Anavex Life Sciences Q2 Fiscal 2024 Financial Results and Business Update

Anavex Life Sciences Corp. (Nasdaq: AVXL), a clinical-stage biopharmaceutical company, has announced its financial results for the fiscal quarter ending on March 31, 2024. The company specializes in developing unique therapeutics for a range of neurodegenerative, neurodevelopmental, and neuropsychiatric disorders, including Alzheimer’s disease, Parkinson’s disease, Rett syndrome, and schizophrenia.

Dr. Christopher U Missling, President and CEO of Anavex, expressed optimism regarding recent FDA guidance on Early Alzheimer’s disease. This guidance suggests that a single cognitive measurement, such as ADAS-Cog13, could serve as a primary endpoint for early Alzheimer’s disease. Missling believes this opens a new pathway for progressing the Marketing Authorisation application of blarcamesine to the European Medicines Agency (EMA).

Anavex has reported several significant updates in its key pipeline programs:

Alzheimer’s Disease: Full results from the Phase 2b/3 clinical trial of blarcamesine will soon be published in a peer-reviewed journal. The company has begun the process of submitting a Marketing Authorisation application to the EMA, which would allow market access throughout the European Union. Approximately 7 million people in Europe suffer from Alzheimer’s, with this number expected to double by 2030. RNA sequencing analysis from the Phase 2b/3 trial is ongoing, with interim data expected by mid-2024. The 96-week ATTENTION-AD open-label extension trial is also in progress, with interim results anticipated in the second half of 2024.

Schizophrenia: The ANAVEX®3-71-SZ-001 Phase 2 clinical trial is progressing well, with the first cohort of patients fully enrolled.

Parkinson’s Disease: The company plans to initiate an imaging-focused trial and a Phase 2b/3 six-month trial for ANAVEX®2-73 in the latter half of 2024.

Rett Syndrome: Positive Real World Evidence (RWE) feedback continues to come in from patients and caregivers involved in the open-label extension trial and Compassionate Use Program. This has encouraged Anavex to move forward with a Phase 3 12-week efficacy study. An educational presentation will be given at the 2024 IRSF Rett Syndrome Scientific Meeting. ANAVEX®2-73 has received Fast Track, Rare Pediatric Disease, and Orphan Drug designations from the FDA for Rett syndrome treatment.

Fragile X Syndrome: New biomarker data for ANAVEX®2-73 will be presented at the 19th National Fragile X Foundation Conference in July 2024, supporting the initiation of a potentially pivotal Phase 2/3 trial.

New Rare Disease: Initiation of a potentially pivotal ANAVEX®2-73 Phase 2/3 clinical trial is planned.

Recent business highlights include the screening of the first patient in the U.S. FDA-cleared Phase 2 clinical study of ANAVEX®3-71 for schizophrenia, and a new peer-reviewed publication in Clinical Pharmacology in Drug Development, which highlights the safety and pharmacokinetics of ANAVEX®3-71.

Financially, Anavex reported cash and equivalents of $139.4 million as of March 31, 2024, down from $151.0 million at the end of September 2023. General and administrative expenses were $2.8 million for the quarter, with research and development expenses at $9.7 million. The net loss for the quarter was $10.5 million, or $0.13 per share, compared to a net loss of $13.1 million, or $0.17 per share, for the same period in the previous fiscal year.

Anavex continues to advance its diverse portfolio, leveraging its precision medicine platform to deliver scalable treatments for various brain disorders.

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