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<p style="margin: 0"></p>

<!-- Field: Rule-Page --><div style="margin-top: 12pt; margin-bottom: 3pt; width: 100%"><div style="border-top: Black 2pt solid; border-bottom: Black 1pt solid; font-size: 1pt">&#160;</div></div><!-- Field: /Rule-Page -->

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 14pt"><b>UNITED
STATES</b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 14pt"><b>SECURITIES
AND EXCHANGE COMMISSION</b></span></p>

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

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 18pt"><b>FORM
<span id="xdx_905_edei--DocumentType_c20211001__20211231_zifwzZErv6V9"><ix:nonNumeric contextRef="From2021-10-01to2021-12-31" name="dei:DocumentType">10-Q</ix:nonNumeric></span></b></span></p>

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

<p style="font: 10pt Times New Roman, Times, Serif; text-align: left; margin-top: 0; margin-bottom: 0"><span style="font-family: Times New Roman, Times, Serif">(Mark
One)</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 31.5pt"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: center"><span style="font: normal 12pt Times New Roman, Times, Serif"><b><span id="xdx_907_edei--DocumentQuarterlyReport_c20211001__20211231_zyyE0SmfXq6g"><ix:nonNumeric contextRef="From2021-10-01to2021-12-31" format="ixt:booleantrue" name="dei:DocumentQuarterlyReport">&#9746;</ix:nonNumeric></span>
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE&#160;ACT&#160;OF 1934</b></span></p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: center"><span style="font-family: Times New Roman, Times, Serif">For
the quarterly period ended: <b><span style="text-decoration: underline"><span id="xdx_906_edei--DocumentPeriodEndDate_c20211001__20211231_zrDUxBA8h8c3"><ix:nonNumeric contextRef="From2021-10-01to2021-12-31" format="ixt:datemonthdayyearen" name="dei:DocumentPeriodEndDate">December 31, 2021</ix:nonNumeric></span></span></b></span></p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 12pt"><b><span id="xdx_90D_edei--DocumentTransitionReport_c20211001__20211231_zFRwHyYzsJb9"><ix:nonNumeric contextRef="From2021-10-01to2021-12-31" format="ixt:booleanfalse" name="dei:DocumentTransitionReport">&#9744;</ix:nonNumeric></span>&#160;&#160;TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE&#160;ACT&#160;OF 1934</b></span></p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: center"><span style="font-family: Times New Roman, Times, Serif">For
the transition period from _____to _____</span></p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: center"><span style="font-family: Times New Roman, Times, Serif">Commission
File Number: <span style="text-decoration: underline"><span id="xdx_907_edei--EntityFileNumber_c20211001__20211231_zKHO0LQoHh97"><ix:nonNumeric contextRef="From2021-10-01to2021-12-31" name="dei:EntityFileNumber">001-37606</ix:nonNumeric></span></span></span></p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 24pt"><b><span style="text-decoration: underline"><span id="xdx_90E_edei--EntityRegistrantName_c20211001__20211231_zhodB74t2mA1"><ix:nonNumeric contextRef="From2021-10-01to2021-12-31" name="dei:EntityRegistrantName">ANAVEX LIFE SCIENCES CORP.</ix:nonNumeric></span></span></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: center"><span style="font-family: Times New Roman, Times, Serif">(Exact
name of registrant as specified in its charter)</span></p>

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

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="vertical-align: top">
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    <td style="text-align: center"><span style="font-family: Times New Roman, Times, Serif">(IRS Employer</span></td></tr>
  <tr style="vertical-align: top">
    <td style="text-align: center"><span style="font-family: Times New Roman, Times, Serif">incorporation or organization)</span></td>
    <td style="text-align: center"><span style="font-family: Times New Roman, Times, Serif">Identification No.)</span></td></tr>
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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: center"><span style="font-family: Times New Roman, Times, Serif">&#160;&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: center"><span style="font-family: Times New Roman, Times, Serif"><b><span style="text-decoration: underline"><span id="xdx_90F_edei--EntityAddressAddressLine1_c20211001__20211231_zQ8WbqaheAw6"><ix:nonNumeric contextRef="From2021-10-01to2021-12-31" name="dei:EntityAddressAddressLine1">630 5th Avenue</ix:nonNumeric></span>, <span id="xdx_90B_edei--EntityAddressAddressLine2_c20211001__20211231_zHI2sBgTNila"><ix:nonNumeric contextRef="From2021-10-01to2021-12-31" name="dei:EntityAddressAddressLine2">20th Floor</ix:nonNumeric></span>, <span id="xdx_905_edei--EntityAddressCityOrTown_c20211001__20211231_zyK8RCd5GC37"><ix:nonNumeric contextRef="From2021-10-01to2021-12-31" name="dei:EntityAddressCityOrTown">New York</ix:nonNumeric></span>, <span id="xdx_901_edei--EntityAddressStateOrProvince_c20211001__20211231_zxZTfQnwjZRf"><ix:nonNumeric contextRef="From2021-10-01to2021-12-31" name="dei:EntityAddressStateOrProvince">NY</ix:nonNumeric></span> <span id="xdx_901_edei--EntityAddressCountry_c20211001__20211231_zGXRyZYzdzv4"><ix:nonNumeric contextRef="From2021-10-01to2021-12-31" format="ixt-sec:countrynameen" name="dei:EntityAddressCountry">USA</ix:nonNumeric></span> <span id="xdx_907_edei--EntityAddressPostalZipCode_c20211001__20211231_zzAxcpiGLUxh"><ix:nonNumeric contextRef="From2021-10-01to2021-12-31" name="dei:EntityAddressPostalZipCode">10111</ix:nonNumeric></span></span></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: center"><span style="font-family: Times New Roman, Times, Serif">&#160;(Address
of principal executive offices) (Zip Code)</span></p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: center"><span style="font-family: Times New Roman, Times, Serif"><b><span style="text-decoration: underline">1-<span id="xdx_90C_edei--CityAreaCode_c20211001__20211231_zfRo1SylVLVg"><ix:nonNumeric contextRef="From2021-10-01to2021-12-31" name="dei:CityAreaCode">844</ix:nonNumeric></span>-<span id="xdx_90F_edei--LocalPhoneNumber_c20211001__20211231_zE0zodVWs5Bb"><ix:nonNumeric contextRef="From2021-10-01to2021-12-31" name="dei:LocalPhoneNumber">689-3939</ix:nonNumeric></span></span></b></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: center"><span style="font-family: Times New Roman, Times, Serif"><b>&#160;</b>(Registrant&#8217;s
telephone number, including area code)</span></p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif">Securities
Registered Pursuant to Section&#160;12(b) of the Act:</span></p>

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

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr>
    <td style="border-bottom: Black 1pt solid; vertical-align: bottom; text-align: center"><span style="font-family: Times New Roman, Times, Serif">Title
    of Each Class</span></td>
    <td style="vertical-align: top; padding-bottom: 1pt; text-align: center"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="border-bottom: Black 1pt solid; vertical-align: bottom; text-align: center"><span style="font-family: Times New Roman, Times, Serif">Trading
    Symbol</span></td>
    <td style="vertical-align: top; padding-bottom: 1pt; text-align: center"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="border-bottom: Black 1pt solid; vertical-align: bottom; text-align: center"><span style="font-family: Times New Roman, Times, Serif">Name
    of Each Exchange on Which Registered</span></td></tr>
  <tr style="vertical-align: top; background-color: #CCEEFF">
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    <td style="width: 1%; text-align: center"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="width: 32%; text-align: center"><span style="font-family: Times New Roman, Times, Serif"><span id="xdx_90A_edei--TradingSymbol_c20211001__20211231_zxRdjtoYrO16"><ix:nonNumeric contextRef="From2021-10-01to2021-12-31" name="dei:TradingSymbol">AVXL</ix:nonNumeric></span></span></td>
    <td style="width: 1%; text-align: center"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="width: 34%; text-align: center"><span style="font-family: Times New Roman, Times, Serif">The <span id="xdx_906_edei--SecurityExchangeName_c20211001__20211231_ztbft1GED9rb"><ix:nonNumeric contextRef="From2021-10-01to2021-12-31" format="ixt-sec:exchnameen" name="dei:SecurityExchangeName">NASDAQ</ix:nonNumeric></span> Stock Market LLC</span></td></tr>
  </table>
<p style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: right"><span style="font-family: Times New Roman, Times, Serif"><b>&#9746;&#160;&#160;<span id="xdx_90B_edei--EntityCurrentReportingStatus_c20211001__20211231_zwOwvrnSaiL2"><ix:nonNumeric contextRef="From2021-10-01to2021-12-31" name="dei:EntityCurrentReportingStatus">Yes</ix:nonNumeric></span>&#160;&#160;&#9744;&#160;&#160;No</b></span></p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif">Indicate
by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule
405 of Regulation S-T (&#167;232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant
was required to submit such files).</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: right"><span style="font-family: Times New Roman, Times, Serif"><b>&#9746;&#160;&#160;<span id="xdx_903_edei--EntityInteractiveDataCurrent_c20211001__20211231_znNFFw2RRIV8"><ix:nonNumeric contextRef="From2021-10-01to2021-12-31" name="dei:EntityInteractiveDataCurrent">Yes</ix:nonNumeric></span>&#160;&#160;&#9744;&#160;&#160;No</b></span></p>

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

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

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

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="vertical-align: top">
    <td style="width: 27%; text-align: justify"><span style="font-family: Times New Roman, Times, Serif"><span id="xdx_900_edei--EntityFilerCategory_c20211001__20211231_zpwKYbu8Wb63"><ix:nonNumeric contextRef="From2021-10-01to2021-12-31" format="ixt-sec:entityfilercategoryen" name="dei:EntityFilerCategory">Large accelerated filer</ix:nonNumeric></span></span></td>
    <td style="width: 3%; text-align: justify">&#9746;</td>
    <td style="width: 41%; text-align: justify"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="width: 26%; text-align: justify"><span style="font-family: Times New Roman, Times, Serif">Accelerated filer</span></td>
    <td style="width: 3%; text-align: justify"><span style="font-family: Times New Roman, Times, Serif">&#9744;</span></td></tr>
  <tr style="vertical-align: top">
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif">Non-accelerated filer</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif">&#9744;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif">Smaller reporting company</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif"><span id="xdx_90B_edei--EntitySmallBusiness_c20211001__20211231_zUAYxDS0Dwjg"><ix:nonNumeric contextRef="From2021-10-01to2021-12-31" format="ixt:booleanfalse" name="dei:EntitySmallBusiness">&#9744;</ix:nonNumeric></span></span></td></tr>
  <tr style="vertical-align: top">
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
    <td style="text-align: justify"><span style="font-family: Times New Roman, Times, Serif">&#160;</span></td>
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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif">&#160;&#160;</span></p>

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

<!-- Field: Page; Sequence: 1 -->
    <div style="border-bottom: Black 2pt solid; margin-top: 6pt; margin-bottom: 6pt"><p style="margin: 0pt">&#160;</p></div>
    <div style="break-before: page; margin-top: 6pt; margin-bottom: 6pt"><p style="margin: 0pt">&#160;</p></div>
    <!-- Field: /Page -->

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif">If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act</span></p>

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

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif">Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: right"><span style="font-family: Times New Roman, Times, Serif"><b>&#9744;&#160;&#160;Yes&#160;&#160;&#9746;&#160;&#160;<span id="xdx_904_edei--EntityShellCompany_c20211001__20211231" title="Entity Shell Company"><ix:nonNumeric contextRef="From2021-10-01to2021-12-31" format="ixt:booleanfalse" name="dei:EntityShellCompany">No</ix:nonNumeric></span></b></span></p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif">Indicate
the number of shares outstanding of each of the issuer&#8217;s classes of common stock, as of the latest practicable date: <span id="xdx_900_edei--EntityCommonStockSharesOutstanding_iI_c20220208_zQuy7M9FbL3i"><ix:nonFraction name="dei:EntityCommonStockSharesOutstanding" contextRef="AsOf2022-02-08" format="ixt:numdotdecimal" decimals="INF" unitRef="Shares">76,174,887</ix:nonFraction></span></span><span style="font-family: Times New Roman, Times, Serif">
shares of common stock outstanding as of February 8, 2022.</span></p>

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

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

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




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

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

<table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; text-transform: uppercase; margin-top: 0; margin-bottom: 0"><tr style="vertical-align: top">
<td colspan="2"><a href="#a_001">PART I - FINANCIAL INFORMATION&#9;PART I - FINANCIAL INFORMATION</a></td>
                                                                   <td style="text-align: right">4</td></tr>
                                                                                                                                                                 <tr style="vertical-align: top">
<td colspan="2">&#160;</td>
                                                                   <td style="text-align: right">&#160;</td></tr>
                                                                                                                                                                 <tr style="vertical-align: top">
<td style="width: 10%">Item 1.</td><td style="width: 85%"><a href="#a_002">FINANCIAL STATEMENTS</a>&#9;</td>
                                                                   <td style="text-align: right; width: 5%">4</td></tr>
<tr style="vertical-align: top">
<td>&#160;</td><td>&#160;</td>
                                                                   <td style="text-align: right">&#160;</td></tr>
<tr style="vertical-align: top">
<td>Item 2.</td><td><a href="#a_003">Management&#8217;s Discussion and Analysis of Financial Condition and Results of Operations.</a>&#9;</td>
                         <td style="text-align: right">19</td></tr>
<tr style="vertical-align: top">
<td>&#160;</td><td>&#160;</td>
                         <td style="text-align: right">&#160;</td></tr>
<tr style="vertical-align: top">
<td>Item 3.</td><td><a href="#a_004">Quantitative and Qualitative Disclosures about Market Risks.</a></td>
                         <td style="text-align: right">34</td></tr>
<tr style="vertical-align: top">
<td>&#160;</td><td>&#160;</td>
                         <td style="text-align: right">&#160;</td></tr>
<tr style="vertical-align: top">
<td>Item 4.</td><td><a href="#a_005">Controls and Procedures.</a></td>
                                                                   <td style="text-align: right">34</td></tr><tr style="vertical-align: top">
<td>&#160;</td><td>&#160;</td>
                                                                   <td style="text-align: right">&#160;</td></tr>
                                                                                                                 <tr style="vertical-align: top">
<td colspan="2"><a href="#a_006">PART II &#8211; OTHER INFORMATION</a></td>
                                                                   <td style="text-align: right">34</td></tr>

<tr style="vertical-align: top">
<td colspan="2">&#160;</td>
                                                                   <td style="text-align: right">&#160;</td></tr>
<tr style="vertical-align: top">
<td style="width: 10%">Item 1.</td><td style="width: 85%"><a href="#a_007">Legal Proceedings.</a>&#9;</td>
                                                                   <td style="text-align: right; width: 5%">34</td></tr>
<tr style="vertical-align: top">
<td>&#160;</td><td>&#160;</td>
                                                                   <td style="text-align: right">&#160;</td></tr>
<tr style="vertical-align: top">
<td>Item 1A.</td><td><a href="#a_008">Risk Factors.</a>&#9;</td>
                          <td style="text-align: right">34</td></tr>
<tr style="vertical-align: top">
<td>&#160;</td><td>&#160;</td>
                          <td style="text-align: right">&#160;</td></tr>
<tr style="vertical-align: top">
<td>Item 2.</td><td><a href="#a_009">Unregistered Sales of Equity Securities and Use of Proceeds.</a>&#9;</td>
                         <td style="text-align: right">35</td></tr>
<tr style="vertical-align: top">
<td>&#160;</td><td>&#160;</td>
                         <td style="text-align: right"></td></tr>
<tr style="vertical-align: top">
<td>Item 3.</td><td><a href="#a_010">Defaults Upon Senior Securities.</a>&#9;</td>
                         <td style="text-align: right">35</td></tr>
<tr style="vertical-align: top">
<td>&#160;</td><td>&#160;</td>
                         <td style="text-align: right">&#160;</td></tr>
<tr style="vertical-align: top">
<td>Item 4.</td><td><a href="#a_011">Mine Safety Disclosures</a>&#9;</td>
                         <td style="text-align: right">35</td></tr>
<tr style="vertical-align: top">
<td>&#160;</td><td>&#160;</td>
                         <td style="text-align: right">&#160;</td></tr>
<tr style="vertical-align: top">
<td>Item 5.</td><td><a href="#a_012">Other Information.</a>&#9;</td>
                         <td style="text-align: right">35</td></tr>
<tr style="vertical-align: top">
<td>&#160;</td><td>&#160;</td>
                         <td style="text-align: right">&#160;</td></tr>
<tr style="vertical-align: top">
<td>Item 6. </td><td><a href="#a_013">Exhibits.</a></td>
                                                                    <td style="text-align: right">35</td></tr><tr style="vertical-align: top">
<td>&#160;</td><td>&#160;</td>
                                                                    <td style="text-align: right">&#160;</td></tr>
                                                                                                              <tr style="vertical-align: top">
<td colspan="2"><a href="#a_014">SIGNATURES</a></td>
                                                                    <td style="text-align: right">36</td></tr>
                                                                                                              </table>

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

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

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



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<p style="font: bold 10pt Times New Roman, Times, Serif; margin: 0; text-transform: uppercase; text-align: justify"><span id="a_001"></span>PART I - FINANCIAL
INFORMATION</p>

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

<p style="font: bold 10pt Times New Roman, Times, Serif; margin: 0; text-transform: uppercase; text-align: justify"><span id="a_002"></span>Item 1. FINANCIAL
STATEMENTS</p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-indent: 0pt; text-align: center"><b>Anavex Life Sciences Corp.</b></p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-indent: 0pt; text-align: center">Interim Condensed Consolidated Financial Statements</p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-indent: 0pt; text-align: center">December 31, 2021</p>

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

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

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

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

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-indent: 0pt; text-align: center"><b>Anavex Life Sciences Corp.</b></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: center; text-indent: 0pt">Interim Condensed Consolidated
Balance Sheets</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: center; text-indent: 0pt">As at December 31,
2021 and September 30, 2021</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 218.65pt 0 0; text-align: center; text-indent: 4.6pt">&#160;&#160;</p>

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  <tr style="vertical-align: bottom; background-color: White">
    <td style="padding: 0pt 0pt 0pt 10pt; text-indent: -10pt">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td id="xdx_495_20211231" style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td id="xdx_492_20210930" style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td></tr>
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    <td style="padding: 0pt 0pt 0pt 10pt; text-align: center; text-indent: -10pt">&#160;</td><td style="font-weight: bold">&#160;</td>
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    <td colspan="3" style="font-weight: bold; text-align: center">September 30,</td></tr>
  <tr style="vertical-align: bottom">
    <td style="padding: 0pt 0pt 1pt 10pt; text-align: center; text-indent: -10pt">&#160;</td><td style="padding-bottom: 1pt; font-weight: bold">&#160;</td>
    <td colspan="3" style="border-bottom: Black 1pt solid; font-weight: bold; text-align: center">2021</td><td style="padding-bottom: 1pt; font-weight: bold">&#160;</td>
    <td colspan="3" style="border-bottom: Black 1pt solid; font-weight: bold; text-align: center">2021</td></tr>
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    <td style="padding: 0pt 0pt 0pt 10pt; text-align: center; text-indent: -10pt">&#160;</td><td style="font-weight: bold">&#160;</td>
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    <td style="padding: 0pt 0pt 0pt 10pt; font-weight: bold; text-indent: -10pt">Assets</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="padding: 0pt 0pt 0pt 10pt; text-align: left; text-indent: -10pt">Current assets</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 id="xdx_404_eus-gaap--CashAndCashEquivalentsAtCarryingValue_i02I_maCzfop_zjC18kiRhNTe" style="vertical-align: bottom; background-color: rgb(204,238,255)">
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    <td style="padding: 0pt 0pt 2.5pt 10pt; text-align: left; text-indent: -10pt">Total assets</td><td style="padding-bottom: 2.5pt; font-weight: bold">&#160;</td>
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    <td style="padding: 0pt 0pt 0pt 10pt; text-indent: -10pt">&#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="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="padding: 0pt 0pt 0pt 10pt; text-align: left; text-indent: -10pt">Current Liabilities</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="padding: 0pt 0pt 0pt 20pt; text-align: left; text-indent: -10pt">Accrued liabilities (Note 4)</td><td style="font-weight: bold">&#160;</td>
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  <tr id="xdx_409_eus-gaap--LiabilitiesCurrent_i02TI_mtCzeNv_maCzfbu_zldrHGFcHgi6" style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="padding: 0pt 0pt 1pt 10pt; text-align: left; text-indent: -10pt">Total liabilities</td><td style="padding-bottom: 1pt; font-weight: bold">&#160;</td>
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    <td style="padding: 0pt 0pt 0pt 10pt; text-indent: -10pt">&#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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  <tr id="xdx_407_eus-gaap--CommonStockValue_iI_maSEzLXy_zLlj3aon3lQh" style="vertical-align: bottom; background-color: rgb(204,238,255)">
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  <tr id="xdx_408_eus-gaap--AdditionalPaidInCapitalCommonStock_iI_maSEzLXy_zjAHdz941KT3" style="vertical-align: bottom; background-color: White">
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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0">&#160;</p>

<p style="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0; margin-bottom: 0">See Accompanying Notes to Condensed Consolidated Interim Financial Statements</p>

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

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

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

<p style="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><b>Anavex Life Sciences
Corp.</b></p>

<p style="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt">Interim Condensed Consolidated</p>

<p style="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt">Statements of Operations
and Comprehensive Loss</p>

<p style="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt">For the three months ended December 31,
2021 and 2020 (Unaudited)</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 177.85pt 0 0; text-align: center; text-indent: 15.6pt">&#160;&#160;</p>

<table cellpadding="0" cellspacing="0" id="xdx_309_113_zmGGH55zIQif" summary="xdx: Statement -  INTERIM CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited)" style="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 100%">
  <tr style="vertical-align: bottom; background-color: White">
    <td>&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td id="xdx_49F_20211001_20211231" style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td id="xdx_49D_20201001_20201231" style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td></tr>
<tr style="vertical-align: bottom">
    <td style="padding-bottom: 1pt; text-align: center">&#160;</td><td style="padding-bottom: 1pt; font-weight: bold">&#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></tr>
  <tr id="xdx_407_eus-gaap--GeneralAndAdministrativeExpense_i01_maCz4Bp_zHs40hRpKgy5" style="vertical-align: bottom; background-color: White">
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  <tr id="xdx_406_eus-gaap--ResearchAndDevelopmentExpense_i01_maCz4Bp_zWUt1G4EGyhd" style="vertical-align: bottom; background-color: rgb(204,238,255)">
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  <tr id="xdx_400_eus-gaap--InterestIncomeExpenseNet_i01_maCzJrT_zq45u3DrbOX8" style="vertical-align: bottom; background-color: White">
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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0">&#160;</p>

<p style="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0; margin-bottom: 0">See Accompanying Notes to Condensed Consolidated Interim Financial Statements</p>

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

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

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

<p style="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><b>Anavex Life Sciences
Corp.&#160;</b></p>

<p style="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt">Interim Condensed Consolidated
Statement of Changes in Stockholders&#8217; Equity</p>

<p style="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt">For the three months ended December 31, 2021 and 2020</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 97.85pt 0 0">&#160;&#160;</p>

<table cellpadding="0" cellspacing="0" id="xdx_306_114_zomiAHqPztBe" summary="xdx: Statement -  INTERIM CONDENSED CONSOLIDATED STATEMENT OF CHANGES IN STOCKHOLDER&apos;S EQUITY (Unaudited)" style="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 100%">
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  <tr id="xdx_405_eus-gaap--ShareBasedCompensation_zNoM2iwLfEAl" style="vertical-align: bottom; background-color: White">
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  <tr id="xdx_40B_eus-gaap--ProfitLoss_zI3DAObMMuI4" style="vertical-align: bottom; background-color: rgb(204,238,255)">
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  <tr id="xdx_439_c20211001__20211231_eus-gaap--StockholdersEquity_iE_zKXLVbNhGhz8" style="vertical-align: bottom; background-color: White">
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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><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 id="xdx_436_c20201001__20201231_eus-gaap--StockholdersEquity_iS_z3S5Z9gfkAMj" style="vertical-align: bottom; background-color: White">
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  <tr id="xdx_40F_eus-gaap--StockIssuedDuringPeriodValueNewIssues_iP3us-gaap--SharesOutstanding_zc3dtDReoT9b" 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><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="color: rgb(204,238,255); text-align: right">-<span style="-sec-ix-hidden: xdx2ixbrl0221">&#160;</span></td><td style="text-align: left">&#160;</td></tr>
  <tr id="xdx_40E_eus-gaap--StockIssuedDuringPeriodValuePurchaseOfAssets_iP3us-gaap--StockIssuedDuringPeriodValueNewIssues_zFDGXo6Yvgc8" style="vertical-align: bottom; background-color: White">
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    <td style="text-align: left">&#160;</td><td style="text-align: right"><span style="-sec-ix-hidden: xdx2ixbrl0225">&#8212;</span></td><td style="text-align: left">&#160;</td><td>&#160;</td>
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  <tr id="xdx_403_ecustom--CommitmentSharesValue_iP3us-gaap--StockIssuedDuringPeriodSharesPurchaseOfAssets_zYdXKWOAHc4k" style="vertical-align: bottom; background-color: rgb(204,238,255)">
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    <td style="text-align: left">&#160;</td><td id="xdx_98E_ecustom--CommitmentSharesShares_iP3custom--CommitmentSharesValue_c20201001__20201231__us-gaap--StatementEquityComponentsAxis__us-gaap--CommonStockMember_z9Nt6v43YN1f" title="Commitment shares, shares" style="text-align: right"><ix:nonFraction name="avxl:CommitmentSharesShares" contextRef="From2020-10-012020-12-31_us-gaap_CommonStockMember" format="ixt:numdotdecimal" decimals="INF" unitRef="Shares">56,642</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 name="avxl:CommitmentSharesValue" contextRef="From2020-10-012020-12-31_us-gaap_AdditionalPaidInCapitalMember" format="ixt:numdotdecimal" decimals="0" sign="-" unitRef="USD">56</ix:nonFraction></td><td style="text-align: left">)</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><span style="-sec-ix-hidden: xdx2ixbrl0232">&#8212;</span></td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><span style="-sec-ix-hidden: xdx2ixbrl0233">&#8212;</span></td><td style="text-align: left">&#160;</td></tr>
  <tr id="xdx_404_eus-gaap--StockIssuedDuringPeriodValueOther_i_pp0p0" style="vertical-align: bottom; background-color: White">
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    <td style="text-align: left">&#160;</td><td style="text-align: right"><span style="-sec-ix-hidden: xdx2ixbrl0239">&#8212;</span></td><td style="text-align: left">&#160;</td><td>&#160;</td>
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  <tr id="xdx_405_eus-gaap--ShareBasedCompensation_i_pp0p0" style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="padding: 0pt 0pt 0pt 10pt; text-indent: -10pt">Share based compensation</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">&#8212;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><span style="-sec-ix-hidden: xdx2ixbrl0244">&#8212;</span></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"><span style="-sec-ix-hidden: xdx2ixbrl0246">&#8212;</span></td><td style="text-align: left">&#160;</td><td>&#160;</td>
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  <tr id="xdx_404_eus-gaap--ProfitLoss_i_pp0p0" style="vertical-align: bottom; background-color: White">
    <td style="padding: 0pt 0pt 1pt 10pt; text-align: left; text-indent: -10pt">Net loss</td><td style="padding-bottom: 1pt">&#160;</td>
    <td style="padding-bottom: 1pt; text-align: left">&#160;</td><td style="border-bottom: Black 1pt solid; text-align: right">&#8212;</td><td style="padding-bottom: 1pt; text-align: left">&#160;</td><td style="padding-bottom: 1pt">&#160;</td>
    <td style="border-bottom: Black 1pt solid; text-align: left">&#160;</td><td style="border-bottom: Black 1pt solid; text-align: right"><span style="-sec-ix-hidden: xdx2ixbrl0249">&#8212;</span></td><td style="padding-bottom: 1pt; text-align: left">&#160;</td><td style="padding-bottom: 1pt">&#160;</td>
    <td style="border-bottom: Black 1pt solid; text-align: left">&#160;</td><td style="border-bottom: Black 1pt solid; text-align: right"><span style="-sec-ix-hidden: xdx2ixbrl0250">&#8212;</span></td><td style="padding-bottom: 1pt; text-align: left">&#160;</td><td style="padding-bottom: 1pt">&#160;</td>
    <td style="border-bottom: Black 1pt solid; text-align: left">&#160;</td><td style="border-bottom: Black 1pt solid; text-align: right">(<ix:nonFraction name="us-gaap:ProfitLoss" contextRef="From2020-10-012020-12-31_us-gaap_RetainedEarningsMember" format="ixt:numdotdecimal" decimals="0" sign="-" unitRef="USD">7,855,065</ix:nonFraction></td><td style="padding-bottom: 1pt; text-align: left">)</td><td style="padding-bottom: 1pt">&#160;</td>
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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0">&#160;</p>

<p style="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0; margin-bottom: 0">See Accompanying Notes to Condensed
Consolidated Interim Financial Statements</p>

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

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

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

<p style="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><b>Anavex Life Sciences
Corp.&#160;</b></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center">Interim Condensed Consolidated
Statements of Cash Flows</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center">For the three months ended
December 31, 2021 and 2020</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center">(Unaudited)</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 179pt 0 0; text-align: center">&#160;&#160;</p>

<table cellpadding="0" cellspacing="0" id="xdx_303_112_znMHvXNiaIak" summary="xdx: Statement - INTERIM CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited)" style="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 100%">
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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></tr>
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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0">&#160;</p>

<p style="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0; margin-bottom: 0">See Accompanying Notes to Condensed Consolidated Interim Financial Statements</p>

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

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

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0"><b>Anavex Life Sciences Corp.</b></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0">Notes to the Condensed Consolidated Interim Financial Statements</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0">December 31, 2021</p>

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

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

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 42.55pt; text-align: justify">Description of
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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 42pt; text-align: justify">Anavex Life Sciences Corp. (&#8220;Anavex&#8221;
or the &#8220;Company&#8221;) is a clinical stage biopharmaceutical company engaged in the development of differentiated therapeutics
by applying precision medicine to central nervous system (&#8220;CNS&#8221;) diseases with high unmet need. Anavex analyzes genomic data
from clinical studies to identify biomarkers, which are used to select patients that will receive the therapeutic benefit for the treatment
of neurodegenerative and neurodevelopmental diseases. The Company&#8217;s lead compound ANAVEX<sup>&#174;</sup>2-73 is being developed
to treat Alzheimer&#8217;s disease, Parkinson&#8217;s disease and potentially other central nervous system diseases, including rare diseases,
such as Rett syndrome, a rare severe neurological monogenic disorder caused by mutations in the X-linked gene, methyl-CpG-binding protein
2 (&#8220;MECP2&#8221;).</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 42pt; text-align: justify">&#160;</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 42.55pt; text-align: justify; text-indent: 2pt">Basis of Presentation</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 42.55pt; text-align: justify">&#160;</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 42.55pt; text-align: justify">These unaudited interim condensed consolidated
financial statements have been prepared pursuant to the rules and regulations of the Securities and Exchange Commission (&#8220;SEC&#8221;)
and accounting principles generally accepted in the United States of America (&#8220;U.S. GAAP&#8221;) for interim reporting. Accordingly,
certain information and note disclosures normally included in the annual financial statements in accordance with U.S. GAAP have been condensed
or omitted pursuant to such rules and regulations. In the opinion of management, the disclosures are adequate to make the information
presented not misleading.</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 42.55pt; text-align: justify">&#160;</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 42.55pt; text-align: justify">These accompanying unaudited interim condensed
consolidated financial statements reflect all adjustments, consisting of normal recurring adjustments, which in the opinion of management
are necessary for fair presentation of the information contained herein. The consolidated balance sheet as of September 30, 2021 was derived
from the audited annual financial statements but does not include all disclosures required by U.S. GAAP. The accompanying unaudited interim
condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes
thereto included in the Company&#8217;s annual report on Form 10-K for the year ended September 30, 2021 filed with the SEC on November
24, 2021. The Company follows the same accounting policies in the preparation of interim reports.</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 42.55pt; text-align: justify">&#160;</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 42.55pt; text-align: justify">Operating results for the three months
ended December 31, 2021 are not necessarily indicative of the results that may be expected for the year ending September 30, 2022.</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 42.55pt; text-align: justify">&#160;</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 42.55pt; text-align: justify">Liquidity</p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 42.55pt; text-align: justify">All of the Company&#8217;s potential drug
compounds are in the clinical development stage and the Company cannot be certain that its research and development efforts will be successful
or, if successful, that its potential drug compounds will ever be approved for sales to pharmaceutical companies or generate commercial
revenues. To date, we have not generated any revenues from our operations. The Company expects the business to continue to experience
negative cash flows for the foreseeable future and cannot predict when, if ever, our business might become profitable.</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 42.55pt; text-align: justify">&#160;</p>

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<ix:exclude><p id="xdx_238_z2syj7xUmet7" style="font: 10pt Times New Roman, Times, Serif; margin: 0"><b>Anavex Life Sciences Corp.</b></p></ix:exclude>

<ix:exclude><p id="xdx_23E_zsifUe2sTP04" style="font: 10pt Times New Roman, Times, Serif; margin: 0">Notes to the Condensed Consolidated Interim Financial Statements</p></ix:exclude>

<ix:exclude><p id="xdx_23E_zoBDIJdRQpf5" style="font: 10pt Times New Roman, Times, Serif; margin: 0">December 31, 2021</p></ix:exclude>

<ix:exclude><p id="xdx_235_ztFfpRnzyeLk" style="font: 10pt Times New Roman, Times, Serif; margin: 0">(Unaudited)</p></ix:exclude>


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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 42.55pt; text-align: justify">Management believes that the current working
capital position will be sufficient to meet the Company&#8217;s working capital requirements beyond the next 12 months after the date
that these interim condensed consolidated financial statements are issued. The process of drug development can be costly, and the timing
and outcomes of clinical trials is uncertain.&#160;The assumptions upon which the Company has based its estimates are routinely evaluated
and may be subject to change.&#160;The actual amount of the Company&#8217;s expenditures will vary depending upon a number of factors
including but not limited to the design, timing and duration of future clinical trials, the progress of the Company&#8217;s research and
development programs and the level of financial resources available. The Company has the ability to adjust its operating plan spending
levels based on the timing of future clinical trials.</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 42.55pt; text-align: justify">&#160;</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 42.55pt; text-align: justify">Other than our rights related to the Sales
Agreement (as defined below in Note 5), there can be no assurance that additional financing will be available to us when needed or, if
available, that it can be obtained on commercially reasonable terms. If the Company is not able to obtain the additional financing on
a timely basis, if and when it is needed, it will be forced to delay or scale down some or all of its research and development activities.</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 42.55pt; text-align: justify">&#160;</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 42.55pt; text-align: justify">Coronavirus Disease 2019 (COVID-19)</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 42.55pt; text-align: justify">&#160;</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 42.55pt; text-align: justify">The recent global outbreak of COVID-19
has not had a material impact on the Company&#8217;s result of operations or financial condition as of December 31, 2021. However, the
pandemic continues to rapidly evolve as of the date these consolidated financial statements are issued and has created a dynamic and uncertain
situation in the global economy. As such, it is uncertain as to the full magnitude that the outbreak will have on the Company&#8217;s
financial condition and future results of operations. Management is actively monitoring the global situation on its business, including
on its clinical trials and operations and financial condition. Given the daily evolution of the COVID-19 situation, and the global responses
to curb its spread, the Company is not able to estimate the effects COVID-19 may have on its future results of operations or financial
condition.</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 42.55pt; text-align: justify">&#160;</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 42.55pt; text-align: justify; color: black"><span style="font-style: normal">Use
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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 42.55pt; text-align: justify">The preparation of financial
statements in accordance with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of
assets and liabilities at the date of the financial statements and the reported amounts of revenue and expenses in the reporting
period. The Company regularly evaluates estimates and assumptions related to accounting for research and development costs,
incentive income receivable, valuation and recoverability of deferred tax assets, asset impairment, stock-based compensation, and
loss contingencies. The Company bases its estimates and assumptions on current facts, historical experience, and various other
factors that it believes to be reasonable under the circumstances, the results of which form the basis for making judgments about
the carrying values of assets and liabilities and the accrual of costs and expenses that are not readily apparent from other
sources. The actual results experienced by the Company may differ materially and adversely from the Company&#8217;s estimates. To
the extent there are material differences between the estimates and the actual results, future results of operations will be
affected.</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 42.55pt; text-align: justify">&#160;</p>

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<ix:exclude><p id="xdx_232_zy0MUCseZqNb" style="font: 10pt Times New Roman, Times, Serif; margin: 0"><b>Anavex Life Sciences Corp.</b></p></ix:exclude>

