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Dec 31, 2024
Taysha Gene Therapies Q4 2024 Earnings Report
Taysha Gene Therapies reported its full-year 2024 financial results, highlighting progress in its TSHA-102 clinical program and providing a corporate update.
Key Takeaways
Taysha Gene Therapies reported a net loss of $89.3 million for the full year ended December 31, 2024, an improvement from the $111.6 million net loss in the prior year. The company's TSHA-102 clinical program for Rett syndrome showed continued progress, with high and low doses being generally well tolerated across all treated patients. Research and development expenses increased to $66.0 million, driven by manufacturing and clinical trial activities, while general and administrative expenses decreased slightly.
TSHA-102 continues to be generally well tolerated across all pediatric, adolescent, and adult patients in both REVEAL trials, with no treatment-related SAEs or DLTs.
Dosing of all 10 patients in Part A of both REVEAL trials has been completed, and the maturing dataset supports advancement toward a pivotal Part B trial.
Productive ongoing discussions with the FDA are solidifying the regulatory pathway for TSHA-102, with an update on pivotal trial design expected in H1 2025.
Clinical data from cohort two (high dose) and cohort one (low dose) of both REVEAL trials are expected in H1 2025.
Forward Guidance
Taysha Gene Therapies anticipates providing updates on the pivotal trial design for TSHA-102 and clinical data from Part A of the REVEAL trials in the first half of 2025. The company expects its current cash resources to support planned operating expenses and capital requirements into the fourth quarter of 2026.
Positive Outlook
- Update on pivotal trial design for TSHA-102 expected in H1 2025.
- Safety and efficacy data from REVEAL Adolescent and Adult Trial (cohort two high dose; n=3 and cohort one low dose; n=2) expected in H1 2025.
- Safety and efficacy data from REVEAL Pediatric Trial (cohort two high dose; n=3 and cohort one low dose; n=2) expected in H1 2025.
- Current cash resources are expected to support planned operating expenses and capital requirements into Q4 2026.
- Continued confidence in TSHA-102's potential to provide meaningful therapeutic benefit to a broad population of patients with Rett syndrome.
Challenges Ahead
- No specific negative forward guidance was explicitly stated in the provided text.
- Reliance on future clinical trial results and regulatory approvals for TSHA-102.
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