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Dec 31, 2022
Taysha Gene Therapies Q4 2022 Earnings Report
Reported financial results for the fourth quarter and full-year ended December 31, 2022, and provided a corporate update.
Key Takeaways
Taysha Gene Therapies reported its Q4 and full-year 2022 financial results. They initiated screening for their REVEAL Rett syndrome trial and are on track for first patient dosing in H1 2023. A protocol amendment was submitted to allow younger patients in the study. FDA feedback suggests alternative trial designs for TSHA-120 in GAN.
Screening initiated for first potential adult patient with Rett syndrome for the Phase 1/2 REVEAL trial
Submitted protocol amendment expanding enrollment eligibility to include subjects ≥ 15 years
FDA feedback suggests consideration of alternative clinical trial designs for clinically meaningful and objectively measured treatment effects for TSHA-120 in GAN
Submission of a formal meeting request to the FDA planned in Q2 2023
Forward Guidance
Taysha Gene Therapies expects that its current cash resources will support planned operating expenses and capital requirements into the first quarter of 2024.
Positive Outlook
- Dosing of the first adult patient with Rett syndrome anticipated in H1 2023
- Initial available Phase 1/2 clinical data, primarily on safety, for TSHA-102 in adult patients with Rett syndrome expected in H1 2023, with planned quarterly updates on available clinical data thereafter
- CTA submission to UK MHRA for TSHA-102 in pediatric patients with Rett syndrome anticipated in mid-2023
- IND application submission to U.S. FDA for Rett syndrome expected in H2 2023
- Continued dosing of adult patients with Rett syndrome in the REVEAL trial in H2 2023
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