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Dianthus Therapeutics, Inc. /DE/ (DNTH)·Q4 2024 Earnings Summary

Executive Summary

  • Q4 2024 reflected continued pipeline execution with total revenue of $1.325M and EPS of ($0.81), as operating spend ramped with three active clinical programs; cash, cash equivalents and investments were $357.0M, with runway guided “into 2H’27.”
  • Management reiterated/updated key timelines: Phase 2 gMG top-line in 2H’25; Phase 3 CAPTIVATE in CIDP now ongoing with an interim responder analysis in 2H’26; Phase 2 MMN top-line in 2H’26.
  • Sequentially, revenue declined vs Q3 ($1.325M vs $2.172M) while EPS widened to ($0.81) vs ($0.74) as R&D and G&A increased with trial activity; YoY, revenue rose vs Q4’23 ($0.457M) and opex stepped up from the prior year as programs advanced.
  • Near-term stock catalysts concentrate on clinical readouts (gMG 2H’25) and CAPTIVATE progress (CIDP interim 2H’26), supported by a strengthened balance sheet limiting financing overhang risk near-term.

What Went Well and What Went Wrong

  • What Went Well

    • Advanced pipeline breadth with three active trials; CEO emphasized “on track” timelines for gMG Phase 2 in 2H’25 and excitement around initiating the pivotal CAPTIVATE Phase 3 in CIDP, with MMN Phase 2 also progressing. “We remain on track to report top-line data in 2H’25… We are excited to have initiated our pivotal Phase 3 CAPTIVATE trial in CIDP…” — Marino Garcia, CEO.
    • Balance sheet: $357.0M in cash, cash equivalents and investments at 12/31 supports runway into 2H’27, reducing near-term financing risk.
    • YoY revenue improved in Q4 ($1.325M vs $0.457M) with the addition of non–related-party license revenue in the quarter.

  • What Went Wrong

    • Sequential revenue declined ($1.325M in Q4 vs $2.172M in Q3) as license revenue from related party was lower, while total operating expenses increased to $33.241M vs $32.072M in Q3.
    • EPS/loss per share widened sequentially to ($0.81) from ($0.74) with higher R&D ($26.413M vs $25.544M) and G&A ($6.828M vs $6.528M) tied to trial start-up and scale-up.
    • No earnings call transcript was available for Q4, limiting external Q&A clarity on quarter-to-quarter moving pieces (e.g., license revenue cadence, spend phasing). (No transcript found.)

Financial Results

Quarterly sequential trend (oldest → newest):

MetricQ2 2024Q3 2024Q4 2024
Total Revenues ($USD Millions)$1.863 $2.172 $1.325
R&D Expense ($USD Millions)$18.070 $25.544 $26.413
G&A Expense ($USD Millions)$5.997 $6.528 $6.828
Total Operating Expenses ($USD Millions)$24.067 $32.072 $33.241
Net Loss ($USD Millions)$(17.607) $(25.174) $(28.438)
Diluted EPS ($)$(0.51) $(0.74) $(0.81)
Weighted-Average Shares (Millions)34.227 34.237 35.034

Year-over-year for the quarter:

MetricQ4 2023Q4 2024
Total Revenues ($USD Millions)$0.457 $1.325
R&D Expense ($USD Millions)$8.781 $26.413
G&A Expense ($USD Millions)$4.632 $6.828
Total Operating Expenses ($USD Millions)$13.413 $33.241
Net Loss ($USD Millions)$(10.563) $(28.438)
Diluted EPS ($)$(0.71) $(0.81)

Balance sheet and liquidity KPIs:

KPIQ2 2024Q3 2024Q4 2024
Cash, Cash Equivalents & Investments (Mgmt disclosure)$360.7M $342.6M $357.0M
Total Assets ($USD Millions)$368.959 $354.248 $374.008
Total Stockholders’ Equity ($USD Millions)$358.218 $337.898 $352.477

Notes:

  • DNTH is pre-commercial; gross margin/operating margin are not meaningful at this stage. (See operating expense and net loss detail above.)

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
gMG (DNTH103) Phase 2 top-line2H 20252H 2025 (Q2 press release) 2H 2025 (reiterated) Maintained
CIDP (DNTH103) Phase 3 status2024/2026Initiation by YE’24 (Q3 press release) Trial ongoing; interim responder analysis in 2H’26 Achieved initiation; added interim timing
MMN (DNTH103) Phase 2 top-line2H 20262H 2026 (Q2/Q3 press releases) 2H 2026 (reiterated) Maintained
Cash runwayMulti-yearInto 2H’27 (Q2/Q3) Into 2H’27 (reiterated) Maintained

Earnings Call Themes & Trends

(No Q4 earnings call transcript was available; themes synthesized from company press materials and filings.)

