MoonLake Immunotherapeutics Announces Q1 2024 Financial Results and Business Update

MoonLake Immunotherapeutics, a clinical-stage biotechnology company, has announced its financial results for the first quarter of 2024 and provided a business update. The company, based in Zug, Switzerland, focuses on developing advanced therapies for inflammatory diseases, especially utilizing their novel Nanobody® technology, specifically sonelokimab.

For the first quarter of 2024, MoonLake reported cash holdings of $547.1 million, including cash equivalents and short-term marketable debt securities. This financial strength is expected to support their strategic roadmap through to the end of 2026. Research and development expenses rose to $13.0 million from $8.1 million the previous quarter, due to costs associated with the initiation of new clinical trials. General and administrative expenses remained steady at $6.8 million.

Dr. Jorge Santos da Silva, CEO of MoonLake, expressed optimism about the company’s trajectory in 2024. The company has reported positive data for sonelokimab in treating psoriatic arthritis (PsA) and is on track to begin a Phase 3 program for hidradenitis suppurativa (HS) soon. Additional Phase 3 trials for juvenile HS and Phase 2 trials for other dermatological and rheumatological conditions are also planned for 2024.

During the first quarter, MoonLake announced details of its Phase 3 trial, named VELA, for sonelokimab in HS. This trial will enroll 800 patients and follows favorable feedback from both the FDA and EMA. Additionally, data from the MIRA trial of sonelokimab in HS showed impressive results, with significant treatment effects observed at both 12 and 24 weeks.

The company also held an R&D Day featuring presentations from leading experts in dermatology and rheumatology. Significant improvements with sonelokimab were reported over 24 weeks in the ARGO Phase 2 trial for PsA, showing multi-domain responses and indicating a potential best-in-class profile. Plans for four additional clinical trials of sonelokimab in conditions such as palmo-plantar pustulosis (PPP), juvenile HS, and seronegative spondyloarthritis were also announced.

MoonLake has entered a three-year technology partnership with Komodo Health to advance research into inflammatory skin and joint conditions. Initial data from this partnership highlighted that at least two million Americans have been diagnosed with HS, pointing to a significant unmet need and a potential market opportunity exceeding $10 billion by 2035.

Financially, MoonLake ended the first quarter of 2024 in a robust position. CFO Matthias Bodenstedt emphasized that their healthy cash balance is expected to fund their ambitious roadmap through to the end of 2026. The company anticipates significant milestones, including the primary readout of the Phase 3 HS VELA program by mid-2025 and subsequent regulatory filing. The data from recent U.S. launches of treatments like secukinumab in HS and bimekizumab in psoriasis further validate MoonLake’s market opportunity and the demand for new treatment options.

Key events anticipated for MoonLake in 2024 include the initiation of the Phase 3 VELA program in HS, end-of-Phase 2 meetings with the FDA and EMA for PsA, and the start of additional studies in various dermatological and rheumatological indications.

MoonLake Immunotherapeutics aims to revolutionize treatments for inflammatory diseases with sonelokimab, a Nanobody® that inhibits IL-17A and IL-17F, thereby addressing conditions like HS and PsA. Founded in 2021, the company is dedicated to unlocking the full potential of sonelokimab and expanding its pipeline to meet significant unmet medical needs.