Taysha Gene Therapies, Inc. Q4 FY2025 earnings call

2025 was a year of significant execution. Announced Reveal Phase 1-2 data, received FDA breakthrough therapy designation for TASHA-102, secured FDA alignment on trial designs. Initiated Reveal Pivotal trial and ASPIRE trial. Aligned with FDA on CMC requirements. Appointed Brad Martin as Senior Vice President of Market Access and Value to strengthen commercial leadership team.

Research and development expenses were $86.4 million in 2025 vs. $66 million in 2024. General and administrative expenses were $33.9 million in 2025 vs. $29 million in 2024. Net loss in 2025 was $109 million or $0.34 per share vs. $89.3 million or $0.36 per share in 2024. Cash and cash equivalents as of Dec 31, 2025 were $319.8 million.

Current cash resources are expected to fund operating expenses into 2028. On track to complete dosing for Reveal Pivotal trial in Q2 2026 and for ASPIRE trial in Q2 2026.

Various risks may cause actual results to differ materially from forward-looking statements. For a list and description of risks, see reports filed with the SEC.

Q: Kristin Kluska asked about community understanding of intrathecal administration and favorable reasons.

A: Sean responded on reasons like familiarity, practical logistics, etc.

Q: Salveen Richter asked about Brad Martin's priorities and Part A data update.

A: Sean responded on Part A data update and market access mapping.

Q: Biren Amin asked about BLA PPQ lots completion and BLA filing after interim data.

A: Sean responded on PPQ lot completion and potential BLA filing scenarios.

Q: Kazeen Ahmad asked about read-through from Debut's CHMP opinion and Europe pricing.

A: Sean responded on data uniqueness and strong pricing position.

Q: Mari Raycroft asked about Part A sub-analysis and patient vignettes.

A: Sean responded on highlighting patient vignettes and aggregate data focus.

Q: Gil Blum asked about Aspire study alignment and CMC feedback.

A: Sean and Sukhu responded on Aspire study alignment and CMC feedback.

Q: Chris Raymond asked about six-month endpoint meaningfulness and commercial breakdown.

A: Sean and Sukhu responded on six-month endpoint and commercial footprint.

Q: Jack Allen asked about enrollment in pivotal studies.

A: Suku responded on enrollment progress and milestone screening.

Q: Yonemzu asked about data pooling and 12-month data expectation.

A: Sean and Sukhu responded on data pooling and continuous gains.

Q: Whitney Ijum asked about Aspire extrapolation and dosing scaling.

A: Sean and Sukhu responded on Aspire extrapolation and dosing scaling.