Anavex Life Sciences Corp.: Form 10-K/A for the period ended Sep 30, 2025

As previously disclosed in a Current Report on Form 8-K, filed with the Securities and Exchange Commission (“SEC”) on May 6, 2026, on April 30, 2026, a special committee (the “Special Committee”) composed of independent directors of our Board of Directors (the “Board”) terminated the employment of our former Chief Executive Officer (“CEO”) for Cause (as defined in the Employment Agreement, dated as of June 27, 2013, between us and our former CEO, as amended and restated) effective immediately for, among other things, conduct that the Special Committee believed was inconsistent with Company policy.

As a result of the review by the Special Committee, management, in consultation with the Audit Committee of the Board, re-assessed the effectiveness of our disclosure controls and procedures and our internal control over financial reporting as of September 30, 2025, as reported in our Original Form 10-K. The re-evaluation of our disclosure controls and procedures and our internal control over financial reporting considers the circumstances in effect at September 30, 2025, prior to the termination of our former CEO.

Evaluation of Disclosure Controls and Procedures (Amended and Restated)

We maintain disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) promulgated under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), that are designed to provide reasonable assurance that material information required to be disclosed in our periodic reports filed under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in the SEC rules and forms and to provide reasonable assurance that such information is accumulated and communicated to our principal executive officer and our principal financial officer to allow timely decisions regarding required disclosure.

We carried out an evaluation, under the supervision and with the participation of our management, including our principal executive officer and our principal financial officer, of the effectiveness of the design and operation of our disclosure controls and procedures as of September 30, 2025. At the time of filing our Annual Report on Form 10-K for the fiscal year ended September 30, 2025, with the SEC on November 25, 2025 (the “Original Form 10-K”), our principal executive officer and principal financial officer concluded that our disclosure controls and procedures were effective as of September 30, 2025. Subsequent to the filing of the Original Form 10-K, management identified a material weakness in internal control over financial reporting that existed as of September 30, 2025. Based on the re-evaluation, our principal executive officer and our principal financial officer concluded that our disclosure controls and procedures were not effective as of September 30, 2025, due to the material weakness in internal control over financial reporting described below.

Management’s Annual Report on Internal Control Over Financial Reporting (Amended and Restated)

Our management is responsible for establishing and maintaining adequate internal control over financial reporting as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act. Under the supervision and with the participation of our management, including our principal executive officer and principal financial officer, we conducted an evaluation of the effectiveness of our internal control over financial reporting based on criteria established in the framework in Internal Control — Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission. At the time of filing our Original Form 10-K, our principal executive officer and principal financial officer concluded that our internal control over financial reporting were effective as of September 30, 2025. Subsequent to the filing of our Original Form 10-K, management identified a material weakness in internal control over financial reporting (described below) that existed as of September 30, 2025. As a result of this material weakness, management reassessed their conclusion and concluded that our internal control over financial reporting was not effective as of September 30, 2025.

Material Weakness in Internal Control over Financial Reporting

Management identified deficiencies in our Control Environment and Information and Communication controls related to the historical flow of regulatory, clinical and non-financial information.

We did not maintain an effective Control Environment because our former CEO failed to set an appropriate tone at the top. There was a lack of transparency with the Board regarding regulatory, clinical and non-financial matters, and the former CEO failed to foster an environment which prioritized regulatory and clinical compliance and in fact took steps to disincentivize such efforts.

Additionally, we failed to maintain effective controls over Information and Communication as historically, our former CEO served as a principal source and decision-maker with respect to regulatory, clinical and non-financial matters and related communications. We did not maintain sufficiently independent and formalized mechanisms to ensure that regulatory, clinical and non-financial information was communicated completely and timely to our principal financial officer, the Audit Committee and the Board, and other disclosure-process participants.

