Downing v. Anavex Life Sciences Corporation — Entry #23: DECLARATION of Theodore L
Case: Downing v. Anavex Life Sciences Corporation nysd · 1:24-cv-03529
filed May 08, 2024
What this document is
Docket entry #23 · filed August 23, 2024
DECLARATION of Theodore L. Kornobis in Support re: 22 MOTION to Dismiss .. Document filed by Anavex Life Sciences Corporation, Christopher U. Missling. (Attachments: # 1 Exhibit Form 10-K, # 2 Exhibit Form 10-K, # 3 Exhibit Press Release, # 4 Exhibit Transcript, # 5 Exhibit Presentation, # 6 Exhibit Report, # 7 Exhibit Earnings Call, # 8 Exhibit Transcript, # 9 Exhibit Press Release, # 10 Exhibit Press Release, # 11 Exhibit Press Release).(Kornobis, Theodore) (Entered: 08/23/2024)
Who is involved
- Anavex Life Sciences Corporation
- Christopher U. Missling
- Kenneth Downing
Why we have it
We follow this case because it names a company we track, although that company is not a party:
- CleanSpark: its name “CleanSpark, Inc.” appears in a filing in this case.
…Page(s) Bishins v. CleanSpark, Inc., No. 21-cv-511 (LAP), 2021 WL 5741574 n…
A free copy from the RECAP archive of federal court filings (mirrored at the Internet Archive), retrieved October 25, 2026. Federal court filings are public records.
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Case 1:24-cv-03529-CM Document 23-2 Filed 08/23/24 Page 1 of 18
Case 1:24-cv-03529-CM Document 23-2 Filed 08/23/24 Page 2 of 18
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-K
(Mark One)
☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the fiscal year ended September 30, 2022
☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from ______________ to________________
Commission file number: 001-37606
ANAVEX LIFE SCIENCES CORP.
(Exact name of registrant as specified in its charter)
Nevada 98-0608404
(State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identification No.)
630 5th Avenue, 20th Floor, New York, NY USA 10111
(Address of principal executive offices) (Zip Code)
Registrant’s telephone number, including area code 1-844-689-3939
Securities registered under Section 12(b) of the Act:
Common Stock, $0.001 par value AVXL NASDAQ Stock Market LLC
Title of each class Trading Symbol Name of each exchange on which registered
Securities registered pursuant to Section 12(g) of the Act:
None
(Title of class)
Indicate by checkmark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.
Yes ☒ No ☐
Indicate by checkmark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Act.
Yes ☐ No ☒
Indicate by checkmark whether the registrant has (1) filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of
1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to
such filing requirements for the past 90 days.
Yes ☒ No ☐
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405
of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit
and post such files).
Yes ☒ No ☐
Indicate by checkmark whether the registrant is a large accelerated filer, an accelerated filer, a non- accelerated filer, a smaller reporting company, or
an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer”, “smaller reporting company” and “emerging growth
company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer ☒ Accelerated filer ☐
Smaller reporting company ☐
Non-accelerated filer ☐
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with
any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act
☐
Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its
internal controls over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting
firm that prepared or issued its audit report.
Yes ☒ No ☐
Case 1:24-cv-03529-CM Document 23-2 Filed 08/23/24 Page 3 of 18
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act).
Yes ☐ No ☒
State the aggregate market value of the voting and non-voting common equity held by non-affiliates computed by reference to the price at which
the common equity was last sold, or the average bid and asked price of such common equity, as of the last business day of the registrant’s most
recently completed second fiscal quarter: $921 million based on a price of $12.31 per share, being the closing price of the registrant’s common stock
on March 31, 2022.
Indicate the number of shares outstanding of each of the registrant’s classes of common stock, as of the latest practicable date: 77,961,815 issued
and outstanding as of November 28, 2022.
DOCUMENTS INCORPORATED BY REFERENCE
None.
