PROSPECTUS
SUPPLEMENT |
Filed Pursuant to Rule
424(b)(5) |
(To Prospectus Dated July 15,
2019) |
Registration No. 333-232550 |
Anavex Life Sciences Corp.
Up to $30,331,854
Common Stock
This prospectus supplement relates to the issuance and sale of up
to $30,331,854 in shares of our common stock, to Lincoln Park
Capital Fund, LLC, or 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, or the Purchase Agreement, whereby Lincoln Park committed to
purchase up to $50,000,000 of our common stock. 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, or the
Securities Act.
Our common stock is currently listed on the Nasdaq Capital Market
under the symbol “AVXL”. On April 27, 2020 the last reported sale
price of our common stock was $3.41 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-7 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 May 1,
2020.
TABLE OF CONTENTS
PROSPECTUS SUPPLEMENT
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:
|
· |
our ability to generate any revenue
or to continue as a going concern; |
|
· |
our ability to
successfully conduct clinical and preclinical trials for our
product candidates; |
|
· |
our ability to raise
additional capital on favorable terms and the impact of such
activities on our stockholders and stock price; |
|
· |
the impact of the
COVID-19 outbreak and its effect on us; |
|
· |
our ability to execute
our development plan on time and on budget; |
|
· |
our products’ ability
to demonstrate efficacy or an acceptable safety profile of our
product candidates; |
|
· |
our ability to obtain
the support of qualified scientific collaborators; |
|
· |
our ability, whether
alone or with commercial partners, to successfully commercialize
any of our product candidates that may be approved for
sale; |
|
· |
our ability to
identify and obtain additional product candidates; |
|
· |
our reliance on third
parties in non-clinical and clinical studies; |
|
· |
our ability to defend
against product liability claims; |
|
· |
our ability to
safeguard against security breaches; |
|
· |
our ability to obtain
and maintain sufficient intellectual property protection for our
product candidates; |
|
· |
our ability to comply
with our intellectual property licensing agreements; |
|
· |
our ability to defend
against claims of intellectual property infringement; |
|
· |
our ability to comply
with the maintenance requirements of the government patent
agencies; |
|
· |
our ability to protect
our intellectual property rights throughout the world; |
|
· |
the anticipated start
dates, durations and completion dates of our ongoing and future
clinical studies; |
|
· |
the anticipated
designs of our future clinical studies; |
|
· |
our anticipated future
regulatory submissions and our ability to receive regulatory
approvals to develop and market our product candidates;
and |
|
· |
our anticipated future
cash position. |
We have based these forward-looking statements largely on our
current expectations and projections about future events, including
the responses we expect from the U.S. Food and Drug Administration,
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, 2019. 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, 2019 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 August
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, additional regions are being 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 October 2019, we initiated a long-term open label extension
study, entitled the ATTENTION-AD study, for patients who have
completed the 48-week Phase 2b/3 placebo-controlled trial. This
study is expected to last two years and will give patients the
opportunity to continue their treatment.
Rett Syndrome
In February 2016, we presented positive preclinical data for
ANAVEX®2-73 in Rett syndrome, a rare neurodevelopmental
disease. The study was funded by the International Rett Syndrome
Foundation (“Rettsyndrome.org”). In January 2017, we were awarded a
financial grant from Rettsyndrome.org of a minimum of $0.6 million
to cover some of the costs of a multicenter Phase 2 clinical trial
of ANAVEX®2-73 for the treatment of Rett syndrome. This
award is being received in quarterly instalments which commenced
during fiscal 2018.
In March 2019, we commenced the first Phase 2 clinical trial in a
planned Rett syndrome program of ANAVEX®2-73 for the
treatment of Rett syndrome. The studies will be conducted in a
range of patient age demographics and geographic regions.
The first Phase 2 study, which commenced in March 2019, 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 21 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. 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, we commenced the second Phase 2 study of
ANAVEX®2-73 for the treatment of Rett syndrome, called
the AVATAR study. This study is taking place in Australia 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 33 patients over a 7-week
treatment period including ANAVEX®2-73 specific
precision medicine biomarkers. All patients who participate in the
study will be eligible to receive ANAVEX®2-73 under a
voluntary open label extension protocol.
