Anavex Life Sciences Presents New Data from its AD-004 Phase IIb/III Trial at AD/PD 2026 Conference Demonstrating Consistent Correlation Between the Treatment Effect of Oral[...]

New data show brain-volume preservation correlates with patient outcomes

Long-term clinical data indicate 77.4 weeks (17.8 months) time saved with oral blarcamesine compared to ADNI[1] control group after 144 weeks (33.1 months) of treatment

Oral presentation at the AD/PD^TM 2026 Conference Symposium: 'Advances in AD treatment' highlights the convenience of oral blarcamesine for both patients and families

NEW YORK - March 23, 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 announced new data of blarcamesine was presented at the AD/PD^TM 2026 Conference by Prof. Dr. Timo Grimmer, MD, and collaborators, titled, Advancing Alzheimer's Disease Care: Convenience for both Patients and Families with Oral Blarcamesine with Long-term Time Saved, drawing from the ANAVEX®2-73-AD-004 (NCT03790709) Phase IIb/III clinical program and its long-term open-label extension, ANAVEX®2-73-AD-EP-004 (NCT04314934).

"The patient-friendly oral administration, the manageable side effects, and the clinical efficacy-particularly in the genetically defined ABCLEAR3[2] population-make blarcamesine, in conjunction with the associated biomarker signal, a promising drug candidate for patients with early-stage Alzheimer's disease," said Prof. Dr Timo Grimmer, MD, member of the Anavex Scientific Advisory Board and National Coordinating Investigator for the blarcamesine Phase IIb/III ANAVEX®2-73-AD-004 study. "Alzheimer's disease is a devastating chronic disease that affects millions worldwide. We believe, these new results will contribute to the growing body of scientific data demonstrating the long-term beneficial effect of blarcamesine in early Alzheimer's disease."

Data from the ANAVEX®2-73-AD-004 study also show that patients with wild-type (WT) SIGMAR1 and COL24A1 genes, the ABCLEAR3² population, may experience substantially greater clinical and structural benefit from blarcamesine. This reinforces Anavex's precision medicine strategy, leveraging genomic and biomarker-based indicators to optimize therapeutic efficacy.[3]

A dedicated analysis of MRI biomarkers demonstrated a highly consistent correlation between slowing of atrophy and improvements across primary and secondary clinical endpoints, including:

• ADAS-Cog13 (cognition)
• ADCS-ADL (activities of daily living)
• CDR-SB (global clinical cognitive and functional outcome)

In the genetically defined ABCLEAR3² precision medicine population, the correlation (R²) strength improved markedly, with R² increasing by 78% for ADAS-Cog13 (from R²=0.23 to R²=0.41)-firmly within the "very suggestive" range for clinical relevance.

"These results indicate that blarcamesine's clinical effects are biologically coherent with MRI-based measures of neuroprotection," said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex. "The consistent relation between structural preservation of brain volume and functional outcomes further drives our dedication to developing a novel disease-modifying Alzheimer's treatment with our oral blarcamesine."

The AD/PD™ 2026 Conference presentation is available on the Investors section of the Company's website at https://www.anavex.com.

This release discusses investigational uses of an agent in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that any investigational uses of such product will successfully complete clinical development or gain health authority approval.

About AD/PD™ 2026 Conference

The AD/PD™ Alzheimer's Disease and Parkinson's Disease Conference will present all the latest breakthroughs in treatment, translational R&D, early diagnosis, drug development, and clinical trials in Alzheimer's, Parkinson's, and other related neurological disorders.

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, blarcamesine (ANAVEX®2-73), 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. Blarcamesine 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. Blarcamesine 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 blarcamesine 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.

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]

[1] ADNI = Alzheimer's Disease Neuroimaging Initiative. https://adni.loni.usc.edu

[2] ABCLEAR3 = Alzheimer's Blarcamesine Cognition Efficacy and Resilience gene variants non-carrier population (SIGMAR1 wild type [WT]/COL24A1 wild type [WT])

[3] https://www.medrxiv.org/content/10.1101/2025.09.27.25336656v1.full.pdf