**Taysha Gene Therapies Reports Financial Results and Operational Progress in 10-K Filing**
Taysha Gene Therapies, Inc., a clinical-stage biotechnology company, released its 10-K filing, detailing its financial performance and operational advancements. The company, focused on AAV-based gene therapies for central nervous system (CNS) disorders, reported a net loss of $109.0 million for the year ended December 31, 2025, compared to a net loss of $89.3 million for the previous fiscal year. The increased loss was attributed to higher research and development expenses, primarily driven by increased headcount and ongoing clinical trial activities for its lead program, TSHA-102, targeting Rett syndrome. Revenue for 2025 totaled $9.8 million, up from $8.3 million in 2024, derived from its option agreement with Astellas Gene Therapy.
The company's research and development expenses increased to $86.4 million in 2025 from $66.0 million in 2024, reflecting the advancement of TSHA-102 through clinical trials and BLA-enabling manufacturing initiatives. General and administrative expenses also rose to $33.9 million from $29.0 million, due to increased compensation expenses and legal and professional fees. Taysha reported cash and cash equivalents of $319.8 million as of December 31, 2025. The company believes its current financial resources will be sufficient to fund operations into 2028.
Operationally, Taysha made significant progress with TSHA-102, completing dosing in Part A of its REVEAL trials and reporting positive clinical data. The company finalized FDA alignment on the REVEAL pivotal trial protocol and statistical analysis plan, including a 6-month interim analysis that may serve as the basis for a BLA submission. Dosing is underway in the REVEAL pivotal trial, and the company expects to complete dosing of all patients in the second quarter of 2026. The ASPIRE trial, a safety-focused study, is also progressing, with dosing expected to be completed in the second quarter of 2026.
Taysha's pipeline includes early-stage gene therapy programs targeting CNS diseases, such as TSHA-113 for tauopathies and TSHA-114 for Fragile X syndrome. The company has received orphan drug designation and rare pediatric disease designation from the FDA, as well as orphan drug designation from the European Commission, for TSHA-102. The company also received Fast Track Designation and Breakthrough Therapy designation from the FDA for TSHA-102. The company anticipates that its expenses will increase substantially as it continues to advance its clinical programs, seek regulatory approval, and establish commercialization infrastructure.
About Taysha Gene Therapies, Inc.
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