Anavex Life Sciences Announces Successful Development of Once-Daily Oral Tablet Formulation for the ANAVEX®3-71 Program

ANAVEX3-71-002 trial achieved its primary endpoint demonstrating safety and tolerability in both male and female adults

Oral ANAVEX ^® 3-71 tablet exhibits superior pharmacokinetics compared to the current immediate-release oral capsule, enabling once-daily dosing

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 successful development of a once-daily oral tablet formulation for the ANAVEX ® 3-71 program. The once-daily modified-release oral tablet exhibits superior pharmacokinetics compared to the current immediate-release oral capsule, enabling once-daily dosing. This achievement was confirmed in a Phase 1b clinical trial comparing the two dosage forms (ANAVEX3-71-002 trial).

The completed open-label, randomized study evaluated the pharmacokinetics and safety of immediate- and modified release formulations of ANAVEX ^® 3-71 administered orally in healthy male and female adults 18 years or older. Study results demonstrated a pharmacokinetic profile supportive of once-daily dosing with a safety profile consistent with prior ANAVEX ^® 3-71 studies.

"We are pleased to see that our latest ANAVEX ^® 3-71 formulation study meets our expectations for safety and tolerability," said Christopher U Missling, PhD, President and Chief Executive Officer of Anavex. "We believe that with the preferred modified release formulation, we can advance a competitive molecule into future studies, with the goal of addressing the present and persistent medical needs of people living with schizophrenia and neurodegenerative disorders."

ANAVEX ^® 3-71 (formerly AF710B) is a dual SIGMAR1 receptor agonist and M1 positive allosteric modulator with agonistic effects. ^{1 , 2} ANAVEX ^® 3-71 has previously been studied in healthy volunteers prior to study ANAVEX3-71-002 and the Phase 2 study ANAVEX3-71-SZ-001. ^{3 , 4} This novel mechanism of action offers the potential to treat all symptom domains (positive, negative, and cognitive) of schizophrenia without the side effects of standard of care antipsychotics.

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

¹ Fisher A, Bezprozvanny I, Wu L, et al. AF710B, a Novel M1/σ1 Agonist with Therapeutic Efficacy in Animal Models of Alzheimer's Disease. Neurodegener Dis . 2016;16(1-2):95-110. doi:10.1159/000440864
² Hall H, Iulita MF, Gubert P, et al. AF710B, an M1/sigma-1 receptor agonist with long-lasting disease-modifying properties in a transgenic rat model of Alzheimer's disease. Alzheimers Dement . 2018;14(6):811-823. doi:10.1016/j.jalz.2017.11.009
³ Fadiran EO, Hammond E, Tran J, et al. Concentration-QTc Relationship from a Single Ascending Dose Study of ANAVEX3-71, a Novel Sigma-1 Receptor and Allosteric M1 Muscarinic Receptor Agonist in Development for the Treatment of Frontotemporal Dementia, Schizophrenia, and Alzheimer's Disease. Clin Pharmacol Drug Dev . 2023;12(9):888-901. doi:10.1002/cpdd.1303
⁴ Fadiran EO, Hammond E, Tran J, Missling CU, Ette E. Population-Based Characterization of the Pharmacokinetics and Food Effect of ANAVEX3-71, a Novel Sigma-1 Receptor and Allosteric M1 Muscarinic Receptor Agonist in Development for Treatment of Frontotemporal Dementia, Schizophrenia, and Alzheimer Disease. Clin Pharmacol Drug Dev . 2024;13(1):21-31. doi:10.1002/cpdd.1323