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PROSPECTUS SUPPLEMENT
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Filed Pursuant to Rule 424(b)(5)
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(To Prospectus Dated July 15, 2019)
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Registration No. 333-232550
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Anavex Life Sciences Corp.
Up to $15,514,532 of
Common Stock
This prospectus supplement relates to the
issuance and sale of up to $15,514,532 in shares of our common stock, to Lincoln Park Capital Fund, LLC (“Lincoln
Park”), from time to time, in one or more transactions in amounts, at prices, and on terms that will be determined at
the time these securities are offered pursuant to a purchase agreement between us and Lincoln Park, dated as of June 7, 2019
(the “Purchase Agreement”). See “The Lincoln Park Transaction” for a description of the Purchase
Agreement.
Lincoln Park is an “underwriter”
within the meaning of Section 2(a)(11) of the Securities Act of 1933, as amended (the “Securities Act”).
Our common stock is currently traded on the
Nasdaq Capital Market under the symbol “AVXL”. On September 11, 2019, the last reported sale price of our common stock
was $2.99 per share.
We will pay the expenses incurred in registering
the shares, including legal and accounting fees. See “Plan of Distribution”.
Investing in our securities involves
a high degree of risk. See the section entitled “Risk Factors” on page S-4 of this prospectus supplement and the
section entitled “Risk Factors” beginning on page 11 of the accompanying prospectus, and in the documents we filed
with the Securities and Exchange Commission that are incorporated in this prospectus supplement by reference for certain risks
and uncertainties you should consider.
Neither the Securities and Exchange
Commission nor any state securities commission has approved or disapproved of these securities or passed upon the adequacy or accuracy
of this prospectus. Any representation to the contrary is a criminal offense.
The date of this prospectus supplement
is September 13, 2019.
TABLE OF CONTENTS
PROSPECTUS
ABOUT THIS PROSPECTUS SUPPLEMENT
We are providing information to you about
this offering of our common stock in two separate documents that are bound together: (1) this prospectus supplement, which describes
the specific terms of this offering, and (2) the accompanying base prospectus, which provides general information, some of which
may not apply to this offering. This prospectus supplement may also add to, update or change information contained in the accompanying
base prospectus. If information in this prospectus supplement is inconsistent with the accompanying base prospectus, you should
rely on this prospectus supplement. Generally, when we refer to this “prospectus,” we are referring to both documents
combined.
This prospectus supplement, the accompanying
base prospectus and any free-writing prospectus that we prepare or authorize contain and incorporate by reference information that
you should consider when making your investment decision. We have not, and Lincoln Park has not, authorized anyone to provide you
with additional or different information. If anyone provides you with different or inconsistent information, you should not rely
on it. You should not assume that the information contained in this prospectus supplement or the accompanying base prospectus is
accurate as of any date other than the date on the front of those documents or that any information we have incorporated by reference
is accurate as of any date other than the date of the document incorporated by reference. Our business, financial condition, results
of operations and prospects may have changed since those dates.
This prospectus supplement is part of a
registration statement that we filed with the Securities and Exchange Commission (the “SEC”), using a “shelf”
registration process. Under the shelf registration process, we may from time to time offer and sell any combination of the securities
described in the accompanying prospectus up to a total dollar amount of $250 million, of which this offering is a part.
We are not, and Lincoln Park is not, making
an offer or sale of our common stock in any jurisdiction where such offer or sale is not permitted.
The information in this prospectus supplement
is not complete. You should carefully read this prospectus supplement and the accompanying base prospectus, including the information
incorporated by reference herein and therein, before you invest, as these documents contain information you should consider when
making your investment decision.
None of Anavex Life Sciences Corp., Lincoln
Park or any of their representatives are making any representation to you regarding the legality of an investment in our common
stock by you under applicable laws. You should consult with your own advisors as to legal, tax, business, financial and related
aspects of an investment in our common stock.
CAUTIONARY NOTE REGARDING FORWARD-LOOKING
STATEMENTS
This prospectus supplement contains forward-looking
statements. All statements other than statements of historical facts contained in this prospectus supplement, 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:
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our ability to successfully conduct clinical and preclinical trials for our product candidates;
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our ability to raise additional capital on favorable terms;
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our ability to execute our development plan on time and on budget;
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our ability to demonstrate efficacy or an acceptable safety profile of our product candidates;
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our ability to obtain the support of qualified scientific collaborators;
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our ability, whether alone or with commercial partners, to successfully commercialize any of our
product candidates that may be approved for sale;
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our ability to identify and obtain additional product candidates;
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our ability to obtain and maintain sufficient intellectual property protection for our product
candidates;
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our ability to comply with our intellectual property licensing agreements;
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our ability to defend against claims of intellectual property infringement;
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our ability to comply with the maintenance requirements of the government patent agencies;
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our ability to protect our intellectual property rights throughout the world;
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the anticipated start dates, durations and completion dates of our ongoing and future clinical
studies;
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the anticipated designs of our future clinical studies;
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our anticipated future regulatory submissions and our ability to receive regulatory approvals to
develop and market our product candidates;
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our anticipated future cash position; and
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our ability to generate any revenue or to continue as a going concern.
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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, or 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 for the fiscal year ended September 30, 2018.
These risks are not exhaustive. 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.
PROSPECTUS SUPPLEMENT SUMMARY
This summary highlights information
contained elsewhere in this prospectus supplement and the accompanying base prospectus. It does not contain all of the information
that you should consider before making an investment decision. You should read this entire prospectus supplement, the accompanying
base prospectus and the documents incorporated herein by reference for a more complete understanding of this offering of common
stock. Please read “Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended September 30, 2018 for
information regarding risks you should consider before investing in our common stock.
Throughout
this prospectus supplement, when we use the terms “Anavex,” “we,” “us,” “our” or
the “Company,” we are referring either to Anavex Life Sciences Corp. in its individual capacity or to Anavex Life Sciences
Corp. and its operating subsidiaries collectively, as the context requires.
Our Company
Overview
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”).
Clinical Studies Overview
Alzheimer’s Disease
In November 2016, we completed a Phase
2a clinical trial, consisting of PART A and PART B, which lasted a total of 57 weeks, for ANAVEX®2-73 in mild-to-moderate
Alzheimer’s patients. This open-label randomized trial met both primary and secondary endpoints and was designed to assess
the safety and exploratory efficacy of ANAVEX®2-73 in 32 patients. ANAVEX®2-73 targets sigma-1 and
muscarinic receptors, which have been shown in preclinical studies to reduce stress levels in the brain believed to restore cellular
homeostasis and to reverse the pathological hallmarks observed in Alzheimer’s disease. In October 2017, we presented positive
pharmacokinetic (PK) and pharmacodynamic (PD) data from the Phase 2a study, which established a concentration-effect relationship
between ANAVEX®2-73 and study measurements. These measures obtained from all patients who participated in the entire
57 weeks include exploratory cognitive and functional scores as well as biomarker signals of brain activity. Additionally, the
study appears to show that ANAVEX®2-73 activity is enhanced by its active metabolite (ANAVEX19-144), which also
targets the sigma-1 receptor and has a half-life approximately twice as long as the parent molecule.
In March 2016, we received approval from
the Ethics Committee in Australia to extend the Phase 2a clinical trial by an additional 108 weeks, which had been requested by
patients and their caregivers. Subsequently, in May 2018, we received approval from the Ethics Committee in Australia to further
extend the Phase 2a extension trial for an additional two years. The two consecutive trial extensions 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 October 2018, we presented new long-term
clinical data for ANAVEX®2-73 in a presentation at the 2018 Clinical Trials on Alzheimer’s Disease (CTAD)
Meeting. At 148 weeks into the five-year extended Phase 2a clinical study, data confirmed a significant association between ANAVEX®2-73
concentration and both exploratory functional and cognitive endpoints as measured by the Alzheimer’s Disease Cooperative
Study-Activities of Daily Living (ADCS-ADL) evaluation and the Mini Mental State Examination (MMSE), respectively. The cohort of
patients treated with higher ANAVEX®2-73 concentration maintained ADCS-ADL performance compared to the lower concentration
cohort (p<0.0001). As well, the patient cohort with the higher ANAVEX®2-73 concentration performed better at
MMSE compared to the lower concentration cohort (p<0.0008). A significant impact on the drug response levels of both the SIGMAR1
(p<0.0080) and COMT (p<0.0014) genomic biomarkers, identified and specified at week 57, was also confirmed over the 148-week
period. Further, ANAVEX®2-73 demonstrated continued favorable safety and tolerability through 148 weeks.
A larger Phase 2b/3 double-blind, placebo-controlled
study of ANAVEX®2-73 in Alzheimer’s disease commenced in October 2018, which is independent of the ongoing
Phase 2a extension study. The Phase 2b/3 study will enroll approximately 450 patients for 48 weeks, randomized 1:1:1 to two different
ANAVEX®2-73 doses or placebo. The trial is currently taking place in Australia; however, North American sites may
also be added. 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).
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 is being received in quarterly instalments which commenced during fiscal 2018.
In March 2019, we commenced a Phase 2 clinical
trial of ANAVEX®2-73 for the treatment of Rett syndrome. The study is the first in a planned Anavex Rett syndrome
program in a range of patient age demographics and geographic regions. The Phase 2 study is taking place in the United States and
is a randomized double-blind, placebo-controlled safety, tolerability, pharmacokinetic and efficacy study of oral liquid ANAVEX®2-73
formulation to treat Rett syndrome. Pharmacokinetic and dose findings will be investigated in a total of 15 patients over a 7-week
treatment period including ANAVEX®2-73-specific genomic 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. This study
is being followed by a placebo- controlled safety and efficacy evaluation of ANAVEX®2-73 over a 3-month treatment
period. Primary and secondary endpoints include safety as well as Rett syndrome conditions such as cognitive impairment, motor
impairment, behavioral symptoms and seizure activity. The ANAVEX®2-73 Phase 2 Rett syndrome study designs incorporate
genomic precision medicine biomarkers identified in the ANAVEX®2-73 Phase 2a Alzheimer’s disease study.
