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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 |
|
EXHIBIT 99.1
Anavex Life Sciences Reports
Fiscal 2026 First Quarter Financial Results and
Provides Business Update
Company to host a webcast
today at 8:30 am Eastern Time
NEW YORK – February 9, 2026 – Anavex
Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company focused
on developing innovative treatments for Alzheimer’s disease, Parkinson’s disease, schizophrenia, neurodevelopmental, neurodegenerative,
and rare diseases, including Rett syndrome, and other central nervous system (CNS) disorders, today reported financial results for its
first quarter of fiscal 2026.
“As we have entered 2026, we continue to progress
our innovative clinical pipeline with particular focus on our lead candidate, oral blarcamesine in early Alzheimer’s disease. Based
on our commitment to improving the lives of patients with neurological disorders, we remain excited about the therapeutic potential of
oral blarcamesine. We look forward to working with the regulatory agencies in Europe and the U.S. to advance oral blarcamesine as a potential
new treatment option for patients.” said Christopher U. Missling, PhD, President and CEO of Anavex. “An estimated 7.2 million
people in the U.S. and 7 million in Europe are living with Alzheimer’s disease. Our mission is to develop targeted, orally
delivered therapies aimed at a range of CNS related diseases, and specifically early-stage Alzheimer’s, where intervention may have
the greatest impact.”
Expected Development Milestones:
| ● | Update on regulatory pathway for blarcamesine in early Alzheimer’s disease |
| ● | Progress on clinical development program in Parkinson’s disease through targeted approach, potentially addressing the highest
disease burden in Parkinson’s disease |
| ● | Regulatory and clinical trial update for blarcamesine in Parkinson’s disease |
| ● | Regulatory and clinical trial update for blarcamesine in Rett syndrome |
| ● | Fragile X development update: Design of Phase 2/3 clinical trial |
| ● | Advancing ANAVEX®3-71 towards pivotal clinical studies for the treatment of schizophrenia related disorders |
| ● | Progressing collaborative initiatives and strategic partnership activities |
| ● | New scientific findings to be presented at upcoming conferences or publications: |
| o | Oral Presentation at 16th Intrinsic Capacity, Frailty and Sarcopenia Research Conference for Healthy Longevity (ICFSR26),
to be held on March 10-12, 2026 at Johns Hopkins University Bloomberg Center Washington, D.C.: “Exploring Treatment for
Older Adults with Pre-Frailty to Mitigate Cognitive and Physical Decline Targeting Autophagy with Oral Blarcamesine” |
| o | Clinical relationship with biomarker: Correlation between clinical endpoints and reduced brain region atrophy with blarcamesine
in early Alzheimer’s disease |
| o | Publication Alzheimer’s disease: Precision Medicine ABCLEAR populations of the ANAVEX®2-73-AD-004 Phase
2b/3 trial |
| o | Publication Alzheimer’s disease: Precision Medicine gene, COL24A1, with estimated >70% prevalence in the early AD
population has the potential to establish effective treatment of early Alzheimer’s disease through effectiveness of autophagy-enhancing
blarcamesine |
| o | Publication Fragile X: Blarcamesine corrects EEG biomarkers of cortical dysfunction in a mouse model of fragile X syndrome |
Recent Corporate Developments:
| ● | On January 13, 2026, Anavex announced its participation as a key industry partner in ACCESS-AD, a major
new European initiative designed to accelerate the adoption of innovative diagnostic and therapeutic approaches for Alzheimer’s
disease across real-world clinical settings. The multi-year program is funded by the European Commission’s Innovative Health Initiative
(IHI) and unites leading academic centers, technology developers, industry innovators and patient organizations to strengthen equitable
access to timely and effective Alzheimer’s disease care. |
| ● | On January 8, 2026, Anavex announced the appointment of Wolfgang Liedtke, MD PhD, as Senior Vice President,
Global Head of Neurology. Dr. Liedtke is a board-certified neurologist, who brings more than 25 years of extensive experience in developing
and delivering innovative medicines in a broad range of CNS diseases, including genetic medicines and global therapeutic development.
