Taysha Gene Therapies (TSHA) Q1 2026 earnings summary

Executive summary

• Advanced TSHA-102 clinical development with pivotal and pediatric trials, including dosing completion in REVEAL and ASPIRE trials expected in Q2 2026, and all patients in Part A and multiple in Part B dosed as of Q1 2026.

• Maintained constructive FDA dialogue, achieving alignment on pivotal trial design, endpoints, statistical analysis, CMC requirements, and BLA submission scenarios, including potential approval based on six-month interim analysis.

• TSHA-102 continues to show favorable tolerability, with no treatment-related serious adverse events or dose-limiting toxicities across all trials as of May 2026.

• Orphan drug, rare pediatric disease, Fast Track, RMAT, and Breakthrough Therapy designations received for TSHA-102.

• Commercial infrastructure expanded with experienced leadership to support potential product launch.

Financial highlights

• Research and development expenses rose to $33.8M for Q1 2026, up from $15.6M in Q1 2025, mainly due to BLA-enabling manufacturing and higher clinical costs.

• General and administrative expenses increased to $9.7M from $8.2M year-over-year, mainly due to higher compensation and consulting fees.

• Net loss for Q1 2026 was $42.4M ($0.12/share), compared to $21.5M ($0.08/share) in Q1 2025.

• Cash and cash equivalents stood at $276.6M as of March 31, 2026, expected to fund operations into 2028.

• No revenue recognized in Q1 2026; $2.3M recognized in Q1 2025 from Astellas collaboration, now fully recognized.

Outlook and guidance

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

• Anticipates reporting 12+ month follow-up data from all 12 patients in REVEAL Part A later in Q2 2026.

• BLA-enabling PPQ campaign for TSHA-102 to be completed in Q4 2026.

• Plans to share further commercial strategy details in the second half of 2026.

• Existing cash expected to fund operations into 2028; additional capital may be required for further development and commercialization.