TN-201

May 06, 2026 — Tenaya Therapeutics, Inc. (NASDAQ: TNYA) reported Q1 2026 financial results and outlined upcoming catalysts across its gene therapy and small-molecule pipeline. For TN-201 (gene therapy for MYBPC3-associated hypertrophic cardiomyopathy; MyPEAK-1 Phase 1b/2), investigators identified protocol adjustments (earlier sirolimus, lower starting prednisone, weekly monitoring) enabling faster tapering and reduced cumulative immunosuppression; safety data for the first seven patients will be discussed at the ESC Heart Failure meeting (May 9, 2026). Tenaya expects interim Cohort 2 (6E13 vg/kg) data and Cohort 1 (3E13 vg/kg) updates in Q2 2026; enrollment resumed in January after FDA-aligned protocol amendments.

For TN-401 (gene therapy for PKP2-associated ARVC; RIDGE-1 Phase 1b/2), one-year Cohort 1 and initial Cohort 2 data will be presented as an ASGCT late-breaker (May 15, 2026). A DSMB review of six treated patients supported an acceptable safety profile and continued enrollment.

Tenaya presented preclinical DMD data for TN-301 (selective HDAC6 inhibitor) showing improved grip strength to wild-type levels (≥3 mg/kg) vs givinostat and favorable biomarker/cellular effects; TN-301 received FDA Rare Pediatric Disease and Orphan Drug designations for DMD and is planned for clinical trials in 2026.

Business development: Tenaya entered a multi-target research collaboration with Alnylam, receiving a $10.0M upfront payment (April 2026) with potential milestones up to $1.1B plus cost reimbursement.

Financials (Q1 2026): cash and equivalents $80.9M (3/31/26), expected runway into 2H 2027 (including Alnylam upfront); R&D $14.8M (vs $21.1M Q1 2025), G&A $5.4M (vs $6.5M), net loss $19.3M ($0.09/share) vs $26.9M ($0.24/share).