Company: LIMN
Filing Date: 2025-01-27
Form Type: POS AM
Source: 0001104659-25-006325
Chunk: 164

Company: Liminatus Pharma, Inc.
Filing Date: 2025-01-27
Form: POS AM
Chunk 164
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atus with information about the ongoing clinical trials on a timely basis. The third parties may also violate the terms of the agreements governing such clinical trials in various ways, including asserting intellectual property rights that contractually belong to Liminatus. Some of these third parties may terminate their engagements with Liminatus at any time. If Liminatus needs to enter into alternative arrangements, it would delay Liminatus’s drug development activities.

Liminatus’s reliance on these third parties for research and development activities will reduce Liminatus’s control over these activities but will not relieve Liminatus of its regulatory responsibilities. For example, Liminatus will remain responsible for ensuring that each of its clinical trials is conducted in accordance with the general investigational plan and protocols for the trial. Moreover, the FDA requires Liminatus to comply with GCP standards, regulations for conducting, recording and reporting the results of clinical trials to assure that data and reported results are credible and accurate and that the rights, integrity, and confidentiality of trial participants are protected. The EMA also requires Liminatus to comply with similar standards. Regulatory authorities enforce these GCP requirements through periodic inspections of trial sponsors, principal investigators, and trial sites. If Liminatus or any of its CROs fail to comply with applicable GCP requirements, the clinical data generated in Liminatus’s clinical trials may be deemed unreliable and the FDA, EMA, or comparable foreign regulatory authorities may require Liminatus to perform additional clinical trials before approving its marketing applications. Liminatus cannot assure you that upon inspection by a given regulatory authority, such regulatory authority will determine that any of Liminatus’s clinical trials comply with GCP regulations. In addition, Liminatus’s clinical trials must be conducted with product produced under current GMP regulations. Liminatus’s failure or the failure of the third parties Liminatus engages to comply with these regulations may require Liminatus to repeat clinical trials, which would delay the marketing approval process. Liminatus also is required to register certain ongoing clinical trials and post the results of certain completed clinical trials on a government-sponsored database, ClinicalTrials.gov, within certain timeframes. Failure to do so can result in delays in being permitted to initiate patient recruitment at some trial sites, slowing the delivery of clinical trial data, which can lead to sanctions from scientific journals in which Liminatus would seek to publish its study results.

The third parties Liminatus relies on for these services may also have relationships with other entities, some of which may be Limin