Item 1. Legal Proceedings
ITEM 1. LEGAL PROCEEDINGS
The Company is subject to claims and legal proceedings
that arise during the course of business. The Company is currently subject to the following lawsuits:
On March 13,
2024, a shareholder class action complaint was filed in the United States District Court for the Southern District of New York (the “Initial
Action”). The complaint was captioned Blum v. Anavex Life Sciences, Corp. et al., case number 1:24-cv-01910, and it named the Company
and Christopher Missling as Defendants. The complaint alleged violations of the Securities and Exchange Act of 1934 associated with disclosures
and statements made with respect to certain clinical trials for ANAVEX ® 2-73 related to Rett syndrome (the “March
2024 Complaint”). At a hearing on or about June 13, 2024, the Court named another purported Company shareholder, Quintessa Huey,
as lead plaintiff with respect to the March 2024 Complaint. An Amended Complaint was filed by the appointed lead plaintiff on July 12,
2024, which asserts allegations related to purported violations of Section 10(b) of the Securities Exchange Act tied to disclosures associated
with the same clinical trials related to Rett Syndrome, and which names the Company and Christopher Missling as defendants. The Amended
Complaint seeks unspecified damages, as well as costs, including counsel and expert witness fees, on behalf of class of investors who
purchased stock of the Company on the NASDAQ during the period February 1, 2022 through January 1, 2024. The defendants filed a motion
to dismiss the complaint. The motion to dismiss is fully-briefed and awaiting a decision by the Court.
On May 8, 2024,
a similar complaint was filed in the same court by Kenneth Downing (case no. 1:2024-cv-03529), a purported shareholder of the Company,
against the same defendants as the March 2024 Complaint. The defendants filed a motion to dismiss the complaint. Plaintiff Downing voluntarily
dismissed his complaint subsequent to the filing of the motion to dismiss.
On or about
May 13, 2024, a derivative lawsuit was filed against the Company (as nominal defendant), Christopher Missling, and members of the Company’s
Board of Directors in the U.S. District Court for the District of Nevada by another purported shareholder named Denise Deangelis. The
complaint asserts various common law claims (including breach of fiduciary duty) and violation of Section 14(a) of the Securities Exchange
Act regarding the same or similar allegations at issue in the two purported class action lawsuits related to disclosures and statements
made about certain clinical trials related to Rett Syndrome. On January 22, 2025, pursuant to a stipulation of the parties, the Court
entered an order staying this purported derivative lawsuit until the motion to dismiss filed by defendants in the Initial Action is decided
by the U.S. District Court for the Southern District of New York.
We
know of no other material pending legal or governmental proceedings, other than ordinary routine litigation incidental to our business,
to which our Company or our subsidiaries are a party or of which any of their property is subject. There are no other proceedings in which
any of our directors, officers or affiliates, or any registered or beneficial stockholder holding more than 5% of our shares, or any associate
of such persons, is an adverse party or has a material interest adverse to our or our subsidiaries’ interest.
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ITEM 1A. RISK FACTORS
There have been no material changes to the risk factors
discussed in “Risk Factors” in Part I, Item 1A of our Annual Report on Form 10-K for the fiscal year ended September 30, 2024,
filed with the SEC on December 23, 2024.
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