MoonLake Immunotherapeutics announced the pricing of an upsized underwritten public offering expected to generate approximately $200 million in gross proceeds. The clinical-stage biotechnology company, focused on inflammatory skin and joint diseases, priced 9,000,000 Class A ordinary shares at $20.00 per share. Additionally, certain investors may purchase pre-funded warrants to buy up to 1,000,000 Class A ordinary shares at $19.9999 per warrant, which are exercisable immediately. The offering is scheduled to close on or about June 25, 2026.

MoonLake intends to use the net proceeds from this offering, alongside existing cash, cash equivalents, and marketable securities, to fund the research, development, pre-commercialization, and commercialization of sonelokimab, if approved, and for general corporate purposes. The company has granted underwriters a 30-day option to purchase up to an additional 1,500,000 Class A ordinary shares at the public offering price, less underwriting discounts and commissions. All securities are being offered by MoonLake Immunotherapeutics.

Offering Details

Leerink Partners, Guggenheim Securities, Cantor, and LifeSci Capital are acting as joint bookrunning managers, while H.C. Wainwright & Co. and Clear Street are acting as lead managers. A shelf registration statement related to these securities was filed with the Securities and Exchange Commission (SEC) and became effective on September 11, 2023. The offering is being made solely by means of a prospectus supplement and related prospectus filed with the SEC.

MoonLake Immunotherapeutics is developing sonelokimab, a novel investigational Nanobody designed to inhibit IL-17A and IL-17F for the treatment of inflammatory diseases. The company's focus includes hidradenitis suppurativa, psoriatic arthritis, axial spondyloarthritis, and palmoplantar pustulosis. MoonLake was founded in 2021 and is headquartered in Zug, Switzerland.

MoonLake Immunotherapeutics announced positive Week 52 results from its Phase 3 VELA program for sonelokimab in adults with moderate-to-severe hidradenitis suppurativa (HS). The data demonstrated a potential best-in-class profile, with 67.2% of patients achieving HiSCR75 and 33.1% reaching HiSCR100 at Week 52. The company confirmed plans to submit a Biologics License Application (BLA) to the FDA by the end of September 2026.

Phase 3 VELA Program Results

The pooled analysis from the VELA-1 and VELA-2 trials (n=396) showed consistent responses across both studies. VELA-1 reported 68.3% HiSCR75 and 31.2% HiSCR100, while VELA-2 showed 66.0% HiSCR75 and 35.1% HiSCR100. Additionally, 26.0% of patients achieved IHS4-100, indicating inflammatory remission defined as a 100% reduction in abscesses, nodules, and draining tunnels.

Patient-reported outcomes showed substantial improvements. The mean score difference in HS-specific Quality of Life (HiSQOL) was -15.3 in VELA-1 and -14.8 in VELA-2. Furthermore, 46.5% of patients experienced a marked reduction in pain, defined as at least a 3-point reduction from baseline in the worst skin pain Numerical Rating Scale.

Safety and Tolerability

The safety profile of sonelokimab remained consistent through Week 52, with no new safety signals detected. Approximately 90% of patients rolled over into the two-year open-label extension (VELA-OLE), validating the tolerability and convenience of the 120mg once every four weeks dosing regimen.

VELA-TEEN Interim Data

Interim Week 24 data from the Phase 3 VELA-TEEN trial in adolescent patients (n=22) indicated strong therapeutic responses. Approximately 68% of patients achieved HiSCR75, 86% achieved HiSCR50, and 45% reached HiSCR100. No new safety signals were observed in this population.

Regulatory Milestones and Investor Day

MoonLake plans to submit the BLA for HS at the end of September 2026, following the conclusion of pre-BLA meetings. The company expects clarity on the Prescription Drug User Fee Act (PDUFA) date by the end of November 2026. MoonLake will host an Investor Day webcast on June 22, 2026, from 8:00 – 9:30 a.m. EST to discuss the data and provide guidance on upcoming events.