Taysha Gene Therapies
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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.
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Q3 2026 earnings summary12 Nov, 2026

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.

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Frequently asked questions

Taysha Gene Therapies Inc. is a biotechnology company focused on developing gene therapies for the treatment of monogenic diseases of the central nervous system. The company leverages its adeno-associated virus (AAV) gene therapy platform to create treatments targeting rare genetic disorders, particularly those affecting the brain and spinal cord. Taysha's pipeline includes therapies aimed at conditions such as neurodegenerative and neurodevelopmental diseases, with a mission to provide life-changing treatments for patients with limited or no therapeutic options. The company is advancing its programs through research, clinical development, and regulatory processes. The company is headquartered in Dallas, Texas, and its shares are listed on the NASDAQ.