Sign in
DT

Dyne Therapeutics, Inc. (DYN)·Q1 2025 Earnings Summary

Executive Summary

  • Q1 2025 showed continued clinical/regulatory progress but a wider loss; EPS was -$1.05 vs S&P Global consensus of -$0.84, a miss of $0.21, with no product revenue as Dyne remains pre-commercial . EPS consensus values from S&P Global*.
  • ACHIEVE (DYNE-101, DM1) registrational expansion cohort was initiated following an FDA Type C meeting; DELIVER (DYNE-251, DMD) registrational expansion cohort was fully enrolled (32 patients), reaffirming targeted U.S. Accelerated Approval submissions in 2026 .
  • Operating investments accelerated: R&D rose to $106.4M, total OpEx to $122.4M; G&A was $15.9M. Cash, cash equivalents and marketable securities were $677.5M, with runway at least into 2H 2026 .
  • Stock-relevant catalysts: late-2025 DELIVER REC data, H1 2026 ACHIEVE REC data to support potential U.S. Accelerated Approval filings; plus near-term regulatory update on DYNE-101 post FDA meeting minutes .

What Went Well and What Went Wrong

What Went Well

  • Initiated ACHIEVE registrational expansion (up to 48 participants) after a May Type C FDA meeting; management plans a regulatory update once minutes are received .
  • Fully enrolled the DELIVER registrational expansion cohort (32 patients), keeping the DMD program on track for late-2025 data and early-2026 BLA submission for U.S. Accelerated Approval .
  • CEO tone confident: “Our two lead programs continue to demonstrate compelling and favorable data… We are urgently advancing both programs toward potential U.S. Accelerated Approval submissions in 2026 and possible commercial launches in 2027.” .

What Went Wrong

  • EPS missed S&P Global consensus by $0.21 driven by stepped-up R&D spend; net loss widened to $115.4M vs $65.6M in Q1 2024 and $89.5M in Q4 2024 . EPS consensus values from S&P Global*.
  • R&D expenses more than doubled year-over-year to $106.4M as the company advanced registrational activities and trial preparations, pressuring quarterly loss metrics .
  • No earnings call transcript was available to glean Q&A color or further guidance clarifications; investor updates were delivered via press releases and event announcements [ListDocuments: earnings-call-transcript returned 0 for 2025-04–06] .

Financial Results

Income Statement and EPS (USD)

MetricQ1 2024Q3 2024Q4 2024Q1 2025
R&D Expense ($USD Millions)$44.5 $92.8 $81.8 $106.4
G&A Expense ($USD Millions)$24.6 $12.9 $15.3 $15.9
Total Operating Expenses ($USD Millions)$69.2 $105.7 $97.1 $122.4
Loss from Operations ($USD Millions)$(69.2) $(105.7) $(97.1) $(122.4)
Other (Expense) Income, net ($USD Millions)$3.5 $8.5 $7.6 $7.0
Net Loss ($USD Millions)$(65.6) $(97.1) $(89.5) $(115.4)
EPS (basic & diluted, $USD)-$0.81 -$0.96 -$0.88 -$1.05
Weighted Avg Shares (basic & diluted)81,043,741 100,882,042 101,982,168 109,911,628
EPS Consensus Mean (S&P Global)*———-$0.84*
Revenue Consensus Mean (S&P Global, $USD Millions)*———$0.00*

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

Balance Sheet and Liquidity (USD)

MetricQ3 2024Q4 2024Q1 2025
Cash, Cash Equivalents & Marketable Securities ($USD Millions)$723.7 $642.3 $677.5
Total Assets ($USD Millions)$768.8 $691.2 $721.1
Liabilities ($USD Millions)$63.3 $61.4 $52.1
Stockholders’ Equity ($USD Millions)$705.5 $629.8 $669.0
Cash Runway (company view)at least into 2H 2026 at least into 2H 2026 at least into 2H 2026

Segments and KPIs

  • Dyne reported no product revenue; company remains pre-commercial and focused on clinical development .
  • Clinical/regulatory KPIs: | KPI | Q3 2024 | Q4 2024 | Q1 2025 | |-----|---------|---------|---------| | DYNE-101 (DM1) FDA Interactions | IND cleared; additional ACHIEVE data planned early Jan-2025 | Fast Track designation granted (Jan 2025 noted) and planning REC (up to 48) with full enrollment mid-2025 | Type C meeting held May 2025; REC initiated (up to 48), full enrollment mid-2025; Phase 3 goal to initiate in 2025 | | DYNE-251 (DMD) Registrational Cohort | Enrolling registrational cohort at 20 mg/kg | Anticipated completion of enrollment in Q1 2025; late-2025 data | Registrational expansion cohort fully enrolled (32); late-2025 data; early-2026 BLA targeted |

