Company: PTHS
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001753926-25-000503
Chunk: 58

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 58
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 nature and timing of any such dispute, a resolution
of a legal matter could materially affect our future operating results, our cash flows or both.

33 

Risks
Related to Development, Clinical Testing, and Regulatory Approval

We
are early in our efforts to develop CC8464, which is the only compound that we have advanced into clinical development. If we
are unable to advance CC8464 through clinical trials, obtain regulatory approval and ultimately commercialize CC8464, or if we
experience significant delays in doing so, our business will be materially harmed.

We
are early in our development of CC8464. The development and commercialization of CC8464 (or any other compound that we may advance
towards clinical development in the future) is subject to many uncertainties, including the following:

    ●
    successful enrollment
    and completion of the two studies we are planning to conduct in the next phase of our clinical trials (Phase 2);

    ●
    positive results
    from our current and planned future clinical trials;

    ●
    receipt of regulatory
    approvals from applicable regulatory authorities;

    ●
    successful development
    of our internal manufacturing processes on an ongoing basis and maintenance of our potential future arrangements with third-party
    manufacturers for clinical supply;

    ●
    commercial launch
    of CC8464, if and when approved, whether alone or in collaboration with others; and

    ●
    acceptance of CC8464,
    if and when approved, by patients, the medical community and third-party payors.

If
we fail in one or more of these factors, we could experience significant delays or an inability to successfully commercialize
CC8464, which would materially harm our business. If we do not receive regulatory approvals for CC8464, our business, financial
condition, results of operations and prospects could be materially and adversely affected. Advancing a different compound than
CC8464 towards clinical development would take substantial time and resources and be subject to the same risks as described here
for CC8464.

We
are early in our efforts to develop CT2000 and have not moved into clinical trials. If we are unable to advance CT2000 through
clinical trials, obtain regulatory approval and ultimately commercialize CT2000, or if we experience significant delays in doing
so, our business will be materially harmed.

We
are early in our development of CT2000. The development and commercialization of CT2000 (or any other compound that we may