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Design Therapeutics, Inc. (DSGN)·Q1 2025 Earnings Summary

Executive Summary

  • Q1 2025 EPS of $(0.31) missed Wall Street consensus of $(0.28) by $0.03; revenue remains non-material for this clinical-stage company, with consensus at $0.00 and no product revenue disclosed . EPS consensus and revenue consensus from S&P Global data: $(0.28)* and $0.00*.
  • R&D expenses rose to $15.4M, up both sequentially and year-over-year, reflecting program ramp in FA (DT-216P2) and FECD (DT-168); G&A was $5.0M .
  • Management highlighted favorable Phase 1 data for DT-168 supporting advancement to a Phase 2 biomarker trial in 2H 2025, and continued progress of DT-216P2 with a Phase 1/2 MAD in FA anticipated to begin mid-2025 .
  • Cash, cash equivalents and investment securities were $229.7M, with runway expected to fund planned operating expenses into 2029; prior quarter cash was $245.5M .

What Went Well and What Went Wrong

What Went Well

  • Favorable Phase 1 DT-168 safety data (no treatment‑emergent adverse events, systemic exposure below quantitation) and biomarker reference range studies support a Phase 2 biomarker trial in FECD in 2H 2025 .
  • FA program advancing: ongoing Phase 1 SAD trial in healthy volunteers; plan to initiate Phase 1/2 MAD in mid‑2025 .
  • Management tone confident: “These programs anchor a differentiated GeneTAC pipeline… with the potential for multiple clinical proof‑of‑concept readouts over the next few years” (Pratik Shah, CEO) .

What Went Wrong

  • EPS missed consensus by $0.03 (actual $(0.31) vs $(0.28) consensus)*, driven by higher operating expenses as R&D rose to $15.4M and total operating expenses increased to $20.4M .
  • Year-over-year net loss widened to $(17.7)M from $(11.1)M, reflecting increased spending as programs progress .
  • Cash decreased to $229.7M from $245.5M in Q4, consistent with the operating burn as programs scale .

Financial Results

Income Statement and EPS (Quarterly)

MetricQ3 2024Q4 2024Q1 2025
R&D Expense ($USD Millions)$11.9 $12.2 $15.4
G&A Expense ($USD Millions)$4.4 $4.5 $5.0
Total Operating Expenses ($USD Millions)$16.2 $16.7 $20.4
Other Income, net ($USD Millions)$3.2 $3.0 $2.7
Net Loss ($USD Millions)$(13.0) $(13.7) $(17.7)
Net Loss per Share ($USD)$(0.23) $(0.24) $(0.31)

Balance Sheet KPIs (Quarterly)

MetricQ3 2024Q4 2024Q1 2025
Cash, Cash Equivalents & Investment Securities ($USD Millions)$254.1 $245.5 $229.7
Total Assets ($USD Millions)$261.6 $252.1 $237.5
Total Stockholders’ Equity ($USD Millions)$252.5 $242.1 $227.9

Results vs. Wall Street Consensus (Q1 2025)

MetricActualConsensusSurprise
EPS ($USD)$(0.31) $(0.28)*$(0.03) miss
Revenue ($USD Millions)N/A$0.00*N/A

Values marked with * retrieved from S&P Global.

YoY Comparison (Q1 2025 vs Q1 2024)

MetricQ1 2024Q1 2025Change
R&D Expense ($USD Millions)$9.8 $15.4 +$5.6 (+57%)
G&A Expense ($USD Millions)$4.6 $5.0 +$0.4 (+9%)
Net Loss ($USD Millions)$(11.1) $(17.7) $(6.6) (+59%)
Net Loss per Share ($USD)$(0.20) $(0.31) $(0.11)

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
DT-216P2 (FA) Phase 1/2 MAD patient study startMid-2025Mid-2025 (Q4 2024 update) Mid-2025 (Q1 2025 PR) Maintained
DT-168 (FECD) Phase 2 biomarker trial start2H 2025Not previously specified; Phase 1 data expected 1H 2025 (Q4 2024) Plans to initiate 2H 2025 New specificity (timing set)
Cash runwayThrough planned operating expenses into 2029Into 2029 (Q4 2024) Into 2029 (Q1 2025) Maintained
DM1 development candidate selection2025Expected in 2025 (Q4 2024) Later in 2025 (Q1 2025) Maintained (timing refined)

Earnings Call Themes & Trends

Note: No Q1 2025 earnings call transcript was found for DSGN within the relevant period; management commentary is based on press releases and the 8‑K item 2.02 filing .

