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Dec 31, 2022
Tenaya Therapeutics 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
Tenaya Therapeutics reported its Q4 and full year 2022 financial results, highlighting a cash position of $204.2 million and progress in its clinical programs, including the clearance of the TN-201 IND and the commencement of dosing in the TN-301 clinical trial.
TN-201 IND was cleared in January, with plans to begin Phase 1b dosing in MYBPC3-associated HCM patients in Q3 2023.
Dosing commenced in the multiple-ascending dose stage of the first-in-human clinical trial of TN-301, with data anticipated in the second half of 2023.
Year-end cash and investments for 2022 totaled $204 million, expected to fund operations into the first half of 2025.
The company plans to submit an IND for its TN-401 gene therapy candidate and present additional data on pipeline candidates and platform innovations.
Tenaya Therapeutics
Tenaya Therapeutics
Forward Guidance
Tenaya anticipates several key milestones in 2023, including clinical testing of TN-201, data from the TN-301 trial, and submission of the TN-401 IND.
Positive Outlook
- Initiate clinical testing of TN-201.
- Share data from the first-in-human clinical trial of TN-301.
- Submit an IND for the TN-401 gene therapy candidate.
- Present additional data detailing insights on current pipeline candidates.
- Present additional data detailing insights on emerging platform innovations.
Challenges Ahead
- Ability to develop, initiate or complete preclinical studies and clinical trials for its product candidates
- Timing, scope and likelihood of regulatory filings and approvals
- Availability of data at the referenced times
- Risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics and operating as an early stage company
- Ability to raise any additional funding it will need to continue to pursue its business and product development plans