Company: LIMN
Filing Date: 2025-07-28
Form Type: S-1/A
Source: 0001410578-25-001518
Chunk: 44

Company: Liminatus Pharma, Inc.
Filing Date: 2025-07-28
Form: S-1/A
Chunk 44
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 may seek to develop in the future will ever obtain regulatory approval.

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Applications for Liminatus’s product candidates could fail to receive regulatory approval in an initial or subsequent indication for many reasons, including the following:

| ● | the FDA, EMA, or comparable foreign regulatory authorities may disagree with the design, implementation, or results of Liminatus’s clinical trials; |

| ● | the FDA, EMA, or comparable foreign regulatory authorities may determine that Liminatus’s product candidates are not safe and effective, only moderately effective, or have undesirable or unintended side effects, toxicities, or other characteristics that preclude it obtaining marketing approval or prevent or limit commercial use; |

| ● | the population studied in the clinical program may not be sufficiently broad or representative to assure safety and efficacy in the full population for which Liminatus seeks approval, including, for example, due to biologic and genetic differences that might occur in subjects in certain populations such as defined by race or other factors; |

| ● | Liminatus may be unable to demonstrate to the FDA, EMA, or comparable foreign regulatory authorities that a product candidate’s risk-benefit ratio when compared to the standard of care is acceptable; |

| ● | the FDA, EMA, or comparable foreign regulatory authorities may disagree with Liminatus’s interpretation of data from preclinical studies or clinical trials; |

| ● | the data collected from clinical trials of Liminatus’s product candidates may not be sufficient to support the submission of a Biologics License Application (“BLA”), New Drug Application (“NDA”), or other submission or to obtain regulatory approval in the United States or elsewhere; |

| ● | Liminatus may be unable to demonstrate to the FDA, EMA, or comparable foreign regulatory authorities that a product candidate’s risk-benefit ratio for a proposed indication is acceptable; |

| ● | the FDA, EMA, or comparable foreign regulatory authorities may fail to approve the manufacturing processes, test procedures and specifications, or facilities of third-party manufacturers with which Liminatus contracts for clinical and commercial supplies; and |

| ● | the approval policies or regulations of the FDA, EMA, or comparable foreign regulatory authorities may significantly change in a manner rendering Liminatus’s clinical data insufficient for approval. |

Further, development of Liminatus’s product candidates and/or regulatory approval may be delayed for reasons beyond its control. For example, a U.S. federal government shutdown, such as one that occurred during from December 2018 to January 2019,