TopicPrevious Mentions (Q3 2024)Previous Mentions (Q4 2024)Current Period (Q1 2025)Trend
FA (DT-216P2) clinical progressPhase 1 SAD planned 1H25 Phase 1 SAD initiated; MAD expected mid-2025 Phase 1 SAD ongoing; MAD planned mid-2025 On track
FECD (DT-168) clinical progressPhase 1 initiated; data 1H25 Phase 1 dosing complete; data 1H25 Favorable Phase 1 results; advance to Phase 2 biomarker in 2H25 Positive momentum
Cash runway$254.1M; runway into 2029 $245.5M; runway into 2029 $229.7M; runway into 2029 Stable runway; decreasing cash balance
Pipeline (DM1, HD)Advancing preclinical programs DM1 candidate selection expected 2025; HD characterization ongoing DM1 candidate selection later in 2025; HD ongoing Continued progress

Management Commentary

  • “Design continued its progress through the first quarter of 2025, marked by the favorable results from our Phase 1 trial in FECD… support advancing DT-168 into a Phase 2 biomarker trial in patients later this year.” — Pratik Shah, Ph.D., CEO .
  • “We are also conducting our Phase 1 SAD trial in healthy volunteers for FA, where favorable results would position us to begin a Phase 1/2 trial of DT-216P2 in patients.” — Pratik Shah, Ph.D., CEO .
  • “These programs anchor a differentiated GeneTAC pipeline… with the potential for multiple clinical proof-of-concept readouts over the next few years.” — Pratik Shah, Ph.D., CEO .

Q&A Highlights

  • No Q1 2025 earnings call transcript was available; the company furnished results via an 8‑K press release with program and financial updates .

Estimates Context

  • Q1 2025 EPS of $(0.31) was below consensus of $(0.28), a $(0.03) miss*, driven by higher operating expenses as R&D scaled with program activity . Consensus values from S&P Global.
  • Revenue consensus was $0.00*, aligning with the company’s non-commercial status and absence of disclosed product revenue in filings .
  • Analysts may revisit expense trajectories given R&D increased to $15.4M vs $12.2M in Q4 2024 and $9.8M in Q1 2024 .

Values marked with * retrieved from S&P Global.

Consensus Detail (Q1 2025)

MetricConsensus# of Estimates
EPS ($USD)$(0.28)*3*
Revenue ($USD Millions)$0.00*3*

Values marked with * retrieved from S&P Global.

Key Takeaways for Investors

  • EPS missed by $0.03 relative to consensus as operating expenses rose with clinical progress; watch for continued spend as FA and FECD programs advance .
  • FECD program delivered favorable Phase 1 safety data and biomarker groundwork, with Phase 2 biomarker trial targeted for 2H 2025 — a potential clinical read-through catalyst in 2025-2026 .
  • FA program remains a core value driver with MAD patient study initiation planned mid‑2025 and 12‑week dosing data anticipated in 2026 (per Q4 update) .
  • Cash runway into 2029 provides financing security for multiple POC attempts, despite sequential cash draw ($229.7M vs $245.5M) .
  • Near-term milestones (FECD Phase 2 initiation, FA MAD start) are likely stock catalysts; subsequent regulatory interactions and data updates should be monitored closely .
  • Organizational strengthening with appointment of an experienced CMO enhances execution capability across development and regulatory strategy .
  • For positioning, focus on milestone timing adherence and any clarity on biomarker validation and PD (FXN) readouts that can de-risk GeneTAC modality over the next 12–24 months .

Additional Relevant Press Releases (Q1 2025)

  • Participation in Leerink Global Healthcare Conference announced on March 3, 2025 (investor engagement) .
  • Q4 2024 results and pipeline progress update issued March 10, 2025 (sets context for 1H 2025 milestones) .

Subsequent event:

  • June 4, 2025: First FA patient dosed in RESTORE‑FA; initial SAD safety/PK favorable; FDA clinical hold on U.S. IND noted (regulatory overhang to monitor) .