In June 2019, the we commenced a Phase
2 double-blind, randomized, placebo-controlled study of ANAVEX®2-73 for the treatment of Rett syndrome, called AVATAR.
The Phase 2 study is taking place in Australia and is using a convenient once-daily oral liquid ANAVEX®2-73 formulation.
Similar to the United States based Phase 2 study for Rett syndrome, the study will evaluate the safety and efficacy of ANAVEX®2-73
in approximately 30 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.
Parkinson’s Disease
In September 2016, we presented positive
preclinical data for ANAVEX®2-73 in Parkinson’s disease, which demonstrated significant improvements on all
measures: behavioral, histopathological, and neuroinflammatory endpoints. The study was funded by the Michael J. Fox Foundation.
Additional data was announced in October 2017 from the model for experimental parkinsonism. The data presented 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.
In October 2018, we initiated in Spain,
a double-blind, randomized, placebo-controlled 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 120 patients for 14 weeks, randomized 1:1:1 to two different ANAVEX®2-73 doses or placebo.
The ANAVEX®2-73 Phase 2 PDD study design incorporates genomic precision medicine biomarkers identified in the ANAVEX®2-73
Phase 2a study.
Corporate Information
Our principal executive office is located
at 51 West 52nd Street, 7th Floor, New York, NY 10019-6163, and our telephone number is 844.689.3939. Our website address is www.anavex.com.
No information found on our website is part of this prospectus. Also, this prospectus may include the names of various government
agencies or the trade names of other companies. Unless specifically stated otherwise, the use or display by us of such other parties’
names and trade names in this prospectus is not intended to and does not imply a relationship with, or endorsement or sponsorship
of us by, any of these other parties.
THE OFFERING
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Common stock offered by us:
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Up to $15,365,495 of shares of our common stock we may sell to Lincoln Park from time to time until the expiration of the registration statement of which this prospectus is a part or the earlier termination of the Purchase Agreement by us; and
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Up to 49,845 additional commitment shares valued at $149,037 based on $2.99 per share, the closing price of
our common stock on The Nasdaq Capital Market on September 11, 2019, which is the amount of additional shares of our common stock
we may issue for no cash consideration to Lincoln Park from time to time pro-rata in connection with the purchase of $15,365,495
of shares of our common stock under the Purchase Agreement.
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Common stock to be outstanding after this offering:
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Up to 57,839,328 shares assuming (i) the sale of 5,138,962 shares of our common stock (which would be the
full amount offered under this prospectus supplement at an assumed offering price of $2.99 per share, the closing price of our
common stock on The Nasdaq Capital Market on September 11, 2019) and (ii) the issuance of 49,845 additional commitment shares (which
is the number of additional commitment shares that will be issued if we direct Lincoln Park to purchase $15,365,495 of shares of
our common stock at an offering price of $2.99 per share under the Purchase Agreement). The actual number of shares issued will
vary depending on the sales prices under this offering.
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Use of Proceeds
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We intend to use the net proceeds from this offering for general corporate purposes, which may include, among other things, working capital, capital expenditures and funding additional clinical and preclinical development of our pipeline candidates. See “Use of Proceeds” on page S-5.
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Risk Factors
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You should read the “Risk Factors” section on page S-4 of this prospectus supplement and the other risks identified in the documents incorporated by reference herein before making a decision to purchase common stock in this offering.
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Nasdaq Capital Market symbol
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“AVXL.”
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The number of shares of common stock shown
above to be outstanding after this offering is based on 52,650,521 shares of common stock outstanding as of September 11, 2019
and excludes the following:
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8,482,933 shares of common stock issuable upon the exercise of outstanding stock options, vested
and unvested, with a weighted- average exercise price of $3.57 per share; and
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350,000 shares of common stock issuable upon the exercise of outstanding warrants with a weighted-average
exercise price of $4.19 per share.
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RISK FACTORS
An investment in our common stock involves
a significant degree of risk. Before you invest in our common stock you should carefully consider those risk factors included in
our most recent Annual Report on Form 10-K, our most recent Quarterly Report on Form 10-Q, any subsequently filed Quarterly Reports
on Form 10-Q and any subsequently filed Current Reports on Form 8-K, which are incorporated herein by reference, and those risk
factors that may be included in any applicable prospectus supplement, together with all of the other information included in this
prospectus supplement, the accompanying base prospectus and the documents we incorporate by reference, in evaluating an investment
in our common stock. If any of the risks discussed in the foregoing documents were to occur, our business, financial condition,
results of operations and cash flows could be materially adversely affected. Please read “Cautionary Statement Regarding
Forward-Looking Statements.”
Risks Relating to the Purchase Agreement
The sale or issuance of our
common stock to Lincoln Park may cause dilution and the sale of the shares of common stock acquired by Lincoln Park, or the perception
that such sales may occur, could cause the price of our common stock to fall.
On June 7, 2019, we entered into the Purchase
Agreement with Lincoln Park, pursuant to which Lincoln Park has committed to purchase up to $50 million of shares of our common
stock (of which $15,365,495 of such shares are registered hereunder), and we may still issue up to 147,159 additional commitment
shares (of which 49,845 of such shares are registered hereunder) pro-rata in connection with the purchase of shares of our common
stock under the Purchase Agreement. We may sell purchase shares to Lincoln Park pursuant to the Purchase Agreement at our discretion
from time to time for a 36-month period, which commenced on June 7, 2019.
We also previously issued 324,383 shares of
our common stock to Lincoln Park for no cash consideration as a fee for Lincoln Park’s execution of the Purchase Agreement,
we have issued 15,032 additional commitment shares pro-rata in connection with the purchase of 1,500,000 shares of our common
stock under the Purchase Agreement since June 7, all of which were registered under our registration statement (File No. 333-207600).
The purchase price for the shares that
we may sell to Lincoln Park under the Purchase Agreement will fluctuate based on the price of our common stock. Depending on market
liquidity at the time, sales of such shares may cause the trading price of our common stock to fall.
We have the right to control the timing
and amount of any sales of our shares to Lincoln Park in our sole discretion, subject to certain limits on the amount of shares
that can be sold on a given date. Sales of shares of our common stock, if any, to Lincoln Park will depend upon market conditions
and other factors to be determined by us. Therefore, Lincoln Park may ultimately purchase all, some or none of the shares of our
common stock that may be sold pursuant to the Purchase Agreement and, after it has acquired shares, Lincoln Park may sell all,
some or none of those shares. Sales to Lincoln Park by us could result in substantial dilution to the interests of other holders
of our common stock. Additionally, the sale of a substantial number of shares of our common stock to Lincoln Park, or the anticipation
of such sales, could make it more difficult for us to sell equity or equity- related securities in the future at a time and at
a price that we might otherwise wish to effect sales, which could have a materially adverse effect on our business and operations.
You may experience future dilution
as a result of future equity offerings.
To raise additional capital, we may in
the future offer additional shares of our common stock or other securities convertible into or exchangeable for our common stock
at prices that may not be the same as the price per share in this offering. We may sell shares or other securities in any other
offering at a price per share that is less than the price per share paid by investors in this offering, and investors purchasing
shares or other securities in the future could have rights superior to existing stockholders. The price per share at which we sell
additional shares of our common stock, or securities convertible or exchangeable into common stock, in future transactions may
be higher or lower than the price per share paid by investors in this offering.
We may not be able to access
sufficient funds under the Purchase Agreement when needed.
Our ability to sell shares to Lincoln
Park and obtain funds under the Purchase Agreement is limited by the terms and conditions in the Purchase Agreement, including
restrictions on the amounts we may sell to Lincoln Park at any one time, and a limitation on our ability to sell shares to Lincoln
Park to the extent that it would cause Lincoln Park to beneficially own more than 4.99% of our outstanding shares of common stock.
Additionally, we are only registering $15,365,495 of shares of our common stock for sale hereunder. Therefore, we currently do
not and may not in the future have access to the full amount available to us under the Purchase Agreement. In addition, any amounts
we sell under the Purchase Agreement may not satisfy all of our funding needs, even if we are able and choose to sell all $15,365,495
of our common stock registered under this prospectus supplement.
Our management might apply
the net proceeds from this offering in ways with which you do not agree and in ways that may impair the value of your investment.
We currently intend to use the net proceeds
from this offering primarily for working capital and general corporate purposes. Our management has broad discretion as to the
use of such proceeds and you will be relying on the judgment of our management regarding the application of these proceeds. Our
management might apply these proceeds in ways with which you do not agree, or in ways that ultimately do not yield a favorable
return. If our management applies such proceeds in a manner that does not yield a significant return, if any, on our investment
of such net proceeds, it could compromise our ability to pursue our growth strategy and adversely affect the market price of our
common stock.
USE OF PROCEEDS
We may receive up to $15,365,495 in aggregate
gross proceeds under the Purchase Agreement from any sales to Lincoln Park of shares of common stock registered hereunder pursuant
to the Purchase Agreement after the date of this prospectus supplement. We may sell fewer than all of the shares offered by this
prospectus supplement, in which case our aggregate proceeds will be less. Because we are not obligated to sell any shares of our
common stock under the Purchase Agreement, the actual total offering amount and proceeds to us, if any, are not determinable at
this time. There can be no assurance that we will receive any proceeds under or fully utilize the Purchase Agreement. See “Plan
of Distribution” elsewhere in this prospectus supplement for more information.
We intend to use
the net proceeds of this offering for general corporate purposes, which may include, among other things, working capital, capital
expenditures and funding additional clinical and preclinical development of our pipeline candidates.
DILUTION
The sale of our common stock to Lincoln
Park pursuant to the Purchase Agreement will have a dilutive impact on our stockholders. In addition, the lower our stock price
is at the time we exercise our right to sell shares to Lincoln Park, the more shares of our common stock we will have to issue
to Lincoln Park pursuant to the Purchase Agreement and our existing stockholders would experience greater dilution. We calculate
net tangible book value per share by dividing the net tangible book value, which is tangible assets less total liabilities, by
the number of outstanding shares of common stock. Dilution represents the difference between the portion of the amount per share
paid by purchasers of shares in this offering and the as adjusted net tangible book value per share of our common stock immediately
after giving effect to this offering. Our net tangible book value as of June 30, 2019 was approximately $17.6 million, or $0.34
per share.
