Moonlake Immunotherapeutics (NASDAQ: MLTX) has announced positive topline results from its phase 2 clinical trial of sonelokimab in axial spondyloarthritis (axspa) and reported its financial results for the fourth quarter and year ended December 31, 2025.
In the phase 2 S-olaris clinical trial in axspa, sonelokimab demonstrated clinically meaningful benefit, with 81% of patients achieving an assessment of spondyloarthritis international society 40 (ASAS40) response at week 12. Additionally, other clinical and imaging scores also showed improvements of 80% or more by week 12 for patients treated with sonelokimab. PET/MRI imaging data showed a significant reduction in inflammation and osteoblast activity deep in affected joints, suggesting potential for disease modification in axspa.
As of December 31, 2025, Moonlake held $394 million in cash, cash equivalents, and short-term marketable debt securities. 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.
The company's research and development expenses for the quarter ended December 31, 2025, were $56.0 million, compared to $60.6 million in the previous quarter. General and administrative expenses for the quarter ended December 31, 2025, were $9.2 million, compared to $10.8 million incurred in the previous quarter.
Moonlake expects its cash, cash equivalents, and short-term marketable debt securities to be sufficient to fund its operating expenses and capital expenditure requirements into the second half of 2027.
The company also announced an investor day webcast scheduled for February 23, 2026, where Moonlake’s CEO, CCO, and CFO will present the axspa S-olaris data and discuss the outcomes of the recent Type B FDA meeting for hidradenitis suppurativa (HS) and next steps regarding label strategy and BLA submission. They will also share an update on the company's financial position and outline key 2026 catalysts.
Moonlake Immunotherapeutics is a clinical-stage biopharmaceutical company focused on creating next-level therapies for inflammatory diseases, with a major focus on conditions such as hidradenitis suppurativa, psoriatic arthritis, axial spondyloarthritis, and palmoplantar pustulosis. Sonelokimab, the company's investigational nanobody®, is being assessed in various phase 3 trials for different indications, including HS, psoriatic arthritis, and palmoplantar pustulosis. Today the company's shares have moved 2.51% to a price of $16.76. If you want to know more, read the company's complete 8-K report here.
