreign currency gain or loss if
the dividend is converted into U.S. dollars after the date of receipt.
109
Distributions paid on our
Common shares will not be eligible for the "dividends received" deduction generally allowed to corporate shareholders with
respect to dividends received from U.S. corporations under the Internal Revenue Code. Dividends paid by a "qualified foreign corporation''
to non-corporate U.S. Holders are eligible for taxation at a reduced capital gains rate rather than the marginal tax rates generally
applicable to ordinary income provided that a holding period requirement (more than 60 days of ownership, without protection from the
risk of loss, during the 121-day period beginning 60 days before the ex-dividend date) and certain other requirements are met. Each U.S.
Holder is advised to consult its tax advisors regarding the availability of the reduced tax rate on dividends to its particular circumstances.
However, if we are a PFIC for the taxable year in which the dividend is paid or the preceding taxable year (see discussion above under
"— Passive Foreign Investment Company Rules''), we will not be treated as a qualified foreign corporation, and
therefore the reduced capital gains tax rate described above will not apply.
A non-United States corporation
(other than a corporation that is classified as 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 with respect to any dividend it pays on Common shares that are readily
tradable on an established securities market in the United States.
The amount of any dividend
income that is paid in Pounds Sterling will be the U.S. dollar amount calculated by reference to the exchange rate in effect on the date
of receipt, regardless of whether the payment is in fact converted into U.S. dollars. If the dividend is converted into U.S. dollars
on the date of receipt (actual or constructive), a U.S. Holder should not be required to recognize foreign currency gain or loss in respect
of the dividend income. A U.S. Holder may have foreign currency gain or loss if the dividend is converted into U.S. dollars after the
date of receipt (actual or constructive).
Sale, Exchange or Other Taxable Disposition
of Our
Common shares
Subject to the discussion
above under "— Passive Foreign Investment Company Rules," a U.S. Holder generally will recognize capital gain or loss
for U.S. federal income tax purposes upon the sale, exchange or other disposition of our Common shares in an amount equal to the difference,
if any, between the amount realized (
i.e
., the amount of cash plus the fair market value of any property received) on the sale,
exchange or other disposition and such U.S. Holder's adjusted tax basis in the Common shares. Such capital gain or loss generally
will be long-term capital gain taxable at a reduced rate for non-corporate U.S. Holders or long-term capital loss if, on the date of
sale, exchange or other disposition, the Common shares were held by the U.S. Holder for more than one year. Any capital gain of a non-corporate
U.S. Holder that is not long-term capital gain is taxed at ordinary income rates. The deductibility of capital losses is subject to limitations.
Any gain or loss recognized from the sale or other disposition of our Common shares will generally be gain or loss from sources within
the United States for U.S. foreign tax credit purposes.
Medicare Tax
Certain U.S. Holders that
are individuals, estates or trusts and whose income exceeds certain thresholds generally are subject to a 3.8% tax on all or a portion
of their net investment income, which may include their gross dividend income and net gains from the disposition of our Common shares.
If you are a U.S. Holder that is an individual, estate or trust, you are encouraged to consult your tax advisors regarding the applicability
of this Medicare tax to your income and gains in respect of your investment in our Common shares.
Information Reporting and Backup Withholding
U.S. Holders may be required
to file certain U.S. information reporting returns with the IRS with respect to an investment in our Common shares, including, among others,
IRS Form 8938 (Statement of Specified Foreign Financial Assets). In addition, each U.S. Holder who is a shareholder of a PFIC must file
an annual report containing certain information. U.S. Holders paying more than $100,000 for our Common shares may be required to file
IRS Form 926 (Return by a U.S. Transferor of Property to a Foreign Corporation) reporting this payment. Substantial penalties and other
adverse circumstances may be imposed upon a U.S. Holder that fails to comply with the required information reporting.
110
Dividends on and proceeds
from the sale or other disposition of our Common shares generally have to be reported to the IRS unless the U.S. Holder establishes a
basis for exemption. Backup withholding may apply to amounts subject to reporting if the holder (1) fails to provide an accurate U.S.
taxpayer identification number or otherwise establish a basis for exemption, or (2) is described in certain other categories of persons.
However, U.S. Holders that are corporations generally are excluded from these information reporting and backup withholding tax rules.
Backup withholding is not
an additional tax. Any amounts withheld under the backup withholding rules generally will be allowed as a refund or a credit against
a U.S. Holder's U.S. federal income tax liability if the required information is furnished by the U.S. Holder on a timely basis
to the IRS.
U.S. Holders should consult
their own tax advisors regarding the backup withholding tax and information reporting rules.
EACH PROSPECTIVE INVESTOR
IS URGED TO CONSULT ITS OWN TAX ADVISOR ABOUT THE TAX CONSEQUENCES TO IT OF AN INVESTMENT IN OUR
COMMON SHARES
IN LIGHT OF THE
INVESTOR'S OWN CIRCUMSTANCES. IN ADDITION, SIGNIFICANT CHANGES IN U.S. FEDERAL INCOME TAX LAWS WERE RECENTLY ENACTED. PROSPECTIVE
INVESTORS SHOULD ALSO CONSULT WITH THEIR TAX ADVISORS WITH RESPECT TO SUCH CHANGES IN U.S. TAX LAW AS WELL AS POTENTIAL CONFORMING CHANGES
IN STATE TAX LAWS.
Bermuda Tax Considerations
Under present Bermuda law,
no Bermuda withholding tax on dividends or other distributions, or any Bermuda tax computed on profits or income or on any capital asset,
gain or appreciation will be payable by us or applicable to our operations, and there is no Bermuda tax in the nature of estate duty
or inheritance tax applicable to our shares, debentures or other obligations held by non-residents of Bermuda.
Tax Assurance
We have obtained an assurance
from the Minister of Finance of Bermuda under the Exempted Undertakings Tax Protection Act 1966 that, in the event that any legislation
is enacted in Bermuda imposing any tax computed on profits or income, or computed on any capital asset, gain or appreciation or any tax
in the nature of estate duty or inheritance tax, such tax shall not, until March 31,2035, be applicable to us or to any of our operations
or to our shares, debentures or other obligations except insofar as such tax applies to persons ordinarily resident in Bermuda or is
payable by us in respect of real property owned or leased by us in Bermuda.
Taxation of Shareholders
Shareholders should seek
advice from their tax advisor to determine the taxation to which they may be subject based on the shareholder's circumstances.
111
F. Dividends and Paying Agents
Not applicable.
G. Statements by Experts
Not applicable
H. Documents on Display
We are subject to the informational
requirements of the Exchange Act. Accordingly, we are required to file reports and other information with the SEC, including annual reports
on Form 20-F and reports on Form 6-K. You may inspect and copy reports and other information filed with the SEC at the public reference
facilities of the SEC located at 100 F Street, N.E., Washington, D.C. 20549. You may also obtain copies of the documents at prescribed
rates by writing to the Public Reference Section of the SEC at 100 F Street, N.E., Washington, DC 20549. Please call the SEC at 1-800-SEC-0330
for further information on the public reference room. The SEC also maintains a website at http://www.sec.gov from which certain filings
may be accessed.
We also make available on
our website, free of charge, our Annual Report and the text of our reports on Form 6-K, including any amendments to these reports, as
well as certain other SEC filings, as soon as reasonably practicable after they are electronically filed with or furnished to the SEC.
Our website address is "www.tizianalifesciences.com." The information contained on our website is not incorporated by reference
in this Annual Report.
Members of the general public
have a right to inspect the public documents of a company available at the office of the Registrar of Companies in Bermuda. These documents
include the company's memorandum of association, including its objects and powers, and certain alterations to the memorandum of
association. The shareholders have the additional right to inspect the bye-laws of the company, minutes of general meetings and the company's
audited financial statements, which must be presented to the annual general meeting. The register of members of a company is also open
to inspection by shareholders and by members of the general public without charge. The register of members is required to be open for
inspection for not less than two hours in any business day (subject to the ability of a company to close the register of members for
not more than thirty days in a year). A company is required to maintain its share register in Bermuda but may, subject to the provisions
of the Companies Act, establish a branch register outside of Bermuda. A company is required to keep at its registered office a register
of directors and officers that is open for inspection for not less than two hours in any business day by members of the public without
charge. A company is also required to file with the Registrar of Companies in Bermuda a list of its directors to be maintained on a register,
which register will be available for public inspection subject to such conditions as the Registrar may impose and on payment of such
fee as may be prescribed. Bermuda law does not, however, provide a general right for shareholders to inspect or obtain copies of any
other corporate records.
I. Subsidiary Information
For information on our subsidiaries,
see "Item 4C. Organizational Structure."
112
ITEM 11: QUANTITATIVE AND QUALITATIVE DISCLOSURES
ABOUT MARKET RISK
We are exposed to market
risks in the ordinary course of our business, which are principally limited to interest rate fluctuations and foreign currency exchange
rate fluctuations. We maintain significant amounts of cash and cash equivalents that are in excess of federally insured limits in various
currencies, placed with one or more financial institutions for varying periods according to expected liquidity requirements.
Interest Rate Risk
Our exposure to interest
rate sensitivity is impacted by changes in the underlying U.S. and U.K. bank interest rates. Our surplus cash and cash equivalents have
been invested in interest-bearing savings and money market accounts from time to time. We have not entered into investments for trading
or speculative purposes. Due to the conservative nature of our investment portfolio, which is predicated on capital preservation of investments
with short-term maturities, we do not believe an immediate one percentage point change in interest rates would have a material effect
on the fair market value of our portfolio, and therefore we do not expect our operating results or cash flows to be significantly affected
by changes in market interest rates.
Foreign Currency Exchange Risk
We maintain our consolidated
financial statements in the functional currency US Dollar. Monetary assets and liabilities denominated in currencies other than the functional
currency are translated into the functional currency at rates of exchange prevailing at the balance sheet dates. Non-monetary assets
and liabilities denominated in foreign currencies are translated into the functional currency at the exchange rates prevailing at the
date of the transaction. Exchange gains or losses arising from foreign currency transactions are included in the determination of net
income (loss) for the respective periods.
The currencies of our subsidiaries
are generally their functional currencies, In translating the financial statements of those subsidiaries or branches whose functional
currency is other than the U.S. dollar, assets and liabilities are converted into U.S. dollars using the rates of exchange in effect
at the balance sheet dates, and revenues and expenses are converted using the average foreign exchange rates for the period. Translation
adjustments are not included in determining net income (loss) but are included in foreign exchange adjustment to accumulate other comprehensive
loss, a component of shareholders' equity.
