MoonLake’s Sonelokimab Delivers 81% ASAS40 Response; $394M Cash Fund Runs Into H2 2027

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In Phase 2 S-OLARIS, 81% of axSpA patients treated with sonelokimab achieved ASAS40 by Week 12; 80% reached ASDAS-CRP response and PET imaging showed reduced inflammation. MoonLake ended Q4 2025 with $394M cash, a $75M equity raise, a $25M debt draw and $400M non-dilutive funding, extending runway into H2 2027.

1. Phase 2 S-OLARIS Efficacy Results

In the Phase 2 S-OLARIS trial in radiographic and non-radiographic axSpA, sonelokimab achieved an ASAS40 response in 81% of patients by Week 12 (n=26, mNRI), with 80% of patients also meeting ASDAS-CRP improvement thresholds, suggesting strong clinical efficacy across key disease metrics.

2. Imaging and Biomarker Findings

Objective imaging data from SPARCC MRI and PET with an 18F-NaF tracer demonstrated significant reductions in joint inflammation and osteoblast activity by Week 12, while peripheral blood and tissue biomarker analyses showed rapid decreases in key inflammatory mediators without new safety signals.

3. Financial Position and Funding

MoonLake closed Q4 2025 with $394 million in cash and equivalents, secured $75 million in equity proceeds, drew $25 million under its amended debt facility and retains access to $400 million in non-dilutive financing, positioning the company to fund operations into H2 2027.

4. Next Steps and Investor Day

An Investor Day webcast is scheduled for February 23, 2026, including an open Q&A session, as MoonLake prepares to outline plans for sonelokimab’s Phase 3 program and broader inflammatory disease pipeline.

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