TT
Tenaya Therapeutics, Inc. (TNYA)·Q1 2025 Earnings Summary
Executive Summary
- Q1 2025 showed disciplined OpEx control and extended runway: total operating expenses fell 18% YoY to $27.5M, net loss improved to $26.9M (from $32.2M), and cash, cash equivalents and marketable securities ended at $88.2M; with March financing, management guides runway into 2H26 .
- EPS of $(0.24) missed S&P Global consensus of $(0.205) by ~$0.04, with interest income down materially YoY ($0.64M vs $1.45M) and continued R&D investment as key non-operating and operating drivers, respectively . EPS consensus values from S&P Global*.
- Strategic and clinical momentum: positive MyPEAK-1 TN-201 low-dose cohort signals (biopsy transduction/expression and NYHA improvements) and RIDGE seroprevalence data de-risk eligibility for TN-401; initial data readouts for both programs remain on track for 2H25 .
- Catalysts and setup: 2H25 data from TN-201 and TN-401, plus restructuring (expected $1.6–$2.7M charges) aimed at clinical execution, position shares for data-driven inflections while the CIRM $8.0M grant and undrawn $45M SVB facility provide incremental funding flexibility .
What Went Well and What Went Wrong
- What Went Well
- Positive TN-201 signals: “well tolerated” at 3E13 vg/kg with robust DNA transduction and RNA expression; two of three patients showed ≥60% drops in cardiac troponin and all improved to NYHA Class I post-treatment in Cohort 1 .
- Eligibility de-risk for TN-401: >90% of PKP2-ARVC adults had low AAV9 antibody titers; RIDGE highlights large unmet need and supports enrollment feasibility and endpoint selection for RIDGE-1 .
- Balance sheet extended: $48.8M net offering proceeds and cost actions extend cash runway into 2H26, reducing near-term financing overhang .
- What Went Wrong
- EPS miss vs consensus: $(0.24) actual vs $(0.205)* consensus, despite YoY OpEx reductions; interest income fell YoY ($0.64M vs $1.45M), limiting offset to OpEx . EPS consensus values from S&P Global*.
- Continued losses reflect ongoing R&D investment: Q1 net loss of $26.9M, though improved YoY, underscores pre-revenue profile through upcoming clinical readouts .
- Restructuring costs: workforce reduction and related charges of $1.6–$2.7M expected by Q3 2025 introduce near-term P&L noise despite longer-term savings .
Financial Results
Estimate comparison (Q1 2025):
Notes: Company’s condensed statements present operating expenses and other income; no revenue line item was reported for the periods shown . Consensus values marked with “*” are from S&P Global.
KPI details (OpEx components):
Guidance Changes
Earnings Call Themes & Trends
Note: No Q1 2025 earnings call transcript was available in our source set; themes reflect company releases.
Management Commentary
- “2025 is off to a strong start…positive data from our MyPEAK‑1 clinical trial evaluating TN‑201…shared new findings from the RIDGE…study of adults with PKP2‑associated ARVC, and extended our cash runway into the second half of 2026.” – Faraz Ali, CEO .
- “We…focus our financial resources on clinical execution to help ensure we can take TN‑201 and TN‑401 through to important clinical milestones in 2026.” .
Q&A Highlights
Note: No Q1 2025 earnings call transcript located. Key clarifications from management materials:
- TN-201 efficacy markers: serial biopsies show increasing TN‑201 mRNA and MyBP‑C protein in available patients; improvements in hypertrophy measures and normalization of troponin observed in subset .
- TN-401 enrollment feasibility: >90% with low AAV9 titers and significant arrhythmia burden suggests ample eligible population and clinically meaningful endpoints for RIDGE‑1 .
- Capital plan: $48.8M net offering, $8.0M CIRM grant, undrawn $45M facility; restructuring to reduce cash burn and extend runway to 2H26 .
- Data cadence: initial TN-201 Cohort 2 and additional Cohort 1 data, plus TN‑401 Cohort 1 biopsy/safety, all targeted for 2H25 .
Estimates Context
- Q1 2025 EPS of $(0.24) missed S&P Global consensus of $(0.205) by ~$0.035; 6 estimates contributed to the EPS consensus (Primary EPS – # of Estimates: 6)*. Actual EPS from company filings .
- Consensus revenue was $0.0*, consistent with the company’s presentation of no revenue line item in its condensed statements .
- Given lower YoY interest income ($0.64M vs $1.45M) and continued clinical investment, Street models may modestly recalibrate non‑operating income and OpEx phasing ahead of 2H25 readouts .
Values marked with * retrieved from S&P Global.
Key Takeaways for Investors
- Runway extended to 2H26 reduces near-term financing risk; restructuring and CIRM grant further support a data-driven 2H25–2026 plan .
- TN‑201 early biopsy/clinical signals and TN‑401 eligibility/need data create asymmetric optionality around 2H25 readouts; these are likely the primary stock catalysts over the next 6–12 months .
- Despite OpEx discipline (Q1 OpEx $27.5M vs $33.8M YoY) and improved net loss YoY, EPS missed consensus—investors should expect near-term P&L to remain driven by trial cadence and interest income variability until clinical inflections .
- Maintain focus on enrollment progress (MyPEAK‑1 Cohort 2 completion and RIDGE‑1 Cohort 1 completion) to support on-time 2H25 disclosures .
- Manufacturing advances (HEK293 single‑plasmid yields; novel capsids) may enhance future cost structure and competitive positioning in cardiac gene therapy .
- Watch for MyClimb (pediatric HCM) and additional RIDGE updates to deepen disease understanding and inform endpoints for later-stage studies .
Appendix: Source Documents
- Q1 2025 Form 8‑K and Exhibit 99.1 press release, May 7, 2025 ; companion press release –.
- Q4 2024 Form 8‑K and Exhibit 99.1 press release, March 10, 2025 –; companion press release –.
- Q3 2024 Form 8‑K and press release, November 6, 2024 – –.
- Ridge/ASGCT and strategic updates: Apr 24, 2025 RIDGE data –; May 13, 2025 ASGCT abstracts –; Jan 13, 2025 strategic priorities –.
Footnote: Consensus estimates marked with * are from S&P Global.