Company: PTHS
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001753926-25-000503
Chunk: 270

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1A
Chunk 270
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 of information obtained during clinical
trials or interactions with the FDA or other regulatory authorities, which could result in criminal and civil penalties or sanctions
and cause serious harm to our reputation. It is not always possible to identify and deter employee misconduct, and the precautions
we take to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or in protecting
us from government investigations or other actions or lawsuits stemming from a failure to comply with these laws or regulations.
If any such actions are instituted against us and we are not successful in defending ourselves or asserting our rights, those
actions could have a significant impact on our business, financial condition, results of operations and prospects, including the
imposition of significant fines, criminal penalties, or other sanctions.

47 

In
addition, principal investigators for our clinical trials may serve as scientific advisors or consultants to us from time to time
and receive compensation in connection with such services. Under certain circumstances, we may be required to report some of these
relationships to the FDA. The FDA may conclude that a financial relationship between us and a principal investigator has created
a conflict of interest or otherwise affected interpretation of the trial. The FDA may therefore question the integrity of the
data generated at the applicable clinical trial site and the utility of the clinical trial itself may be jeopardized. This could
result in a delay in approval, or rejection, of our marketing applications by the FDA and may ultimately lead to the denial of
marketing approval of our current and future drug candidates.

We
may be subject, directly or indirectly, to federal and state healthcare fraud and abuse laws, false claims laws and health information
privacy and security laws. If we are unable to comply, or have not fully complied, with such laws, we could face substantial penalties.

If
we obtain FDA approvals for CC8464, CT2000 and CT3000 and begin commercializing them in the United States, our operations will
be directly, or indirectly through our prescribers, customers and purchasers, subject to various federal and state fraud and abuse
laws and regulations, including, without limitation, the federal Anti-Kickback Statute, federal civil and criminal false claims
laws and the Physician Payments Sunshine Act and regulations. These laws will impact, among other things, our proposed sales,
marketing and educational programs. In addition, we may be subject to patient privacy laws by both the federal government and
the states in which we conduct our business as well as other jurisdictions. The laws that