In September 2019, we announced approval from the Australian Human
Research Ethics Committee to commence the third study of
ANAVEX®2-73 for the treatment of Rett syndrome, called
the EXCELLENCE study. Similar to the AVATAR study, this study is
taking place in Australia and is using a convenient once-daily oral
liquid ANAVEX®2-73 formulation. The study will evaluate
the safety and efficacy of ANAVEX®2-73 in at least 69
pediatric patients, aged 5 to 18, over a 12-week treatment period
incorporating ANAVEX®2-73 specific precision medicine
biomarkers. All patients who participate in the study will be
eligible to receive ANAVEX®2-73 under a voluntary open
label extension protocol.
Parkinson’s Disease
In September 2016, we presented positive preclinical data for
ANAVEX®2-73 in 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 dementia.
In October 2018, we initiated a
double-blind, randomized, placebo-controlled Phase 2 trial with
ANAVEX®2-73 in Parkinson’s Disease Dementia (PDD), 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. The study has completed
enrollment and topline results from this study are expected by
mid-2020.
Recent Developments
On March 11, 2020, the World
Health Organization declared the outbreak of a novel strain of
coronavirus, COVID-19, a global pandemic, which continues to spread
throughout the United States and around the world. Effective as of
March 20, 2020, the governor of the State of New York issued a
shelter-in-place order, which directed all businesses in the State
of New York to cease non-essential operations at physical locations
in the counties, and these orders will continue to be in effect
through April 29, 2020, unless extended, rescinded, or amended.
Similar orders have been issued in other state and local
jurisdictions across the United States and in other countries.
Because of the nature of our operations, we are currently
considered to be an essential business so, to date, our operations
have only been partially affected by this order. As we continue to
actively advance all of our clinical programs, we are in close
contact with our principal investigators and clinical sites, which
are primarily located in the United States and Australia, and are
assessing the impact of COVID-19 on our clinical trials, product
candidate testing, expected timelines and costs on an ongoing
basis. In light of recent developments relating to the COVID-19
global pandemic, the focus of healthcare providers and hospitals is
the prioritization of healthcare resources toward fighting the
virus. This partial disruption, although temporary, may impact our
operations and overall business by delaying the progress of our
research and development programs, including our planned
preclinical studies and clinical trials. The impact of COVID-19 is
evolving rapidly and its future effects are uncertain. Given the
uncertainty of the situation, the duration of the disruption and
related financial impact cannot be reasonably estimated at this
time. We will continue to evaluate the impact of the COVID-19
pandemic on our business and expect to reevaluate the timing of our
anticipated preclinical and clinical objectives as we learn more
and the impact of COVID-19 on our industry becomes more
clear.
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
Common
stock offered by us in the Lincoln Park offering |
Up to $30,000,000 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
Up to 97,318 additional commitment shares valued at $331,854 based
on $3.41, the closing price of our common stock on The Nasdaq
Capital Market on April 27 2020, which is the amount of additional
shares we may issue for no cash consideration to Lincoln Park
from time to time pro-rata in connection with the purchase of
$30,000,000 of shares of our common stock under the Purchase
Agreement.
|
|
|
Use
of Proceeds |
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-8. |
|
|
Risk
Factors |
You
should read the “Risk Factors” section on page S-7 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. |
|
|
Nasdaq
Capital Market symbol |
“AVXL.” |
The number of shares of common stock shown above to be outstanding
after this offering is based on 58,664,946 shares of common stock
outstanding as of April 27, 2020 and excludes the following:
|
● |
9,986,266
shares of common stock issuable upon the exercise of outstanding
stock options, vested and unvested, with a weighted- average
exercise price of $3.47 per share; and |
|
● |
500,000
shares of common stock issuable upon the exercise of outstanding
warrants with a weighted-average exercise price of $3.88 per
share. |
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
$30,000,000 of such shares are registered hereunder), and we may
still issue up to 97,318 additional commitment shares 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 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, and we 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 between June 7 and July 19, 2019, all of which were
registered under our registration statement (File No. 333-207600).
Following the effectiveness of the registration statement of which
this prospectus supplement is a part, we also issued 49,841
additional commitment shares pro-rata in connection with the
purchase of 5,964,584 shares of our common stock under the Purchase
Agreement pursuant to a prospectus supplement dated September 13,
2019.
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 or the exercise of stock options.
