Company: PTHS
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001753926-25-000503
Chunk: 64

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 64
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 can
demonstrate that any serious adverse events are not product-related, such occurrences could affect patient recruitment or the
ability of enrolled patients to complete the trial. Moreover, if we elect, or are required, to delay, suspend or terminate any
clinical trial of CC8464, the commercial prospects of such compound may be harmed and our ability to generate revenues from this
compound may be delayed or eliminated. Any of these occurrences may harm our ability to develop other product candidates, and
may harm our business, financial condition and prospects significantly. As CC8464 is our only compound in clinical development,
any setback may have a significant negative effect on our business.

37 

Additionally,
if CC8464 receives marketing approval, the FDA could require us to adopt 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.