We do not currently engage
in currency hedging activities in order to reduce our currency exposure, but we may begin to do so in the future. Instruments that may
be used to hedge future risks may include foreign currency forward and swap contracts. These instruments may be used to selectively manage
risks, but there can be no assurance that we will be fully protected against material foreign currency fluctuations.
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.
113
PART II
ITEM 13: DEFAULTS, DIVIDEND ARREARAGES AN DELINQUENCIES
None.
ITEM 14: MATERIAL MODIF
IC
ATIONS TO THE
RIGHTS OF SECURITY HOLDERS AND USE OF PROCEEDS
None.
ITEM 15: CONTROLS AND PROCEDURES
Evaluation of Disclosure Controls and Procedures
Disclosure Controls and Procedures
The Company's management,
with the participation of the Company's Chief Executive Officer and Finance Director, have evaluated the effectiveness of the Company's
disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934,
as amended (the "Exchange Act")) as of December 31, 2022. Based on that evaluation, the Company's Chief Executive
Officer and the Company's Finance Director have concluded that as of December 31, 2022, due to the existence of the material
weaknesses in the Company's internal control over financial reporting described below, the Company's disclosure controls and
procedures were not effective.
Management's Annual Report on Internal Control over Financial
Reporting
The Company's management
is responsible for establishing and maintaining adequate internal controls over financial reporting as defined in Rules 13a-15(f)
and 15d-15(f) under the Exchange Act. The Company's internal control over financial reporting is a process designed to provide
reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes
in accordance with International Financial Reporting Standards (IFRS) as issued by the International Accounting Standards Board (IASB),
and IFRIC interpretations as applicable to companies reporting under IFRS.
Because of their inherent
limitations, internal controls over financial reporting may not prevent or detect misstatements. Also, 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.
Under the supervision and
with the participation of management, the Company's Chief Executive Officer and the Company's Finance Director, the Company
conducted an evaluation of the effectiveness of its internal control over financial over financial reporting based on the framework described
in Internal Control-Integrated Framework issued by the Commission of Sponsoring Organizations of the Treadway Commission, as revised in 2013.
Based on that evaluation, management has concluded that the Company did not maintain effective internal control over financial reporting
as of the period ended December 31, 2022 due to the existence of the material weaknesses in internal control over financial
reporting described below.
Material Weaknesses
A deficiency in internal
control over financial reporting exists when the design or operation of a control does not allow management or employees, in the normal
course of performing their assigned functions, to prevent or detect misstatements on a timely basis. A material weakness is a deficiency,
or a combination of deficiencies, in internal controls over financial reporting, such that there is a reasonable possibility that a material
misstatement of the Company's annual or interim financial statements will not be prevented or detected on a timely basis.
114
Management has determined
that the Company did not maintain effective internal control over financial reporting as of the period ended December 31, 2022 due
to the existence of the following material weaknesses identified by management. The material weaknesses identified below did not result
in a material misstatement of our consolidated financial statements, and management believes that our consolidated financial statements
present fairly the consolidated financial position, results of operations and cash flows for the periods covered. However, management
recognizes that the failure of the internal control over financial reporting to operate effectively as described below could have resulted
in a material misstatement which may not have been detected by our controls:
Control Environment
The Company did not maintain
an effective control environment. The control environment, which is the responsibility of senior management, sets the tone of the organization,
influences the control consciousness of its people, and is the foundation for all other components of internal control over financial
reporting. Our control environment was ineffective because:
●
We did not timely develop
    and communicate an employee handbook for employees to consult in the event an issue arises
Remediation efforts
Management intends to remediate
this item in the following manner:
i.
Develop and maintain an
    Employee Handbook, for employees to reference.
We intend to complete the
remediation of the material weaknesses discussed above as soon as practicable, but we can give no assurance that we will be able to do
so. Designing and implementing effective disclosure controls and procedures is a continuous effort that requires us to anticipate and
react to changes in our business and the economic and regulatory environments and to devote significant resources to maintain a financial
reporting system that adequately satisfies our reporting obligations. The remedial measures that we have taken and intend to take may
not fully address the material weaknesses that we have identified, and material weaknesses in our disclosure controls and procedures
may be identified in the future. Should we discover such conditions, we intend to remediate them as soon as practicable. We are committed
to taking appropriate steps for remediation, as needed.
ITEM 16A: AUDIT COMMITTEE FINANCIAL EXPERT
The members of our audit
committee are Mr John Brancaccio and Mr. Willy Simon. Mr. John Brancaccio is the chair of the audit committee. Each of our audit committee
members satisfies the independence requirements of Rule 5605(a)(2) of the Nasdaq Stock Market Marketplace Rules and the independence
requirements of Rule 10A-3(b)(1) under the Exchange Act. Our board of directors has determined that Mr. John Brancaccio is an "audit
committee financial expert" as defined in Item 16A of Form 20-F.
ITEM 16B: CODE OF ETHICS
Our Code of Business Conduct
and Ethics is applicable to all of our employees, officers and directors and is available on our website at https://www.tizianalifesciences.com.
Our Code of Business Conduct and Ethics provides that our directors and officers are expected to avoid any action, position or interest
that conflicts with the interests of our company or gives the appearance of a conflict. Our directors and officers have an obligation
under our Code of Business Conduct and Ethics to advance our company's interests when the opportunity to do so arises. We expect
that any amendment to this code, or any waivers of its requirements, will be disclosed on our website. Information contained on, or that
can be accessed through, our website is not incorporated by reference into this Annual Report, and you should not consider information
on our website to be part of this Annual Report.
ITEM 16C: PRINCIPAL ACCOUNTANT FEES AND SERVICES
The following table sets
forth, for each of the years indicated, the aggregate fees billed to us for services rendered by PKF and Mazars, our independent registered
public accounting firm.
Year Ending December 31,
2022
2021
(in thousands)
Audit fees
297
292
Other assurance services
28
32
Total
325
324
115
ITEM 16D: EXEMPTIONS FROM THE LISTING STANDARDS
FOR AUDIT COMMITTEES
Not applicable.
ITEM 16E: PURCHASES OF EQUITY SECURITIES BY
THE ISSUER AND AFFILIATED PURCHASERS
During the year ended December 31, 2022, we purchased
1,683,544 of our common shares at an average price of $0.78 (excluding fees).
ITEM 16F: CHANGE IN REGISTRANTS CERTIFYING
ACCOUNTANT
None.
ITEM 16G: CORPORATE GOVERNANCE
The Sarbanes-Oxley Act of
2002, as well as related rules subsequently implemented by the SEC, requires foreign private issuers, including our company, to comply
with various corporate governance practices. In addition, Nasdaq rules provide that foreign private issuers may follow home country practice
in lieu of the Nasdaq corporate governance standards, subject to certain exceptions and except to the extent that such exemptions would
be contrary to U.S. federal securities laws. The home country practices followed by our company in lieu of Nasdaq rules are described
below:
●
We do not follow Nasdaq's
    quorum requirements applicable to meetings of shareholders. Such quorum requirements are not required under Bermuda law. In accordance
    with generally accepted business practice, our Bye-laws provide alternative quorum requirements that are generally applicable to
    meetings of shareholders.
●
We do not follow Nasdaq's
    requirements that non-management directors meet on a regular basis without management present. Our board of directors may choose
    to meet in executive session at their discretion.
●
We do not follow Nasdaq's
    requirements to seek shareholder approval for the implementation of certain equity compensation plans, the issuances of ordinary
    shares under such plans, or in connection with certain private placements of equity securities. In accordance with Bermuda  law,
    we are not required to seek shareholder approval to allot ordinary shares in connection with applicable employee equity compensation
    plans. We will follow Bermuda. law with respect to any requirement to obtain shareholder approval prior to any private placements
    of equity securities.
We intend to take all actions
necessary for us to maintain compliance as a foreign private issuer under the applicable corporate governance requirements of the Sarbanes-Oxley
Act of 2002, the rules adopted by the SEC and Nasdaq's listing standards.
Because we are a foreign
private issuer, our directors and senior management are not subject to short-swing profit and insider trading reporting obligations under
Section 16 of the U.S. Securities Exchange Act of 1934, as amended, or Exchange Act. They are, however, subject to the obligations to
report changes in share ownership under Section 13 of the Exchange Act and related SEC rules.
ITEM 16H: MINE SAFETY DISCLOSURE
Not applicable.
ITEM 16I: DISCLOSURE REGARDING FOREIGN JURISDICTIONS
THAT PREVENT INSPECTIONS
Not applicable.
116
PART III
ITEM 17: FINANCIAL STATEMENTS
We have elected to furnish financial statements
and related information specified in Item 18.
ITEM 18: FINANCIAL STATEMENTS
See the Financial Statements beginning on page
F-1.
ITEM 19: EXHIBITS
Exhibit
    No.
Description
2.1
Description of registrant's securities (incorporated by reference to Form 8-K filed on October 21, 2021).
3.2
Memorandum
    of Association of Tiziana Life Sciences Ltd, adopted as of October 20, 2021 (incorporated by reference to Exhibit 3.1 to Form 8-K12B
    filed on October 21, 2021).
3.3
Amended
    and restated bye-laws of Tiziana Life Sciences Ltd, adopted as of October 20, 2021 (incorporated by reference to Exhibit 3.2 to Form
    8-K12B filed on October 21, 2021).
4.1
License
    Agreement relating to Milciclib between Nerviano Medical Services S.r.l. and Tiziana Life Sciences PLC, dated January 2015
    (incorporated by reference to Exhibit 10.1 to Amendment No. 1 to Form F-1 filed on August 23, 2018).
4.2
License
    and Sublicence Agreement relating to CD3 (NI-0401) between Novimmune SA and Tiziana Life Sciences PLC, dated December 2014. incorporated
    by reference to Exhibit 10.2 to Amendment No. 1 to Form F-1 filed on August 23, 2018).
4.3
License
    and Sublicence Agreement relating to IL-6r (NI-1201) between Novimmune SA and Tiziana Life Sciences PLC, dated December 2016. (incorporated
    by reference to Exhibit 10.3 to Amendment No. 1 to Form F-1 filed on August 23, 2018).
