MoonLake Immunotherapeutics (NASDAQ:MLTX) shares advanced 6.6% in premarket trading Monday after the company reported positive topline findings from its Phase 2 S-OLARIS study evaluating sonelokimab for axial spondyloarthritis (axSpA).
According to the company, 81% of patients receiving sonelokimab achieved an ASAS40 response at Week 12, indicating at least a 40% improvement across key disease measures. More than 80% of participants also recorded clinically meaningful improvement based on ASDAS-CRP scores over the same period.
Imaging data further supported the clinical outcomes. PET scans demonstrated a notable reduction in inflammation and osteoblast activity within affected sacroiliac joints, a process associated with irreversible bone formation in axSpA. Improvements were also confirmed through SPARCC MRI scoring by Week 12.
MoonLake said the safety profile observed in the S-OLARIS trial aligned with prior studies, with no new safety concerns identified.
The company ended the fourth quarter with $394 million in cash, cash equivalents, and short-term marketable debt securities. Combined with $75 million in gross proceeds from a recent equity raise, MoonLake expects its cash runway to extend into the second half of 2027.
MoonLake also disclosed an amendment to its debt agreement with Hercules Capital, including an immediate $25 million drawdown while retaining access to as much as $400 million in additional non-dilutive funding.
Research and development expenses totaled $56.0 million for the quarter ended December 31, 2025, down from $60.6 million in the previous quarter, while general and administrative costs declined to $9.2 million from $10.8 million.
Looking ahead, the company anticipates reporting 52-week results from its VELA-1 and VELA-2 hidradenitis suppurativa trials in the second quarter of 2026, with primary endpoint data from Phase 3 studies in psoriatic arthritis expected around mid-2026.