Company: PTHS
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001753926-25-000503
Chunk: 247

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1A
Chunk 247
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 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 advance
towards clinical development in the future) is subject to many uncertainties, including the following:

    ●
    successful final
    completion of the formula for eye drops;

    ●
    positive results
    from our planned future pre-clinical and 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 CT2000, if and when approved, whether alone or in collaboration with others; and

    ●
    acceptance of CT2000,
    if and when approved, by patients, the medical