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Dec 30, 2024
Tenaya Therapeutics Q4 2024 Earnings Report
Tenaya Therapeutics reported its fourth quarter and full year 2024 financial results, highlighting advancements in its cardiovascular gene therapy pipeline and a recent financing round.
Key Takeaways
Tenaya Therapeutics reported a net loss of $23.8 million for Q4 2024, or $0.28 per share. The company made significant progress in its clinical trials for TN-201 and TN-401, with initial data from MyPEAK-1 Cohort 1 accepted for presentation and dosing initiated in MyPEAK-1 Cohort 2. A recent financing round of $48.9 million extended the cash runway into mid-2026.
Dosing initiated in Cohort 2 of the MyPEAK-1 Phase 1b/2 clinical trial for TN-201, targeting MYBPC3-Associated Hypertrophic Cardiomyopathy.
Initial data from MyPEAK-1 Cohort 1 of TN-201 accepted for late-breaker presentation at the American College of Cardiology Meeting.
Initial data from RIDGE-1 Phase 1b clinical trial of TN-401 for PKP2-Associated Arrhythmogenic Right Ventricular Cardiomyopathy expected in 2H25.
Secured $48.9 million in financing, extending cash runway into mid-2026.
Tenaya Therapeutics
Tenaya Therapeutics
Forward Guidance
Tenaya Therapeutics anticipates a data-rich 2025, with expected data releases from both the TN-201 MyPEAK-1 and TN-401 RIDGE-1 clinical trials. The company's recent financing is expected to extend its cash runway into mid-2026.
Positive Outlook
- Expects to have greater than one-year follow-up in the high-dose cohort of MyPEAK-1 in the first half of next year.
- Anticipates one-year follow-up for the first few patients enrolled in the RIDGE-1 clinical trial in the first half of next year.
- On track to complete enrollment in Cohort 2 of MyPEAK-1 in the first half of 2025.
- Plans to release initial Cohort 2 data for MyPEAK-1 and further follow-up data from Cohort 1 in the second half of 2025.
- Anticipates sharing data from the ongoing RIDGE seroprevalence and natural history study in the second half of 2025.
Challenges Ahead
- No specific negative forward guidance was provided in the report.
- Potential for unexpected concerns arising from adverse safety events in clinical trials.
- Risk of product candidates failing to demonstrate safety and/or efficacy in clinical testing.
- Clinical trial results may differ from preclinical, interim, preliminary, topline, or expected results.
- Ability to raise additional funding may be needed to continue business and product development plans.