After giving effect to the sale of common stock
pursuant to this prospectus supplement and accompanying prospectus in the aggregate amount of $15,365,495 at an assumed offering
price of $2.99 per share, the last reported sale price of our common stock on the Nasdaq Capital Market on September 11, 2019,
and after deducting estimated aggregate offering expenses payable by us and accounting for the issuance of all of the commitment
shares registered hereunder, our net tangible book value as of June 30, 2019 would have been $33.0, or $0.58 per share of common
stock. This represents an immediate increase in the net tangible book value of $0.24 per share to our existing stockholders and
an immediate dilution in net tangible book value of $2.41 per share to new investors. The following table illustrates this per
share dilution:
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Assumed public offering price per share
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$
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2.99
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Net tangible book value per share as of June 30, 2019
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$
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0.34
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Increase per share attributable to new investors
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$
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0.24
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As adjusted net tangible book value per share as of June 30, 2019 after giving effect to this offering
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$
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0.58
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Dilution per share to new investors purchasing shares in this offering
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$
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2.41
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The table above assumes for illustrative purposes
that an aggregate of 5,138,962 shares of our common stock are sold pursuant to this prospectus supplement and the accompanying
prospectus at a price of $2.99 per share, the last reported sale price of our common stock on the Nasdaq Capital Market on September
11, 2019, for aggregate gross proceeds of $15,365,495, and 49,845 additional commitment shares are issued in connection with such
sales. The shares sold in this offering, if any, will be sold from time to time at various prices. An increase of $1.00 per share
in the price at which the shares are sold from the assumed offering price of $2.99 per share shown in the table above, assuming
all of our common stock in the aggregate amount of $15,365,495 is sold at that price, would result in an adjusted net tangible
book value per share after the offering of $0.60 per share and would increase the dilution in net tangible book value per share
to new investors in this offering to $3.39 per share, after deducting estimated aggregate offering expenses payable by us. A decrease
of $1.00 per share in the price at which the shares are sold from the assumed offering price of $2.99 per share shown in the table
above, assuming all of our common stock in the aggregate amount of $15,365,495 is sold at that price, would result in an adjusted
net tangible book value per share after the offering of $0.56 per share and would decrease the dilution in net tangible book value
per share to new investors in this offering to $1.43 per share, after deducting estimated aggregate offering expenses payable by
us.
The above table and discussion are based
on 51,509,871 shares of common stock outstanding as of June 30, 2019 and excludes the following, all as of June 30, 2019:
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8,461,266 shares of common stock issuable upon the exercise of outstanding stock options, vested
and unvested, with a weighted-average exercise price of $3.58 per share; and
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357,500 shares of common stock issuable upon the exercise of outstanding warrants with a weighted-average
exercise price of $4.12 per share.
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To the extent that options or warrants
outstanding as of June 30, 2019 have been or are exercised, or other shares are issued, investors purchasing shares in this offering
could experience further dilution. In addition, we may choose to raise additional capital due to market conditions or strategic
considerations, even if we believe we have sufficient funds for our current or future operating plans. To the extent that additional
capital is raised through the sale of equity or convertible debt securities, the issuance of these securities could result in further
dilution to our stockholders.
LINCOLN PARK TRANSACTION
On June 7, 2019, we entered into the Purchase
Agreement and a Registration Rights Agreement (the “RRA”) with Lincoln Park. Pursuant to the terms of the Purchase
Agreement, Lincoln Park has agreed to purchase from us up to $50 million of shares of our common stock (subject to certain limitations).
On June 12, 2019, we filed a prospectus supplement
to our registration statement (File No. 333-207600) (the “2016 Registration Statement”) covering the issuance and sale
of (i) up to $20 million in shares of our common stock, (ii) 324,383 initial commitment shares as a commitment fee for Lincoln
Park for entering into the Purchase Agreement and (iii) 64,877 additional commitment shares. As of September 11, 2019, we have
sold 1,500,000 shares of common stock under the Purchase Agreement for gross proceeds of $ 4,634,505 and have issued 15,032 additional
commitment shares (in addition to the 324,383 initial commitment shares), all of which were registered under the 2016 Registration
Statement. As of September 6, 2019, the 2016 Registration Statement was no longer remain effective pursuant to Rule 415 under the
Securities Act), so we have deregistered all remaining shares of common stock issuable under the Purchase Agreement and registered
under the 2016 Registration Statement that have not been issued to Lincoln Park.
On July 3, 2019, we filed the registration
statement of which this prospectus is a part, registering up to $250 million in securities utilizing a shelf registration process.
Pursuant to the terms of the RRA, which requires us to register purchase shares and additional commitment shares in order to sell
purchase shares to Lincoln Park, we are filing this prospectus supplement to cover (i) the offer and sale of up to $15,365,495
of shares of our common stock and (ii) the issuance of up to 49,845 additional commitment shares to be issued pro-rata to Lincoln
Park if and when we direct Lincoln Park to purchase $15,365,495 of shares of common stock under the Purchase Agreement.
Purchase of Shares Under the Purchase
Agreement
From the date hereof, we may, from time
to time until July 1, 2022, in our sole discretion and subject to certain conditions outside of Lincoln Park’s control, direct
Lincoln Park to purchase up to 200,000 shares (the “Regular Purchase Share Limit”) of our common stock on any business
day (each such purchase, a “Regular Purchase”); provided that (i) the Regular Purchase Share Limit may be increased
to up to 225,000 shares if the closing price of our common stock is not below $4.00 on such date and (ii) the Regular Purchase
Share Limit may be increased to up to 250,000 shares if the closing price of our common stock is not below $6.00 on such date;
and provided further that we may also mutually agree with Lincoln Park to increase the Regular Purchase Share Limit to up to 1,000,000
shares and to make multiple purchases in a given day. Additionally, all such share and dollar amounts shall be appropriately adjusted
for any reorganization, recapitalization, non-cash dividend, stock split or other similar transaction as provided in the Purchase
Agreement, and in no event shall Lincoln Park purchase more than $2,000,000 worth of our common stock pursuant to a Regular Purchase
on any single business day. The purchase price per share for each such Regular Purchase will be equal to the lower of:
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the lowest sale price for our common stock on the purchase date of such shares; or
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●
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the arithmetic average of the three lowest closing sale prices for our common stock during the
10 consecutive business days ending on the business day immediately preceding the purchase date of such shares.
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In addition to the Regular Purchases described
above, in the event we have directed Lincoln Park to purchase shares of our common stock not less than the Regular Purchase Share
Limit then in effect, on such purchase date we may also direct Lincoln Park to purchase an additional amount of our common stock
on the following business day (an “Accelerated Purchase”), not to exceed the lesser of:
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30% of the aggregate shares of our common stock traded during normal trading hours on the purchase
date; and
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200% of the number of purchase shares purchased pursuant to the corresponding Regular Purchase.
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The purchase price per share for each such
Accelerated Purchase will be equal to the lower of:
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96% of the volume weighted average price during (i) the entire trading day on the purchase date,
if the volume of shares of our common stock traded on the purchase date has not exceeded a volume maximum calculated in accordance
with the Purchase Agreement, or (ii) the portion of the trading day of the purchase date (calculated starting at the beginning
of normal trading hours) until such time at which the volume of shares of our common stock traded has exceeded such volume maximum;
or
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the closing sale price of our common stock on the purchase date.
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In the event we have directed Lincoln Park
to purchase shares of our common stock in the full amount available for an Accelerated Purchase, on the date of such Accelerated
Purchase (which is the business day following the corresponding Regular Purchase), we may also direct Lincoln Park to purchase
an additional amount of our common stock under the same terms set forth above for an Accelerated Purchase (an “Additional
Accelerated Purchase”).
In the case of Regular Purchases, Accelerated
Purchases and Additional Accelerated Purchases, the purchase price per share will be adjusted for any reorganization, recapitalization,
non-cash dividend, stock split, reverse stock split or other similar transaction as set forth in the Purchase Agreement.
The Purchase Agreement limits our sales
of shares of common stock to Lincoln Park to 10,076,680 shares of our common stock, representing 19.99% of the shares of common
stock outstanding on the date of the Purchase Agreement unless (i) shareholder approval is obtained to issue more than such amount
or (ii) the average price of all applicable sales of our common stock to Lincoln Park under the Purchase Agreement equals or exceeds
the lower of (A) the closing price of our common stock on the Nasdaq Capital Market immediately preceding on June 7, 2019 or (B)
the average of the closing price of our common stock on the Nasdaq Capital Market for the five Business Days immediately preceding
on June 7, 2019.
Other than as set forth above, there are
no trading volume requirements or restrictions under the Purchase Agreement, and we will control the timing and amount of any sales
of our common stock to Lincoln Park.
Events of Default
Events of default under the Purchase Agreement
include the following:
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the effectiveness of the registration statement of which this prospectus forms a part, or any other
registration statement registering securities under the Purchase Agreement, lapses for any reason (including, without limitation,
the issuance of a stop order), or any required prospectus supplement and accompanying prospectus are unavailable for the sale by
Lincoln Park of our common stock offered hereby, and such lapse or unavailability continues for a period of 10 consecutive business
days or for more than an aggregate of 30 business days in any 365-day period;
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suspension by our principal market of our common stock from trading on the Nasdaq Capital Market
for a period of three consecutive business days;
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the delisting of the Common Stock from the NASDAQ Capital Market; provided, however, that the Common
Stock is not immediately thereafter trading on the New York Stock Exchange, the NASDAQ Global Market, he NASDAQ Global Select Market,
the NYSE American, the NYSE Arca or the OTC Bulletin Board, OTCQX or OTCQB operated by the OTC Markets Group, Inc. (or nationally
recognized successor to any of the foregoing);
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the transfer agent’s failure for three business days to issue to Lincoln Park shares of our
common stock which Lincoln Park is entitled to receive under the Purchase Agreement;
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any breach of the representations or warranties or covenants contained in the Purchase Agreement
or any related agreement which has or which could have a material adverse effect on us subject to a cure period of five business
days;
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any voluntary or involuntary participation or threatened participation in insolvency or bankruptcy
proceedings by or against us; and
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if at any time we are not eligible to transfer our common stock electronically or a material adverse
change in our business, financial condition, operations or prospects has occurred.
