Company: LIMN
Filing Date: 2025-07-28
Form Type: S-1/A
Source: 0001410578-25-001518
Chunk: 24

Company: Liminatus Pharma, Inc.
Filing Date: 2025-07-28
Form: S-1/A
Chunk 24
---
; |

| ● | 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; |

| ● | successful launch of commercial sales following any marketing approval; |

| ● | a continued acceptable safety profile following any marketing approval; |

| ● | commercial acceptance by patients, the medical community, and third-party payors; and |

| ● | Liminatus’s ability to compete with other therapies. |

Liminatus does not have complete control over many of these factors, including certain aspects of clinical development and the regulatory submission process, including trial design, implementation, and timely provision of data in its collaboration based clinical trials and ISTs; potential threats to its intellectual property rights; and the manufacturing, marketing, distribution, and sales efforts of any future collaborator. If Liminatus is unable to achieve one or more of the objectives set forth above, its business will be materially harmed. The outcome of preclinical testing and early clinical trials may not be predictive of the success of later clinical trials, and the results of Liminatus’s clinical trials may not satisfy the requirements of the FDA, EMA or other comparable foreign regulatory authorities. Liminatus will be required to demonstrate with substantial evidence through well-controlled clinical trials that its product candidates are safe and effective for use in a diverse population before it can seek marketing approvals for their commercial sale. Preclinical and clinical testing is expensive and can take many years to complete, and its outcome is inherently uncertain. Failure can occur at any time during the preclinical study and clinical trial processes, and, because Liminatus’s product candidates are in