MoonLake reported a FY 2025 net loss of USD 230.3 million, with an operating loss of USD 244.8 million. Research and development expenses were USD 202.9 million (up 79.9%), while general and administrative expenses were USD 42.0 million (up 38.4%). Interest expense was USD 7.2 million, other income (net) was USD 22.4 million, and income tax expense was USD 0.6 million. The company said it has not generated revenue from product sales. MoonLake ended FY 2025 with USD 334.5 million in cash and cash equivalents and USD 394.0 million in cash, cash equivalents and short-term marketable securities, and reported FY 2025 net cash used in operating activities of USD 196.0 million. The company said its available cash, cash equivalents and short-term marketable securities are expected to fund operations into the second half of 2027. On the pipeline, MoonLake highlighted Phase 3 HS data from the VELA-1 and VELA-2 trials of sonelokimab (SLK), reporting a 34% HiSCR75 response at week 16 for SLK 120 mg in each study; VELA-1 met statistical significance across primary and key secondary endpoints, while VELA-2’s primary endpoint was affected by a higher-than-expected placebo response (composite strategy p=0.053). The company also said the FDA advised it may establish substantial evidence of effectiveness without additional HS trials and expects to submit a BLA for SLK in adult and adolescent HS in H2 2026, with a planned first U.S. commercial launch in H2 2027, subject to approval. In PsA, MoonLake said it completed enrollment for the Phase 3 IZAR-1 trial and expects the primary and key secondary endpoint readout in mid-2026. In PPP, MoonLake reported Fast Track designation from the FDA for SLK and expects to start a Phase 3 trial in Q3 2026.
Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Moonlake Immunotherapeutics published the original content used to generate this news brief via EDGAR, the Electronic Data Gathering, Analysis, and Retrieval system operated by the U.S. Securities and Exchange Commission (Ref. ID: 0001821586-26-000002), on February 25, 2026, and is solely responsible for the information contained therein.
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