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Lincoln Park does not have the right to
terminate the Purchase Agreement upon any of the events of default set forth above. During an event of default, all of which are
outside of Lincoln Park’s control, shares of our common stock cannot be sold by us or purchased by Lincoln Park under the
Purchase Agreement.
Our Termination Rights
We have the unconditional right, at any
time, for any reason and without any payment or liability to us, to give notice to Lincoln Park to terminate the Purchase Agreement.
In the event of bankruptcy proceedings by or against us, the Purchase Agreement will automatically terminate without action of
any party.
No Short-Selling or Hedging by Lincoln
Park
Lincoln Park has agreed that neither it
nor any of its affiliates shall engage in any direct or indirect short-selling or hedging of our common stock during any time prior
to the termination of the Purchase Agreement.
Lincoln Park’s Registration Rights
Although the Purchase Agreement provides
that we may sell up to $50 million of shares of our common stock to Lincoln Park, we are only registering $15,365,495 in shares
of common stock, and we are only registering 49,845 of the 147,159 remaining additional commitment shares issuable under the Purchase
Agreement under this prospectus supplement, as permitted by the RRA (following the issuance of 15,032 additional commitment shares
registered under our prior registration statement (File No. 333-207600)). Additionally, if we do sell all of the shares of common
stock covered hereunder, we will be required to file a new registration statement covering additional shares of common stock to
be sold, and issued as additional commitment shares, to Lincoln Park under the Purchase Agreement.
Amount of Potential Proceeds to be
Received under the Purchase Agreement
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Assumed Average Purchase Price Per Share
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Number of Registered Shares to be Issued if Full Purchase(1)
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Percentage of Outstanding Shares After Giving Effect to the Issuance to Lincoln Park(2)
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Proceeds from the Sale of Shares Under the Purchase Agreement Registered in this Offering
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$
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2.50
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6,196,043
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10.53
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%
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$
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15,365,495
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$
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2.99
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(3)
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5,138,962
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8.96
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%
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$
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15,365,495
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$
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5.00
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3,122,944
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5.60
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%
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$
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15,365,495
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$
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7.50
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2,098,578
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3.83
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%
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$
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15,365,495
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$
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10.00
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1,586,395
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2.92
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%
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$
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15,365,495
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(1)
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Although the Purchase Agreement provides that we may sell up to $50,000,000 of our common stock to Lincoln
Park, we are registering $15,514,532 of shares hereunder (inclusive of the 49,845 additional commitment shares that may be issued
to Lincoln Park as a commitment fee) under this prospectus supplement, which may or may not cover all the shares we ultimately
sell to Lincoln Park under the Purchase Agreement, depending on the purchase price per share. As a result, we have included in
this column only those shares that we have initially reserved.
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(2)
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The denominator is based on 52,700,366 shares outstanding as of September 11, 2019, which is inclusive of
the 49,845 additional commitment shares and the number of shares set forth in the adjacent column which we would have sold to Lincoln
Park at the applicable assumed average purchase price per share. The numerator includes the 49,845 additional commitment shares
that may be issued to Lincoln Park pro rata. The number of shares in such column does not include shares that may be issued to
Lincoln Park under the Purchase Agreement which are not covered under this prospectus supplement.
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(3)
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The closing price of our common stock on September 11, 2019.
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PLAN OF DISTRIBUTION
This prospectus supplement and the accompanying
prospectus relate to the issuance and sale of up to $15,365,495 of shares of our common stock that we may issue to Lincoln Park
from time to time under the Purchase Agreement. This prospectus supplement and the accompanying prospectus also cover the resale
of these shares by Lincoln Park to the public.
We entered into the
Purchase Agreement with Lincoln Park on June 7, 2019. In consideration for entering into the Purchase Agreement, we issued 324,383
shares of our common stock to Lincoln Park as initial commitment shares, and may issue up to 162,191 shares of our common stock
as additional commitment shares (of which 49,845 additional commitment shares are registered hereunder) in connection with the
purchase of our common stock by Lincoln Park. The Purchase Agreement provides that, upon the terms and subject to the conditions
set forth therein, Lincoln Park is committed to purchase an aggregate of up to $50 million of shares of our common stock ($15,365,495
in shares is registered hereunder) over the 36-month term of the Purchase Agreement. See “Lincoln Park Transaction.”
Lincoln Park is an “underwriter”
within the meaning of Section 2(a)(11) of the Securities Act. Lincoln Park has informed us that it will use an unaffiliated broker-dealer
to effectuate all sales, if any, of the common stock that it may purchase from us pursuant to the Purchase Agreement. Such sales
will be made on the NASDAQ Capital Market at prices and at terms then prevailing or at prices related to the then current market
price. Each such unaffiliated broker-dealer will be an underwriter within the meaning of Section 2(a)(11) of the Securities Act.
Lincoln Park has informed us that each such broker-dealer will receive commissions from Lincoln Park that will not exceed customary
brokerage commissions.
We know of no existing arrangements between
Lincoln Park and any other stockholder, broker, dealer, underwriter, or agent relating to the sale or distribution of the shares
offered by this Prospectus. At the time a particular offer of shares is made, a prospectus supplement, if required, will be distributed
that will set forth the names of any agents, underwriters, or dealers and any compensation from the selling stockholder, and any
other required information.
We will pay all of the expenses incident
to the registration, offering, and sale of the shares to Lincoln Park.
We have agreed to indemnify Lincoln Park
and certain other persons against certain liabilities in connection with the offering of shares of common stock offered hereby,
including liabilities arising under the Securities Act or, if such indemnity is unavailable, to contribute amounts required to
be paid in respect of such liabilities.
Lincoln Park represented to us that at
no time prior to the date of the Purchase Agreement has Lincoln Park or its agents, representatives or affiliates engaged in or
effected, in any manner whatsoever, directly or indirectly, any short sale (as such term is defined in Rule 200 of Regulation SHO
of the Exchange Act) of our Common Stock or any hedging transaction. Lincoln Park agreed that during the term of the Purchase Agreement,
it, its agents, representatives or affiliates will not enter into or effect, directly or indirectly, any of the foregoing transactions.
We have advised Lincoln Park that it is
required to comply with Regulation M promulgated under the Exchange Act. With certain exceptions, Regulation M precludes Lincoln
Park, any affiliated purchasers, and any broker-dealer or other person who participates in the distribution from bidding for or
purchasing, or attempting to induce any person to bid for or purchase any security which is the subject of the distribution until
the entire distribution is complete. Regulation M also prohibits any bids or purchases made in order to stabilize the price of
a security in connection with the distribution of that security. All of the foregoing may affect the marketability of the shares
offered by this prospectus supplement.
Nevada Agency and Transfer Company is transfer
agent and registrar for the Common Stock. Our common stock is listed on The Nasdaq Capital Market under the symbol “AVXL”.
LEGAL MATTERS
The validity of the securities offered
by this prospectus has been passed upon for us by Snell & Wilmer, L.L.P., Reno, Nevada.
EXPERTS
The financial statements as of September
30, 2018 and 2017 and for each of the three years in the period ended September 30, 2018 and management’s assessment of the
effectiveness of internal control over financial reporting as of September 30, 2018 incorporated by reference in this Prospectus
have been so incorporated in reliance on the reports of BDO USA, LLP, an independent registered public accounting firm, incorporated
herein by reference, given on the authority of said firm as experts in auditing and accounting.
WHERE YOU CAN FIND MORE INFORMATION
We file annual, quarterly and current reports,
proxy statements and other information with the SEC. The SEC maintains a website that contains reports, proxy statements and other
information regarding issuers that file electronically with the SEC, including Anavex. The address of the SEC website is www.sec.gov.
We make available free of charge on our
internet website at www.anavex.com our annual reports on Form 10-K, our quarterly reports on Form 10-Q, our current reports on
Form 8-K and any amendments to those reports, as soon as reasonably practicable after we electronically file such material with,
or furnish it to, the SEC. Information contained on our website is not incorporated by reference into this prospectus supplement
and you should not consider such information as part of this prospectus supplement.
DOCUMENTS INCORPORATED BY REFERENCE
The SEC allows us to “incorporate
by reference” into this prospectus certain information that we file with the SEC, which means that we can disclose important
information to you by referring you to other documents separately filed by us with the SEC that contain such information. The
information we incorporate by reference is considered to be part of this prospectus and information we later file with the SEC
will automatically update and supersede the information in this prospectus. The following documents filed by us with the SEC pursuant
to Section 13(a) of the Exchange Act and any of our future filings under Sections 13(a), 13(c), 14 or 15 (d) of the Exchange Act,
except for information furnished under Item 2.02 or 7.01 of Current Report on Form 8-K, or exhibits related thereto, made before
the termination of the offering are incorporated by reference herein:
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(1)
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our Annual Report on Form 10-K for the fiscal year
ended September 30, 2018, filed with the SEC on December 12, 2018, and the amendment thereto on Form 10-K/A filed on January 25,
2019;
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(2)
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our Proxy Statement on Schedule 14A filed on February
11, 2019 (excluding those portions that are not incorporated by reference into our Annual Report on Form 10-K);
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(3)
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our Quarterly Reports on Form 10-Q for quarter ended December
31, 2018 filed on February 7, 2019, for the quarter ended March
31, 2019 filed on May 9, 2019 and for the quarter ended June
30, 2019 filed on August 7, 2019;
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(5)
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the description of our common stock contained in the Registration Statement on Form 8-A (File No.
001-37606) filed with the SEC on October 23, 2005.
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Any statement contained herein or in any
document incorporated or deemed to be incorporated by reference herein shall be deemed to be modified or superseded for the purposes
of this prospectus to the extent that a statement contained herein or in any other subsequently filed document which also is or
is deemed to be incorporated by reference herein modifies or replaces such statement. Any such statement so modified or superseded
shall not be deemed to constitute a part of this prospectus, except as so modified or superseded.
