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Did Anavex Life Sciences beat or miss consensus estimates last quarter?

- **Regulatory Reexamination**: CHMP negative opinion expected, but Anavex to present 144-week cognitive benefit data (17.8 months saved) and Collagen 24A1 biomarker targeting 71% responsive patients.
- **Financial Strength**: $120M+ cash runway, reduced clinical trial costs.
- **Breakthrough Biomarker**: Collagen 24A1 mutation predicts blarcamesine response, 71% patient benefit.

**【Management Opening Remarks】**
- Clint Tomlinson provided standard opening remarks, outlining the call's purpose and regulatory disclaimers.

**【CEO Commentary】**
- **Regulatory Update**: The CHMP is expected to adopt a negative opinion on the MAA in December, but Anavex plans to request reexamination with additional biomarker data.
- **Clinical Data Highlights**: Blarcamesine demonstrated a 17.8-month cognitive benefit over 144 weeks vs. ADNI controls, with 70% of patients showing Quality of Life improvement.
- **New Biomarker**: Collagen 24A1 mutation correlates with reduced efficacy, identifying a 71% responsive patient population.
- **ANAVEX 3-71 Success**: Phase II schizophrenia trial met safety endpoints and showed neuroinflammatory marker reductions (GFAP, YKL-40).

**【CFO Financial Summary】**
- **Cash Position**: $120M+ runway, $7.3M R&D (down 37% YoY), $3.5M G&A (up 29% YoY), net loss $0.11/share.

**【Q&A Highlights】**
- **Regulatory Strategy**: Reexamination will emphasize objective biomarkers (brain atrophy) and partnership discussions for global commercialization.
- **FDA Engagement**: Initial U.S. interactions planned, with updates pending.
- **Pipeline Expansion**: Exploring ANAVEX 3-71 for depression in Alzheimer's (40% prevalence, no approved therapies).

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