Company: PTHS
Filing Date: 2025-09-16
Form Type: 8-K/A
Source: 0001753926-25-001500
Chunk: 52

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-09-16
Form: 8-K/A
Chunk 52
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 requirements. We also do not currently
have the ability to conduct any clinical trials in-house. The FDA and regulatory authorities in other jurisdictions require us
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. We 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 we will have
agreements governing our activities, we will control only certain aspects of our activities and will have limited influence over
their actual performance. The third parties with whom we may contract for execution of our GLP preclinical studies and our 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 our employees and, except for restrictions imposed by our contracts with such third parties,
we will have limited ability to control the amount or timing of resources that they devote to our programs. Although we plan to
rely on these third parties to conduct GLP-compliant preclinical studies and GCP-compliant clinical trials, we will remain responsible
for ensuring that each of these studies and clinical trials is conducted in accordance with our investigational plan and protocol
and applicable laws and regulations, and our reliance on the third parties will not relieve us of our regulatory responsibilities.
In addition, if any of our third parties terminate their involvement with us for any reason, we may not be able to enter into similar
arrangements with alternative third parties within a short period of time or do so on commercially reasonable terms.

Many of the third parties with whom we may contract may also have relationships with other commercial entities, including our competitors, for whom they may also be conducting clinical trials or other drug development activities that could harm our competitive position. If the third parties conducting our preclinical studies or clinical trials do not perform their contractual duties or obligations, experience work stoppages, do not meet expected deadlines, terminate their agreements with us or need to be replaced, or if the quality or accuracy of the clinical data they obtain is compromised due to their failure to adhere to our clinical trial protocols, GLPs or GCPs, or