TopicPrevious Mentions (Q-2: Q2 2024)Previous Mentions (Q-1: Q3 2024)Current Period (Q4 2024)Trend
R&D execution across gMG/CIDP/MMNgMG Ph2 ongoing; MMN Ph2 IND cleared; planning CIDP Ph2; data timelines set (gMG 2H’25; MMN 2H’26) Anticipated CIDP Ph3 initiation by YE’24; reiterated gMG/MMN timelines gMG Ph2 on track 2H’25; CAPTIVATE (CIDP Ph3) ongoing with interim in 2H’26; MMN Ph2 on track 2H’26 Positive execution; CIDP progressed to Ph3
Competitive validation (active C1s/classical pathway)AAN/EAN data and head-to-head in vitro vs riliprubart noted Further AANEM/ICNMD posters; head-to-head data vs riliprubart Corporate deck reiterates potency/affinity vs riliprubart; differentiated profile Reinforced differentiation
Cash runway/financing riskRunway into 2H’27 disclosed Runway into 2H’27 reiterated Runway into 2H’27 reiterated with $357M cash/investments Stable/adequate
Regulatory/Phase 3 design (CIDP)Plan for CIDP trial in 2H’24 Detailed randomized withdrawal design described; YE’24 initiation guide Phase 3 ongoing; interim responder analysis window specified (2H’26) Milestone achieved and clarified
Safety/TPP positioningEmphasis on differentiated safety; subcutaneous, Q2W dosing Continued emphasis on profile and convenience Corporate presentation reiterates half-life (~60 days), potency, selective C1s activity Consistent positive narrative

Management Commentary

  • “We remain on track to report top-line data in 2H’25 from our Phase 2 clinical trial of DNTH103 in gMG… We are excited to have initiated our pivotal Phase 3 CAPTIVATE trial in CIDP, which is on track for an interim responder analysis in 2H’26, along with top-line results from our Phase 2 trial in MMN.” — Marino Garcia, Chief Executive Officer.
  • Corporate updates noted addition of a Chief Commercial Officer (John C. King) and a new Board member (Sujay Kango) on March 5, 2025, signaling early commercial readiness planning.
  • The company reiterated that $357.0M in cash, cash equivalents and investments provides runway into 2H’27.

Q&A Highlights

  • No Q4 2024 earnings call transcript was available; therefore, there are no Q&A highlights or on-call guidance clarifications to report. (No transcript found.)

Estimates Context

  • We attempted to retrieve Wall Street consensus (S&P Global) for Q4 2024 revenue and EPS, but the data was unavailable during this session; as a result, we cannot provide a results-vs-consensus comparison for this quarter.
  • Given DNTH’s pre-commercial status and reliance on license revenue, Street modeling coverage for quarterly revenue/EPS may be limited; we recommend revisiting SPGI for consensus ahead of the next event.

Key Takeaways for Investors

  • Balance sheet strength: $357.0M cash/investments and runway into 2H’27 materially de-risks near-term financing amid heavy clinical activity.
  • Execution momentum: CAPTIVATE (CIDP Ph3) is now underway with an interim analysis in 2H’26; gMG Ph2 top-line remains the primary 2025 catalyst (2H’25), with MMN Ph2 in 2H’26.
  • Operating spend will remain elevated as three trials progress; Q4 showed higher opex and a wider sequential EPS loss as trials ramped.
  • Sequential revenue volatility is expected given license-revenue-driven model; YoY revenue improvement in Q4 reflected incremental licensing, but revenue is not a key near-term driver vs clinical catalysts.
  • Differentiation narrative persists: selective active C1s inhibition with long half-life and subcutaneous Q2W dosing positions DNTH103 as potentially best-in-class; corporate materials reinforce potency/affinity vs competitor molecules.
  • 2025 setup: The gMG Phase 2 readout in 2H’25 is the central inflection point; continued CAPTIVATE enrollment/progress updates may also influence sentiment through 2025–2026.
  • Strategic build-out: Early commercial leadership additions suggest the company is preparing for potential late-stage outcomes while maintaining R&D focus.