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

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<p style="font: bold 10pt Times New Roman, Times, Serif; margin: 0; text-align: center"><span style="font: 14pt Times New Roman, Times, Serif">UNITED
STATES&#160;</span></p>

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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">(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"><span id="xdx_90A_edei--CityAreaCode_c20201001__20210630_z9tXcwo2kjz9"><ix:nonNumeric contextRef="From2020-10-01to2021-06-30" name="dei:CityAreaCode">1-844</ix:nonNumeric></span>-<span id="xdx_904_edei--LocalPhoneNumber_c20201001__20210630_zubcBWN8Z8Il"><ix:nonNumeric contextRef="From2020-10-01to2021-06-30" 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></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">(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: center"><span style="font-family: Times New Roman, Times, Serif"><b><span style="text-decoration: underline">N/A</span></b><br />
(Former name, former address and former fiscal year, if changed since last report)</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: justify"><span style="font: 10pt Times New Roman, Times, Serif">Title
of Each Class</span></td>
<td style="vertical-align: top; padding-bottom: 1pt; text-align: justify"><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td>
<td style="border-bottom: Black 1pt solid; vertical-align: bottom; text-align: justify"><span style="font: 10pt Times New Roman, Times, Serif">Trading
Symbol</span></td>
<td style="vertical-align: top; padding-bottom: 1pt; text-align: justify"><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td>
<td style="border-bottom: Black 1pt solid; vertical-align: bottom; text-align: justify"><span style="font: 10pt Times New Roman, Times, Serif">Name
of Each Exchange on Which Registered</span></td></tr>
<tr style="vertical-align: top; background-color: #CCEEFF">
<td style="width: 32%; text-align: justify"><span style="font: 10pt Times New Roman, Times, Serif"><span id="xdx_90A_edei--Security12bTitle_c20201001__20210630_zcEBcITbXVU2"><ix:nonNumeric contextRef="From2020-10-01to2021-06-30" name="dei:Security12bTitle">Common Stock Par Value $0.001</ix:nonNumeric></span></span></td>
<td style="width: 1%; text-align: justify"><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td>
<td style="width: 32%; text-align: justify"><span style="font: 10pt Times New Roman, Times, Serif"><span id="xdx_904_edei--TradingSymbol_c20201001__20210630_zhrt4J8zi8ml"><ix:nonNumeric contextRef="From2020-10-01to2021-06-30" name="dei:TradingSymbol">AVXL</ix:nonNumeric></span></span></td>
<td style="width: 1%; text-align: justify"><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td>
<td style="width: 34%; text-align: justify"><span style="font: 10pt Times New Roman, Times, Serif"><span id="xdx_903_edei--SecurityExchangeName_c20201001__20210630_zB1bcXLBwZ38"><ix:nonNumeric contextRef="From2020-10-01to2021-06-30" 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"></p>

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    <div style="border-bottom: Black 2pt solid; margin-top: 12pt; margin-bottom: 6pt"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%"><tr><td style="text-align: center; width: 100%">&#160;</td></tr></table></div>
    <div style="page-break-before: always; margin-top: 6pt; margin-bottom: 12pt"><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%"><tr><td style="text-align: center; width: 100%">&#160;</td></tr></table></div>
    <!-- Field: /Page -->

<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="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: 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: right"><span style="font-family: Times New Roman, Times, Serif">&#9746;&#160;
<b><span id="xdx_905_edei--EntityCurrentReportingStatus_c20201001__20210630_zyy5Hr2ziY21"><ix:nonNumeric contextRef="From2020-10-01to2021-06-30" name="dei:EntityCurrentReportingStatus">Yes</ix:nonNumeric></span>&#160;&#9744;&#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: 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: right; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif">&#9746;&#160;
<b><span id="xdx_90D_edei--EntityInteractiveDataCurrent_c20201001__20210630_zYTqhizMyeGa"><ix:nonNumeric contextRef="From2020-10-01to2021-06-30" name="dei:EntityInteractiveDataCurrent">Yes</ix:nonNumeric></span>&#160;&#9744;&#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: 10pt Times New Roman, Times, Serif">Large accelerated filer</span></td>
<td style="width: 3%; text-align: justify"><span style="font: 10pt Times New Roman, Times, Serif">&#9744;</span></td>
<td style="width: 41%; text-align: justify"><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td>
<td style="width: 26%; text-align: justify"><span style="font: 10pt Times New Roman, Times, Serif">Accelerated filer</span></td>
<td style="width: 3%; text-align: justify"><span style="font: 10pt Times New Roman, Times, Serif">&#9744;</span></td></tr>
<tr style="vertical-align: top">
<td style="text-align: justify"><span style="font: 10pt Times New Roman, Times, Serif"><span id="xdx_903_edei--EntityFilerCategory_c20201001__20210630_zLiqry7Ob4C9"><ix:nonNumeric contextRef="From2020-10-01to2021-06-30" format="ixt-sec:entityfilercategoryen" name="dei:EntityFilerCategory">Non-accelerated Filer</ix:nonNumeric></span></span></td>
<td style="text-align: justify"><span style="font: 10pt Times New Roman, Times, Serif">&#9746;</span></td>
<td style="text-align: justify"><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td>
<td style="text-align: justify"><span style="font: 10pt Times New Roman, Times, Serif">Smaller reporting company</span></td>
<td style="text-align: justify"><span style="font: 10pt Times New Roman, Times, Serif"><span id="xdx_905_edei--EntitySmallBusiness_c20201001__20210630_zTvukw9V7cQl"><ix:nonNumeric contextRef="From2020-10-01to2021-06-30" format="ixt:booleantrue" name="dei:EntitySmallBusiness">&#9746;</ix:nonNumeric></span></span></td></tr>
<tr style="vertical-align: top">
<td style="text-align: justify"><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td>
<td style="text-align: justify"><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td>
<td style="text-align: justify"><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td>
<td style="text-align: justify"><span style="font: 10pt Times New Roman, Times, Serif">Emerging growth company</span></td>
<td style="text-align: justify"><span style="font: 10pt Times New Roman, Times, Serif"><span id="xdx_90F_edei--EntityEmergingGrowthCompany_c20201001__20210630_z0dFDXw9qRai"><ix:nonNumeric contextRef="From2020-10-01to2021-06-30" format="ixt:booleanfalse" name="dei:EntityEmergingGrowthCompany">&#9744;</ix:nonNumeric></span></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"></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify">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</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: right; text-indent: 0.5in"><b>&#9744;</b></p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify">Indicate by check mark whether the registrant
is a shell company (as defined in Rule 12b-2 of the Exchange Act).</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: right">&#160;&#9744;&#160; <b>Yes&#160;&#9746;&#160; <span id="xdx_90C_edei--EntityShellCompany_c20201001__20210630_ztwDBp0TMRf6"><ix:nonNumeric contextRef="From2020-10-01to2021-06-30" format="ixt:booleanfalse" name="dei:EntityShellCompany">No</ix:nonNumeric></span></b></p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify">Indicate the number of shares outstanding of
each of the issuer&#8217;s classes of common stock, as of the latest practicable date: <span><span id="xdx_909_edei--EntityCommonStockSharesOutstanding_iI_c20210812_ze3MgfQrfCEe"><ix:nonFraction name="dei:EntityCommonStockSharesOutstanding" contextRef="AsOf2021-08-12" format="ixt:numdotdecimal" decimals="INF" unitRef="Shares">75,707,382</ix:nonFraction></span></span>
<span style="color: black">shares of common stock outstanding as of August <span>12, </span>2021</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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    <!-- Field: /Page -->

<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>TABLE OF CONTENTS </b></p>

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

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

<table cellspacing="0" cellpadding="0" style="font: 11pt Calibri, Helvetica, Sans-Serif; width: 100%; border-collapse: collapse">
<tr style="vertical-align: top">
<td style="width: 95%"><span style="font: 10pt Times New Roman, Times, Serif">PART I -<a href="#a_001"> FINANCIAL INFORMATION</a></span></td>
<td style="text-align: right; width: 5%"><span style="font: 10pt Times New Roman, Times, Serif">3</span></td></tr>
<tr style="vertical-align: top">
<td><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td>
<td style="text-align: right"><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td></tr>
<tr style="vertical-align: top">
<td><span style="font: 10pt Times New Roman, Times, Serif">ITEM 1.<a href="#a_002"> FINANCIAL STATEMENTS</a></span></td>
<td style="text-align: right"><span style="font: 10pt Times New Roman, Times, Serif">3</span></td></tr>
<tr style="vertical-align: top">
<td><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td>
<td style="text-align: right"><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td></tr>
<tr style="vertical-align: top">
  <td><span style="font: 10pt Times New Roman, Times, Serif">ITEM 2.<a href="#a_003"> MANAGEMENT&#8217;S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.</a></span></td>
  <td style="text-align: right">&#160; <span style="font: 10pt Times New Roman, Times, Serif">16</span></td>
</tr>
<tr style="vertical-align: top">
<td><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td>
<td style="text-align: right"><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td></tr>
<tr style="vertical-align: top">
<td><span style="font: 10pt Times New Roman, Times, Serif">ITEM 3.<a href="#a_004"> QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISKS.</a></span></td>
<td style="text-align: right"><span style="font: 10pt Times New Roman, Times, Serif">30</span></td></tr>
<tr style="vertical-align: top">
<td><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td>
<td style="text-align: right"><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td></tr>
<tr style="vertical-align: top">
<td><span style="font: 10pt Times New Roman, Times, Serif">ITEM 4.<a href="#a_005"> CONTROLS AND PROCEDURES.</a></span></td>
<td style="text-align: right"><span style="font: 10pt Times New Roman, Times, Serif">30</span></td></tr>
<tr style="vertical-align: top">
<td><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td>
<td style="text-align: right"><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td></tr>
<tr style="vertical-align: top">
<td><span style="font: 10pt Times New Roman, Times, Serif">PART II&#160;&#160;&#160;<a href="#a_006">OTHER INFORMATION</a></span></td>
<td style="text-align: right"><span style="font: 10pt Times New Roman, Times, Serif">31</span></td></tr>
<tr style="vertical-align: top">
<td><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td>
<td style="text-align: right"><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td></tr>
<tr style="vertical-align: top">
<td><span style="font: 10pt Times New Roman, Times, Serif">ITEM 1.<a href="#a_007"> LEGAL PROCEEDINGS.</a></span></td>
<td style="text-align: right"><span style="font: 10pt Times New Roman, Times, Serif">31</span></td></tr>
<tr style="vertical-align: top">
<td><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td>
<td style="text-align: right"><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td></tr>
<tr style="vertical-align: top">
<td><span style="font: 10pt Times New Roman, Times, Serif">ITEM 1A.<a href="#a_008"> RISK FACTORS</a></span></td>
<td style="text-align: right"><span style="font: 10pt Times New Roman, Times, Serif">31</span></td></tr>
<tr style="vertical-align: top">
<td><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td>
<td style="text-align: right"><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td></tr>
<tr style="vertical-align: top">
<td><span style="font: 10pt Times New Roman, Times, Serif">ITEM 2.<a href="#a_009"> UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS</a></span></td>
<td style="text-align: right"><span style="font: 10pt Times New Roman, Times, Serif">33</span></td></tr>
<tr style="vertical-align: top">
<td><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td>
<td style="text-align: right"><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td></tr>
<tr style="vertical-align: top">
<td><span style="font: 10pt Times New Roman, Times, Serif">ITEM 3.<a href="#a_010"> DEFAULTS UPON SENIOR SECURITIES.</a></span></td>
<td style="text-align: right"><span style="font: 10pt Times New Roman, Times, Serif">33</span></td></tr>
<tr style="vertical-align: top">
<td><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td>
<td style="text-align: right"><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td></tr>
<tr style="vertical-align: top">
<td><span style="font: 10pt Times New Roman, Times, Serif">ITEM 4.<a href="#a_011"> MINE SAFETY DISCLOSURES</a></span></td>
<td style="text-align: right"><span style="font: 10pt Times New Roman, Times, Serif">33</span></td></tr>
<tr style="vertical-align: top">
<td><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td>
<td style="text-align: right"><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td></tr>
<tr style="vertical-align: top">
<td><span style="font: 10pt Times New Roman, Times, Serif">ITEM 5.<a href="#a_012"> OTHER INFORMATION.</a></span></td>
<td style="text-align: right"><span style="font: 10pt Times New Roman, Times, Serif">33</span></td></tr>
<tr style="vertical-align: top">
<td><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td>
<td style="text-align: right"><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td></tr>
<tr style="vertical-align: top">
<td><span style="font: 10pt Times New Roman, Times, Serif">ITEM 6.<a href="#a_013"> EXHIBITS.</a></span></td>
<td style="text-align: right"><span style="font: 10pt Times New Roman, Times, Serif">34</span></td></tr>
<tr style="vertical-align: top">
<td><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td>
<td style="text-align: right"><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td></tr>
<tr style="vertical-align: top">
<td><span style="font: 10pt Times New Roman, Times, Serif"><a href="#a_014">SIGNATURES</a></span></td>
<td style="text-align: right"><span style="font: 10pt Times New Roman, Times, Serif">35</span></td></tr>
</table>

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

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

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

<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;</p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
<tr style="vertical-align: bottom">
    <td style="white-space: nowrap; width: 100%; padding-top: 0.75pt; padding-right: 0.75pt; padding-left: 0.75pt; text-align: center"><span style="color: black"><b>ANAVEX
    LIFE SCIENCES CORP.</b></span></td></tr>
<tr style="vertical-align: bottom">
    <td style="white-space: nowrap; padding-top: 0.75pt; padding-right: 0.75pt; padding-left: 0.75pt; text-align: center"><span style="color: black"><b>INTERIM
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<tr style="vertical-align: bottom">
    <td style="white-space: nowrap; padding-top: 0.75pt; padding-right: 0.75pt; padding-left: 0.75pt; text-align: center"><span style="color: black"><b>June
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</table>
<p style="font: 10pt Times New Roman, Times, Serif; margin: 0"><b>&#160;</b></p>

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    <td style="padding: 0pt 0pt 0pt 10pt; color: black; text-indent: -10pt">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td id="xdx_497_20210630" 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_491_20200930" 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="color: black; font-weight: bold; padding-bottom: 1pt">&#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>
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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="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-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>
  <tr id="xdx_40D_eus-gaap--CommitmentsAndContingencies_i01I_zNuPJVeVvUxg" style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <td style="padding: 0pt 0pt 0pt 10pt; color: black; text-align: left; text-indent: -10pt">Commitments and Contingencies - Note 5</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td></tr>
  <tr style="vertical-align: bottom; background-color: White">
    <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>
  <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></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></tr>
  <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"><b>&#160;</b></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: center">See Accompanying Notes to Condensed Consolidated
Interim Financial Statements</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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<tr style="vertical-align: bottom">
    <td style="white-space: nowrap; padding-top: 0.65pt; padding-right: 0.65pt; padding-left: 0.65pt; text-align: center"><span style="color: black"><b>INTERIM
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  <tr id="xdx_40D_ecustom--ResearchAndDevelopmentIncentiveIncome_i01_maCz13q_zoqWDNZ3oh6c" style="vertical-align: bottom; background-color: rgb(204,238,255)">
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  <tr id="xdx_40F_eus-gaap--InterestIncomeExpenseNet_i01_maCz13q_zGOwtTUeBPkg" style="vertical-align: bottom; background-color: White">
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  <tr id="xdx_405_eus-gaap--ForeignCurrencyTransactionGainLossBeforeTax_i01_maCz13q_zXR07O8OpfN9" style="vertical-align: bottom; background-color: rgb(204,238,255)">
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    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
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  <tr id="xdx_404_eus-gaap--NonoperatingIncomeExpense_iT_mtCz13q_maCzSTZ_zQagkkg7xBt6" style="vertical-align: bottom; background-color: rgb(204,238,255)">
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  <tr id="xdx_404_eus-gaap--IncomeLossFromContinuingOperationsBeforeIncomeTaxesExtraordinaryItemsNoncontrollingInterest_iT_mtCzSTZ_maCz6oO_zsnPJcNOR2Rd" 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: 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><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_40C_eus-gaap--CurrentIncomeTaxExpenseBenefit_iN_di_msCz6oO_zKckUZ1d3gj4" style="vertical-align: bottom; background-color: White">
    <td style="padding: 0pt 0pt 0pt 10pt; color: black; text-align: left; text-indent: -10pt">Income tax expense, current</td><td style="color: black; font-weight: bold; padding-bottom: 1pt">&#160;</td>
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
    <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><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--NetIncomeLoss_iT_mtCz6oO_zx4GZTh6OCil" 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: 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><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_40F_eus-gaap--EarningsPerShareBasicAndDilutedAbstract_iB_z26tudMnOPX7" style="vertical-align: bottom; background-color: White">
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    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td></tr>
  <tr id="xdx_408_eus-gaap--EarningsPerShareBasicAndDiluted_i01_zAacziQj0Lmg" style="vertical-align: bottom; background-color: rgb(204,238,255)">
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    <td style="border-bottom: Black 1pt solid; color: black; font-weight: bold; text-align: left">$</td><td style="border-bottom: Black 1pt solid; color: black; font-weight: bold; text-align: right">(<ix:nonFraction name="us-gaap:EarningsPerShareBasicAndDiluted" contextRef="From2021-04-012021-06-30" format="ixt:numdotdecimal" decimals="INF" sign="-" unitRef="USDPShares">0.14</ix:nonFraction></td><td style="padding-bottom: 1pt; color: black; font-weight: bold; text-align: left">)</td><td style="color: black; padding-bottom: 1pt">&#160;</td>
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  </table>


<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: center">See Accompanying Notes to Condensed Consolidated
Interim Financial Statements</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: 0; text-align: center">&#160;</p>

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

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
<tr style="vertical-align: bottom">
    <td style="white-space: nowrap; width: 100%; padding-top: 0.65pt; padding-right: 0.65pt; padding-left: 0.65pt; text-align: center"><span style="color: black"><b>ANAVEX
    LIFE SCIENCES CORP.</b></span></td></tr>
<tr style="vertical-align: bottom">
    <td style="white-space: nowrap; padding-top: 0.65pt; padding-right: 0.65pt; padding-left: 0.65pt; text-align: center"><span style="color: black"><b>INTERIM
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<tr style="vertical-align: bottom; background-color: white">
    <td style="white-space: nowrap; padding-top: 0.65pt; padding-right: 0.65pt; padding-left: 0.65pt; text-align: center"><span style="color: black"><b>For
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<tr style="vertical-align: bottom; background-color: white">
    <td style="white-space: nowrap; padding-top: 0.65pt; padding-right: 0.65pt; padding-left: 0.65pt; text-align: center"><span style="color: black"><b>(Unaudited)</b></span></td></tr>
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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0">&#160;</p>

<table cellpadding="0" cellspacing="0" id="xdx_301_112_zDHcIcbaoD28" summary="xdx: Statement - INTERIM CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited)" style="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 100%">
  <tr style="vertical-align: bottom; background-color: White">
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    <td style="padding: 0pt 0pt 0pt 10pt; text-align: center; text-indent: -10pt">&#160;</td><td style="color: black; font-weight: bold; padding-bottom: 1pt">&#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>
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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; text-align: center">See Accompanying Notes to Condensed Consolidated
Interim Financial Statements</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: 0; text-align: center">&#160;</p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
<tr style="vertical-align: bottom">
    <td style="white-space: nowrap; width: 100%; padding-top: 0.65pt; padding-right: 0.65pt; padding-left: 0.65pt; text-align: center"><span style="color: black"><b>ANAVEX
    LIFE SCIENCES CORP.</b></span></td></tr>
<tr style="vertical-align: bottom">
    <td style="white-space: nowrap; padding-top: 0.65pt; padding-right: 0.65pt; padding-left: 0.65pt; text-align: center"><span style="color: black"><b>INTERIM
    CONDENSED CONSOLIDATED STATEMENT OF CHANGES IN STOCKHOLDERS&#8217; EQUITY</b></span></td></tr>
<tr style="vertical-align: bottom">
    <td style="white-space: nowrap; padding-top: 0.65pt; padding-right: 0.65pt; padding-left: 0.65pt; text-align: center"><span style="color: black"><b>For
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    <td style="white-space: nowrap; padding-top: 0.65pt; padding-right: 0.65pt; padding-left: 0.65pt; text-align: center"><span style="color: black"><b>(Unaudited)</b></span></td></tr>
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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0">&#160;</p>