<ix:exclude><p id="xdx_230_zXBOV38uuQjg" style="font: 10pt Times New Roman, Times, Serif; margin: 0">Notes to the Condensed Consolidated Interim Financial Statements</p></ix:exclude>

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<ix:exclude><p id="xdx_234_zYGAVl8vFPCj" style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify">Note 1&#160;&#160;&#160;&#160;&#160;&#160; &#9;<span style="text-decoration: underline">Description of Business and Basis of
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<ix:exclude><p id="xdx_23D_z6Fac7twUkE" style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify">&#160;</p></ix:exclude>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 42.55pt; text-align: justify">Principles of Consolidation</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 42.55pt; text-align: justify">&#160;</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 42.55pt; text-align: justify">These consolidated financial statements
include the accounts of Anavex Life Sciences Corp. and its wholly-owned subsidiaries, Anavex Australia Pty Limited. (&#8220;Anavex Australia&#8221;),
a company incorporated under the laws of Australia, Anavex Germany GmbH, a company incorporated under the laws of Germany, and Anavex
Canada Ltd., a company incorporated under the laws of the Province of Ontario, Canada. All inter-company transactions and balances have
been eliminated.</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 42.55pt; text-align: justify">&#160;</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 42.55pt; text-align: justify; color: black"><span style="font-style: normal">Fair
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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 42.55pt; text-align: justify; color: black"><span style="font-style: normal">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 42.55pt; text-align: justify">The fair value hierarchy under GAAP is
based on three levels of inputs, of which the first two are considered observable and the last unobservable, that may be used to measure
fair value which are the following:</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 42.55pt; text-align: justify">&#160;</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 103.5pt; text-align: justify; text-indent: -40.5pt">Level 1 - &#9;quoted
prices (unadjusted) in active markets for identical assets or liabilities;</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 103.5pt; text-align: justify; text-indent: -40.5pt">&#160;</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 103.5pt; text-align: justify; text-indent: -40.5pt">Level 2 - observable
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assets and liabilities in markets that are not active, and model-derived prices whose inputs are observable or whose significant value
drivers are observable; and</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 103.5pt; text-align: justify; text-indent: -40.5pt">&#160;</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 103.5pt; text-align: justify; text-indent: -40.5pt">Level 3 - &#9;assets
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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 103.5pt; text-align: justify; text-indent: -40.5pt">&#160;</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 42.55pt; text-align: justify">The book value of cash and cash equivalents
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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 42.55pt; text-align: justify">&#160;</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 42.55pt; text-align: justify">At December 31, 2021 and September 30,
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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 42.55pt; text-align: justify">&#160;</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 42.55pt; text-align: justify; color: black"><span style="font-style: normal">Basic
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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 42.55pt; text-align: justify">Basic income/(loss) per common share is
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the period. Diluted income/(loss) per common share is computed by dividing net income/(loss) available to common stockholders by the sum
of (1) the weighted-average number of common shares outstanding during the period, (2) the dilutive effect of the assumed exercise of
options and warrants using the treasury stock method and (3) the dilutive effect of other potentially dilutive securities. For purposes
of the diluted net loss per share calculation, options and warrants are potentially dilutive securities and are excluded from the calculation
of diluted net loss per share because their effect would be anti-dilutive.</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 42.55pt; text-align: justify">&#160;</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 42.55pt; text-align: justify">As of December 31, 2021, loss per share
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as their effect was anti-dilutive.</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 42.55pt; text-align: justify">&#160;</p>

<ix:exclude><p id="xdx_23F_zhgEcAAPbCF1" style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 42.55pt; text-align: justify"></p></ix:exclude>

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<ix:exclude><p id="xdx_235_zcp9t8s85uOf" style="font: 10pt Times New Roman, Times, Serif; margin: 0"><b>Anavex Life Sciences Corp.</b></p></ix:exclude>

<ix:exclude><p id="xdx_23B_zJKLWeLC3uE9" style="font: 10pt Times New Roman, Times, Serif; margin: 0">Notes to the Condensed Consolidated Interim Financial Statements</p></ix:exclude>

<ix:exclude><p id="xdx_235_zzzWOe9HvLrg" style="font: 10pt Times New Roman, Times, Serif; margin: 0">December 31, 2021</p></ix:exclude>

<ix:exclude><p id="xdx_23E_z4KZoWLkfTkc" style="font: 10pt Times New Roman, Times, Serif; margin: 0">(Unaudited)</p></ix:exclude>


<ix:exclude><p id="xdx_234_zSBKuDfgft0h" style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 42.55pt; text-align: justify">&#160;</p></ix:exclude>

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

<ix:nonNumeric contextRef="From2021-10-01to2021-12-31" escape="true" name="us-gaap:NewAccountingPronouncementsPolicyPolicyTextBlock"><p id="xdx_846_eus-gaap--NewAccountingPronouncementsPolicyPolicyTextBlock_zUO8BYw2NYma" style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 42.55pt; text-align: justify; background-color: white"><span id="xdx_863_zD5cBxvCJu8h">Recently Adopted
Accounting Pronouncements</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 42.55pt; text-align: justify; background-color: white">&#160;</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 42.55pt; text-align: justify; background-color: white">Effective October
1, 2021, the Company adopted ASU 2019-12, &#8220;Simplifying the Accounting for Income Taxes (ASC 740)&#8221;, which is intended to simplify
various aspects related to accounting for income taxes by removing certain exceptions to the general principles in Topic 740 and clarifying
and amending existing guidance to improve consistent application. There was no material impact on the Company&#8217;s operations, financial
condition, or cash flows.</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 42.55pt; text-align: justify; background-color: white">&#160;</p>

</ix:nonNumeric></ix:nonNumeric><ix:nonNumeric contextRef="From2021-10-01to2021-12-31" escape="true" name="avxl:OtherIncomeDisclosureTextBlock"><p id="xdx_804_ecustom--OtherIncomeDisclosureTextBlock_zluVmor3G4sk" style="font: 10pt Times New Roman, Times, Serif; margin: 0">Note 3&#9;&#160;&#160;&#160;&#160;&#160;&#160;&#160;<span style="text-decoration: underline"><span id="xdx_828_zaV3cL0MM5V5">Other Income</span> </span></p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 45pt; text-align: justify; background-color: white">Grant Income</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 45pt; text-align: justify; background-color: white">&#160;</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 45pt; text-align: justify; background-color: white">During the year
ended September 30, 2021, the Company received $<span id="xdx_901_eus-gaap--ResearchAndDevelopmentArrangementContractToPerformForOthersCompensationEarned_pp0p0_c20211001__20211231__us-gaap--RelatedPartyTransactionsByRelatedPartyAxis__custom--ParkinsonMember_z1AsLRT9ojul" title="Research and development incentive income"><ix:nonFraction name="us-gaap:ResearchAndDevelopmentArrangementContractToPerformForOthersCompensationEarned" contextRef="From2021-10-012021-12-31_custom_ParkinsonMember" format="ixt:numdotdecimal" decimals="0" scale="0" unitRef="USD">497,931</ix:nonFraction></span> of a $995,862 research grant awarded by the Michael J. Fox Foundation for Parkinson&#8217;s
Research. The grant will be used to fund a clinical trial of the Company&#8217;s lead compound, ANAVEX<sup>&#174;</sup>2-73 related to
Parkinson&#8217;s disease.</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 45pt; text-align: justify; background-color: white">&#160;</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 45pt; text-align: justify; background-color: white">The grant income
is being deferred when received and amortized to other income as the related research and development expenditures are incurred. During
the three months ended December 31, 2021 and 2020, the Company did not recognize any of this grant on its statements of operations. At
December 31, 2021, an amount of $<span id="xdx_904_ecustom--NonOperatingIncomeFromGrant_pp0p0_c20211001__20211231_ztn8klf9Fue2" title="Grant income"><ix:nonFraction name="avxl:NonOperatingIncomeFromGrant" contextRef="From2021-10-01to2021-12-31" format="ixt:numdotdecimal" decimals="0" scale="0" unitRef="USD">443,831</ix:nonFraction></span> (September 30, 2021: $<span id="xdx_909_ecustom--NonOperatingIncomeFromGrant_pp0p0_c20201001__20210930_zM2aXTHpLf33" title="Grant income"><ix:nonFraction name="avxl:NonOperatingIncomeFromGrant" contextRef="From2020-10-012021-09-30" format="ixt:numdotdecimal" decimals="0" scale="0" unitRef="USD">443,831</ix:nonFraction></span>) of this grant is recorded as deferred grant income, representing
the amount of this grant which has not yet been amortized to other income. The Company will recognize this income on its statement of
operations as the relating expenditures are incurred to offset the income.</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 45pt; text-align: justify; background-color: white">&#160;</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 45pt; text-align: justify; background-color: white">Research and development
incentive income</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 45pt; text-align: justify; background-color: white">&#160;</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 45pt; text-align: justify; background-color: white">Research and development
incentive income represents the receipt by Anavex Australia, of the Australian research and development incentive credit, (the &#8220;R&amp;D
Incentive Credit&#8221;).</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 45pt; text-align: justify; background-color: white">&#160;</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 45pt; text-align: justify; background-color: white">During the three
months ended December 31, 2021, the Company recorded research and development incentive income of $<span id="xdx_90C_eus-gaap--ResearchAndDevelopmentArrangementContractToPerformForOthersCompensationEarned_pp0p0_c20211001__20211231_zxIM8dcfeFPh" title="Research and development incentive income"><ix:nonFraction name="us-gaap:ResearchAndDevelopmentArrangementContractToPerformForOthersCompensationEarned" contextRef="From2021-10-01to2021-12-31" format="ixt:numdotdecimal" decimals="0" scale="0" unitRef="USD">810,730</ix:nonFraction></span> (AUD <span id="xdx_905_eus-gaap--ResearchAndDevelopmentArrangementContractToPerformForOthersCompensationEarned_c20211001__20211231__srt--CurrencyAxis__currency--AUD_pp0p0" title="Research and development incentive income"><ix:nonFraction name="us-gaap:ResearchAndDevelopmentArrangementContractToPerformForOthersCompensationEarned" contextRef="From2021-10-012021-12-31_currency_AUD" format="ixt:numdotdecimal" decimals="0" scale="0" unitRef="USD">1,116,362</ix:nonFraction></span>) (2020: $<span id="xdx_90B_eus-gaap--ResearchAndDevelopmentArrangementContractToPerformForOthersCompensationEarned_pp0p0_c20201001__20201231_zetSwaPz1gl6" title="Research and development incentive income"><ix:nonFraction name="us-gaap:ResearchAndDevelopmentArrangementContractToPerformForOthersCompensationEarned" contextRef="From2020-10-012020-12-31" format="ixt:numdotdecimal" decimals="0" scale="0" unitRef="USD">1,269,316</ix:nonFraction></span>
(AUD <span id="xdx_90D_eus-gaap--ResearchAndDevelopmentArrangementContractToPerformForOthersCompensationEarned_pp0p0_c20201001__20201231__srt--CurrencyAxis__currency--AUD_zFB0I0xBKZJ5" title="Research and development incentive income"><ix:nonFraction name="us-gaap:ResearchAndDevelopmentArrangementContractToPerformForOthersCompensationEarned" contextRef="From2020-10-012020-12-31_currency_AUD" format="ixt:numdotdecimal" decimals="0" scale="0" unitRef="USD">1,735,962</ix:nonFraction></span>)) in respect of the R&amp;D Incentive Credit for eligible research and development expenses incurred during the period.</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 45pt; text-align: justify; background-color: white">&#160;</p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0">The principal components of accrued liabilities consists of:</p>

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

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    <td style="text-align: left">&#160;</td><td id="xdx_490_20211231_zompnbTVj6ec" style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td id="xdx_49B_20210930_z9MpFvF0PSd9" style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td></tr>
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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0">&#160;</p>

<ix:exclude><p id="xdx_239_znPZP8eQ4Gei" style="font: 10pt Times New Roman, Times, Serif; margin: 0"></p></ix:exclude>

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<ix:exclude><p id="xdx_236_zhPeagdm9xh8" style="font: 10pt Times New Roman, Times, Serif; margin: 0">&#160;</p></ix:exclude>

<ix:exclude><p id="xdx_231_zprFd91Nic5c" style="font: 10pt Times New Roman, Times, Serif; margin: 0"><b>Anavex Life Sciences Corp.</b></p></ix:exclude>

<ix:exclude><p id="xdx_231_zVNCCbdIngd6" style="font: 10pt Times New Roman, Times, Serif; margin: 0">Notes to the Condensed Consolidated Interim Financial Statements</p></ix:exclude>

<ix:exclude><p id="xdx_23E_zgdO15KkLGtl" style="font: 10pt Times New Roman, Times, Serif; margin: 0">December 31, 2021</p></ix:exclude>

<ix:exclude><p id="xdx_23B_zboIPD1qSQNl" style="font: 10pt Times New Roman, Times, Serif; margin: 0">(Unaudited)</p></ix:exclude>


<ix:exclude><p id="xdx_23D_zjltKH5g2V9a" style="font: 10pt Times New Roman, Times, Serif; margin: 0"><span style="font-size: 10pt; background-color: silver"><br /></span></p></ix:exclude>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 1cm; text-align: center">&#160;</p>

</ix:nonNumeric><ix:nonNumeric contextRef="From2021-10-01to2021-12-31" escape="true" name="avxl:EquityOfferingTextBlock"><p id="xdx_800_ecustom--EquityOfferingTextBlock_zl0TxZ1GVku8" style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify">Note 5&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#9;<span style="text-decoration: underline"><span id="xdx_82F_zl20FE9SSJ0j">Equity Offerings</span></span></p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 42.55pt; text-align: justify">Common Stock</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 42.55pt; text-align: justify">&#160;</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 42.55pt; text-align: justify">Common shares are voting and are entitled
to dividends as declared at the discretion of the Board of Directors.</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 42.55pt; text-align: justify">&#160;</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 42.55pt; text-align: justify">Preferred Stock</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 42.55pt; text-align: justify">&#160;</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 42.55pt; text-align: justify">The Company&#8217;s Board of Directors
(the &#8220;Board&#8221;) has the authority to issue preferred stock in one or more series and to fix the rights, preferences, privileges,
restrictions and the number of shares constituting any series of the designation of the series.</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 42.55pt; text-align: justify">&#160;</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 42.55pt; text-align: justify">Sales Agreement</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 42.55pt; text-align: justify">&#160;</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 42.55pt; text-align: justify">The Company entered into a Controlled
Equity Offering Sales Agreement on July 6, 2018, which was amended and restated on May 1, 2020 (the &#8220;Sales Agreement&#8221;) with
Cantor Fitzgerald&#160;&amp; Co. and SVB Leerink LLC (together the &#8220;Sales Agents&#8221;), pursuant to which the Company may offer
and sell shares of common stock registered under an effective registration statement from time to time through the Sales Agents (the &#8220;Offering&#8221;).</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 42.55pt; text-align: justify">&#160;</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 42.55pt; text-align: justify">Upon delivery of a placement notice based
on the Company&#8217;s instructions and subject to the terms and conditions of the Sales Agreement, the Sales Agents may sell the Shares
by methods deemed to be an &#8220;at the market offering&#8221; offering, in negotiated transactions at market prices prevailing at the
time of sale or at prices related to such prevailing market prices, or by any other method permitted by law, including negotiated transactions,
subject to the prior written consent of the Company. The Company is not obligated to make any sales of Shares under the Sales Agreement.
The Company or Sales Agents may suspend or terminate the offering of Shares upon notice to the other party, subject to certain conditions.
The Sales Agents will act as agent on a commercially reasonable efforts basis consistent with their normal trading and sales practices
and applicable state and federal law, rules&#160;and regulations and the rules&#160;of Nasdaq.</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 42.55pt; text-align: justify">&#160;</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 42.55pt; text-align: justify">The Company has agreed to pay the Sales
Agents commissions for their services of up to 3.0% of the gross proceeds from the sale of the Shares pursuant to the Sales Agreement.
The Company also agreed to provide the Sales Agents with customary indemnification and contribution rights. During the three months ended
December 31, 2021, <span id="xdx_907_eus-gaap--StockIssuedDuringPeriodSharesNewIssues_c20211001__20211231__us-gaap--TypeOfArrangementAxis__custom--EquityOfferingSalesAgreementMember__dei--LegalEntityAxis__custom--CantorFitzgeraldAndCoMember_zk8q2lcWl834" title="Share issued for offering, shares"><ix:nonFraction name="us-gaap:StockIssuedDuringPeriodSharesNewIssues" contextRef="From2021-10-012021-12-31_custom_EquityOfferingSalesAgreementMember_custom_CantorFitzgeraldAndCoMember" format="ixt:numdotdecimal" decimals="INF" unitRef="Shares">99,588</ix:nonFraction></span> shares were sold pursuant to the Offering for gross proceeds of $<span id="xdx_907_ecustom--GrossProceedsFromSaleOfCommonStock_pp0p0_c20211001__20211231__us-gaap--TypeOfArrangementAxis__custom--EquityOfferingSalesAgreementMember__dei--LegalEntityAxis__custom--CantorFitzgeraldAndCoMember_zFaMQJiBgp7d" title="Gross proceeds from sale of common stock"><ix:nonFraction name="avxl:GrossProceedsFromSaleOfCommonStock" contextRef="From2021-10-012021-12-31_custom_EquityOfferingSalesAgreementMember_custom_CantorFitzgeraldAndCoMember" format="ixt:numdotdecimal" decimals="0" scale="0" unitRef="USD">2,312,785</ix:nonFraction></span> (net proceeds of $<span id="xdx_90A_eus-gaap--ProceedsFromIssuanceInitialPublicOffering_c20211001__20211231__us-gaap--TypeOfArrangementAxis__custom--EquityOfferingSalesAgreementMember__dei--LegalEntityAxis__custom--CantorFitzgeraldAndCoMember_pp0p0" title="Proceed from offering"><ix:nonFraction name="us-gaap:ProceedsFromIssuanceInitialPublicOffering" contextRef="From2021-10-012021-12-31_custom_EquityOfferingSalesAgreementMember_custom_CantorFitzgeraldAndCoMember" format="ixt:numdotdecimal" decimals="0" scale="0" unitRef="USD">2,149,701</ix:nonFraction></span> after
deducting offering expenses) (December 31, 2020: <span id="xdx_90A_eus-gaap--StockIssuedDuringPeriodSharesNewIssues_c20201001__20201231__us-gaap--TypeOfArrangementAxis__custom--EquityOfferingSalesAgreementMember__dei--LegalEntityAxis__custom--CantorFitzgeraldAndCoMember_pdd" title="Share issued for offering, shares"><ix:nonFraction name="us-gaap:StockIssuedDuringPeriodSharesNewIssues" contextRef="From2020-10-012020-12-31_custom_EquityOfferingSalesAgreementMember_custom_CantorFitzgeraldAndCoMember" format="ixt:numdotdecimal" decimals="INF" unitRef="Shares">1,514,829</ix:nonFraction></span> shares were sold for gross proceeds of $<span id="xdx_90B_ecustom--GrossProceedsFromSaleOfCommonStock_c20201001__20201231__us-gaap--TypeOfArrangementAxis__custom--EquityOfferingSalesAgreementMember__dei--LegalEntityAxis__custom--CantorFitzgeraldAndCoMember_pp0p0" title="Gross proceeds from sale of common stock"><ix:nonFraction name="avxl:GrossProceedsFromSaleOfCommonStock" contextRef="From2020-10-012020-12-31_custom_EquityOfferingSalesAgreementMember_custom_CantorFitzgeraldAndCoMember" format="ixt:numdotdecimal" decimals="0" scale="0" unitRef="USD">8,782,017</ix:nonFraction></span> (net proceeds of $<span id="xdx_908_eus-gaap--ProceedsFromIssuanceInitialPublicOffering_c20201001__20201231__us-gaap--TypeOfArrangementAxis__custom--EquityOfferingSalesAgreementMember__dei--LegalEntityAxis__custom--CantorFitzgeraldAndCoMember_pp0p0" title="Proceed from offering"><ix:nonFraction name="us-gaap:ProceedsFromIssuanceInitialPublicOffering" contextRef="From2020-10-012020-12-31_custom_EquityOfferingSalesAgreementMember_custom_CantorFitzgeraldAndCoMember" format="ixt:numdotdecimal" decimals="0" scale="0" unitRef="USD">8,518,557</ix:nonFraction></span>)).
At December 31, 2021, an amount of $<span id="xdx_90D_ecustom--SalesOfAgreementAmount_iI_pp0p0_c20211231_zUptSGynmtw7" title="Sales of agreement amount"><ix:nonFraction name="avxl:SalesOfAgreementAmount" contextRef="AsOf2021-12-31" format="ixt:numdotdecimal" decimals="0" scale="0" unitRef="USD">161,079,765</ix:nonFraction></span> (September 30, 2021: $<span id="xdx_903_ecustom--SalesOfAgreementAmount_iI_pp0p0_c20210930_zFdVdAaChNf8" title="Sales of agreement amount"><ix:nonFraction name="avxl:SalesOfAgreementAmount" contextRef="AsOf2021-09-30" format="ixt:numdotdecimal" decimals="0" scale="0" unitRef="USD">163,392,550</ix:nonFraction></span>) was registered pursuant to an effective registration
statement and remained available to be sold under the Sales Agreement.</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 42.55pt; text-align: justify">&#160;</p>

<ix:exclude><p id="xdx_239_zPY9cYCNAPg" style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 42.55pt; text-align: justify"></p></ix:exclude>

<ix:exclude><!-- Field: Page; Sequence: 13; Value: 4 -->
    <div id="xdx_237_zqz22WWCR8p3" style="border-bottom: Black 2pt solid; margin-top: 6pt; margin-bottom: 6pt"><p id="xdx_23C_zzaxQ4M45YTa" style="font-size: 10pt; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><!-- Field: Sequence; Type: Arabic; Name: PageNo -->13<!-- Field: /Sequence --></p></div>
    <div id="xdx_231_zyRgrtbbX6T3" style="break-before: page; margin-top: 6pt; margin-bottom: 6pt"><p style="margin: 0pt">&#160;</p></div>
    <!-- Field: /Page --></ix:exclude>

<ix:exclude><p id="xdx_230_zzp8VAzvxaEh" style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 42.55pt; text-align: justify">&#160;</p></ix:exclude>

<ix:exclude><p id="xdx_233_zFR2UcZZymV4" style="font: 10pt Times New Roman, Times, Serif; margin: 0"><b>Anavex Life Sciences Corp.</b></p></ix:exclude>

<ix:exclude><p id="xdx_238_z79dp2h9JEja" style="font: 10pt Times New Roman, Times, Serif; margin: 0">Notes to the Condensed Consolidated Interim Financial Statements</p></ix:exclude>

<ix:exclude><p id="xdx_23A_zG4cb9TYyAYe" style="font: 10pt Times New Roman, Times, Serif; margin: 0">December 31, 2021</p></ix:exclude>

<ix:exclude><p id="xdx_236_z2TeUG44MeG1" style="font: 10pt Times New Roman, Times, Serif; margin: 0">(Unaudited)</p></ix:exclude>


<ix:exclude><p id="xdx_230_zPUCclQ496Hh" style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 42.55pt; text-align: justify">&#160;</p></ix:exclude>

<ix:exclude><p id="xdx_233_z5BuN0L6FBr8" style="font: 10pt Times New Roman, Times, Serif; margin: 0">Note 5&#160;&#160;&#160;&#160;&#160;&#160;&#9;<span style="text-decoration: underline">Equity Offerings</span> &#8211; (continued)</p></ix:exclude>

<ix:exclude><p id="xdx_230_zK3EdrlpMDie" style="font: 10pt Times New Roman, Times, Serif; margin: 0">&#160;</p></ix:exclude>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 42.55pt; text-align: justify">2019 Purchase Agreement</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 42.55pt; text-align: justify">&#160;</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 42.55pt; text-align: justify">On June 7, 2019, the Company entered into
a $<span id="xdx_90C_ecustom--ValueOfSharesObligatedToPurchase_pp0p0_c20190606__20190607__us-gaap--TypeOfArrangementAxis__custom--PurchaseAgreement1Member__dei--LegalEntityAxis__custom--LincolnParkCapitalFundLLCMember_zdbSU8YLjkL7" title="Total number of shares obligated to purchase"><ix:nonFraction name="avxl:ValueOfSharesObligatedToPurchase" contextRef="From2019-06-062019-06-07_custom_PurchaseAgreement1Member_custom_LincolnParkCapitalFundLLCMember" format="ixt:numdotdecimal" decimals="0" scale="0" unitRef="USD">50,000,000</ix:nonFraction></span> purchase agreement (the &#8220;2019 Purchase Agreement&#8221;) with Lincoln Park, as amended on July 1, 2020, pursuant to
which the Company had the right to sell and issue to Lincoln Park, and Lincoln Park was obligated to purchase, up to $<span id="xdx_908_eus-gaap--ProceedsFromIssuanceOrSaleOfEquity_pp0p0_c20190606__20190607__us-gaap--TypeOfArrangementAxis__custom--PurchaseAgreement1Member__dei--LegalEntityAxis__custom--LincolnParkCapitalFundLLCMember_zXVcp3FcTGi8" title="Proceeds from Issuance or Sale of Equity"><ix:nonFraction name="us-gaap:ProceedsFromIssuanceOrSaleOfEquity" contextRef="From2019-06-062019-06-07_custom_PurchaseAgreement1Member_custom_LincolnParkCapitalFundLLCMember" format="ixt:numdotdecimal" decimals="0" scale="0" unitRef="USD">50,000,000</ix:nonFraction></span> in value
of its shares of common stock from time to time over a three-year period until July 1, 2022.</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 42.55pt; text-align: justify">&#160;</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 42.55pt; text-align: justify">In consideration for entering into the
2019 Purchase Agreement, the Company issued to Lincoln Park 324,383 shares of common stock as a commitment fee during the year ended September
30, 2019 and agreed to issue up to <span id="xdx_90A_ecustom--NumberOfSharesObligatedToPurchaseProrataBasic_c20190606__20190607__us-gaap--TypeOfArrangementAxis__custom--PurchaseAgreement1Member__dei--LegalEntityAxis__custom--LincolnParkCapitalFundLLCMember_zTkAiWogLmT9" title="Pro rata basic number of shares obligated to purchase"><ix:nonFraction name="avxl:NumberOfSharesObligatedToPurchaseProrataBasic" contextRef="From2019-06-062019-06-07_custom_PurchaseAgreement1Member_custom_LincolnParkCapitalFundLLCMember" format="ixt:numdotdecimal" decimals="INF" unitRef="Shares">162,191</ix:nonFraction></span> shares pro rata, when and if, Lincoln Park purchased, at the Company&#8217;s discretion, the
$50,000,000 aggregate commitment.</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 42.55pt; text-align: justify">&#160;</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 42.55pt; text-align: justify">At December 31, 2021 and September 30,
2021, no shares remained available for issuance under the 2019 Purchase Agreement. During the three months ended December 31, 2020, the
Company issued to Lincoln Park an aggregate of <span id="xdx_902_eus-gaap--StockIssuedDuringPeriodSharesNewIssues_c20201001__20201231__us-gaap--TypeOfArrangementAxis__custom--PurchaseAgreement1Member__dei--LegalEntityAxis__custom--LincolnParkCapitalFundLLCMember_zhtwFvurfetj" title="Share issued for aggregate, shares"><ix:nonFraction name="us-gaap:StockIssuedDuringPeriodSharesNewIssues" contextRef="From2020-10-012020-12-31_custom_PurchaseAgreement1Member_custom_LincolnParkCapitalFundLLCMember" format="ixt:numdotdecimal" decimals="INF" unitRef="Shares">3,402,930</ix:nonFraction></span> shares of common stock including <span id="xdx_90D_eus-gaap--StockIssuedDuringPeriodSharesOther_c20201001__20201231__us-gaap--TypeOfArrangementAxis__custom--PurchaseAgreement1Member__dei--LegalEntityAxis__custom--LincolnParkCapitalFundLLCMember_zgRJbbanxDAd" title="Additional common shares"><ix:nonFraction name="us-gaap:StockIssuedDuringPeriodSharesOther" contextRef="From2020-10-012020-12-31_custom_PurchaseAgreement1Member_custom_LincolnParkCapitalFundLLCMember" format="ixt:numdotdecimal" decimals="INF" unitRef="Shares">3,346,288</ix:nonFraction></span> shares of common stock for an aggregate
purchase price of $<span id="xdx_90D_ecustom--StockIssuedDuringPeriodValueNewIssues1_pp0p0_c20201001__20201231__us-gaap--TypeOfArrangementAxis__custom--PurchaseAgreement1Member__dei--LegalEntityAxis__custom--LincolnParkCapitalFundLLCMember_zXzMRXpmVMs7" title="Number of shares issued for aggregate purchase price, value"><ix:nonFraction name="avxl:StockIssuedDuringPeriodValueNewIssues1" contextRef="From2020-10-012020-12-31_custom_PurchaseAgreement1Member_custom_LincolnParkCapitalFundLLCMember" format="ixt:numdotdecimal" decimals="0" scale="0" unitRef="USD">17,461,402</ix:nonFraction></span> and <span id="xdx_909_ecustom--StockIssuedDuringPeriodSharesNewIssues1_c20201001__20201231__us-gaap--TypeOfArrangementAxis__custom--PurchaseAgreement1Member__dei--LegalEntityAxis__custom--LincolnParkCapitalFundLLCMember_zWVTLdRcoidk" title="Number of shares issued for commitment"><ix:nonFraction name="avxl:StockIssuedDuringPeriodSharesNewIssues1" contextRef="From2020-10-012020-12-31_custom_PurchaseAgreement1Member_custom_LincolnParkCapitalFundLLCMember" format="ixt:numdotdecimal" decimals="INF" unitRef="Shares">56,642</ix:nonFraction></span> commitment shares.</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 42.55pt; text-align: justify">&#160;</p>

</ix:nonNumeric><ix:nonNumeric contextRef="From2021-10-01to2021-12-31" escape="true" name="us-gaap:CommitmentsDisclosureTextBlock"><p id="xdx_80E_eus-gaap--CommitmentsDisclosureTextBlock_zYuJPyeLiJ4i" style="font: 10pt Times New Roman, Times, Serif; margin: 0">Note 6 &#160;&#160;&#160;&#160;&#160;&#160;&#9;<span style="text-decoration: underline"><span id="xdx_82D_z4z315gt58wk">Commitments and Contingencies</span> </span></p>

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

<table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; margin-top: 0; margin-bottom: 0; color: black"><tr style="vertical-align: top">
<td style="width: 42.75pt"></td><td style="width: 18pt"><span style="font-size: 11pt; font-style: normal">a)</span></td><td><span style="font-size: 10pt; font-style: normal">Leases </span></td></tr></table>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 60.75pt; text-indent: -18pt; color: black"><span style="font-style: normal">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 2cm; text-align: justify"><span style="font-weight: normal">During the
three months ended December 31, 2021, the Company incurred office lease expense of $<span id="xdx_903_eus-gaap--LeaseAndRentalExpense_c20211001__20211231_pp0p0" title="Operating Leases, Rent Expense"><ix:nonFraction name="us-gaap:LeaseAndRentalExpense" contextRef="From2021-10-01to2021-12-31" format="ixt:numdotdecimal" decimals="0" scale="0" unitRef="USD">4,845</ix:nonFraction></span> (2020: $<span id="xdx_901_eus-gaap--LeaseAndRentalExpense_c20201001__20201231_pp0p0" title="Operating Leases, Rent Expense"><ix:nonFraction name="us-gaap:LeaseAndRentalExpense" contextRef="From2020-10-012020-12-31" format="ixt:numdotdecimal" decimals="0" scale="0" unitRef="USD">68,387</ix:nonFraction></span>).</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 2cm; text-align: justify"><span style="font-weight: normal">&#160;</span></p>

<table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; margin-top: 0; margin-bottom: 0"><tr style="vertical-align: top">
<td style="width: 42.75pt"></td><td style="width: 18pt"><span style="font-size: 11pt">b)</span></td><td><span style="font-size: 10pt">Employee 401(k) Benefit Plan</span></td></tr></table>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 60.75pt; text-indent: -18pt">&#160;</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 2cm; text-align: justify"><span style="font-weight: normal">The Company
has a defined-contribution savings plan under Section 401(k) of the Internal Revenue Code. The plan covers all United States based employees.
United States based employees eligible to participate in the plan may contribute up to the current statutory limits under the Internal
Revenue Service regulations. The 401(k) plan permits the Company to make additional matching contributions on behalf of contributing employees.
During the three months ended December 31, 2021, the Company made $<span id="xdx_906_eus-gaap--PensionContributions_c20211001__20211231_pp0p0" title="Contribution amount"><ix:nonFraction name="us-gaap:PensionContributions" contextRef="From2021-10-01to2021-12-31" format="ixt:numdotdecimal" decimals="0" scale="0" unitRef="USD">22,682</ix:nonFraction></span> (2020: $<span id="xdx_904_eus-gaap--PensionContributions_c20201001__20201231_pp0p0" title="Contribution amount"><ix:nonFraction name="us-gaap:PensionContributions" contextRef="From2020-10-012020-12-31" format="ixt:numdotdecimal" decimals="0" scale="0" unitRef="USD">16,556</ix:nonFraction></span>) in matching contributions under the 401(k) plan.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 2cm; text-align: justify"><span style="font-weight: normal">&#160;</span></p>

<table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; margin-top: 0; margin-bottom: 0; color: black"><tr style="vertical-align: top">
<td style="width: 42.75pt"></td><td style="width: 18pt"><span style="font-size: 11pt; font-style: normal">c)</span></td><td><span style="font-size: 10pt; font-style: normal">Litigation</span></td></tr></table>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 60.75pt; text-indent: -18pt; color: black"><span style="font-style: normal">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 2cm; text-align: justify"><span style="font-weight: normal">The Company
is subject to claims and legal proceedings that arise in the ordinary course of business. Such matters are inherently uncertain, and
there can be no guarantee that the outcome of any such matter will be decided favorably to the Company or that the resolution of any
such matter will not have a material adverse effect upon the Company&#8217;s consolidated financial statements. The Company does not
believe that any of such pending claims and legal proceedings will have a material adverse effect on its consolidated financial statements.</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 2cm; text-align: justify"><span style="font-weight: normal">&#160;</span></p>

<ix:exclude><p id="xdx_238_zjDbhk7TVxpl" style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 2cm; text-align: justify"><span style="font-weight: normal"></span></p></ix:exclude>

<ix:exclude><!-- Field: Page; Sequence: 14; Value: 4 -->
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    <div id="xdx_235_zs5escza1NT1" style="break-before: page; margin-top: 6pt; margin-bottom: 6pt"><p style="margin: 0pt">&#160;</p></div>
    <!-- Field: /Page --></ix:exclude>

<ix:exclude><p id="xdx_23C_zysxtaoI2b19" style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 2cm; text-align: justify"><span style="font-weight: normal">&#160;</span></p></ix:exclude>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 2cm; text-align: justify"></p><ix:exclude><p id="xdx_23C_zNuqdhDFMTIl" style="font: 10pt Times New Roman, Times, Serif; margin: 0"><b>Anavex Life Sciences Corp.</b></p></ix:exclude>

<ix:exclude><p id="xdx_231_zqiQzuwur0s3" style="font: 10pt Times New Roman, Times, Serif; margin: 0">Notes to the Condensed Consolidated Interim Financial Statements</p></ix:exclude>

<ix:exclude><p id="xdx_23F_zK330P2z1WEh" style="font: 10pt Times New Roman, Times, Serif; margin: 0">December 31, 2021</p></ix:exclude>

<ix:exclude><p id="xdx_231_zBbNIc7Vh4nb" style="font: 10pt Times New Roman, Times, Serif; margin: 0">(Unaudited)</p></ix:exclude>

<ix:exclude><p id="xdx_234_zXQYs1io4Fe1" style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 2cm; text-align: justify"><span style="font-weight: normal">&#160;</span></p></ix:exclude>

<ix:exclude><p id="xdx_239_zDJMuP5XQ1D4" style="font: 10pt Times New Roman, Times, Serif; margin: 0">Note 6&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#9;<span style="text-decoration: underline">Commitments and Contingencies</span> &#8211; (Continued)</p></ix:exclude>

<ix:exclude><p id="xdx_233_z3MFOQUaZv12" style="font: 10pt Times New Roman, Times, Serif; margin: 0">&#160;</p></ix:exclude>

<table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; margin-top: 0; margin-bottom: 0; color: black"><tr style="vertical-align: top">
<td style="width: 42.75pt"></td><td style="width: 18pt"><span style="font-size: 11pt; font-style: normal">d)</span></td><td><span style="font-size: 10pt; font-style: normal">Share Purchase Warrants</span></td></tr></table>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 60.75pt; text-indent: -18pt; color: black"><span style="font-style: normal">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 58.5pt; text-align: justify">A summary of the status of the Company&#8217;s
outstanding share purchase warrants is presented below:</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 58.5pt; text-align: justify">&#160;</p>