To raise additional capital, we may in the future offer additional
shares of our common stock at prices that may not be the same as
the price per share in this offering. The price per share at which
we sell additional shares of our common stock in future
transactions may be higher or lower than the price per share paid
by investors in this offering. In addition, we have a significant
number of stock options outstanding. To the extent that outstanding
stock options may be exercised, or other shares issued, you may
experience further dilution.
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 will only be
able to sell or issue to Lincoln Park 10,076,680 shares in total,
which is equal to 19.99% of the shares of common stock outstanding
on the date of the Purchase Agreement unless we obtain shareholder
approval or the average price of such sales exceeds the price of
our common stock on June 7, 2019 as determined under NASDAQ rules.
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 and issue all of our common stock currently
registered.
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.
Risks Relating to Our Business Operations
The COVID-19 coronavirus could adversely impact our business,
including our clinical trials, and financial condition.
In December 2019, a novel strain of coronavirus, COVID-19, was
reported to have surfaced in Wuhan, China. Since then, the COVID-19
coronavirus has spread to multiple countries, including the United
States, Australia and European and Asia-Pacific countries,
including countries in which we have planned or active clinical
trial sites. On January 30, 2020, the World Health Organization
announced a global health emergency and in March 2020 classified
the outbreak of the COVID-19 coronavirus as a pandemic, based on
the rapid increase in exposure globally. As the COVID-19
coronavirus continues to spread around the globe, we may experience
disruptions that could potentially impact our business and clinical
trials.
In addition, the spread of COVID-19 coronavirus has had and may
continue to severely impact the trading price of shares of our
common stock and could further severely impact our ability to raise
additional capital on a timely basis or at all.
The
global outbreak of the COVID-19 coronavirus continues to rapidly
evolve. The extent to which the COVID-19 coronavirus may impact our
business, including our clinical trials, and financial condition
will depend on future developments, which are highly uncertain and
cannot be predicted with confidence, such as the ultimate
geographic spread of the disease, the duration of the outbreak,
travel restrictions and social distancing in the United States and
other countries, business closures or business disruptions and the
effectiveness of actions taken in the United States and other
countries to contain and treat the disease.
As a result of the COVID-19 coronavirus, on March 27, 2020, the
President of the United States signed into law the Coronavirus Aid,
Relief, and Economic Security (CARES) Act. The CARES Act, among
other things, includes provisions relating to refundable payroll
tax credits, deferment of employer side social security payments,
net operating loss carryback periods, alternative minimum tax
credit refunds, modifications to the net interest deduction
limitations, increased limitations on qualified charitable
contributions, and technical corrections to tax depreciation
methods for qualified improvement property.
It also appropriated funds for the SBA Paycheck Protection Program
loans that are forgivable in certain situations to promote
continued employment, as well as Economic Injury Disaster Loans to
provide liquidity to small businesses harmed by COVID-19. There is
no assurance we are eligible for these funds or will be able to
obtain them.
We do not expect the enactment of the CARES Act will have a
material impact on our financial condition, results of operations,
or liquidity.
USE OF PROCEEDS
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.
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 December 31, 2019 was approximately $26.0 million, or $0.46 per share.
After giving effect to the sale of common stock pursuant to this prospectus supplement and accompanying prospectus in the aggregate amount of $30,000,000 at an assumed offering price of $3.41 per share, the last reported sale price of our common stock on the Nasdaq Capital Market on April 27, 2020, and after deducting estimated aggregate offering expenses payable by us, our net tangible book value as of December 31, 2019 would have been $55.9 million, or $0.85 per share of common stock. This represents an immediate increase in the net tangible book value of $0.39 per share to our existing stockholders and an immediate dilution in net tangible book value of $2.56 per share to new investors. The following table illustrates this per share dilution:
Assumed public offering
price per share |
|
|
|
|
$ |
3.41 |
|
Net tangible book value per share
as of December 31, 2019 |
|
$ |
0.46 |
|
|
|
|
Increase per
share attributable to new investors |
|
$ |
0.39 |
|
|
|
|
As adjusted
net tangible book value per share as of December 31, 2019 after
giving effect to this offering |
|
|
|
|
$ |
0.85 |
|
Dilution per
share to new investors purchasing shares in this offering |
|
|
|
|
$ |
2.56 |
|
The table above assumes for illustrative purposes that an aggregate
of 8,797,654 shares of our common stock are sold pursuant to this
prospectus supplement and the accompanying prospectus at a price of
$3.41 per share, the last reported sale price of our common stock
on the Nasdaq Capital Market on April 27, 2020, for aggregate gross
proceeds of $30.0 million. 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 $3.41 per share shown in the table
above, assuming all of our common stock in the aggregate amount of
$30.0 million is sold at that price, would result in an adjusted
net tangible book value per share after the offering of $0.87 per
share and would increase the dilution in net tangible book value
per share to new investors in this offering to $3.54 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 $3.41 per share shown
in the table above, assuming all of our common stock in the
aggregate amount of $30.0 million is sold at that price, would
result in an adjusted net tangible book value per share after the
offering of $0.80 per share and would decrease the dilution in net
tangible book value per share to new investors in this offering to
$1.61 per share, after deducting estimated aggregate offering
expenses payable by us.