We will provide to each person, including
any beneficial owner, to whom a prospectus is delivered, a copy of any or all of the reports or documents that have been incorporated
by reference in the prospectus contained in the registration statement but not delivered with the prospectus, other than an exhibit
to these filings unless we have specifically incorporated that exhibit by reference into the filing, upon written or oral request
and at no cost to the requester. Requests should be made by writing or telephoning us at the following address:
Anavex Life Sciences
Corp.
51 West 52nd Street, 7th Floor
New York, NY 10019-6163
(844) 689-3939
PROSPECTUS
Anavex Life Sciences Corp.
$250,000,000 of Common Stock
and Warrants
Anavex Life Sciences Corp., a Nevada corporation
(“us”, “we”, “our”, “Anavex” or the “Company”)
may offer and sell from time to time, in one or more series or issuances and on terms that we will determine at the time of the
offering, shares of our common stock, par value $0.001 per share (“Common Stock“) and warrants (“Warrants”)
described in this prospectus, up to an aggregate amount of $250,000,000.
This prospectus provides you with a general
description of the securities offered. Each time we offer and sell securities, we will file a prospectus supplement to this prospectus
that contains specific information about the offering and, if applicable, the amounts, prices and terms of the securities. Such
supplements may also add, update or change information contained in this prospectus. You should carefully read this prospectus
and the applicable prospectus supplement before you invest in any of our securities. This prospectus may not be used to consummate
sales of securities unless accompanied by a prospectus supplement.
We may offer and sell the securities described
in this prospectus and any prospectus supplement directly to our stockholders or to other purchasers or through agents on our behalf
or through underwriters or dealers as designated from time to time. If any agents or underwriters are involved in the sale of any
of these securities, the applicable prospectus supplement will provide the names of the agents or underwriters and any applicable
fees, commission or discounts.
Our Common Stock is currently quoted on
the Nasdaq Capital Market under the symbol “AVXL”. On July 2, 2019, the last reported sale price of our Common Stock
was $3.90 per share.
Investing in our securities
involves a high degree of risk. See the section entitled “Risk Factors” on page 11 of this prospectus and in the
documents we filed with the Securities and Exchange Commission that are incorporated in this prospectus by reference for
certain risks and uncertainties you should consider.
Neither the Securities and Exchange
Commission nor any state securities commission has approved or disapproved of these securities or passed upon the adequacy or accuracy
of this prospectus. Any representation to the contrary is a criminal offense.
This prospectus is dated July 15, 2019.
TABLE OF CONTENTS
ABOUT THIS PROSPECTUS
This prospectus of Anavex Life Sciences
Corp., a Nevada corporation (collectively with all of its subsidiaries, the “Company”, “Anavex”, or “we”,
“us”, or “our”) is a part of a registration statement on Form S-3 that we filed with the Securities and
Exchange Commission (“SEC”) utilizing a “shelf” registration process. Under this shelf registration process,
we may, from time to time, sell the securities described in this prospectus in one or more offerings up to a total dollar amount
of $250,000,000 as described in this prospectus.
The registration statement of which this
prospectus is a part provides additional information about us and the securities offered under this prospectus. The registration
statement, including the exhibits and the documents incorporated herein by reference, can be read on the SEC website or at the
SEC offices mentioned under the heading “Prospectus Summary - Where You Can Find More Information.”
We will provide a prospectus supplement
containing specific information about the amounts, prices and terms of the securities for a particular offering. The prospectus
supplement may add, update or change information in this prospectus. If the information in the prospectus is inconsistent with
a prospectus supplement, you should rely on the information in that prospectus supplement. You should read both this prospectus
and, if applicable, any prospectus supplement. See “Prospectus Summary — Where You Can Find More Information”
for more information.
You should rely only on the information
contained or incorporated by reference in this prospectus and in any prospectus supplement. We have not authorized any other person
to provide you with different information. If anyone provides you with different or inconsistent information, you should not rely
on it. We are not making offers to sell or solicitations to buy the securities in any jurisdiction in which an offer or solicitation
is not authorized or in which the person making that offer or solicitation is not qualified to do so or to anyone to whom it is
unlawful to make an offer or solicitation. You should not assume that the information in this prospectus or any prospectus supplement,
as well as the information we file or previously filed with the SEC that we incorporate by reference in this prospectus or any
prospectus supplement, is accurate as of any date other than the date of such document. Our business, financial condition, results
of operations and prospects may have changed since those dates.
PROSPECTUS
SUMMARY
The items in the following summary
are described in more detail later in this prospectus. This summary does not contain all of the information you should consider.
Before investing in our securities, you should read the entire prospectus carefully, including the “Risk Factors” beginning
on page 11 and the financial statements incorporated by reference.
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 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”).
Our total portfolio currently consists
of five programs. To prioritize the allocation of our resources, we designate certain programs as core programs and others as seed
programs, and we currently have two core programs and three seed programs. Our core programs are at various stages of clinical
and preclinical development, in neurodegenerative and neurodevelopmental diseases.
We have 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.
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. 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 or planned
to be studied.
Clinical Studies Overview
In November 2016, we completed a Phase
2a clinical trial, consisting of PART A and PART B, which lasted a total of 57 weeks, for ANAVEX®2-73 in mild-to-moderate
Alzheimer’s patients. This open-label randomized trial met both primary and secondary endpoints and was designed to assess
the safety and exploratory efficacy of ANAVEX®2-73 in 32 patients. ANAVEX®2-73 targets sigma-1 and
muscarinic receptors, which have been shown in preclinical studies to reduce stress levels in the brain believed to restore cellular
homeostasis and to reverse the pathological hallmarks observed in Alzheimer’s disease. In October 2017, we presented positive
pharmacokinetic (PK) and pharmacodynamic (PD) data from the Phase 2a study, which established a concentration-effect relationship
between ANAVEX®2-73 and study measurements. These measures obtained from all patients who participated in the entire
57 weeks include exploratory cognitive and functional scores as well as biomarker signals of brain activity. Additionally, the
study appears to show that ANAVEX®2-73 activity is enhanced by its active metabolite (ANAVEX19-144), which also
targets the sigma-1 receptor and has a half-life approximately twice as long as the parent molecule.
In March 2016, we received approval from
the Ethics Committee in Australia to extend the Phase 2a clinical trial by an additional 108 weeks, which had been requested by
patients and their caregivers. Subsequently, in May 2018, we received approval from the Ethics Committee in Australia to further
extend the Phase 2a extension trial for an additional two years. The two consecutive trial extensions 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 October 2018, we presented new long-term
clinical data for ANAVEX®2-73 in a presentation at the 2018 Clinical Trials on Alzheimer’s Disease (CTAD)
Meeting. At 148 weeks into the five-year extended Phase 2a clinical study, data confirmed a significant association between ANAVEX®2-73
concentration and both exploratory functional and cognitive endpoints as measured by the Alzheimer’s Disease Cooperative
Study-Activities of Daily Living (ADCS-ADL) evaluation and the Mini Mental State Examination (MMSE), respectively. The
cohort of patients treated with higher ANAVEX®2-73 concentration maintained ADCS-ADL performance compared to the
lower concentration cohort (p<0.0001). As well, the patient cohort with the higher ANAVEX®2-73 concentration
performed better at MMSE compared to the lower concentration cohort (p<0.0008). A significant impact on the drug response levels
of both the SIGMAR1 (p<0.0080) and COMT (p<0.0014) genomic biomarkers, identified and specified at week 57, was also confirmed
over the 148-week period. Further, ANAVEX®2-73 demonstrated continued favorable safety and tolerability through
148 weeks.
A larger Phase 2b/3 double-blind, placebo-controlled
study of ANAVEX®2-73 in Alzheimer’s disease commenced in October 2018, which is independent of the ongoing
Phase 2a extension study. The Phase 2b/3 study will enroll approximately 450 patients for 48 weeks, randomized 1:1:1 to two different
ANAVEX®2-73 doses or placebo. The trial is currently taking place in Australia; however, North American sites may
also be added. 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).
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 is being received in quarterly instalments which commenced during fiscal 2018. Further,
in March 2019, the Company commenced a Phase 2 clinical trial of ANAVEX®2-73 for the treatment of Rett syndrome.
The Phase 2 study is taking place in the United States and is a randomized double-blind, placebo-controlled safety, tolerability,
pharmacokinetic and efficacy study of oral liquid ANAVEX®2-73 formulation to treat Rett syndrome. Pharmacokinetic
and dose findings will be investigated in a total of 15 patients over a 7-week treatment period including ANAVEX®2-73-specific
genomic 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. This study will be followed by a planned placebo-controlled safety and efficacy
evaluation of ANAVEX®2-73 over a 3-month treatment period. Primary and secondary endpoints include safety as well
as Rett syndrome conditions such as cognitive impairment, motor impairment, behavioral symptoms and seizure activity. The ANAVEX®2-73
Phase 2 Rett syndrome study design incorporates genomic precision medicine biomarkers identified in the ANAVEX®2-73
Phase 2a Alzheimer’s disease study.
In September 2016, we presented positive
preclinical data for ANAVEX®2-73 in Parkinson’s disease, which demonstrated significant improvements on all
measures: behavioral, histopathological, and neuroinflammatory endpoints. The study was funded by the Michael J. Fox Foundation.
Additional data was announced in October 2017 from the model for experimental parkinsonism. The data presented 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.
In October 2018, we initiated in Spain,
a double-blind, randomized, placebo-controlled Phase 2 trial with ANAVEX®2-73 in Parkinson’s Disease Dementia
(PDD) in Spain, which will study the effect of the compound on both the cognitive and motor impairment of Parkinson’s disease.
The Phase 2 study will enroll approximately 120 patients for 14 weeks, randomized 1:1:1 to two different ANAVEX®2-73
doses or placebo. The ANAVEX®2-73 Phase 2 PDD study design incorporates genomic precision medicine biomarkers identified
in the ANAVEX®2-73 Phase 2a study.
Our Pipeline
Our research and development pipeline includes
ANAVEX®2-73 currently in three different clinical studies, and several compounds in different stages of 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.
