other material
confidence high
sentiment positive
materiality 0.75
Taysha secures FDA alignment on TSHA-102 pivotal trial design; Q1 net loss $21.5M
Taysha Gene Therapies, Inc.
- FDA alignment on pivotal Part B trial design; IND amendment with protocol/SAP expected Q2 2025, potentially expediting registration.
- TSHA-102 well tolerated: no treatment-related SAEs or DLTs in 10 patients (6 high dose, 4 low dose) as of April 10, 2025 cutoff.
- Q1 2025 net loss $21.5M ($0.08/sh) vs $24.1M ($0.10/sh) in Q1 2024; cash $116.6M expected into Q4 2026.
- R&D expenses $15.6M, down from $20.7M YoY due to lower manufacturing costs; G&A expenses $8.2M, up from $7.1M.