Company: LIMN
Filing Date: 2025-01-16
Form Type: POS AM
Source: 0001104659-25-003835
Chunk: 121

Company: Liminatus Pharma, Inc.
Filing Date: 2025-01-16
Form: POS AM
Chunk 121
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 still need to meet regulatory approval requirements for the combined therapy to become commercially available. In addition, if the standard of care were to evolve or change, the clinical utility of Liminatus’s product candidates could be diminished or eliminated. If any of these were to occur, Liminatus’s business could be materially harmed.

Liminatus may use companion diagnostics in the future in its development programs, and if such companion diagnostics for its product candidates are not successfully, and in a timely manner, validated, developed, or approved, Liminatus may not achieve marketing approval or realize the full commercial potential of its product candidates.

Liminatus may use companion diagnostics in its future product candidate development programs. If such companion diagnostics are developed in conjunction with clinical programs, the FDA, EMA, or

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comparable regulatory authority may require regulatory approval of a companion diagnostic as a condition to approval of the product candidate. For example, if Liminatus uses a diagnostic to test which patients are most likely to benefit from its product candidate for the treatment of a particular indication as a criterion for enrollment, then it will likely be required to obtain FDA approval or clearance of the companion diagnostic, concurrent with approval of its product candidate. Liminatus may also be required to demonstrate to the FDA the predictive utility of a companion diagnostic, i.e. , that the diagnostic selects for patients in whom the therapy will be effective or more effective compared to patients not selected for by the diagnostic. Liminatus does not have experience or capabilities in developing or commercializing diagnostics and plan to rely in large part on third parties to perform these functions. Liminatus does not currently have any agreement in place with any third party to develop or commercialize companion diagnostics for any of its product candidates. Companion diagnostics are subject to regulation by the FDA, the EMA, and other foreign regulatory authorities as medical devices and require separate regulatory approval or clearance prior to commercialization.

If Liminatus or its partners, or any third party, are unable to successfully develop companion diagnostics in the future in its product candidates, or experience delays in doing so:

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the development of Liminatus’s product candidates may be adversely affected if it is unable to appropriately select patients for enrollment in its planned clinical trials;

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Liminatus’s product candidates may not receive marketing approval if their safe and effective use depends on a companion diagnostic; and

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Liminatus may not realize the full commercial potential of any product candidates that receive marketing approval if, among