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TABLE OF CONTENTS
PART I 6
ITEM 1. BUSINESS 6
ITEM 1A. RISK FACTORS 30
ITEM 1B. UNRESOLVED STAFF COMMENTS 51
ITEM 2. PROPERTIES 51
ITEM 3. LEGAL PROCEEDINGS 51
ITEM 4. MINE SAFETY DISCLOSURES 51
PART II 51
ITEM 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF 51
EQUITY SECURITIES
ITEM 6 [Reserved] 52
ITEM 7 MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATION
52
ITEM 7A QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK 57
ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA 58
ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL MATTERS 82
ITEM 9A. CONTROLS AND PROCEDURES 82
ITEM 9B OTHER INFORMATION 82
PART III 83
ITEM 10 DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE 83
ITEM 11. EXECUTIVE COMPENSATION 83
ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER 83
MATTERS.
ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE
83
ITEM 14. PRINCIPAL ACCOUNTING FEES AND SERVICES 83
PART IV 84
ITEM 15. EXHIBITS, FINANCIAL STATEMENT SCHEDULES 84
ITEM 16. FORM 10-K SUMMARY 85
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Case 1:24-cv-03529-CM Document 23-2 Filed 08/23/24 Page 5 of 18
Forward Looking Statements.
This Annual Report on Form 10-K includes forward-looking statements. All statements other than statements of historical facts contained in this
Annual Report on Form 10-K, 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,” “potential,” “predict,” “could,” “would,” “will,” “suggest,”
“plan” and similar expressions, as they relate to us, are intended to identify forward-looking statements. Such forward-looking statements include,
without limitation, statements regarding:
● volatility in our stock price and in the markets in general;
● our ability to successfully conduct preclinical studies and clinical trials for our product candidates;
● our ability to raise additional capital on favorable terms and the impact of such activities on our stockholders and stock price;
● the impact of the COVID-19 outbreak and its effect on us;
● our ability to generate any revenue or to continue as a going concern;
● our ability to execute our research and development plan on time and on budget;
● our products candidates’ 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 reliance on third parties in non-clinical studies and clinical trials;
● our ability to defend against product liability claims;
● our ability to safeguard against security breaches;
● our ability to obtain and maintain sufficient intellectual property protection for our product candidates;
● our ability to comply with our intellectual property licensing agreements;
● our ability to defend against claims of intellectual property infringement;
● our ability to comply with the maintenance requirements of the government patent agencies;
● our ability to protect our intellectual property rights throughout the world;
● competition;
● the anticipated start dates, durations and completion dates of our ongoing and future clinical trials;
● the anticipated designs of our future clinical trials;
● our ability to attract and retain qualified employees;
● the impact of Fast Track designation on receipt of actual FDA approval;
● our anticipated future regulatory submissions and our ability to receive regulatory approvals to develop and market our product
candidates, including any orphan drug or Fast Track designations; and
● our anticipated future cash position and ability to obtain funding for our operations.
We have based these forward-looking statements largely on our current expectations and projections about future events, including the responses
we expect from the U.S. Food and Drug Administration, (“FDA”), and other regulatory authorities and financial trends that we believe may affect
our financial condition, results of operations, business strategy, preclinical and clinical trials, and financial needs. These forward-looking
statements are subject to a number of risks, uncertainties and assumptions including, without limitation, the risks described in “Risk Factors” in
Part I, Item 1A of this Annual Report on Form 10-K. These risks are not exhaustive. Other sections of this Annual Report on Form 10-K include
additional factors which could adversely impact our business and financial performance. Moreover, we operate in a very competitive and rapidly
changing environment. New risk factors emerge from time to time and it is not possible for our management to predict all risk factors, nor can we
assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ
materially from those contained in any forward-looking statements. You should not rely upon forward-looking statements as predictions of future
events. We cannot assure you that the events and circumstances reflected in the forward-looking statements will be achieved or occur and actual
results could differ materially from those projected in the forward-looking statements. Except as required by applicable laws including the securities
laws of the United States, we assume no obligation to update or supplement forward-looking statements.
As used in this Annual Report on Form 10-K, the terms “we,” “us,” “our,”, “Company” and “Anavex” mean Anavex Life Sciences Corp., unless the
Case 1:24-cv-03529-CM Document 23-2 Filed 08/23/24 Page 6 of 18
context clearly requires otherwise.
