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Tenaya Therapeutics, Inc. (TNYA)·Q3 2025 Earnings Summary

Executive Summary

  • Tenaya delivered a cleaner quarter operationally: R&D and G&A declined year over year, narrowing net loss to $20.3M and GAAP EPS to ($0.12), which came in better than S&P Global consensus of ($0.15)*; company reiterated cash runway into 2H 2026 .
  • Clinically, TN-201 continued to de-risk: Cohort 1 showed deeper, durable reductions in hypertrophy at 52–78 weeks and improved NYHA class; Cohort 2 showed early dose-responsive increases in transduction and MyBP-C protein (+14% at 12 weeks), with safety generally manageable .
  • A procedural FDA clinical hold (protocol standardization) temporarily pauses MyPEAK-1 dosing; management expects swift resolution and does not foresee impacts to near-term data timelines or overall development plans .
  • Near-term stock catalysts: (1) RIDGE-1 TN-401 Cohort 1 safety/biopsy data before year-end 2025; (2) additional TN-201 Cohort 2 biopsy/clinical data in 1H 2026; (3) potential lifting of clinical hold and resumption of TN-201 dosing .

What Went Well and What Went Wrong

  • What Went Well

    • “We were particularly pleased with the positive safety and promising clinical data presented on TN-201… at the recent AHA Scientific Sessions” — CEO Faraz Ali; DSMB endorsed dose expansion for TN-201 with acceptable safety .
    • Cohort 2 demonstrated early, dose-responsive increases in TN-201 transduction and MyBP-C protein (+14% at 12 weeks in Patient 6); Cohort 1 showed robust DNA/mRNA expression with protein rising over time .
    • Multiple clinical measures improved in Cohort 1: troponin I declined 48–74% to normal/near-normal, LVPWT reduced 21–39% at week 52, and all Cohort 1 patients reached NYHA Class I by one year .

  • What Went Wrong

    • FDA placed MyPEAK-1 on clinical hold to standardize monitoring and immunosuppression across sites; dosing paused pending protocol amendment (management does not expect timeline impact) .
    • Lab signs of complement activation observed in two Cohort 2 patients post-dose, including one SAE classified for monitoring; all resolved without additional therapy, but underscores immune-management vigilance in AAV programs .
    • One patient (Patient 5) withdrew from follow-up after week 12; LVMI can lag LVPWT improvements and is sensitive to measurement/physiology, adding variability to early efficacy readouts .

Financial Results

P&L and cash (GAAP; $USD Millions except per-share and shares):

MetricQ1 2025Q2 2025Q3 2025
Revenue— (not reported) — (not reported) — (not reported)
R&D Expense$21.08 $17.37 $15.36
G&A Expense$6.46 $6.71 $5.57
Total Operating Expenses$27.54 $24.08 $20.94
Other Income (Net)$0.67 $0.80 $0.66
Net Loss$(26.86) $(23.28) $(20.28)
GAAP EPS$(0.24) $(0.14) $(0.12)
Wtd-Avg Shares (Diluted)109,869,278 162,791,579 163,345,972
Cash & Marketable Sec. (end of period)$88.16 $71.67 $56.31

Q3 2025 Actual vs S&P Global Consensus

MetricQ3 2025 ActualQ3 2025 Consensus*
GAAP EPS$(0.12) $(0.15)*
RevenueNot disclosed; pre-revenue $0.00*

Values marked with * are retrieved from S&P Global.

Notes:

  • Margins are not meaningful given no reported revenue; analysis focuses on OpEx, net loss, and cash .
  • Company reiterated cash runway “into the second half of 2026” .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash RunwayThrough 2H 2026“Sufficient to support operations into the second half of 2026” (as of Q2) “Into the second half of 2026” (as of Q3) Maintained
TN-201: MyPEAK-1 dosing statusNear termPost-DSMB: expansion allowed at 3E13 or 6E13 FDA clinical hold to standardize protocol across sites; dosing to resume post-amendment New hold; timelines unchanged per mgmt
TN-401: RIDGE-1 Cohort 1 dataQ4 2025“Initial Cohort 1 safety/biopsy data in Q4 2025” “On track for company presentation before year-end 2025” Maintained
TN-201: Additional Cohort 2 data1H 2026Cohort 2 enrollment complete; data expected after maturation Maturation and additional biopsy/clinical data in 1H 2026 Maintained

Earnings Call Themes & Trends

TopicPrevious Mentions (Q1 & Q2 2025)Current Period (Q3 2025)Trend
TN-201 safety/efficacyCohort 1: well-tolerated at 3E13; NYHA improved; early hypertrophy signals Cohort 1 deeper, durable hypertrophy reductions; Cohort 2 early dose-responsive protein/transduction; safety manageable Improving data depth/dose response
Regulatory/Trial statusTN-201 DSMB endorsed expansion; TN-401 DSMB endorsed escalation/expansion FDA clinical hold to standardize monitoring/tapering; mgmt expects swift resolution; timelines intact Process refinement; manageable overhang
Immunosuppression & complementNot highlightedMinor protocolization across sites; some complement activation labs resolved without therapy Risk-managed; learnings incorporated
Endpoints/Path to pivotalNot specifiedDiscussion of co-primary surrogate framework (protein + LVMI) informed by peers; 2026 engagement with FDA Greater clarity emerging
TN-401 programEnrollment progress; Q4 data planned Cohort 2 dosed; Cohort 1 data by year-end 2025 On schedule
Pediatric strategy (TN-201)MyClimb natural history study Potential compassionate use for severe infants; pediatric path under consideration Early access considerations
Platform/AI—JACC paper: AI-enabled discovery platform highlighted Capability signaling