4.4
License
    Agreement relating to a novel formulation of Foralumab in a medical device for nasal administration between The Brigham and Women's
    Hospital, Inc. and Tiziana Life Sciences plc, dated April 2018. (incorporated by reference to Exhibit 10.4 to Amendment No. 1 to
    Form F-1 filed on August 23, 2018).
4.5*
Annual Lease for 14-15 Conduit Street, London W1S 2XJ United Kingdom
4.7*
Lease agreement for 601 New Britain Road, Suite 102, Doylestown Old Easton Road, Doylestown, Pennsylvania, 18901, United States, dated August 29, 2022.
4.8
Tiziana
    Life Sciences plc Employee Share Option Plan, with Non-Employee Sub-Plan and US Sub-Plan, adopted by the Board on 23 March 2016 and
    approved by shareholders on June 30, 2016. (Incorporated by reference to Exhibit 4.7 to Form 20-F filed on April 4, 2019).
4.9
Amended and Restated Service Agreement dated July 11, 2019, between the Registrant and Dr. Kunwar Shailubhai (incorporated by reference to Exhibit 10.9 to Amendment No. 2 to Form F-1 filed on September 20, 2019)
4.10
Form
    of Deed of Indemnity for board members. (Incorporated by reference to Exhibit 10.10 to Amendment No. 1 to Form F-1 filed on August
    23, 2018).
4.12
Tiziana
    Life Sciences Ltd 2021 Equity Incentive Plan (incorporated by reference to Exhibit 10.3 to Form 8-K12B filed on October 21, 2021).
8.1
List of Subsidiaries. (Incorporated by reference to Exhibit 8.1 to Form 20-F filed on May 23, 2022).
12.1*
Certification by the Principal Executive Officer pursuant to Securities 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 by the Principal Financial Officer pursuant to Securities 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 by the Principal Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
13.2*
Certification by the Principal Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
15.1
Consent of Mazars LLP (Incorporated by reference to Exhibit 15.1 to Form 20-F filed on May 23, 2022).
15.2*
Consent of PKF Littlejohn.
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 (formatted as Inline
    XBRL and contained in Exhibit 101).
*
Filed Herewith
117
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
registration statement on its behalf.
Tiziana Life
Sciences Ltd
By:
/s/ Gabriele
    Cerrone
Gabriele Cerrone
Acting Chief Executive Officer
Date: April 26, 2023
118
INDEX TO CONSOLIDATED FINANCIAL STATEMENTS
TIZIANA LIFE SCIENCES LTD
Report of Independent Registered Public Accounting Firm (PKF Littlejohn, London, United Kingdom, PCAOB ID
2814
)
F-2
Consolidated Balance Sheets
F-3
Consolidated Statements of Operations and Comprehensive Loss
F-4
Consolidated Statements of Shareholders' Equity
F-5
Consolidated Statements of Cash Flows
F-6
Notes to Consolidated Financial Statements
F-7
Consolidated Financial Statements and Notes
to Financial Statements to be provided under separate cover.
F-
1
REPORT OF INDEPENDENT REGISTERED
PUBLIC ACCOUNTING FIRM
Opinion on the Consolidated Financial Statements
We have audited the accompanying Consolidated
Statements of financial position of Tiziana Life Sciences Limited its subsidiaries (the "Group") as of December 31, 2022 and
the related Consolidated Statements of comprehensive income, Consolidated Statements of cash flow and Consolidated Statements of changes
in equity for the year ended December 31, 2022 and the related notes (collectively referred to as the "consolidated financial statements").
In our opinion, the consolidated financial statements referred to above present fairly, in all material respects, the financial position
of the Group as of December 31, 2022and the results of its operations and its cash flows for the year ended December 31, 2022 in conformity
with International Financial Reporting Standards as issued by the International Accounting Standards Board.
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. The Company is not required to have, nor were we
engaged to perform, an audit of its internal control over financial reporting. As part of our audits, we are required to obtain an understanding
of internal control over financial reporting, but not for the purpose of expressing an opinion on the effectiveness of the Company's
internal control over financial reporting. Accordingly, we express no such opinion.
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.
PKF Littlejohn LLP
We have served as the Group's auditor since 2022.
London, England
April 26, 2023
F-
2
TIZIANA LIFE SCIENCES LTD
Consolidated Balance Sheets
(In thousands)
Year ended
December 31,
2022
2021
$
$
ASSETS
Current assets:
Notes
Cash and cash equivalents
18,122
42,186
Prepayments and other receivables
12
300
1,301
Taxation receivable
10
4,246
4,736
Related party receivables
21
1,614
456
Total current assets
24,282
48,679
Non – Current Assets:
Property and equipment, net
17
17
Right of use asset
22
372
-
Intangible asset
-
130
Investment in related party
19
1,806
-
Total non-current assets
2,195
147
Total assets
26,477
48,826
LIABILITIES AND SHAREHOLDERS' EQUITY
Liabilities:
Current liabilities:
Accounts payable and accrued expenses
18
6,532
6,181
Lease Liability
22
122
-
Related party payable
-
1,355
Other liabilities
9
10
Total current liabilities
6,663
7,546
Lease Liability (Non-Current)
22
243
-
Total liabilities
6,906
7,546
Shareholders' Equity:
Called up share capital (
102,272,614
shares are issued and outstanding; 2021:
102,272,614
)
102
102
Share premium
15,596
15,596
Share based payment reserve – Options
5,190
13,797
Share based payment reserve – warrants
697
697
Merger relief reserve
118,697
118,697
Treasury shares
(
1,320
)
-
Translation reserve
(
3,128
)
454
Retained earnings
(
116,263
)
(
108,063
)
Total shareholders' equity
19,571
41,280
Total liabilities and shareholders' equity
26,477
48,826
The accompanying notes are an integral part of
these consolidated financial statements.
F-
3
TIZIANA LIFE SCIENCES LTD
Consolidated Statements of Operations and Comprehensive
Loss
(In thousands, except loss per share)
Year ended
December 31,
2022
2021
2020
$
$
$
Operating Expenses
Notes
Research and Development
(
12,955
)
(
13,208
)
(
5,993
)
Operating expenses
(
1,631
)
(
13,311
)
(
11,203
)
Realization bonus
-
(
855
)
(
13,214
)
Impairment of other non-current asset
-
-
(
279
)
Gain from disposal of intellectual property
-
-
2,663
Total operating expenses
(
14,586
)
(
27,374
)
(
28,026
)
Loss from operations
(
14,586
)
(
27,374
)
(
28,026
)
Other income/(expense):
Finance Income/(expense)
9
(
7
)
(
176
)
(
312
)
Other income/(losses)
4
(
804
)
893
-
Total other income/(expense)
(
811
)
717
(
312
)
Loss from operations before income taxes
(
15,397
)
(
26,657
)
(
28,338
)
Income tax credit
-
3,240
2,207
Loss for the year
(
15,397
)
(
23,417
)
(
26,131
)
Other Comprehensive loss:
Gain/(Loss) on currency translation
(
3,582
)
(
4,478
)
3,474
Comprehensive loss
(
18,979
)
(
27,895
)
(
22,657
)
Basic and diluted loss per share attributable to common shareholders
$
(
0.15
)
$
(
0.24
)
$
(
0.16
)
The accompanying notes are an integral part of
these consolidated financial statements.
F-
4
TIZIANA LIFE SCIENCES LTD
Consolidated Statements of Shareholders'
Equity
(In thousands)
Share
Capital
Share
Premium
Share
Based
Payment
Reserve
(Options)
Share
Based
Payment
Reserve (warrants)
Merger
Reserve
Treasury Shares
Retained
Earnings
Shares to be issued Reserve
Translation
Reserve
Total
Equity
$
$
$
$
$
$
$
$
$
$
Balance at 31 December 2020
97
-
8,624
697
118,697
-
(
84,646
)
13,503
5,414
62,386
Issue of share capital
2
759
-
-
-
-
-
-
-
761
Share based payment charge (options)
-
-
5,173
-
-
-
-
-
-
5,173
Shares issued in lieu of cash realization bonus
3
14,837
-
-
-
-
-
(
13,503
(
482
)
855
Total transactions with owners
5
15,596
5,173
-
-
-
-
(
13,503
(
482
)
6,789
Comprehensive loss
Loss for the period
-
-
-
-
-
-
(
23,417
-
-
(
23,417
)
Translation
-
-
-
-
-
-
-
(
4,478
)
(
4,478
)
Total comprehensive loss
-
-
-
-
-
-
(
23,417
-
(
4,478
)
(
27,895
Balance at 31 December 2021
102
15,596
13,797
697
118,697
-
(
108,063
)
-
454
41,280
Treasury Shares
-
-
-
-
-
(
1,320
)
-
-
-
(
1,320
)
Share based payment charge (options)
-
-
1,811
-
-
-
-
-
-
1,811
Options forfeited/cancelled in the year
-
-
(
3,221
)
-
-
-
-
-
-
(
3,221
)
Reclass of FV for options forfeited/Cancelled
-
-
(
7,197
)
-
-
-
7,197
-
-
-
Total transactions with owners
-
-
(
8,607
)
-
-
-
7,197
-
-
(
1,410
)
Comprehensive loss
Loss for the period
-
-
-
-
-
-
(
15,397
)
-
-
(
15,397
)
Translation
-
-
-
-
-
-
-
(
3,582
)
(
3,582
)
Total comprehensive loss
-
-
-
-
-
(
15,397
)
-
(
3,582
)
(
18,979
)
Balance at 31 December 2022
102
15,596
5,190
697
118,697
(
1,320
)
(
116,263
)
-
(
3,128
)
19,571
The accompanying notes are an integral part of
these consolidated financial statements.