The above table and
discussion are based on 57,080,356
shares of common stock
outstanding as of
December 31, 2019
and exclude the
following, all as of December 31, 2019:
|
· |
8,726,266
shares of common
stock issuable upon the exercise of outstanding stock options,
vested and unvested, with a weighted-average exercise price of
$3.54
per
share; and |
|
· |
500,000
shares of common
stock issuable upon the exercise of outstanding warrants with a
weighted-average exercise price of $3.88
per
share. |
To
the extent that options or warrants outstanding as of December 31,
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, 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. At September 11, 2019, we had 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 supplement is a part, registering up to $250 million in
securities utilizing a shelf registration process and on September
13, 2019 following the deregistration of all shares remaining
registered under the 2016 Registration Statement, we filed a
prospectus supplement to cover the issuance and sale of up to
$15,514,532 of shares of our common stock. As of May 1, 2020 all of
such shares have been sold and/or issued to Lincoln Park.
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 $30,000,000 of
shares of our common stock and (ii) the issuance of up to 97,318
additional commitment shares to be issued pro-rata to Lincoln Park
if and when we direct Lincoln Park to purchase all of the available
shares of common stock under the Purchase Agreement.
Purchase of Shares Under the Purchase Agreement
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:
|
● |
the
lowest sale price for our common stock on the purchase date of such
shares; or |
|
● |
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. |
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:
|
● |
30%
of the aggregate shares of our common stock traded during normal
trading hours on the purchase date; and |
|
● |
200%
of the number of purchase shares purchased pursuant to the
corresponding Regular Purchase. |
The purchase price per share for each such Accelerated Purchase
will be equal to the lower of:
|
● |
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 |
|
● |
the
closing sale price of our common stock on the purchase
date. |
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, in
each case calculated in accordance with Nasdaq rules.
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:
|
● |
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; |
|
● |
suspension
by our principal market of our common stock from trading on the
Nasdaq Capital Market for a period of three consecutive business
days; |
|
● |
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); |
|
● |
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; |
|
● |
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; |
|
● |
any
voluntary or involuntary participation or threatened participation
in insolvency or bankruptcy proceedings by or against us;
and |
|
● |
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. |
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 the $30,000,000 in shares of common stock remaining to
be purchased under the Purchase Agreement, and we are only
registering the 97,318 remaining additional commitment shares
issuable under the Purchase Agreement under this prospectus
supplement, as permitted by the RRA. Additionally, if we do sell
all of the shares of common stock covered hereunder, we will be
required to file a new prospectus supplement 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
Assumed
Average Purchase Price Per Share |
|
|
Number
of Registered Shares to be Issued if Full
Purchase(1) |
|
|
Percentage
of Outstanding Shares After Giving Effect to the Issuance to
Lincoln Park(2) |
|
|
Proceeds
from the Sale of Shares Under the Purchase Agreement Registered in
this Offering |
|
$ |
2.50 |
|
|
|
12,097,318 |
|
|
|
17.10% |
|
|
|
$30,000,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
3.41 |
(3) |
|
|
8,894,972 |
|
|
|
13.17% |
|
|
|
$30,000,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
5.00 |
|
|
|
6,097,318 |
|
|
|
9.41% |
|
|
|
$30,000,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
7.50 |
|
|
|
4,097,318 |
|
|
|
6.53% |
|
|
|
$30,000,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
10.00 |
|
|
|
3,097,318 |
|
|
|
5.01% |
|
|
|
$30,000,000 |
|
_______________
|
(1) |
Although
the Purchase Agreement provides that we may sell up to $50,000,000
of our common stock to Lincoln Park, we are registering $30,331,854
of shares hereunder (inclusive of the 97,318 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. |
|
(2) |
The
denominator is based on 58,664,946 shares outstanding as of April
27, 2020 and is inclusive of
the 97,318 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 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. |
|
(3) |
The
closing price of our common stock on April 27, 2020. |
PLAN OF DISTRIBUTION
This prospectus supplement and the accompanying prospectus include
the issuance and sale of up to $30,331,854 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 97,318
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 ($30,000,000 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, 2019 and 2018
and for each of the two years in the period ended September 30,
2019 and management’s assessment of the effectiveness of internal
control over financial reporting as of September 30, 2019
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. BDO’s report on the effectiveness of
internal controls over financial reporting expresses an adverse
opinion on the effectiveness of the Company’s internal control over
financial reporting as of September 30, 2019.
