Company: LIMN
Filing Date: 2025-07-28
Form Type: S-1/A
Source: 0001410578-25-001518
Chunk: 31

Company: Liminatus Pharma, Inc.
Filing Date: 2025-07-28
Form: S-1/A
Chunk 31
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 third-party drug products, delays in procuring such third-party drug products and the delivery of such third-party drug products to clinical trial sites, or the inability to procure such third-party drug products at all; and |

| ● | regulators revising the requirements for approving Liminatus’s product candidates, including as a result of newly approved agents changing the standard of care of an indication. |

Any unforeseen events may cause Liminatus to be required to conduct additional clinical trials or other testing of Liminatus’s product candidates beyond those that it currently contemplates, or to be unable to successfully complete clinical trials of Liminatus’s product candidates or other testing. Clinical trial or test results may also not be positive or may be only modestly positive or may have safety concerns. Any of the foregoing events may cause us to incur unplanned costs, be delayed in obtaining marketing approval, if ever, receive more limited or restrictive marketing approval, be subject to additional post-marketing testing requirements, or have the drug removed from the market after obtaining marketing approval. The outcome of preclinical testing and early clinical trials that Liminatus obtains and that it publishes may not be predictive of the success of later clinical trials, and the results of its clinical trials may not satisfy the requirements of the FDA, EMA, or comparable foreign regulatory authorities. Liminatus currently has no products approved for sale and it cannot guarantee that it will ever have marketable drugs. Clinical failure can occur at any stage of clinical development. Clinical trials may produce negative or inconclusive results, and Liminatus or any future collaborators may decide, or regulators may require it, to conduct additional clinical trials or preclinical studies. Liminatus will be required to demonstrate with substantial evidence through well-controlled clinical trials that its product candidates are safe and effective for use in a diverse population before it can seek marketing approvals for their commercial sale. Success in preclinical studies and early-stage clinical trials does not mean that future larger registration clinical trials will be successful. This is because product candidates in later-stage clinical trials may fail to demonstrate sufficient safety and efficacy to the satisfaction of the FDA, EMA, and other regulatory authorities despite having progressed through preclinical studies and early-stage clinical trials. In addition, the outcome of preclinical studies and early-stage clinical trials may not be predictive of the success of later-stage clinical trials. Liminatus does not

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know whether any clinical trials it may conduct will demonstrate consistent or adequate efficacy and safety results sufficient to obtain marketing approval to market its product candidates.

Summary or