MoonLake Immunotherapeutics Reports Third Quarter 2025 Financial Results and Announces New Data from Clinical Trials of its Nanobody® Sonelokimab

Core Insights - MoonLake Immunotherapeutics reported its financial results for Q3 2025, highlighting significant cash reserves and ongoing clinical trials for its investigational therapy sonelokimab [1][2]. Financial Performance - As of September 30, 2025, the company had cash, cash equivalents, and short-term marketable debt securities totaling $380.5 million, which is expected to fund operations into the second half of 2027 [2]. - Research and development expenses for Q3 2025 were $60.6 million, an increase from $49.8 million in the previous quarter, attributed to higher costs associated with clinical trials and consulting [2]. - General and administrative expenses remained stable at $10.8 million compared to $10.9 million in the previous quarter [2]. Clinical Trials and Data - New data from the Phase 2 LEDA trial indicated that sonelokimab (SLK) provided a 64% mean percent change in the Palmoplantar Psoriasis Area and Severity Index (PPPASI) at week 16, with 39% of patients achieving a ≥75% reduction [3]. - Interim analyses from the VELA-1 and VELA-2 Phase 3 trials in adult patients with Hidradenitis Suppurativa (HS) showed continuous clinical improvement beyond the primary endpoint at week 16 [4]. - The VELA-TEEN trial, focusing on adolescent HS patients, reported that 46% of participants achieved a HiSCR75 response at week 16 [5]. Regulatory and Future Milestones - A Type B meeting with the FDA is scheduled for December 15, 2025, to discuss the clinical evidence package for SLK in HS to support a Biologics License Application (BLA) [4][6]. - Upcoming milestones include the primary endpoint readout of the Phase 2 S-OLARIS trial in axial spondyloarthritis (axSpA) in Q1 2026 and the initiation of a Phase 3 trial in palmoplantar pustulosis (PPP) in Q3 2026 [6][8]. Market Context - Hidradenitis Suppurativa affects an estimated 2% of the population, with a projected market opportunity reaching $15 billion by 2035 due to the significant unmet need for effective treatments [24]. - The company is focused on inflammatory diseases with high unmet needs, including HS, psoriatic arthritis, and axial spondyloarthritis, which affect millions globally [10][14].