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Mar 31
Taysha Gene Therapies Q1 2025 Earnings Report
Taysha Gene Therapies reported a narrower net loss and continued clinical progress in Q1 2025.
Key Takeaways
The company narrowed its net loss year-over-year and made notable regulatory strides for its TSHA-102 Rett syndrome program, receiving FDA alignment on the pivotal trial design.
Net loss decreased to $21.5 million from $24.1 million a year ago.
Revenue was $2.3 million for the quarter.
The FDA advised the company to proceed directly with an IND amendment submission, potentially expediting TSHA-102's pivotal trial.
High and low dose TSHA-102 treatments remained well tolerated with no treatment-related SAEs or DLTs across 10 patients.
Taysha Gene Therapies
Taysha Gene Therapies
Forward Guidance
The company expects to submit the pivotal Part B trial protocol in Q2 2025 and anticipates releasing key safety and efficacy data at the IRSF Rett Syndrome Scientific Meeting.
Positive Outlook
- FDA alignment on pivotal Part B trial protocol for TSHA-102
- IND amendment approach may expedite trial initiation
- High and low dose TSHA-102 well tolerated with no SAEs or DLTs
- Clinical data and regulatory updates planned for IRSF meeting in Q2
- Cash runway expected to last into Q4 2026
Challenges Ahead
- Revenue declined from $3.41 million in Q1 2024 to $2.3 million in Q1 2025
- Continued operating losses and net loss reported
- General and administrative expenses increased year-over-year
- No update on partnership or commercialization strategy
- Ongoing need for successful pivotal trial to support future growth