Company: MLTX
Filing Date: 2025-05-12
Form Type: 10-Q
Source: 0001821586-25-000011
Chunk: 147

Company: MoonLake Immunotherapeutics
Filing Date: 2025-05-12
Form: 10-Q
Item: Part I, Item 8
Chunk 147
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 planned clinical trials will begin or be completed on time or at all. In addition, we have not yet demonstrated an ability to obtain marketing approvals, manufacture a commercial-scale product or arrange for a third party to do so on our behalf, or conduct sales, marketing and distribution activities necessary for successful product commercialization. Our ability to generate revenue depends on a number of factors, including, but not limited to, our ability to:  

•successfully complete our ongoing and planned preclinical and clinical studies for SLK;

•timely file and gain acceptance of Investigational New Drug(“IND”)applications for our programs in order to commence planned clinical trials or future clinical trials;

•successfully enroll subjects in, and complete, our ongoing and planned clinical trials;

•obtain data related to SLK and generated prior to the In-License Agreement, but not transferred from MHKDG, which may delay our development and commercialization;

•initiate and successfully complete all safety and efficacy studies required to obtain U.S. and foreign regulatory approval for our product candidates, and additional clinical trials or other studies beyond those planned to support the approval and commercialization of SLK;

•successfully demonstrate to the satisfaction of the FDA, EMA, or similar foreign regulatory authorities the safety and efficacy and acceptable risk to benefit profile of SLK or any future SLK product candidates;

•successfully manage the prevalence, duration and severity of potential side effects or other safety issues experienced with our product candidates, if any;

•obtain the timely receipt of necessary marketing approvals from the FDA, EMA and similar foreign regulatory authorities;

•establish commercial manufacturing capabilities or make arrangements with third-party manufacturers for clinical supply and commercial manufacturing;

•obtain and maintain patent and trade secret protection or regulatory exclusivity for our product candidates;

•launch commercial sales of our products, if and when approved, whether alone or in collaboration with others;

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•obtain and maintain acceptance of the products, if and when approved, by patients, the medical community and third-party payers;

•position our product conducts to effectively compete with other therapies;

•obtain and maintain healthcare coverage and adequate reimbursement for our products;

•enforce and defend intellectual property rights and claims; and

•maintain a continued acceptable safety profile of SLK following approval.

Due to the uncertainties and risks associated with these activities, we are unable to accurately and precisely predict the timing and amount of revenues, the extent of any further losses or if or when we might achieve profitability. Consequently, any predictions you make about our future success or viability