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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>
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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; text-align: center">See Accompanying Notes to Condensed Consolidated
Interim Financial Statements</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: 0; text-align: center">&#160;</p>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
<tr style="vertical-align: bottom">
    <td style="white-space: nowrap; width: 100%; padding-top: 0.65pt; padding-right: 0.65pt; padding-left: 0.65pt; text-align: center"><span style="color: black"><b>ANAVEX
    LIFE SCIENCES CORP.</b></span></td></tr>
<tr style="vertical-align: bottom">
    <td style="white-space: nowrap; padding-top: 0.65pt; padding-right: 0.65pt; padding-left: 0.65pt; text-align: center"><span style="color: black"><b>INTERIM
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<tr style="vertical-align: bottom">
    <td style="white-space: nowrap; padding-top: 0.65pt; padding-right: 0.65pt; padding-left: 0.65pt; text-align: center"><span style="color: black"><b>For
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<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; border-collapse: collapse; width: 100%">
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  <tr id="xdx_40E_eus-gaap--EmployeeBenefitsAndShareBasedCompensation_zia42ndYmL4b" style="vertical-align: bottom; background-color: White">
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    <td style="border-bottom: Black 1pt solid; color: black; text-align: left">&#160;</td><td style="border-bottom: Black 1pt solid; color: black; text-align: right"><span style="-sec-ix-hidden: xdx2ixbrl0412">&#8212;</span></td><td style="padding-bottom: 1pt; color: black; text-align: left">&#160;</td><td style="color: black; padding-bottom: 1pt">&#160;</td>
    <td style="border-bottom: Black 1pt solid; color: black; text-align: left">&#160;</td><td style="border-bottom: Black 1pt solid; color: black; text-align: right"><span style="-sec-ix-hidden: xdx2ixbrl0413">&#8212;</span></td><td style="padding-bottom: 1pt; color: black; text-align: left">&#160;</td><td style="color: black; padding-bottom: 1pt">&#160;</td>
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  <tr id="xdx_43B_c20201001__20210630_eus-gaap--StockholdersEquity_iE_zmvPTyIIfxLe" style="vertical-align: bottom; background-color: White">
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    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
    <td style="text-align: left">&#160;</td><td style="text-align: right">&#160;</td><td style="text-align: left">&#160;</td><td>&#160;</td>
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  <tr id="xdx_434_c20191001__20200630_eus-gaap--StockholdersEquity_iS_z4ZB4mSSMQUl" 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: 0pt 0pt 0pt 10pt; color: black; text-align: left; text-indent: -10pt">Shares issued under 2019 Purchase Agreement</td><td>&#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; margin: 0; text-align: center">See Accompanying Notes to Condensed Consolidated
Interim Financial Statements</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: 0; text-align: center">&#160;</p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 130.6pt 0 0">Notes to the Condensed Consolidated Interim Financial Statements<br />

June 30, 2021<br />
 (Unaudited)</p>

<ix:nonNumeric contextRef="From2020-10-01to2021-06-30" escape="true" name="us-gaap:OrganizationConsolidationAndPresentationOfFinancialStatementsDisclosureTextBlock"><p id="xdx_80B_eus-gaap--OrganizationConsolidationAndPresentationOfFinancialStatementsDisclosureTextBlock_zhhjFNwEkW1f" style="font: 10pt Times New Roman, Times, Serif; margin: 0 130.6pt 0 0">&#160;</p>

<table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><tr style="vertical-align: top; text-align: justify">
<td style="width: 42pt; text-align: left">Note 1</td><td style="text-align: justify"><span style="text-decoration: underline"><span id="xdx_82A_zUO5DzJkHDoa">Business Description
and Basis of Presentation</span></span></td>
</tr></table>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 42pt; text-align: justify; text-indent: 0pt">Business</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 42pt; text-align: justify">Anavex Life Sciences Corp. (&#8220;Anavex&#8221;
or the &#8220;Company&#8221;) <span style="color: black">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. </span>The Company&#8217;s
lead compound ANAVEX<sup>&#174;</sup>2-73 <span style="color: black">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;)</span>.</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: 0 0 0 42pt; text-align: justify">On May 25, 2021, the Company filed
a Certificate of Amendment to its Articles of Incorporation with the Secretary of the State of Nevada effecting an amendment to
increase the number of authorized shares of the Company&#8217;s common stock, par value $<span id="xdx_904_eus-gaap--CommonStockParOrStatedValuePerShare_iI_c20210525_z8AbwXUUyDza" title="Common stock, par value"><ix:nonFraction name="us-gaap:CommonStockParOrStatedValuePerShare" contextRef="AsOf2021-05-25" format="ixt:numdotdecimal" decimals="INF" unitRef="USDPShares">0.001</ix:nonFraction> </span>per share, from <span id="xdx_908_eus-gaap--ExcessStockSharesAuthorized_iI_c20210525__srt--RangeAxis__srt--MinimumMember_zx1M2oZ5SxFk"><ix:nonFraction name="us-gaap:ExcessStockSharesAuthorized" contextRef="AsOf2021-05-25_srt_MinimumMember" format="ixt:numdotdecimal" decimals="INF" unitRef="Shares">100,000,000</ix:nonFraction></span> shares
to <span id="xdx_905_eus-gaap--ExcessStockSharesAuthorized_iI_c20210525__srt--RangeAxis__srt--MaximumMember_zewSnWm0soxl"><ix:nonFraction name="us-gaap:ExcessStockSharesAuthorized" contextRef="AsOf2021-05-25_srt_MaximumMember" format="ixt:numdotdecimal" decimals="INF" unitRef="Shares">200,000,000</ix:nonFraction></span> shares. The Certificate of Amendment was approved by the Company&#8217;s stockholders at an annual meeting of stockholders
on May 25, 2021.</p>

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

<ix:nonNumeric contextRef="From2020-10-01to2021-06-30" escape="true" name="us-gaap:NewAccountingPronouncementsPolicyPolicyTextBlock"><p id="xdx_84D_eus-gaap--NewAccountingPronouncementsPolicyPolicyTextBlock_zxbVJpCHdrD4" style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 0pt; text-align: justify; text-indent: 42.55pt"><span id="xdx_863_z4w2j1Gyuuce">Basis of
Presentation</span></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.<span style="color: black"> 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.</span></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, 2020 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, 2020 filed with the SEC on December 28, 2020. 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"><span style="color: black">Operating
results for the three and nine months ended </span>June 30<span style="color: black">, 2021 are not necessarily indicative of the
results that may be expected for the year ending September 30, 2021.</span></p>

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

</ix:nonNumeric><ix:nonNumeric contextRef="From2020-10-01to2021-06-30" escape="true" name="avxl:LiquidityPolicyTextBlock"><p id="xdx_848_ecustom--LiquidityPolicyTextBlock_zgpITkUS9fIe" style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 42.55pt; text-align: justify"><span id="xdx_86C_zfo8cXMui8Uf">Liquidity</span></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">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>

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<ix:exclude><p id="xdx_235_zS77iJI7YMmh" style="font: 10pt Times New Roman, Times, Serif; margin: 0">Anavex Life Sciences Corp.</p></ix:exclude>

<ix:exclude><p id="xdx_231_zAXjka33Gjaa" style="font: 10pt Times New Roman, Times, Serif; margin: 0 130.6pt 0 0">Notes to the Condensed Consolidated Interim Financial Statements<br />

June 30, 2021<br />
 (Unaudited)</p></ix:exclude>

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<td style="width: 42pt; text-align: left">Note 1</td><td style="text-align: justify"> <span style="text-decoration: underline">Business Description and Basis of Presentation</span> &#8211; (Continued)</td>
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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 4), 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">In December 2019, a novel strain
of coronavirus, COVID-19, was reported to have surfaced in Wuhan, China. In March 2020, the World Health Organization declared
COVID-19 to be a global pandemic as a result of the rapid spread of the virus beyond its point of origin.</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 global outbreak of COVID-19
continues to rapidly evolve as of the date these interim condensed consolidated financial statements are issued. 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. The effects of COVID-19 did not have a material impact on the Company&#8217;s result of operations or
financial condition for the period ended June 30, 2021. However, 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"><i style="font-style: normal; font-weight: normal">Use of Estimates</i></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">&#160;</span></p>

<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, valuation and recoverability
of deferred tax assets, incentive and tax receivables, 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>

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<ix:exclude><p id="xdx_238_zlEjDY6msy44" style="font: 10pt Times New Roman, Times, Serif; margin: 0">Anavex Life Sciences Corp.</p></ix:exclude>

<ix:exclude><p id="xdx_239_zGE7eS5oNmAf" style="font: 10pt Times New Roman, Times, Serif; margin: 0 130.6pt 0 0">Notes to the Condensed Consolidated Interim Financial Statements<br />

June 30, 2021<br />
 (Unaudited)</p></ix:exclude>

<ix:exclude><p id="xdx_237_zhMkwabcwUMe" style="font: 10pt Times New Roman, Times, Serif; margin: 0">&#160;</p></ix:exclude>

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<td style="width: 40pt; text-align: left">Note 1</td><td style="text-align: justify"> &#9;<span style="text-decoration: underline">Business Description and Basis of Presentation</span> &#8211; (Continued)</td>
</tr></table></ix:exclude>

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

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<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., 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"><i style="font-style: normal; font-weight: normal">Fair Value Measurements</i></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">&#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 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</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 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.</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 42.55pt; text-align: justify">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.</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 June 30, 2021 and September
30, 2020, the Company did not have any Level 3 assets or liabilities.</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"><i style="font-style: normal; font-weight: normal">Basic and Diluted
Loss per Share</i></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">&#160;</span></p>

<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 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.</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 June 30, 2021, loss per share
excludes <span id="xdx_90F_eus-gaap--AntidilutiveSecuritiesExcludedFromComputationOfEarningsPerShareAmount_c20201001__20210630_pdd" title="Loss per share for potentially dilutive common shares"><ix:nonFraction name="us-gaap:AntidilutiveSecuritiesExcludedFromComputationOfEarningsPerShareAmount" contextRef="From2020-10-01to2021-06-30" format="ixt:numdotdecimal" decimals="INF" unitRef="Shares">11,059,202</ix:nonFraction></span> (September 30, 2020 &#8211; <span id="xdx_901_eus-gaap--AntidilutiveSecuritiesExcludedFromComputationOfEarningsPerShareAmount_c20191001__20200930_pdd" title="Loss per share for potentially dilutive common shares"><ix:nonFraction name="us-gaap:AntidilutiveSecuritiesExcludedFromComputationOfEarningsPerShareAmount" contextRef="From2019-10-012020-09-30" format="ixt:numdotdecimal" decimals="INF" unitRef="Shares">10,576,266</ix:nonFraction></span>) potentially dilutive common shares related to outstanding options and
warrants, as their effect was anti-dilutive.</p>

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<ix:exclude><p id="xdx_23F_zAZsUqijmPW" style="font: 10pt Times New Roman, Times, Serif; margin: 0">Anavex Life Sciences Corp.</p></ix:exclude>

<ix:exclude><p id="xdx_231_zRNdJ8HK8be5" style="font: 10pt Times New Roman, Times, Serif; margin: 0 130.6pt 0 0">Notes to the Condensed Consolidated Interim Financial Statements<br />

June 30, 2021<br />
 (Unaudited)</p></ix:exclude>

</ix:nonNumeric></ix:nonNumeric><ix:nonNumeric contextRef="From2020-10-01to2021-06-30" escape="true" name="us-gaap:NewAccountingPronouncementsAndChangesInAccountingPrinciplesTextBlock"><p id="xdx_80E_eus-gaap--NewAccountingPronouncementsAndChangesInAccountingPrinciplesTextBlock_z9betADO0Syk" style="font: 10pt Times New Roman, Times, Serif; margin: 0 130.6pt 0 0">&#160;</p>

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<td style="width: 42pt; text-align: left">Note 2</td><td style="text-align: justify"><span style="text-decoration: underline"><span id="xdx_82E_z0ifvhz4vHZ6">Recent Accounting Pronouncements</span></span></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; margin: 0 0 0 42.55pt; text-align: justify"><i>Recent Accounting Pronouncements
Not Yet Adopted</i></p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 42.55pt; text-align: justify">The Company does not expect the
adoption of recently issued accounting pronouncements to have a significant impact on its results of operations, financial position
or cash flows.</p>

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<td style="width: 42pt; text-align: left">Note 3</td><td style="text-align: justify"><span style="text-decoration: underline"><span id="xdx_826_zTXy9RVvs1Ob">Other Income</span></span></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; margin: 0 0 0 42pt; text-align: justify; background-color: white">Grant Income</p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 42pt; text-align: justify; background-color: white">During the
nine months ended June 30, 2021, the Company received $<span id="xdx_904_eus-gaap--ResearchAndDevelopmentArrangementContractToPerformForOthersCompensationEarned_c20210401__20210630__us-gaap--RelatedPartyTransactionsByRelatedPartyAxis__custom--ParkinsonMember_pp0p0" title="Research and development incentive income"><ix:nonFraction name="us-gaap:ResearchAndDevelopmentArrangementContractToPerformForOthersCompensationEarned" contextRef="From2021-04-012021-06-30_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 in the Company&#8217;s lead compound, ANAVEX<sup>&#174;</sup>2-73
for the treatment of Parkinson&#8217;s disease.</p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 42pt; 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.
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its statements of operations within grant income.</p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 42pt; text-align: justify; background-color: white">During the
year ended September 30, 2017, the Company was awarded grant funding in the amount of $<span id="xdx_908_ecustom--NonOperatingIncomeFromGrant_c20161001__20170930_pp0p0" title="Grant income"><ix:nonFraction name="avxl:NonOperatingIncomeFromGrant" contextRef="From2016-10-012017-09-30" format="ixt:numdotdecimal" decimals="0" scale="0" unitRef="USD">597,886</ix:nonFraction></span>. The grant was received in equal
quarterly installments over a period of two years ending during the year ended September 30, 2020, in exchange for a commitment
to complete clinical testing for a therapeutic drug candidate for the treatment of Rett syndrome.</p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 42pt; text-align: justify; background-color: white">The grant
income was deferred when received and amortized to other income as the related research and development expenditures were incurred.
During the three and nine months ended June 30, 2020, the Company recognized $nil and $<span id="xdx_901_ecustom--NonOperatingIncomeFromGrant_c20191001__20200630_pp0p0" title="Grant income"><ix:nonFraction name="avxl:NonOperatingIncomeFromGrant" contextRef="From2019-10-012020-06-30" format="ixt:numdotdecimal" decimals="0" scale="0" unitRef="USD">149,888</ix:nonFraction></span>, respectively of this grant on its
statements of operations within grant income.</p>

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

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 42pt; text-align: justify; background-color: white">Research
and development incentive income represents income earned by the Company&#8217;s Australian subsidiary, of the <span style="color: black">Australian
research and development incentive credit, </span>(the &#8220;ATO R&amp;D Credit&#8221;).</p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 42pt; text-align: justify; background-color: white">During the
three and nine months ended June 30, 2021, the Company recorded research and development incentive income of $<span id="xdx_90D_eus-gaap--ResearchAndDevelopmentArrangementContractToPerformForOthersCompensationEarned_c20210401__20210630_pp0p0" title="Research and development incentive income"><ix:nonFraction name="us-gaap:ResearchAndDevelopmentArrangementContractToPerformForOthersCompensationEarned" contextRef="From2021-04-012021-06-30" format="ixt:numdotdecimal" decimals="0" scale="0" unitRef="USD">1,363,661</ix:nonFraction></span> (AUD <span id="xdx_908_eus-gaap--ResearchAndDevelopmentArrangementContractToPerformForOthersCompensationEarned_c20210401__20210630__srt--CurrencyAxis__currency--AUD_pp0p0" title="Research and development incentive income"><ix:nonFraction name="us-gaap:ResearchAndDevelopmentArrangementContractToPerformForOthersCompensationEarned" contextRef="From2021-04-012021-06-30_currency_AUD" format="ixt:numdotdecimal" decimals="0" scale="0" unitRef="USD">1,770,444</ix:nonFraction></span>)
and $<span id="xdx_901_eus-gaap--ResearchAndDevelopmentArrangementContractToPerformForOthersCompensationEarned_c20201001__20210630_pp0p0" title="Research and development incentive income"><ix:nonFraction name="us-gaap:ResearchAndDevelopmentArrangementContractToPerformForOthersCompensationEarned" contextRef="From2020-10-01to2021-06-30" format="ixt:numdotdecimal" decimals="0" scale="0" unitRef="USD">3,593,856</ix:nonFraction> </span>(AUD <span id="xdx_904_eus-gaap--ResearchAndDevelopmentArrangementContractToPerformForOthersCompensationEarned_c20201001__20210630__srt--CurrencyAxis__currency--AUD_pp0p0" title="Research and development incentive income"><ix:nonFraction name="us-gaap:ResearchAndDevelopmentArrangementContractToPerformForOthersCompensationEarned" contextRef="From2020-10-012021-06-30_currency_AUD" format="ixt:numdotdecimal" decimals="0" scale="0" unitRef="USD">4,750,539</ix:nonFraction></span>) (2020: $<span id="xdx_90F_eus-gaap--ResearchAndDevelopmentArrangementContractToPerformForOthersCompensationEarned_c20200401__20200630_pp0p0" title="Research and development incentive income"><ix:nonFraction name="us-gaap:ResearchAndDevelopmentArrangementContractToPerformForOthersCompensationEarned" contextRef="From2020-04-012020-06-30" format="ixt:numdotdecimal" decimals="0" scale="0" unitRef="USD">1,319,913</ix:nonFraction></span> (AUD <span id="xdx_906_eus-gaap--ResearchAndDevelopmentArrangementContractToPerformForOthersCompensationEarned_c20200401__20200630__srt--CurrencyAxis__currency--AUD_pp0p0" title="Research and development incentive income"><ix:nonFraction name="us-gaap:ResearchAndDevelopmentArrangementContractToPerformForOthersCompensationEarned" contextRef="From2020-04-012020-06-30_currency_AUD" format="ixt:numdotdecimal" decimals="0" scale="0" unitRef="USD">1,923,000</ix:nonFraction></span>) and $<span id="xdx_908_eus-gaap--ResearchAndDevelopmentArrangementContractToPerformForOthersCompensationEarned_c20191001__20200630_pp0p0" title="Research and development incentive income"><ix:nonFraction name="us-gaap:ResearchAndDevelopmentArrangementContractToPerformForOthersCompensationEarned" contextRef="From2019-10-012020-06-30" format="ixt:numdotdecimal" decimals="0" scale="0" unitRef="USD">2,980,456</ix:nonFraction></span> (AUD <span id="xdx_90D_eus-gaap--ResearchAndDevelopmentArrangementContractToPerformForOthersCompensationEarned_c20191001__20200630__srt--CurrencyAxis__currency--AUD_pp0p0" title="Research and development incentive income"><ix:nonFraction name="us-gaap:ResearchAndDevelopmentArrangementContractToPerformForOthersCompensationEarned" contextRef="From2019-10-012020-06-30_currency_AUD" format="ixt:numdotdecimal" decimals="0" scale="0" unitRef="USD">4,471,000</ix:nonFraction></span>)), respectively, in respect of the
ATO R&amp;D Credit for eligible research and development expenses incurred during the period.</p>

