Company: LIMN
Filing Date: 2025-08-13
Form Type: 424B3
Source: 0001410578-25-001746
Chunk: 82

Company: Liminatus Pharma, Inc.
Filing Date: 2025-08-13
Form: 424B3
Chunk 82
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apeutics is complex. It is anticipated that during development from early clinical trials to commercialization that changes to the manufacturing process or analytical methods will occur. These changes carry the risk that the intended goals of such changes are not achievable and that further development work may be needed to reach these goals, which may delay Liminatus’s ability to meet clinical or commercial supply needs. If Liminatus were to experience an unexpected loss of supply of its product candidates for any reason, whether as a result of manufacturing, supply, or storage issues or otherwise, Liminatus could experience delays, disruptions, suspensions or terminations of, or be required to restart or repeat, any pending or ongoing clinical trials. Replacement of Liminatus’s current manufacturers for each product would likely result in substantial delay and could interrupt Liminatus’s clinical trials if Liminatus had not previously obtained enough supply of its product candidates. Liminatus expects to continue to rely on third-party manufacturers for the commercial supply of any of its product candidates for which Liminatus obtains marketing approval. Liminatus may be unable to maintain or establish required agreements with third-party manufacturers or to do so on acceptable terms. Even if Liminatus is able to establish agreements with third-party manufacturers, reliance on third-party manufacturers entails additional risks, including:

| ● | the possible failure of the third party to manufacture Liminatus’s product candidates according to its specifications; |

| ● | the possible failure of the third party to manufacture Liminatus’s product candidates according to Liminatus’s schedule, or at all, including if Liminatus’s third-party contractors give greater priority to the supply of other products over Liminatus’s |

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| product candidates or otherwise do not satisfactorily perform according to the terms of the agreements between Liminatus and them; |

| ● | the possible failure of Liminatus’s third-party manufacturer to procure raw materials from third-party suppliers and potential exposure to supply chain issues impacting delivery dates, quality, quantity and pricing of; |

| ● | raw materials, which may result in additional costs and delays in production of clinical trial materials, commercial product and regulatory approvals; |

| ● | the possible termination or nonrenewal of agreements by Liminatus’s third-party contractors at a time that is costly or inconvenient for Liminatus; |

| ● | the possible breach by the third-party contractors of Liminatus’s agreements with them; |

| ● | the failure of third-party contractors to comply with applicable regulatory requirements; |

| ● |