Company: MLTX
Filing Date: 2025-02-26
Form Type: 10-K
Source: 0001821586-25-000006
Chunk: 20

Company: MoonLake Immunotherapeutics
Filing Date: 2025-02-26
Form: 10-K
Item: Item 1
Chunk 20
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 patient outcomes. In February 2024 and June 2024, we announced the successful outcome of our end-of-Phase 2 interactions with the FDA, as well as positive feedback from our interactions with the EMA, with both regulatory bodies supporting our proposed approach for advancing our Phase 3 programs of SLK in HS and PsA, respectively. In May 2024, we announced the screening of the first patients in the Phase 3 VELA program in HS and expect primary endpoint data as of mid 2025. We commenced the Phase 3 IZAR program in PsA in November 2024, and expect primary endpoint data in the first half of 2026. In January 2025, we announced that patients have been screened in the Phase 3 VELA-TEEN trial and the Phase 2 LEDA and S-OLARIS trials, and we expect to initiate patient enrollment in the Phase 2 P-OLARIS trial in the first half of 2025.

•Strengthening the differentiation elements for future SLK patients — In parallel with our clinical trials, we conduct non-clinical research to continue refining our understanding of SLK/Nanobody biology and the potential impact in our selected therapeutic indications. This research will inform our clinical efforts and includes the study of SLK’s pharmacokinetics and pharmacodynamics in a variety of cellular, deep-tissue, and disease models (in vitro and in vivo), including exploration of tissue penetration and targeting of SLK in disease models. We expect these studies to provide a more complete picture of IL-17A and IL-17F regulation. We expect this work to more clearly differentiate SLK, a Nanobody, from monoclonal antibody-based treatment options, including other IL-17A and IL-17F inhibitors. We also expect this work to contribute to the furthering of our intellectual property.

•Preparing for commercialization of SLK — We have started preparing the BLA to seek approval of SLK in the U.S. in HS and adolescent HS. We expect to submit the BLA in 2026 after completion of the VELA program, and, subject to FDA approval, we expect a commercial launch in the U.S. in 2027. We plan to further invest in our commercial capabilities. In 2024, we started hiring dedicated personnel to our marketing, access and pricing functions and intend to continue building out this team to prepare for commercial launches of SLK in our target indications.