</ix:nonNumeric><ix:nonNumeric contextRef="From2020-10-01to2021-06-30" escape="true" name="avxl:EquityOfferingAgreementsTextBlock"><p id="xdx_80B_ecustom--EquityOfferingAgreementsTextBlock_zJr0lD85aytc" style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 45pt; text-align: justify; background-color: white">&#160;</p>

<table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><tr style="vertical-align: top; text-align: justify">
<td style="width: 42pt; text-align: left">Note 4</td><td style="text-align: justify"><span style="text-decoration: underline"><span id="xdx_82A_zR1783jA5m2c">Equity Offerings</span></span></td>
</tr></table>

<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">Registered Direct Offering</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 22, 2021, the Company and
Deep Track Capital entered into a securities purchase agreement pursuant to which the Company sold to Deep Track Capital an aggregate
of <span id="xdx_903_eus-gaap--StockIssuedDuringPeriodSharesNewIssues_c20210601__20210622__us-gaap--TypeOfArrangementAxis__custom--EquityOfferingSalesAgreementMember__dei--LegalEntityAxis__custom--CantorFitzgeraldAndCoMember_zR6mGDdDeuo5" title="Share issued for offering, shares"><ix:nonFraction name="us-gaap:StockIssuedDuringPeriodSharesNewIssues" contextRef="From2021-06-012021-06-22_custom_EquityOfferingSalesAgreementMember_custom_CantorFitzgeraldAndCoMember" format="ixt:numdotdecimal" decimals="INF" unitRef="Shares">2,380,953</ix:nonFraction></span> shares of common stock at $<span id="xdx_90D_eus-gaap--SharePrice_iI_pp0p0_c20210622__us-gaap--TypeOfArrangementAxis__custom--EquityOfferingSalesAgreementMember__dei--LegalEntityAxis__custom--CantorFitzgeraldAndCoMember_zJjzmvmTiZE2" title="Common stock price"><ix:nonFraction name="us-gaap:SharePrice" contextRef="AsOf2021-06-22_custom_EquityOfferingSalesAgreementMember_custom_CantorFitzgeraldAndCoMember" format="ixt:numdotdecimal" decimals="0" scale="0" unitRef="USDPShares">21</ix:nonFraction></span> per share in a registered direct offering, for gross proceeds of $<span id="xdx_90E_ecustom--GrossProceedsFromSaleOfCommonStock_pp0p0_c20210601__20210622__us-gaap--TypeOfArrangementAxis__custom--EquityOfferingSalesAgreementMember__dei--LegalEntityAxis__custom--CantorFitzgeraldAndCoMember_zttELwpFLcfi" title="Gross proceeds from sale of common stock"><ix:nonFraction name="avxl:GrossProceedsFromSaleOfCommonStock" contextRef="From2021-06-012021-06-22_custom_EquityOfferingSalesAgreementMember_custom_CantorFitzgeraldAndCoMember" format="ixt:numdotdecimal" decimals="0" scale="0" unitRef="USD">50,000,013</ix:nonFraction></span>. Net proceeds
of the offering were $<span id="xdx_908_eus-gaap--ProceedsFromIssuanceInitialPublicOffering_pp0p0_c20210601__20210622__us-gaap--TypeOfArrangementAxis__custom--EquityOfferingSalesAgreementMember__dei--LegalEntityAxis__custom--CantorFitzgeraldAndCoMember_z1CDELzc6tb4" title="Proceed from offering"><ix:nonFraction name="us-gaap:ProceedsFromIssuanceInitialPublicOffering" contextRef="From2021-06-012021-06-22_custom_EquityOfferingSalesAgreementMember_custom_CantorFitzgeraldAndCoMember" format="ixt:numdotdecimal" decimals="0" scale="0" unitRef="USD">46,904,062</ix:nonFraction> </span>after deducting offering fees and expenses.</p>

<ix:exclude><p id="xdx_23B_zIcjxTb4geC8" 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_232_z4QHVjaCVdpl" 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: 12; Value: 1 -->
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    <!-- Field: /Page --></ix:exclude>

<ix:exclude><p id="xdx_23C_zdsFkrBYrLg" 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_236_zPtXeUmoQivi" style="font: 10pt Times New Roman, Times, Serif; margin: 0">Anavex Life Sciences Corp.</p></ix:exclude>

<ix:exclude><p id="xdx_23F_z96KKFkwqQci" style="font: 10pt Times New Roman, Times, Serif; margin: 0 130.6pt 0 0">Notes to the Condensed Consolidated Interim Financial Statements<br />

June 30, 2021<br />
 (Unaudited)</p></ix:exclude>

<ix:exclude><p id="xdx_23F_z7veyu3CMk29" style="font: 10pt Times New Roman, Times, Serif; margin: 0 130.6pt 0 0">&#160;</p></ix:exclude>

<ix:exclude><table cellpadding="0" cellspacing="0" id="xdx_231_z4cB9eJYSdZ1" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><tr style="vertical-align: top; text-align: justify">
<td style="width: 42pt; text-align: left">Note 4</td><td style="text-align: justify"><span style="text-decoration: underline">Equity Offerings</span> &#8211; (Continued)</td>
</tr></table></ix:exclude>

<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">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 <span id="xdx_901_ecustom--PercentageOfGrossProceedsFromSales_dp_c20201001__20210630__us-gaap--TypeOfArrangementAxis__custom--EquityOfferingSalesAgreementMember__dei--LegalEntityAxis__custom--CantorFitzgeraldAndCoMember_zngz6jyIzOG4" title="Percentage of gross proceeds from sales"><ix:nonFraction name="avxl:PercentageOfGrossProceedsFromSales" contextRef="From2020-10-012021-06-30_custom_EquityOfferingSalesAgreementMember_custom_CantorFitzgeraldAndCoMember" format="ixt:numdotdecimal" decimals="INF" scale="-2" unitRef="Pure">3.0</ix:nonFraction></span>% 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
nine months ended June 30, 2021, <span id="xdx_906_eus-gaap--StockIssuedDuringPeriodSharesNewIssues_c20201001__20210630__us-gaap--TypeOfArrangementAxis__custom--EquityOfferingSalesAgreementMember__dei--LegalEntityAxis__custom--CantorFitzgeraldAndCoMember_pdd" title="Share issued for offering, shares"><ix:nonFraction name="us-gaap:StockIssuedDuringPeriodSharesNewIssues" contextRef="From2020-10-012021-06-30_custom_EquityOfferingSalesAgreementMember_custom_CantorFitzgeraldAndCoMember" format="ixt:numdotdecimal" decimals="INF" unitRef="Shares">5,634,576</ix:nonFraction></span> shares were sold pursuant to the Offering for gross proceeds of $<span id="xdx_906_ecustom--GrossProceedsFromSaleOfCommonStock_c20201001__20210630__us-gaap--TypeOfArrangementAxis__custom--EquityOfferingSalesAgreementMember__dei--LegalEntityAxis__custom--CantorFitzgeraldAndCoMember_pp0p0" title="Gross proceeds from sale of common stock"><ix:nonFraction name="avxl:GrossProceedsFromSaleOfCommonStock" contextRef="From2020-10-012021-06-30_custom_EquityOfferingSalesAgreementMember_custom_CantorFitzgeraldAndCoMember" format="ixt:numdotdecimal" decimals="0" scale="0" unitRef="USD">79,107,547</ix:nonFraction></span> (net proceeds
of $<span id="xdx_90D_eus-gaap--ProceedsFromIssuanceInitialPublicOffering_c20201001__20210630__us-gaap--TypeOfArrangementAxis__custom--EquityOfferingSalesAgreementMember__dei--LegalEntityAxis__custom--CantorFitzgeraldAndCoMember_pp0p0" title="Proceed from offering"><ix:nonFraction name="us-gaap:ProceedsFromIssuanceInitialPublicOffering" contextRef="From2020-10-012021-06-30_custom_EquityOfferingSalesAgreementMember_custom_CantorFitzgeraldAndCoMember" format="ixt:numdotdecimal" decimals="0" scale="0" unitRef="USD">76,670,025</ix:nonFraction></span> after deducting offering expenses).</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">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_90D_ecustom--ValueOfSharesObligatedToPurchase_c20190606__20190607__us-gaap--TypeOfArrangementAxis__custom--PurchaseAgreement1Member__dei--LegalEntityAxis__custom--LincolnParkCapitalFundLLCMember_pp0p0" 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_90F_eus-gaap--ProceedsFromIssuanceOrSaleOfEquity_c20190606__20190607__us-gaap--TypeOfArrangementAxis__custom--PurchaseAgreement1Member__dei--LegalEntityAxis__custom--LincolnParkCapitalFundLLCMember_pp0p0" 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 <span id="xdx_90C_eus-gaap--StockIssuedDuringPeriodSharesNewIssues_c20190606__20190607__us-gaap--TypeOfArrangementAxis__custom--PurchaseAgreement1Member__dei--LegalEntityAxis__custom--LincolnParkCapitalFundLLCMember_pdd" title="Share issued for offering, shares"><ix:nonFraction name="us-gaap:StockIssuedDuringPeriodSharesNewIssues" contextRef="From2019-06-062019-06-07_custom_PurchaseAgreement1Member_custom_LincolnParkCapitalFundLLCMember" format="ixt:numdotdecimal" decimals="INF" unitRef="Shares">324,383</ix:nonFraction></span> 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_pdd" 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">During the nine months ended June
30, 2021, the Company issued to Lincoln Park an aggregate of <span id="xdx_90B_eus-gaap--StockIssuedDuringPeriodSharesNewIssues_c20201001__20210630__us-gaap--TypeOfArrangementAxis__custom--PurchaseAgreement1Member__dei--LegalEntityAxis__custom--LincolnParkCapitalFundLLCMember_pdd" title="Share issued for offering, shares"><ix:nonFraction name="us-gaap:StockIssuedDuringPeriodSharesNewIssues" contextRef="From2020-10-012021-06-30_custom_PurchaseAgreement1Member_custom_LincolnParkCapitalFundLLCMember" format="ixt:numdotdecimal" decimals="INF" unitRef="Shares">4,086,209</ix:nonFraction></span> (2020 &#8211; <span id="xdx_903_eus-gaap--StockIssuedDuringPeriodSharesNewIssues_c20191001__20200630__us-gaap--TypeOfArrangementAxis__custom--PurchaseAgreement1Member__dei--LegalEntityAxis__custom--LincolnParkCapitalFundLLCMember_pdd" title="Share issued for offering, shares"><ix:nonFraction name="us-gaap:StockIssuedDuringPeriodSharesNewIssues" contextRef="From2019-10-012020-06-30_custom_PurchaseAgreement1Member_custom_LincolnParkCapitalFundLLCMember" format="ixt:numdotdecimal" decimals="INF" unitRef="Shares">7,431,049</ix:nonFraction></span>) shares of common stock under the
2019 Purchase Agreement, including <span id="xdx_908_ecustom--StockIssuedDuringPeriodSharesNewIssues4_c20201001__20210630__us-gaap--TypeOfArrangementAxis__custom--PurchaseAgreement1Member__dei--LegalEntityAxis__custom--LincolnParkCapitalFundLLCMember_pdd" title="Number of shares issued for aggregate purchase price"><ix:nonFraction name="avxl:StockIssuedDuringPeriodSharesNewIssues4" contextRef="From2020-10-012021-06-30_custom_PurchaseAgreement1Member_custom_LincolnParkCapitalFundLLCMember" format="ixt:numdotdecimal" decimals="INF" unitRef="Shares">4,007,996</ix:nonFraction></span> (2020: <span id="xdx_90F_ecustom--StockIssuedDuringPeriodSharesNewIssues4_c20191001__20200630__us-gaap--TypeOfArrangementAxis__custom--PurchaseAgreement1Member__dei--LegalEntityAxis__custom--LincolnParkCapitalFundLLCMember_pdd" title="Number of shares issued for aggregate purchase price"><ix:nonFraction name="avxl:StockIssuedDuringPeriodSharesNewIssues4" contextRef="From2019-10-012020-06-30_custom_PurchaseAgreement1Member_custom_LincolnParkCapitalFundLLCMember" format="ixt:numdotdecimal" decimals="INF" unitRef="Shares">7,364,584</ix:nonFraction></span>) shares of common stock for an aggregate purchase price of $<span id="xdx_904_ecustom--StockIssuedDuringPeriodValueNewIssues3_c20201001__20210630__us-gaap--TypeOfArrangementAxis__custom--PurchaseAgreement1Member__dei--LegalEntityAxis__custom--LincolnParkCapitalFundLLCMember_pp0p0" title="Number of shares issued for aggregate purchase price, value"><ix:nonFraction name="avxl:StockIssuedDuringPeriodValueNewIssues3" contextRef="From2020-10-012021-06-30_custom_PurchaseAgreement1Member_custom_LincolnParkCapitalFundLLCMember" format="ixt:numdotdecimal" decimals="0" scale="0" unitRef="USD">24,111,198</ix:nonFraction></span>
(2020: $<span id="xdx_90C_ecustom--StockIssuedDuringPeriodValueNewIssues3_c20191001__20200630__us-gaap--TypeOfArrangementAxis__custom--PurchaseAgreement1Member__dei--LegalEntityAxis__custom--LincolnParkCapitalFundLLCMember_pp0p0" title="Number of shares issued for aggregate purchase price, value"><ix:nonFraction name="avxl:StockIssuedDuringPeriodValueNewIssues3" contextRef="From2019-10-012020-06-30_custom_PurchaseAgreement1Member_custom_LincolnParkCapitalFundLLCMember" format="ixt:numdotdecimal" decimals="0" scale="0" unitRef="USD">20,490,297</ix:nonFraction></span>) and <span id="xdx_909_ecustom--StockIssuedDuringPeriodSharesNewIssues3_c20201001__20210630__us-gaap--TypeOfArrangementAxis__custom--PurchaseAgreement1Member__dei--LegalEntityAxis__custom--LincolnParkCapitalFundLLCMember_pdd" title="Number of shares issued for commitment"><ix:nonFraction name="avxl:StockIssuedDuringPeriodSharesNewIssues3" contextRef="From2020-10-012021-06-30_custom_PurchaseAgreement1Member_custom_LincolnParkCapitalFundLLCMember" format="ixt:numdotdecimal" decimals="INF" unitRef="Shares">78,213</ix:nonFraction> </span>(2020: <span id="xdx_90C_ecustom--StockIssuedDuringPeriodSharesNewIssues3_c20191001__20200630__us-gaap--TypeOfArrangementAxis__custom--PurchaseAgreement1Member__dei--LegalEntityAxis__custom--LincolnParkCapitalFundLLCMember_pdd" title="Number of shares issued for commitment"><ix:nonFraction name="avxl:StockIssuedDuringPeriodSharesNewIssues3" contextRef="From2019-10-012020-06-30_custom_PurchaseAgreement1Member_custom_LincolnParkCapitalFundLLCMember" format="ixt:numdotdecimal" decimals="INF" unitRef="Shares">66,465</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>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 42.55pt; text-align: justify">At June 30, 2021, <span id="xdx_901_ecustom--StockIssuedDuringPeriodValueNewIssues4_pp0p0_do_c20201001__20210630__us-gaap--TypeOfArrangementAxis__custom--PurchaseAgreement1Member__dei--LegalEntityAxis__custom--LincolnParkCapitalFundLLCMember_z1pZMS22sfic" title="Amount of shares remain available"><ix:nonFraction name="avxl:StockIssuedDuringPeriodValueNewIssues4" contextRef="From2020-10-012021-06-30_custom_PurchaseAgreement1Member_custom_LincolnParkCapitalFundLLCMember" format="ixt-sec:numwordsen" decimals="0" scale="0" unitRef="USD">no</ix:nonFraction></span> amount remained
available under the 2019 Purchase Agreement (September 30, 2020: $<span id="xdx_90D_ecustom--StockIssuedDuringPeriodValueNewIssues4_c20191001__20200630__us-gaap--TypeOfArrangementAxis__custom--PurchaseAgreement1Member__dei--LegalEntityAxis__custom--LincolnParkCapitalFundLLCMember_pp0p0" title="Amount of shares remain available"><ix:nonFraction name="avxl:StockIssuedDuringPeriodValueNewIssues4" contextRef="From2019-10-012020-06-30_custom_PurchaseAgreement1Member_custom_LincolnParkCapitalFundLLCMember" format="ixt:numdotdecimal" decimals="0" scale="0" unitRef="USD">24,111,198</ix:nonFraction></span>).</p>

<ix:exclude><p id="xdx_23F_zSmOrYHEiwqj" 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_234_zr6hjqR8j7F8" 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_23C_zofY4zQvWW5i" style="font: 10pt Times New Roman, Times, Serif; margin: 0">Anavex Life Sciences Corp.</p></ix:exclude>

<ix:exclude><p id="xdx_236_zzekje94ayo8" style="font: 10pt Times New Roman, Times, Serif; margin: 0 130.6pt 0 0">Notes to the Condensed Consolidated Interim Financial Statements<br />

June 30, 2021<br />
 (Unaudited)</p></ix:exclude>

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<table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><tr style="vertical-align: top; text-align: justify">
<td style="width: 42pt; text-align: left">Note 5</td><td style="text-align: justify"> <span style="text-decoration: underline"><span id="xdx_82C_zlOevWvPjd6g">Commitments and Contingencies</span></span></td>
</tr></table>

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

<p style="font: 12pt Times New Roman, Times, Serif; margin: 0 0 0 60.75pt; text-indent: -18pt; color: black"><span style="font-size: 11pt">a)</span><span style="font: 7pt Times New Roman, Times, Serif">&#160;&#160;&#160;&#160;&#160;
</span><span style="font-size: 10pt"><i style="font-style: normal; font-weight: normal">Leases </i></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 60.75pt; 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 and nine months ended June 30, 2021, the Company incurred office lease expense of $<span id="xdx_908_eus-gaap--LeaseAndRentalExpense_c20210401__20210630_pp0p0" title="Lease expense"><ix:nonFraction name="us-gaap:LeaseAndRentalExpense" contextRef="From2021-04-012021-06-30" format="ixt:numdotdecimal" decimals="0" scale="0" unitRef="USD">18,994</ix:nonFraction></span> and $<span id="xdx_904_eus-gaap--LeaseAndRentalExpense_c20201001__20210630_pp0p0" title="Lease expense"><ix:nonFraction name="us-gaap:LeaseAndRentalExpense" contextRef="From2020-10-01to2021-06-30" format="ixt:numdotdecimal" decimals="0" scale="0" unitRef="USD">117,284</ix:nonFraction></span>, respectively
(2020: $<span id="xdx_906_eus-gaap--LeaseAndRentalExpense_c20200401__20200630_pp0p0" title="Lease expense"><ix:nonFraction name="us-gaap:LeaseAndRentalExpense" contextRef="From2020-04-012020-06-30" format="ixt:numdotdecimal" decimals="0" scale="0" unitRef="USD">58,554</ix:nonFraction></span> and $<span id="xdx_90B_eus-gaap--LeaseAndRentalExpense_c20191001__20200630_pp0p0" title="Lease expense"><ix:nonFraction name="us-gaap:LeaseAndRentalExpense" contextRef="From2019-10-012020-06-30" format="ixt:numdotdecimal" decimals="0" scale="0" unitRef="USD">169,469</ix:nonFraction></span>, respectively).</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>

<p style="font: 12pt Times New Roman, Times, Serif; margin: 0 0 0 60.75pt; text-indent: -18pt; color: black"><span style="font-size: 11pt">b)</span><span style="font: 7pt Times New Roman, Times, Serif">&#160;&#160;&#160;&#160;&#160;
</span><span style="font-size: 10pt"><i style="font-style: normal; font-weight: normal">Litigation</i></span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 60.75pt; 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>

