Taysha Gene Therapies (TSHA) Q3 2026 earnings summary

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.