Highest-materiality recent filing
MoonLake files FDA BLA for sonelokimab in hidradenitis suppurativa
BLA submitted September 30, 2026 seeking approval of tri-specific nanobody sonelokimab for moderate-to-severe hidradenitis suppurativa in adults and pediatric patients 12 and older.
MoonLake Phase 3 IZAR-1 meets all endpoints; Q2 cash $537M, runway to mid-2028
IZAR-1 Week 16: ACR50 42.1%, ACR20 66.5%, MDA 41.2%, PASI90 61% for sonelokimab 60mg.
MoonLake Immunotherapeutics launches $200M public offering of 9M shares at $20.00 each
Offering consists of 9,000,000 Class A ordinary shares at $20.00/share plus pre-funded warrants for up to 1,000,000 shares at $19.9999 each.
MoonLake Phase 3 VELA Week 52: 67% HiSCR75, 33% HiSCR100; BLA submission end-Sept 2026
Across VELA-1/2, 67.2% of SLK-treated patients achieved HiSCR75, 33.1% HiSCR100 at Week 52 (n=396).
Master Commercial Supply Agreement signed May 22, 2026 with Vetter for manufacturing pre-filled application systems.
MoonLake aligns with FDA on BLA for sonelokimab in HS; Q1 cash $357.9M
FDA pre-BLA meeting positive; alignment on submission plans, adolescent data inclusion, and safety strategy.
Phase 2 S-OLARIS trial: 81% of SLK-treated patients achieved ASAS40 response at Week 12 (n=26, mNRI).
MoonLake gets FDA clarity on SLK in HS; no new trials needed for BLA submission
FDA confirms MoonLake can establish substantial evidence of effectiveness using existing VELA-1, VELA-2, and MIRA trials; no additional HS trials required.
MoonLake Immunotherapeutics raises $75M in equity offering of 7.1M shares at $10.50/share
Offering of 7,142,857 Class A ordinary shares at $10.50 per share for gross proceeds of $75M.
MoonLake Q3 2025: $380.5M cash, positive Phase 2 PPP data for Sonelokimab
Cash and equivalents $380.5M as of Sept 30, 2025; runway into H2 2027.
VELA-1 achieved HiSCR75 at week 16 with 34.8% vs 17.5% placebo, delta 17.3% (p<0.001).
MoonLake Q2 cash $425M; Phase 3 HS readout expected Sept 2025
R&D expenses Q2 $49.8M (up from $36.5M Q1) on trial ramp-up and BLA preparation.
Cash, cash equivalents and short-term marketable debt securities of $480.1M as of March 31, 2025.
MoonLake secures up to $500M non-dilutive loan from Hercules Capital; $75M drawn at close
Up to $500M non-dilutive term loan facility from Hercules Capital; $75M funded at close on March 31, 2025.
MoonLake reports FY 2024 net loss of $121.2M, cash of $448M; advances sonelokimab to Phase 3
Net loss for 2024 was $121.2M, compared to $44.1M in 2023, driven by increased R&D spending.
MoonLake Q3 cash $493.9M; Phase 3 HS readout on track for mid-2025
Cash, equivalents and short-term debt securities of $493.9M as of Sep 30; runway to end of 2026.
Q2 2024 cash, equivalents and short-term debt securities of $519.8M; cash runway to end-2026 unchanged.
FDA and EMA back MoonLake's Phase 3 program for sonelokimab in psoriatic arthritis
FDA and EMA unanimously supported MoonLake's proposed Phase 3 IZAR program for sonelokimab in PsA.
MoonLake Q1 cash $547.1M; positive FDA/EMA feedback for Phase 3 sonelokimab in HS
Cash and equivalents $547.1M at March 31, 2024, expected to fund operations to end of 2026.
MoonLake reports 24-week PsA data with ~60% ACR50; plans Phase 3 HS trials in Q2 2024
ARGO trial: ~60% ACR50 at week 24; ~40% ACR70; >80% PASI90; ~60% PASI100; low discontinuation ~5%.
