Company: LIMN
Filing Date: 2025-02-07
Form Type: 424B3
Source: 0001104659-25-010605
Chunk: 103

Company: Liminatus Pharma, Inc.
Filing Date: 2025-02-07
Form: 424B3
Chunk 103
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the maintenance of existing or the establishment of new supply arrangements with third-party drug product suppliers and manufacturers;

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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;

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

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

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successful launch of commercial sales following any marketing approval;

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a continued acceptable safety profile following any marketing approval;

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

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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 early stages of developments, there is a high risk of failure and Liminatus may never succeed in developing marketable products.

The results of preclinical studies may not be predictive of the results of clinical trials of Liminatus’s product candidates. Moreover, the results of early clinical trials may not be predictive of the results of later-stage clinical trials. Although product candidates may demonstrate promising results in preclinical studies and early clinical trials, they may not prove to be safe or effective in subsequent clinical trials. Favorable results from certain animal studies may not accurately predict the results of other