TSHA · Taysha Gene Therapies, Inc.

Taysha Gene Therapies announced first quarter 2026 financial results alongside significant clinical progress for its lead candidate TSHA-102 in Rett syndrome. Research and development expenses surged 117% year-over-year to $33.8 million, primarily due to BLA-enabling PPQ manufacturing initiatives and elevated clinical costs from the REVEAL pivotal and ASPIRE trials. General and administrative expenses increased 19% to $9.7 million, driven by higher compensation, stock-based compensation, and commercial launch-readiness consulting. This resulted in a net loss of $42.4 million, or $0.12 per share, compared to $21.5 million, or $0.08 per share, in the prior year quarter, reflecting accelerated investment in the TSHA-102 program. CEO Sean Nolan highlighted reaffirmed FDA alignment from a breakthrough therapy Type B meeting on the BLA pathway, including pivotal trial design, endpoints, and potential submission based on the REVEAL six-month interim analysis. Dosing advanced in the REVEAL trial (15 females aged 6-<22 years, high dose 1x10^15 vg IT), with primary endpoint of response rate on 28 natural history milestones assessed by blinded raters. ASPIRE enrollment continues for younger patients (2-<4 years), supporting broad labeling. Safety remains strong with no treatment-related serious adverse events or dose-limiting toxicities across trials. BLA-enabling PPQ started in April using commercial process, on track for Q4 completion. Cash of $276.6 million supports operations into 2028, providing runway through key milestones like Q2 dosing completions and Part A longer-term data readout.