Form 8-K

8-K — ANAVEX LIFE SCIENCES CORP.

Accession: 0001731122-26-001143

Filed: 2026-08-25

Period: 2026-08-25

CIK: 0001314052

SIC: 2836 (BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES))

Item: Results of Operations and Financial Condition

Item: Financial Statements and Exhibits

Documents

8-K — e7897_8-k.htm (Primary)

EX-99.1 — EXHIBIT 99.1 (e7897_ex99-1.htm)

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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): August 25, 2026

ANAVEX

LIFE SCIENCES CORP.

(Exact name of Registrant as Specified in Its Charter)

Nevada

001-37606

98-0608404

(State or Other Jurisdiction

of Incorporation)

(Commission File Number)

(IRS 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

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:

☐ 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 August 25, 2026, Anavex Life Sciences Corp. (the “Company”)

issued a press release reporting financial results for its third quarter ended June 30, 2026 (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

Exhibit No.

Description

99.1

Press Release dated August 25, 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.

Date: August 25, 2026

By:

/s/ Sandra Boenisch

Sandra Boenisch, CPA, CGA

Principal Financial Officer, Treasurer

EX-99.1 — EXHIBIT 99.1

EX-99.1

Filename: e7897_ex99-1.htm · Sequence: 2

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 foundational clinical pharmacology studies and nonclinical work that are required for

a potential future approval of blarcamesine, and we anticipate the FDA will have the same

requirements.

● The

foundational clinical pharmacology studies for blarcamesine under the IND - the ADME study

and the DDI study - will provide critical support across the Company’s pipeline programs,

with the first participant visit in the ADME study recently completed and the last participant

in the DDI study expected to complete the last study visit by the end of September. This

will then represent the completion of the clinical conduct of the DDI study.

● Anavex

has refreshed and streamlined its Scientific Advisory Board to a focused group of Alzheimer’s

disease key opinion leaders and treating physicians, who have confirmed their continued interest

in supporting the Company’s efforts. Their input will be critical in designing a practical

and clear protocol, helping guide the development of blarcamesine from a physician and patient

perspective.

Rett Syndrome Program

● The

FDA has granted Orphan Drug Designation, Rare Pediatric Disease Designation and Fast Track

Designation for blarcamesine in Rett syndrome.

● The

Company is moving forward with initiating an adult Phase 3 study while working with the FDA

in parallel to align on the inclusion of pediatric patients in the program. Anavex has submitted

a formal meeting request to the FDA to discuss adding pediatric patients to the Company’s

approved protocol for a Phase 3 study (ANAVEX2-73-RS-005) in Rett syndrome.

● The

Company also plans to meet with the Clinical Trials Committee of the International Rett Syndrome

Foundation to work in tandem with this important patient advocacy foundation on the ANAVEX2-73-RS-005

study.

● The

planned ANAVEX2-73-RS-005 study is a Phase 3, randomized, double-blind, placebo-controlled,

study evaluating the safety, tolerability and efficacy of oral blarcamesine in approximately

170 participants with Rett syndrome. Participants are randomized 1:1 to blarcamesine or placebo

for a 16-week double-blind treatment period, followed by a safety follow-up period, with

the option to continue into an open-label extension.

Fragile X Syndrome Program

● The

Company is preparing to initiate the Fragile X clinical program. The IND for Fragile X syndrome

is expected to be submitted in September, supported by the Orphan Drug Designation already

granted by the FDA.

Nasdaq Compliance

● The

Company plans to file its outstanding Form 10-Q filings for the second and third fiscal quarters

of 2026 in the near term and continues to work diligently with Nasdaq to officially fully

regain compliance as quickly as possible.

Webcast / Conference Call Information

Anavex intends to host its next

webcast and conference call with its 2026 fourth quarter and full year fiscal financial results. Management will be available for select

meetings. Please email Investor Relations for further details.

Fiscal Third Quarter 2026 Highlights

Cash and cash equivalents were

$118.3 million as of June 30, 2026, compared to $102.6 million as of fiscal year end September 30, 2025. The Company’s cash balance

at the end of the third fiscal quarter of 2026 is expected to fund operations into mid to late fiscal 2028.

General and administrative expenses

(recovery) were $(2.0) million for the third fiscal quarter of 2026 compared to $4.5 million for the third fiscal quarter of 2025. The

decrease in expenses resulting in a net recovery was primarily related to the reversal of $7.5 million in stock-based compensation expense

during the period associated with the termination of employees, primarily the former Chief Executive Officer.

Research and development expenses

(recovery) were $(4.7) million for the third fiscal quarter of 2026 compared to $10.0 million for the third fiscal quarter of 2025. The

decrease in expenses resulting in a net recovery was primarily related to the reversal of $9.9 million in stock-based compensation expense

during the period associated with the termination of employees, primarily the former Chief Executive Officer.

Net income for the third fiscal

quarter was $7.8 million, or $0.08 per share, compared to a net loss of $13.2 million, or $0.16 per share, for the third fiscal quarter

of 2025. The decrease in net loss was primarily related to the recovery of stock-based compensation expense, as more fully described above.

About Anavex Life Sciences

Corp.

Anavex Life Sciences

Corp. (Nasdaq: AVXL) is a publicly traded clinical stage biopharmaceutical company engaged in the development of novel therapeutics for

the treatment of central nervous system (“CNS”) diseases with high unmet medical need. Further information is available at

www.anavex.com.

