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ANAVEX LIFE SCIENCES CORP.

ANAVEX LIFE SCIENCES CORP. Q2 FY2025 earnings call

May 13, 2025 · fiscal period ended 2025-03

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Summary

Generated 2025-05-13

Management highlights

• Portfolio of non-invasive targeted upstream precision compounds advancing, focusing on Alzheimer's and schizophrenia. • Presented open-label extension data of blarcamesine for Alzheimer's at AD/PD 2025 conference, showing continued benefit for early patients. • Completed enrollment in Phase 2 clinical study of ANAVEX3-71 for schizophrenia, with Part A completed and Part B to provide more data. • Expanded scientific advisory board with appointment of Professor Dr. Audrey Gabelle. • Cash runway of approximately four years based on current utilization rate.

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Segment performance

No detailed breakdown of financial performance by product segments provided; overall cash position on March 31st was $115.8 million with no debt. General and administrative expenses were $2.6 million, research and development expenses were $9.9 million, and net loss was $11.2 million for the quarter.

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Guidance

• Expect to receive feedback from EMA around end of this year or early next quarter. • Plan to discuss with regulatory authorities in parallel for regions like Canada, Australia, etc. • Anticipate top-line data from schizophrenia Phase 2 study in second half of the year. • Runway of ~four years based on current cash utilization at the current rate.

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Risks

• Risks inherent in development and commercialization of potential products. • Uncertainty in clinical trial results and regulatory approvals. • Need and ability to obtain future capital. • Maintenance of intellectual property rights.

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Q&A highlights

Q: What's the timeline around hearing back from EMA for blarcamesine?

A: Expect feedback by end of this year or early next quarter, with no interim updates; will report final EMA decision.

Q: Key inflection point for 2025?

A: Phase II study of ANAVEX3-71 for schizophrenia in second half, focusing on safety, biomarker effect, especially negative symptoms.

Q: Details on schizophrenia trial duration?

A: Part A was short, Part B is 28 days (4 weeks) with 55 participants.

Q: Pre-launch plans for blarcamesine in Europe?

A: Initiated discussions with potential partners and CROs to prepare for distribution and sales force setup.

Q: Advantage of oral blarcamesine for patients?

A: Timely access, no cumbersome procedures, less caregiver stress and financial strain compared to antibodies.

Q: Follow-up on advantages for family and physicians?

A: Less caregiver stress, no logistical barriers for physicians, avoiding complex procedures, and timely treatment preventing delayed benefit.

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Key numbers

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Transcript

May 13, 2025

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