F-
5
TIZIANA LIFE SCIENCES LTD
Consolidated Statements of Cash Flows
(In thousands)
Year ended
December 31,
2022
2021
2020
CASH FLOWS FROM OPERATING ACTIVITIES:
Loss from operations before income taxes
$
(
15,397
)
$
(
26,657
)
$
(
28,338
)
Adjustments to reconcile net loss to net cash used in operating activities:
Convertible loan interest accrued
-
163
272
Shares issued in lieu of fees
-
-
466
Share based payment – options
1,811
5,173
5,070
Share based payment – warrants
-
-
26
Fair value loss on investment
869
-
-
Loss on disposal of asset
129
-
-
Bonus to be settled in equity
-
855
13,503
Depreciation
1
8
5
(Gain)/ loss on foreign exchange
(
3,183
)
(
1,899
)
237
Options forfeited during the year
(
3,221
)
-
-
Depreciation of right-of-use asset
50
133
86
(Gain)/loss on disposal of right of use asset
-
(
28
)
-
Proceeds from finance lease reclassified as an investing activity
-
(
152
)
-
Cash inflow from taxation
490
1,415
-
Impairment of SharDNA SPA
-
-
296
Gain from disposal of intellectual property
-
-
(
2,663
)
Net (increase) in related party receivables
(
1,158
)
(
88
)
(
31
)
Net (decrease)/increase in related party payables
(
1,355
)
(
685
)
1,145
Net (increase)/decrease in operating assets/other receivables
1,002
516
(
437
)
Net increase/(decrease) in operating liabilities /other liabilities
347
(
516
)
(
972
)
Net cash used in operating activities
(
19,615
)
(
21,762
)
(
11,335
)
CASH FLOWS FROM INVESTING ACTIVITIES
Purchase of PPE
-
(
22
)
(
3
)
Purchase of Act D
-
-
(
120
)
Proceeds from finance lease
-
152
-
Investment in Related Party
(
2,676
)
-
-
Purchase of Treasury Shares
(
1,320
)
-
-
Net cash used in Investing activities
(
3,996
)
130
(
123
)
CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from issuance of ordinary shares
-
-
71,157
Proceeds from issuance of convertible loan notes
-
-
163
Proceeds from issuance of warrants
-
129
3,364
Proceeds from issuance of options
-
-
939
Repayment of leasing liabilities
(
55
)
(
152
)
(
277
)
Net cash (used in)/provided by financing activities
(
55
)
(
23
)
75,346
Net decrease in cash and cash equivalents
(
23,666
)
(
21,655
)
63,888
Cash and cash equivalent, beginning of year
42,186
65,824
200
Exchange difference on cash and cash equivalents
(
398
)
(
1,983
)
1,736
Cash and cash equivalent, end of year
18,122
42,186
65,824
F-
6
TIZIANA LIFE SCIENCES LTD
Notes to Consolidated Financial Statements
1. GENERAL INFORMATION
Tiziana Life Sciences Ltd,
(the "company") is a public limited company incorporated in Bermuda and at the year end is quoted on the NASDAQ Capital Market
(NASDAQ: TLSA). The previous parent, Tiziana Life Sciences PLC, delisted from the main market of the London Stock Exchange (LSE: TILS)
on October 21, 2021. The address of its registered office is given on page 1. The principal activities of the Company and its subsidiaries
(the Group) are that of a clinical stage biotechnology company that specializes in the development of transformative therapies for neurodegenerative
and lung diseases . Our clinical pipeline includes drug assets for Secondary Progressive Multiple Sclerosis, ALS. Alzheimer's, Crohn's
Disease and KRAS+ NSCLC.
The functional currency for
the Company is also US dollars ($) indicative of the primary economic environment in which the Company operates. These consolidated financial
statements are presented in thousands of dollars ($'000) which is the presentational currency of the Company.
2. ACCOUNTING POLICIES
The principal accounting
policies applied in the preparation of these consolidated financial statements are set out below. These policies have been applied consistently
to all the years presented unless otherwise stated.
Basis of preparation
The consolidated financial
statements of the Group have been prepared in accordance with International Financial Reporting Standards (IFRS) as issued by the International
Accounting Standards Board (IASB), and International Financial Reporting Interpretations Committee IFRIC interpretations as applicable
to companies reporting under IFRS. These accounts have been prepared under the historical cost convention except for the following items:
-
Financial instruments – fair value
                                            through profit or loss
-
Financial instruments – fair value
                                            through other comprehensive income
Going Concern
The Group incurred losses
during the year and has net assets at the year end.
The Group is in the early
stages of developing its business focusing on the discovery and development of novel molecules that treat human disease in oncology and
immunology. As the Group is pre-revenue, the Directors expect the Group to incur further losses and to require significant capital expenditure
in continuing to develop clinical stage development therapeutic candidates in both oncology and immunology. The Group has successfully
funded clinical trials to date and going forward will need to continue to secure additional investment to fund the clinical trials.
The Directors have prepared
cash flow projections that include the costs associated with the continued clinical trials and additional investment to fund that operation. 
Based on those projections, the directors conclude that the company will be able to meet its liabilities as they fall due until at least
April 2024, with a cash surplus of approximately $
1
m projected at this date. Accordingly, the Directors believe it appropriate that the
consolidated financial statements have been prepared on a going concern basis.
New and Revised Standards
Standards in effect in 2022
There are no new IFRS standards,
amendments to standards or interpretations that are mandatory for the financial year beginning on January 1, 2022, that are relevant
to the Group and that have had any impact in the year to December 31, 2022. New standards, amendments to standards and interpretations
that are not yet effective, which have been deemed by the Group as currently not relevant and are not listed here.
F-
7
Basis of consolidation
Subsidiary undertakings are
all entities over which the Group exercises control. The Group has control when it can demonstrate all of the following: (a) power over
the investee; (b) exposure, or rights, to variable returns from its involvement with the investee; and (c) the ability to use its power
over the investee to affect the amount of the investor's return.
The existence and effect
of both current voting rights and potential voting rights that are currently exercisable or convertible are considered when assessing
whether control of an entity is exercised. Subsidiaries are consolidated from the date at which the Group obtains control and are de-consolidated
from the date at which control ceases.
Business combination
The Group undertook a group
reorganisation exercise during the year to December 31, 2021. As part of this process, Tiziana Life Sciences Ltd (a Bermudan entity) was
inserted above Tiziana Life Sciences Limited (formerly Tiziana Life Sciences Plc) in the Group's structure. As both entities were
under common control of Planwise Ltd, the transaction does not constitute a business combination under IFRS 3 'Business combinations'
and instead has been accounted for as a group reorganization, using the pooling of interest method. This results in assets and liabilities
being measured at their carrying amount in Tiziana Life Sciences Limited (formerly Tiziana Life Sciences Plc) but share capital being
that of Tiziana Life Sciences Ltd (a Bermudan entity). Merger accounting has been used to account for this transaction (See note 15 for
details).
On 21 October 2021, Tiziana
Life Sciences Ltd. (the 'Company') acquired the entire shareholding of the former Tiziana Life Sciences Plc and its related
subsidiaries, by a way of a share for share exchange with Tiziana Life Sciences Ltd becoming the Group's immediate parent company.
On 21 October 2021, the Company
was admitted for listing on the NASDAQ Capital Market Exchange and the former Tiziana Life Sciences Plc was delisted from the London
Stock Exchange.
Segment reporting
Operating segments are reported
in a manner consistent with the internal reporting provided to the Board. The Board considers there to be only
one
operating segment
being the research and development of biotechnological and pharmaceutical products.
F-
8
Taxation
The tax expense for the year
represents the total of current taxation and deferred taxation. The charge in respect of current taxation is based on the estimated taxable
profit for the year. Current tax is provided at amounts expected to be paid (or recovered) using the tax rates and laws that have been
enacted or substantively enacted by the balance sheet date.
Deferred tax is provided
in full, using the liability method, on temporary differences arising between the tax bases of assets and liabilities and their carrying
amounts in the consolidated financial statements. Deferred tax is determined using tax rates (and laws) that have been enacted or substantially
enacted by the balance sheet date and expected to apply when the related deferred tax is realized, or the deferred liability is settled.
Deferred tax assets are recognized to the extent that it is probable that the future taxable profit will be available against which the
temporary differences can be utilized.
Research and Development
tax credits are provided for in the year that the costs are incurred. These are estimated based on eligible research and development
expenditure. Any differences that are rebated are recognized in the following year, when the cash is received from the UK tax authorities.
Foreign currency translation
Items included in the financial
statements of each of the Group's entities are measured using the currency of the primary economic environment in which the entity
operates (the functional currency). The consolidated financial statements are presented in US dollars, which is the Group's presentational
currency.
Foreign currency transactions
are translated into the functional currency using exchange rates prevailing at the dates of the transactions. Foreign exchange gains
and losses resulting from the settlement of foreign currency transactions and from the translation at year-end exchange rates of monetary
assets and liabilities denominated in foreign currencies are recognized in the Consolidated statements of operations and comprehensive
loss.
The financial statements
of overseas subsidiary undertakings are translated into US dollars on the following basis:
●
Assets and liabilities at the rate of exchange ruling
    at the year-end date.
●
Profit and loss account items at the average rate of
    exchange for the year.
Exchange differences arising
from the translation of the net investment in foreign entities, borrowings and other currency instruments designated as hedges of such
investments, are taken to equity (and recognized in the Consolidated statements of operations and comprehensive loss) on consolidation.
License fees
Payments made which provide
the right to perform research are carefully evaluated to determine whether such payments are to fund research or acquire an asset. "License
fees expenses" are recognized as incurred.
Research and development
All
on-going research and development expenditure is currently expensed in the period in which it is incurred. Due to the regulatory environment
inherent in the development of the Group's products, the criteria for development costs to be recognized as an asset, as set out
in IAS 38 'Intangible Assets', are not met until a product has been granted regulatory approval and it is probable that future
economic benefit will flow to the Group. The Group currently has no qualifying expenditure.
Fair Value Measurement
Management have assessed the
categorisation of the fair value measurements using the IFRS 13 fair value hierarchy. Categorisation within the hierarchy has been determined
on the basis of the lowest level of input that is significant to the fair value measurement of the relevant asset as follows;
Level 1 - valued using quoted prices in active
markets for identical assets
Level 2 - valued by reference to valuation techniques
using observable inputs other than quoted prices included within Level 1;
Level 3 - valued by reference to valuation techniques
using inputs that are not based on observable market data.
F-
9
Financial instruments
The Group classifies a financial
instrument, or its component parts, as a financial liability, a financial asset or an equity instrument in accordance with the substance
of the contractual arrangement and the definitions of a financial liability, a financial asset and an equity instrument.
The Group evaluates the terms
of the financial instrument to determine whether it contains an asset, a liability or an equity component. Such components shall be classified
separately as financial assets, financial liabilities or equity instruments.
A financial instrument is
any contract that gives rise to a financial asset of one entity and a financial liability or equity instrument of another entity.
(a) Financial assets, initial
recognition and measurement and subsequent measurement
All financial assets not recorded
at fair value through profit or loss, such as receivables and deposits, are recognized initially at fair value plus transaction costs.
