ANAVEX LIFE SCIENCES CORP. Q3 FY2025 earnings call

• Development of noninvasive targeted upstream compounds for Alzheimer's disease and schizophrenia continues to advance, with blarcamesine showing continued clinically meaningful benefit in early-stage Alzheimer's patients from 4-year open-label extension data.
• At AAIC 2025, data on blarcamesine was presented, including prespecified precision medicine Phase IIb/III trial data confirming its upstream mechanism.
• A survey of Alzheimer's disease stakeholders in EU member states highlighted the preference for oral therapies like blarcamesine due to greater accessibility.
• Focus is on continuing to advance precision medicine compounds, emphasizing scalable treatment with oral administration as a key advantage.

As of June 30, the cash position was $101.2 million with no debt. During the quarter, operating activities utilized $12.5 million in cash. Research and development expenses for the quarter were $10 million, down from $11.8 million in the comparable quarter of fiscal 2024. General and administrative expenses were $4.5 million, up from $2.8 million in the comparable quarter of fiscal 2024. The company reported a net loss of $13.2 million for the quarter, or $0.16 per share. Revenue contribution details weren't provided as the focus was on overall financials and R&D/G&A spending.

• Anticipates an approximate cash runway of more than 3 years at the current adjusted cash utilization rate.
• Plans to continue advancing precision medicine compounds.
• Estimates first quarter of next year to receive feedback on EMA review of blarcamesine.
• Expresses interest in the FDA's accelerated voucher program and views it as beneficial for programs with unmet need.

• Uncertainty in the results of clinical trials or regulatory approvals.
• Need and ability to obtain future capital.
• Maintenance of intellectual property rights.

Q: Could you explain the difference between ADAS-Cog13 and ADL in the blarcamesine data?

A: ADAS-Cog13 is more sensitive to immediate actions and has a more variable trajectory, while ADL has a bit of latency and a smoother trajectory. Also, patients who were interrupted or had a short interruption had a better outcome in ADAS-Cog13 in the active arm.

Q: Were patients in the open-label extension restaged?

A: No, patients were allowed to continue in the trial irrespective of staging as they were eligible to stay on study drug.

Q: Any guidance on EMA review timeline?

A: Filed in November last year, accepted in December last year, with an estimate of first quarter next year for feedback.

Q: Could CRISPR technology be used to correct SIGMAR1 genotype for blarcamesine?

A: In theory, but most patients have a functional SIGMAR1 gene, and blarcamesine benefits most patients even without CRISPR intervention.

Q: Any Alzheimer's prevention planning?

A: There's preclinical work showing blarcamesine can prevent dementia onset in animals, and plans to conduct a preventative trial but need more resources.

Q: Strategic objectives of lobbying engagements?

A: To raise awareness, educate policymakers about the unmet need of Alzheimer's patients, and emphasize funding and attention for these patients.

Q: Interest in FDA's accelerated voucher?

A: Definitely interested as it's beneficial for programs with unmet need.

Q: When might we see additional orphan indications for blarcamesine?

A: Preparing and planning a study in another rare disease orphan designation and will disclose once ready.

Q: Timeline for deciding commercialization strategy (solo vs partnership)?

A: Historically, partnering after market entry or approval can increase shareholder value, and they'll aim for that.

Q: Have you filed in the U.K.?

A: Planning to reach out to other jurisdictions, including the U.K.

Q: Any back and forth with EMA causing delay?

A: Procedure is standard, nothing unusual, and proceeding as normal.