NASDAQ: AVXL

NASDAQ: AVXL

Anavex Life Sciences Reports Fiscal 2025 Second Quarter Financial Results and Provides Business Update

May 13, 2025

NEW YORK – May 13, 2025

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, which investigated multiple ascending doses, has been completed with encouraging preliminary safety and EEG biomarker results. Part B will provide more comprehensive clinical and biomarker data. The Company expects to report top-line data in the second half of 2025.
  • On April 23, 2025, Anavex announced the appointment of Professor Dr. Audrey Gabelle, MD, PhD, a specialist in predictive, personalized medicine and digital health in Alzheimer’s disease and related disorders, to the Anavex Scientific Advisory Board. Dr. Gabelle is a Professor of Neurology at the Memory Resources Research Center and the Rare and Early Dementia Reference Center, as well as a researcher at the Montpellier Institute of Neurosciences and a 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, presented “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 of clinical decline and continued clinically meaningful benefit for early Alzheimer’s disease patients, with benefits accruing through up to four years as measured by ADAS-Cog13 and ADCS-ADL. Results were presented at the AD/PD™ 2025 Conference.

Financial Highlights:

  • Cash and cash equivalents were $115.8 million at March 31, 2025, compared to $132.2 million at year-end September 30, 2024. The Company anticipates a runway of approximately 4 years based on current utilization rates.
  • General and administrative expenses for the quarter were $2.6 million compared to $2.9 million for the comparable quarter of fiscal 2024.
  • Research and development expenses for the quarter were $9.9 million compared to $9.7 million for the comparable quarter of fiscal 2024.
  • Net loss for the second quarter was $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 also be accessed by dialing 1-929-205-6099 for participants in the U.S. using Meeting ID# 856 5033 5285 and passcode 014 352. A replay will be available on the Company’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 neurodegenerative, neurodevelopmental, and neuropsychiatric disorders, including Alzheimer’s disease, Parkinson’s disease, schizophrenia, Rett syndrome, and other CNS diseases, pain, and various cancers.

Anavex’s lead drug candidate, ANAVEX®2-73 (blarcamesine), has successfully completed a Phase 2a and a Phase 2b/3 trial for Alzheimer’s disease, a Phase 2 proof-of-concept study in Parkinson’s disease dementia, and both Phase 2 and Phase 3 studies in adult patients and a Phase 2/3 study in pediatric patients with Rett syndrome. ANAVEX®2-73 is designed to restore cellular homeostasis by targeting SIGMAR1 and muscarinic receptors. Preclinical studies demonstrated potential to halt or reverse Alzheimer’s disease progression. The compound also exhibited anticonvulsant, anti-amnesic, neuroprotective, and anti-depressant properties in animal models.

ANAVEX®3-71 targets SIGMAR1 and M1 muscarinic receptors and has shown disease-modifying activity in models of Alzheimer’s disease, including improvements in cognition, amyloid, tau, 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 are forward-looking statements. These statements are predictions based on current information and expectations and involve risks and uncertainties. Actual events or results may differ materially due to various factors, including risks described 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. Anavex undertakes no obligation to update any forward-looking statements 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: info@anavex.com

Investors:

Andrew J. Barwicki
Investor Relations
Tel: 516-662-9461
Email: andrew@barwicki.com