MoonLake FY 2023 net loss $44.1M; cash $511M; sonelokimab Phase 3 prep advances
Cash, cash equivalents and short-term marketable debt securities $511.0M at Dec 31, 2023, up from $496M at Sep 30, 2023.
MoonLake gets FDA & EMA support for Phase 3 sonelokimab in hidradenitis suppurativa
FDA and EMA both support Phase 3 design for sonelokimab (SLK) in HS; trial named VELA.
MoonLake Q3 cash $496M; positive Phase 2 data for sonelokimab in HS and PsA
Cash & equivalents $496.0M at Sept 30, 2023, expected to fund Phase 3 programs and regulatory filings.
MoonLake Phase 2 ARGO trial meets primary endpoint; sonelokimab ACR50 46-47% vs placebo
ACR50 achieved by 46% (60mg) and 47% (120mg) with induction at week 12 (p<0.01 vs placebo; ITT-NRI).
57% of patients on sonelokimab 120mg achieved HiSCR75 at week 24 (+10 ppt from week 12); 38% achieved HiSCR90 (+14 ppt).
MoonLake reports Q2 cash $501.8M after $460M offering; positive Phase 2 MIRA data in HS
Raised ~$460M gross in upsized public offering (8M shares at $50); cash & equivalents $501.8M at June 30, 2023.
MoonLake raises $460M in offering; Phase 2 MIRA trial meets primary endpoint with HiSCR75 at week 12
Priced 9.2M Class A ordinary shares at $50/sh (8M firm + 1.2M option) for $460M gross proceeds.
MoonLake's sonelokimab hits HiSCR75 with 29 ppt delta (p=0.0002) in Phase 2 HS trial
Primary endpoint HiSCR75 met with 29 ppt delta vs placebo (p=0.0002) at week 12.
Moonlake reports FY2022 net loss $64.5M; HS trial top-line expected June 2023
Net loss for year ended Dec 31, 2022 was $64.5M vs $53.6M for prior period (March 2021 to Dec 2021).
Net loss of $15.88M for three months ended March 31, 2022; accumulated deficit of $69.5M.
MoonLake Immunotherapeutics (fka Helix Acquisition) closes business combination, lists on Nasdaq
Closed business combination Apr 5, 2022; Helix acquired MoonLake AG, renamed MoonLake Immunotherapeutics (MLTX).
Business Combination Agreement with MoonLake Immunotherapeutics AG approved; 11.5M votes for, 549K against.
Helix Acquisition to restate financials after reclassifying all public shares as temporary equity
Non-reliance on previously issued financial statements from Oct 2020 through Sep 2021 due to share classification error.
In connection with the Closing, Bihua Chen, Dr. Nancy Chang, Will Lewis and John Schmid resigned as directors of Helix, and Bihua Chen and Dr. Andrew J. Phillips resigned as officers of Helix.
In connection with the Closing, Bihua Chen, Dr. Nancy Chang, Will Lewis and John Schmid resigned as directors of Helix, and Bihua Chen and Dr. Andrew J. Phillips resigned as officers of Helix.
In connection with the Closing, Bihua Chen, Dr. Nancy Chang, Will Lewis and John Schmid resigned as directors of Helix, and Bihua Chen and Dr. Andrew J. Phillips resigned as officers of Helix.
In connection with the Closing, Bihua Chen, Dr. Nancy Chang, Will Lewis and John Schmid resigned as directors of Helix, and Bihua Chen and Dr. Andrew J. Phillips resigned as officers of Helix.
In connection with the Closing, Bihua Chen, Dr. Nancy Chang, Will Lewis and John Schmid resigned as directors of Helix, and Bihua Chen and Dr. Andrew J. Phillips resigned as officers of Helix.
In connection with the Closing, Bihua Chen, Dr. Nancy Chang, Will Lewis and John Schmid resigned as directors of Helix, and Bihua Chen and Dr. Andrew J. Phillips resigned as officers of Helix.
Max materiality 0.90 · Median 0.72 · Most common event other_material