<p style="font: 12pt Times New Roman, Times, Serif; margin: 0 0 0 60.75pt; text-indent: -18pt; color: black"><span style="font-size: 11pt">c)</span><span style="font: 7pt Times New Roman, Times, Serif">&#160;&#160;&#160;&#160;&#160;
</span><span style="font-size: 10pt"><i style="font-style: normal; font-weight: normal">Share Purchase Warrants</i></span></p>

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

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

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

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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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    <td style="border-bottom: Black 1pt solid; color: black; text-align: left">&#160;</td><td id="xdx_98D_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardEquityInstrumentsOtherThanOptionsNonvestedNumber_iS_c20201001__20210630__us-gaap--AwardTypeAxis__custom--PurchaseWarrantsMember_zmCdkSLH3Dx9" title="Share Purchase Warrants Balance, at ending" style="border-bottom: Black 1pt solid; color: black; text-align: right"><ix:nonFraction name="us-gaap:ShareBasedCompensationArrangementByShareBasedPaymentAwardEquityInstrumentsOtherThanOptionsNonvestedNumber" contextRef="AsOf2020-09-30_custom_PurchaseWarrantsMember" format="ixt:numdotdecimal" decimals="INF" unitRef="Shares">500,000</ix:nonFraction></td><td style="padding-bottom: 1pt; color: black; text-align: left">&#160;</td><td style="color: black; padding-bottom: 1pt">&#160;</td>
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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    <td style="border-bottom: Black 1pt solid; color: black; text-align: left">&#160;</td><td id="xdx_98D_ecustom--ShareBasedCompensationArrangementByShareBasedPaymentAwardEquityInstrumentsOtherThanOptionsExercisedInPeriod_c20201001__20210630__us-gaap--AwardTypeAxis__custom--PurchaseWarrantsMember_zIG3Y1h7hoLe" title="Share Purchase Warrants Exercised" style="border-bottom: Black 1pt solid; color: black; text-align: right">(<ix:nonFraction name="avxl:ShareBasedCompensationArrangementByShareBasedPaymentAwardEquityInstrumentsOtherThanOptionsExercisedInPeriod" contextRef="From2020-10-012021-06-30_custom_PurchaseWarrantsMember" format="ixt:numdotdecimal" decimals="INF" sign="-" unitRef="Shares">350,000</ix:nonFraction></td><td style="padding-bottom: 1pt; color: black; text-align: left">)</td><td style="color: black; padding-bottom: 1pt">&#160;</td>
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  <tr style="vertical-align: bottom; background-color: White">
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  </table>


</ix:nonNumeric><p id="xdx_8AC_zlJXGQXwINx1" style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 42.55pt">&#160;</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 58.5pt; text-indent: -0.8pt">At June 30, 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-indent: -0.8pt">&#160;</p>

<ix:nonNumeric contextRef="From2020-10-01to2021-06-30" escape="true" name="avxl:ScheduleOfSharePurchaseWarrantsOutstandingTableTextBlock"><table cellpadding="0" cellspacing="0" id="xdx_899_ecustom--ScheduleOfSharePurchaseWarrantsOutstandingTableTextBlock_zDKAuYt6dEG" summary="xdx: Disclosure - Commitments and Contingencies (Details 1)" style="font: 10pt Times New Roman, Times, Serif; margin-left: auto; border-collapse: collapse; width: 60%; margin-right: auto">
  <tr style="vertical-align: bottom">
    <td colspan="3" style="color: black; text-align: center"><span id="xdx_8B0_zXQOBbmxKaSl" style="display: none">Schedule of share purchase warrants outstanding</span></td><td style="color: black; padding-bottom: 1pt">&#160;</td>
    <td colspan="3" style="color: black; text-align: center">&#160;</td><td style="color: black; padding-bottom: 1pt">&#160;</td>
    <td style="color: black; text-align: center">&#160;</td></tr>
  <tr style="vertical-align: bottom">
    <td colspan="3" style="color: black; text-align: center">Number</td><td style="color: black; padding-bottom: 1pt">&#160;</td>
    <td colspan="3" style="border-bottom: Black 1pt solid; color: black; text-align: center">Exercise Price</td><td style="color: black; padding-bottom: 1pt">&#160;</td>
    <td style="border-bottom: Black 1pt solid; color: black; text-align: center">Expiry Date</td></tr>
  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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</ix:nonNumeric><p id="xdx_8A4_zLtsZsKbyRy" style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 99.25pt; text-indent: -0.8pt">&#160;</p>

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<ix:exclude><p id="xdx_23D_zimikjkwabti" style="font: 10pt Times New Roman, Times, Serif; margin: 0">Anavex Life Sciences Corp.</p></ix:exclude>

<ix:exclude><p id="xdx_230_zjmEjU9RKgK5" style="font: 10pt Times New Roman, Times, Serif; margin: 0 130.6pt 0 0">Notes to the Condensed Consolidated Interim Financial Statements<br />

June 30, 2021<br />
 (Unaudited)</p></ix:exclude>

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<ix:exclude><table cellpadding="0" cellspacing="0" id="xdx_239_zwsdsdCa6J34" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><tr style="vertical-align: top; text-align: justify">
<td style="width: 42pt; text-align: left">Note 5</td><td style="text-align: justify"><span style="text-decoration: underline">Commitments</span> &#8211; (Continued)</td>
</tr></table></ix:exclude>

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

<p style="font: 10pt/normal Times New Roman, Times, Serif; margin: 0 0 0 60.75pt; text-align: justify; text-indent: -18pt; color: black"><span style="font-size: 11pt">d)</span><span style="font: 7pt Times New Roman, Times, Serif">&#160;&#160;
</span><i style="font-style: normal; font-weight: normal">Stock&#8211;based Compensation Plan</i></p>

<p style="font: 10pt/normal Times New Roman, Times, Serif; margin: 0 0 0 60.75pt; 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 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 of Directors (the &#8220;Board&#8221;) 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_90E_eus-gaap--CommonStockCapitalSharesReservedForFutureIssuance_c20210630__us-gaap--PlanNameAxis__custom--StockOptionPlan2015Member_pdd" title="Maximum number of common shares reserved for future issuance"><ix:nonFraction name="us-gaap:CommonStockCapitalSharesReservedForFutureIssuance" contextRef="AsOf2021-06-30_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 June 30, 2021, <span id="xdx_903_eus-gaap--CommonStockCapitalSharesReservedForFutureIssuance_c20210630__us-gaap--PlanNameAxis__custom--StockOptionPlan2015Member__us-gaap--AwardTypeAxis__custom--OptionsMember_pdd" title="Maximum number of common shares reserved for future issuance"><ix:nonFraction name="us-gaap:CommonStockCapitalSharesReservedForFutureIssuance" contextRef="AsOf2021-06-30_custom_StockOptionPlan2015Member_custom_OptionsMember" format="ixt:numdotdecimal" decimals="INF" unitRef="Shares">146,371</ix:nonFraction></span> (September 30, 2020: <span id="xdx_901_eus-gaap--CommonStockCapitalSharesReservedForFutureIssuance_c20200930__us-gaap--PlanNameAxis__custom--StockOptionPlan2015Member__us-gaap--AwardTypeAxis__custom--OptionsMember_pdd" title="Maximum number of common shares reserved for future issuance"><ix:nonFraction name="us-gaap:CommonStockCapitalSharesReservedForFutureIssuance" contextRef="AsOf2020-09-30_custom_StockOptionPlan2015Member_custom_OptionsMember" 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>

<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_901_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardNumberOfAdditionalSharesAuthorized_c20201001__20210630__us-gaap--PlanNameAxis__custom--StockOptionPlan2019Member_pdd" title="Additional shares of common stock available for issuance"><ix:nonFraction name="us-gaap:ShareBasedCompensationArrangementByShareBasedPaymentAwardNumberOfAdditionalSharesAuthorized" contextRef="From2020-10-012021-06-30_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"><span id="xdx_909_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardDescription_c20201001__20210630__us-gaap--PlanNameAxis__custom--StockOptionPlan2019Member" title="Description of grant option"><ix:nonNumeric contextRef="From2020-10-012021-06-30_custom_StockOptionPlan2019Member" name="us-gaap:ShareBasedCompensationArrangementByShareBasedPaymentAwardDescription">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 June 30, 2021, <span id="xdx_905_eus-gaap--CommonStockCapitalSharesReservedForFutureIssuance_c20210630__us-gaap--PlanNameAxis__custom--StockOptionPlan2019Member_pdd" title="Maximum number of common shares reserved for future issuance"><ix:nonFraction name="us-gaap:CommonStockCapitalSharesReservedForFutureIssuance" contextRef="AsOf2021-06-30_custom_StockOptionPlan2019Member" format="ixt:numdotdecimal" decimals="INF" unitRef="Shares">1,706,665</ix:nonFraction></span> (September 30, 2020: <span id="xdx_907_eus-gaap--CommonStockCapitalSharesReservedForFutureIssuance_c20200930__us-gaap--PlanNameAxis__custom--StockOptionPlan2019Member_pdd" title="Maximum number of common shares reserved for future issuance"><ix:nonFraction name="us-gaap:CommonStockCapitalSharesReservedForFutureIssuance" contextRef="AsOf2020-09-30_custom_StockOptionPlan2019Member" format="ixt:numdotdecimal" decimals="INF" unitRef="Shares">3,161,665</ix:nonFraction></span>) options remain available for issue under
the 2019 Plan.</ix:nonNumeric></span></p>

<ix:exclude><p id="xdx_239_zg3qvZXvBTz3" style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 2cm; text-align: justify">&#160;</p></ix:exclude>

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<ix:exclude><p id="xdx_236_zoaWuDWUVjB5" 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_23E_z4mahD0hb9Ml" style="font: 10pt Times New Roman, Times, Serif; margin: 0">Anavex Life Sciences Corp.</p></ix:exclude>

<ix:exclude><p id="xdx_239_zRaGeJUOhU1d" style="font: 10pt Times New Roman, Times, Serif; margin: 0 130.6pt 0 0">Notes to the Condensed Consolidated Interim Financial Statements<br />

June 30, 2021<br />
 (Unaudited)</p></ix:exclude>

<ix:exclude><p id="xdx_230_zKNTKRNuHyk" style="font: 10pt Times New Roman, Times, Serif; margin: 0 130.6pt 0 0">&#160;</p></ix:exclude>

<ix:exclude><table cellpadding="0" cellspacing="0" id="xdx_23D_z3IeqigWleEa" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><tr style="vertical-align: top; text-align: justify">
<td style="width: 42pt; text-align: left">Note 5</td><td style="text-align: justify"><span style="text-decoration: underline">Commitments</span> &#8211; (Continued)</td>
</tr></table></ix:exclude>

<ix:exclude><p id="xdx_23E_zGNhQFIpTNDg" style="font: 10pt Times New Roman, Times, Serif; margin: 0">&#160;</p></ix:exclude>

<ix:exclude><table cellpadding="0" cellspacing="0" id="xdx_23A_zinRaj3EEth3" style="font: 10pt/normal 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">d)</td><td style="text-align: justify"><i style="font-style: normal; font-weight: normal">Stock-based Compensation Plan &#8211; (Continued)</i></td></tr></table></ix:exclude>

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

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

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

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    <td style="color: black; text-align: left">&#160;</td><td style="color: black; text-align: right">&#160;</td><td style="color: black; text-align: left">&#160;</td><td style="color: black">&#160;</td>
    <td style="color: black; text-align: left">&#160;</td><td style="color: black; text-align: right">&#160;</td><td style="color: black; text-align: left">&#160;</td><td style="color: black">&#160;</td>
    <td style="color: black; text-align: left">&#160;</td><td style="color: black; text-align: right">&#160;</td><td style="color: black; text-align: left">&#160;</td>
    <td>&#160;</td>
    <td>&#160;</td></tr>
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    <td colspan="3" style="border-bottom: Black 1pt solid; color: black; text-align: center">Weighted Average Exercise Price ($)</td><td style="color: black; padding-bottom: 1pt">&#160;</td>
    <td colspan="3" style="border-bottom: Black 1pt solid; color: black; text-align: center">Weighted Average Grant Date Fair Value ($)</td><td style="color: black; padding-bottom: 1pt">&#160;</td>
    <td style="border-bottom: Black 1pt solid; color: black; text-align: center">Aggregate intrinsic value ($)</td></tr>
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    <td style="width: 1%; color: black; text-align: left">&#160;</td><td id="xdx_98D_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsOutstandingNumber_iS_c20191001__20200930__us-gaap--PlanNameAxis__custom--StockOptionPlan2015Member_zZi9dn5TUxF9" title="Options Outstanding at beginning" style="width: 19%; color: black; text-align: right"><ix:nonFraction name="us-gaap:ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsOutstandingNumber" contextRef="AsOf2019-09-30_custom_StockOptionPlan2015Member" format="ixt:numdotdecimal" decimals="INF" unitRef="Shares">8,462,933</ix:nonFraction></td><td style="width: 1%; color: black; text-align: left">&#160;</td><td style="width: 5%; color: black">&#160;</td>
    <td style="width: 1%; color: black; text-align: left">&#160;</td><td id="xdx_984_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsOutstandingWeightedAverageExercisePrice_iS_c20191001__20200930__us-gaap--PlanNameAxis__custom--StockOptionPlan2015Member_z3GmxeYlX9uf" title="Weighted Average Exercise Price Outstanding at beginning" style="width: 19%; color: black; text-align: right"><ix:nonFraction name="us-gaap:ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsOutstandingWeightedAverageExercisePrice" contextRef="AsOf2019-09-30_custom_StockOptionPlan2015Member" format="ixt:numdotdecimal" decimals="INF" unitRef="USDPShares">3.58</ix:nonFraction></td><td style="width: 1%; color: black; text-align: left">&#160;</td><td style="width: 5%">&#160;</td>
    <td style="width: 1%; text-align: left">&#160;</td><td style="width: 19%; text-align: right">&#160;</td><td style="width: 1%; text-align: left">&#160;</td><td style="width: 5%; color: black">&#160;</td>
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<p style="font: 10pt/normal Times New Roman, Times, Serif; margin: 0 0 0 58.5pt">&#160;</p>

</ix:nonNumeric><p id="xdx_8A0_zKDIGJ8QmK2k" style="font: 10pt/normal Times New Roman, Times, Serif; margin: 0 0 0 58.5pt">&#160;</p>

<p style="font: 10pt/normal Times New Roman, Times, Serif; margin: 0 0 0 2cm">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 June 30, 2021.</p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 2cm; text-align: justify">During the three and nine months ended
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These amounts have been included in general and &#9;administrative expenses and research and development expenses on the Company&#8217;s
statements 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>

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    <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>
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    <td style="border-bottom: Black 1pt solid; text-align: left">$</td><td id="xdx_983_eus-gaap--AllocatedShareBasedCompensationExpense_c20210401__20210630__us-gaap--IncomeStatementLocationAxis__us-gaap--ResearchAndDevelopmentExpenseMember_pp0p0" title="Total share based compensation" style="border-bottom: Black 1pt solid; text-align: right"><ix:nonFraction name="us-gaap:AllocatedShareBasedCompensationExpense" contextRef="From2021-04-012021-06-30_us-gaap_ResearchAndDevelopmentExpenseMember" format="ixt:numdotdecimal" decimals="0" scale="0" unitRef="USD">1,245,319</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)">
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</ix:nonNumeric><p id="xdx_8AD_zx4xeshKWBng" style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 2cm; text-align: justify">&#160;</p>

<ix:exclude><p id="xdx_239_zIzfk6RYaER2" style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 2cm; text-align: justify"></p></ix:exclude>

<ix:exclude><!-- Field: Page; Sequence: 16; Value: 1 -->
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<ix:exclude><p id="xdx_234_zXtk0LLZEx5g" style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 2cm; text-align: justify">&#160;</p></ix:exclude>

<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_c20210630_pp0p0" title="Remaining stock based compensation"><ix:nonFraction name="us-gaap:EmployeeServiceShareBasedCompensationNonvestedAwardsTotalCompensationCostNotYetRecognizedStockOptions" contextRef="AsOf2021-06-30" format="ixt:numdotdecimal" decimals="0" scale="0" unitRef="USD">6,664,000</ix:nonFraction></span>
in stock-based compensation is expected to be recorded over the remaining term &#9;of such options through fiscal 2024.</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 fair
value of each option award granted during the nine months ended June 30, 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;</p>

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</ix:nonNumeric><p id="xdx_8AA_zOv4f1JK5yae" style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 63.8pt; text-align: justify">&#160;</p>

</ix:nonNumeric><p id="xdx_81B_zfqfYJhJ4Vgc" style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 63.8pt; text-align: justify"></p>