Financial assets carried at fair value through profit or loss (FVTPL) are initially recognized at fair value, and transaction costs are
expensed in the consolidated statements of operations and comprehensive loss. The measurement of financial assets depends on their classification.
Financial assets such as receivables and deposits are subsequently measured at amortized cost using the effective interest method, less
loss allowance. The Group holds an investment in Accustem Inc.as a financial assets at fair value through profit or loss or fair value
through other comprehensive income.
(b) Financial liabilities,
initial recognition and measurement and subsequent measurement
Financial liabilities are
classified as measured at amortized cost or FVTPL.
A financial liability is
classified as at FVTPL if it is a derivative. Financial liabilities at FVTPL are measured at fair value and net gains and losses, including
any interest expense, are recognized in profit or loss. Other financial liabilities are subsequently measured at amortized cost using
the effective interest method. Interest expense and foreign exchange gains and losses are recognized in profit or loss. Any gain or loss
on derecognition is also recognized in profit or loss.
The Group's financial
liabilities include trade and other payables.
Warrants
Warrants are issued by the
Group in return for services and as part of a financing transaction.
Warrants issued in return for services.
These warrants fall within
the scope of IFRS 2. The Company recognises that the fair value at the date of grant of these warrants should be expensed to the Statement
of Income and recognised over the life of the service for which the warrant was provided. These warrants have been valued by reference
to the equity instruments granted as they are all tied to Convertible loan notes. The measurement date is therefore the date that the
Convertible loan note was entered into.
Warrants issued as part of a financing transaction.
Warrants issued as part of
a financing transaction fall outside the scope of IFRS 2. These are classified as equity instruments because a fixed amount of cash is
exchanged for a fixed amount of equity. The fair value is recognised within equity and is not remeasured.
F-
10
Share capital
Ordinary shares of the Company
are classified as equity.
Property, plant and equipment
(i
) Recognition and
measurement
Items of property, plant
and equipment are measured at cost less accumulated depreciation and accumulated impairment losses. Costs include expenditures that are
directly attributable to the acquisition of the asset. Purchased software that is integral to the functionality of the related equipment
is capitalised as part of that equipment.
When parts of an item of
property, plant and equipment have different useful lives, they are accounted for as separate items (major components) of property, plant
and equipment.
Gains and losses on disposal
of an item of property, plant and equipment are determined by comparing the proceeds from disposal with the carrying amount of property,
plant and equipment, and are recognised in profit or loss.
(ii) Depreciation
Depreciation is calculated
on the depreciable amount, which is the cost of an asset, or other amount substituted for cost, less its residual value.
Depreciation is recognised
in consolidated statements of operations and comprehensive loss on a straight-line basis over the estimated useful life of each part
of an item of property, plant and equipment. Leased assets are depreciated over the shorter of the lease term and their useful lives
unless it is reasonably certain that the Group will obtain ownership by the end of the lease term in which case they are depreciated
over their useful lives.
The estimated useful lives
for the current period and the comparative period are as follows.
Fixtures and fittings
5
years
IT and equipment
3
years
Right of use asset
Economic life of contractual relationship
Depreciation methods, useful
lives and residual values are reviewed at each reporting date. Depreciation is allocated to the operating expenses line of the Consolidated
statements of operations and comprehensive loss.
Impairment
Impairment of financial assets
measured at amortised cost
At each reporting date the
Group recognises a loss allowance for expected credit losses on financial assets measured at amortised cost.
In establishing the appropriate
amount of loss allowance to be recognised, the Group applies either the general approach or the simplified approach, depending on the
nature of the underlying group of financial assets.
General approach
The general approach is applied
to the impairment assessment of refundable lease deposits and other refundable lease contributions, and cash and cash equivalents.
Under the general approach
the Group recognises a loss allowance for a financial asset at an amount equal to the 12-month expected credit losses, unless the credit
risk on the financial asset has increased significantly since initial recognition, in which case a loss allowance is recognised at an
amount equal to the lifetime expected credit losses.
F-
11
Simplified approach
The simplified approach is
applied to the impairment assessment of trade receivables.
Under the simplified approach
the Group always recognises a loss allowance for a financial asset at an amount equal to the lifetime expected credit losses.
Impairment of non-financial assets
Non-financial assets are
tested for impairment whenever events or changes in circumstances indicate that the carrying amount may not be recoverable.
Non-financial assets are
impaired when carrying amounts exceed recoverable amounts. The recoverable amount is measured as the higher of fair value less cost of
disposal and value in use. The value in use is calculated as being net projected cash flows based on financial forecasts discounted back
to present value at a pre-tax discount rate.
Contingent Liabilities
The Company is required to
make judgments about contingent liabilities including the probability of pending and potential future litigation outcomes that, by their
nature, are dependent on future events that are inherently uncertain. In making its determination of possible scenarios, management considers
the evaluation of outside counsel knowledgeable about each matter, as well as known outcomes in case law.
Leases
All leases are accounted
for by recognizing a right-of-use asset and a lease liability except for:
●
Leases of low value assets;
    and
●
Leases with a duration
    of 12 months or less.
The Group has leases for
its offices. Each lease is reflected on the consolidated balance sheet as a right-of-use asset and a lease liability. The Group does
not have any leases of low value assets. Variable lease payments which do not depend on an index or a rate (such as lease payments based
on a percentage of Group sales) are excluded from the initial measurement of the lease liability and asset. The Group classifies its
right-of-use assets in a consistent manner to its property, plant and equipment (see Note 21).
For leases over office buildings
and factory premises the Group must keep those properties in a good state of repair and return the properties in their original condition
at the end of the lease. The expected costs of returning to original condition are considered negligible.
At lease commencement date,
the Group recognises a right-of-use asset and a lease liability in its consolidated balance sheets. The right-of-use asset is measured
at cost, which is made up of the initial measurement of the lease liability, any initial direct costs incurred by the Group, an estimate
of any costs to dismantle and remove the asset at the end of the lease, and any lease payments made in advance of the lease commencement
date (net of any incentives received).
At the commencement date,
the Group measures the lease liability at the present value of the lease payments unpaid at that date, discounted using the Group's
incremental borrowing rate because as the lease contracts are negotiated with third parties it is not possible to determine the interest
rate that is implicit in the lease. The incremental borrowing rate is the estimated rate that the Group would have to pay to borrow the
same amount over a similar term, and with similar security to obtain an asset of equivalent value. This rate is adjusted should the lessee
entity have a different risk profile to that of the Group.
The Group depreciates the
right-of-use asset on a straight-line basis from the lease commencement date to the earlier of the end of the useful life of the right-of-use
asset or the end of the lease term. The Group also assesses the right-of-use asset for impairment when such indicators exist.
F-
12
Lease payments included in
the measurement of the lease liability are made up of fixed payments (including in substance fixed), variable payments based on an index
or rate, amounts expected to be payable under a residual value guarantee and payments arising from options reasonably certain to be exercised.
Subsequent to initial measurement,
the liability will be reduced by lease payments that are allocated between repayments of principal and finance costs. The finance cost
is the amount that produces a constant periodic rate of interest on the remaining balance of the lease liability.
Short term leases exempt
from IFRS 16 are classified as operating leases. Payments made under operating leases are recognised in profit and loss on a straight-line
basis over the term of the lease.
Share – based payments
The calculation of the fair
value of equity-settled share-based awards and the resulting charge to the Consolidated statements of operations and comprehensive loss
requires assumptions to be made regarding future events and market conditions. These assumptions include the future volatility of the
Company's share price. These assumptions are then applied to a recognised valuation model in order to calculate the fair value
of the awards.
Where employees and directors
are rewarded using share-based payments, the fair value of the employees', directors' and/or advisers' services are
determined by reference to the fair value of the share options/warrants awarded. Their value is appraised at the date of grant and excludes
the impact of any nonmarket vesting conditions (for example, profitability and sales growth targets).
In accordance with IFRS 2,
a charge is made to the Consolidated statements of operations and comprehensive loss for all share-based payments including share options
based upon the fair value of the instrument used. A corresponding credit is made to an equity reserve, in the case of options/warrants
awarded to employees, directors, advisers and other consultants.
If vesting periods or other
vesting conditions apply, the expense is allocated over the vesting period, based on the best available estimate of the number of share
options/warrants expected to vest. Non market vesting conditions are included in assumptions about the number of options/warrants that
are expected to become exercisable.
Estimates are subsequently
revised, if there is any indication that the number of share options/warrants expected to vest differs from previous estimates. No adjustment
is made to the expense or share issue cost recognised in prior periods if fewer share options ultimately are exercised than originally
estimated.
Upon exercise of share options/warrants,
the proceeds received are allocated to share capital with any excess being recorded as share premium. A corresponding debit is made to
the share–based payment reserve.
Where share options are cancelled,
this is treated as an acceleration of the vesting period of the options. The amount that otherwise would have been recognised for services
received over the remainder of the vesting period is recognised immediately within the Consolidated statements of operations and comprehensive
loss.
All goods and services received
in exchange for the grant of any share – based payment are measured at their fair value.
F-
13
Sub license income
In September 2021 the Company
signed a collaboration agreement signed with Precision Biosciences, Inc. under which $
750
k was recognized as an upfront payment in accordance
with the contract for the grant of an exclusive license to use foralumab as a lymphodepletion agent in conjunction with Precision Biosciences,
Inc's allogeneic CAR T therapeutics for the treatment of cancers. Sublicense income is included in other income on the consolidated
statements of operations and comprehensive loss.
Other intangible assets
Other intangible assets that
are acquired by the Group are stated at cost less accumulated impairment losses.
At each balance sheet date
non-financial assets are assessed to determine whether there is an indication that the asset or the asset's cash generating unit
may be impaired. If there is such an indication the recoverable amount of the asset or asset's cash generating unit is compared
to the carrying amount.
3. CRITICAL ACCOUNTING JUDGEMENT
The preparation of financial
information in accordance with generally accepted accounting practice, in the case of the Group being International Financial Reporting
Standards as issued by the IASB, requires the directors to make estimates and judgements that affect the reported amount of assets, liabilities,
income and expenditure and the disclosures made in the consolidated financial statements. Such estimates and judgements must be continually
evaluated based on historical experience and other factors, including expectations of future events.
The following are considered
to be critical accounting estimates:
Share-based payments
The Group accounts for share-based
payment transactions for employees in accordance with IFRS 2 Share-based Payment, which requires the measurement of the cost of employee
services received in exchange for the options on our ordinary shares, based on the fair value of the award on the grant date.