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
DYNE-101 (DM1) REC size/timing2025Plan: up to 48; full enrollment mid-2025 Initiated REC; up to 48; full enrollment mid-2025 Advanced (initiated)
DYNE-101 (DM1) U.S. Accelerated Approval BLA timingH1 2026Anticipated H1 2026 Anticipated H1 2026 Maintained
DYNE-101 Phase 3 initiation2025—Goal to initiate Phase 3 in 2025 New
DYNE-251 (DMD) REC enrollment status2025Anticipated completion Q1 2025 Fully enrolled (32 patients) Completed
DYNE-251 (DMD) late-2025 data2025Planned late-2025 data Planned late-2025 data Maintained
DYNE-251 (DMD) U.S. Accelerated Approval BLA timingEarly 2026Early 2026 Early 2026 Maintained
Cash runwayThrough 2H 2026At least into 2H 2026 At least into 2H 2026 Maintained
Potential commercial launches2027“transformational opportunity to launch two important therapies in 2027” “possible commercial launches in 2027” Maintained

Earnings Call Themes & Trends

(Note: No Q1 2025 earnings call transcript was found; themes below track press releases and company updates.)

TopicPrevious Mentions (Q-2 and Q-1)Current PeriodTrend
Regulatory interactions (DM1)Q3’24: IND cleared for DYNE-101 ; Q4’24: Fast Track designation Q1’25: FDA Type C meeting held; regulatory update pending minutes Progressing regulatory engagement
Enrollment and registrational designQ3’24: DELIVER registrational cohort enrolling ; Q4’24: DYNE-101 REC planning; DYNE-251 REC completion targeted Q1’25 Q1’25: DYNE-101 REC initiated; DYNE-251 REC fully enrolled Advancing to registrational datasets
Clinical efficacy narrativeQ3’24: Encouraging biomarker/functional data (DMD) Q4’24: “substantial functional benefit… reversal of disease progression” (DM1) Q1’25: “evidence of functional improvement” across DM1 & DMD
Liquidity/runwayQ3’24: runway ≥2H 2026 Q4’24: runway ≥2H 2026 (includes ATM proceeds) Q1’25: runway ≥2H 2026
Leadership readiness—Q4’24: strategic focus highlighted Q1’25: CFO/CBO/CSO/CIO appointments to prepare for filings/launch

Management Commentary

  • “Our two lead programs continue to demonstrate compelling and favorable data, including evidence of functional improvement across multiple measures in DM1 and DMD. We are urgently advancing both programs toward potential U.S. Accelerated Approval submissions in 2026 and possible commercial launches in 2027.” — John Cox, President & CEO .
  • “Our most recent clinical data for DYNE-101 from the ACHIEVE trial in DM1 patients showed substantial functional benefit, including the reversal of disease progression… We are moving rapidly to initiate a Registrational Expansion Cohort to support a potential submission for U.S. Accelerated Approval.” — John Cox .
  • “Our recent long-term DELIVER trial results demonstrated clinically relevant and sustained functional improvement through 18 months… We are pleased that the EC has granted orphan drug designation to DYNE-251…” — Doug Kerr, MD, PhD, CMO .

Q&A Highlights

  • No Q1 2025 earnings call transcript was available; management provided prepared updates via press releases and event/webcast announcements (e.g., June 17 DYNE-101 investor webcast) .

Estimates Context

  • EPS: -$1.05 actual vs S&P Global consensus -$0.84; miss of $0.21. Bold miss reflects stepped-up R&D investment and registrational activities. EPS consensus values from S&P Global* .
  • Revenue: S&P Global consensus $0.00; company reported no product revenue as pre-commercial. Revenue consensus values from S&P Global* .
MetricQ1 2024Q3 2024Q4 2024Q1 2025
EPS (Actual, $USD)-$0.81 -$0.96 -$0.88 -$1.05
EPS (Consensus Mean, $USD)*———-$0.84*
Revenue (Consensus Mean, $USD Millions)*———$0.00*

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

Key Takeaways for Investors

  • EPS miss was driven by higher R&D investment as Dyne initiated and advanced registrational activities; this spending is aligned with near-term clinical/regulatory catalysts rather than core financial performance .
  • DYNE-251 (DMD) is de-risked from an operational standpoint with registrational expansion fully enrolled and late-2025 data targeted to support early-2026 U.S. Accelerated Approval submission; this is a key potential stock catalyst window .
  • DYNE-101 (DM1) achieved FDA Type C meeting and initiated the registrational expansion cohort, with H1 2026 data planned to support Accelerated Approval filing—another catalyst path .
  • Liquidity remains solid with $677.5M in cash and runway at least into 2H 2026, supporting execution to key milestones without near-term financing dependency .
  • Leadership additions (CFO/CBO/CSO/CIO) strengthen execution capacity ahead of filings and commercial planning, potentially improving readiness and partner optionality .
  • Near-term events to watch: FDA meeting minutes/regulatory update on DYNE-101; continued site activation/protocol progress; late-2025 DELIVER REC readout .
  • Medium-term thesis hinges on sustained functional improvement signals translating into surrogate endpoint-based approvals and a credible path to 2027 launches in DMD and DM1 as management reaffirmed .