<!-- Field: Page; Sequence: 17; Value: 1 -->
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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 63.8pt; 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;</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: 20.65pt"><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td>
<td style="width: 18pt"><span style="font: 10pt Times New Roman, Times, Serif">&#9679;</span></td>
<td style="text-align: justify"><span style="font: 10pt Times New Roman, Times, Serif">volatility in our stock and
in the markets in general;</span></td></tr>
<tr style="vertical-align: top">
<td><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td>
<td><span style="font: 10pt Times New Roman, Times, Serif">&#9679;</span></td>
<td style="text-align: justify"><span style="font: 10pt Times New Roman, Times, Serif">our ability to successfully
conduct clinical and preclinical trials for our product candidates;</span></td></tr>
<tr style="vertical-align: top">
<td><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td>
<td><span style="font: 10pt Times New Roman, Times, Serif">&#9679;</span></td>
<td style="text-align: justify"><span style="font: 10pt Times New Roman, Times, Serif">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><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td>
<td><span style="font: 10pt Times New Roman, Times, Serif">&#9679;</span></td>
<td style="text-align: justify"><span style="font: 10pt Times New Roman, Times, Serif">the impact of the COVID-19
outbreak and its effect on us;</span></td></tr>
<tr style="vertical-align: top">
<td><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td>
<td><span style="font: 10pt Times New Roman, Times, Serif">&#9679;</span></td>
<td style="text-align: justify"><span style="font: 10pt Times New Roman, Times, Serif">our ability to generate any
revenue or to continue as a going concern;</span></td></tr>
<tr style="vertical-align: top">
<td><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td>
<td><span style="font: 10pt Times New Roman, Times, Serif">&#9679;</span></td>
<td style="text-align: justify"><span style="font: 10pt Times New Roman, Times, Serif">our ability to execute our
research and development plan on time and on budget;</span></td></tr>
<tr style="vertical-align: top">
<td><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td>
<td><span style="font: 10pt Times New Roman, Times, Serif">&#9679;</span></td>
<td style="text-align: justify"><span style="font: 10pt Times New Roman, Times, Serif">our products ability to demonstrate
efficacy or an acceptable safety profile of our product candidates;</span></td></tr>
<tr style="vertical-align: top">
<td><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td>
<td><span style="font: 10pt Times New Roman, Times, Serif">&#9679;</span></td>
<td style="text-align: justify"><span style="font: 10pt Times New Roman, Times, Serif">our ability to obtain the support
of qualified scientific collaborators;</span></td></tr>
<tr style="vertical-align: top">
<td><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td>
<td><span style="font: 10pt Times New Roman, Times, Serif">&#9679;</span></td>
<td style="text-align: justify"><span style="font: 10pt Times New Roman, Times, Serif">our ability, whether alone
or with commercial partners, to successfully commercialize any of our product candidates that may be approved for sale;</span></td></tr>
<tr style="vertical-align: top">
<td><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td>
<td><span style="font: 10pt Times New Roman, Times, Serif">&#9679;</span></td>
<td style="text-align: justify"><span style="font: 10pt Times New Roman, Times, Serif">our ability to identify and
obtain additional product candidates;</span></td></tr>
<tr style="vertical-align: top">
<td><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td>
<td><span style="font: 10pt Times New Roman, Times, Serif">&#9679;</span></td>
<td style="text-align: justify"><span style="font: 10pt Times New Roman, Times, Serif">our reliance on third parties
in non-clinical and clinical studies;</span></td></tr>
<tr style="vertical-align: top">
<td><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td>
<td><span style="font: 10pt Times New Roman, Times, Serif">&#9679;</span></td>
<td style="text-align: justify"><span style="font: 10pt Times New Roman, Times, Serif">our ability to defend against
product liability claims;</span></td></tr>
<tr style="vertical-align: top">
<td><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td>
<td><span style="font: 10pt Times New Roman, Times, Serif">&#9679;</span></td>
<td style="text-align: justify"><span style="font: 10pt Times New Roman, Times, Serif">our ability to safeguard against
security breaches;</span></td></tr>
<tr style="vertical-align: top">
<td><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td>
<td><span style="font: 10pt Times New Roman, Times, Serif">&#9679;</span></td>
<td style="text-align: justify"><span style="font: 10pt Times New Roman, Times, Serif">our ability to obtain and maintain
sufficient intellectual property protection for our product candidates;</span></td></tr>
<tr style="vertical-align: top">
<td><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td>
<td><span style="font: 10pt Times New Roman, Times, Serif">&#9679;</span></td>
<td style="text-align: justify"><span style="font: 10pt Times New Roman, Times, Serif">our ability to comply with
our intellectual property licensing agreements;</span></td></tr>
<tr style="vertical-align: top">
<td><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td>
<td><span style="font: 10pt Times New Roman, Times, Serif">&#9679;</span></td>
<td style="text-align: justify"><span style="font: 10pt Times New Roman, Times, Serif">our ability to defend against
claims of intellectual property infringement;</span></td></tr>
<tr style="vertical-align: top">
<td><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td>
<td><span style="font: 10pt Times New Roman, Times, Serif">&#9679;</span></td>
<td style="text-align: justify"><span style="font: 10pt Times New Roman, Times, Serif">our ability to comply with
the maintenance requirements of the government patent agencies;</span></td></tr>
<tr style="vertical-align: top">
<td><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td>
<td><span style="font: 10pt Times New Roman, Times, Serif">&#9679;</span></td>
<td style="text-align: justify"><span style="font: 10pt Times New Roman, Times, Serif">our ability to protect our
intellectual property rights throughout the world;</span></td></tr>
<tr style="vertical-align: top">
<td><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td>
<td><span style="font: 10pt Times New Roman, Times, Serif">&#9679;</span></td>
<td style="text-align: justify"><span style="font: 10pt Times New Roman, Times, Serif">competition;</span></td></tr>
<tr style="vertical-align: top">
<td><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td>
<td><span style="font: 10pt Times New Roman, Times, Serif">&#9679;</span></td>
<td style="text-align: justify"><span style="font: 10pt Times New Roman, Times, Serif">the anticipated start dates,
durations and completion dates of our ongoing and future clinical studies;</span></td></tr>
<tr style="vertical-align: top">
<td><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td>
<td><span style="font: 10pt Times New Roman, Times, Serif">&#9679;</span></td>
<td style="text-align: justify"><span style="font: 10pt Times New Roman, Times, Serif">the anticipated designs of
our future clinical studies;</span></td></tr>
<tr style="vertical-align: top">
<td><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td>
<td><span style="font: 10pt Times New Roman, Times, Serif">&#9679;</span></td>
<td style="text-align: justify"><span style="font: 10pt Times New Roman, Times, Serif">the impact of fast track designation
on receipt of actual FDA approval;</span></td></tr>
<tr style="vertical-align: top">
<td><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td>
<td><span style="font: 10pt Times New Roman, Times, Serif">&#9679;</span></td>
<td style="text-align: justify"><span style="font: 10pt Times New Roman, Times, Serif">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 </span></td></tr>
<tr style="vertical-align: top">
<td><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td>
<td><span style="font: 10pt Times New Roman, Times, Serif">&#9679;</span></td>
<td style="text-align: justify"><span style="font: 10pt Times New Roman, Times, Serif">our anticipated future cash
position. </span></td></tr>
</table>


<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 38.65pt; text-align: justify">&#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 December 28, 2020. 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;</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; margin: 0">&#160;</p>

<p style="font: 12pt Times New Roman, Times, Serif; margin: 0"><img src="image_001.jpg" alt="" style="height: 237pt; 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">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: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify">&#160;</p>

<p style="font: 12pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><img src="image_002.jpg" alt="" style="height: 329.25pt; width: 468pt" /></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>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 these two identified biomarker variants (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.</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">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"><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. The Phase 2a trial demonstrated positive pharmacokinetic (PK)
and pharmacodynamic (PD) data, 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
450-patient study of ANAVEX<sup>&#174;</sup>2-73 in Alzheimer&#8217;s disease commenced in August 2018. The Phase 2b/3 study is
a 48-week study, with participants randomized 1:1:1 to two different ANAVEX<sup>&#174;</sup>2-73 doses or placebo. The trial commenced
in Australia; and 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 enrollment beyond 450 patients 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.</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">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
are being 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"></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">The first Phase 2 study, 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,
drug exposure-dependent response in the Rett Syndrome Behaviour Questionnaire (RSBQ) Total scores, when compared to placebo, in
the ITT cohort (all participants, p = 0.048). 66.7% of ANAVEX<sup>&#174;</sup>2-73 treated subjects showed a statistically significant
improvement in drug exposure-dependent 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). 86.7% of
ANAVEX<sup>&#174;</sup>2-73 treated subjects showed a statistically significant CGI-I response, defined as sustained improvement
to treatment, as compared to 40% of the subjects on 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">The second Phase 2 study of ANAVEX<sup>&#174;</sup>2-73
for the treatment of Rett syndrome, called the AVATAR study, commenced in June 2019. This study is taking place in Australia and
the United Kingdom using a higher dose than the U.S. based Phase 2 study for Rett syndrome. The study will evaluate the safety
and efficacy of ANAVEX<sup>&#174;</sup>2-73 in approximately 33 patients over a 7-week treatment period including 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">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 at least 69 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">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. 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 August 2020, we announced a financial commitment
by Shake It Up Australia Foundation for Parkinson&#8217;s Research to fund up to 50% of the costs of an Australian clinical study
to develop ANAVEX<sup>&#174;</sup>2-73 for the disease modifying treatment of Parkinson&#8217;s disease. The financial commitment
would be made through private placement purchases of our common stock at 200% of the fair market value on the purchase date and
will be contingent upon the completion of certain clinical trial milestones relating to the proposed clinical trial. The proposed
clinical trial will use a convenient, once-daily oral ANAVEX<sup>&#174;</sup>2-73 formulation to confirm the potential disease modifying
features of ANAVEX<sup>&#174;</sup>2-73 in an animal model of Parkinson&#8217;s disease. Safety and efficacy will be investigated
in an appropriately powered placebo-controlled clinical study of Parkinson&#8217;s disease patients over at least 48-weeks including
ANAVEX<sup>&#174;</sup>2-73-specific precision medicine biomarkers.</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 January 2021, we announced we were awarded
a research grant of $1.0 million from&#160;<span style="text-underline-style: none; color: windowtext">The Michael J. Fox Foundation
for Parkinson&#8217;s Research</span>&#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, which 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 will be a prospective double-blind, randomized, placebo-controlled study. A total of at least 36 healthy male
and female subjects will be included. Single escalating doses of ANAVEX<sup>&#174;</sup>3-71 will be 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. This study is expected to be followed by longer duration dosing including patients with FTD or other dementia
indications with unmet medical need, incorporating exploratory efficacy and disease biomarker measures<span style="color: #1F1F1F">.</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; 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">&#160;</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"></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. This study,
which took place in the United States, was completed in December 2020, however two other clinical trials in Rett syndrome, the
AVATAR study and the EXCELLENCE study, are still underway. The studies are being conducted in a range of patient age demographics
and geographic regions, as more fully described above under <i>Clinical Studies Overview &#8211; 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 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">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"></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 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 has completed enrollment, randomized 1:1:1 to either two different ANAVEX<sup>&#174;</sup>2-73 doses or placebo, commenced
in October 2018.</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">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
new 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"></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"><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 ANAVEX<sup>&#174;</sup>3-71, with focus on the treatment of Frontotemporal Dementia (FTD) and <span style="background-color: white">other
dementia indications with unmet medical need</span>. The study is 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"><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 receptor
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"></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"><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 clinical and pre-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">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="width: 100%; font-size: 10pt"><tr style="vertical-align: top"><td style="width: 20px"></td><td style="width: 20px"><span style="font: 10pt Times New Roman, Times, Serif">&#9679;</span></td><td><span style="font: 10pt Times New Roman, Times, Serif">Alzheimer&#8217;s
                                            disease &#8211; In 2020, an estimated 5.8 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.</span></td></tr>
<tr style="vertical-align: top">
<td><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td><td><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td><td><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td></tr>
<tr style="vertical-align: top"><td style="width: 20px"></td><td style="width: 20px"><span style="font: 10pt Times New Roman, Times, Serif">&#9679;</span></td><td><span style="font: 10pt Times New Roman, Times, Serif">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.</span></td></tr>
<tr style="vertical-align: top">
<td><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td><td><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td><td><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td></tr>
<tr style="vertical-align: top"><td style="width: 20px"></td><td style="width: 20px"><span style="font: 10pt Times New Roman, Times, Serif">&#9679;</span></td><td><span style="font: 10pt Times New Roman, Times, Serif">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 leads 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.</span></td></tr>
<tr style="vertical-align: top">
<td><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td><td><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td><td><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td></tr>
<tr style="vertical-align: top"><td style="width: 20px"></td><td style="width: 20px"><span style="font: 10pt Times New Roman, Times, Serif">&#9679;</span></td><td><span style="font: 10pt Times New Roman, Times, Serif">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.</span></td></tr>
<tr style="vertical-align: top">
<td><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td><td><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td><td><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td></tr>
</table>

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

<table cellpadding="0" cellspacing="0" style="width: 100%; font-size: 10pt">
<tr style="vertical-align: top"><td style="width: 20px"></td><td style="width: 20px"><span style="font: 10pt Times New Roman, Times, Serif">&#9679;</span></td><td><span style="font: 10pt Times New Roman, Times, Serif">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.</span></td></tr>
<tr style="vertical-align: top">
<td><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td><td><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td><td><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td></tr>
<tr style="vertical-align: top">
    <td style="width: 24px"><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td>
    <td style="width: 24px"><span style="font: 10pt Times New Roman, Times, Serif">&#9679;</span></td>
    <td style="text-align: justify"><span style="font: 10pt Times New Roman, Times, Serif">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.</span></td></tr>
</table>
<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">Cancer</p>

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

<table cellpadding="0" cellspacing="0" style="width: 100%; font-size: 10pt"><tr style="vertical-align: top"><td style="width: 20px"></td><td style="width: 20px"><span style="font: 10pt Times New Roman, Times, Serif">&#9679;</span></td><td><span style="font: 10pt Times New Roman, Times, Serif">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 IMS Health the worldwide malignant
                                            melanoma market is expected to grow to $4.4 billion by 2022.</span></td></tr>
<tr style="vertical-align: top">
<td><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td><td><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td><td><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td></tr>
<tr style="vertical-align: top"><td style="width: 20px"></td><td style="width: 20px"><span style="font: 10pt Times New Roman, Times, Serif">&#9679;</span></td><td><span style="font: 10pt Times New Roman, Times, Serif">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.</span></td></tr>
<tr style="vertical-align: top">
<td><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td><td><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td><td><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td></tr>
<tr style="vertical-align: top"><td style="width: 20px"></td><td style="width: 20px"><span style="font: 10pt Times New Roman, Times, Serif">&#9679;</span></td><td><span style="font: 10pt Times New Roman, Times, Serif">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 GBI Research forecast that the market for the pharmaceutical treatment
                                            of pancreatic cancer in the United States and five largest European countries willincrease
                                            to $2.9 billion by 2021.</span></td></tr></table>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 36pt; text-align: justify">&#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 thirteen
U.S. patents, seventeen 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 two issued U.S. patents
each with claims directed to crystalline forms of ANAVEX<sup>&#174;</sup>2-73. The first of these two 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 two 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 on 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 the seizure treatment being co-timely or coordinated administration of anti-epilepsy
drugs and (i) ANAVEX<sup>&#174;</sup>19-144 or (ii) ANAVEX 19-144<sup>&#174;</sup> with 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.</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">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, and 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, and 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">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: 0; text-align: justify">&#160;</p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify">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 December 28, 2020.</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">Financial Highlights</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 0 6pt; text-align: justify">At June 30, 2021, our cash position had increased
to $157.6 million, from $29.2 million at our fiscal year end of September 30, 2020.</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 6pt; text-align: justify">Operating expenses for the third quarter of
fiscal 2021 were $11.4 million, compared to $8.1 million for the comparable quarter in fiscal 2020. The operating expenses include an
aggregate of $2.3 million, as compared to $1.3 million in the third quarter of fiscal 2020, in non-cash charges related to the issuance
and vesting of stock options. Our research and development expenses for the third quarter of fiscal 2021 were $9.0 million, compared
to $6.7 million in the comparable period in fiscal 2020. The increase is attributable to the continued advancement of our ongoing clinical
trials.</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 6pt; text-align: justify">Net loss for the third quarter of fiscal 2021
was $10.2 million, or $0.14 per share, as compared to $6.5 million, or $0.11 per share in the comparative quarter of fiscal 2020.</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 6pt; text-align: justify"></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 6pt; text-align: justify"></p>

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

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

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

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

<p style="font: italic 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><span style="font-style: normal">We
are in the development stage and have not earned any revenues since our inception and 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: 0; text-align: justify"><span style="font-style: normal">&#160;</span></p>

<p style="font: italic 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><span style="font-style: normal"><b>Three
and nine months ended June 30, 2021 compared to three and nine months ended June 30, 2020.</b></span></p>

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

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

<p style="font: italic 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="color: black">Total operating
expenses for the third quarter of fiscal 2021 were $11.4 million, compared to $8.1 million for the comparable quarter of fiscal
2020.</span> <span style="color: black">Total operating expenses for the nine-month period ended June 30, 2021 were $29.8 million
compared to $23.6 million for the same period in fiscal 2020. This represents an increase of $3.3 million for the three-month period
and $6.2 million for the nine-month period.</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="color: black">Research and development
expenses for the third quarter of fiscal 2021 were $9.0 million, compared to $6.7 million for the third quarter of fiscal 2020
and $23.6 million for the nine-month period ended June 30, 2021, as compared to $19.1 million for the applicable prior year period.
This increase in both the current quarter and the year-to-date period is attributable to the continued advancement of our ongoing
clinical trials, most notably, the </span>expansion of our Phase 2b/3 Alzheimer&#8217;s disease trial internationally, and the
continued enrollment and advancement of the international Rett syndrome program.</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">General and administrative expenses increased
to $2.4 million for the three months ended June 30, 2021, as compared to $1.4 million for the third quarter of fiscal 2020. Similarly,
general and administrative expenses increased to $6.1 million for the nine-month period ended June 30, 2021, as compared to $4.5
million for the applicable prior year period. The increase in general and administrative expenses was primarily related to an increase
in our staff, corporate activities and transactions, and an increase in non-cash stock option compensation charges.</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>Other income </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">The net amount of other income was $1.3 million
for the three-month period ended June 30, 2021 as compared to $1.6 million for the three-month period ended June 30, 2020 and $3.7
million for the nine-month period as compared to $3.3 million for the comparable nine-month period in fiscal 2020. The Company
experienced an increase in Australian research and development incentive income for the nine-month period, in connection with the
increase in eligible clinical activities in Australia over the comparable year to date period, however in the current quarter the
Company incurred foreign exchange losses which were related to the fluctuations in the Australian dollar against the US dollar
and its related impact on incentive and tax receivables.</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">Liquidity and Capital Resources</p>

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

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

<p style="font: italic 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"></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; padding-bottom: 1pt">&#160;</td>
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  <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">Current Assets</td><td style="width: 8%">&#160;</td>
    <td style="width: 1%; text-align: left">$</td><td style="width: 12%; text-align: right">166,419,501</td><td style="width: 1%; text-align: left">&#160;</td><td style="width: 8%">&#160;</td>
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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 6pt; text-align: justify"><br />
At June 30, 2021, we had $157.6 million in cash and cash equivalents, an increase of $128.3 million from September 30, 2020. During
the nine-month period ended June 30, 2021, we received cash of $151.0 million, net of issuance costs, primarily from the issuance
of shares of common stock under the 2019 Purchase Agreement, through the Sales Agreement, as well as a registered direct offering,
each as more fully described elsewhere in this Quarterly Report.</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"></p>

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

<table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 100%">
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  <tr style="vertical-align: bottom">
    <td style="padding: 0pt 0pt 0pt 10pt; text-align: center; text-indent: -10pt">&#160;</td><td style="font-weight: bold">&#160;</td>
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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    <td style="padding: 0pt 0pt 0pt 10pt; text-align: left; text-indent: -10pt">Net cash flows from financing activities</td><td>&#160;</td>
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  <tr style="vertical-align: bottom; background-color: rgb(204,238,255)">
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<p style="font: italic 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify">&#160;</p>

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

<p style="font: italic 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 6pt; text-align: justify">Net cash used in operating activities for the
<span style="color: black">first nine months of fiscal 2021 </span>was $22.7 million, compared to $15.0 million during the comparable
period of fiscal 2020. The principal reason for this increase in net cash used from operating activities in the current period is due
to an increase in research and development expenses and an increase in research and development incentive income receivable, as compared
to the comparable period.</p>

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

<p style="font: italic 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 6pt; text-align: justify">Cash provided by financing activities for the
<span style="color: black">first nine months in fiscal 2021 </span>was $151.0 million, net of financing costs, primarily attributable
to cash received from the issuance of common shares at various market prices under the 2019 Purchase Agreement, the Sales Agreement and
a direct registered offering we completed for net proceeds of $46.9 million, after deducting expenses associated with the offering.</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 6pt; text-align: justify">Cash provided by financing activities for the
<span style="color: black">first nine months in fiscal 2020 </span>was $20.5 million, attributable to cash received from the issuance
of common shares at various market prices under the 2019 Purchase Agreement<span style="color: black">.</span></p>

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

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; background-color: white">On June 7, 2019, we
entered into a Purchase Agreement (the &#8220;2019 Purchase Agreement&#8221;) with Lincoln Park Capital Fund, LLC (&#8220;Lincoln
Park&#8221;), as amended on July 1, 2020, pursuant to which Lincoln Park committed to purchase up to $50.0 million of our common
stock. Concurrently with the execution of the 2019 Purchase Agreement in 2019, we issued 324,383 shares of our common stock to
Lincoln Park as a fee for its commitment to purchase shares of our common stock under the 2019 Purchase Agreement and became obligated
to issue up to 162,191 shares pro rata, when and if Lincoln Park purchased, at our discretion, the $50.0 million aggregate commitment.</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">During the nine months ended June 30, 2021,
the Company issued to Lincoln Park an aggregate of 4,086,209 shares of common stock under the 2019 Purchase Agreement, including
4,007,996 shares of common stock for an aggregate purchase price of $24.1 million and 78,213 commitment shares. As of<span style="color: black">
June 30, 2021, no shares of our common stock remain available for purchase by Lincoln Park under the 2019 Purchase Agreement.</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"><b>Controlled Equity Offering Sales Agreement</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">On May
1, 2020, we entered into an Amended and Restated&#160;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: 0; text-align: justify"><span style="background-color: white">&#160;</span></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 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&#160;and regulations and the rules&#160;of Nasdaq.</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">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: 0; text-align: justify">&#160;</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify">During the nine months ended June 30, 2021,
5,634,576 shares were sold pursuant to the At-the-Market Offering for gross proceeds of $79.1 million (net proceeds of $76.7 million
after deducting commissions and offering expenses).</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>Registered Direct Offering</b></p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify">On June 24, 2021, the Company completed a registered
direct offering off of the Company&#8217;s shelf registration statement on Form S-3 filed with the SEC on July 3, 2019. The Company
issued 2,380,953 common shares at $21.00 per share for gross proceeds of $50.0 million (net proceeds of $46.9 million after deducting
offering fees and expenses).</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"><span style="font-style: normal">Off-Balance
Sheet Arrangements</span></p>