Compounds that have been subjects of our
research include the following:
ANAVEX®2-73
ANAVEX®2-73 may offer a
disease-modifying approach in neurodegenerative and neurodevelopmental diseases by activation of sigma-1 receptors.
In Rett syndrome, administration of ANAVEX®2-73
resulted in both significant and dose related improvements in an array of behavioral paradigms in the MECP2 HET Rett syndrome disease
model. In addition, in a further experiment sponsored by Rettsyndrome.org, ANAVEX®2-73 was evaluated in automatic
visual response and respiration tests in 7-month old mice, an age at which advanced pathology is evident. Vehicle-treated MECP2
mice demonstrated fewer automatic visual responses than wild-type mice. Treatment with ANAVEX®2-73 for four weeks
significantly increased the automatic visual response in the MECP2 Rett syndrome disease mouse. Additionally, chronic oral dosing
daily for 6.5 weeks of ANAVEX®2-73 starting at ~5.5 weeks of age was conducted in the MECP2 HET Rett syndrome disease
mouse model assessed the different aspects of muscular coordination, balance, motor learning and muscular strengths, some of the
core deficits observed in Rett syndrome. Administration of ANAVEX®2-73 resulted in both significant and dose related
improvements in an array of these behavioral paradigms in the MECP2 HET Rett syndrome disease model.
In March 2019, the Company initiated a
Phase 2 clinical trial of ANAVEX®2-73 for the treatment of Rett syndrome. The Phase 2 study is taking place in the
United States and is a randomized double-blind, placebo-controlled safety, tolerability, pharmacokinetic and efficacy study of
oral liquid ANAVEX®2-73 formulation to treat Rett syndrome. Pharmacokinetic and dose finding will be investigated
in a total of 15 patients over a 7-week treatment period using ANAVEX®2-73-specific genomic 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. This
study is part of a planned Rett syndrome program.
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.
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 July 2018 the
Company received approval from the Spanish Agency for Medicinal Products and Medical Devices (AEMPS), to initiate its Phase 2,
double-blind, placebo-controlled 14-week trial of the safety and efficacy of ANAVEX®2-73 for the treatment of Parkinson’s
disease dementia. The Phase 2 study commenced in October 2018 and will involve approximately 120 patients, randomized 1:1:1 to
two different ANAVEX®2-73 doses or placebo, in up to 24 clinical study sites.
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 both amyloid and tau pathology. 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.
The ANAVEX®2-73 Phase 1
SAD trial was conducted as a randomized, placebo-controlled study. Healthy male volunteers between the ages of 18 and 55 received
single, ascending oral doses over the course of the trial. Study endpoints included safety and tolerability together with pharmacokinetic
parameters. Pharmacokinetics includes the absorption and distribution of a drug, the rate at which a drug enters the blood and
the duration of its effect, as well as chemical changes of the substance in the body. This study was conducted in Germany in collaboration
with ABX-CRO, a clinical research organization that has conducted several Alzheimer’s disease studies, and the Technical
University of Dresden.
In December 2014, a Phase 2a clinical trial
was initiated for ANAVEX®2-73, which is being evaluated 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 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 study met both primary and
secondary objectives of the study. The 31-week preliminary exploratory safety and efficacy data from the Phase
2a study of ANAVEX®2-73 in Alzheimer’s patients, with most receiving also donepezil, the current standard
of care, demonstrated favorable safety, maximum tolerated dose, positive dose response, sustained efficacy response
through 31 weeks for both cognitive and functional measures, as well as positive unexpected therapeutic response events. ANAVEX®2-73
continued to demonstrate a favorable adverse event (AE) profile through 31 weeks in a patient population of elderly Alzheimer’s
patients with varying degrees of physical fragility. The most common side effects across all AE categories tended to be of
mild severity grade 1 and were resolved with dose reductions that were anticipated within the adaptive design of the study
protocol.
Through 57 weeks,
Alzheimer’s patients taking a daily oral dose between 10mg and 50mg of ANAVEX®2-73 was well tolerated. There
were no clinically significant treatment-related adverse events and no serious adverse events. Despite non-optimized dosing of
ANAVEX®2-73 throughout the 57-week study, continued significant improvements from baseline of cognitive, functional
and behavioral scores in a group of patients were observed, respectively. This data was analyzed using refined mathematical modeling
methods in conjunction with the detailed pharmacokinetic (PK) information.
In October 2017,
we presented positive PK and PD data from the Phase 2a study, which established a concentration-effect relationship between ANAVEX®2-73
and study measurements. These measures, obtained from all patients who participated in the entire 57 weeks, include exploratory
cognitive and functional scores as well as biomarker signals of brain activity. Additionally, the study appears to show that ANAVEX®2-73
activity is enhanced by its active metabolite (ANAVEX19-144), which also targets the sigma-1 receptor and has a half-life approximately
twice as long as the parent molecule.
Pre-specified
exploratory analyses included the cognitive (MMSE) and the functional (ADCS-ADL) changes from baseline. A continued stabilization
of both cognitive and functional measures in patients treated with ANAVEX®2-73 was observed. This correlation was
positive within all measured scores (MMSE, ADCS-ADL, Cogstate, HAM-D and EEG/ERP).
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 without the SIGMAR1 (rs1800866) variants, which is about 80 percent of the population worldwide, demonstrated improved
cognitive (MMSE) and the functional (ADCS-ADL) scores. The results from this evaluation may enable a precision medicine approach,
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. 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 is expected to enroll approximately 450 patients, 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.
ANAVEX®3-71
ANAVEX®3-71 is a preclinical
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
mono-therapy that bridges treatment of both cognitive impairments with disease modifications. 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.
ANAVEX®1-41
ANAVEX®1-41 is a sigma-1
agonist. Pre-clinical tests revealed significant neuroprotective benefits (i.e., protects nerve cells from degeneration or death)
through the modulation of endoplasmic reticulum, mitochondrial and oxidative stress, which damages and impairs cell viability.
In addition, in animal models, ANAVEX®1-41 prevented the expression of caspase-3, an enzyme that plays a key role
in apoptosis (programmed cell death) and loss of cells in the hippocampus, the part of the brain that regulates learning, emotion
and memory. These activities involve both muscarinic and sigma-1 receptor systems through a novel mechanism of action.
Preclinical data presented also indicates
that ANAVEX®1-41 demonstrates protective effects of mitochondrial enzyme complexes during pathological conditions,
which, if impaired, are believed to play a role in the pathogenesis of neurodegenerative and neurodevelopmental diseases.
ANAVEX®1066
ANAVEX®1066, a mixed sigma-1/sigma-2
ligand is designed for the potential treatment of neuropathic and visceral pain. ANAVEX®1066 was tested in two preclinical
models of neuropathic and visceral pain that have been extensively validated in rats. In the chronic constriction injury model
of neuropathic pain, a single oral administration of ANAVEX®1066 dose-dependently restored the nociceptive threshold
in the affected paw to normal levels while leaving the contralateral healthy paw unchanged. Efficacy was rapid and remained significant
for two hours. In a model of visceral pain, chronic colonic hypersensitivity was induced by injection of an inflammatory agent
directly into the colon and a single oral administration of ANAVEX®1066 returned the nociceptive threshold to control
levels in a dose-dependent manner. Companion studies in rats demonstrated the lack of any effects on normal gastrointestinal transit
with ANAVEX®1066 and a favorable safety profile in a battery of behavioral measures.
Our compounds are in the pre-clinical and
clinical testing stages of development, and there is no guarantee that the activity demonstrated in pre-clinical models will be
shown in human testing.
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.
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
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Alzheimer’s disease – In 2018, an estimated 5.5 million Americans were suffering from Alzheimer’s disease. The Alzheimer’s Association® reports that by 2025, 7.1 million Americans will be afflicted by the disease, about a 29 percent increase from currently affected patients. 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.
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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 set to expand from $2.1 billion in 2014 to $3.2 billion by 2021, according to business intelligence provider GBI Research.
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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.
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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 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.
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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, epilepsy affects 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. GBI Research estimates that the epilepsy market will increase to $4.5 billion by 2019.
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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.
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Cancer
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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.
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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.
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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 will increase to $2.9 billion by 2021.
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Patents, Trademarks and Intellectual
Property
We hold ownership or exclusive rights to
five U.S. patents, eight 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. A related continuation application is also pending in the U.S. 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 one issued patent with claims
directed to methods for treating or preventing pain with ANAVEX®1066. This patent is expected to expire in November
2036, absent any patent term extension for regulatory delays.
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, formulations and uses 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 Item 1A “Risk Factors.”
Recent Developments
On June 6, 2019, we announced that we had
dosed the first patient in our AVATAR Phase 2 double blind, randomized, placebo-controlled safety and efficacy trial of ANAVEX®2-73
for the treatment of Rett syndrome.
Corporate Information
Our principal executive office is located
at 51 West 52nd Street, 7th Floor, New York, NY 10019-6163, and our telephone number is 844.689.3939. Our website address is www.anavex.com.
No information found on our website is part of this prospectus. Also, this prospectus may include the names of various government
agencies or the trade names of other companies. Unless specifically stated otherwise, the use or display by us of such other parties’
names and trade names in this prospectus is not intended to and does not imply a relationship with, or endorsement or sponsorship
of us by, any of these other parties.
Where You Can Find More Information
We are subject to the information requirements
of the Securities Exchange Act of 1934 (the “Exchange Act”). Accordingly, we file annual, quarterly and current
reports, proxy statements as may be required and other information with the SEC and filed a registration statement on Form S-3
under the Securities Act relating to the securities offered by this prospectus. This prospectus, which forms part of the registration
statement, does not contain all of the information included in the registration statement. For further information, you should
refer to the registration statement and its exhibits.
You may read and copy the registration
statement and any document we file with the SEC at the SEC’s Public Reference Room at 100 F Street, N.E., Washington, D.C.
