Company: PTHS
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001753926-25-000503
Chunk: 81

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 81
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conduct by these
parties could include intentional failures to comply with FDA regulations or the regulations applicable in the European Union
and other jurisdictions, provide accurate information to the FDA, the EMA and other regulatory authorities, comply with healthcare
fraud and abuse laws and regulations in the United States and abroad, report financial information or data accurately or disclose
unauthorized activities to us. Sales, marketing and business arrangements in the healthcare industry are subject to extensive
laws and regulations intended to prevent fraud, misconduct, kickbacks, self-dealing and other abusive practices. These laws and
regulations restrict or prohibit a wide range of pricing, discounting, marketing and promotion, sales commission, customer incentive
programs and other business arrangements. Such misconduct also could involve the improper use 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