Shares of MoonLake Immunotherapeutics (MLTX) rose 6.6% in premarket trading Monday after the company released topline findings from its Phase 2 S-OLARIS trial evaluating sonelokimab in axial spondyloarthritis (axSpA).
The company reported that 81% of patients treated with sonelokimab achieved an ASAS40 response at Week 12, a standard measure indicating at least 40% improvement across key disease domains. In addition, more than 80% of participants attained clinically important improvement according to the ASDAS-CRP score by Week 12, the company said.
Imaging endpoints supported the clinical readouts. Positron emission tomography (PET) imaging demonstrated meaningful reductions in both inflammation and osteoblast activity in affected sacroiliac joints - changes the company described as relevant because osteoblast activity is a principal contributor to irreversible ossification in axSpA. Magnetic resonance imaging assessments using SPARCC scoring in the sacroiliac joint likewise confirmed clinical improvement by Week 12.
MoonLake characterized the safety profile observed in S-OLARIS as consistent with prior trials of sonelokimab and reported no new safety signals in the topline release.
On the financial side, MoonLake closed the fourth quarter with $394.0 million in cash, cash equivalents and short-term marketable debt securities. The company said that, together with gross proceeds of $75.0 million from its most recent equity raise, it expects to have a cash runway into the second half of 2027.
MoonLake also announced an amendment to its debt facility with Hercules Capital, which included a concurrent drawdown of $25.0 million. Under the amended arrangement, the company indicated that up to $400.0 million in non-dilutive funds remain available.
Expense items for the quarter ended December 31, 2025 were reported as follows: research and development costs totaled $56.0 million, down from $60.6 million in the prior quarter; general and administrative expenses were $9.2 million, compared with $10.8 million in the prior quarter.
Looking ahead, MoonLake said it expects to report 52-week data from the VELA-1 and VELA-2 trials in hidradenitis suppurativa in the second quarter of 2026. The company also anticipates primary endpoint readouts from its Phase 3 trials in psoriatic arthritis by mid-2026.
These results and the accompanying financial disclosures will inform how investors and other stakeholders assess the company’s near-term development pathway and funding sufficiency as additional readouts approach in 2026.