Company: PTHS
Filing Date: 2025-05-09
Form Type: PREM14C
Source: 0001140361-25-018219
Chunk: 135

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-05-09
Form: PREM14C
Chunk 135
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 FDA or other such regulatory authorities to timely review and process LNHC’s regulatory submissions, which could have a material adverse effect on LNHC’s business.

**Risks Related to LNHC’s Dependence on Third Parties**

**LNHC will rely on third parties to conduct any preclinical studies and clinical trials. If these third parties do not successfully carry out their contractual duties or meet expected deadlines, LNHC may be unable to obtain regulatory approval for or commercialize any of its future product candidates.

LNHC currently does not have the ability to independently conduct preclinical studies that comply with the regulatory requirements known as good laboratory practice (“GLP”), requirements. It also does not currently have the ability to independently conduct any clinical trials. The FDA and regulatory authorities in other jurisdictions require LNHC to comply with regulations and standards, commonly referred to as GCPs for conducting, monitoring, recording and reporting the results of clinical trials, in order to ensure that the data and results are scientifically credible and accurate and that the trial subjects are adequately informed of the potential risks of participating in clinical trials. LNHC will be required to rely on medical institutions, clinical investigators, contract laboratories and other third parties, such as CROs, to conduct GLP-compliant preclinical studies and GCP-compliant clinical trials on any future product candidates properly and on time. While LNHC will have agreements governing their activities, LNHC will control only certain aspects of their activities and will have limited influence over their actual performance. The third parties with whom LNHC may contract for execution of its GLP preclinical studies and its GCP clinical trials play a significant role in the conduct of these studies and trials and the subsequent collection and analysis of data. These third parties will not be LNHC’s employees and, except for restrictions imposed by its contracts with such third parties, it will have limited ability to control the amount or timing of resources that they devote to LNHC’s programs. Although LNHC plans to rely on these third parties to conduct GLP-compliant preclinical studies and GCP-compliant clinical trials, LNHC will remain responsible for ensuring that each of these studies and clinical trials is conducted in accordance with its investigational plan and protocol and applicable laws and regulations, and its reliance on the third parties will not relieve it of its regulatory responsibilities. In addition, if any of LNHC’s third parties terminate their involvement with LNHC for any reason, LNHC may not be able to enter into similar arrangements with alternative third parties within a short period of time or do so on commercially