20549. Please call the SEC at 1-800-SEC-0330 for further information on the operation of the Public Reference Room. You can also
review our filings by accessing the website maintained by the SEC at http://www.sec.gov. The site contains reports, proxy
and information statements and other information regarding issuers that file electronically with the SEC. In addition to the foregoing,
we maintain a website at http://www.anavex.com. Our website content is made available for informational purposes only. It
should neither be relied upon for investment purposes nor is it incorporated by reference into this prospectus. We make available
at http://www.anavex.com/investors/share-data/ copies of our Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q
and Current Reports on Form 8-K and any amendments to such document as soon as practicable after we electronically file such material
with or furnish such documents to the SEC.
RISK FACTORS
An investment in our securities which may
be offered hereby is subject to numerous risks, including the risks described under the caption “Risk Factors” in our
Annual Report on Form 10-K for the year ended September 30, 2018, which is incorporated by reference herein. You should carefully
consider these risks, along with the information provided elsewhere in this prospectus and the documents we incorporate by reference
in this prospectus before investing in our securities. You could lose all or part of your investment in the securities. You should
consider these matters in conjunction with the other information included or incorporated by reference in this prospectus. The
risks and uncertainties described in this prospectus, any applicable prospectus supplement and the documents incorporated by reference
herein are not the only ones facing us. Additional risks and uncertainties that we do not presently know about or that we currently
believe are not material may also adversely affect our business. Our business, results of operations or financial condition could
be seriously harmed, and the trading price of our Common Stock may decline due to any of these or other risks.
CAUTIONARY NOTE REGARDING FORWARD-LOOKING
STATEMENTS
This prospectus supplement contains forward-looking
statements. All statements other than statements of historical facts contained in this prospectus supplement, 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:
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our ability to successfully conduct clinical and preclinical trials for our product candidates;
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our ability to raise additional capital on favorable terms;
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our ability to execute our development plan on time and on budget;
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our products ability to demonstrate efficacy or an acceptable safety profile;
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our ability to obtain the support of qualified scientific collaborators;
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our ability, whether alone or with commercial partners, to successfully commercialize any of our product candidates that may be approved for sale;
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our ability to identify and obtain additional product candidates;
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our ability to obtain and maintain sufficient intellectual property protection for our product candidates;
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our ability to comply with our intellectual property licensing agreements;
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our ability to defend against claims of intellectual property infringement;
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our ability to comply with the maintenance requirements of the government patent agencies;
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our ability to protect our intellectual property rights throughout the world;
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the anticipated start dates, durations and completion dates of our ongoing and future clinical studies;
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the anticipated designs of our future clinical studies;
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our anticipated future regulatory submissions and our ability to receive regulatory approvals to develop and market our product candidates;
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our anticipated future cash position; and
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our ability to generate any revenue or to continue as a going concern.
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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, or 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 or Annual Report on Form 10-K for the fiscal year ended September 30, 2018.
These risks are not exhaustive. 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.
USE OF PROCEEDS
Unless otherwise specified in the applicable
prospectus supplement, we intend to use the net proceeds from the sale of the securities described in this prospectus in connection
with the primary offering for general corporate and operations purposes and to fund our anticipated growth. The applicable prospectus
supplement will provide more details on the use of proceeds of any specific offering.
DILUTION
We will set forth in
a prospectus supplement the following information regarding any material dilution of the equity interests of investors purchasing
securities in an offering under this prospectus:
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the net tangible book value per share of our equity securities before and after the offering;
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the amount of the increase in such net tangible book value per share attributable to the cash payments made by purchases in the offering; and
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the amount of the immediate dilution from the public offering price which will be absorbed by such purchasers.
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PLAN OF DISTRIBUTION
We may sell the securities described in
this prospectus on a continuous or delayed basis directly to purchasers, through underwriters, broker-dealers or agents that may
receive compensation in the form of discounts, concessions or commissions from us or the purchasers of the securities, in “at
the market offerings” within the meaning of Rule 415(a)(4) of the Securities Act, to or through a market maker or into an
existing trading market, on an exchange, or otherwise or through a combination of any such methods of sale. Discounts, concessions
or commissions as to any particular underwriter, broker-dealer or agent may be in excess of those customary in the types of transactions
involved.
The securities may be sold from time to
time in one or more transactions at fixed prices, which may be changed from time to time, at prevailing market prices at the time
of sale, at varying prices determined at the time of sale or at negotiated prices. These sales may be effected in transactions,
which may involve crosses or block transactions:
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on any national securities exchange or quotation service
on which the securities may be listed or quoted at the time of sale;
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in the over-the-counter market;
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in transactions otherwise than on these exchanges
or services or in the over-the-counter market; or
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through the writing of options, whether the options
are listed on an options exchange or otherwise.
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Each time that we use this prospectus to
sell our securities, we shall also provide a prospectus supplement. For each series of securities, the applicable prospectus supplement
will set forth the terms of the offering including:
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the public offering price;
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the name or names of any underwriters, dealers or
agents;
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the purchase price of the securities;
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the proceeds from the sale of the securities to us;
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any underwriting discounts, agency fees, or other
compensation payable to underwriters or agents;
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any discounts or concessions allowed or reallowed
or repaid to dealers; and
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the securities exchanges on which the securities will
be listed, if any.
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If we use underwriters in the sale of securities,
the securities will be acquired by the underwriters for their own account. The underwriters may then resell the securities in one
or more transactions at a fixed public offering price or at varying prices determined at the time of sale or thereafter. The securities
may be either offered to the public through underwriting syndicates represented by managing underwriters, or directly by underwriters.
The obligations of the underwriters to purchase the securities will be subject to certain conditions. The underwriters will be
obligated to purchase all the securities offered if they purchase any securities. The public offering price and any discounts or
concessions allowed or re-allowed or paid to dealers may be changed from time to time.
If we use dealers in the sale of securities,
we will sell securities to such dealers as principals. The dealers may then resell the securities to the public at varying prices
to be determined by such dealers at the time of resale. We may solicit offers to purchase the securities directly, and we may sell
the securities directly to institutional or other investors, who may be deemed underwriters within the meaning of the Securities
Act with respect to any resales of those securities. The terms of these sales will be described in the applicable prospectus supplement.
If we use agents in the sale of securities, unless otherwise indicated in the prospectus supplement, they will use their reasonable
best efforts to solicit purchases for the period of their appointment. Unless otherwise indicated in a prospectus supplement, if
we sell directly, no underwriters, dealers or agents would be involved. We will not make an offer of securities in any jurisdiction
that does not permit such an offer.
We may grant underwriters who participate
in the distribution of securities an option to purchase additional securities to cover overallotments, if any, in connection with
the distribution. Any underwriter may engage in overallotment, stabilizing transactions, short covering transactions and penalty
bids in accordance with SEC orders, rules and regulations and applicable law. To the extent permitted by applicable law and SEC
orders, rules and regulations, an overallotment involves sales in excess of the offering size, which create a short position. Stabilizing
transactions permit bids to purchase the underlying security so long as the stabilizing bids do not exceed a specified maximum.
To the extent permitted by applicable law and SEC orders, rules and regulations, short covering transactions involve purchases
of the securities in the open market after the distribution is completed to cover short positions. Penalty bids permit the underwriters
to reclaim a selling concession from a dealer when the securities originally sold by the dealer is purchased in a covering transaction
to cover short positions. Those activities may cause the price of the Common Stock to be higher than it would otherwise be. If
commenced, the underwriters may discontinue any of the activities at any time.
Any underwriters who are qualified market
makers on the NASDAQ Stock Market may engage in passive market making transactions in our Common Stock on the NASDAQ Stock Market
in accordance with Rule 103 of Regulation M, during the business day prior to the pricing of the offering, before the commencement
of offers or sales of the Common Stock. Passive market makers must comply with applicable volume and price limitations and must
be identified as passive market makers. In general a passive market maker must display its bid at a price not in excess of the
highest independent bid for such security; if all independent bids are lowered below the passive market maker’s bid, however,
the passive market maker’s bid must then be lowered when certain purchase limits are exceeded. The anti-manipulation rules
under the Exchange Act may apply to sales of shares in the market. Furthermore, Regulation M may restrict the ability of any person
engaged in the distribution of the shares to engage in market-making activities for the particular securities being distributed
for a period of up to five business days before the distribution. The restrictions may affect the marketability of the shares and
the ability of any person or entity to engage in market-making activities for the shares.
Underwriters, dealers and agents that participate
in any distribution of securities may be deemed to be underwriters as defined in the Securities Act. Any discounts, commissions
or profit they receive when they resell the securities may be treated as underwriting discounts and commissions under the Securities
Act. Only underwriters named in the prospectus supplement are underwriters of the securities offered in the prospectus supplement.
We may have agreements with underwriters, dealers and agents to indemnify them against certain civil liabilities, including certain
liabilities under the Securities Act, or to contribute with respect to payments that they may be required to make.
We may authorize underwriters, dealers
or agents to solicit offers from certain institutions whereby the institution contractually agrees to purchase the securities from
us on a future date at a specific price. This type of contract may be made only with institutions that we specifically approve.
Such institutions could include banks, insurance companies, pension funds, investment companies and educational and charitable
institutions. The underwriters, dealers or agents will not be responsible for the validity or performance of these contracts.
Each series of securities will be a new
issue of securities. Our Common Stock is quoted on the Nasdaq Capital Market. Unless otherwise specified in the applicable prospectus
supplement, our securities (other than our Common Stock) will not be listed on any exchange. It has not presently been established
whether the underwriters, if any, of the securities will make a market in the securities. If the underwriters make a market in
the securities, such market making may be discontinued at any time without notice.
Agents, dealers and underwriters may be
entitled to indemnification by us against certain civil liabilities, including liabilities under the Securities Act, or to contribution
with respect to payments which the agents, dealers or underwriters may be required to make in respect thereof. Agents, dealers
or underwriters may be customers of, engage in transactions with, or perform services for us and our subsidiaries in the ordinary
course of business.
