Company: PTHS
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001753926-25-000503
Chunk: 84

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 84
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 restructuring of our operations, any of which could adversely affect
our ability to operate our business and our results of operations.

Efforts
to ensure that our business arrangements with third parties will comply with applicable healthcare laws and regulations will involve
substantial costs. It is possible that governmental authorities will conclude that our business practices may not comply with
current or future statutes, regulations or case law involving applicable fraud and abuse or other healthcare laws and regulations.
If our operations are found to be in violation of any of these laws or any other governmental regulations that may apply to us,
we may be subject to significant civil, criminal and administrative penalties, damages, fines, imprisonment, exclusion of products
from government funded healthcare programs, such as Medicare and Medicaid, and the curtailment or restructuring of our operations.

The
risk of our being found in violation of these laws is increased by the fact that many of them have not been fully interpreted
by the regulatory authorities or the courts, and their provisions are open to a variety of interpretations. Any action against
us for violation of these laws, even if we successfully defend against it, could cause us to incur significant legal expenses
and divert our management’s attention from the operation of our business. The shifting compliance environment and the need
to build and maintain a robust and expandable systems to comply with multiple jurisdictions with different compliance and/or reporting
requirements increases the possibility that a healthcare company may run afoul of one or more of the requirements.

If
we fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or
incur costs that could have a material adverse effect on the success of our business.

We
are subject to numerous environmental, health and safety laws and regulations, including those governing laboratory procedures
and the generation, handling, use, storage, treatment, manufacture, transportation and disposal of, and exposure to, hazardous
materials and wastes, as well as laws and regulations relating to occupational health and safety. Our operations involve the use
of hazardous and flammable materials, including chemicals and biologic materials. Our operations also produce hazardous waste
products. We generally contract with third parties for the disposal of these materials and wastes. We cannot eliminate the risk
of contamination or injury from these materials. In the event of contamination or injury resulting from our use of hazardous materials,
we could be held liable for any resulting damages, and any liability could exceed our resources. We also could incur significant
costs associated with civil or criminal fines and penalties. We