Anavex Life Sciences Announces Q3 FY 2024 Financial Results and Business Update

Anavex Life Sciences Corp., a biopharmaceutical firm specializing in innovative treatments for neurological conditions, announced its financial outcomes for the quarter ending June 30, 2024. The company is advancing its precision medicine program, particularly with its lead drug candidate, blarcamesine (ANAVEX®2-73), aimed at treating Alzheimer's disease. Results from a Phase 2b/3 clinical trial presented at the Alzheimer’s Association International Conference (AAIC) indicated that daily oral doses of blarcamesine significantly slowed clinical decline in early Alzheimer’s patients, with a favorable safety profile.

CEO Christopher U Missling emphasized the company's commitment to developing treatments for various brain disorders. Anavex’s clinical team is ahead of schedule in the ongoing ANAVEX®3-71-SZ-001 Phase 2 trial for schizophrenia. The company is also working on expanding its precision medicine platform to provide scalable treatment options that are easy to administer.

Key Pipeline Developments:
1. Alzheimer's Disease: Anavex plans to publish full data from its Phase 2b/3 trial of blarcamesine in a peer-reviewed journal. The company is preparing to submit a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) by Q4 2024, enabling market access across the European Union. Europe has approximately 7 million Alzheimer’s patients, a figure projected to double by 2030. Interim RNA sequencing data from the trial is expected in the latter half of 2024, providing insights into the disease’s pathology and treatment effects. Additionally, the ATTENTION-AD open-label extension trial has concluded its last patient visit, with interim data anticipated in the second half of 2024.

2. Schizophrenia: The Phase 2 trial of ANAVEX®3-71 for schizophrenia is progressing well, with the first cohort completed and the second cohort nearing full enrollment.

3. Parkinson’s Disease: Anavex plans to initiate a 6-month Phase 2b/3 trial for ANAVEX®2-73 in Parkinson’s disease in the second half of 2024. This trial will include biomarkers to understand the drug’s effects on Parkinson’s disease pathophysiology.

4. Rett Syndrome: At the 2024 IRSF Rett Syndrome Scientific Meeting, Anavex highlighted its commitment to developing treatments for Rett syndrome and received positive feedback from families and investigators.

5. Fragile X Syndrome: New biomarker data supporting the initiation of the ANAVEX®2-73 Phase 2/3 trial was presented at the 19th NFXF International Fragile X Conference. Anavex strengthened its relationship with the Fragile X syndrome community through direct engagement.

6. New Rare Disease: The company plans to start a Phase 2/3 clinical trial for ANAVEX®2-73 targeting a new rare disease.

Recent Business Highlights:
Anavex expanded its leadership with the appointments of Juan Carlos Lopez-Talavera, MD, PhD, Terrie Kellmeyer, PhD, and Jeffrey Edwards, PhD, all of whom have a proven track record of drug development. The presentation of comprehensive results from the Phase 2b/3 blarcamesine trial at the AAIC showed significant benefits on cognitive and functional parameters for Alzheimer’s patients. Additionally, positive preclinical results for biomarkers relevant to Fragile X syndrome were presented, demonstrating translational potential to human treatment.

Financial Highlights:
As of June 30, 2024, Anavex reported cash and cash equivalents of $138.8 million, down from $151.0 million at the end of fiscal 2023. General and administrative expenses for the quarter were $2.9 million, while research and development expenses totaled $11.9 million. The company reported a net loss of $12.2 million, or $0.14 per share, for the quarter, comparable to the previous year’s loss.

The financial information reflects the company's ongoing investment in its pipeline and commitment to advancing treatments for neurological diseases.