MoonLake Announces Positive Topline Results from its Phase 2 Clinical Trial of Sonelokimab in Axial Spondyloarthritis and Reports 2025 Financial Results

Group 1 - MoonLake Immunotherapeutics announced topline results from the S-OLARIS Phase 2 trial of sonelokimab (SLK) in patients with axial spondyloarthritis (axSpA), demonstrating significant clinical benefits [2][5][6] - In the S-OLARIS trial, 81% of patients treated with SLK achieved an ASAS40 response at Week 12, indicating a clinically meaningful improvement [2][5] - The trial also showed over 80% of patients achieved a clinically important improvement as per ASDAS-CRP score, with significant reductions in inflammation and osteoblast activity observed through PET imaging [2][5][6] Group 2 - MoonLake reported financial results for Q4 and the year ended December 31, 2025, with cash and equivalents totaling $394 million, expected to fund operations into the second half of 2027 [7] - Research and development expenses for Q4 2025 were $56 million, down from $60.6 million in the previous quarter, while general and administrative expenses decreased to $9.2 million from $10.8 million [7] - The company amended its debt facility with Hercules Capital, drawing down $25 million, with up to $400 million in non-dilutive funds available for future needs [7] Group 3 - An Investor Day webcast is scheduled for February 23, 2026, where the company will present the S-OLARIS data and discuss upcoming milestones, including the Type B FDA Meeting outcomes for hidradenitis suppurativa [8][12] - The company is pursuing multiple indications for sonelokimab, including hidradenitis suppurativa, psoriatic arthritis, and palmoplantar pustulosis, with significant market opportunities projected [11][27][29]