TAYSHA GENE T. DL -,00001

Taysha Gene Therapies, Inc. (NASDAQ:TSHA ) Q1 2025 Earnings Conference Call May 15, 2025 8:30 AM ET Company Participants Hayleigh Collins - Senior Director, Corporate Communications and Investor Relations Sean P. Nolan - Chief Executive Officer Sukumar Nagendran - President and Head of R&D Kamran Alam - Chief Financial Officer Conference Call Participants Kristen Kluska - Cantor Fitzgerald Gil Blum - Needham and Company Maury Raycroft - Jefferies Yanan Zhu - Wells Fargo Biren Amin - Piper Sandler Whitney Ijem - Canaccord Genuity Jack Allen - Baird Joon Lee - Truist Securities Silvan Tuerkcan - Citizens Malcolm Hoffman - BMO Capital Markets Operator Greetings, and welcome to the Taysha Gene Therapies First Quarter 2025 Earnings Call.» Mehr auf seekingalpha.com

Taysha Gene Therapies, Inc. (TSHA) came out with a quarterly loss of $0.08 per share in line with the Zacks Consensus Estimate. This compares to loss of $0.10 per share a year ago.» Mehr auf zacks.com

Obtained written alignment from the FDA on key elements of TSHA-102 pivotal Part B trial design and next steps on enabling study initiation The FDA advised the Company to submit pivotal Part B trial protocol and associated statistical analysis plan as an amendment to the IND application, eliminating the need for formal end-of-phase meeting and potentially expediting study initiation and registration; IND amendment submission expected in Q2 2025 High dose and low dose of TSHA-102 continue to be generally well tolerated with no treatment-related SAEs or DLTs in the pediatric, adolescent and adult patients treated (high dose, n=6; low dose, n=4) across both REVEAL trials as of April 10, 2025, data cutoff Program update on pivotal trial design, Rett syndrome natural history data analysis and clinical data from cohort two (high dose) and cohort one (low dose) of both REVEAL trials expected in Q2 2025 in conjunction with IRSF Rett Syndrome Scientific Meeting    Conference call and live webcast today at 8:30 AM Eastern Time DALLAS, May 15, 2025 (GLOBE NEWSWIRE) -- Taysha Gene Therapies, Inc. (Nasdaq: TSHA) (“Taysha” or the “Company”), a clinical-stage biotechnology company focused on advancing adeno-associated virus (AAV)-based gene therapies for severe monogenic diseases of the central nervous system (CNS), today reported financial results for the first quarter ended March 31, 2025, and provided a corporate update. “We are pleased with the significant regulatory and clinical progress across our TSHA-102 program in clinical evaluation for children, adolescents and adults suffering from Rett syndrome.» Mehr auf globenewswire.com