Core Insights - Taysha Gene Therapies has commenced site activation for the REVEAL pivotal trial, with patient enrollment expected to begin in Q4 2025 following regulatory feedback from Health Canada and the FDA [1][3][4] - The TSHA-102 treatment has shown a 100% response rate in the primary endpoint of gaining or regaining developmental milestones in the Phase 1/2 trials, indicating strong therapeutic potential [1][5][10] - The company has successfully raised $230 million through a public follow-on offering, extending its cash runway into 2028 [1][8] Company Updates - Taysha Gene Therapies is focused on advancing AAV-based gene therapies for severe monogenic diseases, particularly targeting Rett syndrome with its lead product TSHA-102 [2][12] - The REVEAL pivotal trial is designed as a single-arm, open-label study, with a primary endpoint assessing the percentage of patients who gain or regain developmental milestones [4][5] - The company has received various designations from the FDA, including Regenerative Medicine Advanced Therapy and Fast Track, which facilitate the development of TSHA-102 [10][12] Financial Performance - For Q2 2025, Taysha reported a net loss of $26.9 million, compared to a net loss of $20.9 million in Q2 2024, with research and development expenses increasing to $20.1 million [7][15] - Cash and cash equivalents as of June 30, 2025, were $312.8 million, bolstered by the recent follow-on offering [8][16] - General and administrative expenses rose to $8.6 million in Q2 2025, primarily due to higher legal and professional fees [6][15]
Taysha Gene Therapies Reports Second Quarter 2025 Financial Results and Provides Corporate Update