Most recently he was Chair of Neurology at Regeneron, where he oversaw the integration of discovery into 45 clinical trials (14 Phase
3 studies). |
| ● | On January 6, 2026, Anavex announced feedback from the FDA Type C meeting, in which the FDA shared their
interest and collaborative approach to Anavex’ development plans. The meeting discussed the potential pathways to support an NDA
(New Drug Application) for the treatment of Alzheimer’s disease. In order to move forward, existing data from the Phase IIb/III
ANAVEX2-73-AD-004 program requested by the Agency will be submitted. |
| ● | On December 12, 2025, Anavex provided an update on the regulatory review in the EU for blarcamesine to
treat early Alzheimer’s disease. The CHMP has adopted a negative opinion on the marketing authorisation application for blarcamesine
and, on December 18, 2025, Anavex announced it had requested the EMA to re-examine its opinion. Anavex intends to work closely with the
EMA during the process, which is led by a different rapporteur and co-rapporteur. |
| ● | On November 26, 2025, Anavex announced the presentations at the 18th Clinical Trials on Alzheimer’s
Disease (CTAD) Conference in San Diego, CA. The oral late breaking communication: ‘Oral Blarcamesine Phase IIb/III Trial Confirms
Identified Precision Medicine Patient Population – Significant Broad Clinical and Quality of Life Improvements for Early Alzheimer’s
Disease Patients’, and two poster presentations, titled: ‘Oral Blarcamesine Comparison to Normal Cognitive Aging: Demonstrating
Alignment with Prodromal Cognitive Aging Trajectories in Precision Medicine Patient Population Phase IIb/III Trial – for Early Alzheimer’s
Disease Patients’ and ‘Advancing Alzheimer’s Disease Care: Convenience for Both Patients and Families with Oral Blarcamesine’
featuring blarcamesine’. |
Financial Highlights:
| ● | Cash and cash equivalents of $131.7 million at December 31, 2025 compared to $102.6 million at September
30, 2025. The Company anticipates at its current cash utilization rate, an approximate cash runway of more than 3 years. |
| ● | Research and development expenses for the quarter of $4.7 million compared to $10.4 million for the comparable
quarter of fiscal 2025. |
| ● | General and administrative expenses for the quarter of $2.1 million compared to $3.1 million for the comparable
quarter of fiscal 2025. |
| ● | Net loss for the quarter of $5.7 million, or $0.06 per share, compared to a net loss of $12.1 million,
or $0.14 per share for the comparable fourth quarter of fiscal 2025. |
The financial information for the
fiscal quarter should be read in conjunction with the Company’s condensed consolidated interim financial statements, which will
appear on EDGAR, www.sec.gov.
Webcast / Conference Call Information:
The live webcast of the conference
call will be available on Anavex’s website at www.anavex.com.
The conference call can be also accessed by dialing
1 929 205 6099 for participants in the U.S. using the Meeting ID# 844 4149 6344 and reference passcode 789539. A replay of the conference
call will be available on Anavex’s website for up to 30 days.
About Anavex Life Sciences Corp.
Anavex Life Sciences Corp. (Nasdaq: AVXL) is a publicly
traded biopharmaceutical company dedicated to the development of novel therapeutics for the treatment of neurodegenerative, neurodevelopmental,
and neuropsychiatric disorders, including Alzheimer’s disease, Parkinson’s disease, schizophrenia, Rett syndrome, and other
central nervous system (CNS) diseases, pain, and various types of cancer. Anavex’s lead drug candidate, ANAVEX®2-73 (blarcamesine),
has successfully completed a Phase 2a and a Phase 2b/3 clinical trial for Alzheimer’s disease, a Phase 2 proof-of-concept study
in Parkinson’s disease dementia, and both a Phase 2 and a Phase 3 study in adult patients and one Phase 2/3 study in pediatric patients
with Rett syndrome. ANAVEX®2-73 is an orally available drug candidate designed to restore cellular homeostasis by targeting SIGMAR1
and muscarinic receptors. Preclinical studies demonstrated its potential to halt and/or reverse the course of Alzheimer’s disease.
ANAVEX®2-73 also exhibited anticonvulsant, anti-amnesic, neuroprotective, and anti-depressant properties in animal models, indicating
its potential to treat additional CNS disorders, including epilepsy. The Michael J. Fox Foundation for Parkinson’s Research previously
awarded Anavex a research grant, which fully funded a preclinical study to develop ANAVEX®2-73 for the treatment of Parkinson’s
disease. We believe that ANAVEX®3-71, which targets SIGMAR1 and M1 muscarinic receptors, is a promising clinical stage drug candidate
demonstrating disease-modifying activity against the major hallmarks of Alzheimer’s disease in transgenic (3xTg-AD) mice, including
cognitive deficits, amyloid, and tau pathologies. In preclinical trials, ANAVEX®3-71 has shown beneficial effects on mitochondrial
dysfunction and neuroinflammation. Further information is available at www.anavex.com.
