Company: LIMN
Filing Date: 2025-02-07
Form Type: 424B3
Source: 0001104659-25-010605
Chunk: 364

Company: Liminatus Pharma, Inc.
Filing Date: 2025-02-07
Form: 424B3
Chunk 364
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 activities are central to our business model. Product candidates in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials. We plan to substantially increase our research and development expenses for the foreseeable future as we develop our product candidates and manufacturing processes and conduct discovery and research activities for our preclinical and clinical programs. We cannot determine with certainty the timing of initiation, the duration or the completion costs of current or future preclinical studies and clinical trials of our product candidate due to the inherently unpredictable nature of preclinical and clinical development. Clinical and preclinical development timelines, the probability of success and development costs can differ materially from expectations. We anticipate that we will make determinations as to how we pursue our product candidate and how much funding to direct to each program on an ongoing basis in response to the results of future preclinical studies and clinical trials, regulatory developments and our ongoing assessments as to commercial potential. We will need to raise substantial additional capital in the future. Our clinical development costs are expected to increase significantly as we commence, continue and expand our clinical trials. Our future expenses may vary significantly each period based on factors such as:

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per patient clinical trial costs, including based on the number of doses that patients receive;

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the number of patients who enroll in each clinical trial;

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the number of clinical trials required for approval;

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the number of sites included in the clinical trials;

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the countries in which the clinical trials are conducted;

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the length of time required to enroll eligible patients;

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the drop-out or discontinuation rates of patients;

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potential additional safety monitoring requested by regulatory agencies;

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the duration of patient participation in the clinical trials and follow-up;

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the phase of development of the product candidate;

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third party contractors failing to comply with regulatory requirements or meet their contractual obligations to us in a timely manner, or at all;

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the cost of insurance, including product liability insurance, in connection with clinical trials;

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regulators or institutional review boards requiring that we or our investigators suspend or terminate clinical development for various reasons, including noncompliance with regulatory requirements or a finding that the participants are being exposed to unacceptable health risks; and

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the efficacy and safety profile of our product candidates.

General and Administrative Expenses

General and administrative expenses currently consist of consulting fees for the chief executive officer and professional fees for legal costs relating to our corporate matters, accounting and tax services and travel