Switzerland-based MoonLake Immunotherapeutics (Nasdaq: MLTX) announced a proposed public offering of USD 150 million in Class A ordinary shares — with pre-funded warrants available to select investors — timed to fund pre-commercialization and commercialization activities for sonelokimab (SLK) ahead of a planned Biologics License Application (BLA) submission in hidradenitis suppurativa (HS) scheduled for late September 2026. The raise comes one day after MoonLake reported Week 52 data from its Phase III VELA program showing 67.2% of patients achieving HiSCR75 at one year, a response rate the company described as exceeding those of competing approved agents at comparable timepoints.
The offering consists of Class A ordinary shares at market price, with pre-funded warrants available in lieu of shares for certain investors. Underwriters have been granted a 30-day option to purchase up to an additional USD 22.5 million of shares. Leerink Partners, Guggenheim Securities, Cantor, and LifeSci Capital are acting as joint bookrunning managers. MoonLake stated proceeds will be used alongside existing cash to fund sonelokimab research, development, pre-commercialization, and commercialization activities, if approved, as well as general corporate purposes. As of Q1 2026, the company held USD 357.9 million in cash and short-term marketable securities, with a cash runway projected to end-2027.
Founded in 2021, MoonLake is built around a single asset licensed from Merck KGaA. Its lead program, sonelokimab (SLK), is an approximately 40 kDa humanized Nanobody that simultaneously inhibits IL-17A and IL-17F by blocking the IL-17A/A, IL-17A/F, and IL-17F/F dimers, with a third domain binding human serum albumin to extend half-life and facilitate tissue enrichment. The small-format biologic is designed to achieve deeper tissue penetration than conventional monoclonal antibodies — a property the company has sought to demonstrate across multiple indications.
The most advanced program is in adult and adolescent HS, where the Phase III VELA-1 and VELA-2 trials enrolled 838 patients. Week 52 data reported in June 2026 showed 67.2% HiSCR75 and 33.1% HiSCR100 response rates across both studies, alongside 26% achieving inflammatory remission. The VELA-TEEN trial in adolescents aged 12–17 reported 68% HiSCR75 at Week 24. Following a positive final pre-BLA meeting with the FDA in April 2026 — in which the agency aligned on label strategy, safety data pooling, and the inclusion of adolescent data — MoonLake plans to submit the HS BLA by end of September 2026, with a PDUFA date allocation expected by November 2026. A US commercial launch, absent Priority Review, is targeted for Q3/Q4 2027.
