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MI

MoonLake Immunotherapeutics (MLTX)·Q2 2025 Earnings Summary

Executive Summary

  • Q2 2025 reflected deliberate spend to drive Phase 3/2 programs with cash and liquidity intact; MoonLake ended the quarter with $425.1M in cash, cash equivalents, and short-term marketable securities and reiterated runway into 2028 supported by a $500M non‑dilutive Hercules facility .
  • Management narrowed timing for the pivotal HS Phase 3 VELA primary endpoint readout to “around September 2025”; PPP LEDA moved from “2H 2025” to “Q4 2025,” sharpening near-term catalysts; BLA submission targeted for mid‑2026 and initial launch in 2027 .
  • Operating loss widened as R&D ramped across HS, PsA, PPP, axSpA and adolescent HS: R&D $49.8M (+36% q/q; +110% y/y); EPS was -$0.87 vs -$0.63 in Q1 and -$0.39 in Q2’24, consistent with increased trial and manufacturing activity .
  • Estimates from S&P Global were unavailable; no formal beat/miss analysis provided. Near-term stock reaction catalyst remains the HS VELA readout and subsequent regulatory path disclosure at R&D/medical meetings .

What Went Well and What Went Wrong

  • What Went Well

    • Narrowed HS VELA readout timing to “around September,” adding event clarity; CEO: “Q2 has been another strong quarter…we narrowed guidance for the timing of the primary endpoint readout…around September…” .
    • PPP LEDA interim readout delivered earlier than expected, “further validation” and “derisks” asset; CFO emphasized robust financing enabling confident 2027 launch investment .
    • Liquidity strong: $425.1M cash/short‑term securities; runway into 2028 with $500M Hercules facility (Tranche 1 $75M funded; additional tranches milestone‑based) .

  • What Went Wrong

    • R&D expenses climbed materially with CRO/CMO, consulting and personnel costs; Q2 R&D $49.8M vs $36.5M in Q1 (+$13.3M q/q) and $23.7M in Q2’24 (+$26.1M y/y) .
    • EPS and net loss widened as programs progressed: EPS -$0.87 vs -$0.63 in Q1 and -$0.39 in Q2’24; net loss -$56.1M vs -$40.6M in Q1 and -$24.8M in Q2’24 .
    • Macro/tariff risk disclosures intensified; company flagged potential impacts from new or increased tariffs and retaliatory measures in risk sections of 10‑Q .

Financial Results

MetricQ2 2024Q4 2024Q1 2025Q2 2025
Revenue ($USD Millions)$0.0 $0.0 $0.0 $0.0
R&D Expense ($USD Millions)$23.662 $40.360 $36.459 $49.762
G&A Expense ($USD Millions)$6.916 $9.221 $11.026 $10.936
Total Operating Expenses ($USD Millions)$30.578 $49.580 $47.485 $60.698
Net Loss ($USD Millions)$(24.759) $(46.396) $(40.559) $(56.051)
EPS (Basic & Diluted, $USD)$(0.39) $(0.72) $(0.63) $(0.87)

Liquidity and Financing

MetricQ4 2024Q1 2025Q2 2025
Cash & Equivalents ($USD Millions)$180.426 $271.566 $306.681
Short-term Marketable Debt Securities ($USD Millions)$267.601 $208.564 $118.402
Cash + Short-term Securities ($USD Millions)$448.0 $480.1 $425.1
Long-term Debt (Carrying Value, $USD Millions)$0.000 $73.022 $73.381

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
HS VELA (adult) primary endpoint readoutQ3 2025“Mid‑2025” (pivotal HS data expected as of mid‑2025) → “around September 2025” (Q1 update) “Around September 2025” Narrowed/maintained (date specificity maintained since Q1)
PPP LEDA primary endpoint readout2H/Q4 2025“2H 2025” “Q4 2025” Narrowed (timing specified)
BLA submission (HS)2026Not explicitly dated in prior PRs“Mid‑2026” New/clarified
Expected U.S. launch (HS)2027Not explicitly dated in prior PRs“Expected launch in 2027” New/clarified
Cash runwayThrough 2028“Runway into 2028” “Runway into 2028” Maintained

