Company: PTHS
Filing Date: 2025-05-09
Form Type: PREM14C
Source: 0001140361-25-018219
Chunk: 125

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-05-09
Form: PREM14C
Chunk 125
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 from trial protocols or drop out of a trial, or LNHC’s CROs may not perform in accordance with Good Clinical Practice (“GCP”) requirements or other application regulations; |

| • | LNHC’s future product candidates may have undesirable side effects or other unexpected characteristics, causing LNHC or its investigators, regulators or institutional review boards to suspend or terminate the trials; |

| • | LNHC’s third-party contractors may fail to comply with regulatory requirements or meet their contractual obligations to it in a timely manner, or at all; |

| • | regulatory authorities or institutional review boards may require that LNHC or its 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; |

| • | the cost of clinical trials of LNHC’s future product candidates may be greater than it anticipates; and |

| • | the supply or quality of its future product candidates or other materials necessary to conduct clinical trials of its product candidates may be insufficient or inadequate. |

Clinical trials must be conducted in accordance with the FDA and other applicable regulatory authorities’ legal requirements, regulations and guidelines, and remain subject to oversight by these governmental agencies and ethics committees or IRBs at the medical institutions where such clinical trials are conducted. LNHC could also encounter delays if a clinical trial was suspended or terminated by it, by the institutional review boards of the institutions in which such trials were being conducted, by the safety review committee for such trial or by the FDA or other regulatory authorities. Such authorities may impose such a suspension or termination due to a number of factors, including failure to conduct the clinical trial in accordance with regulatory requirements or LNHC’s clinical protocols, inspection of the clinical trial operations or trial site by the FDA or other regulatory authorities resulting in the imposition of a clinical hold, unforeseen safety issues or adverse side effects, failure to demonstrate a benefit from using a product, changes in governmental regulations or administrative actions or lack of adequate funding to continue the clinical trial. If LNHC experiences delays in the completion of, or termination of, any clinical trial of any potential future product candidates, the commercial prospects of such product candidates will be harmed, and its ability to generate product revenues from any of such product candidates will be delayed. In addition, any delays in completing its clinical trials will increase LNHC’s costs, slow down its product candidate development process and jeopardize its ability to commence product sales and generate revenues. Any of these occurrences may harm LNHC’s business, financial condition and