Forward-Looking Statements

Statements in this press release that are

not strictly historical in nature are forward-looking statements. These statements include, but are not limited to, statements

relating to the Company’s plans to prioritize engagement with the U.S. FDA to align on a clear, data-driven regulatory and

clinical development strategy; the Company’s plans to continue to execute on its mission of developing targeted, orally

delivered therapies for a specific range of CNS-related diseases; the timing, progress and results of advancement of ANAVEX 2-73 in

clinical programs for the treatment of early Alzheimer’s disease, Rett syndrome and Fragile X syndrome; the Company’s

plans to align with the FDA on a U.S. clinical development strategy for early Alzheimer’s disease, align on a Phase 3 protocol

for Rett syndrome that includes pediatric patients, and align on a clinical development strategy for the Fragile X clinical program;

the Company’s plans to file its outstanding Form 10-Q filings for the second and third fiscal quarters of 2026 in the near

term; and the Company’s expectations regarding its cash runway. These statements are based on current information and

expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in

any of such forward-looking statements due to various factors, including, but not limited to, risks related to the Company’s

ability to regain compliance with Nasdaq Listing Rule 5250(c)(1); the Company’s failure to timely file its Form 10-Q for the

quarterly period ended March 31, 2026 and June 30, 2026; the duration and outcomes of any current or future litigation related to

the termination of the Company’s former Chief Executive Officer and any related matters; volatility in the Company’s

stock price and the market in general; the Company’s ability to raise additional capital; challenges seeking, and ultimately

obtaining, regulatory approval for the Company’s product candidates; the ability of Fast Track designation or breakthrough

therapy designation to lead to a faster FDA review and approval process; the Company’s ability to maintain any benefits

associated with Orphan Drug Designation, including market exclusivity; undesirable side effects caused by the Company’s

product candidates; the Company’s ability to attract and retain highly qualified personnel; the Company’s reliance on

third-parties; the Company’s ability to obtain and maintain sufficient intellectual property protection for our product

candidates; the Company’s ability to defend against claims of intellectual property infringement; the Company’s ability

to compete in the highly competitive biotechnology and pharmaceutical industries; and other risks and uncertainties set forth in the

Company’s Annual Report on Form 10-K for the fiscal year ended September 30, 2025, and subsequent filings and furnishings with

the Securities and Exchange Commission. Readers are cautioned not to place undue reliance on these forward-looking statements, which

speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and

Anavex Life Sciences Corp. undertakes no obligation to revise or update this press release to reflect events or circumstances after

the date hereof except as required by law.

Investor Relations & Media

Contact:

SCR Partners, LLC

Alex Arzeno

Tel: 203-550-3972

Email: alex@scr-ir.com

Tripp Sullivan

Tel: 615-942-7077

Email: tsullivan@scr-ir.com

Company Contact:

Sandra Boenisch

Principal Financial Officer

Anavex Life Sciences Corp.

Tel: 1-844-689-3939

Email: ir@anavexcorp.com

Anavex

Life Sciences Corp.

Unaudited

Consolidated Statements of Operations and Comprehensive Loss

(in

thousands, except share and per share amounts)

Three

months ended

June

30,

2026

2025

Operating

expenses (recovery)

General

and administrative (recovery)

$ (2,032 )

$ 4,500

Research

and development (recovery)

(4,705 )

9,959

Total

operating expenses (recovery)

(6,737 )

14,459

Income

(Loss) from operations

6,737

(14,459 )

Total

other income, net

1,087

1,216

Net

income (loss) and comprehensive

income

(loss)

$ 7,824

$ (13,243 )

Net

Loss per share

Basic

$ 0.08

$ (0.16 )

Diluted

$ 0.08

$ (0.16 )

Weighted

average number of shares outstanding

Basic

92,696,842

85,380,587

Diluted

92,899,536

85,380,587

Anavex Life Sciences Corp.

Unaudited Consolidated Statements of Operations and Comprehensive Loss

(in thousands, except share and per share amounts)

Nine months ended

June 30,

2026

2025

Operating expenses

General and administrative

$ 2,385

$ 10,266

Research and development

4,144

30,298

Total operating expenses

6,529

40,564

Loss from operations

(6,529 )

(40,564 )

Total other income, net

3,352

4,014

Net loss before provision for income tax

$ (3,177 )

$ (36,550 )

Income tax expense

(18 )

—

Net loss and comprehensive loss

$ (3,195 )

$ (36,550 )

Net Loss per share

Basic and diluted

$ (0.03 )

$ (0.43 )

Weighted average number of shares outstanding

Basic and diluted

91,453,995

85,085,795

Anavex Life Sciences Corp.

Consolidated Balance Sheets

(in thousands)

June 30,

September 30,

2026

2025

(unaudited)

Assets

Current

Cash and cash equivalents

$ 118,326

$ 102,577

Incentive and tax receivables

995

809

Prepaid expenses

818

429

Total Assets

$ 120,139

$ 103,815

Liabilities and Stockholders' Equity

Current Liabilities

Accounts payable

$ 3,656

$ 4,249

Accrued liabilities

4,036

3,892

Deferred grant income

—

805

Total Current Liabilities

$ 7,692

$ 8,946

Commitments and Contingencies

Stockholders' equity

Common stock

Additional paid-in capital

497,997

477,230

Accumulated deficit

(385,643 )

(382,448 )

Total Stockholders' Equity

$ 112,447

$ 94,869

Total Liabilities and Stockholders' Equity

$ 120,139

$ 103,815

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- Definition

Trading symbol of an instrument as listed on an exchange.

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No definition available.

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- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as written communications pursuant to Rule 425 under the Securities Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Securities Act

-Number 230

-Section 425

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