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Jun 30, 2021
Taysha Gene Therapies Q2 2021 Earnings Report
Taysha Gene Therapies reported financial results for the second quarter and provided a corporate update.
Key Takeaways
Taysha Gene Therapies reported a net loss of $40.9 million for the second quarter ended June 30, 2021. The company had $197.4 million in cash and cash equivalents as of June 30, 2021. They also secured a non-dilutive term loan for up to $100 million.
Positive pre-IND/CTA feedback was obtained from regulatory agencies for Rett syndrome, GM2 gangliosidosis and CLN1 disease programs.
A non-dilutive term loan agreement was entered into with Silicon Valley Bank for up to $100 million.
Multiple successful GMP runs provided drug products to support five planned Phase 1/2 trials.
Phase 1/2 visual acuity data for TSHA-120 in patients with GAN demonstrated a dose-dependent trend towards stabilization of visual acuity.
Forward Guidance
Taysha Gene Therapies expects to report clinical data for TSHA-120, engage with regulatory agencies for approval pathway of TSHA-120, report preliminary Phase 1/2 safety and biomarker data for TSHA-101, submit an IND application in the U.S. for TSHA-101, initiate a Phase 1/2 clinical trial in the U.S. for TSHA-101, initiate a Phase 1/2 clinical trial for TSHA-118, submit IND/CTA filing for TSHA-102, initiate Phase 1/2 clinical trial for TSHA-102, report clinical data for TSHA-102, submit IND/CTA filing for TSHA-104, initiate Phase 1/2 trial for TSHA-104.
Positive Outlook
- Report clinical data for TSHA-120 from the high dose cohort of 3.5x10^14 total vg in second half of 2021
- Engage with key regulatory agencies to discuss the approval pathway and provide a regulatory update by year-end 2021
- Report preliminary Phase 1/2 safety and biomarker data (Queen’s University trial) in second half of 2021
- Submit an Investigational New Drug (IND) application in the U.S. in second half of 2021
- Initiate Phase 1/2 clinical trial in the U.S. in second half of 2021
Challenges Ahead
- No specific negative guidance was provided in the earnings report.
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