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Taysha Gene Therapies (TSHA) investor relations material
Taysha Gene Therapies Q3 2026 earnings summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Executive summary
TSHA-102 is in development for Rett syndrome; dosing is complete in REVEAL Part A, the 17-patient REVEAL pivotal trial and the four-patient ASPIRE trial.
All 33 treated patients cleared acute post-dose safety monitoring; no severe treatment-related serious adverse events or dose-limiting toxicities were reported as of the November 2026 cutoff.
Commercial-scale BLA-enabling PPQ met predefined specifications and comparability criteria, supporting potential inclusion of REVEAL Part A data in a BLA.
Financial highlights
Q3 2026 revenue was $0; operating expenses were $41.9M versus $34.0M in Q3 2025, and net loss was $39.1M versus $32.7M.
Q3 R&D expense was $28.8M versus $25.7M, primarily reflecting higher clinical trial and compensation costs; G&A was $13.1M versus $8.3M, including launch-readiness spending.
9M 2026 revenue was $0 versus $4.3M in 9M 2025; operating expenses were $132.7M versus $86.5M, and net loss was $128.2M versus $81.1M.
9M R&D expense rose $39.7M to $101.2M, driven by PPQ manufacturing and clinical trial costs; G&A rose $9.9M to $34.9M, including launch-readiness spending.
9M operating cash use was $114.2M; investing used $3.5M and financing provided $218.2M.
Outlook and guidance
REVEAL pivotal six-month interim topline data and FDA feedback on the potential BLA pathway are expected in H1 2027; a six-month filing could advance timing by at least two quarters versus waiting for 12-month data, subject to results and FDA feedback.
The six-month interim analysis follows the last participant reaching six months, scheduled within December; data review and FDA interaction are expected before public disclosure.
A CMC Type B meeting is planned for Q4 2026, with FDA feedback expected in Q1 2027 on PPQ results, comparability, potency-release strategy and commercial specifications.
An additional CNS gene therapy candidate nomination and preclinical development start are expected in H1 2027.
R&D and G&A spending are expected to rise with clinical development, manufacturing, precommercial and pipeline activities.
- Dosing completed in pivotal trials; strong efficacy, $230M financing, and cash runway to 2028.TSHA
Q2 2026 - TSHA-102 showed 100% response and durable, multi-domain gains in Rett syndrome patients.TSHA
Corporate presentation - 100% of patients showed durable, multi-domain gains and strong safety, supporting BLA plans.TSHA
Study result - All proposals, including director elections and compensation votes, were approved.TSHA
AGM 2026 - TSHA-102 pivotal trials advance with strong safety, FDA alignment, and widened Q1 2026 net loss.TSHA
Q1 2026 - TSHA-102 trials progressed with strong safety, regulatory alignment, and robust cash position.TSHA
Q4 2025 - TSHA-102 advanced in Rett syndrome trials, improved financials, and strong cash runway into Q4 2026.TSHA
Q3 2024 - FDA alignment accelerates pivotal trial for Rett syndrome; Q1 net loss narrows, cash runway strong.TSHA
Q1 2025 - TSHA-102 Phase II trials completed dosing with strong safety, narrowed net loss, and cash runway into 2026.TSHA
Q4 2024
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