WHERE YOU CAN FIND MORE
INFORMATION
We file annual, quarterly and other reports and other information
with the SEC under the Exchange Act. You may read and copy any
reports, statements or other information filed by us at the SEC’s
public reference room at 100 F Street, N.E., Washington, D.C.
20549. Our filings with the SEC are also available to the public
from commercial document retrieval services and at the SEC’s
website at 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:
|
(1) |
our Annual Report on
Form
10-K for the fiscal year ended September 30, 2019, filed
with the SEC on December 16, 2019; |
|
(2) |
our Quarterly Report on
Form 10-Q for the period ended December 31, 2019, filed on
February 6, 2020; |
|
(3) |
our Current Report on
Form 8-K filed on April 8, 2020; |
|
(4) |
our Definitive Proxy Statement on
Schedule 14A filed on February 20, 2020; and |
|
(5) |
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,
2015. |
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
|
● |
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. |
|
● |
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. |
|
● |
Rett syndrome - Rett
syndrome is a rare X-linked genetic neurological and developmental
disorder that affects the way the brain develops, including protein
transcription, which is altered and as a result leads to severe
disruptions in neuronal homeostasis. It is considered a rare,
progressive neurodevelopmental disorder and is caused by a single
mutation in the MECP2 gene. Because males have a different
chromosome combination from females, boys who have the genetic
MECP2 mutation are affected in devastating ways. Most of them die
before birth or in early infancy. For females who survive infancy,
Rett syndrome leads to severe impairments, affecting nearly every
aspect of the child’s life; severe mental retardation, their
ability to speak, walk and eat, sleeping problems, seizures and
even the ability to breathe easily. Rett syndrome affects
approximately 1 in every 10,000-15,000 females. |
|
● |
Depression - Depression
is a major cause of morbidity worldwide according to the World
Health Organization. Pharmaceutical treatment for depression is
dominated by blockbuster brands, with the leading nine brands
accounting for approximately 75% of total sales. However, the
dominance of the leading brands is waning, largely due to the
effects of patent expiration and generic competition. |
|
● |
Epilepsy - Epilepsy is a
common chronic neurological disorder characterized by recurrent
unprovoked seizures. These seizures are transient signs and/or
symptoms of abnormal, excessive or synchronous neuronal activity in
the brain. According to the Centers for Disease Control and
Prevention, 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. |
|
● |
Neuropathic Pain – We
define neuralgia, or neuropathic pain, as pain that is not related
to activation of pain receptor cells in any part of the body.
Neuralgia is more difficult to treat than some other types of pain
because it does not respond well to normal pain medications.
