Company: MLTX
Filing Date: 2025-05-12
Form Type: 10-Q
Source: 0001821586-25-000011
Chunk: 179

Company: MoonLake Immunotherapeutics
Filing Date: 2025-05-12
Form: 10-Q
Item: Part I, Item 2
Chunk 179
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 of challenging activities, including establishing our business model and key third-party relationships with payers, completing preclinical studies and clinical trials of our product candidates, obtaining marketing approval for these product candidates, manufacturing, marketing, selling those products for which we may obtain marketing approval and satisfying any post-marketing requirements.

Additional capital may not be available in sufficient amounts or on reasonable terms, if at all. The current market environment for small and midcap biotechnology companies, like MoonLake, and broader macroeconomic factors may preclude us from successfully raising additional capital. For example, escalating trade tensions, elevated interest rates and regulatory uncertainty have caused significant market volatility in recent months, and particularly in the biotechnology and biopharmaceutical industries, which such volatility can have an adverse effect on the ability to raise capital.

We have no products approved for commercial sale and, since our inception, we have been incurring significant operating losses, and expect to incur significant losses in the foreseeable future. As with any clinical development, we cannot be certain that our 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