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Case 1:24-cv-03529-CM Document 23-2 Filed 08/23/24 Page 7 of 18
PART I
ITEM 1. BUSINESS
Overview and Strategy
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 trials to identify
biomarkers, which we use in the analysis of our clinical trials.
Our lead product candidate, ANAVEX®2-73, is being developed to treat Alzheimer’s disease, Parkinson’s disease and potentially other central
nervous system diseases, including rare diseases, such as Rett syndrome, a rare severe neurological monogenic disorder caused by mutations in
the X-linked gene, methyl-CpG-binding protein 2 (“MECP2”).
We currently have two core programs and two seed programs. Our core programs are at various stages of clinical and preclinical development, in
neurodegenerative and neurodevelopmental diseases.
The following table summarizes key information about our programs:
* = Orphan Drug Designation by the FDA; Dashed lines indicate planned clinical trials to-date
Anavex has a portfolio of compounds varying in sigma-1 receptor (SIGMAR1) binding activities. The SIGMAR1 gene encodes the SIGMAR1
protein, which is an intracellular chaperone protein with important roles in cellular communication. SIGMAR1 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 SIGMAR1, 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 with SIGMAR1 in the brain.
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Source: Reyes S et al., Sci Rep. 2021 Aug 25;11(1):17150
Cellular Homeostasis
Many diseases are possibly directly caused by chronic homeostatic imbalances or cellular stress of brain cells. In pediatric diseases, such as 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 found 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, and 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
As part of some of our clinical trials, we have incorporated a genomic analysis to better understand potential populations for whom our clinical
programs might benefit. In our clinical trials, a full genomic analysis of Alzheimer’s disease patients treated with ANAVEX®2-73 has helped us
identify 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. We
believe that excluding patients with SIGMAR1 identified biomarker variant (approximately 10%-20% of the population) in prospective studies
would identify approximately 80%-90% patients that would display clinically significant improved functional and cognitive scores. The consistency
between the identified DNA and RNA data related to ANAVEX®2-73, which are considered independent of Alzheimer’s disease pathology, as well
as multiple endpoints and time-points, provides support for the potential precision medicine clinical development of ANAVEX®2-73 by using
genetic biomarkers identified within the trial population itself to target patients who are most likely to respond to ANAVEX®2-73 treatment. We may
in the future utilize such an approach in Alzheimer’s disease as well as indications like Parkinson’s disease dementia or Rett syndrome in which
ANAVEX®2-73 is currently being studied.
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Clinical Trials 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 in Australia 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 clinical trial, which established a concentration-effect relationship between ANAVEX®2-73 and trial 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 clinical trial appeared to show that ANAVEX®2-73 activity was enhanced by its active metabolite (ANAVEX19-144),
which also targets the SIGMAR1 receptor and has a half-life approximately twice as long as the parent molecule.
Two consecutive trial extensions for the Phase 2a trial have allowed participants who completed the 52-week Part B of the trial to continue taking
ANAVEX®2-73, providing us an opportunity to gather extended safety data for a cumulative time period of five years. In August 2020, patients
completing these Phase 2a trial extensions were granted continued access to treatment with ANAVEX®2-73 through the Australian Government
Department of Health - Therapeutic Goods Administration’s compassionate use Special Access Scheme.
A larger Phase 2b/3 double-blind, placebo-controlled trial of ANAVEX®2-73 in Alzheimer’s disease commenced in August 2018. The Phase 2b/3 trial
enrolled 509 patients for 48 weeks, randomized 1:1:1 to two different ANAVEX®2-73 doses or placebo. The trial commenced in Australia; and during
fiscal 2020 additional regions were added in the United Kingdom, The Netherlands, Germany and Canada. 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 addition to the primary endpoints, the
ANAVEX®2-73 Phase 2b/3 trial design incorporated pre-specified statistical analyses related to potential genomic precision medicine biomarkers
identified in the ANAVEX®2-73 Phase 2a clinical trial. The trial completed enrollment in June 2021, exceeding the 450 patient enrollment target at 52
sites across Canada, Europe and Australia.
