Company: PTHS
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001753926-25-000503
Chunk: 61

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 61
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 foregoing scenarios could materially harm the commercial
prospects for CC8464 and materially and adversely affect our business, financial condition, results of operations and prospects.

35 

We
may encounter substantial delays in our pre-clinical and clinical trials, or we may fail to demonstrate safety and efficacy to
the satisfaction of applicable regulatory authorities.

Before
obtaining marketing approval from regulatory authorities for the sale of our drug candidates, CC8464, CT2000 and CT3000 included,
we must conduct extensive clinical trials to demonstrate the safety and efficacy of the drug candidate for its intended indications.
Clinical trials are expensive, time consuming and uncertain as to outcome. We cannot guarantee that any clinical trials will be
conducted as planned or completed on schedule, if at all. A failure of one or more clinical trials can occur at any stage of testing.
Events that may prevent successful or timely completion of clinical development include:

    ●
    delays in reaching
    a consensus with regulatory authorities on trial design;

    ●
    delays in opening
    sites and recruiting suitable patients to participate in our clinical trials;

    ●
    imposition of a
    clinical hold by regulatory authorities as a result of a serious adverse event or concerns with a class of drug candidates,
    or after an inspection of our clinical trial operations or trial sites;

    ●
    delays in having
    patients complete participation in a trial or return for post-treatment follow-up;

    ●
    occurrence of serious
    adverse events associated with the drug candidate that are viewed to outweigh its potential benefits; or

    ●
    changes in regulatory
    requirements and guidance that require amending or submitting new clinical protocols.

In
addition, if we have to make manufacturing or formulation changes to CC8464, CT2000 and CT3000, we would need to conduct additional
studies to bridge our modified compound to earlier versions. Clinical trial delays could also shorten any periods during which
we may have the exclusive right to commercialize CC8464, CT2000, and CT3000, or allow our competitors to bring products to market
before we do, which could limit our potential revenue or impair our ability to successfully commercialize CC8464, CT2000 and CT3000
and may harm our business, financial condition, results of operations and prospects. Any delays, setbacks or failures in our clinical
trials could materially and adversely affect our business, financial condition, results of operations and prospects.

Additionally,
if the results of our