Management Commentary

  • “TN-201… received positive recommendations… to advance into the dose expansion cohorts… We were particularly pleased with the positive safety and promising clinical data presented… at the recent AHA Scientific Sessions.” — CEO Faraz Ali .
  • “Protein levels increased above baseline in all patients over time, and the higher dose of 6E13 resulted in the largest dose response, a 14% increase… within just 12 weeks.” — CMO Whit Tingley .
  • “A surprising but ultimately benign action… [FDA requested] protocol amendments… to minimize potential site-to-site variability… we do not anticipate this action will have any impact… on… milestones.” — CEO Faraz Ali .
  • “TN-201 was generally well tolerated at both… doses. No dose-limiting toxicities… [and] all patients have successfully tapered off immunosuppression.” — CMO Whit Tingley .
  • External KOL: “These initial results are promising… gene therapies such as TN-201 offer the opportunity to further advance and improve patient care.” — Dr. Milind Desai (Cleveland Clinic) .

Q&A Highlights

  • Hold timing and scope: Management has submitted a revised protocol; discussions with FDA “very swift” and collaborative; optimistic for resolution “very soon,” with no change to TN-401 and minimal/no impact to planned TN-201 data milestones .
  • Cohort 2 expectations: Early dose response in protein/transduction is encouraging, but team cautions against over-extrapolating magnitude/kinetics given variability; will share fuller data in 1H 2026 .
  • Endpoint strategy: Peer alignments on surrogate co-primaries (protein expression + LVMI) noted; Tenaya expects to engage FDA in 2026 on pivotal designs for adult and potentially pediatric populations .
  • LVPWT vs LVMI: LVPWT showed pronounced, consistent reductions; LVMI can be noisier and more physiology-sensitive; expectation that LVMI follows with more data/time .
  • Complement management: No clinical TMA; lab complement changes resolved without therapy; protocol will formalize consistent monitoring/readiness to use complement inhibitor if needed .

Estimates Context

  • Q3 EPS beat: GAAP EPS of ($0.12) vs S&P Global consensus ($0.15), a ~$0.03 beat; revenue in-line at $0.00 given pre-revenue status .
  • Target price and coverage: Consensus target price $10.14* on 7 estimates; 8 EPS and 6 revenue estimates in the quarter reflect growing coverage despite early-stage status.*
  • Forward look: Q4 2025 EPS consensus at ($0.15); absent revenue expectations reflect continued focus on OpEx control and clinical catalysts.

Values marked with * are retrieved from S&P Global.

Key Takeaways for Investors

  • Clinical momentum intact: Cohort 1 durability and Cohort 2 early dose response de-risk TN-201 mechanism (DNA→mRNA→protein→biomarker/hypertrophy/symptoms), supporting potential surrogate endpoint strategy .
  • Regulatory overhang appears process-oriented: FDA hold centers on protocol standardization; mgmt expects swift resolution with no change to 2025–2026 milestones .
  • Expense discipline extends runway: Sequential OpEx reduction narrowed net loss; runway reiterated into 2H 2026, lowering near-term financing risk vs many peers .
  • Near-term catalysts: TN-401 (RIDGE-1) initial Cohort 1 safety/biopsy data before year-end 2025; additional TN-201 Cohort 2 data in 1H 2026; potential hold lift and dosing resumption .
  • Stock set-up: Positive clinical momentum and imminent TN-401 readout provide upside optionality; hold resolution could be a relief catalyst; risks include AAV class-safety scrutiny, small-N datasets, and funding optionality if timelines slip .
  • Watch endpoints narrative: Management increasingly frames co-primary surrogates (protein + LVMI) aligned with peers; keep an eye on consistency across LVMI and LVPWT as Cohort 2 matures .
  • Pediatric opportunity: Natural history data (MyClimb) and potential compassionate use suggest strategic intent to expand addressable population pending adult data maturity .

Appendix: Additional Q3 2025 Operational Highlights

  • Cash, cash equivalents and marketable securities: $56.3M at 9/30/2025; debt facility undrawn; runway into 2H 2026 .
  • TN-401 program: Dosing completed in Cohort 2; Cohort 1 safety/biopsy data expected by year-end 2025 .
  • Platform publications: AI-enabled discovery approach and cardiac regeneration preclinical data highlighted in JACC and AHA presentations .

Citations:

  • Q3 2025 8-K and Exhibit 99.1 press release
  • AHA/TN-201 clinical data press releases
  • AHA presentation preview (11/4)
  • Q2 2025 results press/8-K
  • Q1 2025 results press release
  • Webcast transcript (11/10) –