Press release
MoonLake Immunotherapeutics Reports Second Quarter 2024 Financial Results and Announces a Capital Markets Update for September 11
MoonLake Immunotherapeutics Reports Second Quarter 2024 Financial Results and Announces a Capital Markets Update for September 11 Initiated Phase 3 VELA
About this update from Moonlake Immunotherapeutics
[{"type":"text","content":"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-2025Secured 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 psoriatic arthritis (“PsA”) and outlined the clinical plan with topline results anticipated in end-2026Ended the quarter with $519.8 million in cash, cash equivalents and short-term marketable debt securities, expected to support a roadmap rich in potential catalysts whilst providing a cash runway to the end of 2026Capital Markets Update to be held on Wednesday, September 11 – to provide an update on market opportunity and trial execution ZUG, Switzerland, August 7, 2024 – MoonLake Immunotherapeutics (NASDAQ:MLTX) (“MoonLake” or the “Company”), a clinical-stage biotechnology company focused on creating next-level therapies for inflammatory diseases, today announced its financial results for the second quarter of 2024. MoonLake continues to make significant progress in advancing its investigational Nanobody® sonelokimab in a number of dermatological and rheumatological inflammatory indications. Following positive top-line results from its global Phase 2 MIRA trial announced last year, the Company initiated its global Phase 3 VELA program during the quarter to evaluate sonelokimab for a total of 52 weeks in an estimated total of 800 patients with moderate-to-severe HS. Management anticipates topline results of the 16 weeks primary endpoint as of mid-2025. The initiation of an additional Phase 3 study in adolescents with HS, the VELA TEEN trial, is on track for enrollment of the first patients around year-end. MoonLake also received positive regulatory feedback from both the FDA and the EMA during the quarter which clarifies the path for its Phase 3 IZAR program in PsA. IZAR-1 will focus on bio-naïve patients* and radiographic progression whilst IZAR-2 will focus on TNF-IR patients**. The IZAR program will feature risankizumab as a reference arm and is expected to enroll around 1,500 patients, starting in the fourth quarter of 2024. Preparations for the initiation...