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MI

MoonLake Immunotherapeutics (MLTX)·Q3 2025 Earnings Summary

Executive Summary

  • Q3 2025 was a pivotal execution quarter: cash and short-term securities fell to $380.5M as R&D ramped ahead of multiple data readouts; runway now into H2 2027, down from into 2028 in Q2 .
  • Reported GAAP diluted EPS of -$1.10 and net loss of $70.7M, driven by higher R&D and interest expense; sequentially worse vs Q2 (-$0.87 EPS, -$56.1M net loss) .
  • Clinical momentum: PPP Phase 2 LEDA showed 64% mean PPPASI improvement and 39% PPPASI75 at week 16; HS VELA-1/2 week-16 demonstrated significance overall under the pre-specified treatment policy strategy, with VELA-2 composite p=0.053 due to a higher-than-expected placebo response; Type B FDA meeting set for Dec 15, 2025 .
  • Versus estimates: S&P Global consensus was unavailable; third-party shows EPS estimate -$0.91, making an EPS miss of $0.19; this and runway compression, plus VELA-2 composite non-significance, are key stock-reaction catalysts .

What Went Well and What Went Wrong

What Went Well

  • PPP LEDA Phase 2 met clinically meaningful thresholds: mean PPPASI change 64% at week 16; 39% hit PPPASI75; safety consistent with prior trials .
  • HS VELA program showed robust patient-reported outcomes and lesion improvements under treatment policy analysis; combined HiSCR75 35.4% vs 21.6% placebo (p<0.001) .
  • Regulatory path progressing: Type B FDA meeting confirmed for Dec 15, 2025 to discuss adequacy of HS evidence for BLA .
    • Quote: “We are encouraged by the results of VELA-1… the efficacy data… shows the potential for a promising profile of sonelokimab in HS.” — Prof. Kristian Reich, CSO .

What Went Wrong

  • EPS missed third‑party consensus and worsened sequentially: -$1.10 vs -$0.91 estimate and -$0.87 in Q2; drivers were R&D +$10.9M q/q and higher interest expense .
  • VELA-2 composite strategy did not reach significance for the primary endpoint (HiSCR75 delta 9%, p=0.053) due to a higher-than-expected placebo response, creating uncertainty on registrational strategy optics until regulatory discussions .
  • Cash runway guide tightened to H2 2027 from into 2028, reflecting spend ramp toward BLA and Phase 3 programs .

Financial Results

MetricQ1 2025Q2 2025Q3 2025
Cash + Short-term Securities ($USD Millions)$480.1 $425.1 $380.5
R&D Expense ($USD Millions)$36.459 $49.762 $60.635
G&A Expense ($USD Millions)$11.026 $10.936 $10.799
Operating Loss ($USD Millions)$47.485 $60.698 $71.434
Interest Expense ($USD Millions)$0.018 $2.037 $3.198
Other Income, Net ($USD Millions)$7.097 $6.779 $4.053
Net Loss ($USD Millions)$40.559 $56.051 $70.694
Diluted EPS ($USD)-$0.63 -$0.87 -$1.10
Clinical KPIs (Week 16)PlaceboSonelokimabp-value
VELA Combined HiSCR75 (%)21.6 35.4 <0.001
VELA‑1 HiSCR75 (%)17.5 34.8 <0.001
VELA‑2 HiSCR75 (%)25.6 35.9 0.033
VELA Combined HiSCR50 (%)36.7 55.1 <0.001
VELA Combined IHS4‑55 (%)39.4 55.7 <0.001
VELA Combined Pain NRS ≥3pt (%)13.9 29.1 <0.001
VELA Combined DLQI MCID ≥4 (%)38.3 58.6 <0.001
PPP LEDA Mean PPPASI Change (%)—64 —
PPP LEDA PPPASI75 (%)—39 —
Results vs Estimates (Q3 2025)ActualS&P Global ConsensusThird‑Party EstimateResult
Diluted EPS ($USD)-$1.10 N/A (unavailable)*-$0.91 Miss by $0.19
Revenue ($USD Millions)N/A (no product revenue reported in 8‑K) N/A (unavailable)*N/A—

*Values retrieved from S&P Global (consensus not available for MLTX Q3 2025).

