Company to host a webcast today at 8:30 a.m. Eastern Time

NEW YORK, May  13, 2025  (GLOBE NEWSWIRE) -- 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 second quarter of fiscal 2025.

“Anavex’s portfolio with non-invasive targeted upstream precision compounds continues to advance with special focus on Alzheimer’s disease and schizophrenia. We also continue to receive feedback from neurologists preferring convenient orally available and clinically meaningful Alzheimer’s disease treatment options, which can be accessed without logistical restrictions,” said Christopher U Missling, PhD, President and Chief Executive Officer of Anavex. “Furthermore, we were excited to recently present open-label-extension data of blarcamesine for Alzheimer’s disease at AD/PD™ 2025, which confirmed continued clinically meaningful benefit for early Alzheimer’s disease patients.”

Recent Highlights:

On May 1, 2025, Anavex announced the successful completion of enrollment in its Phase 2 clinical study of ANAVEX®3-71 for the treatment of schizophrenia (ANAVEX3-71-SZ-001, NCT06245213). The study has enrolled a total of 71 participants, with 16 participants in Part A and 55 participants in Part B. Part A of the study, which investigated multiple ascending doses, has been completed with encouraging preliminary safety and electroencephalography (EEG) biomarker results previously reported. Part B, which includes more participants and a longer treatment duration, will provide more comprehensive clinical and biomarker data on the efficacy and safety of ANAVEX®3-71 in individuals with schizophrenia. The Company expects to report top-line data from the study in the second half of 2025.On April 23, 2025, Anavex announced the appointment of Professor Dr. Audrey Gabelle, MD, PhD, a specialist of predictive, personalized medicine and digital health in Alzheimer' disease and related disorders, to the Anavex Scientific Advisory Board. Dr. Audrey Gabelle is a Professor of Neurology, MD, PhD, Neurologist and Doctor in Neurosciences at the Memory Resources Research Center, the Rare and Early Dementia Reference Center and the European Neurodegenerative Excellence Center of Montpellier University. Dr. Gabelle is also a researcher at the Montpellier Institute of Neurosciences and member of the European Alzheimer’s Disease Consortium.On April 21, 2025, Anavex announced that Marwan Noel Sabbagh, MD, Professor of Neurology at Barrow Neurological Institute and Chairman of Anavex’s Scientific Advisory Board gave an oral presentation titled, “Oral Blarcamesine Novel Mechanism for Alzheimer Disease: Autophagy Restoration through Upstream SIGMAR1 Activation Clinical Efficacy Phase IIb/III Trial” at the 9th International Conference on Alzheimer’s Disease and Related Disorders in the Middle East.On April 5, 2025, Anavex provided additional long-term data from the Phase IIb/III ATTENTION-AD Open-Label-Extension (OLE) trial. Once-daily oral blarcamesine demonstrated over three years of continuous treatment significant amelioration on clinical decline and showed continued clinically meaningful benefit for early Alzheimer’s disease patients. Blarcamesine-treated patients continue to accrue benefit through up to 4 years, as measured by the clinical endpoints ADAS-Cog13 and ADCS-ADL. The ATTENTION-AD (ANAVEX®2-73-AD-EP-004) trial result was presented at the AD/PDTM 2025 Conference.

Financial Highlights:

Cash and cash equivalents of $115.8 million at March 31, 2025 compared to $132.2 million at year ended September 30, 2024. As of quarter end, the Company anticipates at current cash utilization rates and ranges, a runway of approximately 4 years.General and administrative expenses for the quarter of $2.6 million compared to $2.9 million for the comparable quarter of fiscal 2024.Research and development expenses for the quarter of $9.9 million compared to $9.7 million for the comparable quarter of fiscal 2024.Net loss for the second quarter of $11.2 million, or $0.13 per share, compared to a net loss of $10.5 million, or $0.13 per share for the comparable quarter of fiscal 2024.

The financial information for the quarter ended March 31, 2025, should be read in conjunction with the Company’s consolidated financial statements, which will appear on EDGAR, www.sec.gov and will be available on the Anavex website at www.anavex.com.

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# 856 5033 5285 and reference passcode 014 352. A replay of the conference call will also 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 Statements of Operations and Comprehensive Loss(in thousands, except share and per share amounts)
(Unaudited)  Three months ended March 31, 2025  2024 Operating Expenses General and administrative$2,621 $2,895 Research and development 9,892  9,729 Total operating expenses 12,513  12,624 Operating loss (12,513) (12,624) Other income Research and development incentive income 96  472 Interest income, net 1,210  1,756 Foreign exchange gain 11  (150)Total other income, net 1,317  2,078 Net loss and comprehensive loss$(11,196)$(10,546) Net loss per share Basic and diluted$(0.13)$(0.13) Weighted average number of shares outstanding Basic and diluted 85,073,769  82,464,226

Anavex Life Sciences Corp.Condensed Consolidated Statements of Operations and Comprehensive Loss(in thousands, except share and per share amounts)
(Unaudited)  Six months ended March 31, 2025  2024 Operating Expenses General and administrative$ 5,767 $ 5,590 Research and development  20,338   18,413 Total operating expenses  26,105    24,003 Operating loss  (26,105)  (24,003) Other income (expense) Grant income  12   - Research and development incentive income  508   1,064 Interest income, net  2,604   3,764 Foreign exchange gain (loss)  (326 )  7 Total other income, net  2,798   4,835 Net loss and comprehensive loss$ (23,307)$ (19,168) Net loss per share Basic and diluted$ (0.27)$ (0.23) Weighted average number of shares outstanding Basic and diluted 84,938,400   82,269,965

Anavex Life Sciences Corp. Condensed Consolidated Balance Sheets (in thousands, except share and per share amounts)    March 31,September 30,  2025  2024 Assets Current Cash and cash equivalents$ 115,771 $ 132,187 Incentive and tax receivables  666   2,449 Prepaid expenses and other current assets  702   931 Total Assets$ 117,139 $ 135,567  Liabilities and stockholders' equity Current Liabilities Accounts payable$ 6,997 $ 9,627 Accrued liabilities  9,555   4,835 Deferred grant income  829   842 Total Liabilities  17,381   15,304 Capital Stock  85   85 Additional paid-in capital  459,051   456,249 Accumulated deficit  (359,378)  (336,071) Total Stockholders' Equity  99,758   120,263 Total Liabilities and Stockholders' Equity$ 117,139 $ 135,567

For Further Information:
Anavex Life Sciences Corp.
Research & Business Development
Toll-free: 1-844-689-3939
Email: [email protected]

Investors: Andrew J. Barwicki
Investor Relations
Tel: 516-662-9461
Email: [email protected]