MoonLake Announces S-OLARIS Phase 2 Trial Results and Financials
MoonLake Immunotherapeutics 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. Key highlights: In the Phase 2 S-OLARIS clinical trial in axial spondyloarthritis, sonelokimab demonstrated clinically meaningful benefit with 80+% of patients achieving ASAS40 by Week 12; Consistently, other clinical and imaging scores also showed improvements of 80+% by week 12 for patients treated with SLK, including ASDAS-CRP and SPARCC MRI; axSpA is a disease driven by inflammation leading to irreversible ossification 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 SLK; As 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 detected; MoonLake 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, are expected to provide a cash runway into the second half of 2027; The 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 needs
