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, and it
named the Company and an officer of the Company as Defendants. The complaint was amended on July 12, 2024 (the “Initial Action”).
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. This lawsuit was dismissed by the United States District
Court for the Southern District of New York on June 18, 2025. The plaintiff filed a notice of appeal on July 17, 2025. Briefing on the
appeal concluded October 30, 2025, and oral argument has been scheduled to occur on February 12, 2026. No decision has been entered. No
amount has been recorded in these condensed consolidated interim financial statements for any loss contingencies associated with this
lawsuit as the Company believes that it is not probable that any loss will occur.
On May 8, 2024,
a similar complaint was filed in the same court by Kenneth Downing, a purported shareholder of the Company, against the same defendants.
The Company believed that this lawsuit was without merit and filed a motion to dismiss the complaint. Plaintiff Downing voluntarily dismissed
this 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), an officer of the Company, and members of the
Company’s Board of Directors in the U.S. District Court for the District of Nevada by another purported shareholder. 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 purported class action lawsuit 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. The stay has been extended throughout the appeal. No amount has been recorded in these
condensed consolidated interim financial statements for any loss contingencies associated with this lawsuit as the Company believes that
it is not probable that any loss will occur.
On February
14, 2025, another derivative lawsuit asserting state law breach of fiduciary duty and unjust enrichment claims based upon similar allegations
was filed against the Company (as nominal defendant), an officer of the Company, and members of the Company’s Board of Directors
in the Supreme Court for the State of New York, County of New York, by another purported shareholder. On August 18, 2025, pursuant to
a stipulation of the parties, the Court entered an order staying this purported derivative lawsuit until the appeal in the Initial Action
is resolved. No amount has been recorded in these condensed consolidated interim financial statements for any loss contingencies associated
with this lawsuit as the Company believes that it is not probable that any loss will occur.
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.
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, 2025,
filed with the SEC on November 25, 2025.
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ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
None.
ITEM 3. DEFAULTS UPON SENIOR SECURITIES
None.
ITEM 4. MINE SAFETY DISCLOSURES
Not applicable.
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