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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

MetricQ3 2024Q4 2024Q1 2025
Total Operating Expenses ($USD Thousands)26,711 24,652 27,538
Net Loss ($USD Thousands)(25,634) (23,836) (26,864)
Net Loss per Share ($)(0.30) (0.28) (0.24)
Interest Income ($USD Thousands)1,080 812 635
Cash, Cash Equivalents & Marketable Securities (period-end, $USD Thousands)79,469 61,446 88,158

Estimate comparison (Q1 2025):

MetricConsensusActualSurprise
EPS ($)(0.205)*(0.24) (0.035)* (miss)
Revenue ($USD Millions)0.0*n/a (company did not report a revenue line item) n/a

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):

Metric ($USD Thousands)Q3 2024Q4 2024Q1 2025
R&D Expense20,350 18,688 21,076
G&A Expense6,361 5,964 6,462

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash RunwayMulti‑year“Into mid‑2026” (after Mar’25 financing) “Into 2H26” (post Q1 cost actions) Raised
TN-201 (MyPEAK‑1) Data2025Initial Cohort 2 + further Cohort 1 in 2H25 Initial Cohort 2 + more Cohort 1 in 2H25 (unchanged) Maintained
TN-401 (RIDGE‑1) Data2025Initial Cohort 1 data in 2H25 Initial Cohort 1 data in 2H25 (unchanged) Maintained
Restructuring Charges2025n/a$1.6–$2.7M; substantially all by Q3 2025 New
Credit FacilityOngoing$45M SVB facility, undrawn $45M SVB facility, undrawn Maintained
Non‑dilutive Funding2025n/a$8.0M CIRM clinical grant for RIDGE‑1 New

Earnings Call Themes & Trends

Note: No Q1 2025 earnings call transcript was available in our source set; themes reflect company releases.

TopicPrevious Mentions (Q3’24, Q4’24)Current Period (Q1’25)Trend
TN-201 clinical signalsDSMB endorsed dose escalation; protocol broadened; initial Cohort 1 data slated Dec’24 Low-dose cohort well tolerated; robust biopsy transduction/expression; NYHA improvements; Cohort 2 enrollment on track; 2H25 readout Improving clinical momentum
TN-401 enrollment/eligibilityFirst patient dosed Nov’24; Cohort 1 enrollment in 1H25; 2H25 initial data RIDGE seroprevalence: >90% low AAV9 titers; high arrhythmia burden; 2H25 RIDGE‑1 data De‑risking eligibility; data path intact
Manufacturing/platformASGCT: improved HEK293 single‑plasmid process; novel capsids; prime editing prototypes Platform strengthening
Financing/runway$45M SVB facility; runway into 2H’25 (Q3) and mid‑’26 (Q4 post‑financing) Runway into 2H’26; restructuring to prioritize clinical milestones Extended runway; tighter focus
Regulatory/legalRare pediatric disease designation (TN‑201) and PKP2 method patent Continued IP progress; CIRM grant; patent reminder in Q4 release Supportive backdrop

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.