In October 2019, we initiated a long-term open label extension study of ANAVEX®2-73, entitled the ATTENTION-AD trial, for patients who have
completed the 48-week Phase 2b/3 placebo-controlled trial referenced above. This trial extension for an additional two years gives patients the
opportunity to continue their treatment. Upon request by patients, caretakers and investigators, this extension trial was extended by one additional
year.
Rett Syndrome
In February 2016, we presented positive preclinical data for ANAVEX®2-73 in Rett syndrome, a rare neurodevelopmental disease. The data
demonstrated dose related and significant improvements in an array of behavioral and gait paradigms in a mouse model with a MECP2-null mutation
that causes neurological symptoms that mimic Rett syndrome. The study was funded by the International Rett Syndrome Foundation
(“Rettsyndrome.org”). In January 2017, we were awarded a financial grant from Rettsyndrome.org of a minimum of $0.6 million to cover some of the
costs of a multicenter Phase 2 clinical trial of ANAVEX®2-73 for the treatment of Rett syndrome. This award was received in quarterly instalments
which commenced during fiscal 2018.
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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 clinical trials are being conducted in a range of patient age demographics and geographic regions, utilizing an oral liquid once-daily
formulation of ANAVEX®2-73.
The first Phase 2 trial, (ANAVEX®2-73-RS-001), which took place in the United States, was completed in December 2020. This trial was a
randomized double-blind, placebo-controlled safety, tolerability, PK and efficacy trial of oral liquid ANAVEX®2-73 formulation in 25 adult female
patients with Rett syndrome over a 7-week treatment period including ANAVEX®2-73-specific genomic precision medicine biomarkers. The primary
endpoint of the trial was safety. The dosing of 5 mg ANAVEX®2-73 was well-tolerated and demonstrated dose-proportional PK. All secondary
efficacy endpoints of the trial showed statistically significant and clinically meaningful response in the Rett Syndrome Behaviour Questionnaire
(“RSBQ”) response, when compared to placebo, in the intent to treat (“ITT”) cohort (all participants, p = 0.011). 66.7% of ANAVEX®2-73 treated
subjects showed a statistically significant improvement in RSBQ response as compared to 10% of the subjects on placebo in the ITT cohort (all
participants, p = 0.011). ANAVEX®2-73 treatment resulted in a sustained improvement in Clinical Global Impression Improvement (“CGI-I”) response
throughout the 7-week clinical trial, when compared to placebo in the ITT cohort (all participants, p = 0.014). Consistent with previous ANAVEX®2-
73 clinical trials, patients carrying the common form of the SIGMAR1 gene treated with ANAVEX®2-73 experienced stronger improvements in the
prespecified efficacy endpoints.
The second, international trial of ANAVEX®2-73 for the treatment of Rett syndrome, called the AVATAR trial, commenced in June 2019. This trial
took place in Australia and the United Kingdom using a higher dose than the U.S. based Phase 2 trial for Rett syndrome. The trial was a Phase 3
randomized, double-blind, placebo-controlled trial to evaluate the safety and efficacy of ANAVEX®2-73 in 33 adult patients over a 7-week treatment
period including ANAVEX®2-73 specific precision medicine biomarkers. Based upon the input from the successful U.S. Phase 2 Rett syndrome trial
(ANAVEX®2-73-RS-001), we updated the endpoints for the AVATAR trial (ANAVEX®2-73-RS-002) to appropriately assess the clinically meaningful
outcome following International Conference on Harmonization (ICH) guidelines. These updates were approved by the respective regulatory
authorities in the U.K. and in Australia, respectively, where the AVATAR trial was conducted.
The data from the AVATAR trial was released in February 2022. The clinical trial met all primary and secondary efficacy and safety endpoints, with
consistent improvements in primary efficacy endpoint, RSBQ response (p = 0.037), and secondary efficacy endpoints, ADAMS (p = 0.010) and CGI-
I (p = 0.037) response. Efficacy endpoints demonstrated statistically significant and clinically meaningful reductions in Rett syndrome symptoms.
