Company: PTHS
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001753926-25-000503
Chunk: 65

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 65
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The
clinical trial requirements of the FDA, EMA and other regulatory authorities and the criteria these regulators use to determine
the safety and efficacy of a compound vary substantially according to the type, complexity, novelty and intended use and market
of such compounds. The regulatory approval process for novel compounds such as ours can be more expensive and take longer than
for other, better known or more extensively studied compounds.

Regulatory
requirements governing pain medication products have been changing as side effects and the addictive nature of opioids became
more apparent. The regulatory framework for pain medications has been tightened and these changes may affect our programs and
its commercial potential despite our expectations that CC8464 will not show addictive features. While we are subject to the FDA
and EMA regulatory regimes, these are not the only regulatory regimes to which we may be subject in the event we are able to execute
on our objectives.

These
regulatory review committees and advisory groups and the new guidelines they promulgate may lengthen the regulatory review process,
require us to perform additional studies, increase our development costs, lead to changes in regulatory positions and interpretations,
delay or prevent approval and commercialization of CC8464, CT2000 and CT3000 or future compounds or lead to significant post-approval
limitations or restrictions. As we advance CC8464, CT2000 and CT3000, we will be required to consult with these regulatory and
advisory groups and comply with applicable guidelines. If we fail to do so, we may be required to delay or discontinue development
of CC8464, CT2000 and CT3000. These additional processes may result in a review and approval process that is longer than we otherwise
would have expected. Delay or failure to obtain, or unexpected costs in obtaining, the regulatory approval necessary to bring
a potential product to market could decrease our ability to generate sufficient product revenue, and our business, financial condition,
results of operations and prospects would be materially and adversely affected.

38 

Even
if we obtain regulatory approval for CC8464, CT2000 and CT3000, our compounds will remain subject to regulatory oversight.

Even
if we obtain any regulatory approval for CC8464, CT2000 and CT3000, our lead compounds, they will be subject to ongoing regulatory
requirements for manufacturing, labeling, packaging, storage, advertising, promotion, sampling, record-keeping and submission
of safety and other post-market information. Any regulatory approvals that we receive for CC8464, CT2000 and