Company: PTHS
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001753926-25-000503
Chunk: 248

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1A
Chunk 248
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 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
CT2000, which would materially harm our business. If we do not receive regulatory approvals for CT2000, our business, financial
condition, results of operations and prospects could be materially and adversely affected. Advancing a different compound than
CT2000 towards clinical development would take substantial time and resources and be subject to the same risks as described here
for CT2000.

34 

We
are early in our efforts to develop CT3000 and have not moved into clinical trials. If we are unable to advance CT3000 through
clinical trials, obtain regulatory approval and ultimately commercialize CT3000, or if we experience significant delays in doing
so, our business will be materially harmed.

We
are early in our development of CT3000. The development and commercialization of CT3000 (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 the nerve block;

    ●
    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 CT3000, if and when approved, whether alone or in collaboration with others; and

    ●
    acceptance of CT3000,
    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
CT3000, which would materially harm our business. If we do not receive regulatory approvals for CT3000, our business, financial
condition, results of operations and prospects could be materially and adversely affected. Advancing a different compound than
CT3000 towards clinical development would take substantial time and resources and be subject to the same risks as described here
for CT3000.

CC8464
is in early-stage development, and there is no guarantee that the results from prior clinical and preclinical studies will be
indicative of our ability to complete or the results to be obtained in the current