ANAVEX LIFE SCIENCES CORP. Q1 FY2025 earnings call

• Growing stakeholder support for blarcamesine as a novel precision medicine for early Alzheimer's with convenient oral dosing.
• Top-line long-term data from Phase 2b/3 ATTENTION-AD open-label extension trial showed blarcamesine reduced clinical decline over 3 years; peer-reviewed results in JPAD showed 36.3% slowdown in clinical progression at 48 weeks.
• Issuance of a new U.S. patent for crystalline forms of ANAVEX freebase dihydrogen phosphate salt, covering neuroprotection and treatment of neurodegenerative disorders.
• Expect data from Part B of placebo-controlled Phase 2 study in schizophrenia (ANAVEX 3-71) in first half of 2025.
• Financials: Cash position at $120.8M, no debt; operating activities used $12.1M; net loss $12.1M for the quarter.

No detailed product segment financial performance provided in the transcript. Cash position at December 31 was $120.8 million with no debt. During the quarter, operating activities utilized $12.1 million in cash. General and administrative expenses were $3.1 million, research and development expenses were $10.4 million, and net loss was $12.1 million or $0.14 per share.

• EMA review of Alzheimer indication: Expect feedback by end of 2023, with review taking 210 days from November filing.
• ANAVEX 3-71: Data from Part B of Phase 2 study in schizophrenia expected in first half of 2025.
• Upcoming events: Scientific presentation of ATTENTION-AD open-label extension data at AD/PD conference in April; updates on Parkinson's disease program and other pipelines.

• Clinical trial and regulatory uncertainties: Uncertainty in clinical trial results and regulatory approvals.
• Capital needs: Requirement for future capital to fund development.
• Intellectual property risks: Maintenance of intellectual property rights.
• EMA review timeline: Uncertainties around exact timeline and outcome of EMA review.

Q: Regarding EMA review timeline, what's the expectation?

A: We expect the feedback for the review to complete by the end of this year, with the review taking 210 days from November filing.

Q: Was there discussion about priority review?

A: The requirement for priority review is prime status, and we filed without prime status as encouraged due to unmet need.

Q: What are the upcoming events?

A: Expect ANAVEX 3-71 data in the first half of 2025, scientific presentation of ATTENTION-AD open-label extension data at the AD/PD conference in April, and updates on the Parkinson's disease program.

Q: Status of Rett syndrome?

A: Planning another study to reconfirm due to previous study limitations with small patient numbers and placebo-arm size.

Q: Significance of the crystalline patent?

A: Very significant as the crystallized patent API was used in prior clinical studies and protects the composition for neurodegenerative disorders including Alzheimer's and Parkinson's.

Q: Status of Parkinson's program?

A: Updates on the Parkinson's disease program will be provided shortly.

Q: FDA status for blarcamesine?

A: Planning a meeting with the FDA for the Alzheimer indication.

Q: Status of OLE patients?

A: 74 participants are still on study drug via compassionate use program, used for real-world evidence, and no deaths caused by the drug in studies.

Q: Efficacy vs monoclonal antibodies?

A: Blarcamesine showed 36.3% slowdown in clinical progression vs antibodies' lower delta, with oral convenience and no black box warning like antibodies.

Q: Other countries post EMA approval?

A: Planning to submit to jurisdictions like the UK, Canada, Australia before the end of the year.