Company: LIMN
Filing Date: 2025-06-02
Form Type: 8-K/A
Source: 0001104659-25-055078
Chunk: 12

Company: Liminatus Pharma, Inc.
Filing Date: 2025-06-02
Form: 8-K/A
Chunk 12
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| · | costs related to manufacturing material for preclinical studies and clinical trials, including fees paid 
 to contract manufacturing organizations;                                                                 |

| · | laboratory supplies and research materials; |

| · | costs related to compliance with regulatory requirements; and |

| · | allocated expenses for facilities, depreciation, and other allocated cost. |

Research and
development 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:

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

| · | the number of patients who enroll in each clinical trial; |

| · | the number of clinical trials required for approval; |

| · | the number of sites included in the clinical trials; |

| · | the countries in which the clinical trials are conducted; |

| · | the length of time required to enroll eligible patients; |

| · | the drop-out or discontinuation rates of patients; |

| · | potential additional safety monitoring requested by regulatory agencies; |

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

| · | the phase of development of the product candidate; |

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