<ix:nonNumeric contextRef="From2021-10-01to2021-12-31" escape="true" name="us-gaap:ScheduleOfOtherShareBasedCompensationActivityTableTextBlock"><table cellpadding="0" cellspacing="0" id="xdx_897_eus-gaap--ScheduleOfOtherShareBasedCompensationActivityTableTextBlock_zR8tbH2IjLJ2" summary="xdx: Disclosure - Commitments and Contingencies (Details)" style="font: 10pt Times New Roman, Times, Serif; margin-left: auto; border-collapse: collapse; width: 80%; margin-right: auto">
  <tr style="vertical-align: bottom; background-color: White">
    <td style="text-align: left"><span id="xdx_8BF_zptmiuf4vbz6" style="display: none">Schedule of exercisable share purchase warrants outstanding</span></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">&#160;</td>
    <td>&#160;</td>
    <td colspan="3" style="text-align: center">&#160;</td><td>&#160;</td>
    <td colspan="3" style="text-align: center">Weighted</td></tr>
  <tr style="vertical-align: bottom">
    <td style="text-align: left">&#160;</td>
    <td>&#160;</td>
    <td colspan="3" style="text-align: center">Number of</td><td>&#160;</td>
    <td colspan="3" style="text-align: center">Average Exercise</td></tr>
  <tr style="vertical-align: bottom">
    <td style="padding-bottom: 1pt; text-align: left">&#160;</td>
    <td style="padding-bottom: 1pt">&#160;</td>
    <td colspan="3" style="border-bottom: Black 1pt solid; text-align: center">Shares</td><td style="padding-bottom: 1pt">&#160;</td>
    <td colspan="3" style="border-bottom: Black 1pt solid; text-align: center">Price ($)</td></tr>
  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="padding-bottom: 1pt; width: 40%; text-align: left"><span style="font-size: 10pt">Balance, September 30, 2020</span></td><td style="padding-bottom: 1pt; width: 8%">&#160;</td>
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  <tr style="vertical-align: bottom; background-color: White">
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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: White">
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</ix:nonNumeric><p id="xdx_8A5_zz9Jlv3q2xpj" style="font: 10pt Times New Roman, Times, Serif; margin: 0">&#160;</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 58.5pt; text-align: justify; text-indent: -0.8pt">At December 31, 2021,
the Company had share purchase warrants outstanding as follows:</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 58.5pt; text-align: justify; text-indent: -0.8pt">&#160;</p>

<ix:nonNumeric contextRef="From2021-10-01to2021-12-31" escape="true" name="avxl:ScheduleOfSharePurchaseWarrantsOutstandingTableTextBlock"><table cellpadding="0" cellspacing="0" id="xdx_89D_ecustom--ScheduleOfSharePurchaseWarrantsOutstandingTableTextBlock_z9VRBT14uQY9" summary="xdx: Disclosure - Commitments and Contingencies (Details 1)" style="font: 10pt Times New Roman, Times, Serif; margin-left: auto; border-collapse: collapse; width: 80%; margin-right: auto">
  <tr style="vertical-align: bottom; background-color: White">
    <td style="text-align: left">&#160;</td><td style="text-align: left"><span id="xdx_8B3_zMK5DP9P8Oyj" style="display: none">Schedule of share purchase warrants outstanding</span></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: right">&#160;</td></tr>
<tr style="vertical-align: bottom">
    <td colspan="3" style="border-bottom: Black 1pt solid; text-align: center">Number</td><td style="padding-bottom: 1pt">&#160;</td>
    <td colspan="3" style="border-bottom: Black 1pt solid; text-align: center">Exercise Price</td><td style="padding-bottom: 1pt">&#160;</td>
    <td style="border-bottom: Black 1pt solid; text-align: center">Expiry Date</td></tr>
  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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  <tr style="vertical-align: bottom; background-color: White">
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    <td style="border-bottom: Black 1pt solid; text-align: left">$</td><td id="xdx_982_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsVestedAndExpectedToVestOutstandingWeightedAverageExercisePrice_c20211231__us-gaap--AwardTypeAxis__custom--PurchaseWarrants2Member_pdd" title="Exercise Price" style="border-bottom: Black 1pt solid; text-align: right"><ix:nonFraction name="us-gaap:ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsVestedAndExpectedToVestOutstandingWeightedAverageExercisePrice" contextRef="AsOf2021-12-31_custom_PurchaseWarrants2Member" format="ixt:numdotdecimal" decimals="INF" unitRef="USDPShares">12.00</ix:nonFraction></td><td style="padding-bottom: 1pt; text-align: left">&#160;</td><td style="padding-bottom: 1pt">&#160;</td>
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="padding-bottom: 1pt; text-align: left">&#160;</td><td id="xdx_980_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsVestedAndExpectedToVestOutstandingNumber_c20211231_pdd" title="Number" style="border-bottom: Black 1pt solid; text-align: right"><ix:nonFraction name="us-gaap:ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsVestedAndExpectedToVestOutstandingNumber" contextRef="AsOf2021-12-31" format="ixt:numdotdecimal" decimals="INF" unitRef="Shares">160,000</ix:nonFraction></td><td style="padding-bottom: 1pt; text-align: left">&#160;</td><td style="padding-bottom: 1pt">&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="padding-bottom: 1pt; text-align: left">&#160;</td><td style="padding-bottom: 1pt">&#160;</td>
    <td style="padding-bottom: 1pt; text-align: center">&#160;</td></tr>
  </table>

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

</ix:nonNumeric><p id="xdx_8A3_zlPXKFpFjCu7" style="font: 10pt Times New Roman, Times, Serif; margin: 0">&#160;</p>

<table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; margin-top: 0; margin-bottom: 0; color: black"><tr style="vertical-align: top">
<td style="width: 42.75pt"></td><td style="width: 14.05pt"><span style="font-size: 11pt; font-style: normal">e)</span></td><td style="text-align: justify"><span style="font-style: normal">Stock&#8211;based Compensation Plan</span></td></tr></table>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 60.75pt; text-align: justify; text-indent: -18pt; color: black"><span style="font-style: normal">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 2cm; text-align: justify">2015 Stock Option Plan</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 2cm; text-align: justify">&#160;</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 2cm; text-align: justify">On September 18, 2015, the Company&#8217;s
Board approved a 2015 Omnibus Incentive Plan (the &#8220;2015 Plan&#8221;), which provided for the grant of stock options and restricted
stock awards to directors, officers, employees and consultants of the Company.</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 2cm; text-align: justify">&#160;</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 2cm; text-align: justify">The maximum number of our common shares reserved
for issue under the plan was <span id="xdx_908_eus-gaap--CommonStockCapitalSharesReservedForFutureIssuance_c20211231__us-gaap--PlanNameAxis__custom--StockOptionPlan2015Member_pdd" title="Maximum number of common shares reserved for future issuance"><ix:nonFraction name="us-gaap:CommonStockCapitalSharesReservedForFutureIssuance" contextRef="AsOf2021-12-31_custom_StockOptionPlan2015Member" format="ixt:numdotdecimal" decimals="INF" unitRef="Shares">6,050,553</ix:nonFraction></span> shares, subject to adjustment in the event of a change of the Company&#8217;s capitalization. At
December 31, 2021, <span id="xdx_907_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardNumberOfSharesAvailableForGrant_c20211231__us-gaap--PlanNameAxis__custom--StockOptionPlan2015Member_pdd" title="Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Available for Grant"><ix:nonFraction name="us-gaap:ShareBasedCompensationArrangementByShareBasedPaymentAwardNumberOfSharesAvailableForGrant" contextRef="AsOf2021-12-31_custom_StockOptionPlan2015Member" format="ixt:numdotdecimal" decimals="INF" unitRef="Shares">146,371</ix:nonFraction></span> (September 30, 2021: <span id="xdx_906_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardNumberOfSharesAvailableForGrant_iI_c20210930__us-gaap--PlanNameAxis__custom--StockOptionPlan2015Member_zlDk8QefFfQ7" title="Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Available for Grant"><ix:nonFraction name="us-gaap:ShareBasedCompensationArrangementByShareBasedPaymentAwardNumberOfSharesAvailableForGrant" contextRef="AsOf2021-09-30_custom_StockOptionPlan2015Member" format="ixt:numdotdecimal" decimals="INF" unitRef="Shares">146,371</ix:nonFraction></span>) options remain available for issue under the 2015 Plan.</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 2cm; text-align: justify">&#160;</p>

<ix:exclude><p id="xdx_23D_z86r3BbKu5z2" style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 2cm; text-align: justify"></p></ix:exclude>

<ix:exclude><!-- Field: Page; Sequence: 15; Value: 4 -->
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    <div id="xdx_23F_zbv2PZal2An7" style="break-before: page; margin-top: 6pt; margin-bottom: 6pt"><p style="margin: 0pt">&#160;</p></div>
    <!-- Field: /Page --></ix:exclude>

<ix:exclude><p id="xdx_234_zpMxN1QEEch4" style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 2cm; text-align: justify">&#160;</p></ix:exclude>

<ix:exclude><p id="xdx_235_zijCtCcAI9dk" style="font: 10pt Times New Roman, Times, Serif; margin: 0"><b>Anavex Life Sciences Corp.</b></p></ix:exclude>

<ix:exclude><p id="xdx_23C_z76hi7N4dXI5" style="font: 10pt Times New Roman, Times, Serif; margin: 0">Notes to the Condensed Consolidated Interim Financial Statements</p></ix:exclude>

<ix:exclude><p id="xdx_238_z5E9fn2BNIr1" style="font: 10pt Times New Roman, Times, Serif; margin: 0">December 31, 2021</p></ix:exclude>

<ix:exclude><p id="xdx_23D_zu2QKMA0gJ02" style="font: 10pt Times New Roman, Times, Serif; margin: 0">(Unaudited)</p></ix:exclude>


<ix:exclude><p id="xdx_233_z4fDomnfu4h2" style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 2cm; text-align: justify">&#160;</p></ix:exclude>

<ix:exclude><p id="xdx_237_znnZeypGZP98" style="font: 10pt Times New Roman, Times, Serif; margin: 0">Note 6&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#9;<span style="text-decoration: underline">Commitments and Contingencies</span> &#8211; (Continued)</p></ix:exclude>

<ix:exclude><p id="xdx_230_zbNIT1aIYMrg" style="font: 10pt Times New Roman, Times, Serif; margin: 0">&#160;</p></ix:exclude>

<table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; margin-top: 0; margin-bottom: 0; color: black"><tr style="vertical-align: top">
<td style="width: 42.75pt"></td><td style="width: 14.05pt"><span style="font-style: normal">e)</span></td><td style="text-align: justify"><span style="font-style: normal">Stock-based Compensation Plan &#8211; (Continued)</span></td></tr></table>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 60.75pt; text-align: justify; text-indent: -18pt; color: black"><span style="font-style: normal">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 2cm; text-align: justify">2019 Stock Option Plan</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 2cm; text-align: justify">&#160;</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 2cm; text-align: justify">On January 15, 2019, the Board approved the
2019 Omnibus Incentive Plan (the &#8220;2019 Plan&#8221;), which provides for the grant of stock options and restricted stock awards to
directors, officers, employees, consultants and advisors of the Company. Under the terms of the 2019 Plan, <span id="xdx_90A_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardNumberOfAdditionalSharesAuthorized_c20211001__20211231__us-gaap--PlanNameAxis__custom--StockOptionPlan2019Member_zytI0TLx1wEg" title="Additional shares of common stock available for issuance"><ix:nonFraction name="us-gaap:ShareBasedCompensationArrangementByShareBasedPaymentAwardNumberOfAdditionalSharesAuthorized" contextRef="From2021-10-012021-12-31_custom_StockOptionPlan2019Member" format="ixt:numdotdecimal" decimals="INF" unitRef="Shares">6,000,000</ix:nonFraction></span> additional shares
of Common Stock are available for issuance under the 2019 Plan, in addition to the shares available under the 2015 Plan. Any awards outstanding
under the 2015 Plan or the Company&#8217;s 2007 Stock Option Plan (the &#8220;2007 Plan&#8221;) will remain subject to and be paid under
the 2015 Plan or the 2007 Plan, respectively, and any shares subject to outstanding awards under the 2015 Plan or the 2007 Plan that subsequently
cease to be subject to such awards (other than by reason of settlement of the awards in shares) will automatically become available for
issuance under the 2019 Plan.</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 2cm; text-align: justify">&#160;</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 2cm; text-align: justify">The 2019 Plan provides that it may be administered
by the Board, or the Board may delegate such responsibility to a committee. The exercise price will be determined by the Board at the
time of grant shall be at least equal to the fair market value on such date. If the grantee is a 10% stockholder on the grant date, then
the exercise price shall not be less than 110% of fair market value of the Company&#8217;s shares of common stock on the grant date. Stock
options may be granted under the 2019 Plan for an exercise period of up to ten years from the date of grant of the option or such lesser
periods as may be determined by the board, subject to earlier termination in accordance with the terms of the 2019 Plan. At December 31,
2021, <span id="xdx_901_eus-gaap--StockIssuedDuringPeriodValueStockOptionsExercised_pp0p0_c20211001__20211231__us-gaap--PlanNameAxis__custom--StockOptionPlan2019Member_zJ9yDVMkuGZb" title="Remaining stock options"><ix:nonFraction name="us-gaap:StockIssuedDuringPeriodValueStockOptionsExercised" contextRef="From2021-10-012021-12-31_custom_StockOptionPlan2019Member" format="ixt:numdotdecimal" decimals="0" scale="0" unitRef="USD">406,332</ix:nonFraction></span> (September 30, 2021: <span id="xdx_901_eus-gaap--StockIssuedDuringPeriodValueStockOptionsExercised_pp0p0_c20201001__20210930__us-gaap--PlanNameAxis__custom--StockOptionPlan2019Member_zrTcr8iXNUif"><ix:nonFraction name="us-gaap:StockIssuedDuringPeriodValueStockOptionsExercised" contextRef="From2020-10-012021-09-30_custom_StockOptionPlan2019Member" format="ixt:numdotdecimal" decimals="0" scale="0" unitRef="USD">456,332</ix:nonFraction></span>) options remain available for issue under the 2019 Plan.</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 2cm; text-align: justify">&#160;</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 2cm; text-align: justify">A summary of the status of Company&#8217;s
outstanding stock options is presented below:</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 2cm; text-align: justify">&#160;</p>

<ix:nonNumeric contextRef="From2021-10-01to2021-12-31" escape="true" name="us-gaap:ScheduleOfStockOptionsRollForwardTableTextBlock"><table cellpadding="0" cellspacing="0" id="xdx_893_eus-gaap--ScheduleOfStockOptionsRollForwardTableTextBlock_zjNc9x8Nj2I3" summary="xdx: Disclosure - Commitments and Contingencies (Details 2)" style="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 100%">
  <tr style="vertical-align: bottom; background-color: White">
    <td style="text-align: left"><span id="xdx_8BE_zNxMyvqlO6Ve" style="display: none">Schedule of outstanding stock purchase options</span></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">
    <td style="text-align: left">&#160;</td>
    <td>&#160;</td>
    <td colspan="3" style="text-align: center">&#160;</td><td>&#160;</td>
    <td colspan="3" style="text-align: center">Weighted</td><td>&#160;</td>
    <td colspan="3" style="text-align: center">Weighted</td><td>&#160;</td>
    <td colspan="3" style="text-align: center">&#160;</td></tr>
  <tr style="vertical-align: bottom">
    <td style="text-align: left">&#160;</td>
    <td>&#160;</td>
    <td colspan="3" style="text-align: center">&#160;</td><td>&#160;</td>
    <td colspan="3" style="text-align: center">Average</td><td>&#160;</td>
    <td colspan="3" style="text-align: center">Average Grant</td><td>&#160;</td>
    <td colspan="3" style="text-align: center">Aggregate</td></tr>
  <tr style="vertical-align: bottom">
    <td style="text-align: left">&#160;</td>
    <td>&#160;</td>
    <td colspan="3" style="text-align: center">Number of</td><td>&#160;</td>
    <td colspan="3" style="text-align: center">Exercise Price</td><td>&#160;</td>
    <td colspan="3" style="text-align: center">Date Fair</td><td>&#160;</td>
    <td colspan="3" style="text-align: center">intrinsic value</td></tr>
  <tr style="vertical-align: bottom">
    <td style="padding-bottom: 1pt; text-align: left">&#160;</td>
    <td style="padding-bottom: 1pt">&#160;</td>
    <td colspan="3" style="border-bottom: Black 1pt solid; text-align: center">Shares</td><td style="padding-bottom: 1pt">&#160;</td>
    <td colspan="3" style="border-bottom: Black 1pt solid; padding-bottom: 1pt; text-align: center">($)</td><td style="padding-bottom: 1pt">&#160;</td>
    <td colspan="3" style="border-bottom: Black 1pt solid; text-align: center">Value ($)</td><td style="padding-bottom: 1pt">&#160;</td>
    <td colspan="3" style="border-bottom: Black 1pt solid; padding-bottom: 1pt; text-align: center">($)</td></tr>
  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="width: 32%; text-align: left"><span style="font-size: 10pt">Outstanding, September 30, 2020</span></td><td style="width: 3%">&#160;</td>
    <td style="width: 1%; text-align: left">&#160;</td><td id="xdx_98D_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsOutstandingNumber_iS_c20201001__20210930__us-gaap--PlanNameAxis__custom--StockOptionPlan2015Member_z76JMhWmbfP5" title="Options Outstanding at beginning" style="width: 12%; text-align: right"><ix:nonFraction name="us-gaap:ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsOutstandingNumber" contextRef="AsOf2020-09-30_custom_StockOptionPlan2015Member" format="ixt:numdotdecimal" decimals="INF" unitRef="Shares">10,076,266</ix:nonFraction></td><td style="width: 1%; text-align: left">&#160;</td><td style="width: 3%">&#160;</td>
    <td style="width: 1%; text-align: left">&#160;</td><td id="xdx_980_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsOutstandingWeightedAverageExercisePrice_iS_c20201001__20210930__us-gaap--PlanNameAxis__custom--StockOptionPlan2015Member_zkgbgc8rWrId" title="Weighted Average Exercise Price Outstanding at beginning" style="width: 12%; text-align: right"><ix:nonFraction name="us-gaap:ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsOutstandingWeightedAverageExercisePrice" contextRef="AsOf2020-09-30_custom_StockOptionPlan2015Member" format="ixt:numdotdecimal" decimals="INF" unitRef="USDPShares">3.48</ix:nonFraction></td><td style="width: 1%; text-align: left">&#160;</td><td style="width: 3%">&#160;</td>
    <td style="width: 1%; text-align: left">&#160;</td><td style="width: 12%; text-align: right">&#160;</td><td style="width: 1%; text-align: left">&#160;</td><td style="width: 3%">&#160;</td>
    <td style="width: 1%; text-align: left">&#160;</td><td id="xdx_985_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsOutstandingIntrinsicValue_iS_pp0p0_c20201001__20210930__us-gaap--PlanNameAxis__custom--StockOptionPlan2015Member_zjyL7CjeODZ5" title="Aggregate intrinsic value Outstanding at beginning" style="width: 12%; text-align: right"><ix:nonFraction name="us-gaap:ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsOutstandingIntrinsicValue" contextRef="AsOf2020-09-30_custom_StockOptionPlan2015Member" format="ixt:numdotdecimal" decimals="0" scale="0" unitRef="USD">14,982,581</ix:nonFraction></td><td style="width: 1%; text-align: left">&#160;</td></tr>
  <tr style="vertical-align: bottom; background-color: White">
    <td style="text-align: left"><span style="font-size: 10pt">Granted</span></td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td id="xdx_98C_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsGrantsInPeriodGross_c20201001__20210930__us-gaap--PlanNameAxis__custom--StockOptionPlan2015Member_zg8kDm2nkKgc" title="Options Granted" style="text-align: right"><ix:nonFraction name="us-gaap:ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsGrantsInPeriodGross" contextRef="From2020-10-012021-09-30_custom_StockOptionPlan2015Member" format="ixt:numdotdecimal" decimals="INF" unitRef="Shares">2,732,000</ix:nonFraction></td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td id="xdx_987_eus-gaap--ShareBasedCompensationArrangementsByShareBasedPaymentAwardOptionsGrantsInPeriodWeightedAverageExercisePrice_c20201001__20210930__us-gaap--PlanNameAxis__custom--StockOptionPlan2015Member_zbHgCahb0H3f" title="Weighted Average Exercise Price Granted" style="text-align: right"><ix:nonFraction name="us-gaap:ShareBasedCompensationArrangementsByShareBasedPaymentAwardOptionsGrantsInPeriodWeightedAverageExercisePrice" contextRef="From2020-10-012021-09-30_custom_StockOptionPlan2015Member" format="ixt:numdotdecimal" decimals="INF" unitRef="USDPShares">12.55</ix:nonFraction></td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td id="xdx_984_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsGrantsInPeriodWeightedAverageGrantDateFairValue_c20201001__20210930__us-gaap--PlanNameAxis__custom--StockOptionPlan2015Member_zzhsFA8zlgd1" title="Weighted Average Grant Date Fair Value Granted" style="text-align: right"><ix:nonFraction name="us-gaap:ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsGrantsInPeriodWeightedAverageGrantDateFairValue" contextRef="From2020-10-012021-09-30_custom_StockOptionPlan2015Member" format="ixt:numdotdecimal" decimals="INF" unitRef="USDPShares">9.32</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">&#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"><span style="font-size: 10pt">Forfeited</span></td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td id="xdx_98C_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsForfeituresInPeriod_iN_di_c20201001__20210930__us-gaap--PlanNameAxis__custom--StockOptionPlan2015Member_zydkA4JIAeo7" title="Options Forfeited" style="text-align: right">(<ix:nonFraction name="us-gaap:ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsForfeituresInPeriod" contextRef="From2020-10-012021-09-30_custom_StockOptionPlan2015Member" format="ixt:numdotdecimal" decimals="INF" unitRef="Shares">55,834</ix:nonFraction></td><td style="text-align: left">)</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td id="xdx_98C_eus-gaap--ShareBasedCompensationArrangementsByShareBasedPaymentAwardOptionsForfeituresInPeriodWeightedAverageExercisePrice_c20201001__20210930__us-gaap--PlanNameAxis__custom--StockOptionPlan2015Member_zFgaxSlKcDB9" title="Weighted Average Exercise Price Forfeited" style="text-align: right"><ix:nonFraction name="us-gaap:ShareBasedCompensationArrangementsByShareBasedPaymentAwardOptionsForfeituresInPeriodWeightedAverageExercisePrice" contextRef="From2020-10-012021-09-30_custom_StockOptionPlan2015Member" format="ixt:numdotdecimal" decimals="INF" unitRef="USDPShares">3.04</ix:nonFraction></td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td id="xdx_98B_ecustom--ShareBasedCompensationArrangementsByShareBasedPaymentAwardOptionsForfeituresInPeriodWeightedAverageExercisesPrice_c20201001__20210930__us-gaap--PlanNameAxis__custom--StockOptionPlan2015Member_zbYrcSCgB0E3" title="Weighted Average Grant Date Fair Value Forfeited" style="text-align: right"><ix:nonFraction name="avxl:ShareBasedCompensationArrangementsByShareBasedPaymentAwardOptionsForfeituresInPeriodWeightedAverageExercisesPrice" contextRef="From2020-10-012021-09-30_custom_StockOptionPlan2015Member" format="ixt:numdotdecimal" decimals="INF" unitRef="USDPShares">2.43</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">&#160;</td><td style="text-align: left">&#160;</td></tr>
  <tr style="vertical-align: bottom; background-color: White">
    <td style="padding-bottom: 1pt; text-align: left"><span style="font-size: 10pt">Exercised</span></td><td style="padding-bottom: 1pt">&#160;</td>
    <td style="padding-bottom: 1pt; text-align: left">&#160;</td><td id="xdx_983_eus-gaap--StockIssuedDuringPeriodSharesStockOptionsExercised_iN_di_c20201001__20210930__us-gaap--PlanNameAxis__custom--StockOptionPlan2015Member_zMmqYd7ujKbe" style="border-bottom: Black 1pt solid; text-align: right">(<ix:nonFraction name="us-gaap:StockIssuedDuringPeriodSharesStockOptionsExercised" contextRef="From2020-10-012021-09-30_custom_StockOptionPlan2015Member" format="ixt:numdotdecimal" decimals="INF" unitRef="Shares">1,421,529</ix:nonFraction></td><td style="padding-bottom: 1pt; text-align: left">)</td><td style="padding-bottom: 1pt">&#160;</td>
    <td style="padding-bottom: 1pt; text-align: left">&#160;</td><td id="xdx_98B_eus-gaap--ShareBasedCompensationArrangementsByShareBasedPaymentAwardOptionsExercisesInPeriodWeightedAverageExercisePrice_c20201001__20210930__us-gaap--PlanNameAxis__custom--StockOptionPlan2015Member_z1sAZmZBOP83" title="Weighted Average Exercise Price Exercised" style="border-bottom: Black 1pt solid; text-align: right"><ix:nonFraction name="us-gaap:ShareBasedCompensationArrangementsByShareBasedPaymentAwardOptionsExercisesInPeriodWeightedAverageExercisePrice" contextRef="From2020-10-012021-09-30_custom_StockOptionPlan2015Member" format="ixt:numdotdecimal" decimals="INF" unitRef="USDPShares">2.89</ix:nonFraction></td><td style="padding-bottom: 1pt; text-align: left">&#160;</td><td style="padding-bottom: 1pt">&#160;</td>
    <td style="padding-bottom: 1pt; text-align: left">&#160;</td><td id="xdx_98B_ecustom--ShareBasedCompensationArrangementsByShareBasedPaymentAwardOptionsExercisesInPeriodWeightedAverageExercisesPrice_c20201001__20210930__us-gaap--PlanNameAxis__custom--StockOptionPlan2015Member_zkvDLFAjsqed" title="Weighted Average Grant Date Fair Value Exercised" style="border-bottom: Black 1pt solid; text-align: right"><ix:nonFraction name="avxl:ShareBasedCompensationArrangementsByShareBasedPaymentAwardOptionsExercisesInPeriodWeightedAverageExercisesPrice" contextRef="From2020-10-012021-09-30_custom_StockOptionPlan2015Member" format="ixt:numdotdecimal" decimals="INF" unitRef="USDPShares">2.43</ix:nonFraction></td><td style="padding-bottom: 1pt; text-align: left">&#160;</td><td style="padding-bottom: 1pt">&#160;</td>
    <td style="padding-bottom: 1pt; text-align: left">&#160;</td><td id="xdx_98B_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsExercisesInPeriodTotalIntrinsicValue_pp0p0_c20201001__20210930__us-gaap--PlanNameAxis__custom--StockOptionPlan2015Member_zVNyTicjux19" title="Aggregate intrinsic value Exercised" style="border-bottom: Black 1pt solid; text-align: right"><ix:nonFraction name="us-gaap:ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsExercisesInPeriodTotalIntrinsicValue" contextRef="From2020-10-012021-09-30_custom_StockOptionPlan2015Member" format="ixt:numdotdecimal" decimals="0" scale="0" unitRef="USD">24,446,305</ix:nonFraction></td><td style="padding-bottom: 1pt; text-align: left">&#160;</td></tr>
  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="text-align: left"><span style="font-size: 10pt">Outstanding, September 30, 2021</span></td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td id="xdx_983_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsOutstandingNumber_iS_c20211001__20211231__us-gaap--PlanNameAxis__custom--StockOptionPlan2015Member_z9airy7jroe9" title="Options Outstanding at beginning" style="text-align: right"><ix:nonFraction name="us-gaap:ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsOutstandingNumber" contextRef="AsOf2021-09-30_custom_StockOptionPlan2015Member" format="ixt:numdotdecimal" decimals="INF" unitRef="Shares">11,330,903</ix:nonFraction></td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td id="xdx_987_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsOutstandingWeightedAverageExercisePrice_iS_c20211001__20211231__us-gaap--PlanNameAxis__custom--StockOptionPlan2015Member_zs30VwwFlObh" title="Weighted Average Exercise Price Outstanding at beginning" style="text-align: right"><ix:nonFraction name="us-gaap:ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsOutstandingWeightedAverageExercisePrice" contextRef="AsOf2021-09-30_custom_StockOptionPlan2015Member" format="ixt:numdotdecimal" decimals="INF" unitRef="USDPShares">5.74</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">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
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  <tr style="vertical-align: bottom; background-color: White">
    <td style="text-align: left"><span style="font-size: 10pt">Granted</span></td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td id="xdx_985_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsGrantsInPeriodGross_c20211001__20211231__us-gaap--PlanNameAxis__custom--StockOptionPlan2015Member_pdd" title="Options Granted" style="text-align: right"><ix:nonFraction name="us-gaap:ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsGrantsInPeriodGross" contextRef="From2021-10-012021-12-31_custom_StockOptionPlan2015Member" format="ixt:numdotdecimal" decimals="INF" unitRef="Shares">50,000</ix:nonFraction></td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td id="xdx_988_eus-gaap--ShareBasedCompensationArrangementsByShareBasedPaymentAwardOptionsGrantsInPeriodWeightedAverageExercisePrice_c20211001__20211231__us-gaap--PlanNameAxis__custom--StockOptionPlan2015Member_z7RVt3mDlfWi" title="Weighted Average Exercise Price Granted" style="text-align: right"><ix:nonFraction name="us-gaap:ShareBasedCompensationArrangementsByShareBasedPaymentAwardOptionsGrantsInPeriodWeightedAverageExercisePrice" contextRef="From2021-10-012021-12-31_custom_StockOptionPlan2015Member" format="ixt:numdotdecimal" decimals="INF" unitRef="USDPShares">19.64</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">&#160;</td><td style="text-align: left">&#160;</td></tr>
  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="padding-bottom: 1pt; text-align: left"><span style="font-size: 10pt">Exercised</span></td><td style="padding-bottom: 1pt">&#160;</td>
    <td style="padding-bottom: 1pt; text-align: left">&#160;</td><td id="xdx_983_eus-gaap--StockIssuedDuringPeriodSharesStockOptionsExercised_iN_di_c20211001__20211231__us-gaap--PlanNameAxis__custom--StockOptionPlan2015Member_znomZGu57e8h" title="Options Exercised" style="border-bottom: Black 1pt solid; text-align: right">(<ix:nonFraction name="us-gaap:StockIssuedDuringPeriodSharesStockOptionsExercised" contextRef="From2021-10-012021-12-31_custom_StockOptionPlan2015Member" format="ixt:numdotdecimal" decimals="INF" unitRef="Shares">137,134</ix:nonFraction></td><td style="padding-bottom: 1pt; text-align: left">)</td><td style="padding-bottom: 1pt">&#160;</td>
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  <tr style="vertical-align: bottom; background-color: White">
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="padding-bottom: 2.5pt; text-align: left"><span style="font-size: 10pt">Exercisable, December 31, 2021</span></td><td style="padding-bottom: 2.5pt">&#160;</td>
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  </table>

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




</ix:nonNumeric><p id="xdx_8A8_zkiH39LqkZfg" style="font: 10pt Times New Roman, Times, Serif; margin: 0">&#160;</p>

<ix:exclude><p id="xdx_234_zxh3gzb1PcV1" style="font: 10pt Times New Roman, Times, Serif; margin: 0"></p></ix:exclude>

<ix:exclude><!-- Field: Page; Sequence: 16; Value: 4 -->
    <div id="xdx_234_zrw4gBITt6Oe" style="border-bottom: Black 2pt solid; margin-top: 6pt; margin-bottom: 6pt"><p id="xdx_236_zSnNkv489XJj" style="font-size: 10pt; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><!-- Field: Sequence; Type: Arabic; Name: PageNo -->16<!-- Field: /Sequence --></p></div>
    <div id="xdx_23E_zjjtapwJ1bN2" style="break-before: page; margin-top: 6pt; margin-bottom: 6pt"><p style="margin: 0pt">&#160;</p></div>
    <!-- Field: /Page --></ix:exclude>

<ix:exclude><p id="xdx_231_zswVVjXwM0K" style="font: 10pt Times New Roman, Times, Serif; margin: 0">&#160;</p></ix:exclude>

<ix:exclude><p id="xdx_23F_z7Xt1xLnidQj" style="font: 10pt Times New Roman, Times, Serif; margin: 0"><b>Anavex Life Sciences Corp.</b></p></ix:exclude>

<ix:exclude><p id="xdx_232_zxByquYiAcEi" style="font: 10pt Times New Roman, Times, Serif; margin: 0">Notes to the Condensed Consolidated Interim Financial Statements</p></ix:exclude>

<ix:exclude><p id="xdx_231_zoKrSQFLXG82" style="font: 10pt Times New Roman, Times, Serif; margin: 0">December 31, 2021</p></ix:exclude>

<ix:exclude><p id="xdx_234_zlI6OeFqoCQ5" style="font: 10pt Times New Roman, Times, Serif; margin: 0">(Unaudited)</p></ix:exclude>


<ix:exclude><p id="xdx_23C_zbJYz67X7Xrf" style="font: 10pt Times New Roman, Times, Serif; margin: 0">&#160;</p></ix:exclude>

<ix:exclude><p id="xdx_23B_z64l2gsgDhGa" style="font: 10pt Times New Roman, Times, Serif; margin: 0">Note 6&#9;<span style="text-decoration: underline">Commitments and Contingencies</span> &#8211; (Continued)</p></ix:exclude>

<ix:exclude><p id="xdx_23E_z8CTTHUI4YVi" style="font: 10pt Times New Roman, Times, Serif; margin: 0">&#160;</p></ix:exclude>

<table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; margin-top: 0; margin-bottom: 0; color: black"><tr style="vertical-align: top">
<td style="width: 42.75pt"></td><td style="width: 14.05pt"><span style="font-style: normal">e)</span></td><td style="text-align: justify"><span style="font-style: normal">Stock-based Compensation Plan &#8211; (Continued)</span></td></tr></table>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 60.75pt; text-align: justify; text-indent: -18pt; color: black"><span style="font-style: normal">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 58.5pt; text-align: justify">The following summarizes information about
stock options at December 31, 2021 by a range of exercise prices:</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 58.5pt; text-align: justify">&#160;</p>

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  <tr style="vertical-align: bottom">
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    <td colspan="3" style="text-align: center">Number of</td><td>&#160;</td>
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    <td colspan="3" style="text-align: center">outstanding</td><td>&#160;</td>
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    <td colspan="3" style="text-align: center">Number of</td><td>&#160;</td>
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  <tr style="vertical-align: bottom">
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    <td colspan="3" style="border-bottom: Black 1pt solid; text-align: center">price</td></tr>
  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="width: 1%; text-align: left">$</td><td id="xdx_989_eus-gaap--ShareBasedCompensationSharesAuthorizedUnderStockOptionPlansExercisePriceRangeLowerRangeLimit_c20211001__20211231__us-gaap--AwardTypeAxis__us-gaap--StockOptionMember__us-gaap--ShareBasedCompensationSharesAuthorizedUnderStockOptionPlansByExercisePriceRangeAxis__custom--OptionPrice1Member_pdd" title="Range of exercise prices, lower range limit" style="width: 11%; text-align: right"><ix:nonFraction name="us-gaap:ShareBasedCompensationSharesAuthorizedUnderStockOptionPlansExercisePriceRangeLowerRangeLimit" contextRef="From2021-10-012021-12-31_us-gaap_StockOptionMember_custom_OptionPrice1Member" format="ixt:numdotdecimal" decimals="INF" unitRef="USDPShares">0.92</ix:nonFraction></td><td style="width: 1%; text-align: left">&#160;</td><td style="width: 2%">&#160;</td>
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  <tr style="vertical-align: bottom; background-color: White">
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  <tr style="vertical-align: bottom; background-color: White">
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 58.5pt; text-align: justify">The weighted average grant date fair value
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30, 2021: <span id="xdx_905_eus-gaap--SharebasedCompensationSharesAuthorizedUnderStockOptionPlansExercisePriceRangeExercisableOptionsWeightedAverageRemainingContractualTerm2_dtY_c20201001__20210930_z1ZRdvmlBgg2" title="Options exercisable"><ix:nonNumeric contextRef="From2020-10-012021-09-30" format="ixt-sec:duryear" name="us-gaap:SharebasedCompensationSharesAuthorizedUnderStockOptionPlansExercisePriceRangeExercisableOptionsWeightedAverageRemainingContractualTerm2">5.51</ix:nonNumeric></span> years).</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 58.5pt; text-align: justify">&#160;</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 2cm; text-align: justify">The aggregate intrinsic value is calculated
as the difference between the exercise price of the underlying awards and the quoted market price of the Company&#8217;s stock for the
options that were in-the-money at December 31, 2021.</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 2cm; text-align: justify">&#160;</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 2cm; text-align: justify">During the three months ended December 31,
2021, the Company recognized stock-based compensation expense of $<span id="xdx_904_eus-gaap--AllocatedShareBasedCompensationExpense_c20211001__20211231_pp0p0" title="Share based compensation"><ix:nonFraction name="us-gaap:AllocatedShareBasedCompensationExpense" contextRef="From2021-10-01to2021-12-31" format="ixt:numdotdecimal" decimals="0" scale="0" unitRef="USD">3,908,771</ix:nonFraction></span> (2020: $<span id="xdx_906_eus-gaap--AllocatedShareBasedCompensationExpense_c20201001__20201231_pp0p0" title="Share based compensation"><ix:nonFraction name="us-gaap:AllocatedShareBasedCompensationExpense" contextRef="From2020-10-012020-12-31" format="ixt:numdotdecimal" decimals="0" scale="0" unitRef="USD">939,314</ix:nonFraction></span>) in connection with the issuance and vesting
&#9;of stock options and warrants in exchange for services. These amounts have been included in general and &#9;administrative expenses
and research and development expenses on the Company&#8217;s statement of &#9;operations as follows:</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 2cm; text-align: justify">&#160;</p>

