ANAVEX LIFE SCIENCES CORP. Q1 FY2024 earnings call

• European Medicines Agency agreed oral blarcamesine for Alzheimer disease is eligible for EU marketing authorization submission. Aim to submit application early in 2024. - Full data from blarcamesine Phase 2/3 trial forthcoming, ATTENTION-AD open-label extension ongoing. - Top line data from ANAVEX2-73-RS-003 pediatric trial announced, intend to assess and discuss next steps with regulators. - High enrollment in OLE and Compassionate Use Program for Rett syndrome. - First entire clinical gene pathway data from ANAVEX2-73-RS-002 Rett trial announced. - Initiation of ANAVEX3-71 Phase 2 trial for schizophrenia. - Preparations for Parkinson's program trials. - New biomarker data for Fragile X and new rare disease trials. - Upcoming peer-reviewed publications. - Expansion of patent portfolio. - Cash position at $143.8M at Dec 31, 2023; cash used $7.3M in quarter; G&A expenses $2.6M, R&D expenses $8.7M, net loss $8.6M.

No specific product segment financial performance details provided in the transcript.

• Aim to submit European Marketing Authorization Application for blarcamesine as early as possible in 2024. - Continue to be fiscally responsible with sufficient cash runway to fund operations and clinical programs beyond next four years.

• Uncertainties 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.

Q: On the timeline for submission of publication for Alzheimer’s data and European filing this year.

A: Both in progress, can't provide timelines as paper review and submission process are not in their control, but aiming to do it as soon as possible in 2024 and will update once submitted.

Q: On timeline for OLE data or other update from Alzheimer trial.

A: OLE is ongoing, possibility of interim analysis for safety data.

Q: On timeline for Alzheimer's FDA dialogue and Rett program approval potential.

A: Dialogue with FDA planned, timing favorable; for Rett, will analyze data completely and discuss with agency, backup plan is another 12-week study with larger patient size to address placebo response issues.