Company: LIMN
Filing Date: 2025-06-24
Form Type: S-1
Source: 0001410578-25-001432
Chunk: 21

Company: Liminatus Pharma, Inc.
Filing Date: 2025-06-24
Form: S-1
Chunk 21
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, Development, and Commercialization of Liminatus’s Product Candidates Liminatus is dependent on the success of its product candidates. If Liminatus is unable to obtain approval for and commercialize its product candidates for one or more indications in a timely manner, its business will be materially harmed. Liminatus’s success is dependent on its ability to timely complete clinical trials and obtain marketing approval for, and then successfully commercialize, its product candidates for one or more indications. Liminatus’s product candidate is in the early stages of development and Liminatus is investing the majority of its efforts and financial resources in the research and development of its CD47 immune checkpoint inhibitor, both directly through its own efforts and indirectly through clinical collaboration arrangements, including investigator- and cooperative group-sponsored trials (“ISTs”). Liminatus’s product candidate will require additional clinical development, preclinical and manufacturing activities, marketing approval from government regulators, substantial investment, and significant marketing efforts before it generates any revenue from licensing arrangements. Liminatus is not permitted to market or promote any product candidates, in a jurisdiction before receiving marketing approval from the relevant regulatory authority, including, for example, the FDA for marketing in the United States and the European Medicines Agency (“EMA”) for marketing in the European Union, and it may never receive such marketing approvals.

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The success of Liminatus’s product candidate will depend on numerous factors, including the following:

| ● | successful and timely completion of its ongoing preclinical studies; |

| ● | initiation and successful patient enrollment and completion of clinical trials on a timely basis; |

| ● | efficacy, safety and tolerability profiles that are satisfactory to the FDA, EMA or any comparable foreign regulatory authority for marketing approval; |

| ● | raising additional funds necessary to complete the clinical development of and to commercialize product candidates; |

| ● | timely receipt of marketing approvals for product candidates from applicable regulatory authorities; |

| ● | the extent of any required post-marketing approval commitments to applicable regulatory authorities; |

| ● | the maintenance of existing or the establishment of new supply arrangements with third-party drug product suppliers and manufacturers; |

| ● | the maintenance of existing or the establishment of new scaled production arrangements with third-party manufacturers to obtain finished products that are appropriately packaged for sale; |

| ● | obtaining and maintaining patent protection, trade secret protection and regulatory exclusivity, both in the United States and internationally; |

| ● | protection of Liminatus’s rights in its intellectual property portfolio, including its licensed intellectual property; |

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