MOONLAKE IMMUNOTHERAPEUTICS overview

MoonLake Immunotherapeutics starts Phase 3 IZAR program of the Nanobody® sonelokimab in patients with active psoriatic arthritis Two trials for active psoriatic arthritis (PsA) with one focusing on biologic-naïve patients and including evaluation of radiographic progression (IZAR-1), and the other focusing on TNF-IR patients while being the first trial to include risankizumab as an active reference arm (IZAR-2) Program will evaluate sonelokimab for a total of 52 weeks, across IZAR-1 and...

MoonLake Immunotherapeutics Reports Third Quarter 2024 Financial Results and Provides a Business Update Ended the third quarter with $493.9 million in cash, cash equivalents and short-term marketable debt securities, expected to support a roadmap rich in potential catalysts and a cash runway to the end of 2026 Strong market performance of other IL-17 inhibitors in hidradenitis suppurativa (HS) and other inflammatory indications validating large market opportunity for sonelokimab Phase 3 clinical...

MoonLake Immunotherapeutics to host a Capital Markets Update on Wednesday, September 11 ZUG, Switzerland, September 9, 2024 – MoonLake Immunotherapeutics AG (“MoonLake”; Nasdaq: MLTX), a clinical-stage biotechnology company focused on creating next-level therapies for inflammatory diseases, will host a Capital Markets Update for investors and analysts live from New York on Wednesday, September 11 from 2024, from 9:00 – 10:30 EST/06:00 – 08:30 PST/14:00 – 16:30 CET The event will...

MoonLake Immunotherapeutics Reports Second Quarter 2024 Financial Results and Announces a Capital Markets Update for September 11 Initiated Phase 3 VELA program of the Nanobody ® sonelokimab in hidradenitis suppurativa (“HS”), with topline results anticipated as of mid-2025 Secured positive feedback from both U.S. Food and Drug Administration (“FDA”) and the E.U. European Medicines Agency (“EMA”) on the regulatory path for the Phase 3 program of the Nanobody ® sonelokimab in...

MoonLake Immunotherapeutics Announces Positive Regulatory Feedback from both FDA and EMA on Path for the Phase 3 Program for the Nanobody ® sonelokimab in Psoriatic Arthritis Builds upon the positive regulatory feedback received from FDA and EMA on Phase 3 VELA program for sonelokimab in hidradenitis suppurativa (HS), which has started recruitment Clarified path for PsA Phase 3 program with study design, patient population and endpoints agreed – program is called IZAR and two trials are...

MoonLake Immunotherapeutics starts Phase 3 VELA program of the Nanobody ® sonelokimab in patients with moderate-to-severe hidradenitis suppurativa VELA is the first Phase 3 program in hidradenitis suppurativa to use the higher clinical response level of HiSCR75 as the primary endpoint The topline primary endpoint readout at week 16, together with data on other endpoints, is expected as of mid-2025 Program will evaluate sonelokimab for a total of 52 weeks, across VELA-1 and VELA-2, at sites in...

MoonLake Immunotherapeutics Reports First Quarter 2024 Financial Results and Provides a Business Update Announced positive feedback from both FDA and EMA on the regulatory path for the Phase 3 program of the Nanobody ® sonelokimab in hidradenitis suppurativa (HS) and outlined the development plan with topline results anticipated in mid-2025 Reported significant improvements observed across all key outcomes with sonelokimab over 24 weeks in the ARGO Phase 2 trial in active psoriatic arthritis...

MoonLake Immunotherapeutics inks three-year technology partnership with Komodo Health to advance research on inflammatory skin and joint conditions MoonLake to tap into Komodo’s technology and real-world data to unlock the full potential of its next-gen Nanobody ® therapy San Francisco, US and Zug, Switzerland, April 10, 2024 – MoonLake Immunotherapeutics (“MoonLake”; Nasdaq: MLTX) a clinical-stage biotechnology company focused on creating next-level therapies for inflammatory diseases,...