<ix:nonNumeric contextRef="From2021-10-01to2021-12-31" escape="true" name="us-gaap:ScheduleOfEmployeeServiceShareBasedCompensationAllocationOfRecognizedPeriodCostsTextBlock"><table cellpadding="0" cellspacing="0" id="xdx_89E_eus-gaap--ScheduleOfEmployeeServiceShareBasedCompensationAllocationOfRecognizedPeriodCostsTextBlock_zYZ4T48fmzl7" summary="xdx: Disclosure - Commitments and Contingencies (Details 4)" style="font: 10pt Times New Roman, Times, Serif; margin-left: auto; border-collapse: collapse; width: 80%; margin-right: auto">
  <tr style="vertical-align: bottom; background-color: White">
    <td style="text-align: left"><span id="xdx_8B7_zVT9ZTgfIqRg" style="display: none">Schedule of general and administrative expenses and research and development expenses</span></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-bottom: 1pt; text-align: center">&#160;</td><td style="padding-bottom: 1pt">&#160;</td>
    <td colspan="3" style="border-bottom: Black 1pt solid; text-align: center">2021</td><td style="padding-bottom: 1pt">&#160;</td>
    <td colspan="3" style="border-bottom: Black 1pt solid; text-align: center">2020</td></tr>
  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="width: 56%; text-align: left">General and administrative</td><td style="width: 8%">&#160;</td>
    <td style="width: 1%; text-align: left">$</td><td id="xdx_98A_eus-gaap--AllocatedShareBasedCompensationExpense_c20211001__20211231__us-gaap--IncomeStatementLocationAxis__us-gaap--GeneralAndAdministrativeExpenseMember_pp0p0" title="Total share based compensation" style="width: 12%; text-align: right"><ix:nonFraction name="us-gaap:AllocatedShareBasedCompensationExpense" contextRef="From2021-10-012021-12-31_us-gaap_GeneralAndAdministrativeExpenseMember" format="ixt:numdotdecimal" decimals="0" scale="0" unitRef="USD">1,671,726</ix:nonFraction></td><td style="width: 1%; text-align: left">&#160;</td><td style="width: 8%">&#160;</td>
    <td style="width: 1%; text-align: left">$</td><td id="xdx_988_eus-gaap--AllocatedShareBasedCompensationExpense_c20201001__20201231__us-gaap--IncomeStatementLocationAxis__us-gaap--GeneralAndAdministrativeExpenseMember_pp0p0" title="Total share based compensation" style="width: 12%; text-align: right"><ix:nonFraction name="us-gaap:AllocatedShareBasedCompensationExpense" contextRef="From2020-10-012020-12-31_us-gaap_GeneralAndAdministrativeExpenseMember" format="ixt:numdotdecimal" decimals="0" scale="0" unitRef="USD">422,823</ix:nonFraction></td><td style="width: 1%; text-align: left">&#160;</td></tr>
  <tr style="vertical-align: bottom; background-color: White">
    <td style="text-align: left">Research and development</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td id="xdx_986_eus-gaap--AllocatedShareBasedCompensationExpense_c20211001__20211231__us-gaap--IncomeStatementLocationAxis__us-gaap--ResearchAndDevelopmentExpenseMember_pp0p0" title="Total share based compensation" style="text-align: right"><ix:nonFraction name="us-gaap:AllocatedShareBasedCompensationExpense" contextRef="From2021-10-012021-12-31_us-gaap_ResearchAndDevelopmentExpenseMember" format="ixt:numdotdecimal" decimals="0" scale="0" unitRef="USD">2,237,046</ix:nonFraction></td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td id="xdx_989_eus-gaap--AllocatedShareBasedCompensationExpense_c20201001__20201231__us-gaap--IncomeStatementLocationAxis__us-gaap--ResearchAndDevelopmentExpenseMember_pp0p0" title="Total share based compensation" style="text-align: right"><ix:nonFraction name="us-gaap:AllocatedShareBasedCompensationExpense" contextRef="From2020-10-012020-12-31_us-gaap_ResearchAndDevelopmentExpenseMember" format="ixt:numdotdecimal" decimals="0" scale="0" unitRef="USD">516,491</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">Total stock-based compensation</td><td>&#160;</td>
    <td style="text-align: left">$</td><td id="xdx_98D_eus-gaap--AllocatedShareBasedCompensationExpense_c20211001__20211231_pp0p0" title="Total share based compensation" style="text-align: right"><ix:nonFraction name="us-gaap:AllocatedShareBasedCompensationExpense" contextRef="From2021-10-01to2021-12-31" format="ixt:numdotdecimal" decimals="0" scale="0" unitRef="USD">3,908,771</ix:nonFraction></td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">$</td><td id="xdx_98F_eus-gaap--AllocatedShareBasedCompensationExpense_c20201001__20201231_pp0p0" title="Total share based compensation" style="text-align: right"><ix:nonFraction name="us-gaap:AllocatedShareBasedCompensationExpense" contextRef="From2020-10-012020-12-31" format="ixt:numdotdecimal" decimals="0" scale="0" unitRef="USD">939,314</ix:nonFraction></td><td style="text-align: left">&#160;</td></tr>
  </table>

</ix:nonNumeric><p id="xdx_8A0_zfF44lwTQFWi" style="font: 10pt Times New Roman, Times, Serif; margin: 0">&#160;</p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 2cm; text-align: justify">An amount of approximately $<span id="xdx_903_eus-gaap--EmployeeServiceShareBasedCompensationNonvestedAwardsTotalCompensationCostNotYetRecognizedStockOptions_iI_pp0p0_c20211231_zcbNuMzbgoN9" title="Remaining stock based compensation"><ix:nonFraction name="us-gaap:EmployeeServiceShareBasedCompensationNonvestedAwardsTotalCompensationCostNotYetRecognizedStockOptions" contextRef="AsOf2021-12-31" format="ixt:numdotdecimal" decimals="0" scale="0" unitRef="USD">18,170,000</ix:nonFraction></span> in
stock-based compensation is expected to be recorded over the remaining term &#9;of such options through fiscal 2025.</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 2cm; text-align: justify">&#160;</p>

<ix:exclude><p id="xdx_233_zecbtcMpfKyh" style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 2cm; text-align: justify"></p></ix:exclude>

<ix:exclude><!-- Field: Page; Sequence: 17; Value: 4 -->
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    <div id="xdx_235_zq9ggG1osnwd" style="break-before: page; margin-top: 6pt; margin-bottom: 6pt"><p style="margin: 0pt">&#160;</p></div>
    <!-- Field: /Page --></ix:exclude>

<ix:exclude><p id="xdx_233_zaipl77jWZ6c" style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 2cm; text-align: justify">&#160;</p></ix:exclude>

<ix:exclude><p id="xdx_23C_zE6ifvxwTyr5" style="font: 10pt Times New Roman, Times, Serif; margin: 0"><b>Anavex Life Sciences Corp.</b></p></ix:exclude>

<ix:exclude><p id="xdx_235_zwkkFdZVjWOd" style="font: 10pt Times New Roman, Times, Serif; margin: 0">Notes to the Condensed Consolidated Interim Financial Statements</p></ix:exclude>

<ix:exclude><p id="xdx_236_z9vu4E13O4Pg" style="font: 10pt Times New Roman, Times, Serif; margin: 0">December 31, 2021</p></ix:exclude>

<ix:exclude><p id="xdx_238_zAJtmTBszIJi" style="font: 10pt Times New Roman, Times, Serif; margin: 0">(Unaudited)</p></ix:exclude>


<ix:exclude><p id="xdx_23D_zmlRpAYEj647" style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 2cm; text-align: justify">&#160;</p></ix:exclude>

<ix:exclude><p id="xdx_237_zmDGjFH4trqk" style="font: 10pt Times New Roman, Times, Serif; margin: 0">Note 6&#9;<span style="text-decoration: underline">Commitments and Contingencies</span> &#8211; (Continued)</p></ix:exclude>

<ix:exclude><p id="xdx_235_zO1XAtsPvND5" style="font: 10pt Times New Roman, Times, Serif; margin: 0">&#160;</p></ix:exclude>

<table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; margin-top: 0; margin-bottom: 0; color: black"><tr style="vertical-align: top">
<td style="width: 42.75pt"></td><td style="width: 14.05pt"><span style="font-style: normal">e)</span></td><td style="text-align: justify"><span style="font-style: normal">Stock-based Compensation Plan &#8211; (Continued)</span></td></tr></table>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 60.75pt; text-align: justify; text-indent: -18pt; color: black"><span style="font-style: normal">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 2cm; text-align: justify; text-indent: 0pt">The fair value of each option
award granted during the three months ended December 31, 2021 and 2020 is estimated on the date of grant using the Black Scholes option
pricing model based on the following weighted average assumptions:</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 2cm; text-align: justify">&#160;&#160;</p>

<ix:nonNumeric contextRef="From2021-10-01to2021-12-31" escape="true" name="us-gaap:ScheduleOfShareBasedPaymentAwardStockOptionsValuationAssumptionsTableTextBlock"><table cellpadding="0" cellspacing="0" id="xdx_89F_eus-gaap--ScheduleOfShareBasedPaymentAwardStockOptionsValuationAssumptionsTableTextBlock_zwPsLhoK7iT" summary="xdx: Disclosure - Commitments and Contingencies (Details 5)" style="font: 10pt Times New Roman, Times, Serif; margin-left: auto; border-collapse: collapse; width: 80%; margin-right: auto">
  <tr style="vertical-align: bottom; background-color: White">
    <td style="text-align: left"><span id="xdx_8BA_zUq8JrD5JSwd" style="display: none">Schedule of weighted average assumptions for fair value of each option award</span></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 colspan="3" style="border-bottom: Black 1pt solid; text-align: center">2021</td><td style="padding-bottom: 1pt">&#160;</td>
    <td colspan="3" style="border-bottom: Black 1pt solid; text-align: center">2020</td></tr>
  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="width: 56%; text-align: left">Risk-free interest rate</td><td style="width: 8%">&#160;</td>
    <td style="width: 1%; text-align: left">&#160;</td><td style="width: 12%; text-align: right"><span id="xdx_90F_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardFairValueAssumptionsRiskFreeInterestRate_dp_c20211001__20211231_zlmP78wcUCDa" title="Risk-free interest rate"><ix:nonFraction name="us-gaap:ShareBasedCompensationArrangementByShareBasedPaymentAwardFairValueAssumptionsRiskFreeInterestRate" contextRef="From2021-10-01to2021-12-31" format="ixt:numdotdecimal" decimals="INF" scale="-2" unitRef="Pure">1.37</ix:nonFraction></span></td><td style="width: 1%; text-align: left">%</td><td style="width: 8%">&#160;</td>
    <td style="width: 1%; text-align: left">&#160;</td><td style="width: 12%; text-align: right"><span id="xdx_902_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardFairValueAssumptionsRiskFreeInterestRate_dp_c20201001__20201231_zoDBii2fv6h3" title="Risk-free interest rate"><ix:nonFraction name="us-gaap:ShareBasedCompensationArrangementByShareBasedPaymentAwardFairValueAssumptionsRiskFreeInterestRate" contextRef="From2020-10-012020-12-31" format="ixt:numdotdecimal" decimals="INF" scale="-2" unitRef="Pure">0.62</ix:nonFraction></span></td><td style="width: 1%; text-align: left">%</td></tr>
  <tr style="vertical-align: bottom; background-color: White">
    <td style="text-align: left">Expected life of options (years)</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><span id="xdx_90D_eus-gaap--SharebasedCompensationArrangementBySharebasedPaymentAwardFairValueAssumptionsExpectedTerm1_dtY_c20211001__20211231_znXlzJntB7E2" title="Expected life of options (years)"><ix:nonNumeric contextRef="From2021-10-01to2021-12-31" format="ixt-sec:duryear" name="us-gaap:SharebasedCompensationArrangementBySharebasedPaymentAwardFairValueAssumptionsExpectedTerm1">6.50</ix:nonNumeric></span></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">Annualized volatility</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><span id="xdx_90F_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardFairValueAssumptionsExpectedVolatilityRate_dp_c20211001__20211231_z2SwyH0RMdxb" title="Annualized volatility"><ix:nonFraction name="us-gaap:ShareBasedCompensationArrangementByShareBasedPaymentAwardFairValueAssumptionsExpectedVolatilityRate" contextRef="From2021-10-01to2021-12-31" format="ixt:numdotdecimal" decimals="INF" scale="-2" unitRef="Pure">96.79</ix:nonFraction></span></td><td style="text-align: left">%</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><span id="xdx_901_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardFairValueAssumptionsExpectedVolatilityRate_dp_c20201001__20201231_zgS3NgWIFXeb" title="Annualized volatility"><ix:nonFraction name="us-gaap:ShareBasedCompensationArrangementByShareBasedPaymentAwardFairValueAssumptionsExpectedVolatilityRate" contextRef="From2020-10-012020-12-31" format="ixt:numdotdecimal" decimals="INF" scale="-2" unitRef="Pure">96.16</ix:nonFraction></span></td><td style="text-align: left">%</td></tr>
  <tr style="vertical-align: bottom; background-color: White">
    <td style="text-align: left">Dividend rate</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><span id="xdx_909_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardFairValueAssumptionsExpectedDividendRate_dp_c20211001__20211231_znmFgHEvKVwe" title="Dividend rate"><ix:nonFraction name="us-gaap:ShareBasedCompensationArrangementByShareBasedPaymentAwardFairValueAssumptionsExpectedDividendRate" contextRef="From2021-10-01to2021-12-31" format="ixt:numdotdecimal" decimals="INF" scale="-2" unitRef="Pure">0.00</ix:nonFraction></span></td><td style="text-align: left">%</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right"><span id="xdx_90F_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardFairValueAssumptionsExpectedDividendRate_dp_c20201001__20201231_zRiN97It2KCb" title="Dividend rate"><ix:nonFraction name="us-gaap:ShareBasedCompensationArrangementByShareBasedPaymentAwardFairValueAssumptionsExpectedDividendRate" contextRef="From2020-10-012020-12-31" format="ixt:numdotdecimal" decimals="INF" scale="-2" unitRef="Pure">0.00</ix:nonFraction></span></td><td style="text-align: left">%</td></tr>
  </table>

</ix:nonNumeric><p id="xdx_8A0_zhA8jAC66Gv1" style="font: 10pt Times New Roman, Times, Serif; margin: 0">&#160;</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 2cm; text-align: justify">The fair value of stock compensation charges
recognized during the three months ended December 31, 2021 and 2020 was determined with reference to the quoted market price of the Company&#8217;s
shares on the grant date.</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 2cm; text-align: justify">&#160;</p>

</ix:nonNumeric><p id="xdx_819_zDahumA7YPW4" style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 2cm; text-align: justify">&#160;&#160;</p>

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

<!-- Field: Page; Sequence: 18; Value: 4 -->
    <div style="border-bottom: Black 2pt solid; margin-top: 6pt; margin-bottom: 6pt"><p style="font-size: 10pt; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><!-- Field: Sequence; Type: Arabic; Name: PageNo -->18<!-- Field: /Sequence --></p></div>
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<p style="font: bold 10pt Times New Roman, Times, Serif; margin: 0; text-transform: uppercase; text-align: justify">&#160;</p>

<p style="font: bold 10pt Times New Roman, Times, Serif; margin: 0; text-transform: uppercase; text-align: justify"><span id="a_003"></span>Item 2. Management&#8217;s
Discussion and Analysis of Financial Condition and Results of Operations.</p>

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

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

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify">This Quarterly Report on Form 10-Q includes forward-looking
statements. All statements other than statements of historical facts contained in this Quarterly Report on Form 10-Q, including statements
regarding our anticipated future clinical and regulatory milestone events, future financial position, business strategy and plans and
objectives of management for future operations, are forward-looking statements. The words &#8220;believe,&#8221; &#8220;may,&#8221; &#8220;estimate,&#8221;
&#8220;continue,&#8221; &#8220;anticipate,&#8221; &#8220;intend,&#8221; &#8220;expect&#8221; &#8220;should,&#8221; &#8220;forecast,&#8221;
&#8220;could,&#8221; &#8220;suggest,&#8221; &#8220;plan&#8221; and similar expressions, as they relate to us, are intended to identify
forward-looking statements. Such forward-looking statements include, without limitation, statements regarding:</p>

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

<table cellspacing="0" cellpadding="0" style="width: 100%">
  <tr style="vertical-align: top">
    <td style="width: 28px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">volatility
    in our stock and in the markets in general;</span></td></tr>

<tr style="vertical-align: top">
    <td style="width: 4%"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 3%"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 93%; padding-left: 1.7pt; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">our
    ability to successfully conduct clinical and preclinical trials for our product candidates;</span></td></tr>

<tr style="vertical-align: top">
    <td style="width: 28px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">our
    ability to raise additional capital on favorable terms and the impact of such activities on our stockholders and stock price;</span></td></tr>

<tr style="vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; width: 28px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">the
    impact of the COVID-19 outbreak and its effect on us;</span></td></tr>

<tr style="vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif; width: 28px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">our
    ability to generate any revenue or to continue as a going concern;</span></td></tr>

<tr style="vertical-align: top">
    <td style="width: 28px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">our
    ability to execute our research and development plan on time and on budget;</span></td></tr>

<tr style="vertical-align: top">
    <td style="width: 28px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">our
    products ability to demonstrate efficacy or an acceptable safety profile of our product candidates;</span></td></tr>

<tr style="vertical-align: top">
    <td style="width: 28px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
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    ability to obtain the support of qualified scientific collaborators;</span></td></tr>

<tr style="vertical-align: top">
    <td style="width: 28px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
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    for sale;</span></td></tr>

<tr style="vertical-align: top">
    <td style="width: 28px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
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<tr style="vertical-align: top">
    <td style="width: 28px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
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    reliance on third parties in non-clinical and clinical studies;</span></td></tr>

<tr style="vertical-align: top">
    <td style="width: 28px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
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    ability to defend against product liability claims;</span></td></tr>

<tr style="vertical-align: top">
    <td style="width: 28px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">our
    ability to safeguard against security breaches;</span></td></tr>

<tr style="vertical-align: top">
    <td style="width: 28px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">our
    ability to obtain and maintain sufficient intellectual property protection for our product candidates;</span></td></tr>

<tr style="vertical-align: top">
    <td style="width: 28px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">our
    ability to comply with our intellectual property licensing agreements;</span></td></tr>

<tr style="vertical-align: top">
    <td style="width: 28px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">our
    ability to defend against claims of intellectual property infringement;</span></td></tr>

<tr style="vertical-align: top">
    <td style="width: 28px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
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    ability to comply with the maintenance requirements of the government patent agencies;</span></td></tr>

<tr style="vertical-align: top">
    <td style="width: 28px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">our
    ability to protect our intellectual property rights throughout the world;</span></td></tr>

<tr style="vertical-align: top">
    <td style="width: 28px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
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<tr style="vertical-align: top">
    <td style="width: 28px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
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    anticipated start dates, durations and completion dates of our ongoing and future clinical studies;</span></td></tr>

<tr style="vertical-align: top">
    <td style="width: 28px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
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  <tr style="vertical-align: top">
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
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    impact of fast track designation on receipt of actual FDA approval;</span></td></tr>

<tr style="vertical-align: top">
    <td style="width: 28px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
    <td style="font: 10pt Times New Roman, Times, Serif; width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</span></td>
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    anticipated future regulatory submissions and our ability to receive regulatory approvals to develop and market our product candidates,
    including any orphan drug or fast track designations; and</span></td></tr>

<tr style="vertical-align: top">
    <td style="width: 28px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</span></td>
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  </table>
<p style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify">&#160;&#160;</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify">We have based these forward-looking statements largely
on our current expectations and projections about future events, including the responses we expect from the U.S. Food and Drug Administration,
(&#8220;FDA&#8221;), and other regulatory authorities and financial trends that we believe may affect our financial condition, results
of operations, business strategy, preclinical and clinical trials, and financial needs. These forward-looking statements are subject to
a number of risks, uncertainties and assumptions including without limitation the risks described in &#8220;Risk Factors&#8221; in Part
I, Item 1A of our Annual Report on Form 10-K filed with the Securities and Exchange Commission on November 24, 2021. These risks are not
exhaustive. Other sections of this Quarterly Report on Form 10-Q include additional factors which could adversely impact our business
and financial performance. Moreover, we operate in a very competitive and rapidly changing environment. New risk factors emerge from time
to time and it is not possible for our management to predict all risk factors, nor can we assess the impact of all factors on our business
or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any
forward-looking statements. You should not rely upon forward-looking statements as predictions of future events. We cannot assure you
that the events and circumstances reflected in the forward-looking statements will be achieved or occur and actual results could differ
materially from those projected in the forward-looking statements. Except as required by applicable laws including the securities laws
of the United States, we assume no obligation to update or supplement forward-looking statements.</p>

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

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

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify">As used in this Quarterly Report on Form 10-Q, the
terms &#8220;we,&#8221; &#8220;us,&#8221; &#8220;our,&#8221; and &#8220;Anavex&#8221; mean Anavex Life Sciences Corp., unless the context
clearly requires otherwise.</p>

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

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

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify">Anavex Life Sciences Corp. is a clinical stage biopharmaceutical
company engaged in the development of differentiated therapeutics by applying precision medicine to central nervous system (&#8220;CNS&#8221;)
diseases with high unmet need. We analyze genomic data from clinical studies to identify biomarkers, which we use to select patients that
will receive the therapeutic benefit for the treatment of neurodegenerative and neurodevelopmental diseases.</p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify">Our lead compound, ANAVEX<sup>&#174;</sup>2-73, is
being developed to treat Alzheimer&#8217;s disease, Parkinson&#8217;s disease and potentially other central nervous system diseases, including
rare diseases, such as Rett syndrome, a rare severe neurological monogenic disorder caused by mutations in the X-linked gene, methyl-CpG-binding
protein 2 (&#8220;MECP2&#8221;).</p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify">We currently have two core programs and two seed programs.
Our core programs are at various stages of clinical and preclinical development, in neurodegenerative and neurodevelopmental diseases.</p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0">The following table summarizes key information about our
programs:</p>

<p style="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0; margin-bottom: 0"><img src="image_001.jpg" alt="" style="height: 250.5pt; width: 468pt" /></p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><i>* = Orphan Drug Designation by the FDA; Dashed
lines indicate planned clinical studies</i></p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify">Anavex has a portfolio of compounds varying in sigma-1
receptor (S1R) binding activities. The SIGMAR1 gene encodes the S1R protein, which is an intracellular chaperone protein with important
roles in cellular communication. S1R is also involved in transcriptional regulation at the nuclear envelope and restores homeostasis and
stimulates recovery of cell function when activated. In order to validate the ability of our compounds to activate quantitatively the
S1R, we performed, in collaboration with Stanford University, a quantitative Positron Emission Tomography (PET) imaging scan in mice,
which demonstrated a dose-dependent ANAVEX<sup>&#174;</sup>2-73 target engagement or receptor occupancy (RO) with S1R in the brain.</p>

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

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

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<p style="font: 12pt Times New Roman, Times, Serif; margin-top: 0; margin-bottom: 0; text-align: center"><span style="font-size: 10pt"><img src="image_002.jpg" alt="" style="height: 312pt; width: 468pt" /></span></p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0"><i>Source: Reyes S et al., Sci Rep. 2021 Aug 25; 11(1):17150</i></p>

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

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

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify">Many diseases are possibly directly caused by chronic
homeostatic imbalances or cellular stress of brain cells. In pediatric diseases like Rett syndrome or infantile spasms, the chronic cellular
stress is possibly caused by the presence of a constant genetic mutation. In neurodegenerative diseases, such as Alzheimer&#8217;s and
Parkinson&#8217;s diseases, chronic cellular stress is possibly caused by age-correlated buildup of cellular insult and hence chronic
cellular stress. Specifically, defects in homeostasis of protein or ribonucleic acid (&#8220;RNA&#8221;) lead to the death of neurons
and dysfunction of the nervous system. The spreading of protein aggregates resulting in a proteinopathy, a characteristic finding in Alzheimer&#8217;s
and Parkinson&#8217;s diseases that results from disorders of protein synthesis, trafficking, folding, processing or degradation in cells.
The clearance of macromolecules in the brain is particularly susceptible to imbalances that result in aggregation and degeneration in
nerve cells. For example, Alzheimer&#8217;s disease pathology is characterized by the presence of amyloid plaques, neurofibrillary tangles,
which are aggregates of hyperphosphorylated Tau protein that are a marker of other diseases known as tauopathies as well as inflammation
of microglia. With the SIGMAR1 activation through SIGMAR1 agonists like ANAVEX<sup>&#174;</sup>2-73, our approach is to restore cellular
balance, i.e. homeostasis. Therapies that correct defects in cellular homeostasis might have the potential to halt or delay neurodevelopmental
and neurodegenerative disease progression.</p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0"><b><i>ANAVEX</i></b><sup>&#174;</sup><b><i>2-73-specific Biomarkers</i></b></p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify">A full genomic analysis of Alzheimer&#8217;s disease
(AD) patients treated with ANAVEX<sup>&#174;</sup>2-73 resulted in the identification of actionable genetic variants. A significant impact
of the genomic biomarkers SIGMAR1, the direct target of ANAVEX<sup>&#174;</sup>2-73 and COMT, a gene involved in memory function, on the
drug response level was identified, leading to an early ANAVEX<sup>&#174;</sup>2-73-specific biomarker hypothesis. It is expected that
<i>excluding</i> patients with SIGMAR1 identified biomarker variant (approximately 10%-20% of the population) in prospective studies would
identify approximately 80%-90% patients that would display clinically significant improved functional and cognitive scores. The consistency
between the identified DNA and RNA data related to ANAVEX<sup>&#174;</sup>2-73, which are considered independent of AD pathology, as well
as multiple endpoints and time-points, provides support for precision medicine clinical development of ANAVEX<sup>&#174;</sup>2-73 by using
genetic biomarkers identified within the study population itself to target patients who are most likely to respond to ANAVEX<sup>&#174;</sup>2-73
treatment in AD as well as indications like Parkinson&#8217;s disease dementia (PDD) or Rett syndrome (RTT) in which ANAVEX<sup>&#174;</sup>2-73
is currently studied.</p>

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

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

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0"><b><i>Clinical Studies Overview</i></b></p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><i>Alzheimer&#8217;s Disease</i></p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify">In November 2016, we completed a Phase 2a clinical
trial, consisting of PART A and PART B, which lasted a total of 57 weeks, for ANAVEX<sup>&#174;</sup>2-73 in mild-to-moderate Alzheimer&#8217;s
patients. This open-label randomized trial met both primary and secondary endpoints and was designed to assess the safety and exploratory
efficacy of ANAVEX<sup>&#174;</sup>2-73 in 32 patients. ANAVEX<sup>&#174;</sup>2-73 targets sigma-1 and muscarinic receptors, which have
been shown in preclinical studies to reduce stress levels in the brain believed to restore cellular homeostasis and to reverse the pathological
hallmarks observed in Alzheimer&#8217;s disease. In October 2017, we presented positive pharmacokinetic (PK) and pharmacodynamic (PD)
data from the Phase 2a study, which established a concentration-effect relationship between ANAVEX<sup>&#174;</sup>2-73 and study measurements.
These measures obtained from all patients who participated in the entire 57 weeks include exploratory cognitive and functional scores
as well as biomarker signals of brain activity. Additionally, the study appears to show that ANAVEX<sup>&#174;</sup>2-73 activity is enhanced
by its active metabolite (ANAVEX19-144), which also targets the sigma-1 receptor and has a half-life approximately twice as long as the
parent molecule.</p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify">Two consecutive trial extensions for the Phase 2a
trial have allowed participants who completed the 52-week PART B of the study to continue taking ANAVEX<sup>&#174;</sup>2-73, providing
an opportunity to gather extended safety data for a cumulative time period of five years. In August 2020, patients completing these Phase
2a trial extensions were granted continued access to treatment with ANAVEX<sup>&#174;</sup>2-73 through the Australian Government Department
of Health &#8211; Therapeutic Goods Administration (TGA) compassionate use Special Access Scheme.</p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify">A larger Phase 2b/3 double-blind, placebo-controlled
study of ANAVEX<sup>&#174;</sup>2-73 in Alzheimer&#8217;s disease commenced in August 2018. The Phase 2b/3 study enrolled 509 patients
for 48 weeks, randomized 1:1:1 to two different ANAVEX<sup>&#174;</sup>2-73 doses or placebo. The trial commenced in Australia; and during
fiscal 2020 additional regions were added in the United Kingdom, The Netherlands, Germany and Canada. The ANAVEX<sup>&#174;</sup>2-73 Phase
2b/3 study design incorporates genomic precision medicine biomarkers identified in the ANAVEX<sup>&#174;</sup>2-73 Phase 2a study. Primary
and secondary endpoints will assess safety and both cognitive and functional efficacy, measured through Alzheimer&#8217;s Disease Assessment
Scale &#8211; Cognition (ADAS-Cog), ADCS-ADL and Clinical Dementia Rating &#8211; Sum of Boxes for cognition and function (CDR-SB). The
study completed enrollment in June 2021, exceeding the 450 patient enrollment target at 52 sites across North America, Europe and Australia.</p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify">In October 2019, we initiated a long-term open label
extension study of ANAVEX<sup>&#174;</sup>2-73, entitled the ATTENTION-AD study, for patients who have completed the 48-week Phase 2b/3
placebo-controlled trial referenced above. This study is expected to last two years and will give patients the opportunity to continue
their treatment. Upon request by patients, caretakers and investigators, this extension study was extended by one further year.</p>

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

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

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify">In February 2016, we presented positive preclinical
data for ANAVEX<sup>&#174;</sup>2-73 in Rett syndrome, a rare neurodevelopmental disease. The study was funded by the International Rett
Syndrome Foundation (&#8220;Rettsyndrome.org&#8221;). In January 2017, we were awarded a financial grant from Rettsyndrome.org of a minimum
of $0.6 million to cover some of the costs of a multicenter Phase 2 clinical trial of ANAVEX<sup>&#174;</sup>2-73 for the treatment of
Rett syndrome. This award was received in quarterly instalments which commenced during fiscal 2018.</p>

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

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

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify">In March 2019, we commenced the first Phase 2 clinical
trial in a planned Rett syndrome program of ANAVEX<sup>&#174;</sup>2-73 for the treatment of Rett syndrome. The studies will be conducted
in a range of patient age demographics and geographic regions, utilizing a convenient oral liquid once-daily formulation of ANAVEX<sup>&#174;</sup>2-73.</p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify">The first Phase 2 study, (ANAVEX&#174;2-73-RS-001), which took place in the
United States, was completed in December 2020. This trial was a randomized double-blind, placebo-controlled safety, tolerability, pharmacokinetic
and efficacy study of oral liquid ANAVEX<sup>&#174;</sup>2-73 formulation in 25 adult female patients with Rett syndrome over a 7-week
treatment period including ANAVEX<sup>&#174;</sup>2-73-specific genomic precision medicine biomarkers. The primary endpoint of the trial
was safety. The dosing of 5 mg ANAVEX<sup>&#174;</sup>2-73 was well-tolerated and demonstrated dose-proportional PK (pharmacokinetics).
All secondary efficacy endpoints of the trial showed statistically significant and clinically meaningful response in the Rett Syndrome
Behaviour Questionnaire (RSBQ AUC) Total scores, when compared to placebo, in the ITT cohort (all participants, p = 0.011). 66.7% of ANAVEX<sup>&#174;</sup>2-73
treated subjects showed a statistically significant improvement in RSBQ response as compared to 10% of the subjects on placebo in the
ITT cohort (all participants, p = 0.011). ANAVEX<sup>&#174;</sup>2-73 treatment resulted in a sustained improvement in Clinical Global
Impression Improvement (CGI-I) scores throughout the 7-week study, when compared to placebo in the ITT cohort (all participants, p = 0.014).
Consistent with previous ANAVEX<sup>&#174;</sup>2-73 clinical trials, patients carrying the common form of the SIGMAR1 gene treated with
ANAVEX<sup>&#174;</sup>2-73 experienced stronger improvements in the prespecified efficacy endpoints.</p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; background-color: white"><span style="background-color: white">The
second, international study of ANAVEX<sup>&#174;</sup>2-73 for the treatment of Rett syndrome, called the AVATAR study, commenced in June
2019.</span> This study took place in Australia and the United Kingdom using a higher dose than the U.S. based Phase 2 study for Rett
syndrome. The study was a Phase 3 randomized, double-blind, placebo-controlled trial to evaluate the safety and efficacy of ANAVEX<sup>&#174;</sup>2-73
in 33 patients over a 7-week treatment period including ANAVEX<sup>&#174;</sup>2-73 specific precision medicine biomarkers. Following the
successful completion of the U.S. Phase 2 Rett syndrome study (ANAVEX&#174;2-73-RS-001), and the knowledge gained from it, the endpoints
for the AVATAR study (ANAVEX&#174;2-73-RS-002) were appropriately updated according to ICH guidelines and were approved by the U.K. Medicines
and Healthcare products Regulatory Agency (MHRA) and in Australia by the Human Research Ethics Committees (HREC), where the AVATAR study
was conducted. Subsequently the AVATAR study was updated from a Phase 2 to a Phase 3 study.</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; background-color: white; color: #222222">&#160;</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify">The data of the AVATAR study was released in
February 2022. The study met all primary and secondary efficacy and safety endpoints, with consistent improvements in primary
efficacy endpoint, RSBQ AUC (p = 0.037) response, and secondary efficacy endpoints, ADAMS (p = 0.010) and CGI-I (p = 0.037)
response. Efficacy endpoints demonstrated statistically significant and clinically meaningful reductions in Rett syndrome symptoms.
Convenient once daily oral liquid doses of up to 30mg of ANAVEX<sup>&#174;</sup>2-73 were also well tolerated with good medication
compliance. All patients who participated in the study are eligible to receive ANAVEX<sup>&#174;</sup>2-73 under a voluntary open
label extension protocol, which is currently ongoing.</p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify">In July 2020, we commenced the third study of ANAVEX<sup>&#174;</sup>2-73
for the treatment of Rett syndrome, called the EXCELLENCE study. This Phase 2/3 study in pediatric patients with Rett syndrome will evaluate
the safety and efficacy of ANAVEX<sup>&#174;</sup>2-73 in approximately 84 pediatric patients, aged 5 to 18, over a 12-week treatment period
incorporating ANAVEX<sup>&#174;</sup>2-73 specific precision medicine biomarkers. All patients who participate in the study will be eligible
to receive ANAVEX<sup>&#174;</sup>2-73 under a voluntary open label extension protocol.</p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><i>Parkinson&#8217;s Disease</i></p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify">In September 2016, we presented positive preclinical
data for ANAVEX<sup>&#174;</sup>2-73 in an animal model of Parkinson&#8217;s disease, which demonstrated significant improvements on behavioral,
histopathological, and neuroinflammatory endpoints. The study was funded by the Michael J. Fox Foundation. Additional data announced in
October 2017 indicates that ANAVEX<sup>&#174;</sup>2-73 induces robust neurorestoration in experimental Parkinsonism. The encouraging results
we have gathered in this model, coupled with the favorable profile of this compound in the Alzheimer&#8217;s disease trial, support the
notion that ANAVEX<sup>&#174;</sup>2-73 is a promising clinical candidate drug for Parkinson&#8217;s disease dementia.</p>

