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Taysha Gene Therapies
Taysha Gene Therapies (TSHA) investor relations material
Taysha Gene Therapies Q1 2026 earnings summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Q1 2026 earnings summary6 May, 2026
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.
Explain statistical analysis for milestone gains
Impact of PPQ campaign timing on BLA filing
How is efficacy extrapolated for ASPIRE cohort?
FDA's comfort with 6-month BLA submission
Impact of 30x transduction efficiency on TSHA-102
Scalability benefits of intrathecal delivery
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Latest events from Taysha Gene Therapies
- TSHA-102 trials progressed with strong safety, regulatory alignment, and robust cash position.TSHA
Q4 20256 May 2026 - Annual meeting covers director elections, auditor ratification, and executive pay votes.TSHAProxy filing22 Apr 2026
- Proxy covers director elections, auditor ratification, executive pay, and governance matters.TSHAProxy filing22 Apr 2026
- TSHA-102 delivers sustained, multi-domain benefits and safety in Rett syndrome, advancing to high-dose trials.TSHAStatus Update3 Feb 2026
- TSHA-102 trials showed strong safety, efficacy, and cash runway into Q4 2026 after $76.8M raise.TSHAQ2 20241 Feb 2026
- TSHA-102 shows clinical progress, regulatory momentum, and strong cash runway into Q4 2026.TSHAQ3 202414 Jan 2026
- TSHA-102 Phase II trials completed dosing with strong safety, efficacy, and cash runway into 2026.TSHAQ4 202423 Dec 2025
- Up to $300M in securities registered to fund gene therapy pipeline, led by Rett syndrome program.TSHARegistration Filing16 Dec 2025
- Virtual meeting to elect directors, ratify auditor, and expand authorized shares for future needs.TSHAProxy Filing2 Dec 2025
Next Taysha Gene Therapies earnings date
Q2 202611 Aug, 2026
Taysha Gene Therapies
Next Taysha Gene Therapies earnings date
Q2 202611 Aug, 2026
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