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GlobeNewswire·

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

TSHA
  • Completed dosing in the REVEAL pivotal trial (N=17) and ASPIRE trial (N=4) evaluating TSHA-102 for Rett syndrome.
  • Expect to report topline data from the 6-month interim analysis of the REVEAL trial & FDA feedback on the BLA submission pathway in the first half of 2027.
  • TSHA-102 demonstrated a generally well-tolerated safety profile with no severe treatment-related SAEs or DLTs across 33 patients in REVEAL & ASPIRE trials as of August 2026.
  • Longer-term REVEAL Part A data showed broad, multi-domain functional gains deepening through ≥12 months post-treatment across all ages & disease severities.
  • Advanced commercial readiness activities include market access planning & an expanded strategic partnership with Catalent for future commercial manufacturing.
  • Completed a $230 million follow-on offering, extending cash runway into the second half of 2028 & through potential BLA approval.
  • Research and development expenses were $38.6 million for the quarter ended June 30, 2026, driven by BLA-enabling initiatives & higher clinical trial costs.
  • General and administrative expenses increased to $12.1 million for the quarter ended June 30, 2026, due to higher compensation & commercial launch-readiness fees.
  • Net loss for the quarter ended June 30, 2026, was $46.6 million, with cash & cash equivalents totaling $455.4 million as of June 30, 2026.
  • Appointed Mike Johannesen as Chief Legal Officer in June 2026 to strengthen legal & compliance leadership.
  • TSHA-102 has received Breakthrough Therapy, Regenerative Medicine Advanced Therapy, Fast Track, Orphan Drug, & Rare Pediatric Disease designations from the FDA.
  • Anticipated milestone includes completion of the BLA-enabling Process Performance Qualification campaign in the fourth quarter of 2026.