The Company utilizes the
Black-Scholes-Merton option pricing model as the most appropriate method for determining the estimated fair value of our share-based
awards without market conditions. For performance-based options that include vesting conditions relating to the market performance of
our ordinary shares, a Monte Carlo pricing model was used in order to reflect the valuation impact of price hurdles that have to be met
as conditions to vesting.
The Company makes estimates
as to the useful life of an option award, the expected price volatility of the underlying share, risk free interest rate for the term
of the award and correlations and volatilities of the shares of peer group companies. The Company also makes estimates as to the vesting
period for awards that have performance – based criteria.
F-
14
4 OTHER (EXPENSE)/ INCOME
The Group's other (expense)/
income is made up of the following:
Year Ended December 31,
2022
$'000
2021
$'000
2020
$'000
Sublicense income
-
750
-
Other
65
143
-
Loss on investment at fair value through profit or loss (see note 19)
(
869
)
-
-
Total other (expense)/ income
(
804
)
893
-
Sublicense income has been
classified as other income as the counterparty is not considered a customer but an entity we are collaborating with.
5. OPERATING LOSS
The Group's operating
losses are stated after charging/(crediting) the following:
Year Ended December 31,
2022
$'000
2021
$'000
2020
$'000
License fee
-
(
1,047
)
706
Realization bonus
-
855
13,503
Foreign exchange gain related to the realization bonus
-
-
(
289
)
Depreciation of Property, plant and equipment
1
8
5
Depreciation (Right-of-use asset)
50
133
86
Foreign exchange (gains)/losses
(
3,183
)
(
1,899
)
239
License fees relating to
2020 were waived in 2021 as a result of negotiations by the Group.
A realization bonus of $
13.5
million became payable during the year ended December 31, 2020 to the chairman of the board upon the Company raising funds in excess
of $
28
m (£
20
m), which it successfully raised in August 2020. As the bonus was not settled until November 2021, interest of $
0.9
m
was accrued on the amount due in the year to December 31, 2021. No realization bonus is accounted for in year ended December 31, 2022.
6. SEGMENTAL REPORTING
During the year under review
Management identified the Group's only operating segment as the research and development of biotechnological and pharmaceutical
products. This one segment is monitored and strategic decisions are made based upon it and other non-financial data collated from industry
intelligence. The form of financial reporting reported to the Board is consistent with those presented in the annual consolidated financial
statements.
F-
15
7. EMPLOYEES
Year ended December 31,
2022
$'000
2021
$'000
2020
$'000
Staff costs comprised:
Directors' salaries (including bonus)
554
2,526
14,666
Employees' wages, salaries and bonus
2,014
1,856
1,058
Social security costs
135
176
194
Recruitment fees
197
242
17
Share based payment charge
(
1,410
)
5,173
5,105
1,242
9,973
21,040
The average monthly number of employees, including directors, employed by the group during the year was:
Research and development
3
8
3
Corporate and administration
6
5
8
9
13
11
8. REMUNERATION OF KEY MANAGEMENT PERSONNEL
$'000
Year ended December 31,
2022
2021
2020
Director
Directors'
fee
Bonus
Salary
Share
based
payments
Directors'
fee
Bonus
Salary
Share
based
payments
Directors'
fee
Bonus
Salary
Share based payments
G. Cerrone
(1)
296
148
-
-
330
855
-
624
170
13,588
-
155
Willy Simon
55
83
59
93
49
-
-
31
Gregor MacRae
-
-
-
-
-
-
-
-
27
-
-
-
J Brancaccio
55
--
-
83
59
--
-
93
22
-
-
31
K. Shailubhai
-
-
379
(
145
)
-
210
600
492
-
210
600
2,069
T Adams
-
-
-
(
1,967
)
-
-
413
2,197
-
-
-
-
406
148
379
(
1,946
)
448
1,065
1,013
3,499
268
13,798
600
2,286
(1)
Gabriele Cerrone's 2021 bonus is the interest charged on his 2020 bonus due to delayed issuance of shares; his 2020 bonus includes a $13.2m realization bonus.
F-
16
All bonuses are short term.
No post-employment or termination payments were made.
The following share options
were granted to directors in the following periods:
Year ended December 31,
2022
2021
2020
Number of
options
Number of
options
Number of
options
G. Cerrone
-
-
1,800,000
K. Shailubhai
-
-
-
L. Zanbeletti
-
-
-
W.Simon
-
-
250,000
J. Brancaccio
-
-
250,000
T Adams
-
3,500,000
-
-
3,500,000
2,300,000
Key management personnel
of the Group are comprised of directors and officers of the Company.
No share options were exercised
by directors during the years ended December 31, 2022 and 2021.
2,319,225
share options were exercised by directors in the year to 31
December 2020 for an intrinsic gain of $
4.1
m.
The Company made payments
totaling approximately $
32
K, $
24
K, and $
10
K to defined contribution pension schemes on behalf of directors or employees during 2022,
2021, and 2020, respectively.
9. FINANCE COSTS
Year ended December 31,
2022
$'000
2021
$'000
2020
$'000
Group
Finance Income
Finance income received on net investment in lease
-
-
8
Total finance income
-
-
8
Finance Expense
Finance charge accrued on convertible loan notes
-
163
303
Interest expense on lease liabilities
7
13
17
Total finance expenses
7
176
320
Net finance expense
    recognized in Consolidated statements of operations and comprehensive loss
7
176
312
F-
17
10. TAXATION
Year Ended December 31,
2022
$'000
2021
$'000
2020
$'000
Group
Current year tax (credit)
-
(
3,255
)
(
1,546
)
Adjustments due to prior periods
-
(
15
)
(
661
)
Total tax (credit) for the period
-
(
3,240
)
(
2,207
)
The tax charge for the year is different from the standard rate of corporation tax in the United Kingdom of 19%. The difference can be reconciled as follows:
Loss before taxation
(
15,397
)
(
26,657
)
(
28,337
)
Loss charged at standard rate of corporation tax
19
%
(
2,926
)
(
5,065
)
(
5,384
)
Movement in unrecognized deferred tax
2,319
1,722
1,316
)
Expenses not deductible for taxation
1,036
1,550
4,986
Adjustments due to prior periods
-
(
15
)
(
661
)
Research and development claim
-
(
1,401
)
(
665
)
Income not taxable for tax purposes
(
495
)
(
61
)
(
1,741
Fixed asset differences
(
1
)
-
-
Adjustments to brought forward values
67
-
-
Consolidation adjustment in relation to foreign exchange movements
-
-
(
58
)
-
(
3,313
)
(
2,207
)
The Research and Development
claim has been calculated in accordance with the R&D tax relief available to small and medium sized entities, whereby the entity
is able to claim a cash tax credit (if loss making), worth up to
14.5
% of the surrenderable losses.
The adjustments due to prior
periods relates to R&D tax relief claims for the prior period. Under UK tax legislation, a
2
year window is available under which
R&D tax relief can be claimed.
No deferred tax asset has
been recognized in respect of trading losses carried forward because of uncertainty as to when these losses will be recoverable.
The amount of tax losses for
which no deferred tax assets has been recognized for the year ended December 31, 2022 is $
15,011
k (2021 is $
11,591
k; 2020; $
6,182
k).
11. LOSS PER SHARE
Basic loss per share is calculated
by dividing the loss attributable to equity holders of the Company by the weighted average number of ordinary shares in issue during the
year.
Year ended December 31,
2022
2021
2020
(Loss) attributable to equity holders of the company ($000)
(
15,397
)
(
23,417
)
(
26,131
)
Weighted average number of ordinary shares in issue
101,526,389
97,932,055
97,306,144
Basic loss per share (cents per share)
(
15.2
)
(
23.9
)
(
26.9
)
As the Group is reporting
a loss from continuing operations for the year then, in accordance with IAS 33, share options, warrants and convertible loan notes are
not considered dilutive because the exercise of the share options would have an anti-dilutive effect. The basic and diluted earnings
per share as presented on the face of the income statement are therefore identical. All earnings per share figures presented above arise
from continuing and total operations and therefore no earnings per share for discontinued operations are presented. The weighted average
number of ordinary shares in issuance is stated as net excluding Treasury shares.
F-
18
12. OTHER RECEIVABLES
$000
Year
    ended December 31,
2022
2021
VAT Receivable
-
80
Security deposits receivable
130
35
Prepayments
170
1,186
300
1,301
There are no differences
between the carrying amount and fair value of any of the trade and other receivables above.
13 SHARE CAPITAL AND SHARE PREMIUM
Group
On 21 October 2021, the Company
acquired the entire shareholding of Tiziana Life Sciences Plc and its subsidiaries through a share for share exchange transaction. On
this date Tiziana Life Sciences Ltd became the Group's parent company. This transaction does not constitute a business combination
under IFRS 3 "Business combinations" and has been accounted for as a group reorganization. Merger accounting has been applied
to account for the insertion of the new company. Due to a share consolidation, the effect of this was a decrease in share capital of
the Company with an offset posted to the merger reserve. As a common control transaction, the Group has elected to present the comparative
information as if this transaction had occurred before the start of the comparative period. The share capital arising on the share for
share exchange has been presented as share capital in the comparative period.
Nominal Value
Share
Capital
Share Premium
Merger Reserve
£/$
Shares
$000
$000
$000
At January 1 2021 per 20-F annual report
£
0.03
194,612,289
10,794
111,821
-
Group Reorganization
Elimination of share capital in Tiziana Life Sciences
    Plc
£
0.03
(
194,612,289
)
(
10,794
)
(
111,821
)
122,615
Shares issued pursuant to share for share exchange and
    consolidation
$
0.001
97,306,144
97
-
(
97
)
Elimination of other reserves in Tiziana Life Sciences
    Plc
(
3,821
)
Restated at 1 January 2021
$
0.001
97,306,144
97
-
118,697
Shares issued in the period:
Conversion of warrants
$
0.001
136,854
-
156
-
Conversion of Loan
$
0.001
1,866,907
2
603
-
Issued in lieu of cash bonus
$
0.001
2,962,709
3
14,837
-
At 31 December 2021
102,272,614
102
15,596
118,697
Shares issued in the period:
At 31 December 2022
102,272,614
102
15,596
118,697
Ordinary Shares
Ordinary shares have a par
value of $
0.001
. They entitle the holder to participate in dividends, and to share in the proceeds of winding up the company in proportion
to the number of and amounts paid on the shares held. On a show of hands every holder of ordinary shares present at a meeting in person
or by proxy, is entitled to one vote, and upon a poll each share is entitled to one vote. Ordinary shares include
1,683,544
of shares
that are held in treasury which the Company has purchased pursuant to a share buyback but which are not cancelled upon delivery back to
the Company. The Company has
102,272,614
shares in issue and holds
1,683,544
shares in treasury. The
1,683,544
treasury shares carry no
voting rights and do not rank for dividends or return of capital whilst held in treasury.
