Taysha Gene Therapies Reports Third Quarter 2024 Financial Results and Provides Corporate Update

Core Insights - Taysha Gene Therapies, Inc. reported progress in the development of TSHA-102, a gene therapy for Rett syndrome, with positive clinical data and FDA engagement [1][2][3] Clinical Development - TSHA-102 was well tolerated in patients, with no serious adverse events (SAEs) or dose-limiting toxicities (DLTs) reported in both adolescent/adult and pediatric cohorts [1][4] - The FDA approved the pivotal product for use in REVEAL trials based on successful analytical comparability [2][3] - Clinical data from both low and high dose cohorts of the REVEAL trials are expected to be reported in the first half of 2025 [1][5] Regulatory Engagement - Advanced discussions with the FDA regarding trial design, endpoints, and the use of a natural history dataset for Part B of the REVEAL trials have been established [2][3] - The company has aligned with the FDA on a meeting cadence to expedite the development plan for TSHA-102 [2][3] Financial Performance - Research and development expenses for Q3 2024 were $14.9 million, an increase from$11.8 million in Q3 2023, primarily due to GMP batch activities [5][6] - General and administrative expenses decreased to $7.9 million in Q3 2024 from$8.6 million in Q3 2023 [6] - The net loss for Q3 2024 was $25.5 million, significantly reduced from a net loss of$117.1 million in Q3 2023 [7] Cash Position - As of September 30, 2024, Taysha had $157.7 million in cash and cash equivalents, expected to support operations into Q4 2026 [8] Company Overview - Taysha Gene Therapies focuses on AAV-based gene therapies for severe monogenic diseases, with TSHA-102 as its lead program targeting Rett syndrome [10][12]