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash RunwayCorporateInto 2028 Into H2 2027 Lowered
HS BLA Submission TimingHSMid‑2026 Q3/Q4 2026 Pushed
VELA‑TEEN Primary Endpoint ReadoutAdolescent HSH1 2026 Q2 2026 Narrowed/maintained
PPP Phase 3 Trial InitiationPPPNot previously specifiedQ3 2026 New
S‑OLARIS ReadoutaxSpAQ1 2026 Q1 2026 Maintained
IZAR Program ReadoutsPsAH1 2026 (program) IZAR‑1 Q2 2026; IZAR‑2 H2 2026 Specified timeline

Earnings Call Themes & Trends

TopicPrevious Mentions (Q‑2 and Q‑1)Current PeriodTrend
Regulatory Path (FDA)Phase 3 VELA timing; end‑of‑Phase 2 interactions cited Type B FDA meeting on Dec 15, 2025 to confirm HS path/BLA adequacy Increasing regulatory engagement
HS Program PerformanceQ2 guided VELA readout around Sept; baseline comparability to MIRA VELA‑1/2 week‑16: significant under treatment policy; VELA‑2 composite p=0.053; strong PROs Mixed: efficacy solid; composite optics challenged
PPP ProgramInterim readout earlier than expected in Q1/Q2 LEDA week‑16: 64% mean PPPASI; 39% PPPASI75; Phase 3 to start Q3 2026 Positive momentum
R&D Execution/SpendR&D ramp Q1→Q2 ($36.5M→$49.8M) R&D $60.6M; multiple trials progressing (VELA‑TEEN, IZAR, S‑/P‑OLARIS) Accelerating
Financial RunwayCash $480.1M (Q1), $425.1M (Q2); debt facility up to $500M Cash/STS $380.5M; runway into H2 2027 Tightening
Legal/Investor Backdrop—Multiple investor class-action notices across late Oct–Nov (reflecting stock pressure) Heightened legal noise
Tariffs/MacroQ2 cautionary noted potential tariff risks No new macro changes highlighted in Q3 release Stable/neutral

Management Commentary

  • “We are encouraged by the results of VELA‑1… the convenient dosing, the efficacy data… and the patient reported outcomes… shows the potential for a promising profile of sonelokimab in HS.” — Prof. Kristian Reich, Founder & CSO .
  • “MoonLake is in a robust financial position… $500 million non‑dilutive financing… enables us to confidently fund the launch of sonelokimab in 2027.” — CFO Matthias Bodenstedt (Q2) .
  • “We continue executing… enrolled our Phase 3 VELA program… the interim readout in PPP… further derisking… non‑dilutive facility… extends our projected cash runway into 2028.” — CFO Matthias Bodenstedt (Q1) .

Q&A Highlights

  • The document set did not include an earnings call transcript for Q3 2025. A webcast was held for the VELA data on Sept 29, 2025, but transcript content was not available in our sources .
  • No Q&A highlights can be provided based on available primary documents.

Estimates Context

  • S&P Global EPS and revenue consensus for MLTX Q3 2025 were unavailable in our estimates feed; comparisons to Wall Street consensus cannot be anchored on S&P this quarter.*
  • Third‑party sources indicate EPS estimate of -$0.91; actual EPS was -$1.10, a miss of $0.19, largely driven by R&D and interest expense increases and lower other income .
  • Revenue consensus is not applicable given no reported product revenue in the 8‑K .

*Values retrieved from S&P Global (consensus not available for MLTX Q3 2025).

Key Takeaways for Investors

  • Clinical profile remains competitive: strong PROs and lesion metrics in HS and meaningful PPP efficacy; watch FDA Type B meeting outcome for clarity on BLA sufficiency and composite vs treatment policy strategy implications .
  • EPS miss and sequential step‑up in R&D/interest expense indicate investment intensity ahead of 2026 catalysts; expect continued operating losses into submission/launch preparations .
  • Guidance tightening on runway (H2 2027 vs into 2028) suggests higher burn; monitor cash utilization and debt facility tranching vs milestones .
  • HS registrational optics hinge on VELA‑2 placebo dynamics and 52‑week data; regulators’ reception to dual analysis strategies will be a key stock driver .
  • PPP Phase 3 initiation (Q3 2026) adds optionality beyond HS, with LEDA data supportive; PsA IZAR timelines now specified (Q2/H2 2026) broadening catalyst stack .
  • Elevated legal noise post‑VELA readout underscores sentiment risk; near-term trading likely driven by regulatory communications (FDA minutes ~30 days post 12/15) and any data/IR disclosures .
  • Position sizing should reflect binary/regulatory path dependencies; tactical opportunities around FDA meeting/minutes and upcoming Phase 2/3 readouts (S‑OLARIS Q1 2026, IZAR‑1 Q2 2026) .