Taysha Gene Therapies, Inc. (NASDAQ:TSHA ) Q4 2024 Earnings Conference Call February 26, 2025 8:30 AM ET Company Participants Hayleigh Collins - Director & Head of Investor Relations Sean Nolan - Chief Executive Officer Sukumar Nagendran - President & Head of R&D Kamran Alam - Chief Financial Officer Conference Call Participants Kristen Kluska - Cantor Fitzgerald Salveen Richter - Goldman Sachs Chris Raymond - Piper Sandler Gil Blum - Needham & Company Maury Raycroft - Jefferies Yanan Zhu - Wells Fargo Securities Jack Allen - Baird Silvan Tuerkcan - Citizens JMP Operator Ladies and gentlemen, good morning and welcome to the Taysha Gene Therapies Full Year 2024 Conference Call. At this time all participants are in listen-only mode.
High dose and low dose of TSHA-102 continue to be generally well tolerated with no treatment-related SAEs or DLTs in all pediatric, adolescent and adult patients treated (high dose, n=6; low dose, n=4) across both REVEAL trials as of February 2025 data cutoff Completed dosing of the 10 patients in Part A of both REVEAL trials; maturing dataset continues to support advancement toward pivotal Part B trial Productive ongoing discussions with the FDA to solidify regulatory pathway for TSHA-102; 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 expected in H1 2025 Conference call and live webcast today at 8:30 AM Eastern Time DALLAS, Feb. 26, 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 full year ended December 31, 2024, and provided a corporate update. “We are pleased with the pace at which our TSHA-102 clinical program is advancing across a broad range of ages and stages of patients with Rett syndrome.
DALLAS, Feb. 19, 2025 (GLOBE NEWSWIRE) -- Taysha Gene Therapies, Inc. (Nasdaq: TSHA), 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 announced that it will report its financial results for the full-year ended December 31, 2024, and host a corporate update conference call and webcast on Wednesday, February 26, 2025, at 8:30 AM Eastern Time. Conference Call Details Wednesday, February 26, at 8:30 AM Eastern Time / 7:30 AM Central Time Toll Free: 877-407-0792International: 201-689-8263Conference ID: 13751800Webcast: https://ir.tayshagtx.com/news-events/events-presentations About Taysha Gene Therapies Taysha Gene Therapies (Nasdaq: TSHA) is a clinical-stage biotechnology company focused on advancing adeno-associated virus (AAV)-based gene therapies for severe monogenic diseases of the central nervous system.
Taysha Gene Therapies' TSHA-102 tackles Rett syndrome's root cause with its miniMECP2 transgene and scAAV delivery. So far, this is TSHA's main value driver, and it appears safe and effective in both of its trial's high and low-dose cohorts. TSHA-102 has an RMAT designation, which could accelerate its approval process. Management anticipates a regulatory submission by 2H2025.
Taysha Gene Therapies, Inc. (TSHA) came out with a quarterly loss of $0.09 per share versus the Zacks Consensus Estimate of a loss of $0.08. This compares to loss of $0.13 per share a year ago.
Data from an analysis of five NHP studies showed lumbar IT administration led to widespread and consistent biodistribution of AAV9 gene therapy vectors across brain and spinal cord regions
Taysha Gene Therapies (TSHA) has been upgraded to a Zacks Rank #1 (Strong Buy), reflecting growing optimism about the company's earnings prospects. This might drive the stock higher in the near term.
Taysha Gene Therapies' TSHA-102 shows promising results for Rett syndrome, leveraging miRARE technology to modulate MECP2 expression, improving patients' quality of life in Phase 1/2 trials. TSHA-102's unique miRNA-responsive auto-regulatory feature ensures safe MECP2 levels, with intrathecal administration targeting CNS cells, minimizing systemic adverse effects. Despite recent stock price decline, TSHA has a solid cash runway and potential market, with key catalysts expected by late 2024 and 1H2025.
Presented cohort one (low dose) data from both trials of TSHA-102 at 2024 IRSF Rett Syndrome Scientific Meeting that demonstrated durable improvements across consistent clinical domains and an encouraging safety profile in adult (up to 52 weeks) and pediatric (up to 22 weeks) patients
Taysha Gene Therapies (NASDAQ: TSHA ) stock is taking a beating on Wednesday after the gene therapy company announced a proposed public offering for its shares. Taysha Gene Therapies says that it intends to offer up to $75 million worth of TSHA stock in this offering.