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

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

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

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0cm">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, 2020 as filed with the SEC on December 28, 2020.</p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 21.6pt; text-indent: -21.6pt"><b>RECENT ACCOUNTING PRONOUNCEMENTS</b></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 21.6pt; text-indent: -21.6pt"><b><i>&#160;</i></b></p>

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

<p style="font: bold 10pt Times New Roman, Times, Serif; margin: 0; text-transform: uppercase; text-align: justify"><span id="a_004"></span>Item 3. Quantitative
and Qualitative Disclosures about Market Risks.</p>

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

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0; 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_005"></span>Item 4. Controls
and Procedures.</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 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><b>Disclosure Controls and Procedures
</b></p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify">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: 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">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 June 30, 2021.</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>Changes in Internal Control over Financial
Reporting</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">During the quarter ended June 30, 2021, 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: 0; 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_006"></span>PART II &#8211;
OTHER 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_007"></span>Item 1. Legal
Proceedings.</p>

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

<p style="font: bold 10pt Times New Roman, Times, Serif; margin: 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: 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: 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, 2020 filed with the SEC on December 28, 2020 except for the following new risks:</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 stock price has recently been volatile
and may be volatile in the future.</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 stock price has recently been volatile
and may be volatile in the future. For example, on February 1, 2021, the price of our common stock closed at $6.53 per share while
on February 9, 2021, the price of our common stock closed at $14.99 per share without disclosure of news or other developments
by us. On February 4, 2021, the opening price of our common stock was $19.94 and the intra-day sales price of our common stock
fluctuated between a reported low sale price of $13.80 and a reported high sales price of $28.70, closing at $14.91. Our volume
on this day was 116,590,800, which was a substantial increase from the volume of 18,086,230 and 3,161,525 on the two days immediately
preceding February 4, 2021. We may incur rapid and substantial increases or decreases in our stock price in the foreseeable future
that are do not coincide in timing with the disclosure of news or developments by us. The stock market in general, and the market
for biotechnology and pharmaceutical companies in particular, has experienced extreme volatility that has often been unrelated
to the operating performance of particular companies. The market price for our common stock may be influenced by many factors,
including 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"></p>

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

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%">
<tr style="vertical-align: top">
<td style="width: 24px"><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td>
<td style="width: 24px"><span style="font: 10pt Times New Roman, Times, Serif">&#9679;</span></td>
<td style="text-align: justify"><span style="font: 10pt Times New Roman, Times, Serif">announcements of new data,
clinical trial results or those of companies that are perceived to be similar to us;</span></td></tr>
<tr style="vertical-align: top">
<td><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td>
<td><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td>
<td style="text-align: justify"><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td></tr>
<tr style="vertical-align: top">
<td><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td>
<td><span style="font: 10pt Times New Roman, Times, Serif">&#9679;</span></td>
<td style="text-align: justify"><span style="font: 10pt Times New Roman, Times, Serif">announcements related to any
delays in any preclinical or clinical trials related to our products;</span></td></tr>
<tr style="vertical-align: top">
<td><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td>
<td><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td>
<td style="text-align: justify"><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td></tr>
<tr style="vertical-align: top">
<td><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td>
<td><span style="font: 10pt Times New Roman, Times, Serif">&#9679;</span></td>
<td style="text-align: justify"><span style="font: 10pt Times New Roman, Times, Serif">announcements related to our
products&#8217; ability to demonstrate efficacy or an acceptable safety profile of our product candidates or similar announcements by
companies that are perceived to be similar to us;</span></td></tr>
<tr style="vertical-align: top">
<td><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td>
<td><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td>
<td style="text-align: justify"><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td></tr>
<tr style="vertical-align: top">
<td><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td>
<td><span style="font: 10pt Times New Roman, Times, Serif">&#9679;</span></td>
<td style="text-align: justify"><span style="font: 10pt Times New Roman, Times, Serif">our ability to meet or exceed
expectations of analysts or investors;</span></td></tr>
<tr style="vertical-align: top">
<td><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td>
<td><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td>
<td style="text-align: justify"><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td></tr>
<tr style="vertical-align: top">
<td><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td>
<td><span style="font: 10pt Times New Roman, Times, Serif">&#9679;</span></td>
<td style="text-align: justify"><span style="font: 10pt Times New Roman, Times, Serif">news that the number of patients
required for clinical trials for our drug candidates may be larger than we anticipate, enrollment in these clinical trials may be slower
than we anticipate, participants may drop out of these clinical trials at a higher rate than we anticipate or the duration of these clinical
trials may be longer than we anticipate;</span></td></tr>
<tr style="vertical-align: top">
<td><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td>
<td><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td>
<td style="text-align: justify"><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td></tr>
<tr style="vertical-align: top">
<td><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td>
<td><span style="font: 10pt Times New Roman, Times, Serif">&#9679;</span></td>
<td style="text-align: justify"><span style="font: 10pt Times New Roman, Times, Serif">actions taken by regulatory
agencies with respect to our product candidates or the progress of our clinical studies, including with respect to any fast track or
orphan drug designations;</span></td></tr>
<tr style="vertical-align: top">
<td><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td>
<td><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td>
<td style="text-align: justify"><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td></tr>
<tr style="vertical-align: top">
<td><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td>
<td><span style="font: 10pt Times New Roman, Times, Serif">&#9679;</span></td>
<td style="text-align: justify"><span style="font: 10pt Times New Roman, Times, Serif">announcements of significant
acquisitions, strategic partnerships, joint ventures or capital commitments by us, our strategic collaboration partners or our competitors;</span></td></tr>
<tr style="vertical-align: top">
<td><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td>
<td><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td>
<td style="text-align: justify"><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td></tr>
<tr style="vertical-align: top">
<td><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td>
<td><span style="font: 10pt Times New Roman, Times, Serif">&#9679;</span></td>
<td style="text-align: justify"><span style="font: 10pt Times New Roman, Times, Serif">grants awarded to us or companies
that are perceived to be similar to us from outside entities;</span></td></tr>
<tr style="vertical-align: top">
<td><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td>
<td><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td>
<td style="text-align: justify"><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td></tr>
<tr style="vertical-align: top">
<td><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td>
<td><span style="font: 10pt Times New Roman, Times, Serif">&#9679;</span></td>
<td style="text-align: justify"><span style="font: 10pt Times New Roman, Times, Serif">variations in our financial
results or those of companies that are perceived to be similar to us;</span></td></tr>
<tr style="vertical-align: top">
<td><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td>
<td><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td>
<td style="text-align: justify"><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td></tr>
<tr style="vertical-align: top">
<td><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td>
<td><span style="font: 10pt Times New Roman, Times, Serif">&#9679;</span></td>
<td style="text-align: justify"><span style="font: 10pt Times New Roman, Times, Serif">trading volume of our common
stock;</span></td></tr>
<tr style="vertical-align: top">
<td><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td>
<td><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td>
<td style="text-align: justify"><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td></tr>
<tr style="vertical-align: top">
<td><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td>
<td><span style="font: 10pt Times New Roman, Times, Serif">&#9679;</span></td>
<td style="text-align: justify"><span style="font: 10pt Times New Roman, Times, Serif">developments concerning our
collaborations or partners;</span></td></tr>
<tr style="vertical-align: top">
<td><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td>
<td><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td>
<td style="text-align: justify"><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td></tr>
<tr style="vertical-align: top">
<td><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td>
<td><span style="font: 10pt Times New Roman, Times, Serif">&#9679;</span></td>
<td style="text-align: justify"><span style="font: 10pt Times New Roman, Times, Serif">the impact of the COVID-19
outbreak and its effect on us;</span></td></tr>
<tr style="vertical-align: top">
<td><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td>
<td><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td>
<td style="text-align: justify"><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td></tr>
<tr style="vertical-align: top">
<td><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td>
<td><span style="font: 10pt Times New Roman, Times, Serif">&#9679;</span></td>
<td style="text-align: justify"><span style="font: 10pt Times New Roman, Times, Serif">the perception of the biotechnology
or pharmaceutical industries by the public, legislatures, regulators and the investment community;</span></td></tr>
<tr style="vertical-align: top">
<td><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td>
<td><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td>
<td style="text-align: justify"><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td></tr>
<tr style="vertical-align: top">
<td><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td>
<td><span style="font: 10pt Times New Roman, Times, Serif">&#9679;</span></td>
<td style="text-align: justify"><span style="font: 10pt Times New Roman, Times, Serif">developments or disputes concerning
intellectual property rights;</span></td></tr>
<tr style="vertical-align: top">
<td><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td>
<td><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td>
<td style="text-align: justify"><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td></tr>
<tr style="vertical-align: top">
<td><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td>
<td><span style="font: 10pt Times New Roman, Times, Serif">&#9679;</span></td>
<td style="text-align: justify"><span style="font: 10pt Times New Roman, Times, Serif">significant lawsuits, including
patent or stockholder litigation;</span></td></tr>
<tr style="vertical-align: top">
<td><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td>
<td><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td>
<td style="text-align: justify"><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td></tr>
<tr style="vertical-align: top">
<td><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td>
<td><span style="font: 10pt Times New Roman, Times, Serif">&#9679;</span></td>
<td style="text-align: justify"><span style="font: 10pt Times New Roman, Times, Serif">our ability or inability to
raise additional capital and the terms on which we raise it;</span></td></tr>
<tr style="vertical-align: top">
<td><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td>
<td><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td>
<td style="text-align: justify"><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td></tr>
<tr style="vertical-align: top">
<td><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td>
<td><span style="font: 10pt Times New Roman, Times, Serif">&#9679;</span></td>
<td style="text-align: justify"><span style="font: 10pt Times New Roman, Times, Serif">sales of our common stock by
us or our stockholders;</span></td></tr>
<tr style="vertical-align: top">
<td><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td>
<td><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td>
<td style="text-align: justify"><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td></tr>
<tr style="vertical-align: top">
<td><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td>
<td><span style="font: 10pt Times New Roman, Times, Serif">&#9679;</span></td>
<td style="text-align: justify"><span style="font: 10pt Times New Roman, Times, Serif">declines in the market prices
of stocks generally or of companies that are perceived to be similar to us; and</span></td></tr>
<tr style="vertical-align: top">
<td><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td>
<td><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td>
<td style="text-align: justify"><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td></tr>
<tr style="vertical-align: top">
<td><span style="font: 10pt Times New Roman, Times, Serif">&#160;</span></td>
<td><span style="font: 10pt Times New Roman, Times, Serif">&#9679;</span></td>
<td style="text-align: justify"><span style="font: 10pt Times New Roman, Times, Serif">general economic, industry
and market conditions.</span></td></tr>
</table>

<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 addition, companies trading in the stock
market in general, and The Nasdaq Capital Market in particular, have experienced extreme price and volume fluctuations that have
often been unrelated or disproportionate to the operating performance of these companies. These broad market and industry factors
may seriously harm the market price of our common stock, regardless of our operating performance. In the past, following periods
of volatility in the market, securities class-action litigation has often been instituted against companies. Such litigation, if
instituted against us, could result in substantial costs and diversion of management&#8217;s attention and resources, which could
materially and adversely affect our business, financial condition, results of operations and growth prospects. There can be no
guarantee that our stock price will remain at current prices.</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 common stock may become the target
of a &#8220;short squeeze.&#8221;</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">In the past several months prior to the filing
of this Quarterly Report on Form 10-Q, securities of certain companies have increasingly experienced significant and extreme volatility
in stock price due to short sellers of shares of common stock, known as a &#8220;short squeeze.&#8221; These short squeezes have
caused extreme volatility in those companies and in the market and have led to the price per share of those companies to trade
at a significantly inflated rate that is disconnected from the underlying value of the company. Many investors who have purchased
shares in those companies at an inflated rate face the risk of losing a significant portion of their original investment as the
price per share has declined steadily as interest in those stocks have abated. There can be no assurance that we will not, in the
future be, a target of a short squeeze, and you may lose a significant portion or all of your investment if you purchase our shares
at a rate that is significantly disconnected from our underlying value.</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 addition to the information set forth in
this Form 10-Q, you should carefully review and consider 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, 2020 filed with the SEC on December 28, 2020. These
risks could materially and adversely affect our business, financial condition and results of operations. The risks described in
herein and in our Form 10-K are not the only risks we face. Our operations could also be affected by additional factors that are
not presently known to us or by factors that we currently consider immaterial to our business.</p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 6pt; 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: 0 0 6pt; 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_010"></span>Item 3. Defaults
Upon Senior Securities.</p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 6pt; text-align: justify">None.</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 6pt; 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_011"></span>Item 4. Mine
Safety Disclosures</p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 6pt; text-align: justify">Not applicable.</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 6pt; 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_012"></span>Item 5. Other
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: 10pt Times New Roman, Times, Serif; margin: 0 0 6pt; text-align: justify">None.&#160;</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 6pt; text-align: justify"></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 6pt; 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_013"></span>Item 6. Exhibits.</p>

<p style="font: bold 10pt Times New Roman, Times, Serif; margin: 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: windowtext 1pt solid; width: 12%; padding-right: 5.75pt; padding-left: 5.75pt"><span style="font: 10pt Times New Roman, Times, Serif"><b>Exhibit </b><br /> <b>Number </b></span></td>
<td style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; width: 88%; padding-right: 5.75pt; padding-left: 5.75pt"><span style="font: 10pt Times New Roman, Times, Serif"><br /><b>Description</b></span></td></tr>
<tr style="vertical-align: top">
<td style="border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-right: 5.75pt; padding-left: 5.75pt"><span style="font: 10pt Times New Roman, Times, Serif"><b>(3) </b></span></td>
<td style="border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-right: 5.75pt; padding-left: 5.75pt"><span style="font: 10pt Times New Roman, Times, Serif"><b>Articles of Incorporation and Bylaws </b></span></td></tr>
<tr style="vertical-align: top">
<td style="border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-right: 5.75pt; padding-left: 5.75pt"><span style="font: 10pt Times New Roman, Times, Serif">3.1</span></td>
<td style="border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-right: 5.75pt; padding-left: 5.75pt"><span style="font: 10pt Times New Roman, Times, Serif"><a href="http://www.sec.gov/Archives/edgar/data/1314052/000161577419007324/s118023_ex3-1.htm">Articles of Incorporation (incorporated by reference to Exhibit 3.1 to our Quarterly Report on Form 10-Q for the quarter ended March 31, 2019 filed on May 9, 2019)</a></span></td></tr>
<tr style="vertical-align: top">
<td style="border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-right: 5.75pt; padding-left: 5.75pt">3.2&#160;</td>
<td style="border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-right: 5.75pt; padding-left: 5.75pt"><a href="http://www.sec.gov/Archives/edgar/data/1314052/000173112221000974/e2796_ex3-1.htm">Certificate of Amendment to Articles of Incorporation (incorporated by reference to our Current Report on Form 8-K filed on May 28, 2021)</a>&#160;</td></tr>
<tr style="vertical-align: top">
<td style="border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-right: 5.75pt; padding-left: 5.75pt"><span style="font: 10pt Times New Roman, Times, Serif">3.3</span></td>
<td style="border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-right: 5.75pt; padding-left: 5.75pt"><span style="font: 10pt Times New Roman, Times, Serif"><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></span></td></tr>
<tr style="vertical-align: top">
<td style="border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-right: 5.75pt; padding-left: 5.75pt"><span style="font: 10pt Times New Roman, Times, Serif">3.4</span></td>
<td style="border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-right: 5.75pt; padding-left: 5.75pt"><span style="font: 10pt Times New Roman, Times, Serif"><a href="http://www.sec.gov/Archives/edgar/data/1314052/000108503707000198/form8kexh99_1.htm">Articles of Merger filed with the Secretary of State of Nevada on January 10, 2007 and which is effective January 25, 2007 (incorporated by reference to our Current Report on Form 8-K filed on January 25, 2007)</a></span></td></tr>
<tr style="vertical-align: top">
<td style="border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-right: 5.75pt; padding-left: 5.75pt"><span style="font: 10pt Times New Roman, Times, Serif"><b>(31) </b></span></td>
<td style="border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-right: 5.75pt; padding-left: 5.75pt"><span style="font: 10pt Times New Roman, Times, Serif"><b>Rule 13a-14(a)/15(d)-14(a)Certifications</b></span></td></tr>
<tr style="vertical-align: top">
<td style="border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-right: 5.75pt; padding-left: 5.75pt"><span style="font: 10pt Times New Roman, Times, Serif">31.1*</span></td>
<td style="border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-right: 5.75pt; padding-left: 5.75pt"><span style="font: 10pt Times New Roman, Times, Serif"><a href="e3018_ex31-1.htm">Certification of Christopher Missling, PhD.</a></span></td></tr>
<tr style="vertical-align: top">
<td style="border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-right: 5.75pt; padding-left: 5.75pt"><span style="font: 10pt Times New Roman, Times, Serif">31.2*</span></td>
<td style="border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-right: 5.75pt; padding-left: 5.75pt"><span style="font: 10pt Times New Roman, Times, Serif"><a href="e3018_ex31-2.htm">Certification of Sandra Boenisch</a></span></td></tr>
<tr style="vertical-align: top">
<td style="border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-right: 5.75pt; padding-left: 5.75pt"><span style="font: 10pt Times New Roman, Times, Serif"><b>(32) </b></span></td>
<td style="border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-right: 5.75pt; padding-left: 5.75pt"><span style="font: 10pt Times New Roman, Times, Serif"><b>Section 1350 Certifications</b></span></td></tr>
<tr style="vertical-align: top">
<td style="border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-right: 5.75pt; padding-left: 5.75pt"><span style="font: 10pt Times New Roman, Times, Serif">32.1*</span></td>
<td style="border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-right: 5.75pt; padding-left: 5.75pt"><span style="font: 10pt Times New Roman, Times, Serif"><a href="e3018_ex32-1.htm">Certification of Christopher Missling, PhD and Sandra Boenisch.</a></span></td></tr>
<tr style="vertical-align: top">
<td style="border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-right: 5.75pt; padding-left: 5.75pt"><span style="font: 10pt Times New Roman, Times, Serif"><b>(101)</b></span></td>
<td style="border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-right: 5.75pt; padding-left: 5.75pt"><span style="font: 10pt Times New Roman, Times, Serif"><b>XBRL</b></span></td></tr>
<tr style="vertical-align: top">
<td style="border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-right: 5.75pt; padding-left: 5.75pt"><span style="font: 10pt Times New Roman, Times, Serif">101.INS*</span></td>
<td style="border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-right: 5.75pt; padding-left: 5.75pt"><span style="font: 10pt Times New Roman, Times, Serif">XBRL INSTANCE DOCUMENT</span></td></tr>
<tr style="vertical-align: top">
<td style="border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-right: 5.75pt; padding-left: 5.75pt"><span style="font: 10pt Times New Roman, Times, Serif">101.SCH*</span></td>
<td style="border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-right: 5.75pt; padding-left: 5.75pt"><span style="font: 10pt Times New Roman, Times, Serif">XBRL TAXONOMY EXTENSION SCHEMA</span></td></tr>
<tr style="vertical-align: top">
<td style="border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-right: 5.75pt; padding-left: 5.75pt"><span style="font: 10pt Times New Roman, Times, Serif">101.CAL*</span></td>
<td style="border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-right: 5.75pt; padding-left: 5.75pt"><span style="font: 10pt Times New Roman, Times, Serif">XBRL TAXONOMY EXTENSION CALCULATION LINKBASE</span></td></tr>
<tr style="vertical-align: top">
<td style="border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-right: 5.75pt; padding-left: 5.75pt"><span style="font: 10pt Times New Roman, Times, Serif">101.DEF*</span></td>
<td style="border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-right: 5.75pt; padding-left: 5.75pt"><span style="font: 10pt Times New Roman, Times, Serif">XBRL TAXONOMY EXTENSION DEFINITION LINKBASE</span></td></tr>
<tr style="vertical-align: top">
<td style="border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-right: 5.75pt; padding-left: 5.75pt"><span style="font: 10pt Times New Roman, Times, Serif">101.LAB*</span></td>
<td style="border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-right: 5.75pt; padding-left: 5.75pt"><span style="font: 10pt Times New Roman, Times, Serif">XBRL TAXONOMY EXTENSION LABEL LINKBASE</span></td></tr>
<tr style="vertical-align: top">
<td style="border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-right: 5.75pt; padding-left: 5.75pt"><span style="font: 10pt Times New Roman, Times, Serif">101.PRE*</span></td>
<td style="border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-right: 5.75pt; padding-left: 5.75pt"><span style="font: 10pt Times New Roman, Times, Serif">XBRL TAXONOMY EXTENSION PRESENTATION LINKBASE</span></td></tr>
</table>


