Company: LIMN
Filing Date: 2025-07-28
Form Type: S-1/A
Source: 0001410578-25-001518
Chunk: 29

Company: Liminatus Pharma, Inc.
Filing Date: 2025-07-28
Form: S-1/A
Chunk 29
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 facilitate timely enrollment in clinical trials; |

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| ● | patient referral practices of physicians; |

| ● | clinicians’ and patients’ awareness of, and perceptions as to the potential advantages and risks of, Liminatus’s product candidates in relation to other available therapies, including any new drugs that may be approved for the indications it is investigating; |

| ● | the ability to monitor patients adequately during and after treatment; |

| ● | competing ongoing clinical trials for the same indications as Liminatus’s product candidates; |

| ● | proximity and availability of clinical trial sites for prospective patients; |

| ● | whether Liminatus becomes subject to a partial or full clinical hold on any of its clinical trials; and continued enrollment of prospective patients by clinical trial sites, including delays due to pandemics, wars etc. that can impact patient willingness to participate and travel for investigative therapy and reductions in clinical trial site staff and services. |

Liminatus’s inability to enroll a sufficient number of patients for its clinical trials would result in significant delays or may require it 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