DESCRIPTION OF OUR CAPITAL STOCK
Common Stock
We are authorized to issue 100,000,000
shares of Common Stock with a par value of $0.001. As of July 2, 2019, we had 51,661,413 shares of Common Stock outstanding. Upon
liquidation, dissolution or winding up of the corporation, the holders of Common Stock are entitled to share ratably in all net
assets available for distribution to stockholders after payment to creditors. The Common Stock is not convertible or redeemable
and has no preemptive, subscription or conversion rights. There are no conversion, redemption, sinking fund or similar provisions
regarding the Common Stock. Each outstanding share of Common Stock is entitled to one vote on all matters submitted to a vote of
stockholders. There are no cumulative voting rights.
Each stockholder is entitled to receive
the dividends as may be declared by our board of directors out of funds legally available for dividends and, in the event of liquidation,
to share pro rata in any distribution of our assets after payment of liabilities. Our board of directors is not obligated to declare
a dividend. Any future dividends will be subject to the discretion of our board of directors and will depend upon, among other
things, future earnings, the operating and financial condition of our Company, its capital requirements, general business conditions
and other pertinent factors. It is not anticipated that dividends will be paid in the foreseeable future.
On October 7, 2015, the Company effected
a reverse stock split at a ratio of 1 for 4, whereby every 4 shares of Common Stock became 1 share of Common Stock. The authorized
shares of Common Stock of the Company were therefore proportionally reduced from 400,000,000 to 100,000,000.
Our Common Stock is quoted on the Nasdaq
Capital Market under the trading symbol “AVXL”. On July 2, 2019, the last reported sale price of our Common Stock was
$3.90 per share.
Nevada Anti-Takeover Law and Charter and Bylaws Provisions
Nevada Revised Statutes sections 78.378
to 78.3793 provide state regulation over the acquisition of a controlling interest in certain Nevada corporations unless the articles
of incorporation or bylaws of the corporation provide that the provisions of these sections do not apply. The statute creates a
number of restrictions on the ability of a person or entity to acquire control of a Nevada company by setting down certain rules
of conduct and voting restrictions in any acquisition attempt, among other things. The statute is limited to corporations that
are organized in the state of Nevada and that have 200 or more shareholders, at least 100 of whom are shareholders of record and
residents of the state of Nevada; and do business in the state of Nevada directly or through an affiliated corporation. Because
of these conditions, the statute does not apply to our Company.
There are no provisions in our articles
of incorporation or our bylaws that would delay, defer or prevent a change in control of our Company.
DESCRIPTION OF WARRANTS
We may issue Warrants from time to time
in one or more series for the purchase of our Common Stock. Warrants may be issued independently or together with any shares of
Common Stock or offered by any prospectus supplement and may be attached to or separate from Common Stock. Each series of Warrants
may be issued under a separate warrant agreement to be entered into between us and a warrant agent, or any other bank or trust
company specified in the related prospectus supplement relating to the particular issue of Warrants. A warrant agent may act as
our agent in connection with the Warrants and would not assume any obligation or relationship of agency or trust for or with any
holders of Warrants or beneficial owners of Warrants. The specific terms of any series of Warrants will be described in the applicable
prospectus supplement relating to that series of Warrants along with any general provisions applicable to that series of Warrants.
The following is a general description
of the Warrants we may issue. The applicable prospectus supplement will describe the specific terms of any issuance of Warrants.
The terms of any Warrants we offer may differ from the terms described in this prospectus. As a result, we will describe in the
prospectus supplement the specific terms of the particular series of Warrants offered by that prospectus supplement. Accordingly,
for a description of the terms of a particular series of Warrants, you should carefully read this prospectus, the applicable prospectus
supplement, and the applicable warrant agreement, which will be filed as an exhibit to the registration statement of which this
prospectus forms a part.
Terms
If Warrants are offered by us, the prospectus
supplement will describe the terms of the Warrants, including the following if applicable to the particular offering:
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the title of the Warrants;
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the total number of Warrants;
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the number of shares of Common Stock purchasable upon exercise of the Warrants to purchase Common Stock and the price at which such shares of Common Stock may be purchased upon exercise;
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the date on and after which the Warrants and the related Common Stock will be separately transferable;
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if applicable, the date on which the right to exercise the Warrants will commence and the date on which this right will expire;
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if applicable, the minimum or maximum amount of the Warrants which may be exercised at any one time;
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a discussion of federal income tax, accounting and other special considerations, procedures and limitations relating to the Warrants; and
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any other terms of the Warrants including terms, procedures and limitations relating to the exchange and exercise of the Warrants.
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Warrants may be exchanged for new warrants
of different denominations, may be presented for registration of transfer, and may be exercised at our principal executive office,
the warrant agent or any other office indicated in the prospectus supplement.
Before the exercise of their Warrants,
holders of Warrants will not have any of the rights of holders of shares of Common Stock, including the right to receive payments
of dividends, if any, on the shares of Common Stock or to exercise any applicable right to vote.
Exercise of Warrants
Each Warrant will entitle the holder to
purchase a number of shares of Common Stock at an exercise price as will in each case be described in, or calculable from, the
prospectus supplement relating to those Warrants. Warrants may be exercised at the times set forth in the prospectus supplement
relating to the Warrants. After the close of business on the expiration date (or any later date to which the expiration date may
be extended by us), unexercised Warrants will become void. Subject to any restrictions and additional requirements that may be
set forth in the prospectus supplement relating thereto, Warrants may be exercised by delivery to the warrant agent, or at our
principal executive office or any other office indicated in the prospectus supplement, of the certificate evidencing the Warrants
properly completed and duly executed, and of payment as provided in the prospectus supplement of the amount required to purchase
the shares of Common Stock purchasable upon such exercise. The exercise price will be the price applicable on the date of payment
in full, as set forth in the prospectus supplement relating to the Warrants. Upon receipt of the payment, and the certificate representing
the Warrants to be exercised properly completed and duly executed at our principal executive office, the warrant agent or any other
office indicated in the prospectus supplement, we will, as soon as practicable, issue and deliver the shares of Common Stock purchasable
upon such exercise. If fewer than all of the Warrants represented by that certificate are exercised, a new certificate will be
issued for the remaining amount of Warrants.
The description in the applicable prospectus
supplement and other offering material of any Warrants we offer will not necessarily be complete and will be qualified in its entirety
by reference to the applicable warrant agreement, which will be filed with the SEC if we offer Warrants. For more information on
how you can obtain copies of the applicable warrant agreement if we offer Warrants, see “Where You Can Find More Information”.
We urge you to read the applicable warrant agreement and the applicable prospectus supplement in their entirety.
LEGAL MATTERS
The validity of the securities offered
by this prospectus has been passed upon for us by Snell & Wilmer, L.L.P., Reno, Nevada. If legal matters in connection with
offerings made pursuant to this prospectus are passed upon by counsel for the underwriters, dealers or agents, if any, such counsel
will be named in the prospectus supplement relating to such offering.
EXPERTS
The consolidated financial statements as
of September 30, 2018 and 2017 and for each of the three years in the period ended September 30, 2018 and management’s assessment
of the effectiveness of internal control over financial reporting as of September 30, 2018 incorporated by reference in this Prospectus
have been so incorporated in reliance on the reports of BDO USA, LLP, an independent registered public accounting firm, incorporated
herein by reference, given on the authority of said firm as experts in auditing and accounting.
DISCLOSURE OF COMMISSION POSITION ON
INDEMNIFICATION
Insofar as indemnification for liabilities
arising under the Securities Act, as amended, may be permitted to directors, officers, and controlling persons of the registrant
pursuant to the Company’s constituent documents, or otherwise, the registrant has been advised that in the opinion of the
SEC such indemnification is against public policy as expressed in the Securities Act and is, therefore, unenforceable. In the event
that a claim for indemnification against such liabilities (other than the payment by the registrant of expenses incurred or paid
by a director, officer, or controlling person in the successful defense of any action, suit, or proceeding) is asserted by such
director, officer, or controlling person connected with the securities being registered, we will, unless in the opinion of our
counsel the matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction the question whether
such indemnification by it is against public policy as expressed in the Securities Act and will be governed by the final adjudication
of such issue.
DOCUMENTS INCORPORATED BY REFERENCE
The SEC allows us to “incorporate
by reference” into this prospectus certain information that we file with the SEC, which means that we can disclose important
information to you by referring you to other documents separately filed by us with the SEC that contain such information. The information
we incorporate by reference is considered to be part of this prospectus and information we later file with the SEC will automatically
update and supersede the information in this prospectus. The following documents filed by us with the SEC pursuant to Section 13(a)
of the Exchange Act and any of our future filings under Sections 13(a), 13(c), 14 or 15 (d) of the Exchange Act, except for information
furnished under Item 2.02 or 7.01 of Current Report on Form 8-K, or exhibits related thereto, made before the termination of the
offering are incorporated by reference herein:
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our Annual Report on Form 10-K for the fiscal year
ended September 30, 2018, filed with the SEC on December 12, 2018, and the amendment thereto on Form 10-K/A filed on January 25,
2019;
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our Proxy Statement on Schedule 14A filed on February
11, 2019 (excluding those portions that are not incorporated by reference into our Annual Report on Form 10-K);
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our Quarterly Reports on Form 10-Q for the quarters
ended December 31, 2018 filed on February 7, 2019 and for the quarter ended March 31, 2019 filed on May 9, 2019;
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the description of our common stock contained in the
Registration Statement on Form 8-A (File No. 001-37606) filed with the SEC on October 23, 2005.
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In addition, all documents subsequently
filed by us pursuant to Section 13(a), 13(c), 14 or 15(d) of the Exchange Act before the date the offering of securities hereunder
is terminated or complete are deemed to be incorporated by reference into, and to be a part of, this prospectus.
We will provide to each person, including
any beneficial owner, to whom a prospectus is delivered, a copy of any or all of the reports or documents that have been incorporated
by reference in the prospectus contained in the registration statement but not delivered with the prospectus, other than an exhibit
to these filings unless we have specifically incorporated that exhibit by reference into the filing, upon written or oral request
and at no cost to the requester. Requests should be made by writing or telephoning us at the following address:
Anavex Life Sciences Corp.
51 West 52nd Street, 7th Floor
New York, NY 10019-6163
(844) 689-3939
Anavex Life Sciences Corp.
Up to $15,514,532 of
Common Stock
PROSPECTUS SUPPLEMENT
September 13, 2019
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