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Taysha Gene Therapies Reports Third Quarter 2026 Financial Results and Provides Corporate Update

TSHA
  • REVEAL pivotal and ASPIRE trials for TSHA-102 are ongoing with 33 total patients dosed as of November 2026.
  • TSHA-102 demonstrated a favorable safety profile across all trials with no severe treatment-related serious adverse events or dose-limiting toxicities.
  • All patients have cleared the acute post-dosing safety monitoring period associated with AAV gene therapies.
  • Taysha completed a BLA-enabling Process Performance Qualification (PPQ) manufacturing campaign meeting all predefined product specifications & comparability criteria.
  • The PPQ campaign achieved a single-digit empty capsid percentage, indicating high product quality & patient safety.
  • Results support the potential inclusion of REVEAL Part A Phase 1/2 data in the planned Biologics License Application (BLA) submission.
  • Encore data supporting the TSHA-102 clinical program was presented at the 55th Child Neurology Society Annual Meeting.
  • FDA feedback on the Chemistry Manufacturing and Controls (CMC) Type B meeting is expected in the first quarter of 2027.
  • Topline data from the six-month interim analysis of the REVEAL pivotal trial & FDA feedback on the BLA pathway are expected in the first half of 2027.
  • Taysha anticipates nominating a second gene therapy development candidate targeting a CNS disorder in the first half of 2027.
  • Third quarter 2026 Research and Development expenses were $28.8 million, an increase driven by clinical trial costs & headcount growth.
  • Third quarter 2026 General and Administrative expenses were $13.1 million, primarily due to higher compensation & commercial launch-readiness fees.
  • Net loss for the three months ended September 30, 2026, was $39.1 million, or $0.10 per share.
  • As of September 30, 2026, Taysha held $422.8 million in cash & cash equivalents, sufficient to fund operations into the second half of 2028.
  • TSHA-102 is an investigational AAV9 gene therapy designed to deliver a functional MECP2 gene to treat the genetic root cause of Rett syndrome.
Company
Taysha Gene Therapies, Inc.
Keywords
Nasdaq:TSHA, Taysha Gene Therapies, Inc.