Taysha Gene Therapies (TSHA) Q4 2025 earnings summary

Executive summary

• Achieved significant milestones in 2025, including compelling REVEAL phase I/II data for TSHA-102 in Rett syndrome and FDA Breakthrough Therapy designation.

• Finalized FDA alignment on pivotal and ASPIRE trial designs, enabling a streamlined path to BLA submission.

• Initiated pivotal REVEAL trial and dosed first patient in Q4 2025; multiple patients now dosed with enrollment progressing and dosing completion expected in Q2 2026.

• Maintained constructive FDA dialogue, securing alignment on CMC, pooling of clinical and commercial manufacturing data, and comparability strategy.

• Advanced commercial readiness, including key leadership hires and market research supporting broad adoption and strong demand for TSHA-102.

Financial highlights

• Research and development expenses rose to $86.4M in 2025 from $66M in 2024, driven by increased headcount and clinical activities.

• General and administrative expenses increased to $33.9M from $29M, mainly due to higher compensation, legal, and professional fees.

• Net loss for 2025 was $109M ($0.34/share), compared to $89.3M ($0.36/share) in 2024.

• Ended 2025 with $319.8M in cash and cash equivalents, with an additional $50M raised in Q4 2025.

• Current cash resources are expected to fund operations into 2028.

Outlook and guidance

• On track to complete dosing in pivotal REVEAL and ASPIRE trials by Q2 2026.

• Anticipates reporting 12-month safety and efficacy data for all 12 REVEAL Part A patients in Q2 2026.

• Plans to expand commercial infrastructure and share further commercial strategy details in H2 2026.

• Initiation of BLA-enabling commercial manufacturing process and PPQ lots expected in Q2 2026.

• Proceeds from recent equity raise intended to support potential commercial inventory build in 2027.