Company: LIMN
Filing Date: 2025-06-24
Form Type: S-1
Source: 0001410578-25-001432
Chunk: 28

Company: Liminatus Pharma, Inc.
Filing Date: 2025-06-24
Form: S-1
Chunk 28
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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 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