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Form 8-K

sec.gov

8-K — ANAVEX LIFE SCIENCES CORP.

Accession: 0001731122-26-000988

Filed: 2026-07-30

Period: 2026-07-30

CIK: 0001314052

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

Item: Results of Operations and Financial Condition

Item: Financial Statements and Exhibits

Documents

8-K — e7813_8-k.htm (Primary)

EX-99.1 — EXIBIT 99.1 (e7813_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): July 30, 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 July 30, 2026, Anavex Life Sciences Corp. (the “Company”)

issued a press release reporting preliminary financial results for its second quarter ended March 30, 2026 (the “Press Release”).

The preliminary financial results in the Press Release are subject to completion of the Company’s financial closing procedures.

Actual results may vary materially from these preliminary financial results due to the completion of the Company’s financial closing

procedures and other developments or information that may arise between now and the time of the finalization of the Company’s financial

results for three and six months ended March 31, 2026. 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.

Cautionary Note Regarding Forward-Looking Statements

Statements in this Current Report on Form 8-K 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

preliminary financial results for the second quarter of fiscal 2026. 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, the risk that actual financial results may vary materially from the

preliminary financial results presented in the Press Release and other the 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 the Company undertakes no obligation

to revise or update these statements to reflect events or circumstances after the date hereof except as required by law.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.

Description

99.1

Press Release dated July 30, 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:

July 30, 2026

By:

/s/ Sandra Boenisch

Sandra Boenisch, CPA, CGA

Principal Financial Officer, Treasurer

EX-99.1 — EXIBIT 99.1

EX-99.1

Filename: e7813_ex99-1.htm · Sequence: 2

EXHIBIT 99.1

Anavex

Life Sciences Reports Preliminary Second Quarter 2026 Financial Results and Provides Business Update

Establishing

Disciplined, Data-Driven Strategy with Focus on FDA Engagement for Alzheimer’s Disease

New York, NY, July 30, 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 preliminary financial results

for its fiscal second quarter ended March 31, 2026. The Company’s primary focus is on advancing its lead compound ANAVEX®2-73

(blarcamesine) in the Company’s clinical program for the treatment of mild cognitive impairment (“MCI”) due to Alzheimer’s

disease (“AD”) and mild AD (collectively known as “early AD”), and for Rett syndrome and Fragile X syndrome, both

of which are neurodevelopmental rare diseases.

“Anavex remains firmly committed to our

lead candidate oral blarcamesine (ANAVEX®2-73) for patients with Alzheimer’s disease, and we are prioritizing engagement

with the U.S. FDA to align on a clear, data-driven regulatory and clinical development strategy,” stated Terrie Kellmeyer, PhD,

Interim Chief Executive Officer. “A qualified data-driven approach will guide every decision we make. I have spent nearly three

decades building and leading clinical and regulatory functions in drug development, and I’m bringing that experience to bear every

day as we implement a disciplined regulatory strategy and build the right foundation for our programs. We are committed to advancing blarcamesine

towards a clear regulatory path. I also want to recognize our employees, who have continued to show up for the patients who are counting

on us, and the patients and families living with Alzheimer’s disease, Rett syndrome and Fragile X, who are depending on us to continue

this important work on these urgent unmet medical needs. We are continuing to execute on the mission of developing targeted, orally delivered

therapies for a specific range of CNS related diseases.”

Business Update & Anticipated

Upcoming Milestones

· Anavex is prioritizing programs that the Company believes have the greatest

potential for success. The strategy concentrates resources on blarcamesine across three CNS indications: early Alzheimer’s disease

and Rett syndrome, where the Company’s clinical and regulatory foundation is most advanced, and Fragile X, where FDA Orphan Drug

Designation, supportive preclinical and biomarker data, and the absence of any approved therapy may lead to a promising regulatory path

with the FDA.

Alzheimer’s Disease

Program

· At the end of March 2026, the Company opened an Investigational New Drug

(IND) application for early Alzheimer’s disease with the FDA. This is an important milestone: the IND enables clinical studies to

be conducted in the U.S. and provides the basis for substantive discussions with the FDA to align on the Company’s future clinical

development for early Alzheimer’s disease.

