Company: MLTX
Filing Date: 2025-05-12
Form Type: 10-Q
Source: 0001821586-25-000011
Chunk: 3

Company: MoonLake Immunotherapeutics
Filing Date: 2025-05-12
Form: 10-Q
Item: Part I, Item 3
Chunk 3
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 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 may not be as accurate as they could be if we had a longer operating history. We may never succeed in these activities and, even if we succeed in commercializing SLK, we may never generate revenue that is significant enough to achieve profitability. If we do achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis and we may continue to incur substantial research and development and other expenditures to develop and market additional product candidates. Our failure to become and remain profitable could decrease the value of our shares and impair our ability to raise capital, maintain our research and development efforts, expand our business or continue our operations. Further, we may encounter unexpected expenses, challenges