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MoonLake Announces Positive Topline Results from its Phase 2 Clinical Trial of Sonelokimab in Axial Spondyloarthritis and Reports 2025 Financial Results
In the Phase 2 S-OLARIS clinical trial in axial spondyloarthritis (axSpA), sonelokimab (SLK) demonstrated clinically meaningful benefit with 80+% of patients
About this update from Moonlake Immunotherapeutics
[{"type":"text","content":"In the Phase 2 S-OLARIS clinical trial in axial spondyloarthritis (axSpA), sonelokimab (SLK) demonstrated clinically meaningful benefit with 80+% of patients achieving ASAS40 by Week 12Consistently, other clinical and imaging scores also showed improvements of 80+% by week 12 for patients treated with SLK, including ASDAS-CRP and SPARCC MRIaxSpA is a disease driven by inflammation leading to irreversible ossification (via osteoblast activity) and ultimately to irreversible restriction of mobility – objective PET/MRI imaging data further showed a significant reduction in inflammation and osteoblast activity deep in affected joints, already by week 12, suggesting potential for disease modification in axSpA for SLKAs a biomarker-controlled trial, S-OLARIS data showed SLK reduced the levels of key inflammatory mediators in axSpA, in peripheral blood and biopsy samples from patients – the safety profile of SLK was similar to other trials and no new signals were detectedMoonLake ended the fourth quarter with $394 million in cash, cash equivalents and short-term marketable debt securities which, together with funds from its latest equity raise (gross proceeds of $75 million), are expected to provide a cash runway into the second half of 2027The Company also announced the amendment of its debt facility with Hercules Capital, with a concurrent drawdown of $25 million, and up to $400 million in non-dilutive funds remaining available to support future funding needsAn Investor Day webcast has been confirmed for February 23, 2026, 8.00 – 9.30 am EST (2:00 – 3.30pm CET), including an open Q&A session ZUG, Switzerland, February 22, 2026 – MoonLake Immunotherapeutics (NASDAQ:MLTX) (“MoonLake” or the “Company”), a clinical-stage biotechnology company focused on creating next-level therapies for inflammatory diseases, today announces topline results from the S-OLARIS Phase 2 trial of SLK in patients with radiographic and non-radiographic axSpA and announces its financial results for the fourth quarter and year ended December 31, 2025. An Investor Day webcast has been confirmed for February 23, 2026, 8.00 – 9.30 am EST (2:00 – 3.30pm CET), including an open Q&A session. Topline Phase 2 S-OLARIS clinical trial results of SLK in axSpAIn the Phase 2 S-OLARIS trial in axSpA, SLK demonstrated clinically meaningful and statistically significant benefit....