ANAVEX LIFE SCIENCES CORP. Q4 FY2025 earnings call

• Clinical Trials & Regulatory: Expect CHMP to adopt a negative opinion on blacaramazine's MAA in Europe, plan to request reexamination. Successfully underwent GCP inspection and manufacturing package passed EMA review. Initial contacts with US authorities regarding Alzheimer's disease program; will provide updates on dacamazine in other indications. - Scientific Publications: Announced publications on blacaramazine preventing memory impairment in Alzheimer's model, autophagy mechanism of sigma one receptor, and oral glycogen phase two b/three trial showing improvements for early Alzheimer's patients. - ANAVEX 3-71: Positive Phase two results for schizophrenia, safe and well tolerated with encouraging trends in outcome measures; leverages unique mechanism for neuropsychiatric indications. - Financials: Discussed cash position, R&D, and G&A expenses.

As of September 30, the cash position was $102.6 million with no debt. During the quarter, operating activities utilized $8.6 million in cash and cash equivalents. Current cash balance is over $120 million, with a cash runway of more than three years. Research and development expenses for the quarter were $7.3 million (down from $11.6 million in the comparable quarter of the prior year). General and administrative expenses were $3.5 million (up from $2.7 million in the prior year's comparable quarter). The net loss for the quarter was $9.8 million, or $0.11 per share.

• Continue progressing clinical trials and regulatory actions. - Expand collaborative initiatives and strategic partnerships. - Provide updates on regulatory and clinical trial progress for dacamazine in other indications. - Expect further updates on interaction with FDA regarding Alzheimer's disease program.

• Uncertainty in clinical trial results and regulatory approvals. - Need for future capital and maintenance of intellectual property rights. - Risks inherent in development and commercialization of potential products.

Q: What is the likely commercial impact of the failure of semaglutide on the outlook for blacaramazine in Alzheimer's disease?

A: Semaglutide results highlight complexity of Alzheimer's biology; blacaramazine has upstream mechanism restoring autophagy and demonstrated efficacy in slowing cognitive decline.

Q: When is the next formal discussion of blacaramazine scheduled to take place with the FDA?

A: Updates will be provided as received from initial discussions with US regulators.

Q: What initiatives does Anavex plan near term to pursue blacaramazine approval in regions beyond EU and US?

A: Continuing to explore other regulatory geographies and addressing open questions.

Q: Can you elaborate on biomarker data for blacaramazine?

A: Brain atrophy is an objective biomarker of neurodegeneration; blacaramazine has demonstrated less or halted brain shrinkage in patients.

Q: Details on APCLEAR 1, 2, 3 subpopulations?

A: APCLEAR 1 is prespecified analysis of sigma one wild type patients; APCLEAR 2 and 3 involve genomic analysis revealing collagen 24A1 gene as a strong efficacy driver.

Q: Support from community for blacaramazine approval?

A: Community is aware, and company is committed to partnership with regulators, with expert advisers, investigators, patients, and caregivers supporting continued work.