Company: LIMN
Filing Date: 2025-01-16
Form Type: POS AM
Source: 0001104659-25-003835
Chunk: 108

Company: Liminatus Pharma, Inc.
Filing Date: 2025-01-16
Form: POS AM
Chunk 108
---
 the product from the market. Liminatus cannot predict whether its product candidates will cause toxicities in humans that would preclude or lead to the revocation of regulatory approval based on preclinical studies or early-stage clinical testing.

If Liminatus experiences delays or difficulties in the enrollment of patients in clinical trials, its receipt of necessary marketing approvals could be delayed or prevented.

Liminatus may not initiate, continue or complete clinical trials for its product candidates if it is unable to locate and enroll a sufficient number of eligible patients to participate in these trials as required by the FDA, EMA, or comparable foreign regulatory authorities.

Patient enrollment is a significant factor in the timing of clinical trials, and Liminatus’s ability to enroll eligible patients may be limited or may result in slower enrollment than it anticipates. Patient enrollment may also be affected by other factors, including:

•

size and nature of the patient population;

•

severity of the disease under investigation;

•

availability and efficacy of approved drugs for the disease under investigation;

•

patient eligibility criteria for the trial in question;

•

efforts to facilitate timely enrollment in clinical trials;

•

patient referral practices of physicians;

•

clinicians’ and patients’ awareness of, and perceptions as to the potential advantages and risks of, Liminatus’s product candidates in relation to other available therapies, including any new drugs that may be approved for the indications it is investigating;

•

the ability to monitor patients adequately during and after treatment;

•

competing ongoing clinical trials for the same indications as Liminatus’s product candidates;

•

proximity and availability of clinical trial sites for prospective patients;

•

whether Liminatus becomes subject to a partial or full clinical hold on any of its clinical trials; and

<div align='center'>33</div>

TABLE OF CONTENTS

•

continued enrollment of prospective patients by clinical trial sites, including delays due to pandemics, wars etc. that can impact patient willingness to participate and travel for investigative therapy and reductions in clinical trial site staff and services.

Liminatus’s inability to enroll a sufficient number of patients for its clinical trials would result in significant delays or may require it to abandon one or more of its clinical trials altogether. Enrollment delays in Liminatus’s clinical trials may result in increased development costs for its product candidates and jeopardize its ability to obtain marketing approval for the sale of its product candidates.

The clinical trials of Liminatus’s current and any future product candidates may not demonstrate safety and efficacy to the satisfaction of regulatory authorities or otherwise be timely conducted or produce positive results.

Before