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Dyne Therapeutics, Inc. (DYN)·Q3 2025 Earnings Summary

Executive Summary

  • EPS beat: Q3 2025 diluted EPS of -$0.76 vs S&P Global consensus of -$0.84; net loss narrowed sequentially to $108.0M from $110.9M in Q2, driven by slightly lower operating expenses and $5.9M in other income *.
  • Program momentum: FDA Breakthrough Therapy designation for z-rostudirsen (DYNE-251) in DMD; December 2025 topline DELIVER REC data targeted to underpin a Q2 2026 U.S. Accelerated Approval submission .
  • DM1 timeline reset: ACHIEVE REC enrollment now expected early Q2 2026 vs prior guidance of Q4 2025, following significant U.S. site expansion and protocol revision to vHOT; BLA shifted to early Q3 2027 .
  • Liquidity: Cash, cash equivalents and marketable securities increased to $791.9M; runway reaffirmed into Q3 2027, covering two registrational readouts and potential first launch in Q1 2027 .
  • Near-term catalyst: December DELIVER REC topline (dystrophin by Western blot at 6 months) and accompanying functional outcomes (not powered for significance) likely to drive stock narrative and estimate revisions .

What Went Well and What Went Wrong

What Went Well

  • Breakthrough progress and regulatory momentum: “Our lead programs in DMD and DM1 have now each been granted Breakthrough Therapy Designation… advancing toward anticipated U.S. Accelerated Approval submissions” — CEO John Cox .
  • Clinical validation expectation: “I expect [DELIVER REC topline] to be a validating milestone for our pipeline and platform” — CMO Doug Kerr, M.D., Ph.D. .
  • Balance sheet strength and commercial buildout: “We believe we have sufficient funds to… submit two BLAs… and launch our first commercial product… capital‑efficient rare disease commercial organization” — CFO Erick Lucera .

What Went Wrong

  • DM1 timeline delay: ACHIEVE REC full enrollment moved to early Q2 2026 from prior Q4 2025 guidance due to U.S. site expansion and protocol changes; BLA moved to early Q3 2027 (previously late 2026) .
  • Continued operating losses: Q3 operating loss (EBIT) was -$113.9M, with R&D at $97.2M and G&A at $16.7M; net loss -$108.0M .
  • No reported product revenue; secondary endpoints in DELIVER REC not powered for statistical significance, limiting near-term functional efficacy interpretation from REC alone .

Financial Results

Sequential and Quarterly Detail

MetricQ1 2025Q2 2025Q3 2025
Revenues ($USD Millions)n/an/an/a
Diluted EPS ($)-1.05 -0.97 -0.76
Net Loss ($USD Millions)$115.4 $110.9 $108.0
Loss from Operations (EBIT, $USD Millions)$122.4 $115.8 $113.9
R&D Expense ($USD Millions)$106.4 $99.2 $97.2
G&A Expense ($USD Millions)$15.9 $16.6 $16.7
Other (Expense) Income, net ($USD Millions)$7.0 $4.9 $5.9
Cash, Cash Equivalents & Marketable Securities ($USD Millions)$677.5 $683.9 $791.9

Notes:

  • Dyne did not report product revenue for these periods; all figures are GAAP .

Year-over-Year (Q3 2025 vs Q3 2024)

MetricQ3 2024Q3 2025
R&D Expense ($USD Millions)$92.8 $97.2
G&A Expense ($USD Millions)$12.9 $16.7
Net Loss ($USD Millions)$97.1 $108.0
Diluted EPS ($)-0.96 -0.76

Versus S&P Global Consensus (Q3 2025)

MetricConsensusActualSurprise
Primary EPS Consensus Mean-$0.84*-$0.76 +$0.08 (beat)*
Revenue Consensus Mean$0.00*n/an/a

Values with * retrieved from S&P Global.

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
ACHIEVE REC full enrollment (DM1, z‑basivarsen/DYNE‑101)Trial milestoneQ4 2025 Early Q2 2026 Lowered/Delayed
ACHIEVE BLA submission (U.S. Accelerated Approval)RegulatoryLate 2026 Early Q3 2027 Lowered/Delayed
ACHIEVE confirmatory Phase 3 startClinicalQ1 2026 Q1 2026 (reaffirmed) Maintained
DELIVER REC topline (z‑rostudirsen/DYNE‑251)Data readoutLate 2025 December 2025 Maintained/Narrowed timing
DELIVER BLA (U.S. Accelerated Approval)RegulatoryEarly 2026 Q2 2026 Maintained/Narrowed timing
z‑rostudirsen U.S. launch (Priority Review assumed)CommercialQ1 2027 Q1 2027 Maintained
z‑basivarsen U.S. launch (Priority Review assumed)Commercialn/aQ1 2028 New/Added
Cash runwayLiquidityInto Q3 2027 (extended in Q2) Into Q3 2027 (reaffirmed) Maintained

Earnings Call Themes & Trends

Note: A Q3 2025 earnings call transcript was not available in our document catalog or via external search; themes below reflect Q1–Q3 press releases.