You can also connect with the Company on Twitter, Facebook, Instagram, and LinkedIn.
Forward-Looking Statements
Statements in this press release that
are not strictly historical in nature are forward-looking statements. These statements are only predictions 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 statements due to various factors, including the risks set forth in the Company’s most recent Annual Report on Form
10-K filed with the SEC. 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.
| Anavex Life Sciences Corp. |
| Condensed Consolidated interim Statements of Operations and Comprehensive Loss |
| (in thousands, except share and per share amounts) |
| |
| |
|
Three months ended December 31, |
| |
|
2025 |
|
2024 |
| Operating Expenses |
|
|
|
|
|
|
|
|
| General and administrative |
|
$ |
2,126 |
|
|
$ |
3,146 |
|
| Research and development |
|
|
4,656 |
|
|
|
10,446 |
|
| Total operating expenses |
|
|
6,782 |
|
|
|
13,592 |
|
| Operating loss |
|
|
(6,782 |
) |
|
|
(13,592 |
) |
| |
|
|
|
|
|
|
|
|
| Other income |
|
|
|
|
|
|
|
|
| Grant income |
|
|
— |
|
|
|
12 |
|
| Research and development incentive income |
|
|
33 |
|
|
|
412 |
|
| Interest income, net |
|
|
1,079 |
|
|
|
1,394 |
|
| Foreign exchange gain (loss) |
|
|
7 |
|
|
|
(337 |
) |
| Total other income, net |
|
|
1,119 |
|
|
|
1,481 |
|
| Net loss before provision for income taxes |
|
|
(5,663 |
) |
|
|
(12,111 |
) |
| Income tax expense, current |
|
|
(18 |
) |
|
|
— |
|
| Net loss and comprehensive loss |
|
$ |
(5,681 |
) |
|
$ |
(12,111 |
) |
| |
|
|
|
|
|
|
|
|
| Net loss per share |
|
|
|
|
|
|
|
|
| Basic and diluted |
|
$ |
(0.06 |
) |
|
$ |
(0.14 |
) |
| |
|
|
|
|
|
|
|
|
| Weighted average number of shares outstanding |
|
|
|
|
|
|
|
|
| Basic and diluted |
|
|
89,029,458 |
|
|
|
84,805,974 |
|
| Anavex Life Sciences Corp. |
| Condensed Consolidated Interim Balance Sheets |
| (in thousands, except share and per share amounts) |
| |
|
|
|
|
| |
|
December 31, 2025 |
|
September 30, 2025 |
| Assets |
|
(unaudited) |
|
|
| Current |
|
|
|
|
|
|
|
|
| Cash and cash equivalents |
|
$ |
131,749 |
|
|
$ |
102,577 |
|
| Incentive and tax receivables |
|
|
844 |
|
|
|
809 |
|
| Prepaid expenses and other current assets |
|
|
396 |
|
|
|
429 |
|
| Total Assets |
|
$ |
132,989 |
|
|
$ |
103,815 |
|
| |
|
|
|
|
|
|
|
|
| Liabilities and stockholders’ equity |
|
|
|
|
|
|
|
|
| Current Liabilities |
|
|
|
|
|
|
|
|
| Accounts payable |
|
$ |
2,639 |
|
|
$ |
4,249 |
|
| Accrued liabilities |
|
|
2,927 |
|
|
|
3,892 |
|
| Deferred grant income |
|
|
805 |
|
|
|
805 |
|
| Total Liabilities |
|
|
6,371 |
|
|
|
8,946 |
|
| Capital Stock |
|
|
93 |
|
|
|
87 |
|
| Additional paid-in capital |
|
|
514,654 |
|
|
|
477,230 |
|
| Accumulated deficit |
|
|
(388,129 |
) |
|
|
(382,448 |
) |
| Total Stockholders’ Equity |
|
|
126,618 |
|
|
|
94,869 |
|
| Total Liabilities and Stockholders’ Equity |
|
$ |
132,989 |
|
|
$ |
103,815 |
|
For Further Information:
Anavex Life Sciences Corp.
Research & Business Development
Toll-free: 1-844-689-3939
Email: info@anavex.com
Investors:
Andrew
J. Barwicki
Investor
Relations
Tel:
516-662-9461
Email:
andrew@barwicki.com