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

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

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify">In October 2020, we completed a double-blind, randomized,
placebo-controlled proof-of-concept Phase 2 trial with ANAVEX<sup>&#174;</sup>2-73 in Parkinson&#8217;s Disease Dementia (PDD), to study
the effect of the compound on both the cognitive and motor impairment of Parkinson&#8217;s disease. The Phase 2 study enrolled approximately
132 patients for 14 weeks, randomized 1:1:1 to two different ANAVEX<sup>&#174;</sup>2-73 doses, 30mg and 50mg, or placebo. The ANAVEX<sup>&#174;</sup>2-73
Phase 2 PDD study design incorporated genomic precision medicine biomarkers identified in the ANAVEX<sup>&#174;</sup>2-73 Phase 2a Alzheimer&#8217;s
disease study.</p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify">Within this study ANAVEX<sup>&#174;</sup>2-73 was safe
and well tolerated in oral doses up to 50mg once daily. The results show clinically meaningful, dose-dependent, and statistically significant
improvements in the Cognitive Drug Research (CDR) computerized assessment system analysis. Treatment with ANAVEX<sup>&#174;</sup>2-73 also
resulted in clinically meaningful improvements as measured by the global composite score of Parkinson&#8217;s disease symptom severity,
MDS-UPDRS Total score on top of standard of care including dopaminergic therapy, levodopa and other anti-PD medications after 14 weeks
of treatment, suggesting ANAVEX<sup>&#174;</sup>2-73&#8217;s potential global capability of slowing and reversing symptoms that progress
in Parkinson&#8217;s disease. The study confirmed the precision medicine approach of targeting SIGMAR1 as a genetic biomarker in response
to ANAVEX<sup>&#174;</sup>2-73.</p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify">In January 2021, we announced we were awarded a research
grant of $1.0 million from&#160;The Michael J. Fox Foundation for Parkinson&#8217;s Research&#160;(MJFF) to develop ANAVEX<sup>&#174;</sup>2-73
for the treatment of Parkinson&#8217;s disease. The award will explore utilization of PET imaging biomarkers to enable measurement of
target engagement and pathway activation of the sigma-1 receptor (SIGMAR1) with clinically relevant doses in people with Parkinson&#8217;s
disease.</p>

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

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

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify">In July 2020, we commenced the First-in-Human Phase
1 clinical trial of ANAVEX<sup>&#174;</sup>3-71. ANAVEX<sup>&#174;</sup>3-71 was previously granted orphan drug designation for the treatment
of Frontotemporal Dementia (FTD) by the FDA. ANAVEX<sup>&#174;</sup>3-71 is an orally administered small molecule targeting sigma-1 and
M1 muscarinic receptors that is designed to be beneficial for neurodegenerative diseases. In preclinical studies, <span style="background-color: white">ANAVEX<sup>&#174;</sup>3-71
demonstrated disease-modifying activity against the major hallmarks of Alzheimer&#8217;s disease in transgenic (3xTg-AD) mice, including
cognitive deficits, amyloid and tau pathologies, as well as beneficial effects on mitochondrial dysfunction and neuroinflammation.</span></p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><span style="background-color: white">The Phase 1
clinical trial was a prospective double-blind, randomized, placebo-controlled study. A total of 36 healthy male and female subjects were
included. Single escalating doses of ANAVEX<sup>&#174;</sup>3-71 were administered in order to evaluate the safety, tolerability, and pharmacokinetics
(PK) of ANAVEX<sup>&#174;</sup>3-71 and the effects of food and gender on its PK in healthy volunteers. </span></p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><span style="background-color: white">The study met
its primary and secondary endpoints of safety, with no serious adverse events (SAEs) or dose-limiting toxicities observed. ANAVEX<sup>&#174;</sup>3-71
was well tolerated in all cohorts receiving ANAVEX<sup>&#174;</sup>3-71 in single doses ranging from 5 mg to 200 mg daily with no SAEs
and no significant lab abnormalities in any subject. In the study, ANAVEX<sup>&#174;</sup>3-71 exhibited linear pharmacokinetics. Its pharmacokinetics
was also dose proportional for doses up to 160 mg. Gender had no effect on the PK of the drug and food had no effect on the bioavailability
of ANAVEX<sup>&#174;</sup>3-71. The study also met the secondary objective of characterizing the effect of ANAVEX<sup>&#174;</sup>3-71 on
electrocardiogram (ECG) parameters. There were no clinically significant ECG parameters throughout the study. Participant QTcF measures
were normal across all dose groups with no difference between ANAVEX&#174;3-71 and placebo.</span></p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><span style="background-color: white">Based on these
results, and ANAVEX<sup>&#174;</sup>3-71 pre-clinical profile, the Company intends to advance ANAVEX<sup>&#174;</sup>3-71 into a biomarker-driven
clinical development dementia program for the treatment of FTD, schizophrenias and Alzheimer&#8217;s disease, evaluating longitudinal
effect of treatment with ANAVEX<sup>&#174;</sup>3-71. We believe the results of these studies could serve as the basis for advancing into
respective registration studies in the U.S.</span></p>

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

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

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

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify">Our research and development pipeline includes ANAVEX<sup>&#174;</sup>2-73
currently in three different clinical study indications, and several other compounds in different stages of clinical and pre-clinical
study.</p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify">Our proprietary SIGMACEPTOR&#8482; Discovery Platform
produced small molecule drug candidates with unique modes of action, based on our understanding of sigma receptors. Sigma receptors may
be targets for therapeutics to combat many human diseases, both of neurodegenerative nature, including Alzheimer&#8217;s disease, as well
as of neurodevelopmental nature, like Rett syndrome. When bound by the appropriate ligands, sigma receptors influence the functioning
of multiple biochemical signals that are involved in the pathogenesis (origin or development) of disease. Multiple viruses including SARS-CoV-2
(COVID-19) induce cellular stress by intrinsic mitochondrial apoptosis and other related cellular processes, in order to ensure survival
and replication. Hence, it is possible that S1R could play a role in modulating the cellular response to viral infection and ameliorate
pathogenesis.</p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify">Compounds that have been subjects of our research
include the following:</p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify">ANAVEX<sup>&#174;</sup>2-73 <i>(blarcamesine)</i></p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify">ANAVEX<sup>&#174;</sup>2-73 may offer a disease-modifying
approach in neurodegenerative and neurodevelopmental diseases by activation of sigma-1 receptors.</p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify">In Rett syndrome, administration of ANAVEX<sup>&#174;</sup>2-73
resulted in both significant and dose related improvements in an array of behavioral paradigms in the MECP2 HET Rett syndrome disease
model. In addition, in a further experiment sponsored by Rettsyndrome.org, ANAVEX<sup>&#174;</sup>2-73 was evaluated in automatic visual
response and respiration tests in 7-month old mice, an age at which advanced pathology is evident. Vehicle-treated MECP2 mice demonstrated
fewer automatic visual responses than wild-type mice. Treatment with ANAVEX<sup>&#174;</sup>2-73 for four weeks significantly increased
the automatic visual response in the MECP2 Rett syndrome disease mouse. Additionally, chronic oral dosing daily for 6.5 weeks of ANAVEX<sup>&#174;</sup>2-73
starting at ~5.5 weeks of age was conducted in the MECP2 HET Rett syndrome disease mouse model assessed the different aspects of muscular
coordination, balance, motor learning and muscular strengths, some of the core deficits observed in Rett syndrome. Administration of ANAVEX<sup>&#174;</sup>2-73
resulted in both significant and dose related improvements in an array of these behavioral paradigms in the MECP2 HET Rett syndrome disease
model.</p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify">In May 2016 and June 2016, the FDA granted Orphan
Drug Designation to ANAVEX<sup>&#174;</sup>2-73 for the treatment of Rett syndrome and infantile spasms, respectively. In November 2019,
the FDA granted to ANAVEX<sup>&#174;</sup>2-73 the Rare Pediatric Disease (RPD) designation for the treatment of Rett syndrome. The RPD
designation provides priority review by the FDA to encourage the development of treatments for rare pediatric diseases.</p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify">Further, in February 2020, the FDA granted Fast Track
designation for the ANAVEX<sup>&#174;</sup>2-73 clinical development program for the treatment of Rett syndrome. The FDA Fast Track program
is designed to facilitate and expedite the development and review of new drugs to address unmet medical needs in the treatment of serious
and life-threatening conditions.</p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify">For Parkinson&#8217;s disease, data demonstrates significant
improvements and restoration of function in a disease modifying animal model of Parkinson&#8217;s disease. Significant improvements were
seen on all measures tested: behavioral, histopathological, and neuroinflammatory endpoints. In October 2020, we completed a double-blind,
randomized, placebo-controlled proof-of-concept Phase 2 trial with ANAVEX<sup>&#174;</sup>2-73 in Parkinson&#8217;s Disease Dementia (PDD),
to study the effect of the compound on both the cognitive and motor impairment of Parkinson&#8217;s disease. The Phase 2 study enrolled
approximately 132 patients for 14 weeks, randomized 1:1:1 to two different ANAVEX<sup>&#174;</sup>2-73 doses, 30mg and 50mg, or placebo.
The ANAVEX<sup>&#174;</sup>2-73 Phase 2 PDD study design incorporated genomic precision medicine biomarkers identified in the ANAVEX<sup>&#174;</sup>2-73
Phase 2a Alzheimer&#8217;s disease study.</p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify">The study found that ANAVEX<sup>&#174;</sup>2-73 was
safe and well tolerated in oral doses up to 50mg once daily. The results show clinically meaningful, dose-dependent, and statistically
significant improvements in the Cognitive Drug Research (CDR) computerized assessment system analysis. We anticipate conducting further
clinical trials of ANAVEX<sup>&#174;</sup>2-73 in Parkinson&#8217;s disease dementia after submitting the results of the study to the FDA
to obtain regulatory guidance.</p>

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

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

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify">In Alzheimer&#8217;s disease (AD) animal models, ANAVEX<sup>&#174;</sup>2-73
has shown pharmacological, histological and behavioral evidence as a potential neuroprotective, anti-amnesic, anti-convulsive and anti-depressive
therapeutic agent, due to its potent affinity to sigma-1 receptors and moderate affinities to M1-4 type muscarinic receptors. In addition,
ANAVEX<sup>&#174;</sup>2-73 has shown a potential dual mechanism which may impact amyloid, tau pathology and inflammation. In a transgenic
AD animal model Tg2576, ANAVEX<sup>&#174;</sup>2-73 induced a statistically significant neuroprotective effect against the development
of oxidative stress in the mouse brain, as well as significantly increased the expression of functional and synaptic plasticity markers
that is apparently amyloid-beta independent. It also statistically alleviated the learning and memory deficits developed over time in
the animals, regardless of sex, both in terms of spatial working memory and long-term spatial reference memory.</p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify">Based on the results of pre-clinical testing, we initiated
and completed a Phase 1 single ascending dose (SAD) clinical trial of ANAVEX<sup>&#174;</sup>2-73. In this Phase 1 SAD trial, the maximum
tolerated single dose was defined per protocol as 55-60 mg. This dose is above the equivalent dose shown to have positive effects in mouse
models of AD. There were no significant changes in laboratory or electrocardiogram (ECG) parameters. ANAVEX<sup>&#174;</sup>2-73 was well
tolerated below the 55-60 mg dose with only mild adverse events in some subjects. Observed adverse events at doses above the maximum tolerated
single dose included headache and dizziness, which were moderate in severity and reversible. These side effects are often seen with drugs
that target CNS conditions, including AD.</p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify">In December 2014, a Phase 2a clinical trial was initiated
for ANAVEX<sup>&#174;</sup>2-73, for the treatment of Alzheimer&#8217;s disease. The open-label randomized trial was designed to assess
the safety and exploratory efficacy of ANAVEX<sup>&#174;</sup>2-73 in 32 patients with mild-to-moderate Alzheimer&#8217;s disease. ANAVEX<sup>&#174;</sup>2-73
is an orally available drug candidate that restores cellular homeostasis by targeting sigma-1 and muscarinic receptors. Preclinical studies
demonstrated its potential to halt and/or reverse the course of Alzheimer&#8217;s. The Phase 2a study met both primary and secondary objectives
of the study.</p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; background-color: white">In July 2018, we presented
the results of a genomic DNA and RNA evaluation of the participants in the Phase 2a study. More than 33,000 genes were analyzed using
unbiased, data driven, machine learning, artificial intelligence (AI) system for analyzing DNA &amp; RNA data in patients exposed to ANAVEX<sup>&#174;</sup>2-73.
The analysis identified genetic variants that impacted response to ANAVEX<sup>&#174;</sup>2-73, among them variants related to the Sigma-1
receptor (SIGMAR1), the target for ANAVEX<sup>&#174;</sup>2-73. Results showed that study participants with the common SIGMAR1 wild type
gene variant, which is about 80 percent of the population worldwide, demonstrated improved cognitive (MMSE) and the functional (ADCS-ADL)
scores. The results from this evaluation have been used to establish a precision medicine approach in subsequent clinical trials, since
these signatures can now be applied to neurological indications tested in clinical studies with ANAVEX<sup>&#174;</sup>2-73 including Alzheimer&#8217;s
disease, Parkinson&#8217;s disease dementia and Rett syndrome.</p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; background-color: white">ANAVEX<sup>&#174;</sup>2-73
data presented met prerequisite information in order to progress into a Phase 2b/3 placebo-controlled study. On July 2, 2018, the Human
Research Ethics Committee in Australia approved the initiation of our Phase 2b/3, double-blind, randomized, placebo-controlled 48-week
safety and efficacy trial of ANAVEX<sup>&#174;</sup>2-73 for the treatment of early Alzheimer&#8217;s disease. Clinical trial sites in
Canada, the United Kingdom, the Netherlands and Germany were also added. This Phase 2b/3 study design incorporates inclusion of genomic
precision medicine biomarkers identified in the ANAVEX<sup>&#174;</sup>2-73 Phase 2a study. The Phase 2b/3 study, which commenced in October 2018, randomized 1:1:1 to either two different ANAVEX<sup>&#174;</sup>2-73
doses or placebo, completed enrollment in June 2021.</p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify">Preclinical data also validates ANAVEX<sup>&#174;</sup>2-73
as a prospective platform drug for other neurodegenerative diseases beyond Alzheimer&#8217;s disease, Parkinson&#8217;s disease or Rett
syndrome, more specifically, epilepsy, infantile spasms, Fragile X syndrome, Angelman syndrome, multiple sclerosis and, more recently,
tuberous sclerosis complex (TSC). ANAVEX<sup>&#174;</sup>2-73 demonstrated significant improvements in all of these indications in the
respective preclinical animal models.</p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify">In a study sponsored by the Foundation for Angelman
Syndrome, ANAVEX<sup>&#174;</sup>2-73 was assessed in a mouse model for the development of audiogenic seizures. The results indicated that
ANAVEX<sup>&#174;</sup>2-73 administration significantly reduced audiogenic-induced seizures. In a study sponsored by FRAXA Research Foundation
regarding Fragile X syndrome, data demonstrated that ANAVEX<sup>&#174;</sup>2-73 restored hippocampal brain-derived neurotrophic factor
(BDNF) expression to normal levels. BDNF under-expression has been observed in many neurodevelopmental and neurodegenerative pathologies.
BDNF signaling promotes maturation of both excitatory and inhibitory synapses. ANAVEX<sup>&#174;</sup>2-73 normalization of BDNF expression
could be a contributing factor for the positive data observed in both neurodevelopmental and neurodegenerative disorders like Angelman
and Fragile X syndromes.</p>

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

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

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify">Preclinical data presented also indicates that ANAVEX<sup>&#174;</sup>2-73
demonstrates protective effects of mitochondrial enzyme complexes during pathological conditions, which, if impaired, are believed to
play a role in the pathogenesis of neurodegenerative and neurodevelopmental diseases.</p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify">Preclinical data on ANAVEX<sup>&#174;</sup>2-73 related
to multiple sclerosis indicates that ANAVEX<sup>&#174;</sup>2-73 may promote remyelination in multiple sclerosis disease. Further, data
also demonstrates that ANAVEX<sup>&#174;</sup>2-73 provides protection for oligodendrocytes (&#8220;OL&#8217;s&#8221;) and oligodendrocyte
precursor cells (&#8220;OPC&#8217;s&#8221;), as well as central nervous system neurons in addition to helping repair by increasing OPC
proliferation and maturation in tissue culture.</p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify">In March 2018, we presented preclinical data of ANAVEX<sup>&#174;</sup>2-73
in a genetic mouse model of tuberous sclerosis complex (&#8220;TSC&#8221;). TSC is a rare genetic disorder characterized by the growth
of numerous benign tumors in many parts of the body with a high incidence of seizures. The preclinical data demonstrates that treatment
with ANAVEX<sup>&#174;</sup>2-73 significantly increases survival and reduces seizures.</p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><b>ANAVEX<sup>&#174;</sup>3-71</b></p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify">ANAVEX<sup>&#174;</sup>3-71 is a clinical drug candidate
with a novel mechanism of action via sigma-1 receptor activation and M1 muscarinic allosteric modulation, which has been shown to enhance
neuroprotection and cognition in Alzheimer&#8217;s disease models. ANAVEX<sup>&#174;</sup>3-71 is a CNS-penetrable potential disease modifying
treatment for cognitive impairments. It is highly effective in very small doses against the major Alzheimer&#8217;s hallmarks in transgenic
(3xTg-AD) mice, including cognitive deficits, amyloid and tau pathologies, and also has beneficial effects on inflammation and mitochondrial
dysfunctions. ANAVEX<sup>&#174;</sup>3-71 indicates extensive therapeutic advantages in Alzheimer&#8217;s and other protein-aggregation-related
diseases given its ability to enhance neuroprotection and cognition via sigma-1 receptor activation and M1 muscarinic allosteric modulation.</p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify">A preclinical study examined the response of ANAVEX<sup>&#174;</sup>3-71
in aged transgenic animal models and showed a significant reduction in the rate of cognitive deficit, amyloid beta pathology and inflammation
with the administration of ANAVEX 3-71. In April 2016, the FDA granted Orphan Drug Designation to ANAVEX<sup>&#174;</sup>3-71 for the treatment
of Frontotemporal dementia (FTD).</p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify">During pathological conditions ANAVEX<sup>&#174;</sup>3-71
demonstrated the formation of new synapses between neurons (synaptogenesis) without causing an abnormal increase in the number of astrocytes.
In neurodegenerative diseases such as Alzheimer&#8217;s and Parkinson&#8217;s disease, synaptogenesis is believed to be impaired. Additional
preclinical data presented also indicates that in addition to reducing oxidative stress, ANAVEX<sup>&#174;</sup>3-71 demonstrates protective
effects of mitochondrial enzyme complexes during pathological conditions, which, if impaired, are believed to play a role in the pathogenesis
of neurodegenerative and neurodevelopmental diseases.</p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify">In July 2020, we commenced the first Phase 1 clinical
trial of&#160;ANAVEX<sup>&#174;</sup>3-71. The study took place in Australia and was a double-blind, randomized, placebo-controlled, Phase
1 trial to evaluate safety and tolerability, and pharmacokinetics (PK) of oral escalating doses of ANAVEX<span style="background-color: white"><sup>&#174;</sup></span>3-71
including effects of food and gender in healthy volunteers <span style="background-color: white">The study met its primary and secondary
endpoints of safety, respectively with no serious adverse events (SAEs) or dose-limiting toxicities observed, </span>as more fully described
above under <i>Clinical Studies Overview &#8211; Frontotemporal Dementia</i>.</p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><span style="background-color: white">Based on these
results, and ANAVEX<sup>&#174;</sup>3-71 pre-clinical profile, the Company intends to advance ANAVEX<sup>&#174;</sup>3-71 into a biomarker-driven
clinical development dementia program for the treatment of FTD, schizophrenias and Alzheimer&#8217;s disease, evaluating longitudinal
effect of treatment with ANAVEX<sup>&#174;</sup>3-71. Anavex believes the results of these studies, could serve as the basis for advancing
into respective registration studies in the U.S.</span></p>

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

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

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0"><b>ANAVEX<sup>&#174;</sup>1-41</b></p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify">ANAVEX<sup>&#174;</sup>1-41 is a sigma-1 agonist. Pre-clinical
tests revealed significant neuroprotective benefits (i.e., protects nerve cells from degeneration or death) through the modulation of
endoplasmic reticulum, mitochondrial and oxidative stress, which damages and impairs cell viability. In addition, in animal models, ANAVEX<sup>&#174;</sup>1-41
prevented the expression of caspase-3, an enzyme that plays a key role in apoptosis (programmed cell death) and loss of cells in the hippocampus,
the part of the brain that regulates learning, emotion and memory. These activities involve both muscarinic and sigma-1 receptor systems
through a novel mechanism of action.</p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify">Preclinical data presented also indicates that ANAVEX<sup>&#174;</sup>1-41
demonstrates protective effects of mitochondrial enzyme complexes during pathological conditions, which, if impaired, are believed to
play a role in the pathogenesis of neurodegenerative and neurodevelopmental diseases.</p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><b>ANAVEX<sup>&#174;</sup>1066</b></p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify">ANAVEX<sup>&#174;</sup>1066, a mixed sigma-1/sigma-2
ligand is designed for the potential treatment of neuropathic and visceral pain. ANAVEX<sup>&#174;</sup>1066 was tested in two preclinical
models of neuropathic and visceral pain that have been extensively validated in rats. In the chronic constriction injury model of neuropathic
pain, a single oral administration of ANAVEX<sup>&#174;</sup>1066 dose-dependently restored the nociceptive threshold in the affected paw
to normal levels while leaving the contralateral healthy paw unchanged. Efficacy was rapid and remained significant for two hours. In
a model of visceral pain, chronic colonic hypersensitivity was induced by injection of an inflammatory agent directly into the colon and
a single oral administration of ANAVEX<sup>&#174;</sup>1066 returned the nociceptive threshold to control levels in a dose-dependent manner.
Companion studies in rats demonstrated the lack of any effects on normal gastrointestinal transit with ANAVEX<sup>&#174;</sup>1066 and
a favorable safety profile in a battery of behavioral measures.</p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><b>ANAVEX<sup>&#174;</sup>1037 </b></p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify">ANAVEX<sup>&#174;</sup>1037 is designed for the treatment
of prostate and pancreatic cancer. It is a low molecular weight, synthetic compound exhibiting high affinity for sigma-1 receptors at
nanomolar levels and moderate affinity for sigma-2 receptors and sodium channels at micromolar levels. In advanced pre-clinical studies,
this compound revealed antitumor potential. It has also been shown to selectively kill human cancer cells without affecting normal/healthy
cells and also to significantly suppress tumor growth in immune-deficient mice models. Scientific publications highlight the possibility
that these ligands may stop tumor growth and induce selective cell death in various tumor cell lines. Sigma receptors are highly expressed
in different tumor cell types. Binding by appropriate sigma-1 and/or sigma-2 ligands can induce selective apoptosis. In addition, through
tumor cell membrane reorganization and interactions with ion channels, our drug candidates may play an important role in inhibiting the
processes of metastasis (spreading of cancer cells from the original site to other parts of the body), angiogenesis (the formation of
new blood vessels) and tumor cell proliferation.</p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify">Our compounds are in the pre-clinical and clinical
testing stages of development, and there is no guarantee that the activity demonstrated in pre-clinical models will be shown in human
testing.</p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify">We continue to identify and initiate discussions with
potential strategic and commercial partners to most effectively advance our programs and realize maximum shareholder value. Further, we
may acquire or develop new intellectual property and assign, license, or otherwise transfer our intellectual property to further our goals.</p>

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

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

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify">We have developed compounds with potential application
to two broad categories and several specific indications. including:</p>

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

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

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

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

<table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; margin-top: 0; margin-bottom: 0"><tr style="vertical-align: top">
<td style="width: 18pt"></td><td style="width: 18pt">&#9679;</td><td style="text-align: justify">Alzheimer&#8217;s disease &#8211; In 2021, an estimated 5.7 million Americans were suffering from Alzheimer&#8217;s
disease. The Alzheimer&#8217;s Association<sup>&#174;</sup> estimates that by 2050, this number will rise to nearly 14 million Americans.
Medications on the market today treat only the symptoms of Alzheimer&#8217;s disease and do not have the ability to stop its onset or
its progression. There is an urgent and unmet need for both a disease modifying cure for Alzheimer&#8217;s disease as well as for better
symptomatic treatments.</td></tr></table>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 36pt; text-align: justify; text-indent: -18pt">&#160;</p>

<table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; margin-top: 0; margin-bottom: 0"><tr style="vertical-align: top">
<td style="width: 18pt"></td><td style="width: 18pt">&#9679;</td><td style="text-align: justify">Parkinson&#8217;s disease &#8211; Parkinson&#8217;s disease is a progressive disease of the nervous system
marked by tremors, muscular rigidity, and slow, imprecise movement. It is associated with degeneration of the basal ganglia of the brain
and a deficiency of the neurotransmitter dopamine. Parkinson&#8217;s disease afflicts more than 10 million people worldwide, typically
middle-aged and elderly people. The Parkinson&#8217;s disease market is expected to expand to $11.5 billion by 2029, according to business
intelligence provider GBI Research.</td></tr></table>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 36pt; text-align: justify; text-indent: -18pt">&#160;</p>

<table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; margin-top: 0; margin-bottom: 0"><tr style="vertical-align: top">
<td style="width: 18pt"></td><td style="width: 18pt">&#9679;</td><td style="text-align: justify">Rett syndrome &#8211; Rett syndrome is a rare X-linked genetic neurological and developmental disorder
that affects the way the brain develops, including protein transcription, which is altered and as a result lead to severe disruptions
in neuronal homeostasis. It is considered a rare, progressive neurodevelopmental disorder and is caused by a single mutation in the MECP2
gene. Because males have a different chromosome combination from females, boys who have the genetic MECP2 mutation are affected in devastating
ways. Most of them die before birth or in early infancy. For females who survive infancy, Rett syndrome leads to severe impairments, affecting
nearly every aspect of the child&#8217;s life; severe mental retardation, their ability to speak, walk and eat, sleeping problems, seizures
and even the ability to breathe easily. Rett syndrome affects approximately 1 in every 10,000-15,000 females.</td></tr></table>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 36pt; text-align: justify; text-indent: -18pt">&#160;</p>

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<td style="width: 18pt"></td><td style="width: 18pt">&#9679;</td><td style="text-align: justify">Depression &#8211; Depression is a major cause of morbidity worldwide according to the World Health Organization.
Pharmaceutical treatment for depression is dominated by blockbuster brands, with the leading nine brands historically accounting for approximately
75% of total sales. However, the dominance of the leading brands is waning, largely due to the effects of patent expiration and generic
competition.</td></tr></table>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 36pt; text-align: justify; text-indent: -18pt">&#160;</p>

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<td style="width: 18pt"></td><td style="width: 18pt">&#9679;</td><td style="text-align: justify">Epilepsy &#8211; Epilepsy is a common chronic neurological disorder characterized by recurrent unprovoked
seizures. These seizures are transient signs and/or symptoms of abnormal, excessive or synchronous neuronal activity in the brain. According
to the Centers for Disease Control and Prevention, in 2015 epilepsy affected 3.4 million Americans. Today, epilepsy is often controlled,
but not cured, with medication that is categorized as older traditional anti-epileptic drugs and second generation anti-epileptic drugs.
Because epilepsy afflicts sufferers in different ways, there is a need for drugs used in combination with both traditional anti-epileptic
drugs and second generation anti-epileptic drugs.</td></tr></table>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 36pt; text-align: justify; text-indent: -18pt">&#160;</p>

<table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; margin-top: 0; margin-bottom: 0"><tr style="vertical-align: top">
<td style="width: 18pt"></td><td style="width: 18pt">&#9679;</td><td style="text-align: justify">Neuropathic Pain &#8211; We define neuralgia, or neuropathic pain, as pain that is not related to activation
of pain receptor cells in any part of the body. Neuralgia is more difficult to treat than some other types of pain because it does not
respond well to normal pain medications. Special medications have become more specific to neuralgia and typically fall under the category
of membrane stabilizing drugs or antidepressants.</td></tr></table>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 36pt; text-align: justify; text-indent: -18pt">&#160;</p>

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

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

<table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; margin-top: 0; margin-bottom: 0"><tr style="vertical-align: top">
<td style="width: 18pt"></td><td style="width: 18pt">&#9679;</td><td style="text-align: justify">Malignant Melanoma &#8211; Predominantly a skin cancer, malignant melanoma can also occur in melanocytes
found in the bowel and the eye. Malignant melanoma accounts for 75% of all deaths associated with skin cancer. The treatment includes
surgical removal of the tumor, adjuvant treatment, chemo and immunotherapy, or radiation therapy. According to iHealthcareAnalyst, Inc.
the worldwide malignant melanoma market is expected to grow to $6.4 billion by 2027.</td></tr></table>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 36pt; text-align: justify; text-indent: -18pt">&#160;</p>

<table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; margin-top: 0; margin-bottom: 0"><tr style="vertical-align: top">
<td style="width: 18pt"></td><td style="width: 18pt">&#9679;</td><td style="text-align: justify">Prostate Cancer &#8211; Specific to men, prostate cancer is a form of cancer that develops in the prostate,
a gland in the male reproductive system. The cancer cells may metastasize from the prostate to other parts of the body, particularly the
bones and lymph nodes. Drug therapeutics for prostate cancer are expected to increase to nearly $13.5 billion in 2024 according to Datamonitor
Healthcare.</td></tr></table>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 36pt; text-align: justify; text-indent: -18pt">&#160;</p>

<table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; margin-top: 0; margin-bottom: 0"><tr style="vertical-align: top">
<td style="width: 18pt"></td><td style="width: 18pt">&#9679;</td><td style="text-align: justify">Pancreatic Cancer &#8211; Pancreatic cancer is a malignant neoplasm of the pancreas. In the United States,
approximately 55,000 new cases of pancreatic cancer will be diagnosed this year and approximately 44,000 patients will die as a result
of their cancer, according to the American Cancer Society. Sales predictions by FutureWise forecast that the market for the global pharmaceutical
treatment of pancreatic cancer will increase to $4.7 billion by 2027.</td></tr></table>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 36pt; text-align: justify; text-indent: -18pt">&#160;</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 36pt; text-align: justify; text-indent: -18pt"></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 36pt; text-align: justify; text-indent: -18pt">&#160;</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><b><i>Patents, Trademarks and Intellectual Property
</i></b></p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify">We hold ownership or exclusive rights to fifteen U.S.
patents, sixteen U.S. patent applications, and various PCT or ex-U.S. patent applications relating to our drug candidates, methods associated
therewith, and to our research programs.</p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify">We own one issued U.S. patent entitled &#8220;ANAVEX<sup>&#174;</sup>2-73
and certain anticholinesterase inhibitors composition and method for neuroprotection&#8221; claims a composition of matter of ANAVEX<sup>&#174;</sup>2-73
directed to a novel and synergistic neuroprotective compound combined with donepezil and other cholinesterase inhibitors. This patent
is expected to expire in June 2034, absent any patent term extension for regulatory delays. We own three issued U.S. patents each with
claims directed to crystalline forms of ANAVEX<sup>&#174;</sup>2-73. The first of these three patents claims crystalline forms of ANAVEX<sup>&#174;</sup>2-73,
dosage forms and compositions containing crystalline ANAVEX<sup>&#174;</sup>2-73, and methods of treatment for Alzheimer&#8217;s disease
using them. This patent is expected to expire in July 2036, absent any patent term extension for regulatory delays. The second of these
three patents claims pharmaceutical compositions containing a crystalline form of ANAVEX<sup>&#174;</sup>2-73, and methods of treatment
for Alzheimer&#8217;s disease using the compositions. This patent is expected to expire in June 2037, absent any patent term extension
for regulatory delays. The third of these three patents claims pharmaceutical compositions containing a crystalline form of ANAVEX<sup>&#174;</sup>2-73,
and methods of treatment for Alzheimer&#8217;s disease using the compositions. This patent is expected to expire in June 2037, absent
any patent term extension for regulatory delays. We also own two issued U.S. patents for seizure treatment. The first of these two patents
claims methods and dosage forms for treating seizures, the dosage forms containing a low-dose anti-epilepsy drug combined with either:
(i) ANAVEX<sup>&#174;</sup>2-73 and its active metabolite ANAVEX<sup>&#174;</sup>19-144; or (ii) ANAVEX<sup>&#174;</sup>19-144. The second
of these two patents further claims a combination seizure treatment involving administration of an anti-epilepsy drug combined with (i)
ANAVEX<sup>&#174;</sup>19-144, or (ii) ANAVEX 19-144<sup>&#174;</sup> and ANAVEX 2-73<sup>&#174;</sup>. Both patents are expected to expire
in October 2035, absent any patent term extension for regulatory delays. We also own two issued U.S. patents with claims directed to treating
neurodevelopmental disorders. These patents claim methods for treating a neurodevelopmental disorder or multiple sclerosis by administering
ANAVEX<sup>&#174;</sup>2-73, ANAVEX<sup>&#174;</sup>19-144, and/or ANAVEX<sup>&#174;</sup>1-41 (another sigma receptor ligand similar to
ANAVEX<sup>&#174;</sup>2-73), or compositions thereof. Both patents are expected to expire in January 2037, absent any patent term extension
for regulatory delays. In addition, we own one issued U.S. Patent with claims directed to methods of treating melanoma with a compound
related to ANAVEX<sup>&#174;</sup>2-73. This patent is expected to expire in February 2030, absent any patent term extension for regulatory
delays. We also own an issued U.S. patent that claims crystalline forms of ANAVEX<sup>&#174;</sup>19-144, dosage forms and compositions
containing the crystalline forms of ANAVEX<sup>&#174;</sup>19-144, and methods of treatment for Alzheimer&#8217;s disease. This patent
is expected to expire in July 2036, absent any patent term extension for regulatory delays. Further, we own one issued U.S. Patent with
claims directed to methods of treating cardiac dysfunction with ANAVEX<sup>&#174;</sup>2-73 . This patent is expected to expire in July
2038, absent any patent term extension for regulatory delays.</p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify">We also own two issued U.S. patents related to ANAVEX<sup>&#174;</sup>1066.
The first of these two patents claims methods for treating or preventing pain using (+) ANAVEX<sup>&#174;</sup>1066 isomer. The second
patent claims methods for treating or preventing pain using (-) ANAVEX<sup>&#174;</sup>1066 isomer. Both patents are expected to expire
in November 2036, absent any patent term extension for regulatory delays.</p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify">For ANAVEX<sup>&#174;</sup>2-73, ANAVEX<sup>&#174;</sup>19-144,
ANAVEX<sup>&#174;</sup>1-41, and ANAVEX<sup>&#174;</sup>1066, we also have granted or pending applications in Australia, Canada, China,
Europe, Japan, and Hong Kong, which are expected to expire after 2035.</p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify">With regard to ANAVEX<sup>&#174;</sup>3-71, we own
exclusive rights to two issued U.S. patents with claims respectively directed to the ANAVEX<sup>&#174;</sup>3-71 compound and methods of
treating various diseases including Alzheimer&#8217;s with the same. These patents are expected to expire in April 2030, and January 2030,
respectively, absent any patent term extension for regulatory delays. We also own exclusive rights to related patents or applications
that are granted or pending in Australia, Canada, China, Europe, Japan, Korea, New Zealand, Russia, and South Africa, which are expected
to expire in January 2030.</p>

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

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

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify">We also own other patent applications directed to
enantiomers, crystals, formulations, uses, and patient selection methods that may provide additional protection for one or more of our
product candidates.</p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify">We regard patents and other intellectual property
rights as corporate assets. Accordingly, we attempt to optimize the value of intellectual property in developing our business strategy
including the selective development, protection, and exploitation of our intellectual property rights. In addition to filings made with
intellectual property authorities, we protect our intellectual property and confidential information by means of carefully considered
processes of communication and the sharing of information, and by the use of confidentiality and non-disclosure agreements and provisions
for the same in contractor&#8217;s agreements. While no agreement offers absolute protection, such agreements provide some form of recourse
in the event of disclosure, or anticipated disclosure.</p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; background-color: white"><span style="background-color: white">Our
intellectual property position, like that of many biomedical companies, is uncertain and involves complex legal and technical questions
for which important legal principles are unresolved. For more information regarding challenges to our existing or future patents, see
&#8220;Risk Factors&#8221; &#8220; in Part I, Item 1A of our Annual Report on Form 10-K filed with the Securities and Exchange Commission
on November 24, 2021.</span></p>