§ Two foundational clinical pharmacology studies are proceeding under this

IND in the U.S.: an absorption, distribution, metabolism, and excretion (ADME) study and a drug-drug interaction (DDI) study with a goal

to strengthen and support the Company’s regulatory pathway for all blarcamesine indications.

§ The Company anticipates initiation of the ADME study to take place in the

third quarter of the 2026 calendar year, and dosing in the DDI study is already underway.

§ These studies are not sequential requirements. Rather, they support the overall

FDA regulatory requirements for blarcamesine while the Company continues to advance its early Alzheimer’s disease program in parallel.

· The Company intends to engage with the FDA on a U.S. clinical development

strategy for early Alzheimer’s disease. The Company continues to review the European Medicines Agency (EMA) Committee for Medicinal

Products for Human Use (CHMP) assessment report and intends to use it to inform and support its clinical development strategy with the

FDA.

· In July 2026, Anavex attended the Alzheimer’s Association International

Conference (AAIC) in London, England, which provided the Company with an opportunity to engage with clinicians, researchers and the broader

Alzheimer’s community and to reinforce the Company’s continued commitment to bringing a treatment option to market for patients

with early Alzheimer’s disease.

Rett Syndrome Program

· The FDA has already granted Orphan Drug Designation, Rare Pediatric Disease

(RPD) Designation and Fast Track Designation for blarcamesine in Rett syndrome.

§ The Company has aligned with the FDA on a Phase 3 clinical trial protocol

for Rett syndrome for adults only. The Company intends to discuss with the FDA adding pediatric patients to the protocol, with a more

detailed program update expected at a future date.

Fragile X Syndrome Program

· The FDA has already granted Orphan Drug Designation for Fragile X syndrome.

§ The Company plans to initiate discussions with the FDA on the clinical development

strategy for the Fragile X syndrome clinical program building on this designation, with further details to be shared as the program advances.

Nasdaq Compliance

· On July 20, 2026, the Company submitted a plan to regain compliance with

Nasdaq Listing Rule 5250(c)(1).

Preliminary Fiscal Second Quarter

2026 Highlights

The financial results in this

press release are preliminary and subject to completion of the Company’s financial closing procedures. Actual results may vary materially

from these preliminary financial results due to the completion of the Company’s financial closing procedures and other developments

or information that may arise between now and the time of the finalization of the Company’s financial results for three and six

months ended March 31, 2026.

Preliminary cash and cash equivalents

were $127.4 million as of March 31, 2026, compared to $102.6 million as of September 30, 2025. The Company expects the cash balance at

the end of the second fiscal quarter of 2026 to fund operations into mid-to-late fiscal 2028.

Preliminary general and administrative

expenses were $2.3 million for the second fiscal quarter of 2026 compared to $2.6 million for the second fiscal quarter of 2025. The decrease

was primarily related to a decrease in legal and professional fees over the comparable period.

Preliminary research and development

expenses were $4.2 million for the second fiscal quarter of 2026 compared to $9.9 million for the second fiscal quarter of 2025. The decrease

was primarily attributable to the completion of the ANAVEX® 3-71 clinical trial for schizophrenia and a decrease in clinical

manufacturing activities over the comparable period.

Preliminary Net loss for the second

fiscal quarter of 2026 was $5.3 million, or $0.06 per share, compared to a net loss of $11.2 million, or $0.13 per share, for the second

fiscal quarter of 2025.

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 preliminary financial results for the second quarter of 2026; 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,

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 in both adult and pediatric patients, and align on a clinical

development strategy for the Fragile X clinical program; 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 failure to timely file its Form 10-Q for the quarterly period ended March 31, 2026 and the Company’s

ability to regain compliance with Nasdaq Listing Rule 5250(c)(1); that actual financial results may vary materially from the preliminary

financial results presented in this press release; volatility in the Company’s stock price and the market in general; the Company’s

ability to raise additional capital; Fast Track designation that the Company has received or may seek out may not actually lead to a faster

FDA review and approval process; the Company may be unable 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 ability to obtain the support of qualified scientific collaborators; the Company’s

reliance on third parties; the Company’s ability to obtain and maintain sufficient intellectual property protection for its 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.

