Company: MLTX
Filing Date: 2025-08-05
Form Type: 10-Q
Source: 0001821586-25-000018
Chunk: 15

Company: MoonLake Immunotherapeutics
Filing Date: 2025-08-05
Form: 10-Q
Item: Part I, Item 1
Chunk 15
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 after December 15, 2026, and interim periods within fiscal years beginning after December 15, 2027. The Company is currently evaluating the impact.Prior Period ReclassificationThe amortization expense in the condensed consolidated statements of cash flows in prior periods has been reclassified to conform with the current period presentation. The amortization expense of $619 thousand was reclassified from "Other non-cash items" to "Depreciation and amortization". The change did not have any impact on the net cash flow used in operating activities.

Note 3 – Risks and Liquidity

Going Concern, Liquidity and Capital ResourcesMoonLake is subject to risks common to companies in the biopharmaceutical industry, and the Company believes that changes in any of the following areas could have a material adverse effect on the Company's future financial position or results of operations: ability to obtain future financing, regulatory approval and market acceptance of, and reimbursement for, product candidates, performance of third-party contract research organizations and manufacturers upon which the Company relies, protection of the Company's intellectual property, litigation or claims against the Company based on intellectual property, patent, product, regulatory, clinical or other factors, and the Company's ability to attract and retain employees necessary to support its growth.

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MOONLAKE IMMUNOTHERAPEUTICSNOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS JUNE 30, 2025(Unaudited)

The Company is dependent on third-party manufacturers to supply products for research and development activities in its programs and for eventual commercialization. In particular, the Company relies and expects to continue to rely on a small number of manufacturers to supply the Company with its requirements for the active pharmaceutical ingredients and formulated drugs related to these programs. These programs could be adversely affected by a significant interruption in the supply of active pharmaceutical ingredients and formulated drugs.The Company's ability to generate revenue sufficient to achieve profitability will depend on the successful development and eventual commercialization of SLK in one or more indications, which is expected to take a number of years. The Company expects to continue to incur significant expenses and operating losses for at least the next two years as the Company continues the development of SLK and prepares for commercial launches. It is expected that operating losses will fluctuate significantly from year to year depending on the timing of the Company's planned clinical development programs, efforts to achieve regulatory approval, and marketing and sales expenditures.The Company incurred a loss of $96.6 million for the six months ended June 30, 202