Company: LIMN
Filing Date: 2025-06-24
Form Type: S-1
Source: 0001410578-25-001432
Chunk: 27

Company: Liminatus Pharma, Inc.
Filing Date: 2025-06-24
Form: S-1
Chunk 27
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 to abandon one or more of its clinical trials altogether. Enrollment delays in Liminatus’s clinical trials may result in increased development costs for its product candidates and jeopardize its ability to obtain marketing approval for the sale of its product candidates. The clinical trials of Liminatus’s current and any future product candidates may not demonstrate safety and efficacy to the satisfaction of regulatory authorities or otherwise be timely conducted or produce positive results. Before obtaining marketing approval from regulatory authorities for the sale of its product candidates, Liminatus must complete preclinical development and then conduct extensive clinical trials to demonstrate the safety and efficacy of its product candidates. Clinical testing is expensive, difficult to design and implement, can take many years to complete, and its ultimate outcome is uncertain. A failure of one or more clinical trials can occur at any stage of the process. The outcome of preclinical studies and early-stage clinical trials may not be predictive of the success of later clinical trials. Moreover, preclinical and clinical data are often susceptible to varying interpretations and analyses, and many companies that have believed their product candidates performed satisfactorily in preclinical studies and clinical trials have nonetheless failed to obtain marketing approval of their drugs. Liminatus does not know whether its future clinical trials will begin on time or enroll patients on time, or whether its ongoing and/or future clinical trials will be completed on schedule or at all. Clinical trials can be delayed for a variety of reasons, including delays related to:

| ● | obtaining regulatory approval to commence a trial; |

| ● | delays in reaching, or the inability to reach, agreement on acceptable terms with prospective CROs, clinical trial sites, laboratory service providers, companion diagnostic development partners, contract manufacturing organizations (CMOs), and other service providers Liminatus may engage to support the conduct of its clinical trials; |

| ● | obtaining IRB approval at each clinical trial site; |

| ● | recruiting a sufficient number of suitable patients to participate in a trial; |

| ● | patients failing to comply with trial protocol or dropping out of a trial, rendering them not evaluable for study endpoints; |

| ● | clinical trial sites deviating from trial protocol or dropping out of a trial; |

| ● | the availability of any applicable combination therapies; |

| ● | developments in the safety and efficacy of any applicable combination therapies; |

| ● | the need to add new clinical trial sites; or |

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| ● | delays in the testing, validation and manufacturing of product candidates and the delivery of these product candidates to clinical trial sites. |