Convenient once daily oral liquid doses of up to 30 mg of ANAVEX®2-73 were also well tolerated with good medication compliance. All patients
who participated in the trial were eligible to receive ANAVEX®2-73 under a voluntary open label extension protocol.
In July 2020, we commenced the third trial of ANAVEX®2-73 for the treatment of Rett syndrome, called the EXCELLENCE trial. This Phase 2/3 trial in
pediatric patients with Rett syndrome includes trial sites in Australia, the United Kingdom, and Canada, and will evaluate the safety and efficacy of
ANAVEX®2-73 in approximately 84 pediatric patients, aged 5 to 18, over a 12-week treatment period incorporating ANAVEX®2-73 specific precision
medicine biomarkers. All patients who participate in the trial will be eligible to receive ANAVEX®2-73 under a voluntary open label extension
protocol, which is currently ongoing.
Parkinson’s Disease
In September 2016, we presented positive preclinical data for ANAVEX®2-73 in an animal model of Parkinson’s disease, which demonstrated
significant improvements on behavioral, histopathological, and neuroinflammatory endpoints. The study was funded by the Michael J. Fox
Foundation. Additional data announced in October 2017 indicated that ANAVEX®2-73 induced robust neurorestoration in experimental
Parkinsonism. We believe that the encouraging results we have gathered in this preclinical model, coupled with the favorable profile of this product
candidate in the Alzheimer’s disease trial, support the notion that ANAVEX®2-73 has the potential to treat Parkinson’s disease dementia.
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SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed
on its behalf by the undersigned thereunto duly authorized.
Date: November 28, 2022 ANAVEX LIFE SCIENCES CORP.
By: /s/ Christopher Missling, PhD
Name Christopher Missling, PhD
:
Title: Chief Executive Officer (Principal Executive
Officer)
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the
registrant and in the capacities and on the dates indicated.
Signatures Title(s) Date
November 28, 2022
/s/ Christopher Missling, PhD
Christopher Missling, PhD Chief Executive Officer (Principal Executive Officer)
/s/ Sandra Boenisch November 28, 2022
Sandra Boenisch, CPA, CGA Principal Financial Officer and Treasurer (Principal Accounting
Officer)
/s/ Athanasios Skarpelos November 28, 2022
Athanasios Skarpelos Director
/s/ Claus van der Velden, PhD November 28, 2022
Claus van der Velden, PhD Director
/s/ Steffen Thomas, PhD November 28, 2022
Steffen Thomas, PhD Director
/s/ Peter Donhauser, D.O. November 28, 2022
Peter Donhauser, D.O. Director
/s/ Jiong Ma, PhD November 28, 2022
Jiong Ma, PhD Director
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EXHIBIT 4.1
DESCRIPTION OF THE REGISTRANT’S SECURITIES REGISTERED PURSUANT TO SECTION 12 OF THE SECURITIES EXCHANGE ACT
OF 1934
Anavex Life Sciences Corp (the “Company”) has one class of securities registered under Section 12 of the Securities Exchange Act of 1934, as
amended: the Company’s common stock, par value $0.001 per share (the “Common Stock”)
Description of Common Stock
The following summary description sets forth some of the general terms and provisions of the Common Stock. Because this is a summary
description, it does not contain all of the information that may be important to you. For a more detailed description of the Company’s Common
Stock, you should refer to the provisions of the Company’s Articles of Incorporation, as amended (the “Charter”) and the Company’s Bylaws (the
“Bylaws”), each of which is an exhibit to the Annual Report on Form 10-K to which this description is an exhibit.
Authorized Shares
We are authorized to issue 200,000,000 shares of Common Stock with a par value of $0.001.
Voting Rights
The outstanding shares of our Common Stock are fully paid and non-assessable. The holders of Common Stock are entitled to one vote per share
for the election of directors and with respect to all other matters submitted to a vote of stockholders.
Liquidation, Dissolution or Similar Rights
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.
Dividend 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.
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. Our bylaws provide that these sections do not apply.
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.
Case 1:24-cv-03529-CM Document 23-2 Filed 08/23/24 Page 13 of 18
Indemnification Of Directors And Executive Officers And Limitation On Liability.
