Company: MLTX
Filing Date: 2025-02-26
Form Type: 10-K
Source: 0001821586-25-000006
Chunk: 99

Company: MoonLake Immunotherapeutics
Filing Date: 2025-02-26
Form: 10-K
Item: Item 1A
Chunk 99
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 Sanofi), and IRAK4 degraders (such as Kymera Therapeutics Inc). It also includes UCB as the development and commercializing company for bimekizumab, the only other IL-17A and IL-17F inhibitor beyond SLK that has received approval or is in late-stage clinical development of which we are aware. Other IL-17A and IL-17F inhibitors are in preclinical development stages, including molecules being developed by Protagonist Therapeutics, Inc., Oruka Therapeutics, Inc. and Scinai Immunotherapeutics Ltd. While SLK represents a novel mechanism of action, all of the above mechanisms are also of potential therapeutic use in one or more other indications that we are or may be pursuing. If SLK does not offer sustainable advantages over competing products, we may otherwise not be able to successfully compete against current and future competitors.

Our competitors may obtain regulatory approval of their products more rapidly than we may or may obtain patent protection or other intellectual property rights that limit our ability to develop or commercialize SLK. Our competitors may also develop 

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

drugs that are more effective, more convenient, more widely used and less costly or have a better safety profile than SLK and these competitors may also be more successful than us in manufacturing and marketing their products.

Furthermore, we also face competition more broadly across the market for existing cost-effective and reimbursable inflammatory skin and joint disease treatments. SLK, if approved, may compete with these existing drug and other therapies but may not be competitive with them in price. We expect that if SLK is approved, it will be priced at a significant premium over generic, including branded generic, or biosimilar products. In particular, the availability of biosimilar products of adalimumab and in the future secukinumab may intensify competition. As a result, obtaining market acceptance of, and gaining significant share of the market for, SLK will pose challenges.

SLK may have a safety profile that could prevent regulatory approval, marketing approval or market acceptance, or limit its commercial potential.

Patients in previous SLK trials have experienced adverse events, including oral Candida. If SLK is associated with undesirable side effects or has unexpected characteristics in preclinical studies or clinical trials when used alone or in combination with other approved products or INDs, we may need to interrupt