Company: LIMN
Filing Date: 2025-07-28
Form Type: S-1/A
Source: 0001410578-25-001518
Chunk: 86

Company: Liminatus Pharma, Inc.
Filing Date: 2025-07-28
Form: S-1/A
Chunk 86
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 successfully manufacture material that conforms to Liminatus’s specifications and the strict regulatory requirements of the FDA, EMA, or others, they will not secure and/or maintain marketing approval for their manufacturing facilities. In addition, Liminatus does not have control over the ability of its contract manufacturers to maintain adequate quality control, quality assurance, and qualified personnel. If the FDA, EMA or a comparable foreign regulatory authority does not approve these facilities for the manufacture of Liminatus’s product candidates or if it withdraws any such approval in the future, Liminatus may need to find alternative manufacturing facilities, which would significantly impact Liminatus’s ability to develop, obtain marketing approval for, or market Liminatus’s product candidates, if approved. Liminatus’s failure, or the failure of its third-party manufacturers, to comply with applicable regulations could result in sanctions being imposed on Liminatus, including fines, injunctions, civil penalties, delays, suspension or withdrawal of approvals, license revocation, seizures or recalls of product candidates or drugs, operating restrictions, and criminal prosecutions, any of which could significantly and adversely affect supplies of Liminatus’s drugs and harm its business and results of operations. Liminatus’s current and anticipated future dependence upon others for the manufacture of its product candidates or drugs may adversely affect its future profit margins and its ability to commercialize any drugs that receive marketing approval on a timely and competitive basis. Liminatus may not gain the efficiencies it expects from further scale-up of manufacturing of its product candidates, and Liminatus’s third-party manufacturers may be unable to successfully scale up manufacturing in sufficient quality and quantity for Liminatus’s product candidates, which could delay or prevent the conducting of Liminatus’s clinical trials or the development or commercialization of Liminatus’s other product candidates. Liminatus expects that third-party manufacturers will manufacture Liminatus’s product candidates at a scale and on a timeline that is sufficient for Liminatus to conduct its future clinical trials and, if Liminatus receives marketing approval, to commercialize Liminatus’s product candidates for the indications Liminatus is currently targeting. However, Liminatus may consider increasing the batch scale to gain cost efficiencies. If Liminatus’s current manufacturer or any other manufacturer Liminatus uses is unable to scale-up the manufacture of Liminatus’s product candidates at such time, Liminatus may not gain such cost efficiencies and may not realize the

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benefits that would typically be expected from further scale-up of manufacturing. In