<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 6pt">* Filed herewith.</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 6pt"></p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 6pt">&#160;</p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 6pt; 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.&#160;</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><b>ANAVEX LIFE SCIENCES CORP. </b></p>

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

<table cellspacing="0" cellpadding="0" style="width: 100%; border-collapse: collapse">
  <tr style="vertical-align: top">
    <td style="font: 11pt Calibri, Helvetica, Sans-Serif; width: 45%"><span style="font: 10pt Times New Roman, Times, Serif">/s/Christopher Missling, PhD</span></td>
    <td style="width: 55%">&#160;</td></tr>
  <tr style="vertical-align: top">
    <td style="border-bottom: Black 1pt solid; font: 11pt Calibri, Helvetica, Sans-Serif"></td>
    <td>&#160;</td></tr>
  <tr style="vertical-align: top">
    <td style="font: 11pt Calibri, Helvetica, Sans-Serif"><span style="font: 10pt Times New Roman, Times, Serif">Christopher Missling, PhD</span></td>
    <td>&#160;</td></tr>
  <tr style="vertical-align: top">
    <td style="font: 11pt Calibri, Helvetica, Sans-Serif"><span style="font: 10pt Times New Roman, Times, Serif">Chief Executive Officer</span></td>
    <td>&#160;</td></tr>
  <tr style="vertical-align: top">
    <td style="font: 11pt Calibri, Helvetica, Sans-Serif"><span style="font: 10pt Times New Roman, Times, Serif">(Principal Executive Officer)</span></td>
    <td>&#160;</td></tr>
  <tr style="vertical-align: top">
    <td style="font: 11pt Calibri, Helvetica, Sans-Serif"><span style="font: 10pt Times New Roman, Times, Serif">Date: August <span>12, </span>2021</span></td>
    <td>&#160;</td></tr>
  <tr style="vertical-align: top">
    <td style="font: 11pt Calibri, Helvetica, Sans-Serif">&#160;</td>
    <td>&#160;</td></tr>
  <tr style="vertical-align: top">
    <td style="font: 11pt Calibri, Helvetica, Sans-Serif"><span style="font: 10pt Times New Roman, Times, Serif">/s/Sandra Boenisch</span></td>
    <td>&#160;</td></tr>
  <tr style="vertical-align: top">
    <td style="border-bottom: Black 1pt solid; font: 11pt Calibri, Helvetica, Sans-Serif"></td>
    <td>&#160;</td></tr>
  <tr style="vertical-align: top">
    <td style="font: 11pt Calibri, Helvetica, Sans-Serif"><span style="font: 10pt Times New Roman, Times, Serif">Sandra Boenisch, CPA, CGA</span></td>
    <td>&#160;</td></tr>
  <tr style="vertical-align: top">
    <td style="font: 11pt Calibri, Helvetica, Sans-Serif"><span style="font: 10pt Times New Roman, Times, Serif">Principal Financial Officer</span></td>
    <td>&#160;</td></tr>
  <tr style="vertical-align: top">
    <td style="font: 11pt Calibri, Helvetica, Sans-Serif"><span style="font: 10pt Times New Roman, Times, Serif">(Principal Financial and Accounting Officer)</span></td>
    <td>&#160;</td></tr>
  <tr style="vertical-align: top">
    <td style="font: 11pt Calibri, Helvetica, Sans-Serif"><span style="font: 10pt Times New Roman, Times, Serif">Date: August <span>12, </span>2021</span></td>
    <td>&#160;</td></tr>
  </table>

<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-top: 0; margin-bottom: 0; text-align: center">34</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">&#160;</p>

