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Dianthus Therapeutics, Inc. /DE/ (DNTH)·Q3 2025 Earnings Summary

Executive Summary

  • Q3 2025: Dianthus reported total revenues of $0.396M, net loss of $36.8M, and diluted EPS of $(0.97); R&D expense was $32.5M and G&A was $8.2M .
  • Cash, cash equivalents and investments were approximately $555.5M at quarter-end; pro forma cash of ~$525M after $30M DNTH212 upfront/near-term milestones, with runway guidance extended into 2028 .
  • Clinical and strategic highlights: positive Phase 2 gMG (MaGic) results supporting 2026 Phase 3 initiation; CAPTIVATE (CIDP) interim responder analysis timing accelerated to Q2’26; in-licensed DNTH212 (BDCA2+BAFF/APRIL) expanding pipeline .
  • Wall Street consensus estimates via S&P Global were unavailable for Q3 2025, so no beat/miss assessment can be made (values unavailable via S&P Global).

What Went Well and What Went Wrong

What Went Well

  • Positive gMG Phase 2 outcomes: “Claseprubart 300mg/2mL Q2W…was statistically significant and clinically meaningful across other key efficacy endpoints…strongly support our Phase 3 plans to advance both 300mg/2mL Q2W and 300mg/2mL Q4W” .
  • Execution/cycle-time: CAPTIVATE interim responder analysis accelerated from 2H’26 to Q2’26 due to faster-than-expected enrollment .
  • Pipeline expansion with DNTH212 licensing while maintaining runway: pro forma cash ~$525M and guidance of runway into 2028; management emphasized this “has no impact on previously guided cash runway into 2028” .

What Went Wrong

  • Revenue contraction YoY: total revenues fell from $2.172M (Q3’24) to $0.396M (Q3’25), reflecting the lapse of former related-party license revenue and a smaller Tenacia-related license revenue contribution .
  • Operating spend increased: R&D rose to $32.5M (vs $25.5M YoY), G&A rose to $8.2M (vs $6.5M YoY), driving wider net loss .
  • EPS loss widened YoY from $(0.74) to $(0.97), consistent with increased clinical operations and stock-based compensation supporting mid/late-stage programs .

Financial Results

MetricQ3 2024Q1 2025Q2 2025Q3 2025
Total Revenues ($USD thousands)2,172 1,163 193 396
License revenue – former related party ($USD thousands)2,172 — — —
License revenue ($USD thousands)— 1,163 193 396
Research & Development ($USD thousands)25,544 27,003 26,251 32,489
General & Administrative ($USD thousands)6,528 7,337 8,869 8,195
Net Loss ($USD thousands)(25,174) (29,511) (31,629) (36,765)
Diluted EPS ($USD)$(0.74) $(0.82) $(0.88) $(0.97)
Cash, Cash Equivalents & Investments (period-end, $USD millions)—331.5 309.1 555.5

KPIs

KPIQ3 2024Q1 2025Q2 2025Q3 2025
Shares Outstanding (period-end)29,366,352 32,125,933 32,176,482 42,854,563
Cash Runway Guidance—Into 2H’27 Into 2H’27 Into 2028

Estimates vs Actuals

  • S&P Global consensus for Q3 2025 EPS and revenue was unavailable; therefore, no comparison to estimates can be provided. Values unavailable via S&P Global.

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash runwayCorporateInto 2H’27 Into 2028 Raised
CAPTIVATE (CIDP) interim responder analysisQ2/Q3 20262H’26 Q2’26 Pulled forward
gMG Phase 3 initiation (claseprubart)2026Not specified prior2026 initiation planned New specific timing
DNTH212 Phase 1 HV top-line2H 2026Not applicable2H’26 expected; Phase 1 to initiate by YE’25 New program added
Pro forma cash after DNTH212 upfront/near-termQ3 2025Not applicable~$525M pro forma New disclosure

Earnings Call Themes & Trends

TopicPrevious Mentions (Q-2 and Q-1)Current Period (Q3 2025)Trend
gMG (MaGic) efficacy/safetyEnrollment completed; top-line expected Sept’25 Stat. significant MG-ADL/QMG; supports Phase 3 incl. Q4W dose Strengthened
CIDP (CAPTIVATE) timelineInterim responder analysis in 2H’26 Interim responder analysis pulled forward to Q2’26 Accelerating
MMN (MoMeNtum)Ongoing; top-line in 2H’26 Ongoing; top-line 2H’26 reiterated Stable
Pipeline expansionFocus on complement (C1s) Added DNTH212 (BDCA2+BAFF/APRIL) license; Phase 1 plan Expanded
Cash runwayInto 2H’27 Into 2028; ~$525M pro forma cash post DNTH212 payments Improved
Dosing convenience/safety positioningTargeting infrequent SC dosing; preservational safety rationale Phase 2 data and analyses supporting potential Q4W and safety profile Reinforced

Management Commentary

  • “I’m extremely proud of our team’s outstanding track record…we delivered impressive results from the gMG MaGic trial…accelerated the timing of the interim responder analysis… and in-licensed DNTH212…” — Marino Garcia, CEO .
  • “Under the agreement, we will pay Leads up to $38 million… Importantly…pro forma…approximately $525 million…and we are reaffirming…guidance into 2028…” — Ryan Savitz, CFO & CBO .
  • “DNTH212…targets both the innate and adaptive immune systems…with potential best-in-class efficacy…” — Simrat Randhawa, EVP, Head of R&D .

Q&A Highlights

  • Infection risk with dual targeting: Management chose two targets with “particularly well-characterized and relatively benign” safety profiles; FDA IND feedback for the healthy volunteer study was “very reassuring,” with no added requirements .
  • PK/PD endpoints and go/no-go: Expect interferon suppression consistent with litifilimab; immunoglobulin reductions tracked; human PD to confirm anticipated profile .
  • Mechanism/dosing: DNTH212 designed with high-affinity CRD2 domain and extended half-life for Q4W autoinjector dosing; potential mild B-cell depletion to be evaluated clinically .
  • Indication prioritization: Priorities will weigh probability of clinical/regulatory success and commercial opportunity; update planned for 2026 .

Estimates Context

  • S&P Global consensus for Q3 2025 EPS and revenue was unavailable; thus, no beat/miss analysis can be provided (values unavailable via S&P Global).

Key Takeaways for Investors

  • Cash runway extended into 2028, supported by ~$555.5M quarter-end cash/investments and ~$525M pro forma after DNTH212 payments, reducing financing overhang near term .
  • Clinical momentum: Statistically significant gMG Phase 2 data and a pulled-forward CIDP interim analysis to Q2’26 are tangible catalysts over the next 6–12 months .
  • Pipeline breadth: DNTH212 introduces a differentiated dual-mechanism approach (BDCA2+BAFF/APRIL), with Phase 1 initiation by YE’25 and HV top-line in 2H’26 .
  • Spend trajectory: R&D and G&A increased YoY as programs advance, widening net loss; investors should monitor cost discipline as trials scale .
  • Revenue mix: Non-product license revenue (Tenacia) modest and variable; top-line remains driven by R&D progress rather than commercial sales .
  • Dosing/positioning: Management’s data/analyses aim to position claseprubart as a first-line, patient-friendly biologic with potential Q2W/Q4W autoinjector dosing and favorable safety profile vs terminal complement inhibitors .
  • Near-term narrative drivers: gMG Phase 3 design alignment with FDA, CAPTIVATE interim readout timing, and DNTH212 Phase 1 progress are likely focal points for sentiment .