Company: PTHS
Filing Date: 2025-05-27
Form Type: DEFM14C
Source: 0001140361-25-020509
Chunk: 124

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-05-27
Form: DEFM14C
Chunk 124
---
 clinical trials, and interim results of a clinical trial do not necessarily predict final results. Moreover, preclinical and clinical data are often susceptible to varying interpretations and analyses, and many companies that have believed their product candidates performed satisfactorily in preclinical studies and clinical trials have nonetheless failed to obtain regulatory approval of their products. LNHC cannot assure you that any clinical trial that it may conduct in the future will demonstrate consistent or adequate efficacy and safety to obtain regulatory approval to market any product candidate. LNHC also does not know whether future clinical trials, if any, will begin on time, need to be redesigned, enroll an adequate number of patients on time or be completed on schedule, if at all. It may experience numerous unforeseen events during or as a result of clinical trials that could delay or prevent its ability to receive regulatory approval or commercialize LNHC’s future product candidates, including:

| • | inability to generate sufficient preclinical, toxicology, or other in vivo or in vitro data to support the initiation or continuation of clinical trials; |

| • | LNHC may be unable to reach consensus with regulatory authorities on trial design; |

| • | Regulatory authorities or institutional review boards may not allow or authorize LNHC or its investigators to commence a clinical trial or conduct a clinical trial at a prospective trial site; |

| • | LNHC may experience delays in reaching, or failing to reach, agreement on acceptable clinical trial contracts or clinical trial protocols with prospective trial sites or prospective contract research organizations (“CROs”), the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites; |

| • | LNHC may experience delays in identifying, recruiting and training suitable clinical trial investigators; |

| • | clinical trials may produce negative or inconclusive results, including failure to demonstrate statistical significance, and LNHC may decide, or regulators may require it, to conduct additional clinical trials or abandon product development programs; |

| • | the number of patients required for clinical trials may be larger than LNHC anticipates, enrollment in such clinical trials may be slower than anticipated, or participants may drop out of such clinical trials or fail to return for post-treatment follow-up at a higher rate than anticipated; |

| • | LNHC may be required to amend clinical trial protocols; |

| • | clinical trial sites may deviate 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; |