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Sep 30, 2024
Taysha Gene Therapies Q3 2024 Earnings Report
Reported financial results for the third quarter ended September 30, 2024, and provided a corporate update.
Key Takeaways
Taysha Gene Therapies reported its Q3 2024 financial results, highlighting progress with the FDA on the regulatory pathway for TSHA-102 and FDA approval to use the pivotal product in REVEAL trials. The company's cash resources are expected to support operations into the fourth quarter of 2026.
Advanced discussions with the FDA on trial design, endpoints, and potential use of natural history data for REVEAL trials.
FDA approved the use of pivotal TSHA-102 product in REVEAL trials based on analytical comparability.
Clinical data from cohort two (high dose) and cohort one (low dose) of both REVEAL trials are expected in H1 2025.
High dose TSHA-102 was generally well tolerated with no SAEs or DLTs in initial patients, and IDMC approved continued enrollment in cohort two.
Taysha Gene Therapies
Taysha Gene Therapies
Forward Guidance
Taysha anticipates safety and efficacy data from REVEAL trials in H1 2025 and expects current cash resources to support operations into Q4 2026.
Positive Outlook
- Safety and efficacy data in cohort two (high dose; n=3) and an update on safety and efficacy data in cohort one (low dose; n=2) expected in the first half of 2025 for REVEAL Adolescent and Adult Trial
- Safety and efficacy data in cohort two (high dose; n=3) and an update on safety and efficacy data in cohort one (high dose; n=2) expected in the first half of 2025 for REVEAL Pediatric Trial
- Current cash resources will support planned operating expenses and capital requirements into the fourth quarter of 2026.
- Aligned with the FDA on the Company’s proposed meeting cadence to expedite the development and review of TSHA-102
- The FDA endorsed the intended commercial manufacturing process, proposed analytical methods, and corresponding qualification and validation plans, including mechanism of action potency release assays
Challenges Ahead
- Clinical data from cohort two (high dose) and cohort one (low dose) of both REVEAL trials expected in H1 2025
- Focus on objective measures that clinically capture functional gains
- Safety and efficacy data in cohort two (high dose; n=3) and an update on safety and efficacy data in cohort one (low dose; n=2) expected in the first half of 2025
- Safety and efficacy data in cohort two (high dose; n=3) and an update on safety and efficacy data in cohort one (high dose; n=2) expected in the first half of 2025
- Net loss for the three months ended September 30, 2024, was $25.5 million, or $0.1 per share