Company: LIMN
Filing Date: 2025-07-28
Form Type: S-1/A
Source: 0001410578-25-001518
Chunk: 30

Company: Liminatus Pharma, Inc.
Filing Date: 2025-07-28
Form: S-1/A
Chunk 30
---
 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 |

21

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

Liminatus may experience numerous unforeseen events during, or as a result of, clinical trials that could delay or prevent receipt of marketing approval or its ability to commercialize its product candidates, including:

| ● | receipt of feedback from regulatory authorities that requires Liminatus to modify the design of its clinical trials; |

| ● | negative or inconclusive clinical trial results that may require Liminatus to conduct additional clinical trials or abandon certain drug development programs; |

| ● | regulators or IRBs may not authorize Liminatus, its collaborators, or its investigators to commence a clinical trial or to conduct a clinical trial at a prospective site; |

| ● | the number of patients required for clinical trials being larger than anticipated, enrollment in these clinical trials being slower than anticipated, or participants dropping out of these clinical trials at a higher rate than anticipated; |

| ● | third-party contractors failing to comply with regulatory requirements or meet their contractual obligations to Liminatus in a timely manner, or at all; |

| ● | the suspension or termination of Liminatus’ clinical trials for various reasons, including non-compliance with regulatory requirements, a finding that Liminatus’s product candidates have undesirable side effects, safety or efficacy concerns, or any particular combination therapy or other unexpected characteristics or risks; |

| ● | the cost of clinical trials of Liminatus’s product candidates being greater than anticipated; |

| ● | for clinical trials testing combination treatment of Liminatus’s product candidates with