Special medications have become more specific to neuralgia and
typically fall under the category of membrane stabilizing drugs or
antidepressants. |
Cancer
|
● |
Malignant Melanoma -
Predominantly a skin cancer, malignant melanoma can also occur in
melanocytes found in the bowel and the eye. Malignant melanoma
accounts for 75% of all deaths associated with skin cancer. The
treatment includes surgical removal of the tumor, adjuvant
treatment, chemo and immunotherapy, or radiation therapy. According
to IMS Health the worldwide malignant melanoma market is expected
to grow to $4.4 billion by 2022. |
|
● |
Prostate Cancer –
Specific to men, prostate cancer is a form of cancer that develops
in the prostate, a gland in the male reproductive system. The
cancer cells may metastasize from the prostate to other parts of
the body, particularly the bones and lymph nodes. Drug therapeutics
for prostate cancer are expected to increase to nearly $13.5
billion in 2024 according to Datamonitor Healthcare. |
|
● |
Pancreatic Cancer -
Pancreatic cancer is a malignant neoplasm of the pancreas. In the
United States, approximately 55,000 new cases of pancreatic cancer
will be diagnosed this year and approximately 44,000 patients will
die as a result of their cancer, according to the American Cancer
Society. Sales predictions by GBI Research forecast that the market
for the pharmaceutical treatment of pancreatic cancer in the United
States and five largest European countries will increase to $2.9
billion by 2021. |
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:
|
● |
our ability to
successfully conduct clinical and preclinical trials for our
product candidates; |
|
● |
our ability to raise
additional capital on favorable terms; |
|
● |
our ability to execute
our development plan on time and on budget; |
|
● |
our products ability to
demonstrate efficacy or an acceptable safety profile; |
|
|
|
|
● |
our ability to obtain
the support of qualified scientific collaborators; |
|
● |
our ability, whether
alone or with commercial partners, to successfully commercialize
any of our product candidates that may be approved for
sale; |
|
● |
our ability to identify
and obtain additional product candidates; |
|
● |
our ability to obtain
and maintain sufficient intellectual property protection for our
product candidates; |
|
|
|
|
● |
our ability to comply
with our intellectual property licensing agreements; |
|
|
|
|
● |
our ability to defend
against claims of intellectual property infringement; |
|
● |
our ability to comply
with the maintenance requirements of the government patent
agencies; |
|
|
|
|
● |
our ability to protect
our intellectual property rights throughout the world; |
|
● |
the anticipated start
dates, durations and completion dates of our ongoing and future
clinical studies; |
|
● |
the anticipated designs
of our future clinical studies; |
|
● |
our anticipated future
regulatory submissions and our ability to receive regulatory
approvals to develop and market our product candidates; |
|
● |
our anticipated future
cash position; and |
|
|
|
|
● |
our ability to generate
any revenue or to continue as a going concern. |
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:
|
· |
the net tangible book
value per share of our equity securities before and after the
offering; |
|
· |
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 |
|
· |
the amount of the
immediate dilution from the public offering price which will be
absorbed by such purchasers. |
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:
|
● |
on any national securities exchange
or quotation service on which the securities may be listed or
quoted at the time of sale; |
|
● |
in the over-the-counter
market; |
|
● |
in transactions otherwise than on
these exchanges or services or in the over-the-counter market;
or |
|
● |
through the writing of options,
whether the options are listed on an options exchange or
otherwise. |
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:
|
● |
the public offering price; |
|
● |
the name or names of any
underwriters, dealers or agents; |
|
● |
the purchase price of the
securities; |
|
● |
the proceeds from the sale of the
securities to us; |
|
● |
any underwriting discounts, agency
fees, or other compensation payable to underwriters or agents; |
|
● |
any discounts or concessions
allowed or reallowed or repaid to dealers; and |
|
● |
the securities exchanges on which
the securities will be listed, if any. |
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:
|
● |
the title of the
Warrants; |
|
● |
the total number of
Warrants; |
|
● |
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; |
|
● |
the date on and after
which the Warrants and the related Common Stock will be separately
transferable; |
|
● |
if applicable, the date
on which the right to exercise the Warrants will commence and the
date on which this right will expire; |
|
● |
if applicable, the
minimum or maximum amount of the Warrants which may be exercised at
any one time; |
|
● |
a discussion of federal
income tax, accounting and other special considerations, procedures
and limitations relating to the Warrants; and |
|
● |
any other terms of the
Warrants including terms, procedures and limitations relating to
the exchange and exercise of the Warrants. |
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:
|
(1) |
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; |
|
(2) |
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); |
|
(3) |
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; |
|
(5) |
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. |
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
Up to $30,331,854
Anavex Life Sciences Corp.
Common Stock
PROSPECTUS SUPPLEMENT
May 1, 2020
Anavex Life Sciences (NASDAQ:AVXL)
Historical Stock Chart
From Dec 2020 to Jan 2021
Anavex Life Sciences (NASDAQ:AVXL)
Historical Stock Chart
From Jan 2020 to Jan 2021