Anavex Life Sciences (AVXL) Status update summary

Strategic and operational update

• Regained Nasdaq compliance after filing delayed 10-Qs and addressing internal control deficiencies with a remediation plan overseen by the audit committee.

• Leadership transition completed, with interim CEO emphasizing a renewed focus on transparency, accountability, and disciplined execution.

• Regular quarterly conference calls, including Q&A, will resume in November, with ongoing updates via press releases for material developments.

Clinical development priorities

• Blarcamesine (ANAVEX 2-73) remains the lead asset, with top priority on advancing its development for early Alzheimer's disease and aligning with FDA and EMA on phase III study design.

• Scientific advisory board refreshed to focus on Alzheimer's expertise; engagement with key opinion leaders and treating physicians underway.

• Rett syndrome and Fragile X syndrome identified as core indications, with orphan drug, rare pediatric disease, and fast track designations supporting regulatory strategy.

• FDA meeting secured to discuss inclusion of pediatric participants in Rett syndrome phase III; IND for Fragile X syndrome to be submitted soon.

• Development for schizophrenia and Parkinson's disease paused to concentrate resources on core programs.

Financial and resource management

• Strong cash balance and no long-term debt position the company to invest in prioritized programs.

• Commitment to fiscal discipline, focusing capital allocation on areas with the clearest scientific and regulatory pathways.

• Plans to increase engagement with scientific and investor communities through conferences and direct communication.