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- **FDA Breakthrough Designation**: TATIA-102 granted Breakthrough Therapy status, expediting path to potential approval for Rett Syndrome.
- **Pivotal Trial On Track**: First patient dosing in REVEAL trial scheduled for Q3 2025, with 15-patient enrollment targeting 3-6 months.
- **Strong Financial Position**: $297.3 million cash runway supports operations into 2028, enabling late-stage development.
- **Commercial Expansion**: Appointed Chief Commercial Officer to prepare for potential launch, targeting 10,000-20,000 patients in key markets.

**【CEO Summary Section】**
- Received FDA Breakthrough Therapy Designation for TATIA-102 in Rett Syndrome, recognizing its potential to address an unmet medical need.
- Finalized alignment with FDA on REVEAL pivotal trial protocol and statistical analysis plan, with enrollment of first patient scheduled for Q3 2025.
- Regained full global rights to TATIA-102 following expiration of Astellas option agreement.
- Appointed David McNinch as Chief Commercial Officer to support late-stage development and potential commercialization.

**【CFO Financial Commentary】**
- Q3 2025 R&D expenses: $25.7 million (vs. $14.9 million in Q3 2024), driven by BLA-enabling manufacturing and clinical trial activities.
- G&A expenses: $8.3 million (vs. $7.9 million in Q3 2024), due to debt issuance costs.
- Net loss: $32.7 million (vs. $25.5 million in Q3 2024), with $297.3 million cash runway supporting operations into 2028.

**【Q&A Key Highlights】**
- **Enrollment Expectations**: First patient dosing in pivotal trial scheduled for Q3 2025; potential enrollment of all 15 patients within 3-6 months due to high demand and site readiness.
- **FDA Alignment**: FDA confirmed no outstanding statistical or clinical queries, supporting use of 33% response rate threshold (5/15 patients) for interim analysis.
- **Younger Cohort Strategy**: Planning to initiate safety-focused trial for 2-5 year olds in mid-2026, with dose adjusted for brain volume to ensure safety.
- **Commercial Readiness**: Building infrastructure to support potential BLA submission, with focus on 10,000-20,000 US/EU/UK patients with Rett Syndrome.

Taysha Gene Therapies, Inc. (TSHA) Q3 2025 Earnings Call Transcript

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TSHA

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