Company: LIMN
Filing Date: 2025-06-24
Form Type: S-1
Source: 0001410578-25-001432
Chunk: 34

Company: Liminatus Pharma, Inc.
Filing Date: 2025-06-24
Form: S-1
Chunk 34
---
 databases, scientific literature, surveys of clinics, physician interviews, patient foundations, and market research, and they may prove to be incorrect. Further, new studies may change the estimated incidence or prevalence of these diseases. The number of patients may turn out to be lower than expected. Additionally, the potentially addressable patient population for its product candidates may be more limited than Liminatus originally estimated or may not be amenable to treatment with its product candidates, if and when approved. Even if Liminatus obtains significant market share for its product candidates, small potential target populations for certain indications means it may never achieve profitability without obtaining market approval for additional indications.

25

Many of Liminatus’s additional internal programs and our CD 47 immune checkpoint inhibitor are at early stages of development and may fail in development or suffer delays that adversely affect their commercial viability. All of Liminatus’s internal programs are in preclinical development or at the research stage and may fail in development or suffer delays that adversely affect their commercial viability. These programs may fail to yield product candidates. A product candidate can unexpectedly fail at any stage of preclinical and clinical development. The historical failure rate for product candidates is high due to risks relating to safety, efficacy, clinical execution, changing standards of medical care, and other unpredictable variables. The results from preclinical testing or early clinical trials of a product candidate may not be predictive of the results that will be obtained in later-stage clinical trials of the product candidate. The success of any product candidates Liminatus may develop will depend on many factors, including the following:

| ● | generating sufficient data to support the initiation or continuation of clinical trials; |

| ● | obtaining regulatory permission to initiate clinical trials; |

| ● | contracting with the necessary parties to conduct clinical trials; |

| ● | the successful enrollment of patients in, and the completion of, clinical trials; |

| ● | the timely manufacture of sufficient quantities of the product candidate, and any combination therapy, for use in clinical trials; and |

| ● | acceptable adverse profile in the clinical trials. |

Even if Liminatus successfully advances any other product candidates into clinical development, their success will be subject to all of the clinical, regulatory and commercial risks described elsewhere in this “ Risk Factors” section. Accordingly, Liminatus cannot assure you that it will ever develop, obtain regulatory approval of, commercialize, or generate significant revenue from any product candidate. Any product candidates Liminatus develops may become subject to unfavorable third-party reimbursement practices and pricing regulations. The availability and extent