ANAVEX LIFE SCIENCES CORP. Q4 FY2024 earnings call

• European Medicines Agency accepted the marketing authorization application for Blacamasent for Alzheimer's disease treatment, supported by data from the Phase 2b/3 NOVX004 trial and its open-label extension Study Attention ID.
• Upcoming presentation of top-line long-term data from the Attention AD open-label extension trial at the JPMorgan 2025 Healthcare Conference.
• Peer-reviewed manuscript on Blacamasent for early Alzheimer's disease results accepted, expected to be published soon.
• New data from Phase 2b/3 study showing Blacamasent's pre-specified clinical efficacy via upstream sigma-1 activation presented at CTAD conference.
• Encouraging preliminary EEG biomarker results from Part A of Anavex 371 Phase 2 study for schizophrenia, with Part B data expected in the first half of 2025.

No distinct product segments with specific financial performance and revenue contributions reported as the company focuses on clinical program advancement.

• Cash position at September 30th was $132.2 million with no debt.
• At the current cash utilization rate, there is an anticipated runway of approximately four years.

• Risks inherent in the development and/or commercialization of potential products.
• Uncertainty in the results of clinical trials or regulatory approvals.
• Need and ability to obtain future capital and maintenance of intellectual property rights.

Q: What is the timing for the EMA to make a decision on Blacamasent?

A: The EMA has a 210-day review process, which is standardized.

Q: Any status or update on Australian patients' remarkable results?

A: We expect an update on the open-label extension study Attention ID, with top-line data during the JPMorgan conference.