Company: LIMN
Filing Date: 2025-07-28
Form Type: S-1/A
Source: 0001410578-25-001518
Chunk: 35

Company: Liminatus Pharma, Inc.
Filing Date: 2025-07-28
Form: S-1/A
Chunk 35
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 or other comparable regulatory authorities may fail to approve companion diagnostic tests required for Liminatus’s product candidates; and |

| ● | the approval policies or regulations of the FDA, EMA or other comparable foreign regulatory authorities may significantly change in a manner rendering Liminatus’s clinical data insufficient for approval. |

This lengthy approval process, as well as the unpredictability of the results of clinical trials, may result in Liminatus failing to obtain regulatory approval to market any of its product candidates, which would significantly harm its business, results of operations and prospects. Liminatus is also subject to numerous foreign regulatory requirements governing, among other things, the conduct of clinical trials, manufacturing and marketing authorization, pricing and third-party reimbursement. The foreign regulatory approval process varies among countries, and generally includes all of the risks associated with FDA approval described above as well as risks attributable to the satisfaction of local regulations in foreign jurisdictions. Moreover, the time required to obtain approval may differ from that required to obtain FDA approval.

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Liminatus’s product candidates may not achieve adequate market acceptance among physicians, patients, healthcare payors, and others in the medical community necessary for commercial success. Even if Liminatus’s product candidates receive regulatory approval, they may not gain adequate market acceptance among physicians, patients, healthcare payors, and others in the medical community. For example, current standard-of-care cancer treatments, such as existing chemotherapy and radiation therapy, are well established in the medical community, and doctors may continue to rely on these treatments. The degree of market acceptance of any of Liminatus’s approved product candidates, if approved for commercial sale, will depend on a number of factors, including:

| ● | the efficacy and safety profile as demonstrated in clinical trials; |

| ● | the timing of market introduction of the product candidate as well as competitive products; |

| ● | the approval of other new therapies for the same indications; |

| ● | the clinical indications for which the product candidate is approved; |

| ● | restrictions on the use of Liminatus’s products, if approved, such as boxed warnings, contraindications in labeling, or restrictions on use of Liminatus’s products together with other medications, or a risk evaluation and mitigation strategy (REMS), if any, which may not be required of alternative treatments and competitor products; |

| ● | the potential and perceived advantages of product candidates over alternative treatments or in combination therapies; |

| ● | the cost of treatment in relation to alternative treatments; |

| ● | the availability of