Our Bylaws provide that any person who was or is a party or is threatened to be made a party to any threatened, pending or completed action, suit
or proceeding, whether civil, criminal, administrative or investigative, by reason of the fact that such person is or was a director, officer, employee or
agent of the Company (or is or was serving at the request of the Company as a director, officer, employee or agent of another corporation,
partnership, joint venture, trust or other enterprise) shall be indemnified and held harmless by the Company to the fullest extent permitted by
Nevada law against expenses including attorneys’ fees, judgments, fines and amounts paid in settlement actually and reasonably incurred by such
person in connection with such proceeding.
The Bylaws also provide that the expenses of officers and directors incurred in defending a civil or criminal action, suit or proceeding must be paid
by the Company as they are incurred and in advance of the final disposition of the action, suit or proceeding upon receipt of an undertaking by or
on behalf of the director or officer to repay the amount if it is ultimately determined by a court of competent jurisdiction that he is not entitled to be
indemnified by the Company. Such right of indemnification shall be a contract right which may be enforced in any manner desired by such person.
Such right of indemnification shall not be exclusive of any other right which such directors, officers or representatives may have or hereafter
acquire and, without limiting the generality of such statement, they shall be entitled to their respective rights of indemnification under any bylaw,
agreement, vote of stockholders, provision of law or otherwise, as well as their rights under the Bylaws.
The Bylaws provide that the Board of Directors may cause the Company to purchase and maintain insurance on behalf of any person who is or was
a director or officer of the Company, or is or was serving at the request of the Company as a director or officer of another Company, or as its
representative in a partnership, joint venture, trust or other enterprise against any liability asserted against such person and incurred in any such
capacity or arising out of such status, whether or not the Company would have the power to indemnify such person.
Nevada Revised Statutes 78.751 and 78.7502 have provisions that provide for discretionary and mandatory indemnification of officers, directors,
employees, and agents of a corporation. Under these provisions, such persons may be indemnified by a corporation against expenses, including
attorney’s fees, judgment, fines and amounts paid in settlement, actually and reasonably incurred by him in connection with the action, suit or
proceeding, if he acted in good faith and in a manner which he reasonably believed to be in or not opposed to the best interests of the corporation
and with respect to any criminal action or proceeding had no reasonable cause to believe his conduct was unlawful.
To the extent that a director, officer, employee or agent has been successful on the merits or otherwise in defense of any action, suit or proceeding,
or in defense of any claim, issue or matter, the Nevada Revised Statues provide that he must be indemnified by the Company against expenses,
including attorney’s fees, actually and reasonably incurred by him in connection with the defense.
Section 78.7502 of the Nevada Revised Statues also provides that any discretionary indemnification, unless ordered by a court or advanced by the
Company, may be made only as authorized in the specific case upon a determination that indemnification of the director, officer, employee or agent
is proper in the circumstances.
The determination must be made:
● By the stockholders;
● By the Company’s Board of Directors by majority vote of a quorum consisting of directors who were not parties to that act, suit or
proceeding;
● If a majority vote of a quorum consisting of directors who were not parties to the act, suit or proceeding cannot be obtained, by
independent legal counsel in a written opinion; or
● If a quorum consisting of directors who were not parties to the act, suit or proceeding cannot be obtained, by independent legal counsel in
a written opinion.
Case 1:24-cv-03529-CM Document 23-2 Filed 08/23/24 Page 14 of 18
EXHIBIT 23.1
CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
We have issued our reports dated November 28, 2022, with respect to the consolidated financial statements and internal control over financial
reporting included in the Annual Report of Anavex Life Sciences Corp. on Form 10-K for the year ended September 30, 2022. We consent to the
incorporation by reference of said reports in the Registration Statements of Anavex Life Sciences Corp. on Forms S-3 (No. 333-218292, and No. 333-
259788) and Forms S-8 (No. 333-219934, No. 333-255166 and No. 333-265537)
/s/ GRANT THORNTON LLP
Hartford, CT
November 28, 2022
Case 1:24-cv-03529-CM Document 23-2 Filed 08/23/24 Page 15 of 18
EXHIBIT 23.2
Consent of Independent Registered Public Accounting Firm
Anavex Life Sciences Corp.