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

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

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

<p style="font: italic 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><span style="font-style: normal">We are in
the development stage and have not earned any revenues since our inception in 2004. We do not anticipate earning any revenues until we
can establish an alliance with other companies to develop, co-develop, license, acquire or market our products.</span></p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify">Our operating costs consist primarily of research
and development activities including the cost of clinical studies and clinical supplies as well as clinical drug manufacturing and formulation.
Research and development expenses also include personnel related costs such as salaries and wages, and third-party contract research
organization (CRO) expenses in support of these clinical studies. Personnel costs include salaries and wages, benefits, and non-cash
stock-based compensation charges associated with options and other equity awards granted to employees and consultants who are directly
engaged in support of our research and development activities.</p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify">General and administrative expenses consist
of personnel costs, expenses for outside professional services and expenses associated with operating as a public company. Personnel costs
consist of salaries and wages, benefits and stock-based compensation for general and administrative personnel. Outside professional services
and public company expenses include expenses related to compliance and reporting, additional insurance expenses, audit and SOX compliance,
expenses associated with patent research, applications and filings, investor and shareholder relations activities and other administrative
expenses and professional services.</p>

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

<p style="font: italic 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><span style="font-style: normal"><b>Three months
ended December 31, 2021 compared to three months ended December 31, 2020</b></span></p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify">During the three months ended December 31, 2021, we
completed our second randomized placebo-controlled clinical trial of <span style="background-color: white">ANAVEX<sup>&#174;</sup>2-73
for the treatment of Rett syndrome</span>, the AVATAR Phase 3 study, and reported positive top-line results from this study in February
2022, as described above under <i>Clinical Studies Overview &#8211; Rett Syndrome</i>. We continued to advance enrollment of our EXCELLENCE
international Phase 2/3 pediatric Rett syndrome clinical trial through the activation of additional clinical sites in new regions across
Canada.. We also completed the first in human Phase 1 clinical trial of ANAVEX<sup>&#174;</sup>3-71 with focus on the treatment of Frontotemporal
Dementia (FTD) and positive topline results were announced in January 2022, as described above under <i>Clinical Studies Overview &#8211;
Frontotemporal Dementia.</i></p>
<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify">&#160;&#160;</p>

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

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify">Total operating expenses for the first quarter of
fiscal 2022 were $11.7 million, compared to $9.4 million for the comparable first quarter of fiscal 2021.</p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify">General and administrative expenses were $3.1 million
for the three months ended December 31, 2021, as compared to $1.5 million for the first quarter of fiscal 2021. The increase is primarily
related to an increase in non-cash stock option compensation charges of $1.3 million period over period in connection with the vesting
of milestone-based options.</p>

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

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

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify">Our research and development expenses for the first
quarter of fiscal 2022 were $8.7 million, as compared to $7.9 million for the first quarter of fiscal 2021. The increase is primarily
related to an increase in non-cash stock option compensation charges of $1.7 million period over period in connection with the vesting
of milestone-based options.</p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><span style="background-color: white">We will
continue to see an increase in our research and development expenditures as we advance our ANAVEX<sup>&#174;</sup>2-73 clinical studies,
including extension studies to allow us to continue to gather longer term data, continuing to advance our other pipeline compounds such
as ANAVEX<sup>&#174;</sup>3-71, and as we continue to add additional staff to manage and support these clinical studies.</span></p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><i>Other income (net)</i></p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify">The net amount of other income for the first quarter
of fiscal 2022 was $0.9 million as compared to $1.6 million for the comparable first quarter of fiscal 2021. <span style="background-color: white">The
decrease in other income is attributable to a decrease in Australian research and development incentive income in connection with the
decrease in eligible clinical activities in Australia over the comparable period such as the completion of the </span>ANAVEX<sup>&#174;</sup>3-71
<span style="background-color: white">Phase 1 clinical study. </span></p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><span style="background-color: white">Foreign exchange
gains during the period are primarily related to the fluctuations in the Australian dollar against the US dollar and its related impact
on incentive and tax receivables during the period.</span></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"><i>Net loss</i></p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Net loss for the first quarter of fiscal 2022
was $10.9 million, or $0.14 per share, as compared to $7.9 million, or $0.12 per share in the comparative first quarter of fiscal 2021.</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"><b>Liquidity and Capital Resources </b></p>

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

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

<table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 100%">
  <tr style="vertical-align: bottom">
    <td style="text-align: center">&#160;</td><td style="font-weight: bold; padding-bottom: 1pt">&#160;</td>
    <td colspan="3" style="border-bottom: Black 1pt solid; font-weight: bold; text-align: center">December 31, 2021</td><td style="font-weight: bold; padding-bottom: 1pt">&#160;</td>
    <td colspan="3" style="border-bottom: Black 1pt solid; font-weight: bold; text-align: center">September 30, 2021</td></tr>
  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="width: 56%; text-align: left">Current Assets</td><td style="width: 8%">&#160;</td>
    <td style="width: 1%; text-align: left">$</td><td style="width: 12%; text-align: right">156,896,368</td><td style="width: 1%; text-align: left">&#160;</td><td style="width: 8%">&#160;</td>
    <td style="width: 1%; text-align: left">$</td><td style="width: 12%; text-align: right">161,616,490</td><td style="width: 1%; text-align: left">&#160;</td></tr>
  <tr style="vertical-align: bottom; background-color: White">
    <td style="text-align: left; padding-bottom: 1pt">Current Liabilities</td><td style="padding-bottom: 1pt">&#160;</td>
    <td style="border-bottom: Black 1pt solid; text-align: left">&#160;</td><td style="border-bottom: Black 1pt solid; text-align: right">10,528,662</td><td style="padding-bottom: 1pt; text-align: left">&#160;</td><td style="padding-bottom: 1pt">&#160;</td>
    <td style="border-bottom: Black 1pt solid; text-align: left">&#160;</td><td style="border-bottom: Black 1pt solid; text-align: right">10,798,386</td><td style="padding-bottom: 1pt; text-align: left">&#160;</td></tr>
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    <td style="text-align: left; padding-bottom: 1pt">Working Capital</td><td style="padding-bottom: 1pt">&#160;</td>
    <td style="border-bottom: Black 1pt solid; text-align: left">$</td><td style="border-bottom: Black 1pt solid; text-align: right">146,367,706</td><td style="padding-bottom: 1pt; text-align: left">&#160;</td><td style="padding-bottom: 1pt">&#160;</td>
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  </table>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><br />
At December 31, 2021, we held $151.1 million in cash and cash equivalents, a decrease of $1.0 million from September 30, 2021. Cash expenditures
for the quarter of approximately $7.0 million were offset by a net reduction of incentive and tax receivables of $3.8 million, resulting
in a net cash used in operating activities of $3.5 million for the quarter. We received cash from financing activities of $2.5 million
primarily from the issuance of shares of common stock under the Sales Agreement (as defined below).</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"><span style="background-color: white">We intend to continue to use our
capital resources to advance our clinical trials for ANAVEX<sup>&#174;</sup>2-73 and ANAVEX<sup>&#174;</sup>3-71, and to perform work necessary
to prepare for future development of our pipeline compounds.</span></p>

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

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

<table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 100%">
  <tr style="vertical-align: bottom">
    <td style="padding: 0pt 0pt 0pt 10pt; text-align: center; text-indent: -10pt">&#160;</td><td style="font-weight: bold">&#160;</td>
    <td colspan="7" style="font-weight: bold; text-align: center">Three months ended December 31,</td></tr>
  <tr style="vertical-align: bottom">
    <td style="padding: 0pt 0pt 0pt 10pt; text-align: center; text-indent: -10pt">&#160;</td><td style="font-weight: bold">&#160;</td>
    <td colspan="3" style="font-weight: bold; text-align: center">2021</td><td style="font-weight: bold">&#160;</td>
    <td colspan="3" style="font-weight: bold; text-align: center">2020</td></tr>
  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="padding: 0pt 0pt 0pt 10pt; width: 56%; text-align: left; text-indent: -10pt">Net cash flows used in operating activities</td><td style="width: 8%">&#160;</td>
    <td style="width: 1%; text-align: left">$</td><td style="width: 12%; text-align: right">(3,500,955</td><td style="width: 1%; text-align: left">)</td><td style="width: 8%">&#160;</td>
    <td style="width: 1%; text-align: left">$</td><td style="width: 12%; text-align: right">(7,871,378</td><td style="width: 1%; text-align: left">)</td></tr>
  <tr style="vertical-align: bottom; background-color: White">
    <td style="padding: 0pt 0pt 0pt 10pt; text-align: left; text-indent: -10pt">Net cash flows from financing activities</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">2,539,565</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">25,979,959</td><td style="text-align: left">&#160;</td></tr>
  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="padding: 0pt 0pt 0pt 10pt; text-align: left; text-indent: -10pt">(Decrease) increase in cash and cash equivalents</td><td>&#160;</td>
    <td style="text-align: left">$</td><td style="text-align: right">(961,390</td><td style="text-align: left">)</td><td>&#160;</td>
    <td style="text-align: left">$</td><td style="text-align: right">18,108,581</td><td style="text-align: left">&#160;</td></tr>
  </table>

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

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

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

<p style="font: italic 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Cash flow used in operating activities</p>

<p style="font: italic 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">Net cash used in operating activities for the
first quarter of fiscal 2022 was $3.5 million, compared to $7.9 million during the comparable period of fiscal 2021. The principal reason
for this decrease in net cash used in operating activities in the current period is due to the receipt of research and development incentive
tax refunds during the period, as compared to no such receipts during the comparable period.</p>

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

<p style="font: italic 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Cash flow provided by financing activities</p>

<p style="font: italic 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">Cash provided by financing activities for the
three months ended December 31, 2021 was $2.5 million, primarily attributable to cash received from the issuance of common shares at various
market prices under the Sales Agreement.</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"><span style="background-color: white">Cash provided
by financing activities for the three months ended December 31, 2020 was $26.0 million, attributable to cash received from the issuance
of common shares at various market prices under the 2019 Purchase Agreement and the Sales Agreement.</span></p>

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

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

<p style="font: italic bold 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; background-color: white"><b>Controlled Equity Offering
Sales Agreement </b></p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">On May 1, 2020, we entered into an Amended and Restated
Sales Agreement (the &#8220;Sales Agreement&#8221;) with Cantor Fitzgerald &amp; Co. and SVB Leerink LLC (the &#8220;Sales Agents&#8221;),
pursuant to which we may offer and sell shares of common stock registered under an effective registration statement from time to time
through the Sales Agents (the &#8220;At-the-Market Offering&#8221;).</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">Upon delivery of a placement notice based on our instructions
and subject to the terms and conditions of the Sales Agreement, the Sales Agents may sell shares of common stock by methods deemed to
be an &#8220;at the market offering&#8221;, in negotiated transactions at market prices prevailing at the time of sale or at prices related
to such prevailing market prices, or by any other method permitted by law, including negotiated transactions, subject to our prior written
consent. We are not obligated to make any sales of shares under the Sales Agreement. We or the Sales Agents may suspend or terminate the
At-the-Market Offering upon notice to the other party, subject to certain conditions. The Sales Agents will act as agents on a commercially
reasonable efforts basis consistent with their normal trading and sales practices and applicable state and federal law, rules and regulations
and the rules of Nasdaq.</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">We have agreed to pay the Sales Agents commissions
for their services of 3.0% of the gross proceeds from the sale of the shares pursuant to the Sales Agreement. We have also agreed to provide
the Sales Agents with customary indemnification and contribution rights.</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; background-color: white">During the three months ended
December 31, 2021, 99,588 shares were sold pursuant to the At-the-Market Offering for gross proceeds of $2.3 million (net proceeds of
$2.2 million after deducting commissions and offering expenses).</p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: white"><b>Off-Balance Sheet Arrangements</b></p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: white">We have no off-balance sheet
arrangements that have or are reasonably likely to have a current or future effect on our financial condition, changes in financial condition,
revenues or expenses, results of operations, liquidity, capital expenditures or capital resources that are material to our stockholders.</p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white"><b>CRITICAL ACCOUNTING POLICIES</b></p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: white">We prepare our interim condensed
consolidated financial statements in accordance with accounting principles generally accepted in the United States of America, and make
estimates and assumptions that affect our reported amounts of assets, liabilities, revenue and expenses, and the related disclosures of
contingent liabilities. We base our estimates on historical experience and other assumptions that we believe are reasonable in the circumstances.
Actual results may differ from these estimates.</p>

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

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

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: white">There have been no significant
changes in the critical accounting policies and estimates described in our Annual Report on Form 10-K for the year ended September 30,
2021 as filed with the SEC on November 24, 2021.</p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: white"><b>RECENT ACCOUNTING PRONOUNCEMENTS</b></p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: white">Please refer to Note 2 &#8220;Recent
Accounting Pronouncements&#8221; in notes to our Interim Condensed Consolidated Financial Statements included in this Form 10-Q.</p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: white"><span style="text-transform: uppercase"><b><span id="a_004"></span>ITEM
3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISKS.</b></span></p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: white">Not applicable</p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: white"><span style="text-transform: uppercase"><b><span id="a_005"></span>ITEM
4. CONTROLS AND PROCEDURES</b></span></p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: white"><b>Disclosure Controls and
Procedures</b></p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: white">We maintain disclosure controls
and procedures that are designed to provide reasonable assurance that material information required to be disclosed in our periodic reports
filed under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in the SEC&#8217;s rules
and forms and to provide reasonable assurance that such information is accumulated and communicated to our management, our chief executive
officer and our principal financial officer, to allow timely decisions regarding required disclosure.</p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: white">We carried out an evaluation,
under the supervision and with the participation of our management, including our principal executive officer and principal financial
officer, of the effectiveness of the design and operation of our disclosure controls and procedures, as defined in Rule 13a 15(e) under
the Exchange Act, as of the end of the period covered by this Quarterly Report on Form 10-Q. Based on this evaluation, our principal executive
officer and principal financial officer concluded that our disclosure controls and procedures were effective as of December 31, 2021.</p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: white"><b><i>Changes in Internal
Control over Financial Reporting</i></b></p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: white">During the quarter ended
December 31, 2021, the Company implemented a new Enterprise Resource Planning (&#8220;ERP&#8221;) system and integrated and digitized
certain aspects of its internal controls over financial reporting within this ERP.</p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: white">Other than as noted above,
there were no changes in our internal control over financial reporting identified in management&#8217;s evaluation pursuant to Rules 13a
15(d) or 15d 15(d) of the Exchange Act that materially affected, or are reasonably likely to materially affect, our internal controls
over financial reporting.</p>

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

<p style="font: bold 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-transform: uppercase; text-align: justify"><span id="a_006"></span>PART II &#8211; OTHER
INFORMATION</p>

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

<p style="font: bold 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-transform: uppercase; text-align: justify"><span id="a_007"></span>Item 1. Legal Proceedings.</p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: white"><span style="background-color: white">We
know of no material pending legal proceedings, other than ordinary routine litigation incidental to our business, to which our Company
or our subsidiary is a party or of which any of their property is subject. There are no proceedings in which any of our directors, officers
or affiliates, or any registered or beneficial stockholder holding more than 5% of our shares, is an adverse party or has a material interest
adverse to our or our subsidiary&#8217;s interest.</span></p>

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

<p style="font: bold 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-transform: uppercase; text-align: justify"><span id="a_008"></span>Item 1A. Risk Factors.</p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">There have been no material changes to the risk factors
discussed in &#8220;Risk Factors&#8221; in Part I, Item 1A of our Annual Report on Form 10-K for the fiscal year ended September 30, 2021
filed with the SEC on November 24, 2021.</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"></p>

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

<p style="font: bold 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-transform: uppercase; text-align: justify"><span id="a_009"></span>Item 2. Unregistered
Sales of Equity Securities and Use of Proceeds.</p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">During the period covered by this Quarterly
Report on Form 10-Q, we have not sold any equity securities that were not registered under the Securities Act of 1933 that were not previously
reported in a Current Report on Form 8-K.</p>

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

<p style="font: bold 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-transform: uppercase; text-align: justify"><span id="a_010"></span>Item 3. Defaults Upon
Senior Securities.</p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">None</p>

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

<p style="font: bold 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-transform: uppercase; text-align: justify"><span id="a_011"></span>Item 4. Mine Safety
Disclosures</p>

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

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

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

<p style="font: bold 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-transform: uppercase; text-align: justify"><span id="a_012"></span>Item 5. Other Information.</p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-transform: uppercase; text-align: justify"><span style="font-weight: normal; text-transform: none">None</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-transform: uppercase; text-align: justify"><span style="font-weight: normal; text-transform: none">&#160;</span></p>

<p style="font: bold 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-transform: uppercase; text-align: justify"><span id="a_013"></span>Item 6. Exhibits.</p>

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

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <tr style="vertical-align: top">
    <td style="border: Black 1pt solid; width: 12%; padding-right: 5.75pt; padding-left: 5.75pt"><b>Exhibit <br />
Number </b></td>
    <td style="border-top: Black 1pt solid; border-right: Black 1pt solid; border-bottom: Black 1pt solid; width: 88%; padding-right: 5.75pt; padding-left: 5.75pt"><b><br />
Description</b></td></tr>
  <tr style="vertical-align: top">
    <td style="border-right: Black 1pt solid; border-bottom: Black 1pt solid; border-left: Black 1pt solid; padding-right: 5.75pt; padding-left: 5.75pt"><b>(3) </b></td>
    <td style="border-right: Black 1pt solid; border-bottom: Black 1pt solid; padding-right: 5.75pt; padding-left: 5.75pt"><b>Articles of Incorporation and Bylaws </b></td></tr>
  <tr style="vertical-align: top">
    <td style="border-right: Black 1pt solid; border-bottom: Black 1pt solid; border-left: Black 1pt solid; padding-right: 5.75pt; padding-left: 5.75pt">3.1 </td>
    <td style="border-right: Black 1pt solid; border-bottom: Black 1pt solid; padding-right: 5.75pt; padding-left: 5.75pt"><a href="http://www.sec.gov/Archives/edgar/data/1314052/000173112221002062/e3306_ex3-1.htm">Articles of Incorporation (incorporated by reference to Exhibit 3.1 to our Annual Report on Form 10-K for the year ended September 30, 2021 filed on November 24, 2021)</a></td></tr>
  <tr style="vertical-align: top">
    <td style="border-right: Black 1pt solid; border-bottom: Black 1pt solid; border-left: Black 1pt solid; padding-right: 5.75pt; padding-left: 5.75pt">3.2 </td>
    <td style="border-right: Black 1pt solid; border-bottom: Black 1pt solid; padding-right: 5.75pt; padding-left: 5.75pt"><a href="http://www.sec.gov/Archives/edgar/data/1314052/000108503707002199/exhibit3_1.htm">Bylaws (incorporated by reference to our Current Report on Form 8-K filed on September 28, 2007)</a></td></tr>
  <tr style="vertical-align: top">
    <td style="border-right: Black 1pt solid; border-bottom: Black 1pt solid; border-left: Black 1pt solid; padding-right: 5.75pt; padding-left: 5.75pt"><b>(31) </b></td>
    <td style="border-right: Black 1pt solid; border-bottom: Black 1pt solid; padding-right: 5.75pt; padding-left: 5.75pt"><b>Rule 13a-14(a)/15(d)-14(a)Certifications</b></td></tr>
  <tr style="vertical-align: top">
    <td style="border-right: Black 1pt solid; border-bottom: Black 1pt solid; border-left: Black 1pt solid; padding-right: 5.75pt; padding-left: 5.75pt">31.1*</td>
    <td style="border-right: Black 1pt solid; border-bottom: Black 1pt solid; padding-right: 5.75pt; padding-left: 5.75pt"><a href="e3475_ex31-1.htm">Certification of Christopher Missling, PhD.</a></td></tr>
  <tr style="vertical-align: top">
    <td style="border-right: Black 1pt solid; border-bottom: Black 1pt solid; border-left: Black 1pt solid; padding-right: 5.75pt; padding-left: 5.75pt">31.2*</td>
    <td style="border-right: Black 1pt solid; border-bottom: Black 1pt solid; padding-right: 5.75pt; padding-left: 5.75pt"><a href="e3475_ex31-2.htm">Certification of Sandra Boenisch</a></td></tr>
  <tr style="vertical-align: top">
    <td style="border-right: Black 1pt solid; border-bottom: Black 1pt solid; border-left: Black 1pt solid; padding-right: 5.75pt; padding-left: 5.75pt"><b>(32) </b></td>
    <td style="border-right: Black 1pt solid; border-bottom: Black 1pt solid; padding-right: 5.75pt; padding-left: 5.75pt"><b>Section 1350 Certifications</b></td></tr>
  <tr style="vertical-align: top">
    <td style="border-right: Black 1pt solid; border-bottom: Black 1pt solid; border-left: Black 1pt solid; padding-right: 5.75pt; padding-left: 5.75pt">32.1*</td>
    <td style="border-right: Black 1pt solid; border-bottom: Black 1pt solid; padding-right: 5.75pt; padding-left: 5.75pt"><a href="e3475_ex32-1.htm">Certification of Christopher Missling, PhD and Sandra Boenisch.</a></td></tr>
  <tr style="vertical-align: top">
    <td style="border-right: Black 1pt solid; border-bottom: Black 1pt solid; border-left: Black 1pt solid; padding-right: 5.75pt; padding-left: 5.75pt"><b>(101)</b></td>
    <td style="border-right: Black 1pt solid; border-bottom: Black 1pt solid; padding-right: 5.75pt; padding-left: 5.75pt"><b>XBRL</b></td></tr>
  <tr style="vertical-align: top">
    <td style="border-right: Black 1pt solid; border-bottom: Black 1pt solid; border-left: Black 1pt solid; padding-right: 5.75pt; padding-left: 5.75pt">101.INS*</td>
    <td style="border-right: Black 1pt solid; border-bottom: Black 1pt solid; padding-right: 5.75pt; padding-left: 5.75pt">XBRL INSTANCE DOCUMENT</td></tr>
  <tr style="vertical-align: top">
    <td style="border-right: Black 1pt solid; border-bottom: Black 1pt solid; border-left: Black 1pt solid; padding-right: 5.75pt; padding-left: 5.75pt">101.SCH*</td>
    <td style="border-right: Black 1pt solid; border-bottom: Black 1pt solid; padding-right: 5.75pt; padding-left: 5.75pt">XBRL TAXONOMY EXTENSION SCHEMA</td></tr>
  <tr style="vertical-align: top">
    <td style="border-right: Black 1pt solid; border-bottom: Black 1pt solid; border-left: Black 1pt solid; padding-right: 5.75pt; padding-left: 5.75pt">101.CAL*</td>
    <td style="border-right: Black 1pt solid; border-bottom: Black 1pt solid; padding-right: 5.75pt; padding-left: 5.75pt">XBRL TAXONOMY EXTENSION CALCULATION LINKBASE</td></tr>
  <tr style="vertical-align: top">
    <td style="border-right: Black 1pt solid; border-bottom: Black 1pt solid; border-left: Black 1pt solid; padding-right: 5.75pt; padding-left: 5.75pt">101.DEF*</td>
    <td style="border-right: Black 1pt solid; border-bottom: Black 1pt solid; padding-right: 5.75pt; padding-left: 5.75pt">XBRL TAXONOMY EXTENSION DEFINITION LINKBASE</td></tr>
  <tr style="vertical-align: top">
    <td style="border-right: Black 1pt solid; border-bottom: Black 1pt solid; border-left: Black 1pt solid; padding-right: 5.75pt; padding-left: 5.75pt">101.LAB*</td>
    <td style="border-right: Black 1pt solid; border-bottom: Black 1pt solid; padding-right: 5.75pt; padding-left: 5.75pt">XBRL TAXONOMY EXTENSION LABEL LINKBASE</td></tr>
  <tr style="vertical-align: top">
    <td style="border-right: Black 1pt solid; border-bottom: Black 1pt solid; border-left: Black 1pt solid; padding-right: 5.75pt; padding-left: 5.75pt">101.PRE*</td>
    <td style="border-right: Black 1pt solid; border-bottom: Black 1pt solid; padding-right: 5.75pt; padding-left: 5.75pt">XBRL TAXONOMY EXTENSION PRESENTATION LINKBASE</td></tr>
  </table>
<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">* Filed herewith.</p>

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

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

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

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

<p style="font: bold 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-transform: uppercase; text-align: center"><span id="a_014"></span>SIGNATURES</p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Pursuant to the requirements of the Securities
Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.</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"><b>ANAVEX LIFE SCIENCES CORP. </b></p>

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

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

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

<hr style="border-width: 0; color: Gray; background-color: Gray; height: 1px; width: 40%; margin-top: 3pt; margin-bottom: 3pt" />
<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Christopher Missling, PhD</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 219.75pt; text-indent: -219.75pt; background-color: white">Chief
Executive Officer</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">(Principal Executive Officer)</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Date: February 9, 2022</p>

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

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 219.75pt; text-indent: -219.75pt; background-color: white">Principal
Financial Officer</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">(Principal Financial and Accounting Officer)</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Date: February 9, 2022</p>