TopicPrevious Mentions (Q1 & Q2)Current Period (Q3)Trend
Regulatory designationsDYNE‑101 Breakthrough Therapy in DM1 (June); DELIVER REC fully enrolled; planned AA submissions in 2026 z‑rostudirsen Breakthrough Therapy in DMD; AA timeline reiterated; December topline confirmed Strengthening regulatory momentum
DM1 endpoint strategyvHOT as primary endpoint for REC; Type C meeting with FDA U.S. site activation; protocol revision; enrollment delayed due to expansion Execution complexity; timeline shift
DMD efficacy thesisDELIVER MAD data supported high dystrophin and functional gains; REC fully enrolled December REC topline targeted; secondary endpoints not powered Data inflection imminent; interpretation guardrails
Commercial readinessBuilding capital‑efficient rare disease commercial org Commercial/CMS infrastructure on track; management team in place Continued scaling
Liquidity/runwayRaised equity/entered loan; runway extended to Q3 2027 Runway reaffirmed into Q3 2027; cash increased Stable/improved
Global/regionalPursuing ex‑U.S. pathways in DMD and DM1 U.S. sites activated in DM1 REC; ex‑U.S. pathways reiterated U.S. footprint expanding

Management Commentary

  • “Our lead programs in DMD and DM1 have now each been granted Breakthrough Therapy Designation… advancing toward anticipated U.S. Accelerated Approval submissions” — John Cox, CEO .
  • “Z‑rostudirsen… with a favorable safety profile and the convenience of monthly dosing… prior DELIVER demonstrated dystrophin levels well above… and unprecedented improvements… I expect [REC topline] to be a validating milestone…” — Doug Kerr, M.D., Ph.D., CMO .
  • “We believe we have sufficient funds to generate data from two registrational trials, submit two BLAs… and launch our first commercial product… capital‑efficient rare disease commercial organization… CMC infrastructure” — Erick Lucera, CFO .

Q&A Highlights

No Q3 2025 earnings call transcript was available; Dyne’s disclosures were provided via 8‑K and press releases . Guidance clarifications included the DM1 enrollment delay due to U.S. site expansion and protocol changes, and reaffirmation of DMD timelines .

Estimates Context

  • Q3 2025 EPS: actual -$0.76 vs S&P Global consensus -$0.84; beat of $0.08 per share*.
  • Revenue: consensus $0.00 for Q3; Dyne did not report product revenue this quarter*.
  • Coverage depth: 11 EPS estimates and 14 revenue estimates for Q3*.
  • Implication: Modest EPS beat driven by sequentially lower operating expenses and $5.9M other income; upcoming December DELIVER data likely to drive estimate revisions in DMD, while DM1 enrollment delay may push DM1 commercialization timelines later, affecting LT models .

Values with * retrieved from S&P Global.

Key Takeaways for Investors

  • Near‑term binary catalyst: December DELIVER REC topline (dystrophin at 6 months) is pivotal for AA trajectory and platform validation .
  • DMD path intact: z‑rostudirsen AA submission targeted for Q2 2026; potential U.S. launch in Q1 2027 (Priority Review) maintained .
  • DM1 path delayed: ACHIEVE REC enrollment now early Q2 2026; AA BLA moved to early Q3 2027; factor timeline slippage into DM1 revenue models .
  • Liquidity supports execution: $791.9M cash and runway into Q3 2027 covers registrational data, AA filings, and initial commercial build-out .
  • EPS outperformance: Q3 diluted EPS beat consensus; sequential loss narrowing reflects disciplined OpEx and interest income; watch for sustained expense control into 2026 *.
  • Ex‑U.S. optionality: Orphan Drug designation in Japan for DYNE‑251 adds regulatory leverage; parallel pathways can diversify approval risk .
  • Trading setup: Expect heightened sensitivity to December data and subsequent AA interactions; DM1 delay tempers multi‑asset launch cadence but DMD remains the primary driver near term .

Appendix: Additional Q3 Press Releases

  • Investor conference participation (Nov 3, 2025) .
  • Orphan Drug designation in Japan for DYNE‑251 (Sept 29, 2025) .

Notes:

  • Non‑GAAP: Dyne did not report non‑GAAP measures; all figures cited are GAAP .
  • Earnings call: No Q3 2025 transcript available in our sources .
  • All document‑based facts include citations; S&P Global estimates are marked with * and disclosed as values retrieved from S&P Global.