F-
19
14. SHARE BASED PAYMENTS
Group and Company Options
The Company operates share-based
payment arrangements to remunerate directors and key employees in the form of a share option scheme. The exercise price of the option
is normally equal to the market price of an ordinary share in the Company at the date of grant. The Company is currently operating two
plans (Tiziana Life Sciences PLC) Share Option Plan which is closed for any new issuances and the Tiziana Life Sciences Ltd 2021 Equity
Incentive Plan.
Tiziana Life Sciences PLC Share Option Plan
2022
2021
2020
Weighted
Weighted
Weighted
Average
exercise
price
(cents)
Options
('000)
Average
exercise
price
(cents)
Options
('000)
Average
exercise
price
(cents)
Options
('000)
Outstanding at 1 January
90
22,234
67
17,024
113
16,379
Granted
-
-
166
5,210
111
3,870
Forfeited/Cancelled
176
(
6,910
)
-
-
(
52
)
(
300
)
Exercised
-
-
-
-
(
25
)
(
2,925
)
Outstanding at 31 December
49
15,324
90
22,234
67
17,024
Exercisable at 31 December
48
6,249
54
7,616
65
6,249
No options were exercised
during 2022 or 2021.
2,925,725
options were exercised during the year ending 31 December 2020.
The total outstanding fair
value charge of the share option instruments is deemed to be approximately $
242
k (2021: $
12,339
k, 2020: $
7,046
k).
Under the Tiziana Life Sciences
PLC Share Option Plan, the total expense recognized for the year ending 31 December 2022 arising from share – based payment transactions
under the Tiziana Life Sciences PLC Share Option Plan is ($
1,479
k) of which $
3,221
k was forfeiture during the year (2021 $
5,173
k, 2020:
$
5,105
k).
Share options outstanding
at the end of the year have the following expiry dates and exercise prices:
Grant Date
Expiry Date
Exercise Price
Share Options
at 31 December
2022
('000)
26 June 2014
26 June 2024
$
0.47
1,831
30 April 2018
30 April 2028
$
1.10
500
6 May 2020
5 May 2028
$
0.47
12,393
23 July 2020
26 July 2030
$
2.11
100
25 August 2020
24 August 2030
$
1.98
500
Total
15,324
Fair value of options granted
The Directors have used the
Black-Scholes-Merton option pricing model to estimate the fair value of all of the options granted during the year to December 31, 2021,
applying the assumptions below.
Historical volatility is
based on the historical volatility of the Company itself.
F-
20
The Company has estimated
a forfeiture rate of zero.
The model inputs for options
granted during the year ended 31 December 2021 valued under the Black-Scholes-Merton model included:
2
    February
2021
8
    October
2021
Grant date
    share price
$
2.116
$
0.719
Exercise share price
$
1.357
/
1.983
$
0.719
Risk
    free rate
-
0.10
% to -
0.02
%
0.32
% to
0.65
%
Expected
    volatility
101
% to
162
%
83
% to
122
%
Option life
10
years
10
years
Weighted average share
    price
$
1.818
$
0.719
Weighted average fair value
    per share option
$
0.862
$
0.319
For the options issued in
August 2020 with a market condition attached, the Directors have used the Monte Carlo simulation to estimate the fair value of these
options. The Company uses the following methods to determine its underlying assumptions:
●
expected volatilities are
    based on the historical volatilities of the market;
●
the expected term of the award is
4
years and is based on managements' assessment of when the market condition is likely to be achieved; and
●
a range of fair values
    per share were produced and management have determined the most appropriate value based on their knowledge of the market and vesting
    conditions being fulfilled.
Modification of share – based payments.
In May 2020, the Company
reduced the exercise price for options issued to employees and directors to $
0.48
(£
0.35
). This was approved by shareholders at
a General Meeting held on May 6, 2020.
The fair value of the modified
options at the date of modification was determined using the option pricing models as described above. The incremental fair value was
recognised as an expense over the period from the modification date to the end of the vesting period. The expense for the original option
grant will continue to be recognised as if the terms had not been modified.
The fair value of the modified
options was determined using the same models and principles as described above.
Tiziana Life Sciences Ltd 2021 Equity Incentive
Plan
2022
Weighted
Average
exercise
price
(cents)
Options
('000)
Outstanding at 1 January
-
-
Granted
69
2,575
Forfeited/Cancelled
-
-
Exercised
-
-
Outstanding at 31 December
69
2,575
Exercisable at 31 December
-
-
F-
21
The model inputs for options
granted during the year ended 31 December 2022 valued under the Black-Scholes-Merton Valuation model included:
4 November
2022
1 August
2022
Grant date share price
$
0.679
$
0.741
Exercise share price
$
0.679
$
0.741
Risk free rate
-
0.10
% to -
0.02
%
0.32
% to
0.65
%
Expected volatility
99
% to
122
%
90
% to
126
%
Option life
10
years
10
years
Weighted average share price
$
0.67
$
0.741
Weighted average fair value per share option
$
0.690
$
0.690
During the year ending 31
December 2022 no options were exercised.
The total outstanding fair
value charge of the share option instruments is deemed to be approximately $
1,176
k.
Under the Tiziana Life Sciences
Ltd 2021 Equity Incentive Plan, the total expenses recognized for the year ending 31 December 2022 arising from share based payment transactions
is $
332
k.
Share options outstanding
at the end of the year have the following expiry dates and exercise prices:
Grant Date
Expiry Date
Exercise Price
Share Options as
at 31 December
2022
('000)
01 August 2022
01 August 2032
$
0.74
725
04 November 2022
04 November 2022
$
0.67
1,850
Total
2,575
Group and Company Warrants
No warrants were issued in
2022 or 2021. For warrants issued in 2020, the Directors have estimated the fair value of the warrants using the Black-Scholes valuation
model and assumptions below:
21 January
2020
21 January
2020
1 June
2020
Grant date share price
£
0.43
£
0.43
£
1.15
Exercise share price
£
0.42
£
0.35
£
0.70
Risk free rate
0.64
%
0.40
%
0.04
%
Expected volatility
61.7
%
84.7
%
111
%
2022
$000
2021
$000
2020
$000
Outstanding at 1 January
697
697
2,418
Granted
-
-
324
Transfer to share premium on exercise of warrants
-
-
2,045
)
Outstanding at 31 December
697
697
697
No share-based payment charges
relating to warrants were recorded during 2022 or 2021. Approximately $
26
K of share-based payment charges are included in the consolidated
statement of operations and comprehensive loss for the year ended December 31, 2020.
F-
22
15. RESERVES
The share-based payment reserve
for warrants represents the cost to issue warrants in the future based on their grant date fair value.
The share-based payment reserve
for options represents the cost to issue share-based compensation, primarily share options, based on their grant date fair value.
Retained earnings represent
the cumulative profits/(losses) of the entity which have not been distributed to shareholders. This reserve has been credited as part
of the capital reduction exercise described below.
The translation reserve represents
the unrealised gains or losses from the foreign currency translation of Companies within the Group.
The merger reserve arises
on consolidation as a result of the share for share exchange transaction that took place this year described in note 13. It represents
the difference between the share capital issued and the aggregate carrying value of assets and liabilities and other reserves of the
previous parent on the merger date.
16. FINANCIAL INSTRUMENTS
The main risks arising from
the Group's financial instruments are liquidity risk, foreign currency risk and credit risk. The directors regularly review and
agree policies for managing each of these risks which are summarised below.
Market risk
Market risk encompasses three
types of risk, being foreign currency exchange risk, price risk and fair value interest rate risk. The Group policies for managing fair
value interest rate risk are considered along with those for managing cash flow interest rate risk and are set out in the subsection
entitled "interest rate risk" below. The Directors do not consider the Group's exposure to price risk to be significant.
The Group's risk management is coordinated by the Directors and focuses on actively securing the Group's short to medium
term cash flows by minimising the exposure to financial markets. The Group does not engage in the trading of financial assets for speculative
purposes.
F-
23
Credit risk
Credit risk is managed on
a Group basis. Credit risk arises principally from cash and cash equivalents and deposits with banks and financial institutions as well
as credit exposure to customers including committed transactions and outstanding receivables. The Group reviews its banking arrangements
carefully to minimise such risks and currently has no customers and therefore this risk is viewed as minimal. Management monitor loans
between members of the Group as part of their internal reporting and assess outstanding receivables for ability to be repaid.
Liquidity risk
The Group's policy
is to regularly monitor current and expected liquidity requirements to ensure that it maintains sufficient reserves of cash to meet its
liquidity requirements in the short and long term. The Group ordinarily finances its activities through cash generated from by private
and public offerings of equity and debt securities.
The table below summarizes
the maturity profile of the Group's financial liabilities based on contractual undiscounted payments:
2022
$000
Less than
3 months
3 to 12
months
Total
Trade payables
1,230
3,732
4,962
Lease liabilities
32
98
130
Related party payables
-
-
-
Total
1,262
3,830
5,092
2021
$000
Less than
3 months
3 to 12
months
Total
Trade payables
2,873
1,533
4,406
Related party payables
1,355
-
1,355
Total
4,228
1,533
5,761
Interest rate risk
The Group has limited exposure
to interest-rate risk arising from its bank deposits. These deposit accounts are held at variable interest rates based on Bank of America
base rate.
The Directors do not consider
the impact of possible interest rate changes based on current market conditions to be material to the net result for the year or the
equity position as of year-end for either the year ended 31 December 2022 or 31 December 2021.
F-
24
Foreign currency risk
The Group operates internationally
although the majority of its operations are based in the United Kingdom and the United States, and the majority of assets and liabilities
are denominated in US Dollars, with a small amount denominated in Pound Sterling. It therefore is exposed to some foreign exchange risk
arising from exposure to various currencies primarily the Pound Sterling. The Group monitors currency exchange rates and makes judgments
as to whether to enter into currency hedging contracts. Currently no such hedging contracts are in place.