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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-Q
(Mark
One)
☒
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the quarterly period ended:
December 31, 2021
☐
TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the transition period from _____to _____
Commission
File Number:
001-37606
ANAVEX LIFE SCIENCES CORP.
(Exact
name of registrant as specified in its charter)
Nevada
98-0608404
(State or other jurisdiction of
(IRS Employer
incorporation or organization)
Identification No.)
630 5th Avenue
,
20th Floor
,
New York
,
NY
USA
10111
(Address
of principal executive offices) (Zip Code)
1-
844
-
689-3939
(Registrant's
telephone number, including area code)
Securities
Registered Pursuant to Section 12(b) of the Act:
Title
    of Each Class
Trading
    Symbol
Name
    of Each Exchange on Which Registered
Common Stock Par Value $0.001
AVXL
The
NASDAQ
Stock Market LLC
Indicate
by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange
Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2)
has been subject to such filing requirements for the past 90 days.
☒
Yes
☐  No
Indicate
by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule
405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant
was required to submit such files).
☒
Yes
☐  No
Indicate
by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting
company, or an emerging growth company. See the definitions of "large accelerated filer," "accelerated filer,"
"smaller reporting company," and "emerging growth company" in Rule 12b-2 of the Exchange Act.
Large accelerated filer
☒
Accelerated filer
☐
Non-accelerated filer
☐
Smaller reporting company
☐
Emerging growth company
☐
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act
☐
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).
☐  Yes  ☒
No
Indicate
the number of shares outstanding of each of the issuer's classes of common stock, as of the latest practicable date:
76,174,887
shares of common stock outstanding as of February 8, 2022.
i
TABLE OF CONTENTS
PART I - FINANCIAL INFORMATION	PART I - FINANCIAL INFORMATION
4
Item 1.
FINANCIAL STATEMENTS
4
Item 2.
Management's Discussion and Analysis of Financial Condition and Results of Operations.
19
Item 3.
Quantitative and Qualitative Disclosures about Market Risks.
34
Item 4.
Controls and Procedures.
34
PART II – OTHER INFORMATION
34
Item 1.
Legal Proceedings.
34
Item 1A.
Risk Factors.
34
Item 2.
Unregistered Sales of Equity Securities and Use of Proceeds.
35
Item 3.
Defaults Upon Senior Securities.
35
Item 4.
Mine Safety Disclosures
35
Item 5.
Other Information.
35
Item 6.
Exhibits.
35
SIGNATURES
36
ii
PART I - FINANCIAL
INFORMATION
Item 1. FINANCIAL
STATEMENTS
Anavex Life Sciences Corp.
Interim Condensed Consolidated Financial Statements
December 31, 2021
(Unaudited)
4
Anavex Life Sciences Corp.
Interim Condensed Consolidated
Balance Sheets
As at December 31,
2021 and September 30, 2021
December 31,
September 30,
2021
2021
(Unaudited)
Assets
Current assets
Cash and cash equivalents
$
151,146,355
$
152,107,745
Incentive and tax receivables
5,372,153
9,136,831
Prepaid expenses and other current assets
377,860
371,914
Total assets
$
156,896,368
$
161,616,490
Liabilities and stockholders' equity
Current Liabilities
Accounts payable
$
4,634,791
$
4,739,781
Accrued liabilities (Note 4)
5,450,040
5,614,774
Deferred grant income
443,831
443,831
Total liabilities
10,528,662
10,798,386
Commitments and Contingencies - Note 6
Stockholders' equity
Capital stock
Authorized:
10,000,000
preferred stock, par value $
0.001
per share
-
-
200,000,000
common stock, par value $
0.001
per share
Issued and outstanding:
76,155,187
common shares
(September 30, 2021 -
75,918,465
)
76,156
75,920
Additional paid-in capital
354,759,781
348,328,048
Accumulated deficit
(
208,468,231
)
(
197,585,864
)
Total stockholders' equity
146,367,706
150,818,104
Total liabilities and stockholders' equity
$
156,896,368
$
161,616,490
See Accompanying Notes to Condensed Consolidated Interim Financial Statements
5
Anavex Life Sciences
Corp.
Interim Condensed Consolidated
Statements of Operations
and Comprehensive Loss
For the three months ended December 31,
2021 and 2020 (Unaudited)
2021
2020
Operating expenses
General and administrative
$
3,066,951
$
1,470,656
Research and development
8,656,439
7,925,519
Total operating expenses
(
11,723,390
)
(
9,396,175
)
Other income (expenses)
Research and development incentive income
810,730
1,269,316
Interest income (expense), net
4,910
(
1,559
)
Foreign exchange gain, net
55,363
332,634
Total other income, net
871,003
1,600,391
Net loss before provision for income taxes
(
10,852,387
)
(
7,795,784
)
Income tax expense, current
(
29,980
)
(
59,281
)
Net loss and comprehensive loss
$
(
10,882,367
)
$
(
7,855,065
)
Net Loss per share
Basic and diluted
$
(
0.14
)
$
(
0.12
)
Weighted average number of shares outstanding
Basic and diluted
75,997,738
64,295,143
See Accompanying Notes to Condensed Consolidated Interim Financial Statements
6
Anavex Life Sciences
Corp.
Interim Condensed Consolidated
Statement of Changes in Stockholders' Equity
For the three months ended December 31, 2021 and 2020
Common Stock
Additional
Paid-in
Accumulated
Shares
Par Value
Capital
Deficit
Total
Balance, October 1, 2021
75,918,465
75,920
348,328,048
$
(
197,585,864
)
150,818,104
Shares issued pursuant to exercise of stock options
137,134
137
373,360
—
373,497
Shares issued under Sales Agreement, net of share issuance costs
99,588
99
2,149,602
—
2,149,701
Share based compensation
—
—
3,908,771
—
3,908,771
Net loss
—
—
—
(
10,882,367
)
(
10,882,367
)
Balance, December 31, 2021
76,155,187
$
76,156
$
354,759,781
$
(
208,468,231
)
$
146,367,706
Balance, October 1, 2020
62,045,198
$
62,047
$
186,851,752
$
(
159,677,230
)
$
27,236,569
Shares issued under 2019 purchase agreement
-
-
-
Purchase shares
3,346,288
3,346
17,458,056
—
17,461,402
Commitment shares
56,642
56
(
56
)
—
—
Shares issued under Sales Agreement, net of share issuance costs
1,514,829
1,515
8,517,042
—
8,518,557
Share based compensation
—
—
939,314
—
939,314
Net loss
—
—
—
(
7,855,065
)
(
7,855,065
)
Balance, December 31, 2020
66,962,957
$
66,964
$
213,766,108
$
(
167,532,295
)
$
46,300,777
See Accompanying Notes to Condensed
Consolidated Interim Financial Statements
7
Anavex Life Sciences
Corp.
Interim Condensed Consolidated
Statements of Cash Flows
For the three months ended
December 31, 2021 and 2020
(Unaudited)
2021
2020
Cash flows used in operating activities
Net loss
$
(
10,882,367
)
$
(
7,855,065
)
Adjustments to reconcile net loss to net cash used in operations:
Stock-based compensation
3,908,771
939,314
Changes in non-cash working capital balances related to operations:
Incentive and tax receivables
3,764,678
(
1,728,467
)
Prepaid expenses and other current assets
(
22,311
)
44,999
Accounts payable
(
104,992
)
227,894
Accrued liabilities
(
164,734
)
499,947
Net cash used in operating activities
(
3,500,955
)
(
7,871,378
)
Cash flows provided by financing activities
Issuance of common shares
2,312,785
26,243,419
Share issue costs
(
146,717
)
(
263,460
)
Proceeds from exercise of stock options
373,497
—
Net cash provided by financing activities
2,539,565
25,979,959
(Decrease) increase in cash and cash equivalents during
    the period
(
961,390
)
18,108,581
Cash and cash equivalents, beginning of period
152,107,745
29,249,018
Cash and cash equivalents, end of period
$
151,146,355
$
47,357,599
Supplemental Cash Flow Information
Cash paid for state and local minimum income taxes
$
—
$
—
See Accompanying Notes to Condensed Consolidated Interim Financial Statements
8
Anavex Life Sciences Corp.
Notes to the Condensed Consolidated Interim Financial Statements
December 31, 2021
(Unaudited)
Note 1
Description of Business and Basis of Presentation
Description of
Business
Anavex Life Sciences Corp. ("Anavex"
or the "Company") is a clinical stage biopharmaceutical company engaged in the development of differentiated therapeutics
by applying precision medicine to central nervous system ("CNS") diseases with high unmet need. Anavex analyzes genomic data
from clinical studies to identify biomarkers, which are used to select patients that will receive the therapeutic benefit for the treatment
of neurodegenerative and neurodevelopmental diseases. The Company's lead compound ANAVEX
®
2-73 is being developed
to treat Alzheimer's disease, Parkinson's disease and potentially other central nervous system diseases, including rare diseases,
such as Rett syndrome, a rare severe neurological monogenic disorder caused by mutations in the X-linked gene, methyl-CpG-binding protein
2 ("MECP2").
Basis of Presentation
These unaudited interim condensed consolidated
financial statements have been prepared pursuant to the rules and regulations of the Securities and Exchange Commission ("SEC")
and accounting principles generally accepted in the United States of America ("U.S. GAAP") for interim reporting. Accordingly,
certain information and note disclosures normally included in the annual financial statements in accordance with U.S. GAAP have been condensed
or omitted pursuant to such rules and regulations. In the opinion of management, the disclosures are adequate to make the information
presented not misleading.
These accompanying unaudited interim condensed
consolidated financial statements reflect all adjustments, consisting of normal recurring adjustments, which in the opinion of management
are necessary for fair presentation of the information contained herein. The consolidated balance sheet as of September 30, 2021 was derived
from the audited annual financial statements but does not include all disclosures required by U.S. GAAP. The accompanying unaudited interim
condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes
thereto included in the Company's annual report on Form 10-K for the year ended September 30, 2021 filed with the SEC on November
24, 2021. The Company follows the same accounting policies in the preparation of interim reports.
Operating results for the three months
ended December 31, 2021 are not necessarily indicative of the results that may be expected for the year ending September 30, 2022.
Liquidity
All of the Company's potential drug
compounds are in the clinical development stage and the Company cannot be certain that its research and development efforts will be successful
or, if successful, that its potential drug compounds will ever be approved for sales to pharmaceutical companies or generate commercial
revenues. To date, we have not generated any revenues from our operations. The Company expects the business to continue to experience
negative cash flows for the foreseeable future and cannot predict when, if ever, our business might become profitable.
9
Anavex Life Sciences Corp.
Notes to the Condensed Consolidated Interim Financial Statements
December 31, 2021
(Unaudited)
Note 1
Description of Business and Basis of
Presentation
– (Continued)
Management believes that the current working
capital position will be sufficient to meet the Company's working capital requirements beyond the next 12 months after the date
that these interim condensed consolidated financial statements are issued. The process of drug development can be costly, and the timing
and outcomes of clinical trials is uncertain. The assumptions upon which the Company has based its estimates are routinely evaluated
and may be subject to change. The actual amount of the Company's expenditures will vary depending upon a number of factors
including but not limited to the design, timing and duration of future clinical trials, the progress of the Company's research and
development programs and the level of financial resources available. The Company has the ability to adjust its operating plan spending
levels based on the timing of future clinical trials.
Other than our rights related to the Sales
Agreement (as defined below in Note 5), there can be no assurance that additional financing will be available to us when needed or, if
available, that it can be obtained on commercially reasonable terms. If the Company is not able to obtain the additional financing on
a timely basis, if and when it is needed, it will be forced to delay or scale down some or all of its research and development activities.
Coronavirus Disease 2019 (COVID-19)
The recent global outbreak of COVID-19
has not had a material impact on the Company's result of operations or financial condition as of December 31, 2021. However, the
pandemic continues to rapidly evolve as of the date these consolidated financial statements are issued and has created a dynamic and uncertain
situation in the global economy. As such, it is uncertain as to the full magnitude that the outbreak will have on the Company's
financial condition and future results of operations. Management is actively monitoring the global situation on its business, including
on its clinical trials and operations and financial condition. Given the daily evolution of the COVID-19 situation, and the global responses
to curb its spread, the Company is not able to estimate the effects COVID-19 may have on its future results of operations or financial
condition.
Use
of Estimates
The preparation of financial
statements in accordance with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of
assets and liabilities at the date of the financial statements and the reported amounts of revenue and expenses in the reporting
period. The Company regularly evaluates estimates and assumptions related to accounting for research and development costs,
incentive income receivable, valuation and recoverability of deferred tax assets, asset impairment, stock-based compensation, and
loss contingencies. The Company bases its estimates and assumptions on current facts, historical experience, and various other
factors that it believes to be reasonable under the circumstances, the results of which form the basis for making judgments about
the carrying values of assets and liabilities and the accrual of costs and expenses that are not readily apparent from other
sources. The actual results experienced by the Company may differ materially and adversely from the Company's estimates. To
the extent there are material differences between the estimates and the actual results, future results of operations will be
affected.
10
Anavex Life Sciences Corp.
Notes to the Condensed Consolidated Interim Financial Statements
December 31, 2021
(Unaudited)
Note 1
Description of Business and Basis of
Presentation
– (Continued)
Principles of Consolidation
These consolidated financial statements
include the accounts of Anavex Life Sciences Corp. and its wholly-owned subsidiaries, Anavex Australia Pty Limited. ("Anavex Australia"),
a company incorporated under the laws of Australia, Anavex Germany GmbH, a company incorporated under the laws of Germany, and Anavex
Canada Ltd., a company incorporated under the laws of the Province of Ontario, Canada. All inter-company transactions and balances have
been eliminated.
Fair
Value Measurements
The fair value hierarchy under GAAP is
based on three levels of inputs, of which the first two are considered observable and the last unobservable, that may be used to measure
fair value which are the following:
Level 1 - 	quoted
prices (unadjusted) in active markets for identical assets or liabilities;
Level 2 - observable
inputs other than Level 1, quoted prices for similar assets or liabilities in active 		markets, quoted prices for identical or similar
assets and liabilities in markets that are not active, and model-derived prices whose inputs are observable or whose significant value
drivers are observable; and
Level 3 - 	assets
and liabilities whose significant value drivers are unobservable by little or no market activity and that are significant to the fair
value of the assets or liabilities.
The book value of cash and cash equivalents
and accounts payable and accrued liabilities approximate their fair values due to the short-term maturity of those instruments.
At December 31, 2021 and September 30,
2021, the Company did not have any Level 3 assets or liabilities.
Basic
and Diluted Loss per Share
Basic income/(loss) per common share is
computed by dividing net income/(loss) available to common stockholders by the weighted average number of common shares outstanding during
the period. Diluted income/(loss) per common share is computed by dividing net income/(loss) available to common stockholders by the sum
of (1) the weighted-average number of common shares outstanding during the period, (2) the dilutive effect of the assumed exercise of
options and warrants using the treasury stock method and (3) the dilutive effect of other potentially dilutive securities. For purposes
of the diluted net loss per share calculation, options and warrants are potentially dilutive securities and are excluded from the calculation
of diluted net loss per share because their effect would be anti-dilutive.
As of December 31, 2021, loss per share
excludes
11,403,769
(September 30, 2021 –
11,540,903
) potentially dilutive common shares related to outstanding options and warrants,
as their effect was anti-dilutive.
11
Anavex Life Sciences Corp.
Notes to the Condensed Consolidated Interim Financial Statements
December 31, 2021
(Unaudited)
Note 2
Recent Accounting Pronouncements
Recently Adopted
Accounting Pronouncements
Effective October
1, 2021, the Company adopted ASU 2019-12, "Simplifying the Accounting for Income Taxes (ASC 740)", which is intended to simplify
various aspects related to accounting for income taxes by removing certain exceptions to the general principles in Topic 740 and clarifying
and amending existing guidance to improve consistent application. There was no material impact on the Company's operations, financial
condition, or cash flows.
Note 3
Other Income
Grant Income
During the year
ended September 30, 2021, the Company received $
497,931
of a $995,862 research grant awarded by the Michael J. Fox Foundation for Parkinson's
Research. The grant will be used to fund a clinical trial of the Company's lead compound, ANAVEX
®
2-73 related to
Parkinson's disease.
The grant income
is being deferred when received and amortized to other income as the related research and development expenditures are incurred. During
the three months ended December 31, 2021 and 2020, the Company did not recognize any of this grant on its statements of operations. At
December 31, 2021, an amount of $
443,831
(September 30, 2021: $
443,831
) of this grant is recorded as deferred grant income, representing
the amount of this grant which has not yet been amortized to other income. The Company will recognize this income on its statement of
operations as the relating expenditures are incurred to offset the income.
Research and development
incentive income
Research and development
incentive income represents the receipt by Anavex Australia, of the Australian research and development incentive credit, (the "R&D
Incentive Credit").
During the three
months ended December 31, 2021, the Company recorded research and development incentive income of $
810,730
(AUD
1,116,362
) (2020: $
1,269,316
(AUD
1,735,962
)) in respect of the R&D Incentive Credit for eligible research and development expenses incurred during the period.
Note 4
Accrued liabilities
The principal components of accrued liabilities consists of:
December 31,
September 31,
2021
2021
Clinical site costs and patient visits
$
1,689,740
$
2,035,800
Accrued compensation and benefits
1,205,186
1,201,903
Fixed contract accruals
359,424
649,649
All other accrued liabilities
2,195,690
1,727,422
Total accrued liabilities
$
5,450,040
$
5,614,774
12
Anavex Life Sciences Corp.
Notes to the Condensed Consolidated Interim Financial Statements
December 31, 2021
(Unaudited)
Note 5
Equity Offerings
Common Stock
Common shares are voting and are entitled
to dividends as declared at the discretion of the Board of Directors.
Preferred Stock
The Company's Board of Directors
(the "Board") has the authority to issue preferred stock in one or more series and to fix the rights, preferences, privileges,
restrictions and the number of shares constituting any series of the designation of the series.
Sales Agreement
The Company entered into a Controlled
Equity Offering Sales Agreement on July 6, 2018, which was amended and restated on May 1, 2020 (the "Sales Agreement") with
Cantor Fitzgerald & Co. and SVB Leerink LLC (together the "Sales Agents"), pursuant to which the Company may offer
and sell shares of common stock registered under an effective registration statement from time to time through the Sales Agents (the "Offering").
Upon delivery of a placement notice based
on the Company's instructions and subject to the terms and conditions of the Sales Agreement, the Sales Agents may sell the Shares
by methods deemed to be an "at the market offering" offering, in negotiated transactions at market prices prevailing at the
time of sale or at prices related to such prevailing market prices, or by any other method permitted by law, including negotiated transactions,
subject to the prior written consent of the Company. The Company is not obligated to make any sales of Shares under the Sales Agreement.
The Company or Sales Agents may suspend or terminate the offering of Shares upon notice to the other party, subject to certain conditions.
The Sales Agents will act as agent on a commercially reasonable efforts basis consistent with their normal trading and sales practices
and applicable state and federal law, rules and regulations and the rules of Nasdaq.
The Company has agreed to pay the Sales
Agents commissions for their services of up to 3.0% of the gross proceeds from the sale of the Shares pursuant to the Sales Agreement.
The Company also agreed to provide the Sales Agents with customary indemnification and contribution rights. During the three months ended
December 31, 2021,
99,588
shares were sold pursuant to the Offering for gross proceeds of $
2,312,785
(net proceeds of $
2,149,701
after
deducting offering expenses) (December 31, 2020:
1,514,829
shares were sold for gross proceeds of $
8,782,017
(net proceeds of $
8,518,557
)).
At December 31, 2021, an amount of $
161,079,765
(September 30, 2021: $
163,392,550
) was registered pursuant to an effective registration
statement and remained available to be sold under the Sales Agreement.
13
Anavex Life Sciences Corp.
Notes to the Condensed Consolidated Interim Financial Statements
December 31, 2021
(Unaudited)
Note 5
Equity Offerings
– (continued)
2019 Purchase Agreement
On June 7, 2019, the Company entered into
a $
50,000,000
purchase agreement (the "2019 Purchase Agreement") with Lincoln Park, as amended on July 1, 2020, pursuant to
which the Company had the right to sell and issue to Lincoln Park, and Lincoln Park was obligated to purchase, up to $
50,000,000
in value
of its shares of common stock from time to time over a three-year period until July 1, 2022.
In consideration for entering into the
2019 Purchase Agreement, the Company issued to Lincoln Park 324,383 shares of common stock as a commitment fee during the year ended September
30, 2019 and agreed to issue up to
162,191
shares pro rata, when and if, Lincoln Park purchased, at the Company's discretion, the
$50,000,000 aggregate commitment.
At December 31, 2021 and September 30,
2021, no shares remained available for issuance under the 2019 Purchase Agreement. During the three months ended December 31, 2020, the
Company issued to Lincoln Park an aggregate of
3,402,930
shares of common stock including
3,346,288
shares of common stock for an aggregate
purchase price of $
17,461,402
and
56,642
commitment shares.
Note 6
Commitments and Contingencies
a)
Leases
During the
three months ended December 31, 2021, the Company incurred office lease expense of $
4,845
(2020: $
68,387
).
b)
Employee 401(k) Benefit Plan
The Company
has a defined-contribution savings plan under Section 401(k) of the Internal Revenue Code. The plan covers all United States based employees.
United States based employees eligible to participate in the plan may contribute up to the current statutory limits under the Internal
Revenue Service regulations. The 401(k) plan permits the Company to make additional matching contributions on behalf of contributing employees.
During the three months ended December 31, 2021, the Company made $
22,682
(2020: $
16,556
) in matching contributions under the 401(k) plan.
c)
Litigation
The Company
is subject to claims and legal proceedings that arise in the ordinary course of business. Such matters are inherently uncertain, and
there can be no guarantee that the outcome of any such matter will be decided favorably to the Company or that the resolution of any
such matter will not have a material adverse effect upon the Company's consolidated financial statements. The Company does not
believe that any of such pending claims and legal proceedings will have a material adverse effect on its consolidated financial statements.
14
Anavex Life Sciences Corp.
Notes to the Condensed Consolidated Interim Financial Statements
December 31, 2021
(Unaudited)
Note 6
Commitments and Contingencies
– (Continued)
d)
Share Purchase Warrants
A summary of the status of the Company's
outstanding share purchase warrants is presented below:
Weighted
Number of
Average Exercise
Shares
Price ($)
Balance, September 30, 2020
500,000
3.88
Granted
60,000
12.00
Exercised
(
350,000
)
4.19
Balance, September 30, 2021
210,000
5.69
Forfeited
(
50,000
)
12.00
Balance, December 31, 2021
160,000
3.72
At December 31, 2021,
the Company had share purchase warrants outstanding as follows:
Number
Exercise Price
Expiry Date
150,000
$
3.17
May 6, 2024
10,000
$
12.00
April 21, 2026
160,000
e)
Stock–based Compensation Plan
2015 Stock Option Plan
On September 18, 2015, the Company's
Board approved a 2015 Omnibus Incentive Plan (the "2015 Plan"), which provided for the grant of stock options and restricted
stock awards to directors, officers, employees and consultants of the Company.
The maximum number of our common shares reserved
for issue under the plan was
6,050,553
shares, subject to adjustment in the event of a change of the Company's capitalization. At
December 31, 2021,
146,371
(September 30, 2021:
146,371
) options remain available for issue under the 2015 Plan.
15
Anavex Life Sciences Corp.
Notes to the Condensed Consolidated Interim Financial Statements
December 31, 2021
(Unaudited)
Note 6
Commitments and Contingencies
– (Continued)
e)
Stock-based Compensation Plan – (Continued)
2019 Stock Option Plan
On January 15, 2019, the Board approved the
2019 Omnibus Incentive Plan (the "2019 Plan"), which provides for the grant of stock options and restricted stock awards to
directors, officers, employees, consultants and advisors of the Company. Under the terms of the 2019 Plan,
6,000,000
additional shares
of Common Stock are available for issuance under the 2019 Plan, in addition to the shares available under the 2015 Plan. Any awards outstanding
under the 2015 Plan or the Company's 2007 Stock Option Plan (the "2007 Plan") will remain subject to and be paid under
the 2015 Plan or the 2007 Plan, respectively, and any shares subject to outstanding awards under the 2015 Plan or the 2007 Plan that subsequently
cease to be subject to such awards (other than by reason of settlement of the awards in shares) will automatically become available for
issuance under the 2019 Plan.
The 2019 Plan provides that it may be administered
by the Board, or the Board may delegate such responsibility to a committee. The exercise price will be determined by the Board at the
time of grant shall be at least equal to the fair market value on such date. If the grantee is a 10% stockholder on the grant date, then
the exercise price shall not be less than 110% of fair market value of the Company's shares of common stock on the grant date. Stock
options may be granted under the 2019 Plan for an exercise period of up to ten years from the date of grant of the option or such lesser
periods as may be determined by the board, subject to earlier termination in accordance with the terms of the 2019 Plan. At December 31,
2021,
406,332
(September 30, 2021:
456,332
) options remain available for issue under the 2019 Plan.
A summary of the status of Company's
outstanding stock options is presented below:
Weighted
Weighted
Average
Average Grant
Aggregate
Number of
Exercise Price
Date Fair
intrinsic value
Shares
($)
Value ($)
($)
Outstanding, September 30, 2020
10,076,266
3.48
14,982,581
Granted
2,732,000
12.55
9.32
Forfeited
(
55,834
)
3.04
2.43
Exercised
(
1,421,529
)
2.89
2.43
24,446,305
Outstanding, September 30, 2021
11,330,903
5.74
140,132,451
Granted
50,000
19.64
15.52
Exercised
(
137,134
)
2.72
2.12
2,276,948
Outstanding, December 31, 2021
11,243,769
5.84
132,001,363
Exercisable, December 31, 2021
8,294,684
3.75
112,870,598
16
Anavex Life Sciences Corp.
Notes to the Condensed Consolidated Interim Financial Statements
December 31, 2021
(Unaudited)
Note 6
Commitments and Contingencies
– (Continued)
e)
Stock-based Compensation Plan – (Continued)
The following summarizes information about
stock options at December 31, 2021 by a range of exercise prices:
Weighted
average
Weighted
Weighted
Range of exercise
Number of
remaining
average
average
prices
outstanding
contractual
exercise
Number of
exercise
From
To
options
life (in years)
price
vested options
price
$
0.92
$
2.96
4,172,215
5.94
2.29
4,049,714
2.29
$
3.15
$
4.80
2,117,500
6.08
3.30
1,837,500
3.29
$
5.04
$
8.98
3,397,054
6.20
6.05
2,347,054
6.30
$
12.00
$
13.01
230,000
9.27
12.44
39,166
12.38
$
17.03
$
24.58
1,327,000
9.58
19.35
21,250
24.24
11,243,769
8,294,684
The weighted average grant date fair value
of options vested during the three months ended December 31, 2021 was $
2.85
(2020: $
2.40
). At December 31, 2021, the weighted average
contractual life of options outstanding was
6.54
years (September 30, 2021:
6.79
years) and for options exercisable was
5.31
years (September
30, 2021:
5.51
years).
The aggregate intrinsic value is calculated
as the difference between the exercise price of the underlying awards and the quoted market price of the Company's stock for the
options that were in-the-money at December 31, 2021.
During the three months ended December 31,
2021, the Company recognized stock-based compensation expense of $
3,908,771
(2020: $
939,314
) in connection with the issuance and vesting
	of stock options and warrants in exchange for services. These amounts have been included in general and 	administrative expenses
and research and development expenses on the Company's statement of 	operations as follows:
2021
2020
General and administrative
$
1,671,726
$
422,823
Research and development
2,237,046
516,491
Total stock-based compensation
$
3,908,771
$
939,314
An amount of approximately $
18,170,000
in
stock-based compensation is expected to be recorded over the remaining term 	of such options through fiscal 2025.
17
Anavex Life Sciences Corp.
Notes to the Condensed Consolidated Interim Financial Statements
December 31, 2021
(Unaudited)
Note 6
Commitments and Contingencies
– (Continued)
e)
Stock-based Compensation Plan – (Continued)
The fair value of each option
award granted during the three months ended December 31, 2021 and 2020 is estimated on the date of grant using the Black Scholes option
pricing model based on the following weighted average assumptions:
2021
2020
Risk-free interest rate
1.37
%
0.62
%
Expected life of options (years)
6.50
5.59
Annualized volatility
96.79
%
96.16
%
Dividend rate
0.00
%
0.00
%
The fair value of stock compensation charges
recognized during the three months ended December 31, 2021 and 2020 was determined with reference to the quoted market price of the Company's
shares on the grant date.
18
Item 2. Management's
Discussion and Analysis of Financial Condition and Results of Operations.
Forward-Looking Statements
This Quarterly Report on Form 10-Q includes forward-looking
statements. All statements other than statements of historical facts contained in this Quarterly Report on Form 10-Q, including statements
regarding our anticipated future clinical and regulatory milestone events, future financial position, business strategy and plans and
objectives of management for future operations, are forward-looking statements. The words "believe," "may," "estimate,"
"continue," "anticipate," "intend," "expect" "should," "forecast,"
"could," "suggest," "plan" and similar expressions, as they relate to us, are intended to identify
forward-looking statements. Such forward-looking statements include, without limitation, statements regarding:
●
volatility
    in our stock and in the markets in general;
●
our
    ability to successfully conduct clinical and preclinical trials for our product candidates;
●
our
    ability to raise additional capital on favorable terms and the impact of such activities on our stockholders and stock price;
●
the
    impact of the COVID-19 outbreak and its effect on us;
●
our
    ability to generate any revenue or to continue as a going concern;
●
our
    ability to execute our research and development plan on time and on budget;
●
our
    products ability to demonstrate efficacy or an acceptable safety profile of our product candidates;
●
our
    ability to obtain the support of qualified scientific collaborators;
●
our
    ability, whether alone or with commercial partners, to successfully commercialize any of our product candidates that may be approved
    for sale;
●
our
    ability to identify and obtain additional product candidates;
●
our
    reliance on third parties in non-clinical and clinical studies;
●
our
    ability to defend against product liability claims;
●
our
    ability to safeguard against security breaches;
●
our
    ability to obtain and maintain sufficient intellectual property protection for our product candidates;
●
our
    ability to comply with our intellectual property licensing agreements;
●
our
    ability to defend against claims of intellectual property infringement;
●
our
    ability to comply with the maintenance requirements of the government patent agencies;
●
our
    ability to protect our intellectual property rights throughout the world;
●
competition;
●
the
    anticipated start dates, durations and completion dates of our ongoing and future clinical studies;
●
the
    anticipated designs of our future clinical studies;
●
the
    impact of fast track designation on receipt of actual FDA approval;
●
our
    anticipated future regulatory submissions and our ability to receive regulatory approvals to develop and market our product candidates,
    including any orphan drug or fast track designations; and
●
our
    anticipated future cash position.
We have based these forward-looking statements largely
on our current expectations and projections about future events, including the responses we expect from the U.S. Food and Drug Administration,
("FDA"), and other regulatory authorities and financial trends that we believe may affect our financial condition, results
of operations, business strategy, preclinical and clinical trials, and financial needs. These forward-looking statements are subject to
a number of risks, uncertainties and assumptions including without limitation the risks described in "Risk Factors" in Part
I, Item 1A of our Annual Report on Form 10-K filed with the Securities and Exchange Commission on November 24, 2021. These risks are not
exhaustive. Other sections of this Quarterly Report on Form 10-Q include additional factors which could adversely impact our business
and financial performance. Moreover, we operate in a very competitive and rapidly changing environment. New risk factors emerge from time
to time and it is not possible for our management to predict all risk factors, nor can we assess the impact of all factors on our business
or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any
forward-looking statements. You should not rely upon forward-looking statements as predictions of future events. We cannot assure you
that the events and circumstances reflected in the forward-looking statements will be achieved or occur and actual results could differ
materially from those projected in the forward-looking statements. Except as required by applicable laws including the securities laws
of the United States, we assume no obligation to update or supplement forward-looking statements.
19
As used in this Quarterly Report on Form 10-Q, the
terms "we," "us," "our," and "Anavex" mean Anavex Life Sciences Corp., unless the context
clearly requires otherwise.
Our Current Business
Anavex Life Sciences Corp. is a clinical stage biopharmaceutical
company engaged in the development of differentiated therapeutics by applying precision medicine to central nervous system ("CNS")
diseases with high unmet need. We analyze genomic data from clinical studies to identify biomarkers, which we use to select patients that
will receive the therapeutic benefit for the treatment of neurodegenerative and neurodevelopmental diseases.
Our lead compound, ANAVEX
®
2-73, is
being developed to treat Alzheimer's disease, Parkinson's disease and potentially other central nervous system diseases, including
rare diseases, such as Rett syndrome, a rare severe neurological monogenic disorder caused by mutations in the X-linked gene, methyl-CpG-binding
protein 2 ("MECP2").
We currently have two core programs and two seed programs.
Our core programs are at various stages of clinical and preclinical development, in neurodegenerative and neurodevelopmental diseases.
The following table summarizes key information about our
programs:
* = Orphan Drug Designation by the FDA; Dashed
lines indicate planned clinical studies
Anavex has a portfolio of compounds varying in sigma-1
receptor (S1R) binding activities. The SIGMAR1 gene encodes the S1R protein, which is an intracellular chaperone protein with important
roles in cellular communication. S1R is also involved in transcriptional regulation at the nuclear envelope and restores homeostasis and
stimulates recovery of cell function when activated. In order to validate the ability of our compounds to activate quantitatively the
S1R, we performed, in collaboration with Stanford University, a quantitative Positron Emission Tomography (PET) imaging scan in mice,
which demonstrated a dose-dependent ANAVEX
®
2-73 target engagement or receptor occupancy (RO) with S1R in the brain.
20
Source: Reyes S et al., Sci Rep. 2021 Aug 25; 11(1):17150
Cellular Homeostasis
Many diseases are possibly directly caused by chronic
homeostatic imbalances or cellular stress of brain cells. In pediatric diseases like Rett syndrome or infantile spasms, the chronic cellular
stress is possibly caused by the presence of a constant genetic mutation. In neurodegenerative diseases, such as Alzheimer's and
Parkinson's diseases, chronic cellular stress is possibly caused by age-correlated buildup of cellular insult and hence chronic
cellular stress. Specifically, defects in homeostasis of protein or ribonucleic acid ("RNA") lead to the death of neurons
and dysfunction of the nervous system. The spreading of protein aggregates resulting in a proteinopathy, a characteristic finding in Alzheimer's
and Parkinson's diseases that results from disorders of protein synthesis, trafficking, folding, processing or degradation in cells.
The clearance of macromolecules in the brain is particularly susceptible to imbalances that result in aggregation and degeneration in
nerve cells. For example, Alzheimer's disease pathology is characterized by the presence of amyloid plaques, neurofibrillary tangles,
which are aggregates of hyperphosphorylated Tau protein that are a marker of other diseases known as tauopathies as well as inflammation
of microglia. With the SIGMAR1 activation through SIGMAR1 agonists like ANAVEX
®
2-73, our approach is to restore cellular
balance, i.e. homeostasis. Therapies that correct defects in cellular homeostasis might have the potential to halt or delay neurodevelopmental
and neurodegenerative disease progression.
ANAVEX
®
2-73-specific Biomarkers
A full genomic analysis of Alzheimer's disease
(AD) patients treated with ANAVEX
®
2-73 resulted in the identification of actionable genetic variants. A significant impact
of the genomic biomarkers SIGMAR1, the direct target of ANAVEX
®
2-73 and COMT, a gene involved in memory function, on the
drug response level was identified, leading to an early ANAVEX
®
2-73-specific biomarker hypothesis. It is expected that
excluding
patients with SIGMAR1 identified biomarker variant (approximately 10%-20% of the population) in prospective studies would
identify approximately 80%-90% patients that would display clinically significant improved functional and cognitive scores. The consistency
between the identified DNA and RNA data related to ANAVEX
®
2-73, which are considered independent of AD pathology, as well
as multiple endpoints and time-points, provides support for precision medicine clinical development of ANAVEX
®
2-73 by using
genetic biomarkers identified within the study population itself to target patients who are most likely to respond to ANAVEX
®
2-73
treatment in AD as well as indications like Parkinson's disease dementia (PDD) or Rett syndrome (RTT) in which ANAVEX
®
2-73
is currently studied.
21
Clinical Studies Overview
Alzheimer's Disease
In November 2016, we completed a Phase 2a clinical
trial, consisting of PART A and PART B, which lasted a total of 57 weeks, for ANAVEX
®
2-73 in mild-to-moderate Alzheimer's
patients. This open-label randomized trial met both primary and secondary endpoints and was designed to assess the safety and exploratory
efficacy of ANAVEX
®
2-73 in 32 patients. ANAVEX
®
2-73 targets sigma-1 and muscarinic receptors, which have
been shown in preclinical studies to reduce stress levels in the brain believed to restore cellular homeostasis and to reverse the pathological
hallmarks observed in Alzheimer's disease. In October 2017, we presented positive pharmacokinetic (PK) and pharmacodynamic (PD)
data from the Phase 2a study, which established a concentration-effect relationship between ANAVEX
®
2-73 and study measurements.
These measures obtained from all patients who participated in the entire 57 weeks include exploratory cognitive and functional scores
as well as biomarker signals of brain activity. Additionally, the study appears to show that ANAVEX
®
2-73 activity is enhanced
by its active metabolite (ANAVEX19-144), which also targets the sigma-1 receptor and has a half-life approximately twice as long as the
parent molecule.
Two consecutive trial extensions for the Phase 2a
trial have allowed participants who completed the 52-week PART B of the study to continue taking ANAVEX
®
2-73, providing
an opportunity to gather extended safety data for a cumulative time period of five years. In August 2020, patients completing these Phase
2a trial extensions were granted continued access to treatment with ANAVEX
®
2-73 through the Australian Government Department
of Health – Therapeutic Goods Administration (TGA) compassionate use Special Access Scheme.
A larger Phase 2b/3 double-blind, placebo-controlled
study of ANAVEX
®
2-73 in Alzheimer's disease commenced in August 2018. The Phase 2b/3 study enrolled 509 patients
for 48 weeks, randomized 1:1:1 to two different ANAVEX
®
2-73 doses or placebo. The trial commenced in Australia; and during
fiscal 2020 additional regions were added in the United Kingdom, The Netherlands, Germany and Canada. The ANAVEX
®
2-73 Phase
2b/3 study design incorporates genomic precision medicine biomarkers identified in the ANAVEX
®
2-73 Phase 2a study. Primary
and secondary endpoints will assess safety and both cognitive and functional efficacy, measured through Alzheimer's Disease Assessment
Scale – Cognition (ADAS-Cog), ADCS-ADL and Clinical Dementia Rating – Sum of Boxes for cognition and function (CDR-SB). The
study completed enrollment in June 2021, exceeding the 450 patient enrollment target at 52 sites across North America, Europe and Australia.
In October 2019, we initiated a long-term open label
extension study of ANAVEX
®
2-73, entitled the ATTENTION-AD study, for patients who have completed the 48-week Phase 2b/3
placebo-controlled trial referenced above. This study is expected to last two years and will give patients the opportunity to continue
their treatment. Upon request by patients, caretakers and investigators, this extension study was extended by one further year.
Rett Syndrome
In February 2016, we presented positive preclinical
data for ANAVEX
®
2-73 in Rett syndrome, a rare neurodevelopmental disease. The study was funded by the International Rett
Syndrome Foundation ("Rettsyndrome.org"). In January 2017, we were awarded a financial grant from Rettsyndrome.org of a minimum
of $0.6 million to cover some of the costs of a multicenter Phase 2 clinical trial of ANAVEX
®
2-73 for the treatment of
Rett syndrome. This award was received in quarterly instalments which commenced during fiscal 2018.
22
In March 2019, we commenced the first Phase 2 clinical
trial in a planned Rett syndrome program of ANAVEX
®
2-73 for the treatment of Rett syndrome. The studies will be conducted
in a range of patient age demographics and geographic regions, utilizing a convenient oral liquid once-daily formulation of ANAVEX
®
2-73.
The first Phase 2 study, (ANAVEX®2-73-RS-001), which took place in the
United States, was completed in December 2020. This trial was a randomized double-blind, placebo-controlled safety, tolerability, pharmacokinetic
and efficacy study of oral liquid ANAVEX
®
2-73 formulation in 25 adult female patients with Rett syndrome over a 7-week
treatment period including ANAVEX
®
2-73-specific genomic precision medicine biomarkers. The primary endpoint of the trial
was safety. The dosing of 5 mg ANAVEX
®
2-73 was well-tolerated and demonstrated dose-proportional PK (pharmacokinetics).
All secondary efficacy endpoints of the trial showed statistically significant and clinically meaningful response in the Rett Syndrome
Behaviour Questionnaire (RSBQ AUC) Total scores, when compared to placebo, in the ITT cohort (all participants, p = 0.011). 66.7% of ANAVEX
®
2-73
treated subjects showed a statistically significant improvement in RSBQ response as compared to 10% of the subjects on placebo in the
ITT cohort (all participants, p = 0.011). ANAVEX
®
2-73 treatment resulted in a sustained improvement in Clinical Global
Impression Improvement (CGI-I) scores throughout the 7-week study, when compared to placebo in the ITT cohort (all participants, p = 0.014).
Consistent with previous ANAVEX
®
2-73 clinical trials, patients carrying the common form of the SIGMAR1 gene treated with
ANAVEX
®
2-73 experienced stronger improvements in the prespecified efficacy endpoints.
The
second, international study of ANAVEX
®
2-73 for the treatment of Rett syndrome, called the AVATAR study, commenced in June
2019.
This study took place in Australia and the United Kingdom using a higher dose than the U.S. based Phase 2 study for Rett
syndrome. The study was a Phase 3 randomized, double-blind, placebo-controlled trial to evaluate the safety and efficacy of ANAVEX
®
2-73
in 33 patients over a 7-week treatment period including ANAVEX
®
2-73 specific precision medicine biomarkers. Following the
successful completion of the U.S. Phase 2 Rett syndrome study (ANAVEX®2-73-RS-001), and the knowledge gained from it, the endpoints
for the AVATAR study (ANAVEX®2-73-RS-002) were appropriately updated according to ICH guidelines and were approved by the U.K. Medicines
and Healthcare products Regulatory Agency (MHRA) and in Australia by the Human Research Ethics Committees (HREC), where the AVATAR study
was conducted. Subsequently the AVATAR study was updated from a Phase 2 to a Phase 3 study.
The data of the AVATAR study was released in
February 2022. The study met all primary and secondary efficacy and safety endpoints, with consistent improvements in primary
efficacy endpoint, RSBQ AUC (p = 0.037) response, and secondary efficacy endpoints, ADAMS (p = 0.010) and CGI-I (p = 0.037)
response. Efficacy endpoints demonstrated statistically significant and clinically meaningful reductions in Rett syndrome symptoms.
Convenient once daily oral liquid doses of up to 30mg of ANAVEX
®
2-73 were also well tolerated with good medication