In particular, the historical process did not include certain controls that our management has subsequently determined were necessary to provide reasonable assurance regarding the completeness of regulatory, clinical and non-financial information used in our disclosure and financial reporting processes, including a formal disclosure committee (the “Disclosure Committee”), recurring functional sub-certifications, routine access by appropriate disclosure-process participants to relevant source regulatory, clinical and non-financial information, formal source-document reconciliation procedures and a documented escalation process for regulatory, clinical and non-financial information.

The material weakness resulted from an overreliance on our former CEO as the principal source and gatekeeper for regulatory, clinical and non-financial information, together with insufficient independent controls to ensure that such information was communicated completely and timely to our financial reporting and disclosure-process participants, including the principal financial officer, Audit Committee and Board.

As a result of these deficiencies, established downstream controls, including management review, legal review, Audit Committee review, Board review and executive certifications, could operate while relying on an incomplete information population, and thus were deemed ineffective. The deficiencies also increased the susceptibility of our information and communication processes to senior-management influence and management override.

Management evaluated these deficiencies individually and in combination and concluded that they represent interrelated manifestations of an entity-level control deficiency. Accordingly, management concluded that these deficiencies, in the aggregate, constitute a material weakness because there was a reasonable possibility that a material misstatement of our annual or interim financial statements or related notes would not be prevented or detected on a timely basis. Specifically, the deficiencies could prevent information relevant to financial-reporting and SEC disclosure judgments, disclosures and certifications from entering the financial-reporting and SEC disclosure process before downstream accounting and review controls had an opportunity to operate.

Notwithstanding the material weakness described above, management has concluded that the financial statements included in the Original Form 10-K are fairly presented, in all material respects, in accordance with U.S. GAAP.

Attestation Report of the Registered Public Accounting Firm

The effectiveness of our internal controls over financial reporting as of September 30, 2025 has been audited by Grant Thornton LLP, an independent registered public accounting firm, as stated in their report which appears in this Amendment.

Planned Remediation of the Material Weakness

To address the material weakness in internal control over financial reporting, and building on the leadership change initiated by the Special Committee, we have developed, and our Audit Committee will oversee, a remediation plan, which is described below. We are in the process of implementing measures designed to improve our internal control over financial reporting and remediate the control deficiencies that led to the material weakness described above.

The remediation plans include:

• establishing a formal Disclosure Committee with defined responsibilities for reviewing information relevant to our SEC disclosures;
• enhancing the process for communicating regulatory, clinical and non-financial developments to the principal executive officer, the principal financial officer, the Disclosure Committee, the Audit Committee and the Board;
• providing appropriate financial reporting and disclosure personnel with broader access to underlying regulatory, clinical and non-financial source information;
• implementing functional or departmental sub-certifications designed to support the completeness of information considered in the disclosure process;
• implementing procedures to reconcile significant regulatory, clinical and non-financial source information to matters considered by the Disclosure Committee and other disclosure-process participants;
• establishing a documented escalation process for regulatory, clinical and non-financial developments, conflicting information and disagreements regarding disclosure matters;
• enhancing reporting of significant regulatory, clinical and non-financial and disclosure matters to the Audit Committee;
• strengthening monitoring of our Control Environment and management-override risk; and
• considering independent monitoring and testing of internal controls, including through the development of a more formal internal audit and Sarbanes-Oxley Act of 2002 compliance process.

We established a Disclosure Committee during fiscal 2026, and the Committee has begun performing its responsibilities in connection with our current-period reporting process.

Management is committed to remediating the material weakness and believes these actions are designed to remediate the material weakness. However, the material weakness will not be considered remediated until the applicable controls have been fully implemented, have operated for a sufficient period and management has concluded, through testing, that the controls are operating effectively. Accordingly, we cannot provide assurance that the material weakness will be remediated by a particular date.

Changes in Internal Control Over Financial Reporting

Except as noted above, during the quarter ended September 30, 2025, there were no changes in our internal control over financial reporting identified in management’s evaluation pursuant to Rules 13a 15(d) or 15d 15(d) of the Exchange Act that materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.