MoonLake Immunotherapeutics Reports First Quarter 2024 Financial Results and Provides a Business Update By Investing.com

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 (PsA) including unprecedented multi-domain responses across joints, skin and other domains, supporting potential best-in-class profile of sonelokimab
• Announced the imminent commencement of four additional clinical trials of sonelokimab across dermatology, and rheumatology, including innovative trials in palmo-plantar pustulosis (PPP), juvenile HS and seronegative spondyloarthritis
• Ended the first quarter with $547.1 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

ZUG, Switzerland, May 7, 2024 “ MoonLake Immunotherapeutics (NASDAQ:MLTX) (MoonLake), a clinical-stage biotechnology company focused on creating next-level therapies for inflammatory diseases, today announced its financial results for the first quarter of 2024.

Dr. Jorge Santos da Silva, Chief Executive Officer of MoonLake Immunotherapeutics, said: 2024 is shaping up to be a strong year for MoonLake. We announced more positive data for our Nanobody ^® sonelokimab in PsA at our recent R&D Day and are looking forward to initiating the Phase 3 program in HS imminently, and the Phase 3 program in PsA later this year. We also expect to initiate a further Phase 3 program in juvenile HS, as well as three Phase 2 trials across dermatology, and rheumatology, broadening our pipeline to address some of the fastest growing markets in inflammatory diseases. These new trials ensure that we continue to evaluate the full potential of our Nanobody ^® sonelokimab for indications in which IL-17A and IL-17F are implicated and where there is a need for deep tissue penetration.

Q1 highlights (including post-period end)

• Provided an update on the development of sonelokimab in HS including details on Phase 3 trial design and timelines for this program, named VELA, which is set to enroll 800 patients, and which…