compliance. All patients who participated in the study are eligible to receive ANAVEX
®
2-73 under a voluntary open
label extension protocol, which is currently ongoing.
In July 2020, we commenced the third study of ANAVEX
®
2-73
for the treatment of Rett syndrome, called the EXCELLENCE study. This Phase 2/3 study in pediatric patients with Rett syndrome will evaluate
the safety and efficacy of ANAVEX
®
2-73 in approximately 84 pediatric patients, aged 5 to 18, over a 12-week treatment period
incorporating ANAVEX
®
2-73 specific precision medicine biomarkers. All patients who participate in the study will be eligible
to receive ANAVEX
®
2-73 under a voluntary open label extension protocol.
Parkinson's Disease
In September 2016, we presented positive preclinical
data for ANAVEX
®
2-73 in an animal model of Parkinson's disease, which demonstrated significant improvements on behavioral,
histopathological, and neuroinflammatory endpoints. The study was funded by the Michael J. Fox Foundation. Additional data announced in
October 2017 indicates that ANAVEX
®
2-73 induces robust neurorestoration in experimental Parkinsonism. The encouraging results
we have gathered in this model, coupled with the favorable profile of this compound in the Alzheimer's disease trial, support the
notion that ANAVEX
®
2-73 is a promising clinical candidate drug for Parkinson's disease dementia.
23
In October 2020, we completed a double-blind, randomized,
placebo-controlled proof-of-concept Phase 2 trial with ANAVEX
®
2-73 in Parkinson's Disease Dementia (PDD), to study
the effect of the compound on both the cognitive and motor impairment of Parkinson's disease. The Phase 2 study enrolled approximately
132 patients for 14 weeks, randomized 1:1:1 to two different ANAVEX
®
2-73 doses, 30mg and 50mg, or placebo. The ANAVEX
®
2-73
Phase 2 PDD study design incorporated genomic precision medicine biomarkers identified in the ANAVEX
®
2-73 Phase 2a Alzheimer's
disease study.
Within this study ANAVEX
®
2-73 was safe
and well tolerated in oral doses up to 50mg once daily. The results show clinically meaningful, dose-dependent, and statistically significant
improvements in the Cognitive Drug Research (CDR) computerized assessment system analysis. Treatment with ANAVEX
®
2-73 also
resulted in clinically meaningful improvements as measured by the global composite score of Parkinson's disease symptom severity,
MDS-UPDRS Total score on top of standard of care including dopaminergic therapy, levodopa and other anti-PD medications after 14 weeks
of treatment, suggesting ANAVEX
®
2-73's potential global capability of slowing and reversing symptoms that progress
in Parkinson's disease. The study confirmed the precision medicine approach of targeting SIGMAR1 as a genetic biomarker in response
to ANAVEX
®
2-73.
In January 2021, we announced we were awarded a research
grant of $1.0 million from The Michael J. Fox Foundation for Parkinson's Research (MJFF) to develop ANAVEX
®
2-73
for the treatment of Parkinson's disease. The award will explore utilization of PET imaging biomarkers to enable measurement of
target engagement and pathway activation of the sigma-1 receptor (SIGMAR1) with clinically relevant doses in people with Parkinson's
disease.
Frontotemporal Dementia
In July 2020, we commenced the First-in-Human Phase
1 clinical trial of ANAVEX
®
3-71. ANAVEX
®
3-71 was previously granted orphan drug designation for the treatment
of Frontotemporal Dementia (FTD) by the FDA. ANAVEX
®
3-71 is an orally administered small molecule targeting sigma-1 and
M1 muscarinic receptors that is designed to be beneficial for neurodegenerative diseases. In preclinical studies,
ANAVEX
®
3-71
demonstrated disease-modifying activity against the major hallmarks of Alzheimer's disease in transgenic (3xTg-AD) mice, including
cognitive deficits, amyloid and tau pathologies, as well as beneficial effects on mitochondrial dysfunction and neuroinflammation.
The Phase 1
clinical trial was a prospective double-blind, randomized, placebo-controlled study. A total of 36 healthy male and female subjects were
included. Single escalating doses of ANAVEX
®
3-71 were administered in order to evaluate the safety, tolerability, and pharmacokinetics
(PK) of ANAVEX
®
3-71 and the effects of food and gender on its PK in healthy volunteers.
The study met
its primary and secondary endpoints of safety, with no serious adverse events (SAEs) or dose-limiting toxicities observed. ANAVEX
®
3-71
was well tolerated in all cohorts receiving ANAVEX
®
3-71 in single doses ranging from 5 mg to 200 mg daily with no SAEs
and no significant lab abnormalities in any subject. In the study, ANAVEX
®
3-71 exhibited linear pharmacokinetics. Its pharmacokinetics
was also dose proportional for doses up to 160 mg. Gender had no effect on the PK of the drug and food had no effect on the bioavailability
of ANAVEX
®
3-71. The study also met the secondary objective of characterizing the effect of ANAVEX
®
3-71 on
electrocardiogram (ECG) parameters. There were no clinically significant ECG parameters throughout the study. Participant QTcF measures
were normal across all dose groups with no difference between ANAVEX®3-71 and placebo.
Based on these
results, and ANAVEX
®
3-71 pre-clinical profile, the Company intends to advance ANAVEX
®
3-71 into a biomarker-driven
clinical development dementia program for the treatment of FTD, schizophrenias and Alzheimer's disease, evaluating longitudinal
effect of treatment with ANAVEX
®
3-71. We believe the results of these studies could serve as the basis for advancing into
respective registration studies in the U.S.
24
Our Pipeline
Our research and development pipeline includes ANAVEX
®
2-73
currently in three different clinical study indications, and several other compounds in different stages of clinical and pre-clinical
study.
Our proprietary SIGMACEPTOR™ Discovery Platform
produced small molecule drug candidates with unique modes of action, based on our understanding of sigma receptors. Sigma receptors may
be targets for therapeutics to combat many human diseases, both of neurodegenerative nature, including Alzheimer's disease, as well
as of neurodevelopmental nature, like Rett syndrome. When bound by the appropriate ligands, sigma receptors influence the functioning
of multiple biochemical signals that are involved in the pathogenesis (origin or development) of disease. Multiple viruses including SARS-CoV-2
(COVID-19) induce cellular stress by intrinsic mitochondrial apoptosis and other related cellular processes, in order to ensure survival
and replication. Hence, it is possible that S1R could play a role in modulating the cellular response to viral infection and ameliorate
pathogenesis.
Compounds that have been subjects of our research
include the following:
ANAVEX
®
2-73
(blarcamesine)
ANAVEX
®
2-73 may offer a disease-modifying
approach in neurodegenerative and neurodevelopmental diseases by activation of sigma-1 receptors.
In Rett syndrome, administration of ANAVEX
®
2-73
resulted in both significant and dose related improvements in an array of behavioral paradigms in the MECP2 HET Rett syndrome disease
model. In addition, in a further experiment sponsored by Rettsyndrome.org, ANAVEX
®
2-73 was evaluated in automatic visual
response and respiration tests in 7-month old mice, an age at which advanced pathology is evident. Vehicle-treated MECP2 mice demonstrated
fewer automatic visual responses than wild-type mice. Treatment with ANAVEX
®
2-73 for four weeks significantly increased
the automatic visual response in the MECP2 Rett syndrome disease mouse. Additionally, chronic oral dosing daily for 6.5 weeks of ANAVEX
®
2-73
starting at ~5.5 weeks of age was conducted in the MECP2 HET Rett syndrome disease mouse model assessed the different aspects of muscular
coordination, balance, motor learning and muscular strengths, some of the core deficits observed in Rett syndrome. Administration of ANAVEX
®
2-73
resulted in both significant and dose related improvements in an array of these behavioral paradigms in the MECP2 HET Rett syndrome disease
model.
In May 2016 and June 2016, the FDA granted Orphan
Drug Designation to ANAVEX
®
2-73 for the treatment of Rett syndrome and infantile spasms, respectively. In November 2019,
the FDA granted to ANAVEX
®
2-73 the Rare Pediatric Disease (RPD) designation for the treatment of Rett syndrome. The RPD
designation provides priority review by the FDA to encourage the development of treatments for rare pediatric diseases.
Further, in February 2020, the FDA granted Fast Track
designation for the ANAVEX
®
2-73 clinical development program for the treatment of Rett syndrome. The FDA Fast Track program
is designed to facilitate and expedite the development and review of new drugs to address unmet medical needs in the treatment of serious
and life-threatening conditions.
For Parkinson's disease, data demonstrates significant
improvements and restoration of function in a disease modifying animal model of Parkinson's disease. Significant improvements were
seen on all measures tested: behavioral, histopathological, and neuroinflammatory endpoints. In October 2020, we completed a double-blind,
randomized, placebo-controlled proof-of-concept Phase 2 trial with ANAVEX
®
2-73 in Parkinson's Disease Dementia (PDD),
to study the effect of the compound on both the cognitive and motor impairment of Parkinson's disease. The Phase 2 study enrolled
approximately 132 patients for 14 weeks, randomized 1:1:1 to two different ANAVEX
®
2-73 doses, 30mg and 50mg, or placebo.
The ANAVEX
®
2-73 Phase 2 PDD study design incorporated genomic precision medicine biomarkers identified in the ANAVEX
®
2-73
Phase 2a Alzheimer's disease study.
The study found that ANAVEX
®
2-73 was
safe and well tolerated in oral doses up to 50mg once daily. The results show clinically meaningful, dose-dependent, and statistically
significant improvements in the Cognitive Drug Research (CDR) computerized assessment system analysis. We anticipate conducting further
clinical trials of ANAVEX
®
2-73 in Parkinson's disease dementia after submitting the results of the study to the FDA
to obtain regulatory guidance.
25
In Alzheimer's disease (AD) animal models, ANAVEX
®
2-73
has shown pharmacological, histological and behavioral evidence as a potential neuroprotective, anti-amnesic, anti-convulsive and anti-depressive
therapeutic agent, due to its potent affinity to sigma-1 receptors and moderate affinities to M1-4 type muscarinic receptors. In addition,
ANAVEX
®
2-73 has shown a potential dual mechanism which may impact amyloid, tau pathology and inflammation. In a transgenic
AD animal model Tg2576, ANAVEX
®
2-73 induced a statistically significant neuroprotective effect against the development
of oxidative stress in the mouse brain, as well as significantly increased the expression of functional and synaptic plasticity markers
that is apparently amyloid-beta independent. It also statistically alleviated the learning and memory deficits developed over time in
the animals, regardless of sex, both in terms of spatial working memory and long-term spatial reference memory.
Based on the results of pre-clinical testing, we initiated
and completed a Phase 1 single ascending dose (SAD) clinical trial of ANAVEX
®
2-73. In this Phase 1 SAD trial, the maximum
tolerated single dose was defined per protocol as 55-60 mg. This dose is above the equivalent dose shown to have positive effects in mouse
models of AD. There were no significant changes in laboratory or electrocardiogram (ECG) parameters. ANAVEX
®
2-73 was well
tolerated below the 55-60 mg dose with only mild adverse events in some subjects. Observed adverse events at doses above the maximum tolerated
single dose included headache and dizziness, which were moderate in severity and reversible. These side effects are often seen with drugs
that target CNS conditions, including AD.
In December 2014, a Phase 2a clinical trial was initiated
for ANAVEX
®
2-73, for the treatment of Alzheimer's disease. The open-label randomized trial was designed to assess
the safety and exploratory efficacy of ANAVEX
®
2-73 in 32 patients with mild-to-moderate Alzheimer's disease. ANAVEX
®
2-73
is an orally available drug candidate that restores cellular homeostasis by targeting sigma-1 and muscarinic receptors. Preclinical studies
demonstrated its potential to halt and/or reverse the course of Alzheimer's. The Phase 2a study met both primary and secondary objectives
of the study.
In July 2018, we presented
the results of a genomic DNA and RNA evaluation of the participants in the Phase 2a study. More than 33,000 genes were analyzed using
unbiased, data driven, machine learning, artificial intelligence (AI) system for analyzing DNA & RNA data in patients exposed to ANAVEX
®
2-73.
The analysis identified genetic variants that impacted response to ANAVEX
®
2-73, among them variants related to the Sigma-1
receptor (SIGMAR1), the target for ANAVEX
®
2-73. Results showed that study participants with the common SIGMAR1 wild type
gene variant, which is about 80 percent of the population worldwide, demonstrated improved cognitive (MMSE) and the functional (ADCS-ADL)
scores. The results from this evaluation have been used to establish a precision medicine approach in subsequent clinical trials, since
these signatures can now be applied to neurological indications tested in clinical studies with ANAVEX
®
2-73 including Alzheimer's
disease, Parkinson's disease dementia and Rett syndrome.
ANAVEX
®
2-73
data presented met prerequisite information in order to progress into a Phase 2b/3 placebo-controlled study. On July 2, 2018, the Human
Research Ethics Committee in Australia approved the initiation of our Phase 2b/3, double-blind, randomized, placebo-controlled 48-week
safety and efficacy trial of ANAVEX
®
2-73 for the treatment of early Alzheimer's disease. Clinical trial sites in
Canada, the United Kingdom, the Netherlands and Germany were also added. This Phase 2b/3 study design incorporates inclusion of genomic
precision medicine biomarkers identified in the ANAVEX
®
2-73 Phase 2a study. The Phase 2b/3 study, which commenced in October 2018, randomized 1:1:1 to either two different ANAVEX
®
2-73
doses or placebo, completed enrollment in June 2021.
Preclinical data also validates ANAVEX
®
2-73
as a prospective platform drug for other neurodegenerative diseases beyond Alzheimer's disease, Parkinson's disease or Rett
syndrome, more specifically, epilepsy, infantile spasms, Fragile X syndrome, Angelman syndrome, multiple sclerosis and, more recently,
tuberous sclerosis complex (TSC). ANAVEX
®
2-73 demonstrated significant improvements in all of these indications in the
respective preclinical animal models.
In a study sponsored by the Foundation for Angelman
Syndrome, ANAVEX
®
2-73 was assessed in a mouse model for the development of audiogenic seizures. The results indicated that
ANAVEX
®
2-73 administration significantly reduced audiogenic-induced seizures. In a study sponsored by FRAXA Research Foundation
regarding Fragile X syndrome, data demonstrated that ANAVEX
®
2-73 restored hippocampal brain-derived neurotrophic factor
(BDNF) expression to normal levels. BDNF under-expression has been observed in many neurodevelopmental and neurodegenerative pathologies.
BDNF signaling promotes maturation of both excitatory and inhibitory synapses. ANAVEX
®
2-73 normalization of BDNF expression
could be a contributing factor for the positive data observed in both neurodevelopmental and neurodegenerative disorders like Angelman
and Fragile X syndromes.
26
Preclinical data presented also indicates that ANAVEX
®
2-73
demonstrates protective effects of mitochondrial enzyme complexes during pathological conditions, which, if impaired, are believed to
play a role in the pathogenesis of neurodegenerative and neurodevelopmental diseases.
Preclinical data on ANAVEX
®
2-73 related
to multiple sclerosis indicates that ANAVEX
®
2-73 may promote remyelination in multiple sclerosis disease. Further, data
also demonstrates that ANAVEX
®
2-73 provides protection for oligodendrocytes ("OL's") and oligodendrocyte
precursor cells ("OPC's"), as well as central nervous system neurons in addition to helping repair by increasing OPC
proliferation and maturation in tissue culture.
In March 2018, we presented preclinical data of ANAVEX
®
2-73
in a genetic mouse model of tuberous sclerosis complex ("TSC"). TSC is a rare genetic disorder characterized by the growth
of numerous benign tumors in many parts of the body with a high incidence of seizures. The preclinical data demonstrates that treatment
with ANAVEX
®
2-73 significantly increases survival and reduces seizures.
ANAVEX
®
3-71
ANAVEX
®
3-71 is a clinical drug candidate
with a novel mechanism of action via sigma-1 receptor activation and M1 muscarinic allosteric modulation, which has been shown to enhance
neuroprotection and cognition in Alzheimer's disease models. ANAVEX
®
3-71 is a CNS-penetrable potential disease modifying
treatment for cognitive impairments. It is highly effective in very small doses against the major Alzheimer's hallmarks in transgenic
(3xTg-AD) mice, including cognitive deficits, amyloid and tau pathologies, and also has beneficial effects on inflammation and mitochondrial
dysfunctions. ANAVEX
®
3-71 indicates extensive therapeutic advantages in Alzheimer's and other protein-aggregation-related
diseases given its ability to enhance neuroprotection and cognition via sigma-1 receptor activation and M1 muscarinic allosteric modulation.
A preclinical study examined the response of ANAVEX
®
3-71
in aged transgenic animal models and showed a significant reduction in the rate of cognitive deficit, amyloid beta pathology and inflammation
with the administration of ANAVEX 3-71. In April 2016, the FDA granted Orphan Drug Designation to ANAVEX
®
3-71 for the treatment
of Frontotemporal dementia (FTD).
During pathological conditions ANAVEX
®
3-71
demonstrated the formation of new synapses between neurons (synaptogenesis) without causing an abnormal increase in the number of astrocytes.
In neurodegenerative diseases such as Alzheimer's and Parkinson's disease, synaptogenesis is believed to be impaired. Additional
preclinical data presented also indicates that in addition to reducing oxidative stress, ANAVEX
®
3-71 demonstrates protective
effects of mitochondrial enzyme complexes during pathological conditions, which, if impaired, are believed to play a role in the pathogenesis
of neurodegenerative and neurodevelopmental diseases.
In July 2020, we commenced the first Phase 1 clinical
trial of ANAVEX
®
3-71. The study took place in Australia and was a double-blind, randomized, placebo-controlled, Phase
1 trial to evaluate safety and tolerability, and pharmacokinetics (PK) of oral escalating doses of ANAVEX
®
3-71
including effects of food and gender in healthy volunteers
The study met its primary and secondary
endpoints of safety, respectively with no serious adverse events (SAEs) or dose-limiting toxicities observed,
as more fully described
above under
Clinical Studies Overview – Frontotemporal Dementia
.
Based on these
results, and ANAVEX
®
3-71 pre-clinical profile, the Company intends to advance ANAVEX
®
3-71 into a biomarker-driven
clinical development dementia program for the treatment of FTD, schizophrenias and Alzheimer's disease, evaluating longitudinal
effect of treatment with ANAVEX
®
3-71. Anavex believes the results of these studies, could serve as the basis for advancing
into respective registration studies in the U.S.
27
ANAVEX
®
1-41
ANAVEX
®
1-41 is a sigma-1 agonist. Pre-clinical
tests revealed significant neuroprotective benefits (i.e., protects nerve cells from degeneration or death) through the modulation of
endoplasmic reticulum, mitochondrial and oxidative stress, which damages and impairs cell viability. In addition, in animal models, ANAVEX
®
1-41
prevented the expression of caspase-3, an enzyme that plays a key role in apoptosis (programmed cell death) and loss of cells in the hippocampus,
the part of the brain that regulates learning, emotion and memory. These activities involve both muscarinic and sigma-1 receptor systems
through a novel mechanism of action.
Preclinical data presented also indicates that ANAVEX
®
1-41
demonstrates protective effects of mitochondrial enzyme complexes during pathological conditions, which, if impaired, are believed to
play a role in the pathogenesis of neurodegenerative and neurodevelopmental diseases.
ANAVEX
®
1066
ANAVEX
®
1066, a mixed sigma-1/sigma-2
ligand is designed for the potential treatment of neuropathic and visceral pain. ANAVEX
®
1066 was tested in two preclinical
models of neuropathic and visceral pain that have been extensively validated in rats. In the chronic constriction injury model of neuropathic
pain, a single oral administration of ANAVEX
®
1066 dose-dependently restored the nociceptive threshold in the affected paw
to normal levels while leaving the contralateral healthy paw unchanged. Efficacy was rapid and remained significant for two hours. In
a model of visceral pain, chronic colonic hypersensitivity was induced by injection of an inflammatory agent directly into the colon and
a single oral administration of ANAVEX
®
1066 returned the nociceptive threshold to control levels in a dose-dependent manner.
Companion studies in rats demonstrated the lack of any effects on normal gastrointestinal transit with ANAVEX
®
1066 and
a favorable safety profile in a battery of behavioral measures.
ANAVEX
®
1037
ANAVEX
®
1037 is designed for the treatment
of prostate and pancreatic cancer. It is a low molecular weight, synthetic compound exhibiting high affinity for sigma-1 receptors at
nanomolar levels and moderate affinity for sigma-2 receptors and sodium channels at micromolar levels. In advanced pre-clinical studies,
this compound revealed antitumor potential. It has also been shown to selectively kill human cancer cells without affecting normal/healthy
cells and also to significantly suppress tumor growth in immune-deficient mice models. Scientific publications highlight the possibility
that these ligands may stop tumor growth and induce selective cell death in various tumor cell lines. Sigma receptors are highly expressed
in different tumor cell types. Binding by appropriate sigma-1 and/or sigma-2 ligands can induce selective apoptosis. In addition, through
tumor cell membrane reorganization and interactions with ion channels, our drug candidates may play an important role in inhibiting the
processes of metastasis (spreading of cancer cells from the original site to other parts of the body), angiogenesis (the formation of
new blood vessels) and tumor cell proliferation.
Our compounds are in the pre-clinical and clinical
testing stages of development, and there is no guarantee that the activity demonstrated in pre-clinical models will be shown in human
testing.
We continue to identify and initiate discussions with
potential strategic and commercial partners to most effectively advance our programs and realize maximum shareholder value. Further, we
may acquire or develop new intellectual property and assign, license, or otherwise transfer our intellectual property to further our goals.
Our Target Indications
We have developed compounds with potential application
to two broad categories and several specific indications. including:
28
Central Nervous System Diseases
●
Alzheimer's disease – In 2021, an estimated 5.7 million Americans were suffering from Alzheimer's
disease. The Alzheimer's Association
®
estimates that by 2050, this number will rise to nearly 14 million Americans.
Medications on the market today treat only the symptoms of Alzheimer's disease and do not have the ability to stop its onset or
its progression. There is an urgent and unmet need for both a disease modifying cure for Alzheimer's disease as well as for better
symptomatic treatments.
●
Parkinson's disease – Parkinson's disease is a progressive disease of the nervous system
marked by tremors, muscular rigidity, and slow, imprecise movement. It is associated with degeneration of the basal ganglia of the brain
and a deficiency of the neurotransmitter dopamine. Parkinson's disease afflicts more than 10 million people worldwide, typically
middle-aged and elderly people. The Parkinson's disease market is expected to expand to $11.5 billion by 2029, according to business
intelligence provider GBI Research.
●
Rett syndrome – Rett syndrome is a rare X-linked genetic neurological and developmental disorder
that affects the way the brain develops, including protein transcription, which is altered and as a result lead to severe disruptions
in neuronal homeostasis. It is considered a rare, progressive neurodevelopmental disorder and is caused by a single mutation in the MECP2
gene. Because males have a different chromosome combination from females, boys who have the genetic MECP2 mutation are affected in devastating
ways. Most of them die before birth or in early infancy. For females who survive infancy, Rett syndrome leads to severe impairments, affecting
nearly every aspect of the child's life; severe mental retardation, their ability to speak, walk and eat, sleeping problems, seizures
and even the ability to breathe easily. Rett syndrome affects approximately 1 in every 10,000-15,000 females.
●
Depression – Depression is a major cause of morbidity worldwide according to the World Health Organization.
Pharmaceutical treatment for depression is dominated by blockbuster brands, with the leading nine brands historically accounting for approximately
75% of total sales. However, the dominance of the leading brands is waning, largely due to the effects of patent expiration and generic
competition.
●
Epilepsy – Epilepsy is a common chronic neurological disorder characterized by recurrent unprovoked
seizures. These seizures are transient signs and/or symptoms of abnormal, excessive or synchronous neuronal activity in the brain. According
to the Centers for Disease Control and Prevention, in 2015 epilepsy affected 3.4 million Americans. Today, epilepsy is often controlled,
but not cured, with medication that is categorized as older traditional anti-epileptic drugs and second generation anti-epileptic drugs.
Because epilepsy afflicts sufferers in different ways, there is a need for drugs used in combination with both traditional anti-epileptic
drugs and second generation anti-epileptic drugs.
●
Neuropathic Pain – We define neuralgia, or neuropathic pain, as pain that is not related to activation
of pain receptor cells in any part of the body. Neuralgia is more difficult to treat than some other types of pain because it does not
respond well to normal pain medications. Special medications have become more specific to neuralgia and typically fall under the category
of membrane stabilizing drugs or antidepressants.
Cancer
●
Malignant Melanoma – Predominantly a skin cancer, malignant melanoma can also occur in melanocytes
found in the bowel and the eye. Malignant melanoma accounts for 75% of all deaths associated with skin cancer. The treatment includes
surgical removal of the tumor, adjuvant treatment, chemo and immunotherapy, or radiation therapy. According to iHealthcareAnalyst, Inc.
the worldwide malignant melanoma market is expected to grow to $6.4 billion by 2027.
●
Prostate Cancer – Specific to men, prostate cancer is a form of cancer that develops in the prostate,
a gland in the male reproductive system. The cancer cells may metastasize from the prostate to other parts of the body, particularly the
bones and lymph nodes. Drug therapeutics for prostate cancer are expected to increase to nearly $13.5 billion in 2024 according to Datamonitor
Healthcare.
●
Pancreatic Cancer – Pancreatic cancer is a malignant neoplasm of the pancreas. In the United States,
approximately 55,000 new cases of pancreatic cancer will be diagnosed this year and approximately 44,000 patients will die as a result
of their cancer, according to the American Cancer Society. Sales predictions by FutureWise forecast that the market for the global pharmaceutical
treatment of pancreatic cancer will increase to $4.7 billion by 2027.
29
Patents, Trademarks and Intellectual Property
We hold ownership or exclusive rights to fifteen U.S.
patents, sixteen U.S. patent applications, and various PCT or ex-U.S. patent applications relating to our drug candidates, methods associated
therewith, and to our research programs.
We own one issued U.S. patent entitled "ANAVEX
®
2-73
and certain anticholinesterase inhibitors composition and method for neuroprotection" claims a composition of matter of ANAVEX
®
2-73
directed to a novel and synergistic neuroprotective compound combined with donepezil and other cholinesterase inhibitors. This patent
is expected to expire in June 2034, absent any patent term extension for regulatory delays. We own three issued U.S. patents each with
claims directed to crystalline forms of ANAVEX
®
2-73. The first of these three patents claims crystalline forms of ANAVEX
®
2-73,
dosage forms and compositions containing crystalline ANAVEX
®
2-73, and methods of treatment for Alzheimer's disease
using them. This patent is expected to expire in July 2036, absent any patent term extension for regulatory delays. The second of these
three patents claims pharmaceutical compositions containing a crystalline form of ANAVEX
®
2-73, and methods of treatment
for Alzheimer's disease using the compositions. This patent is expected to expire in June 2037, absent any patent term extension
for regulatory delays. The third of these three patents claims pharmaceutical compositions containing a crystalline form of ANAVEX
®
2-73,
and methods of treatment for Alzheimer's disease using the compositions. This patent is expected to expire in June 2037, absent
any patent term extension for regulatory delays. We also own two issued U.S. patents for seizure treatment. The first of these two patents
claims methods and dosage forms for treating seizures, the dosage forms containing a low-dose anti-epilepsy drug combined with either:
(i) ANAVEX
®
2-73 and its active metabolite ANAVEX
®
19-144; or (ii) ANAVEX
®
19-144. The second
of these two patents further claims a combination seizure treatment involving administration of an anti-epilepsy drug combined with (i)
ANAVEX
®
19-144, or (ii) ANAVEX 19-144
®
and ANAVEX 2-73
®
. Both patents are expected to expire
in October 2035, absent any patent term extension for regulatory delays. We also own two issued U.S. patents with claims directed to treating
neurodevelopmental disorders. These patents claim methods for treating a neurodevelopmental disorder or multiple sclerosis by administering
ANAVEX
®
2-73, ANAVEX
®
19-144, and/or ANAVEX
®
1-41 (another sigma receptor ligand similar to
ANAVEX
®
2-73), or compositions thereof. Both patents are expected to expire in January 2037, absent any patent term extension
for regulatory delays. In addition, we own one issued U.S. Patent with claims directed to methods of treating melanoma with a compound
related to ANAVEX
®
2-73. This patent is expected to expire in February 2030, absent any patent term extension for regulatory
delays. We also own an issued U.S. patent that claims crystalline forms of ANAVEX
®
19-144, dosage forms and compositions
containing the crystalline forms of ANAVEX
®
19-144, and methods of treatment for Alzheimer's disease. This patent
is expected to expire in July 2036, absent any patent term extension for regulatory delays. Further, we own one issued U.S. Patent with
claims directed to methods of treating cardiac dysfunction with ANAVEX
®
2-73 . This patent is expected to expire in July
2038, absent any patent term extension for regulatory delays.
We also own two issued U.S. patents related to ANAVEX
®
1066.
The first of these two patents claims methods for treating or preventing pain using (+) ANAVEX
®
1066 isomer. The second
patent claims methods for treating or preventing pain using (-) ANAVEX
®
1066 isomer. Both patents are expected to expire
in November 2036, absent any patent term extension for regulatory delays.
For ANAVEX
®
2-73, ANAVEX
®
19-144,
ANAVEX
®
1-41, and ANAVEX
®
1066, we also have granted or pending applications in Australia, Canada, China,
Europe, Japan, and Hong Kong, which are expected to expire after 2035.
With regard to ANAVEX
®
3-71, we own
exclusive rights to two issued U.S. patents with claims respectively directed to the ANAVEX
®
3-71 compound and methods of
treating various diseases including Alzheimer's with the same. These patents are expected to expire in April 2030, and January 2030,
respectively, absent any patent term extension for regulatory delays. We also own exclusive rights to related patents or applications
that are granted or pending in Australia, Canada, China, Europe, Japan, Korea, New Zealand, Russia, and South Africa, which are expected
to expire in January 2030.
30
We also own other patent applications directed to
enantiomers, crystals, formulations, uses, and patient selection methods that may provide additional protection for one or more of our
product candidates.
We regard patents and other intellectual property
rights as corporate assets. Accordingly, we attempt to optimize the value of intellectual property in developing our business strategy
including the selective development, protection, and exploitation of our intellectual property rights. In addition to filings made with
intellectual property authorities, we protect our intellectual property and confidential information by means of carefully considered
processes of communication and the sharing of information, and by the use of confidentiality and non-disclosure agreements and provisions
for the same in contractor's agreements. While no agreement offers absolute protection, such agreements provide some form of recourse
in the event of disclosure, or anticipated disclosure.
Our
intellectual property position, like that of many biomedical companies, is uncertain and involves complex legal and technical questions
for which important legal principles are unresolved. For more information regarding challenges to our existing or future patents, see
"Risk Factors" " in Part I, Item 1A of our Annual Report on Form 10-K filed with the Securities and Exchange Commission
on November 24, 2021.
Financial Highlights
We are in
the development stage and have not earned any revenues since our inception in 2004. We do not anticipate earning any revenues until we
can establish an alliance with other companies to develop, co-develop, license, acquire or market our products.
Our operating costs consist primarily of research
and development activities including the cost of clinical studies and clinical supplies as well as clinical drug manufacturing and formulation.
Research and development expenses also include personnel related costs such as salaries and wages, and third-party contract research
organization (CRO) expenses in support of these clinical studies. Personnel costs include salaries and wages, benefits, and non-cash
stock-based compensation charges associated with options and other equity awards granted to employees and consultants who are directly
engaged in support of our research and development activities.
General and administrative expenses consist
of personnel costs, expenses for outside professional services and expenses associated with operating as a public company. Personnel costs
consist of salaries and wages, benefits and stock-based compensation for general and administrative personnel. Outside professional services
and public company expenses include expenses related to compliance and reporting, additional insurance expenses, audit and SOX compliance,
expenses associated with patent research, applications and filings, investor and shareholder relations activities and other administrative
expenses and professional services.
Three months
ended December 31, 2021 compared to three months ended December 31, 2020
During the three months ended December 31, 2021, we
completed our second randomized placebo-controlled clinical trial of
ANAVEX
®
2-73
for the treatment of Rett syndrome
, the AVATAR Phase 3 study, and reported positive top-line results from this study in February
2022, as described above under
Clinical Studies Overview – Rett Syndrome
. We continued to advance enrollment of our EXCELLENCE
international Phase 2/3 pediatric Rett syndrome clinical trial through the activation of additional clinical sites in new regions across
Canada.. We also completed the first in human Phase 1 clinical trial of ANAVEX
®
3-71 with focus on the treatment of Frontotemporal
Dementia (FTD) and positive topline results were announced in January 2022, as described above under
Clinical Studies Overview –
Frontotemporal Dementia.
Operating Expenses
Total operating expenses for the first quarter of
fiscal 2022 were $11.7 million, compared to $9.4 million for the comparable first quarter of fiscal 2021.
General and administrative expenses were $3.1 million
for the three months ended December 31, 2021, as compared to $1.5 million for the first quarter of fiscal 2021. The increase is primarily
related to an increase in non-cash stock option compensation charges of $1.3 million period over period in connection with the vesting
of milestone-based options.
31
Our research and development expenses for the first
quarter of fiscal 2022 were $8.7 million, as compared to $7.9 million for the first quarter of fiscal 2021. The increase is primarily
related to an increase in non-cash stock option compensation charges of $1.7 million period over period in connection with the vesting
of milestone-based options.
We will
continue to see an increase in our research and development expenditures as we advance our ANAVEX
®
2-73 clinical studies,
including extension studies to allow us to continue to gather longer term data, continuing to advance our other pipeline compounds such
as ANAVEX
®
3-71, and as we continue to add additional staff to manage and support these clinical studies.
Other income (net)
The net amount of other income for the first quarter
of fiscal 2022 was $0.9 million as compared to $1.6 million for the comparable first quarter of fiscal 2021.
The
decrease in other income is attributable to a decrease in Australian research and development incentive income in connection with the
decrease in eligible clinical activities in Australia over the comparable period such as the completion of the
ANAVEX
®
3-71
Phase 1 clinical study.
Foreign exchange
gains during the period are primarily related to the fluctuations in the Australian dollar against the US dollar and its related impact
on incentive and tax receivables during the period.
Net loss
Net loss for the first quarter of fiscal 2022
was $10.9 million, or $0.14 per share, as compared to $7.9 million, or $0.12 per share in the comparative first quarter of fiscal 2021.
Liquidity and Capital Resources
Working Capital
December 31, 2021
September 30, 2021
Current Assets
$
156,896,368
$
161,616,490
Current Liabilities
10,528,662
10,798,386
Working Capital
$
146,367,706
$
150,818,104
At December 31, 2021, we held $151.1 million in cash and cash equivalents, a decrease of $1.0 million from September 30, 2021. Cash expenditures
for the quarter of approximately $7.0 million were offset by a net reduction of incentive and tax receivables of $3.8 million, resulting
in a net cash used in operating activities of $3.5 million for the quarter. We received cash from financing activities of $2.5 million
primarily from the issuance of shares of common stock under the Sales Agreement (as defined below).
We intend to continue to use our
capital resources to advance our clinical trials for ANAVEX
®
2-73 and ANAVEX
®
3-71, and to perform work necessary
to prepare for future development of our pipeline compounds.
Cash Flows
Three months ended December 31,
2021
2020
Net cash flows used in operating activities
$
(3,500,955
)
$
(7,871,378
)
Net cash flows from financing activities
2,539,565
25,979,959
(Decrease) increase in cash and cash equivalents
$
(961,390
)
$
18,108,581
32
Cash flow used in operating activities
Net cash used in operating activities for the
first quarter of fiscal 2022 was $3.5 million, compared to $7.9 million during the comparable period of fiscal 2021. The principal reason
for this decrease in net cash used in operating activities in the current period is due to the receipt of research and development incentive
tax refunds during the period, as compared to no such receipts during the comparable period.
Cash flow provided by financing activities
Cash provided by financing activities for the
three months ended December 31, 2021 was $2.5 million, primarily attributable to cash received from the issuance of common shares at various
market prices under the Sales Agreement.
Cash provided
by financing activities for the three months ended December 31, 2020 was $26.0 million, attributable to cash received from the issuance
of common shares at various market prices under the 2019 Purchase Agreement and the Sales Agreement.
Other Financing
Controlled Equity Offering
Sales Agreement
On May 1, 2020, we entered into an Amended and Restated
Sales Agreement (the "Sales Agreement") with Cantor Fitzgerald & Co. and SVB Leerink LLC (the "Sales Agents"),
pursuant to which we may offer and sell shares of common stock registered under an effective registration statement from time to time
through the Sales Agents (the "At-the-Market Offering").
Upon delivery of a placement notice based on our instructions
and subject to the terms and conditions of the Sales Agreement, the Sales Agents may sell shares of common stock by methods deemed to
be an "at the market offering", in negotiated transactions at market prices prevailing at the time of sale or at prices related
to such prevailing market prices, or by any other method permitted by law, including negotiated transactions, subject to our prior written
consent. We are not obligated to make any sales of shares under the Sales Agreement. We or the Sales Agents may suspend or terminate the
At-the-Market Offering upon notice to the other party, subject to certain conditions. The Sales Agents will act as agents on a commercially
reasonable efforts basis consistent with their normal trading and sales practices and applicable state and federal law, rules and regulations
and the rules of Nasdaq.
We have agreed to pay the Sales Agents commissions
for their services of 3.0% of the gross proceeds from the sale of the shares pursuant to the Sales Agreement. We have also agreed to provide
the Sales Agents with customary indemnification and contribution rights.
During the three months ended
December 31, 2021, 99,588 shares were sold pursuant to the At-the-Market Offering for gross proceeds of $2.3 million (net proceeds of
$2.2 million after deducting commissions and offering expenses).
Off-Balance Sheet Arrangements
We have no off-balance sheet
arrangements that have or are reasonably likely to have a current or future effect on our financial condition, changes in financial condition,
revenues or expenses, results of operations, liquidity, capital expenditures or capital resources that are material to our stockholders.
CRITICAL ACCOUNTING POLICIES
We prepare our interim condensed
consolidated financial statements in accordance with accounting principles generally accepted in the United States of America, and make
estimates and assumptions that affect our reported amounts of assets, liabilities, revenue and expenses, and the related disclosures of
contingent liabilities. We base our estimates on historical experience and other assumptions that we believe are reasonable in the circumstances.
Actual results may differ from these estimates.
33
There have been no significant
changes in the critical accounting policies and estimates described in our Annual Report on Form 10-K for the year ended September 30,
2021 as filed with the SEC on November 24, 2021.
RECENT ACCOUNTING PRONOUNCEMENTS
Please refer to Note 2 "Recent
Accounting Pronouncements" in notes to our Interim Condensed Consolidated Financial Statements included in this Form 10-Q.
ITEM
3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISKS.
Not applicable
ITEM
4. CONTROLS AND PROCEDURES
Disclosure Controls and
Procedures
We maintain disclosure controls
and procedures that are designed to provide reasonable assurance that material information required to be disclosed in our periodic reports
filed under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in the SEC's rules
and forms and to provide reasonable assurance that such information is accumulated and communicated to our management, our chief executive
officer and our principal financial officer, to allow timely decisions regarding required disclosure.
We carried out an evaluation,
under the supervision and with the participation of our management, including our principal executive officer and principal financial
officer, of the effectiveness of the design and operation of our disclosure controls and procedures, as defined in Rule 13a 15(e) under
the Exchange Act, as of the end of the period covered by this Quarterly Report on Form 10-Q. Based on this evaluation, our principal executive
officer and principal financial officer concluded that our disclosure controls and procedures were effective as of December 31, 2021.
Changes in Internal
Control over Financial Reporting
During the quarter ended
December 31, 2021, the Company implemented a new Enterprise Resource Planning ("ERP") system and integrated and digitized
certain aspects of its internal controls over financial reporting within this ERP.
Other than as noted above,
there were no changes in our internal control over financial reporting identified in management's evaluation pursuant to Rules 13a
15(d) or 15d 15(d) of the Exchange Act that materially affected, or are reasonably likely to materially affect, our internal controls
over financial reporting.
PART II – OTHER
INFORMATION
Item 1. Legal Proceedings.
We
know of no material pending legal proceedings, other than ordinary routine litigation incidental to our business, to which our Company
or our subsidiary is a party or of which any of their property is subject. There are no proceedings in which any of our directors, officers
or affiliates, or any registered or beneficial stockholder holding more than 5% of our shares, is an adverse party or has a material interest
adverse to our or our subsidiary's interest.
Item 1A. Risk Factors.
There have been no material changes to the risk factors
discussed in "Risk Factors" in Part I, Item 1A of our Annual Report on Form 10-K for the fiscal year ended September 30, 2021
filed with the SEC on November 24, 2021.
34
Item 2. Unregistered
Sales of Equity Securities and Use of Proceeds.
During the period covered by this Quarterly
Report on Form 10-Q, we have not sold any equity securities that were not registered under the Securities Act of 1933 that were not previously
reported in a Current Report on Form 8-K.
Item 3. Defaults Upon
Senior Securities.
None
Item 4. Mine Safety
Disclosures
Not applicable.
Item 5. Other Information.
None
Item 6. Exhibits.
Exhibit
Number
Description
(3)
Articles of Incorporation and Bylaws
3.1
Articles of Incorporation (incorporated by reference to Exhibit 3.1 to our Annual Report on Form 10-K for the year ended September 30, 2021 filed on November 24, 2021)
3.2
Bylaws (incorporated by reference to our Current Report on Form 8-K filed on September 28, 2007)
(31)
Rule 13a-14(a)/15(d)-14(a)Certifications
31.1*
Certification of Christopher Missling, PhD.
31.2*
Certification of Sandra Boenisch
(32)
Section 1350 Certifications
32.1*
Certification of Christopher Missling, PhD and Sandra Boenisch.
(101)
XBRL
101.INS*
XBRL INSTANCE DOCUMENT
101.SCH*
XBRL TAXONOMY EXTENSION SCHEMA
101.CAL*
XBRL TAXONOMY EXTENSION CALCULATION LINKBASE
101.DEF*
XBRL TAXONOMY EXTENSION DEFINITION LINKBASE
101.LAB*
XBRL TAXONOMY EXTENSION LABEL LINKBASE
101.PRE*
XBRL TAXONOMY EXTENSION PRESENTATION LINKBASE
* Filed herewith.
35
SIGNATURES
Pursuant to the requirements of the Securities
Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
ANAVEX LIFE SCIENCES CORP.
/s/Christopher Missling, PhD
Christopher Missling, PhD
Chief
Executive Officer
(Principal Executive Officer)
Date: February 9, 2022
/s/Sandra Boenisch
Sandra Boenisch, CPA, CGA
Principal
Financial Officer
(Principal Financial and Accounting Officer)
Date: February 9, 2022
36