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

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{"company-data": {"conformed-name": "ANAVEX LIFE SCIENCES CORP.", "cik": "0001314052", "assigned-sic": "8731", "irs-number": "208365999", "state-of-incorporation": "NV", "fiscal-year-end": "0930"}, "filing-values": {"form-type": "10-Q", "act": "34", "file-number": "001-37606", "film-number": "211168676"}, "business-address": {"street1": "51 W 52ND STREET,", "street2": "7TH FLOOR", "city": "NEW YORK", "state": "NY", "zip": "10019-6163", "phone": "800-689-3939"}, "mail-address": {"street1": "51 W 52ND STREET,", "street2": "7TH FLOOR", "city": "NEW YORK", "state": "NY", "zip": "10019-6163"}, "former-company": {"former-conformed-name": "Thrifty Printing Inc.", "date-changed": "20050111"}}
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:
June 30, 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.)
51 West 52nd Street,
7th Floor,
New York
,
NY
USA
10019
(Address
of principal executive offices) (Zip Code)
1-844
-
689-3939
(Registrant's
telephone number, including area code)
N/A
(Former name, former address and former fiscal year, if changed since last report)
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
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:
75,707,382
shares of common stock outstanding as of August
12,
2021
.
ii
TABLE OF CONTENTS
PART I -
FINANCIAL INFORMATION
3
ITEM 1.
FINANCIAL STATEMENTS
3
ITEM 2.
MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.
16
ITEM 3.
QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISKS.
30
ITEM 4.
CONTROLS AND PROCEDURES.
30
PART II
OTHER INFORMATION
31
ITEM 1.
LEGAL PROCEEDINGS.
31
ITEM 1A.
RISK FACTORS
31
ITEM 2.
UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
33
ITEM 3.
DEFAULTS UPON SENIOR SECURITIES.
33
ITEM 4.
MINE SAFETY DISCLOSURES
33
ITEM 5.
OTHER INFORMATION.
33
ITEM 6.
EXHIBITS.
34
SIGNATURES
35
iii
PART I - FINANCIAL
INFORMATION
Item 1. FINANCIAL
STATEMENTS
ANAVEX
    LIFE SCIENCES CORP.
INTERIM
    CONDENSED CONSOLIDATED BALANCE SHEETS
June
    30, 2021 and September 30, 2020
June 30,
September 30,
2021
2020
(Unaudited)
Assets
Current
Cash and cash equivalents
$
157,560,045
$
29,249,018
Incentive and tax receivables
8,601,258
4,849,340
Prepaid expenses and deposits
258,198
443,839
Total Assets
$
166,419,501
$
34,542,197
Liabilities and Stockholders' Equity
Current Liabilities
Accounts payable
$
4,176,707
$
3,989,054
Accrued liabilities
4,653,234
3,316,574
Deferred grant income
443,831
—
Total Liabilities
9,273,772
7,305,628
Commitments and Contingencies - Note 5
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:
75,149,833
common shares (September 30, 2020 -
62,045,198
)
75,151
62,047
Additional paid-in capital
342,938,236
186,851,752
Accumulated deficit
(
185,867,658
)
(
159,677,230
)
Total Stockholders' Equity
157,145,729
27,236,569
Total Liabilities and Stockholders' Equity
$
166,419,501
$
34,542,197
See Accompanying Notes to Condensed Consolidated
Interim Financial Statements
1
ANAVEX
    LIFE SCIENCES CORP.
INTERIM
    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
For
    the three and nine months ended June 30, 2021 and 2020
(Unaudited)
Three months ended June 30,
Nine months ended June 30,
2021
2020
2021
2020
Operating expenses
General and administrative
$
2,434,127
$
1,381,477
$
6,138,528
$
4,453,654
Research and development
8,964,528
6,725,002
23,610,888
19,126,717
Total operating expenses
(
11,398,655
)
(
8,106,479
)
(
29,749,416
)
(
23,580,371
)
Other income (expenses)
Grant income
43,280
—
54,100
149,888
Research and development incentive income
1,363,661
1,319,913
3,593,856
2,980,456
Interest income, net
11,453
56,096
19,110
172,996
Foreign exchange gain (loss), net
(
160,880
)
248,665
17,191
(
24,182
)
Total other income, net
1,257,514
1,624,674
3,684,257
3,279,158
Net loss before provision for income taxes
(
10,141,141
)
(
6,481,805
)
(
26,065,159
)
(
20,301,213
)
Income tax expense, current
(
39,000
)
(
4,817
)
(
125,269
)
(
14,031
)
Net loss and comprehensive loss
$
(
10,180,141
)
$
(
6,486,622
)
$
(
26,190,428
)
$
(
20,315,244
)
Net Loss per share
Basic and diluted
$
(
0.14
)
$
(
0.11
)
$
(
0.39
)
$
(
0.35
)
Weighted average number of shares outstanding
Basic and diluted
70,589,561
59,105,399
67,810,774
57,401,387
See Accompanying Notes to Condensed Consolidated
Interim Financial Statements
2
ANAVEX
    LIFE SCIENCES CORP.
INTERIM
    CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
For
    the nine months ended June 30, 2021 and 2020
(Unaudited)
2021
2020
Cash Flows used in Operating Activities
Net loss
$
(
26,190,428
)
$
(
20,315,244
)
Adjustments to reconcile net loss to net cash used in operations:
Stock-based compensation
5,079,395
4,216,306
Changes in non-cash working capital balances related to operations:
Incentive and tax receivables
(
3,751,918
)
(
905,227
)
Prepaid expenses and deposits
185,641
62,367
Accounts payable
187,653
456,872
Accrued liabilities
1,336,660
1,452,652
Deferred grant income
443,831
—
Net cash used in operating activities
(
22,709,166
)
(
15,032,274
)
Cash Flows provided by Financing Activities
Issuance of common shares
153,218,758
20,490,297
Share issue costs
(
5,533,473
)
(
24,508
)
Proceeds from exercise of warrants
1,466,500
—
Proceeds from exercise of stock options
1,868,408
—
Net cash provided by financing activities
151,020,193
20,465,789
Increase in cash and cash equivalents during the period
128,311,027
5,433,515
Cash and cash equivalents, beginning of period
29,249,018
22,185,630
Cash and cash equivalents, end of period
$
157,560,045
$
27,619,145
See Accompanying Notes to Condensed Consolidated
Interim Financial Statements
3
ANAVEX
    LIFE SCIENCES CORP.
INTERIM
    CONDENSED CONSOLIDATED STATEMENT OF CHANGES IN STOCKHOLDERS' EQUITY
For
    the three months ended June 30, 2021 and 2020
(Unaudited)
Common Stock
Additional
Paid-in
Accumulated
Shares
Par Value
Capital
Deficit
Total
Balance, April 1, 2021
70,030,620
$
70,032
$
251,427,781
$
(
175,687,517
)
$
75,810,296
Shares issued under Sales Agreement, net of share issue costs
2,082,263
2,082
39,979,399
—
39,981,481
Shares issued pursuant to registered direct offering, net of share issue costs
2,380,953
2,381
46,901,681
—
46,904,062
Shares issued upon exercise of stock options
305,997
306
869,300
—
869,606
Shares issued pusuant to exercise of warrants
350,000
350
1,466,150
—
1,466,500
Share based compensation
—
—
2,293,925
—
2,293,925
Net loss
—
—
—
(
10,180,141
)
(
10,180,141
)
Balance, June 30, 2021
75,149,833
$
75,151
$
342,938,236
$
(
185,867,658
)
$
157,145,729
Balance, April 1, 2020
58,664,946
$
58,666
$
171,958,462
$
(
147,225,382
)
$
24,791,746
Shares issued under 2019 purchase agreement
Purchase shares
1,400,000
1,400
5,123,405
—
5,124,805
Commitment shares
16,624
16
(
16
)
—
—
Shares issued pursuant to cashless exercise of options
721
1
(
1
)
—
—
Share based compensation
—
—
1,251,129
—
1,251,129
Net loss
—
—
—
(
6,486,622
)
(
6,486,622
)
Balance, June 30, 2020
60,082,291
$
60,083
$
178,332,979
$
(
153,712,004
)
$
24,681,058
See Accompanying Notes to Condensed Consolidated
Interim Financial Statements
4
ANAVEX
    LIFE SCIENCES CORP.
INTERIM
    CONDENSED CONSOLIDATED STATEMENT OF CHANGES IN STOCKHOLDERS' EQUITY
For
    the nine months ended June 30, 2021 and 2020
(Unaudited)
Common Stock
Additional
Paid-in
Accumulated
Shares
Par Value
Capital
Deficit
Total
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
4,007,996
4,008
24,107,190
—
24,111,198
Commitment shares
78,213
78
(
78
)
—
—
Shares issued under Sales Agreement, net of share issue costs
5,634,576
5,634
76,664,391
—
76,670,025
Shares issued pursuant to registered direct offering, net of share issue costs
2,380,953
2,381
46,901,681
—
46,904,062
Shares issued upon exercise of stock options
652,897
653
1,867,755
—
1,868,408
Shares issued pusuant to exercise of warrants
350,000
350
1,466,150
—
1,466,500
Share based compensation
—
—
5,079,395
—
5,079,395
Net loss
—
—
—
(
26,190,428
)
(
26,190,428
)
Balance, June 30, 2021
75,149,833
$
75,151
$
342,938,236
$
(
185,867,658
)
$
157,145,729
Balance, October 1, 2019
52,650,521
$
52,652
$
153,633,807
$
(
133,396,760
)
$
20,289,699
Shares issued under 2019 Purchase Agreement
—
Purchase shares
7,364,584
7,365
20,482,932
—
20,490,297
Commitment shares
66,465
65
(
65
)
—
—
Shares issued pursuant to cashless exercise of options
721
1
(
1
)
—
—
Share based compensation
—
—
4,216,306
—
4,216,306
Net loss
—
—
—
(
20,315,244
)
(
20,315,244
)
Balance, June 30, 2020
60,082,291
$
60,083
$
178,332,979
$
(
153,712,004
)
$
24,681,058
See Accompanying Notes to Condensed Consolidated
Interim Financial Statements
5
Anavex Life Sciences Corp.
Notes to the Condensed Consolidated Interim Financial Statements
June 30, 2021
(Unaudited)
Note 1
Business Description
and Basis of Presentation
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")
.
On May 25, 2021, the Company filed
a Certificate of Amendment to its Articles of Incorporation with the Secretary of the State of Nevada effecting an amendment to
increase the number of authorized shares of the Company's common stock, par value $
0.001
per share, from
100,000,000
shares
to
200,000,000
shares. The Certificate of Amendment was approved by the Company's stockholders at an annual meeting of stockholders
on May 25, 2021.
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, 2020 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, 2020 filed with the SEC on December 28, 2020. The Company follows the same accounting policies in the preparation of interim
reports.
Operating
results for the three and nine months ended
June 30
, 2021 are not necessarily indicative of the
results that may be expected for the year ending September 30, 2021.
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.
6
Anavex Life Sciences Corp.
Notes to the Condensed Consolidated Interim Financial Statements
June 30, 2021
(Unaudited)
Note 1
Business Description 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 4), 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.
In December 2019, a novel strain
of coronavirus, COVID-19, was reported to have surfaced in Wuhan, China. In March 2020, the World Health Organization declared
COVID-19 to be a global pandemic as a result of the rapid spread of the virus beyond its point of origin.
The global outbreak of COVID-19
continues to rapidly evolve as of the date these interim condensed consolidated financial statements are issued. 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. The effects of COVID-19 did not have a material impact on the Company's result of operations or
financial condition for the period ended June 30, 2021. However, 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, valuation and recoverability
of deferred tax assets, incentive and tax receivables, 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.
7
Anavex Life Sciences Corp.
Notes to the Condensed Consolidated Interim Financial Statements
June 30, 2021
(Unaudited)
Note 1
Business Description 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., 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 June 30, 2021 and September
30, 2020, 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 June 30, 2021, loss per share
excludes
11,059,202
(September 30, 2020 –
10,576,266
) potentially dilutive common shares related to outstanding options and
warrants, as their effect was anti-dilutive.
8
Anavex Life Sciences Corp.
Notes to the Condensed Consolidated Interim Financial Statements
June 30, 2021
(Unaudited)
Note 2
Recent Accounting Pronouncements
Recent Accounting Pronouncements
Not Yet Adopted
The Company does not expect the
adoption of recently issued accounting pronouncements to have a significant impact on its results of operations, financial position
or cash flows.
Note 3
Other Income
Grant Income
During the
nine months ended June 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 in the Company's lead compound, ANAVEX
®
2-73
for the treatment of 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 and nine months ended June 30, 2021, the Company recognized $
43,280
and $
54,100
, respectively of this grant on
its statements of operations within grant income.
During the
year ended September 30, 2017, the Company was awarded grant funding in the amount of $
597,886
. The grant was received in equal
quarterly installments over a period of two years ending during the year ended September 30, 2020, in exchange for a commitment
to complete clinical testing for a therapeutic drug candidate for the treatment of Rett syndrome.
The grant
income was deferred when received and amortized to other income as the related research and development expenditures were incurred.
During the three and nine months ended June 30, 2020, the Company recognized $nil and $
149,888
, respectively of this grant on its
statements of operations within grant income.
Research
and Development Incentive Income
Research
and development incentive income represents income earned by the Company's Australian subsidiary, of the
Australian
research and development incentive credit,
(the "ATO R&D Credit").
During the
three and nine months ended June 30, 2021, the Company recorded research and development incentive income of $
1,363,661
(AUD
1,770,444
)
and $
3,593,856
(AUD
4,750,539
) (2020: $
1,319,913
(AUD
1,923,000
) and $
2,980,456
(AUD
4,471,000
)), respectively, in respect of the
ATO R&D Credit for eligible research and development expenses incurred during the period.
Note 4
Equity Offerings
Registered Direct Offering
On June 22, 2021, the Company and
Deep Track Capital entered into a securities purchase agreement pursuant to which the Company sold to Deep Track Capital an aggregate
of
2,380,953
shares of common stock at $
21
per share in a registered direct offering, for gross proceeds of $
50,000,013
. Net proceeds
of the offering were $
46,904,062
after deducting offering fees and expenses.
9
Anavex Life Sciences Corp.
Notes to the Condensed Consolidated Interim Financial Statements
June 30, 2021
(Unaudited)
Note 4
Equity Offerings
– (Continued)
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
nine months ended June 30, 2021,
5,634,576
shares were sold pursuant to the Offering for gross proceeds of $
79,107,547
(net proceeds
of $
76,670,025
after deducting offering expenses).
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.
During the nine months ended June
30, 2021, the Company issued to Lincoln Park an aggregate of
4,086,209
(2020 –
7,431,049
) shares of common stock under the
2019 Purchase Agreement, including
4,007,996
(2020:
7,364,584
) shares of common stock for an aggregate purchase price of $
24,111,198
(2020: $
20,490,297
) and
78,213
(2020:
66,465
) commitment shares.
At June 30, 2021,
no
amount remained
available under the 2019 Purchase Agreement (September 30, 2020: $
24,111,198
).
10
Anavex Life Sciences Corp.
Notes to the Condensed Consolidated Interim Financial Statements
June 30, 2021
(Unaudited)
Note 5
Commitments and Contingencies
a)
Leases
During
the three and nine months ended June 30, 2021, the Company incurred office lease expense of $
18,994
and $
117,284
, respectively
(2020: $
58,554
and $
169,469
, respectively).
b)
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.
c)
Share Purchase Warrants
A summary of the status of the Company's
outstanding share purchase warrants is presented below:
Number of Shares
Weighted Average Exercise Price ($)
Balance, September 30, 2019
350,000
4.19
Granted
150,000
3.17
Balance, September 30, 2020
500,000
3.88
Granted
60,000
12.00
Exercised
(
350,000
)
4.19
Balance, June 30, 2021
210,000
5.69
At June 30, 2021, the Company had
share purchase warrants outstanding as follows:
Number
Exercise Price
Expiry Date
150,000
$
3.17
May 6, 2024
60,000
$
12.00
April 21, 2026
210,000
11
Anavex Life Sciences Corp.
Notes to the Condensed Consolidated Interim Financial Statements
June 30, 2021
(Unaudited)
Note 5
Commitments
– (Continued)
d)
Stock–based Compensation Plan
2015 Stock Option Plan
On September 18, 2015, the Company's
Board of Directors (the "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 June 30, 2021,
146,371
(September 30, 2020:
146,371
) options remain available for issue under the 2015 Plan.
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 June 30, 2021,
1,706,665
(September 30, 2020:
3,161,665
) options remain available for issue under
the 2019 Plan.
12
Anavex Life Sciences Corp.
Notes to the Condensed Consolidated Interim Financial Statements
June 30, 2021
(Unaudited)
Note 5
Commitments
– (Continued)
d)
Stock-based Compensation Plan – (Continued)
A summary of the status of Company's outstanding
stock options is presented below:
Number of Shares
Weighted Average Exercise Price ($)
Weighted Average Grant Date Fair Value ($)
Aggregate intrinsic value ($)
Outstanding, September 30, 2019
8,462,933
3.58
4,115,032
Granted
1,695,000
2.96
2.27
Forfeited
(
68,332
)
3.01
Exercised
(
13,335
)
3.15
Outstanding, September 30, 2020
10,076,266
3.48
14,982,581
Granted
1,455,000
6.59
5.02
Forfeited
(
29,167
)
1.44
Exercised
(
652,897
)
2.86
Outstanding, June 30, 2021
10,849,202
3.94
205,309,996
Exercisable, June 30, 2021
7,930,452
3.64
152,413,269
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 June 30, 2021.
During the three and nine months ended
June 30, 2021, the Company recognized stock-based compensation expense of $
2,293,925
and $
5,079,395
, respectively (2020: $
1,251,129
and $
4,216,306
, respectively) 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
statements of 	operations as follows:
Three months ended June 30,
Nine months ended June 30,
2021
2020
2021
2020
General and administrative
$
1,048,606
$
575,451
$
2,265,387
$
1,863,869
Research and development
$
1,245,319
$
675,678
$
2,814,008
$
2,352,437
Total share based compensation
$
2,293,925
$
1,251,129
$
5,079,395
$
4,216,306
13
An amount of approximately $
6,664,000
in stock-based compensation is expected to be recorded over the remaining term 	of such options through fiscal 2024.
The fair
value of each option award granted during the nine months ended June 30, 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
0.71
%
1.57
%
Expected life of options (years)
5.66
5.53
Annualized volatility
95.87
%
97.80
%
Dividend rate
0.00
%
0.00
%
14
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 December 28, 2020. 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.
15
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:
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.
16
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 these two identified biomarker variants (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.
17
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.
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. The Phase 2a trial demonstrated positive pharmacokinetic (PK)
and pharmacodynamic (PD) data, 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
450-patient study of ANAVEX
®
2-73 in Alzheimer's disease commenced in August 2018. The Phase 2b/3 study is
a 48-week study, with participants randomized 1:1:1 to two different ANAVEX
®
2-73 doses or placebo. The trial commenced
in Australia; and 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 enrollment beyond 450 patients 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.
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.
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
are being conducted in a range of patient age demographics and geographic regions, utilizing a convenient oral liquid once-daily
formulation of ANAVEX
®
2-73.
18
The first Phase 2 study, 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,
drug exposure-dependent response in the Rett Syndrome Behaviour Questionnaire (RSBQ) Total scores, when compared to placebo, in
the ITT cohort (all participants, p = 0.048). 66.7% of ANAVEX
®
2-73 treated subjects showed a statistically significant
improvement in drug exposure-dependent 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). 86.7% of
ANAVEX
®
2-73 treated subjects showed a statistically significant CGI-I response, defined as sustained improvement
to treatment, as compared to 40% of the subjects on 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 Phase 2 study of ANAVEX
®
2-73
for the treatment of Rett syndrome, called the AVATAR study, commenced in June 2019. This study is taking place in Australia and
the United Kingdom using a higher dose than the U.S. based Phase 2 study for Rett syndrome. The study will evaluate the safety
and efficacy of ANAVEX
®
2-73 in approximately 33 patients over a 7-week treatment period including 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.
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 at least 69 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.
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. The study confirmed the
precision medicine approach of targeting SIGMAR1 as a genetic biomarker in response to ANAVEX
®
2-73.
In August 2020, we announced a financial commitment
by Shake It Up Australia Foundation for Parkinson's Research to fund up to 50% of the costs of an Australian clinical study
to develop ANAVEX
®
2-73 for the disease modifying treatment of Parkinson's disease. The financial commitment
would be made through private placement purchases of our common stock at 200% of the fair market value on the purchase date and
will be contingent upon the completion of certain clinical trial milestones relating to the proposed clinical trial. The proposed
clinical trial will use a convenient, once-daily oral ANAVEX
®
2-73 formulation to confirm the potential disease modifying
features of ANAVEX
®
2-73 in an animal model of Parkinson's disease. Safety and efficacy will be investigated
in an appropriately powered placebo-controlled clinical study of Parkinson's disease patients over at least 48-weeks including
ANAVEX
®
2-73-specific precision medicine biomarkers.
19
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, which 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 will be a prospective double-blind, randomized, placebo-controlled study. A total of at least 36 healthy male
and female subjects will be included. Single escalating doses of ANAVEX
®
3-71 will be 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. This study is expected to be followed by longer duration dosing including patients with FTD or other dementia
indications with unmet medical need, incorporating exploratory efficacy and disease biomarker measures
.
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.
20
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. This study,
which took place in the United States, was completed in December 2020, however two other clinical trials in Rett syndrome, the
AVATAR study and the EXCELLENCE study, are still underway. The studies are being conducted in a range of patient age demographics
and geographic regions, as more fully described above under
Clinical Studies Overview – Rett Syndrome
.
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.
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.
21
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 has completed enrollment, randomized 1:1:1 to either two different ANAVEX
®
2-73 doses or placebo, commenced
in October 2018.
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.
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
new preclinical data demonstrates that treatment with ANAVEX
®
2-73 significantly increases survival and reduces seizures.
22
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, with focus on the treatment of Frontotemporal Dementia (FTD) and
other
dementia indications with unmet medical need
. The study is more fully described above under
Clinical Studies Overview
– Frontotemporal Dementia
.
ANAVEX
®
1-41
ANAVEX
®
1-41 is a sigma-1 receptor
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.
23
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 clinical and pre-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:
Central Nervous System Diseases
●
Alzheimer's
                                            disease – In 2020, an estimated 5.8 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 leads 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.
24
●
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 IMS Health the worldwide malignant
                                            melanoma market is expected to grow to $4.4 billion by 2022.
●
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 GBI Research forecast that the market for the pharmaceutical treatment
                                            of pancreatic cancer in the United States and five largest European countries willincrease
                                            to $2.9 billion by 2021.
Patents, Trademarks and Intellectual
Property
We hold ownership or exclusive rights to thirteen
U.S. patents, seventeen 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 two issued U.S. patents
each with claims directed to crystalline forms of ANAVEX
®
2-73. The first of these two 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 two 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 on 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 the seizure treatment being co-timely or coordinated administration of anti-epilepsy
drugs and (i) ANAVEX
®
19-144 or (ii) ANAVEX 19-144
®
with 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.
25
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, and 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, and are expected to expire in January 2030.
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 December 28, 2020.
Financial Highlights
At June 30, 2021, our cash position had increased
to $157.6 million, from $29.2 million at our fiscal year end of September 30, 2020.
Operating expenses for the third quarter of
fiscal 2021 were $11.4 million, compared to $8.1 million for the comparable quarter in fiscal 2020. The operating expenses include an
aggregate of $2.3 million, as compared to $1.3 million in the third quarter of fiscal 2020, in non-cash charges related to the issuance
and vesting of stock options. Our research and development expenses for the third quarter of fiscal 2021 were $9.0 million, compared
to $6.7 million in the comparable period in fiscal 2020. The increase is attributable to the continued advancement of our ongoing clinical
trials.
Net loss for the third quarter of fiscal 2021
was $10.2 million, or $0.14 per share, as compared to $6.5 million, or $0.11 per share in the comparative quarter of fiscal 2020.
26
Results of Operations
Revenue
We
are in the development stage and have not earned any revenues since our inception and 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.
Three
and nine months ended June 30, 2021 compared to three and nine months ended June 30, 2020.
Operating Expenses
Total operating
expenses for the third quarter of fiscal 2021 were $11.4 million, compared to $8.1 million for the comparable quarter of fiscal
2020.
Total operating expenses for the nine-month period ended June 30, 2021 were $29.8 million
compared to $23.6 million for the same period in fiscal 2020. This represents an increase of $3.3 million for the three-month period
and $6.2 million for the nine-month period.
Research and development
expenses for the third quarter of fiscal 2021 were $9.0 million, compared to $6.7 million for the third quarter of fiscal 2020
and $23.6 million for the nine-month period ended June 30, 2021, as compared to $19.1 million for the applicable prior year period.
This increase in both the current quarter and the year-to-date period is attributable to the continued advancement of our ongoing
clinical trials, most notably, the
expansion of our Phase 2b/3 Alzheimer's disease trial internationally, and the
continued enrollment and advancement of the international Rett syndrome program.
General and administrative expenses increased
to $2.4 million for the three months ended June 30, 2021, as compared to $1.4 million for the third quarter of fiscal 2020. Similarly,
general and administrative expenses increased to $6.1 million for the nine-month period ended June 30, 2021, as compared to $4.5
million for the applicable prior year period. The increase in general and administrative expenses was primarily related to an increase
in our staff, corporate activities and transactions, and an increase in non-cash stock option compensation charges.
Other income
The net amount of other income was $1.3 million
for the three-month period ended June 30, 2021 as compared to $1.6 million for the three-month period ended June 30, 2020 and $3.7
million for the nine-month period as compared to $3.3 million for the comparable nine-month period in fiscal 2020. The Company
experienced an increase in Australian research and development incentive income for the nine-month period, in connection with the
increase in eligible clinical activities in Australia over the comparable year to date period, however in the current quarter the
Company incurred foreign exchange losses which were related to the fluctuations in the Australian dollar against the US dollar
and its related impact on incentive and tax receivables.
Liquidity and Capital Resources
Working Capital
June 30, 2021
September 30, 2020
Current Assets
$
166,419,501
$
34,542,197
Current Liabilities
9,273,772
7,305,628
Working Capital
$
157,145,729
$
27,236,569
At June 30, 2021, we had $157.6 million in cash and cash equivalents, an increase of $128.3 million from September 30, 2020. During
the nine-month period ended June 30, 2021, we received cash of $151.0 million, net of issuance costs, primarily from the issuance
of shares of common stock under the 2019 Purchase Agreement, through the Sales Agreement, as well as a registered direct offering,
each as more fully described elsewhere in this Quarterly Report.
27
Cash Flows
Nine months ended June 30,
2021
2020
Net cash flows used in operating activities
$
(22,709,166
)
$
(15,032,274
)
Net cash flows from financing activities
151,020,193
20,465,789
Increase in cash and cash equivalents
$
128,311,027
$
5,433,515
Cash flow used in operating activities
Net cash used in operating activities for the
first nine months of fiscal 2021
was $22.7 million, compared to $15.0 million during the comparable
period of fiscal 2020. The principal reason for this increase in net cash used from operating activities in the current period is due
to an increase in research and development expenses and an increase in research and development incentive income receivable, as compared
to the comparable period.
Cash flow provided by financing activities
Cash provided by financing activities for the
first nine months in fiscal 2021
was $151.0 million, net of financing costs, primarily attributable
to cash received from the issuance of common shares at various market prices under the 2019 Purchase Agreement, the Sales Agreement and
a direct registered offering we completed for net proceeds of $46.9 million, after deducting expenses associated with the offering.
Cash provided by financing activities for the
first nine months in fiscal 2020
was $20.5 million, attributable to cash received from the issuance
of common shares at various market prices under the 2019 Purchase Agreement
.
Other Financing
Purchase Agreement
On June 7, 2019, we
entered into a Purchase Agreement (the "2019 Purchase Agreement") with Lincoln Park Capital Fund, LLC ("Lincoln
Park"), as amended on July 1, 2020, pursuant to which Lincoln Park committed to purchase up to $50.0 million of our common
stock. Concurrently with the execution of the 2019 Purchase Agreement in 2019, we issued 324,383 shares of our common stock to
Lincoln Park as a fee for its commitment to purchase shares of our common stock under the 2019 Purchase Agreement and became obligated
to issue up to 162,191 shares pro rata, when and if Lincoln Park purchased, at our discretion, the $50.0 million aggregate commitment.
During the nine months ended June 30, 2021,
the Company issued to Lincoln Park an aggregate of 4,086,209 shares of common stock under the 2019 Purchase Agreement, including
4,007,996 shares of common stock for an aggregate purchase price of $24.1 million and 78,213 commitment shares. As of
June 30, 2021, no shares of our common stock remain available for purchase by Lincoln Park under the 2019 Purchase Agreement.
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.
28
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 nine months ended June 30, 2021,
5,634,576 shares were sold pursuant to the At-the-Market Offering for gross proceeds of $79.1 million (net proceeds of $76.7 million
after deducting commissions and offering expenses).
Registered Direct Offering
On June 24, 2021, the Company completed a registered
direct offering off of the Company's shelf registration statement on Form S-3 filed with the SEC on July 3, 2019. The Company
issued 2,380,953 common shares at $21.00 per share for gross proceeds of $50.0 million (net proceeds of $46.9 million after deducting
offering fees and 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.
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, 2020 as filed with the SEC on December 28, 2020.
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.
29
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 June 30, 2021.
Changes in Internal Control over Financial
Reporting
During the quarter ended June 30, 2021, 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, 2020 filed with the SEC on December 28, 2020 except for the following new risks:
Our stock price has recently been volatile
and may be volatile in the future.
Our stock price has recently been volatile
and may be volatile in the future. For example, on February 1, 2021, the price of our common stock closed at $6.53 per share while
on February 9, 2021, the price of our common stock closed at $14.99 per share without disclosure of news or other developments
by us. On February 4, 2021, the opening price of our common stock was $19.94 and the intra-day sales price of our common stock
fluctuated between a reported low sale price of $13.80 and a reported high sales price of $28.70, closing at $14.91. Our volume
on this day was 116,590,800, which was a substantial increase from the volume of 18,086,230 and 3,161,525 on the two days immediately
preceding February 4, 2021. We may incur rapid and substantial increases or decreases in our stock price in the foreseeable future
that are do not coincide in timing with the disclosure of news or developments by us. The stock market in general, and the market
for biotechnology and pharmaceutical companies in particular, has experienced extreme volatility that has often been unrelated
to the operating performance of particular companies. The market price for our common stock may be influenced by many factors,
including the following:
30
●
announcements of new data,
clinical trial results or those of companies that are perceived to be similar to us;
●
announcements related to any
delays in any preclinical or clinical trials related to our products;
●
announcements related to our
products' ability to demonstrate efficacy or an acceptable safety profile of our product candidates or similar announcements by
companies that are perceived to be similar to us;
●
our ability to meet or exceed
expectations of analysts or investors;
●
news that the number of patients
required for clinical trials for our drug candidates may be larger than we anticipate, enrollment in these clinical trials may be slower
than we anticipate, participants may drop out of these clinical trials at a higher rate than we anticipate or the duration of these clinical
trials may be longer than we anticipate;
●
actions taken by regulatory
agencies with respect to our product candidates or the progress of our clinical studies, including with respect to any fast track or
orphan drug designations;
●
announcements of significant
acquisitions, strategic partnerships, joint ventures or capital commitments by us, our strategic collaboration partners or our competitors;
●
grants awarded to us or companies
that are perceived to be similar to us from outside entities;
●
variations in our financial
results or those of companies that are perceived to be similar to us;
●
trading volume of our common
stock;
●
developments concerning our
collaborations or partners;
●
the impact of the COVID-19
outbreak and its effect on us;
●
the perception of the biotechnology
or pharmaceutical industries by the public, legislatures, regulators and the investment community;
●
developments or disputes concerning
intellectual property rights;
●
significant lawsuits, including
patent or stockholder litigation;
●
our ability or inability to
raise additional capital and the terms on which we raise it;
●
sales of our common stock by
us or our stockholders;
●
declines in the market prices
of stocks generally or of companies that are perceived to be similar to us; and
●
general economic, industry
and market conditions.
31
In addition, companies trading in the stock
market in general, and The Nasdaq Capital Market in particular, have experienced extreme price and volume fluctuations that have
often been unrelated or disproportionate to the operating performance of these companies. These broad market and industry factors
may seriously harm the market price of our common stock, regardless of our operating performance. In the past, following periods
of volatility in the market, securities class-action litigation has often been instituted against companies. Such litigation, if
instituted against us, could result in substantial costs and diversion of management's attention and resources, which could
materially and adversely affect our business, financial condition, results of operations and growth prospects. There can be no
guarantee that our stock price will remain at current prices.
Our common stock may become the target
of a "short squeeze."
In the past several months prior to the filing
of this Quarterly Report on Form 10-Q, securities of certain companies have increasingly experienced significant and extreme volatility
in stock price due to short sellers of shares of common stock, known as a "short squeeze." These short squeezes have
caused extreme volatility in those companies and in the market and have led to the price per share of those companies to trade
at a significantly inflated rate that is disconnected from the underlying value of the company. Many investors who have purchased
shares in those companies at an inflated rate face the risk of losing a significant portion of their original investment as the
price per share has declined steadily as interest in those stocks have abated. There can be no assurance that we will not, in the
future be, a target of a short squeeze, and you may lose a significant portion or all of your investment if you purchase our shares
at a rate that is significantly disconnected from our underlying value.
In addition to the information set forth in
this Form 10-Q, you should carefully review and consider 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, 2020 filed with the SEC on December 28, 2020. These
risks could materially and adversely affect our business, financial condition and results of operations. The risks described in
herein and in our Form 10-K are not the only risks we face. Our operations could also be affected by additional factors that are
not presently known to us or by factors that we currently consider immaterial to our business.
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.
32
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 Quarterly Report on Form 10-Q for the quarter ended March 31, 2019 filed on May 9, 2019)
3.2
Certificate of Amendment to Articles of Incorporation (incorporated by reference to our Current Report on Form 8-K filed on May 28, 2021)
3.3
Bylaws (incorporated by reference to our Current Report on Form 8-K filed on September 28, 2007)
3.4
Articles of Merger filed with the Secretary of State of Nevada on January 10, 2007 and which is effective January 25, 2007 (incorporated by reference to our Current Report on Form 8-K filed on January 25, 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.
33
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: August
12,
2021
/s/Sandra Boenisch
Sandra Boenisch, CPA, CGA
Principal Financial Officer
(Principal Financial and Accounting Officer)
Date: August
12,
2021
34