Anavex Life Sciences to Present Oral Blarcamesine Data at the 18th Clinical Trials on Alzheimer’s Disease (CTAD) Conference

Rhea-AI Summary

Anavex Life Sciences (Nasdaq: AVXL) will present one oral late-breaking communication and two poster presentations on oral blarcamesine at the 18th Clinical Trials on Alzheimer’s Disease (CTAD) Conference in San Diego, December 1–4, 2025.

Presentations include an oral LB11 on December 2 reporting that the Phase IIb/III trial "confirms identified precision medicine patient population" with reported broad clinical and quality-of-life improvements, and two posters (P076, P084) comparing outcomes to prodromal cognitive aging and discussing patient/family convenience. Company commentary notes Phase IIb/III signals of slowed cognitive decline and an adequate safety profile with no ARIA reported.

Insights

Clinical development analyst

Presentation of Phase IIb/III blarcamesine data at CTAD signals potentially material clinical progress but lacks disclosed metrics.

Blarcamesine is presented as an oral, once-daily therapy purported to restore autophagy, a cellular process linked to neurodegeneration, and the company reports "significant broad clinical and quality of life improvements" in an identified precision-medicine subgroup of early Alzheimer’s disease patients. The mechanism claim connects a biologic rationale (autophagy restoration) to observed clinical signals, which, if corroborated by full data, could support differentiated therapeutic value in a targeted patient population.

Key dependencies and risks remain: the release gives no numeric efficacy endpoints, safety tables, statistical thresholds, or responder rates, and it explicitly disclaims conclusions about efficacy or approval. The absence of primary endpoint statistics and peer-reviewed detail limits the ability to assess robustness, reproducibility, or regulatory relevance; safety is summarized qualitatively ("adequate safety profile (no ARIA)") without adverse-event rates or exposure duration.

What to watch: the oral late-breaking presentation at CTAD on December 2, 2025 (4:35 pm PT) and the two posters on December 1-2, 2025 for full slides, primary endpoint values, confidence intervals, p-values, subgroup definitions, and safety tables. Also monitor any subsequent peer-reviewed publication or regulatory filings that disclose numeric endpoints and statistical analysis over the next 1-6 months.

One Oral Late Breaking Communication and Two Poster Presentations

NEW YORK, Nov. 26, 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 announced that it will present one oral late breaking communication and two poster presentations featuring blarcamesine at the 18th Clinical Trials on Alzheimer’s Disease (CTAD) Conference, being held in San Diego, California from December 1-4, 2025.

Details:
Presentation #1 (LB11)

• Title: 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
• Presenter: Marwan Noel Sabbagh, MD, Professor of Neurology, and Chairman of the Anavex Scientific Advisory Board
• Time: December 2, 4:35 pm PT – 4:50 pm PT
  

Presentation #2 (P076)

• Title: 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
• Presenter: Audrey Gabelle, MD, PhD, Professor of Neurology, Neurologist and Member of the Anavex Scientific Advisory Board 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
• Time: December 1, 3:00 pm PT – December 2, 5:30 pm PT
  

Presentation #3 (P084)

• Title: Advancing Alzheimer’s Disease Care: Convenience for Both Patients and Families with Oral Blarcamesine
• Presenter: Marwan Noel Sabbagh, MD, Professor of Neurology, and Chairman of the Anavex Scientific Advisory Board
• Time: December 1, 3:00 pm PT – December 2, 5:30 pm PT
  

“We are excited to present, backed up by published clinical data, oral, once daily blarcamesine with its upstream mechanism of action restoring autophagy - the key driver in restoring cellular homeostasis, which could be essential to treating Alzheimer’s by activating the brain’s recycling process, which is impaired in Alzheimer’s disease. Blarcamesine demonstrated in early Alzheimer’s disease patients clinically meaningful effects of slowing cognitive decline with an adequate safety profile (no ARIA) as demonstrated in the Phase IIb/III program,” said Marwan Noel Sabbagh, MD, Professor of Neurology, and Chairman of the Anavex Scientific Advisory Board. “Additionally, our steadfast focus is on driving progress in Alzheimer’s disease development and providing meaningful options to improve the lives of patients and those who care for them.”

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 The 18th Clinical Trials on Alzheimer’s Disease (CTAD) Conference

The Clinical Trials on Alzheimer’s Disease (CTAD) Conference, established in 2008, has become a cornerstone event in Alzheimer’s disease (AD) clinical research. Designed by and for AD researchers, CTAD’s mission is to create a platform that prioritizes substantive, clinical research-focused dialogue and collaboration. By fostering an intimate and collegial environment, CTAD has gained a reputation for facilitating impactful international collaborations and advancing the global AD research agenda.
The upcoming 18th annual Clinical Trials on Alzheimer's Disease Conference (CTAD25) to be held in San Diego, CA (USA) on December 1-4, 2025. CTAD25 will build on the momentum of previous years, reflecting the rapid advancements in Alzheimer’s disease diagnostics and therapeutics that make this field one of the most dynamic in medical research today.
CTAD25 also features thought-provoking roundtables and symposia that explore the latest advancements in AD research. Renowned clinicians and leaders from academia, research centers, patient coalitions, and pharmaceutical companies engage in dynamic discussions on diverse topics, from disease-modifying agents to gene therapy, vaccines, and multimodal interventions.
The CTAD scientific program is underpinned by a rigorous peer-review abstract selection process, ensuring the presentation of high-quality research that drives the field forward.

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.

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

FAQ

When will Anavex (AVXL) present blarcamesine data at CTAD 2025?

Anavex will present at CTAD in San Diego December 1–4, 2025; the oral late-breaking talk is December 2 at 4:35 pm PT.

What did the AVXL Phase IIb/III blarcamesine oral presentation (LB11) claim?

The LB11 presentation is described as confirming a precision medicine patient population with significant broad clinical and quality-of-life improvements in early Alzheimer’s patients.

Does Anavex report any key safety findings for blarcamesine (AVXL)?

The company reported an adequate safety profile in the Phase IIb/III program and specifically noted no ARIA observed.

What topics do the two AVXL posters (P076, P084) cover at CTAD 2025?

Poster P076 compares blarcamesine outcomes to normal prodromal cognitive aging; P084 addresses convenience for patients and families with oral once-daily dosing.

Will the CTAD presentations guarantee regulatory approval for blarcamesine (AVXL)?

No; the release states these are investigational results and do not convey conclusions about efficacy or safety or guarantee regulatory approval.

Where can investors view the AVXL CTAD presentations or get more details?

The company announced presentation titles, presenters, and times for CTAD; investors should follow Anavex investor communications for access and post-conference materials.