Company: LIMN
Filing Date: 2025-02-07
Form Type: 424B3
Source: 0001104659-25-010605
Chunk: 114

Company: Liminatus Pharma, Inc.
Filing Date: 2025-02-07
Form: 424B3
Chunk 114
---
 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.

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

<div align='center'>37</div>

TABLE OF CONTENTS

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 coverage and adequate reimbursement and pricing by third parties and government authorities;

•

relative convenience and ease of administration;

•

the effectiveness of sales and marketing efforts;

•

the willingness of the target population to try new therapies and of physicians to prescribe these therapies; and

•

unfavorable publicity relating to the product candidate.

If any product candidate is approved but does not achieve an adequate level of acceptance by physicians, hospitals, healthcare payors, and patients, Liminatus may generate less revenue from that product candidate than anticipated, which could harm its financial results.

The sizes of the patient populations suffering from some of the diseases Liminatus is targeting may be based on estimates that are inaccurate, may be small, or may be smaller than estimated.

Liminatus relies on estimates to project the incidence and prevalence of diseases