MoonLake Reports Clinical Data From Sonelokimab Studies, Nanobody Drug Shows Results In Multiple Trials For Rare Skin Diseases, Eyes FDA Filing In 2026

MoonLake Immunotherapeutics (NASDAQ:MLTX) ("MoonLake" or the "Company"), a clinical-stage biotechnology company focused on creating next-level therapies for inflammatory diseases, today announced its financial results for the third quarter of 2025.

As of September 30, 2025, MoonLake held cash, cash equivalents and short-term marketable debt securities of $380.5 million. The Company expects its cash, cash equivalents and short-term marketable securities, together with committed capital under a previously announced debt facility with Hercules Capital, to be sufficient to fund its operating expenses and capital expenditure requirements into the second half of 2027. Research and development expenses for the quarter ended September 30, 2025, were $60.6 million, compared to $49.8 million in the previous quarter. The increase of $10.8 million was driven by increases in expenses with contract research organizations and contract manufacturing organizations, as well as consulting expenses and personnel-related costs, all to support the further ramp-up of MoonLake's clinical trials and preparations for the anticipated submission of the BLA for sonelokimab in the third quarter of 2026. General and administrative expenses for the quarter ended September 30, 2025 were $10.8 million, similar to the $10.9 million incurred in the previous quarter.

The Company today also released new data from multiple clinical trials of its Nanobody® SLK:

In the Phase 2 LEDA clinical trial in PPP, SLK demonstrated clinically meaningful and statistically significant benefit. Patients treated with SLK achieved a mean percent change from baseline in the Palmoplantar Pustular Psoriasis Area and Severity Index (PPPASI) of 64% at week 16, and 39% of patients achieved a ≥75% reduction in the PPPASI (PPPASI75), suggesting that SLK could provide clinically meaningful improvements in this disease for which there are currently no approved therapies. The safety profile of SLK in the LEDA trial was consistent with previous trials with no new safety signals detected. The Company expects to commence a Phase 3 clinical trial in PPP in Q3 2026.

In an interim analysis of long-term data from MoonLake's Phase 3 clinical trials in adult patients with HS, the VELA-1 and VELA-2 trials, SLK demonstrates continuous clinical improvement and potentially competitive advantages beyond the week 16 primary endpoint. The Company confirmed a Type B meeting with the FDA, which is scheduled to be held on December 15, 2025, to discuss adequacy of the current clinical evidence package of SLK in HS to support a Biologics License Application (BLA).

An interim analysis of the VELA-TEEN clinical trial, a Phase 3 study of SLK in adolescent HS patients, showed that 46% of patients achieved a HiSCR75 response at week 16 (n=11). The trial is expected to enroll a total of 30-35 patients and topline results are expected to become available in 2026. The data is expected to be part of MoonLake's BLA submission.