Sensitivity analysis
A reasonably possible strengthening
(weakening) of the US dollar or Sterling against all other currencies at 31 December 2022 would have affected the measurement of the
financial instruments denominated in a foreign currency and affected equity and profit and loss by the amounts shown below. This analysis
assumes that all other variables remain constant.
Profit
    or loss and equity
December
    31, 2022
Strengthening
Weakening
USD (
5
% movement)
415
(
415
)
17. CAPITAL RISK MANAGEMENT
For the purpose of the Group's
capital management, capital includes called up share capital, share premium, share – based payments for options, share - based
payments for warrants, convertible loan note reserve, and all other equity reserves attributable to the equity holders of the parent
as reflected in the consolidated statement of financial position.
The Company's objectives
when managing capital are to safeguard the Company's ability to continue as a going concern and to maximise shareholder value through
the optimisation of the equity balance.
The Group adjusts its capital
structure in light of changes in economic conditions and expected business demands on capital. The Group may also return capital to shareholders
or issue additional shares.
F-
25
18. TRADE AND OTHER PAYABLES
Year ended
December 31,
Group
2022
2021
$000
$000
Trade payables
4,962
4,406
Accruals
1,570
1,775
6,532
6,181
19. INVESTMENT IN RELATED PARTY
Year ended
December 31,
Group
2022
2021
$000
$000
Investment in Accustem Sciences Inc
2,675
-
Movement in fair value
(
869
)
-
1,806
-
During the year the company
purchased One Million Three Hundred Thirty Seven Thousand Nine Hundred Seventy (
1,337,970
) shares of the Accustem Sciences Inc's Common
Stock, with a par value of $
0.001
, at a price per share of $
2.00
, for an aggregate purchase price of $
2,675,940
. The share price of Accustem
as of December 31, 2022 was $
1.35
, which has resulted in the recognition of a fair value loss of $
869
k. This has been measured using the
Level 1per IFRS 13 fair value hierarchy. Accustem Sciences Inc is listed on the OTC markets and is run by a separate management team which
is independent of the Tiziana management team. Tiziana is therefore not able to assert significant influence over Accustem Sciences Inc.
20. TREASURY SHARES
The company acquired
1,683,544
of its own shares through purchases on the NASDAQ stock exchange during the year ended December 31, 2022. The amount paid to acquire
the shares totaled $
1,320
k, and the shares are held as "treasury shares". The Company has the right to reissue these shares
at a later date. All shares issued by the Company are fully paid.
21. RELATED PARTY TRANSACTIONS
The ultimate controlling
party of the Group is Planwise Group Ltd.
Rasna Therapeutics Inc is
a related party as the entity is controlled by a person that has significant influence over the Group. Rasna is also party to a Shared
Services agreement with Tiziana whereby Rasna is charged for shared services such as the payroll and rent. During 2022,
Tiziana extended a loan to Rasna for $
75,000
at an interest rate of
16
% per annum. As of December 31, 2022, $
206
k (2021: $
106
k (2020:
$
78
k) was owed to Tiziana Life Sciences Ltd in respect of the loan and shared services agreement. The total charged under the shared services
agreement in the year ending 31 December 2022 was $
7
k (2021: $
11
k, 2020: $
6
k).
In addition to the above,
on April 16, 2020, Tiziana also acquired all of the intellectual property relating to a nanoparticle-based formulation of Actinomycin
D (Act D; a.k.a. Dactinomycin), from Rasna to expand its pipeline for a consideration of an initial $
120
k upfront payment and milestone
payments of up to an additional aggregate $
630
k. There were no milestone payments due in the year ending 31 December 2022.
OKYO Pharma Ltd is a related
party as the entity is controlled by a person that has significant influence over the Group. OKYO is also party to a Shared Services agreement with Tiziana whereby
OKYO is charged for shared services such as the payroll and rent. As of December 31, 2022 $
274
k (2021, $
42
k ,2020: $
27
k) was owed to Tiziana
Life Sciences Ltd in respect of this agreement. The total charged under the shared services agreement in the year ending 31 December 2022
was $
125
k (2021: $
98
k, 2020: $
20
k).
In August 2022, the Group
issued a short-term credit facility to OKYO Pharma, a related party, for $
2,000
k in order to support short term liquidity. The loan is
available for a period of 6 months upon first draw-down and carries an interest rate of
16
% per annum, with additional default interest
of
4
% if the loan is not repaid after the 6-month period. As at December 31, 2022 $
1,056
k had been drawn down against the loan and $
19
k
of interest had been accrued.
Gensignia Lifesciences Inc
is a related party as the entity is controlled by a person that has significant influence over the Group. As of December 31, 2022 $
295
k
was written off to bad debt after management assessment and deemed the balance to be irrecoverable (2021, $
295
k, 2020: $
348
k).
Accustem Sciences Inc is
a related party as the entity is controlled by a person that has significant influence over the Group. Accustem is also party to a Shared
Services agreement with Tiziana whereby the Company is charged for shared services such as payroll and rent As of December
31, 2022 $
72
K (2021, ($
1,341
k) (2020: ($
1,346
k)) was the net amount owed from Accustem, including shared service costs of $
72
k.
F-
26
22. LEASES
All leases are accounted for by recognising a
right-of-use asset and a lease liability except for:
●
Leases of low value assets;
    and
●
Leases with a duration
    of 12 months or less.
The Group has leases for
its offices. Each lease is reflected on the balance sheet as a right-of-use asset and a lease liability. The Group does not have leases
of low value assets. Variable lease payments which do not depend on an index or a rate (such as lease payments based on a percentage
of Group sales) are excluded from the initial measurement of the lease liability and asset. The Group classifies its right-of-use assets
in a consistent manner to its property, plant and equipment.
For leases over office buildings
and factory premises the Group must keep those properties in a good state of repair and return the properties in their original condition
at the end of the lease.
During the course of 2022,
the Group entered into a new lease agreement for its London office. Any leases that have a term shorter than 12 months the Group has
applied the exemption allowed by paragraph 5a in IFRS16 in respect of short – term leases.
Right-of-use assets
31 Dec
2022
31 Dec
2021
$000
$000
At 1 January 2022
448
357
Depreciation
(
50
)
(
133
)
Disposal of lease
-
(
224
Exchange differences
(
26
)
372
-
Lease Liabilities
31 Dec
2022
31 Dec
2021
$000
$000
At 1 January 2022
448
555
Interest expense
6
13
Lease payments
(
61
)
(
154
)
Exchange differences
(
28
)
(
20
)
Disposal of lease
-
(
394
)
365
-
Lease liabilities are presented
in the consolidated statement of financial; position as follows:
31 Dec
2022
31 Dec
2021
$000
$000
Current
122
-
Non-current
243
-
365
-
The lease liabilities are
secured by the related underlying assets. Future minimum lease payments as of 31 December 2022 were as follows:
Minimum lease payment due
Within 1 year
1-2 years
2-5 years
Over 5 years
Total
Lease payments
139
139
104
-
382
Finance Charges
(
9
)
(
6
)
(
2
)
-
(
17
)
Net Present Values
130
133
102
365
The total net cash outflow
for leases in the year to 31 December 2022 was $
55
k..
F-
27
23. FINANCIAL COMMITMENTS
The Group's main financial
commitments relate to the contractual payments in respect of its licensing agreements. Due to the uncertain nature of scientific research
and development and the length of time required to reach commercialisation of the products of this research and development, pre-clinical,
clinical and commercial milestone obligations are not detailed until there is a reasonable certainty that the obligation will become
payable.
●
Milciclib project research
    future payments relate to the achievement of clinical milestones or the payment of royalties.
We are obligated to pay Nerviano
the following additional amounts in respect of the first licensed product or service which achieves the stated development milestones:
(a)
$1,000,000 upon initiation of the first Phase II clinical trial, this
is currently being negotiated with BMS.
(b)
$4,000,000 upon FPD of
    the first Phase 3 registration trial in HCC.
(c)
$3,600,000 upon first patient enrollment into a Phase II human clinical
trial
(d)
Upon the first NDA equivalent
    in: thymic carcinoma, $900,000; HCC, $9,000,000; breast cancer, $15,000,000.
●
Foralumab project – Future payments relate to the achievement of clinical milestones or the payment of royalties. Diligence obligations are payable to BMS/Medarex should the project continue to commercialisation. $
750,000
has been recoded as other income in respect of diligence obligations due to Medarex for 2021.
We are obligated to pay BMS
the following additional amounts in respect of the first licensed product or service which achieves the stated development milestones:
(a)
$300,000 upon enrollment of first patient in a Phase I human clinical
trial of the first Phase II Clinical trial, this is currently being negotiated with BMS.
(b)
$1,500,000 upon initiation
    of the first Phase III clinical trial
(c)
$2,000,000 upon filing
    of the first BLA, or equivalent
(d)
$2,000,000 upon approval
    of the first BLA, or equivalent
We are obligated to pay Brighams
Womens Hospital the following hospital milestone payments:
(a)
$300,000 upon first patient
    enrollment into a Phase I human clinical trial
(b)
$300,000 upon first patient
    enrollment into a Phase II human clinical trial
(c)
$1,500,000 upon first patient
    enrollment into a Phase III human clinical trial
(d)
$3,000,000 upon first commercial
    sale of a product
●
ACT D - Tiziana will need to make milestone payments of up to $
630
k depending on the issuance of a US patent from any US patent application in Transferred IP relating to nanoparticle formulations of Act D and upon the successful completion of a Phase II clinical efficacy trial.
24. CONTINGENT LIABILITIES
The group from time to time is involved in legal proceedings, none of which have given rise to contingent liabilities.
Contingencies arising in the ordinary course of business, for which no security has been given, are not expected to result in any material
financial loss.
25. POST BALANCE SHEET EVENTS
On March 20, 2023, the Company
announced the grant of
857,500
share options to directors and members of senior management.
In August 2022, the Group issued a short-term credit facility to Okyo Pharma, a related party, for $
2,000
k in
order to support short term liquidity. As at December 31, 2022 $
1,056
k had been drawn down against the loan and the remaining amount was
drawn down by January 17, 2023. The company further extended its loan facility by $
500
k on February 13, 2023, as of March 2023 the $
500
k
was fully repaid to the company.
F-28