Company: MLTX
Filing Date: 2025-02-26
Form Type: 10-K
Source: 0001821586-25-000006
Chunk: 93

Company: MoonLake Immunotherapeutics
Filing Date: 2025-02-26
Form: 10-K
Item: Item 1A
Chunk 93
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 or if the results of these trials or tests are not positive or are only modestly positive or if there are safety concerns, we may:

•be delayed in obtaining regulatory approval from the FDA, EMA or other regulatory authorities for our product candidates;

•not obtain regulatory approval at all and lose our right and ability under our license from MHKDG to further develop and commercialize SLK;

•obtain regulatory approval for indications or patient populations that are not as broad as intended or desired;

47

MOONLAKE IMMUNOTHERAPEUTICSFORM 10-K FOR THE YEAR ENDED DECEMBER 31, 2024PART I

•continue to be subject to post-marketing testing requirements from the FDA, EMA or other regulatory authorities; or

•experience having the product removed from the market after obtaining regulatory approval.

We are substantially dependent on the success of SLK, and our ongoing and anticipated clinical trials of SLK may not be successful.

Our future success is substantially dependent on our ability to successfully develop SLK for future marketing approval, and then successful commercialization. We are investing a majority of our efforts and financial resources into the research and development of SLK. In October 2023, we announced full 24-week data from the global Phase 2 MIRA clinical trial in HS. In May 2024, we announced the screening of the first patients in the Phase 3 VELA-1 and VELA-2 trials in HS. We expect primary endpoint data from the VELA trials as of mid-2025. In March 2024, we announced full 24-week data from the Phase 2 ARGO trial in PsA. 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 first patients have been screened in the Phase 3 VELA-TEEN trial in adolescent HS, in the Phase 2 LEDA trial in PPP, and in the Phase 2 S-OLARIS trial in axSpA. We expect primary endpoint data from the LEDA trial in 2025, the VELA-TEEN trial in 2026 and the S-OLARIS trial in 2026.

SLK may require additional clinical development, evaluation of clinical, preclinical and manufacturing activities, marketing approval in multiple jurisdictions, substantial investment and significant marketing efforts before we generate any revenues from product sales