Preliminary

Condensed Consolidated Interim Statements of Operations and Comprehensive Loss1

(in

thousands, except share and per share amounts)

(Unaudited)

Three months ended March 31,

2026

2025

Operating Expenses

General and administrative

$ 2,292

$ 2,621

Research and development

4,192

9,892

Total operating expenses

6,484

12,513

Operating loss

(6,484 )

(12,513 )

Other income

Research and development incentive income

27

96

Interest income, net

1,061

1,210

Foreign exchange gain (loss)

58

11

Total other income, net

1,146

1,317

Net loss before provision for income taxes

(5,338 )

(11,196 )

Income tax expense, current

Net loss and comprehensive loss

$ (5,338 )

$ (11,196 )

Net loss per share

Basic and diluted

$ (0.06 )

$ (0.13 )

Weighted average number of shares outstanding

Basic and diluted

92,675,753

85,073,769

[1]

The financial results in this press release are preliminary and subject to completion of the Company’s financial closing procedures.

Actual results may vary materially from these preliminary financial results due to the completion of the Company’s financial closing

procedures and other developments or information that may arise between now and the time of the finalization of the Company’s financial

results for three and six months ended March 31, 2026.

Anavex

Life Sciences Corp.

Preliminary

Condensed Consolidated Interim Statements of Operations and Comprehensive Loss2

(in

thousands, except share and per share amounts)

(Unaudited)

Six months ended March 31,

2026

2025

Operating Expenses

General and administrative

$ 4,417

$ 5,767

Research and development

8,849

20,338

Total operating expenses

13,266

26,105

Operating loss

(13,266 )

(26,105 )

Other income

Grant income

12

Research and development incentive income

60

508

Interest income, net

2,140

2,604

Foreign exchange gain (loss)

65

(326 )

Total other income, net

2,265

2,798

Net loss before provision for income taxes

(11,001 )

(23,307 )

Income tax expense, current

(18 )

Net loss and comprehensive loss

$ (11,019 )

$ (23,307 )

Net loss per share

Basic and diluted

$ (0.12 )

$ (0.27 )

Weighted average number of shares outstanding

Basic and diluted

90,832,571

84,938,400

[2]

The financial results in this press release are preliminary and subject to completion of the Company’s financial closing procedures.

Actual results may vary materially from these preliminary financial results due to the completion of the Company’s financial closing

procedures and other developments or information that may arise between now and the time of the finalization of the Company’s financial

results for three and six months ended March 31, 2026.

Anavex Life Sciences Corp.

Preliminary Condensed Consolidated Interim Balance Sheets[3]

(in thousands, except share and per share amounts)

(Unaudited)

March 31, 2026

September 30, 2025

Assets

(unaudited)

Current

Cash and cash equivalents

$ 127,422

$ 102,577

Incentive and tax receivables

932

809

Prepaid expenses and other current assets

412

429

Total Assets

$ 128,766

$ 103,815

Liabilities and stockholders’ equity

Current Liabilities

Accounts payable

$ 2,520

$ 4,249

Accrued liabilities

3,734

3,892

Deferred grant income

805

805

Total Liabilities

7,059

8,946

Capital Stock

93

87

Additional paid-in capital

515,081

477,230

Accumulated deficit

(393,467 )

(382,448 )

Total Stockholders’ Equity

121,707

94,869

Total Liabilities and Stockholders’ Equity

$ 128,766

$ 103,815

[3]

The financial results in this press release are preliminary and subject to completion of the Company’s financial closing procedures.

Actual results may vary materially from these preliminary financial results due to the completion of the Company’s financial closing

procedures and other developments or information that may arise between now and the time of the finalization of the Company’s financial

results for three and six months ended March 31, 2026.

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Name of the Exchange on which a security is registered.

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

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Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as soliciting material pursuant to Rule 14a-12 under the Exchange Act.

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

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Trading symbol of an instrument as listed on an exchange.

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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.

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

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