Earnings Call Themes & Trends

TopicPrevious Mentions (Q4 2024 and Q1 2025)Current Period (Q2 2025)Trend
R&D execution breadth (HS, PsA, PPP, axSpA, adolescent HS)Initiated Phase 3 HS (VELA), Phase 3 PsA (IZAR), and early 2025 starts (VELA‑TEEN, LEDA, S‑OLARIS); completion of VELA enrollment; PPP interim readout Narrowed HS VELA timing; PPP LEDA timing to Q4; adolescent HS and axSpA progressing Strengthening execution and event clarity
Financing/liquidity strategyYear‑end cash $448.0M; announced capital markets update $425.1M cash/securities; $500M Hercules facility; runway into 2028 Reinforced liquidity; non‑dilutive funding optionality
PPP product performanceInterim LEDA readout derisking and potential validation LEDA primary endpoint readout slated Q4 2025 Advancing toward full readout
Supply chain/CMO dependenceNoted ramp of comparator and logistics in IZAR; general manufacturing scaling Reliance on small number of manufacturers; stock‑piling to start 2H’25 Ongoing dependency; proactive scale plans
Regulatory/legal/macro (tariffs)Standard forward‑looking risk language Explicit tariff/macro risks highlighted (new/increased tariffs, retaliatory measures) Heightened disclosure of macro risk

Note: A Q2 2025 earnings call transcript was not available in our document catalog; MarketBeat indicates a call was scheduled Aug 5, 2025 at 9:30AM ET .

Management Commentary

  • CEO (Jorge Santos da Silva): “Q2 has been another strong quarter…we narrowed guidance for the timing of the primary endpoint readout for our pivotal Phase 3 VELA program in HS to around September…[and] delivered an earlier‑than‑expected interim readout of the Phase 2 LEDA trial in PPP…which we believe derisks the overall development of the asset.”
  • CFO (Matthias Bodenstedt): “MoonLake is in a robust financial position…The $500 million non‑dilutive financing from Hercules Capital has significantly bolstered our cash position and enables us to confidently fund the launch of sonelokimab in 2027…advance additional clinical trials and make further strategic investments…”

Q&A Highlights

  • Transcript unavailable; no Q&A themes or guidance clarifications can be extracted from primary sources. Conference call scheduling reference: Aug 5, 2025 at 9:30AM ET .

Estimates Context

  • S&P Global consensus estimates (EPS and revenue) were unavailable for Q4 2024, Q1 2025, and Q2 2025 via our data retrieval; therefore, formal beat/miss analysis vs S&P Global is not provided.
  • Some third‑party sites reported EPS expectations, but per policy we anchor to S&P Global and do not substitute non‑S&P figures .

Key Takeaways for Investors

  • The HS Phase 3 VELA primary endpoint readout in September is the critical binary event; a positive HiSCR75 outcome would accelerate BLA (mid‑2026) and support 2027 launch positioning .
  • PPP LEDA moved to a specific Q4 2025 readout, adding a second dermatology catalyst with potential to broaden the franchise beyond HS; interim data has “derisked” the asset per management .
  • Liquidity and non‑dilutive debt facility extend runway into 2028, reducing near‑term dilution risk while funding commercial build‑out and additional trials; monitor future tranche milestones tied to clinical success (VELA, IZAR) .
  • Operating losses will likely remain elevated as programs peak in activity; Q2 showed higher CRO/CMO and personnel costs—consistent with late‑stage execution; budget for continued R&D intensity through 2026 .
  • Macro/tariff risks are now more prominently disclosed; while not thesis‑defining, they can pressure COGS/operations in scale‑up scenarios—factor into long‑term margin modeling .
  • With no revenue yet and EPS widening from program spend, trading cues hinge on data and regulatory milestones rather than near‑term P&L; positioning ahead of September HS readout is likely to drive risk‑adjusted re‑rating.
  • Watch upcoming scientific/IR events (EADV in September; fall conferences) for additional detail on VELA baseline comparability and LEDA/S‑OLARIS progress .

Appendices: Source Documents

  • Q2 2025 8‑K + Press Release: Results of Operations; Financials; Program updates .
  • Q2 2025 10‑Q: Full financial statements; liquidity; debt; risk factors; program overview .
  • Q1 2025 Press Release: Prior quarter baseline; PPP interim; VELA enrollment completion .
  • FY/Q4 2024 8‑K + Press Release: Historical spend ramp; cash; program initiation .