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Tenaya Therapeutics (TNYA) investor relations material
Tenaya Therapeutics H. C. Wainwright Genetic Medicines Virtual Conference summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.
Pipeline overview and innovation
TN-201 and TN-401 are AAV9-based gene therapies targeting MYBPC3-positive HCM and PKP2-positive ARVC, respectively, both using cardiomyocyte-specific promoters with unique IP for TN-201.
TN-201 addresses the underlying genetic cause of HCM, especially for non-obstructive patients not eligible for current therapies like Camzyos.
TN-401 targets the leading genetic cause of arrhythmogenic cardiomyopathy, addressing a large orphan population with high unmet need.
Both programs leverage AAV9's robust safety and efficacy profile, operating at lower doses than peers.
Advanced protein quantification methods using mass spectrometry ensure robust measurement of therapeutic impact.
Clinical data highlights and upcoming milestones
Interim MyPeak-1 data for TN-201 showed safety, high transduction, increased RNA/protein, and clinical improvements in severe, refractory HCM patients.
All three initial TN-201 patients improved to NYHA Class I, indicating no daily living impact from disease.
Additional data, including baseline biopsy comparisons and one-year durability, will be presented at AHA as a late-breaking session.
TN-401 preclinical data demonstrated prevention of arrhythmia, fibrosis, and cardiac remodeling, with high survival benefit in models.
First clinical data from RIDGE-1 for TN-401, focusing on safety and biopsy results, is expected in Q4, with further dose escalation ongoing.
Competitive landscape and strategic positioning
TN-201 is positioned as the only therapy directly restoring the missing protein and potentially suitable for pediatric and severe cases.
Current standard-of-care and pipeline therapies do not address the genetic root cause in HCM or ARVC.
The company is cautious in data release, aiming for robust, interpretable results and meaningful peer comparisons.
Accelerated approval pathways may leverage protein as a surrogate biomarker, emphasizing the importance of rigorous quantification.
Ongoing engagement with investors and the medical community is prioritized around key data releases.
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