Company: PTHS
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001753926-25-000503
Chunk: 253

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1A
Chunk 253
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 a post-approval safety monitoring program to ensure that
the benefits outweigh its risks, which may include, among other things, a medication guide outlining the risks of the product
for distribution to patients and a communication plan to health care practitioners. Furthermore, if we or others later identify
undesirable side effects caused by CC8464, several potentially significant negative consequences could result, including:

    ●
    regulatory authorities
    may suspend or withdraw approvals of such compound;

    ●
    regulatory authorities
    may require additional warnings on the label;

    ●
    we may be required
    to change the way a compound is administered or conduct additional clinical trials;

    ●
    we could be sued
    and held liable for harm caused to patients; and

    ●
    our reputation may
    suffer.

Any
of these events could prevent us from achieving or maintaining market acceptance of CC8464 and could significantly harm our business,
financial condition, results of operations and prospects.

Additionally,
other regulatory regimes in other geographies, such as the European Union, India and Japan, where we are initially targeting our
products, may impose similar conditions or post-monitoring requirements as a result of such findings.

We
have yet to begin evaluating CT2000 and CT3000 in humans to determine if it has any side effects, but could face similar or other
issues, including but not limited to the disclosures set forth above for CC8464 with respect to FDA approval, ongoing monitoring
programs and label requirements.

CC8464,
CT2000 and CT3000 are based on specific modes of administration (dose escalation regime, eye drops and injection, respectively),
which makes it difficult to predict the time and cost of development and of subsequently obtaining regulatory approval.

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,