New York, New York
We hereby consent to the incorporation by reference in the Registration Statements on Form S-3 (No. 333-218292 and No. 333-259788) and Form S-8
(No. 333-219934, No. 333-255166 and No. 333-265537) of Anavex Life Sciences Corp. and subsidiaries of our reports dated November 24, 2021,
relating to the consolidated financial statements and the effectiveness of Anavex Life Science Corp.’s internal control over financial reporting,
which appear in this Annual Report on Form 10-K.
/s/ BDO USA, LLP
New York, New York
November 28, 2022
Case 1:24-cv-03529-CM Document 23-2 Filed 08/23/24 Page 16 of 18
EXHIBIT 31.1
CERTIFICATION
I, Christopher Missling, certify that:
1. I have reviewed this Annual Report on Form 10-K of Anavex Life Sciences Corp.;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make
the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered
by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects
the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as
defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-
15(f) and 15d-15(f)) for the registrant and have:
a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our
supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by
others within those entities, particularly during the period in which this report is being prepared;
b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our
supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements
for external purposes in accordance with generally accepted accounting principles;
c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the
effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation;
and
d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most
recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably
likely to materially affect, the registrant’s internal control over financial reporting; and
5. The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial
reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent
functions):
a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are
reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal
control over financial reporting.
Date: November 28, 2022
/s/ Christopher Missling
Christopher Missling, PhD
Chief Executive Officer, President,
Secretary
(Principal Executive Officer)
Case 1:24-cv-03529-CM Document 23-2 Filed 08/23/24 Page 17 of 18
EXHIBIT 31.2
CERTIFICATION
I, Sandra Boenisch, certify that:
1. I have reviewed this Annual Report on Form 10-K of Anavex Life Sciences Corp.;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make
the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered
by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects
the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as
defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-
15(f) and 15d-15(f)) for the registrant and have:
a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our
supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by
others within those entities, particularly during the period in which this report is being prepared;
b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our
supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements
for external purposes in accordance with generally accepted accounting principles;
c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the
effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation;
and
d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most
recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably
likely to materially affect, the registrant’s internal control over financial reporting; and
5. The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial
reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent
functions):
a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are
reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal
control over financial reporting.
Date: November 28, 2022
/s/ Sandra Boenisch
Sandra Boenisch, CPA, CGA
Principal Financial Officer, Treasurer
(Principal Financial and Accounting
Officer)
Case 1:24-cv-03529-CM Document 23-2 Filed 08/23/24 Page 18 of 18
EXHIBIT 32.1
CERTIFICATION
In connection with the Annual Report of Anavex Life Sciences Corp. (the “Company”) on Form 10-K for the fiscal year ending September 30, 2022
as filed with the Securities and Exchange Commission (the “Report”), the undersigned, in the capacities and on the date indicated below, hereby
certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to the best of our
knowledge:
(1) The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, and
(2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the
Company.
Date: November 28, 2022
/s/ Christopher Missling
Christopher Missling, PhD
Chief Executive Officer, President, Secretary (Principal
Executive Officer)
/s/ Sandra Boenisch
Sandra Boenisch, CPA, CGA
Principal Financial Officer, Treasurer
(Principal Financial and Accounting
Officer)
The foregoing certification is being furnished solely to accompany the Report pursuant to 18 U.S.C. § 1350, and is not being filed for purposes
of Section 18 of the Securities Exchange Act of 1934, as amended, and is not to be incorporated by reference into any filing of the Company,
whether made before or after the date hereof, regardless of any general incorporation language in such filing. A signed original of this written
statement required by Section 906, or other document authenticating, acknowledging, or otherwise adopting the signature that appears in typed
form within the electronic version of this written statement required by Section 906, has been provided to the Company and will be retained by the
Company and furnished to the Securities and Exchange Commission or its staff upon request.