AVXL

EX-99.1

2 e7897_ex99-1.htm

EXHIBIT 99.1

EXHIBIT 99.1

Anavex Life Sciences Reports Third Fiscal Quarter 2026 Financial Results and Business Update

Clinical Development Strategy for Alzheimer’s Disease Remains the Focus as Anavex Advances Regulatory Progress Across All Three Programs

Anavex Submits Completed Alzheimer’s Disease Clinical Study Data and Rett Syndrome Formal Meeting Request to FDA, with an IND Submission for Fragile X Syndrome Planned for September

NEW YORK, NY,

August 25, 2026 - Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company focused on developing innovative treatments for central nervous system (“CNS”) diseases with high unmet medical needs, today reported a business update and financial results for its third fiscal quarter ended June 30, 2026.

“I am delighted to report on the continued regulatory momentum we are building across our pipeline. We have submitted all data from our Alzheimer’s disease clinical trials to our newly opened Alzheimer’s IND. These clinical data will serve as the foundation to advance our discussions with the U.S. Food and Drug Administration (“FDA”) regarding our U.S. clinical development program and Phase 3 protocol design for Alzheimer’s disease,” stated Terrie Kellmeyer, Ph.D., Interim Chief Executive Officer. “At the same time, we continue to advance our two essential clinical pharmacology studies, which are required for all indications across our pipeline. We are moving quickly to complete both: the first participant visit occurred in the Absorption, Distribution, Metabolism and Elimination (ADME) study, and the last participant visit is expected by the end of September in the ongoing Drug-drug Interaction (DDI) study. For Rett syndrome, we are moving our adult Phase 3 study forward as quickly as possible, and we have submitted a meeting request to the FDA to discuss adding pediatric patients to the study. In Fragile X syndrome, we expect to submit our IND to the FDA in September. We remain focused on the three indications that we believe demonstrate the most promising regulatory paths forward, serving both our patients and shareholders. We are taking a methodical, financially disciplined, stepwise approach to advance each of our programs along an FDA-aligned regulatory and clinical path.”

Business Update, Recent and Upcoming Milestones

●The Company’s primary focus is advancing its lead compound ANAVEX®2-73 (blarcamesine) for the treatment of mild cognitive impairment due to Alzheimer’s disease (“AD”) and mild AD (collectively known as “early AD”), and for Rett syndrome and Fragile X syndrome. These three indications are the Company’s core focus.

●Anavex will be attending the following upcoming 2026 events:

●The NORD Rare Diseases and Orphan Products Breakthrough Summit taking place on October 25-27 in Washington, DC.

●BIO-Europe 2026 Conference taking place on November 9–11 in Cologne, Germany.

●19th Clinical Trials on Alzheimer’s Disease Conference as a Silver Sponsor with one poster

presentation taking place on November 16-19 in Boston, MA.

Alzheimer’s Disease Program

●Anavex has submitted all data from its Alzheimer’s disease clinical trials to its newly opened Alzheimer’s IND. The Company is using feedback from the European Medicines Agency’s (“EMA”) Committee for Medicinal Products for Human Use (“CHMP”) on its Marketing Authorization Application (“MAA”), together with the EMA’s scientific advice described below and feedback from its Type C meeting with the FDA held in November 2025, to properly position these completed studies within its overall clinical development plan.

●These data and feedback will serve as the foundation for planned discussions with the FDA regarding its U.S. clinical development program and design of a Phase 3 study (ANAVEX2-73-AD-005) for an Alzheimer’s indication. This is a critical step in establishing a solid partnership with the FDA and educating the agency on the Company’s current data package.

●In June 2026, Anavex received Scientific Advice from the EMA, addressing the overall design of the proposed Phase 3 study (ANAVEX2-73-AD-005), including study population, endpoint hierarchy, treatment duration, statistical framework and subgroup strategy.

●Anavex intends to incorporate this additional feedback into its planned discussions with the FDA regarding its Phase 3 study design and the overall development program for blarcamesine, as the Company’s near-term regulatory focus remains on the U.S. path forward. A Phase 3 study in Europe is not being pursued at this time, though it may be considered as part of the program’s development in the future. With EMA feedback now incorporated, Anavex plans to further discuss its proposed Phase 3 protocol with the FDA, with the goal of achieving a strong, well-aligned study design across both regulatory agencies.

●The Company has completed its review of the EMA CHMP assessment report, which clearly outlined the

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UNITED

STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM

8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): February 9, 2026

ANAVEX

LIFE SCIENCES CORP.

(Exact name of registrant as specified in its charter)

Nevada 001-37606 98-0608404

(State or other jurisdiction (Commission (IRS Employer

of incorporation) File Number) Identification No.)

630 5th Avenue, 20th Floor, New York, NY USA 10111

(Address of principal executive offices) (Zip Code)

1-844-689-3939

Registrant’s telephone number, including area code

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a -12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d -2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e -4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of Each Class

Trading Symbol(s)

Name of Each Exchange on which

Registered

Common Stock, par value $0.001 per share

AVXL

Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

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. ☐

Item 2.02 Results of Operations and Financial Condition.

On February 9, 2026, Anavex Life Sciences Corp. (the “Company”) issued a press release reporting financial results for its fiscal quarter ended December 31, 2025 (the “Press Release”). A copy of the Press Release is furnished as Exhibit 99.1 to this Current Report and is incorporated herein by reference.

The information furnished pursuant to Item 2.02 of this Current Report, including Exhibit 99.1 attached hereto, shall not be considered “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liability of such section, nor shall it be incorporated by reference into future filings by the Company under the Securities Act of 1933, as amended, or under the Exchange Act, unless the Company expressly sets forth in such future filing that such information is to be considered “filed” or incorporated by reference therein.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

99.1

Press Release of the Company dated February 9, 2026

104

Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

ANAVEX LIFE SCIENCES CORP.

/s/ Christopher Missling

Name: Christopher Missling, PhD

Title: Chief Executive Officer

Date: February 9, 2026