Company: PTHS
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001753926-25-000503
Chunk: 250

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1A
Chunk 250
---
 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 clinical trials are inconclusive or if there are safety concerns or serious adverse events associated with
our drug candidates, we may:

    ●
    be delayed in obtaining
    marketing approval, if at all, or be required to conduct additional confirmatory safety and/or efficacy studies causing additional
    expenses;

    ●
    obtain approval
    for indications or patient populations that are not as broad as intended or desired;

    ●
    obtain approval
    with labeling that includes significant use or distribution restrictions or safety warnings;

    ●
    be subject to additional
    post-marketing testing requirements;

    ●
    be required to perform
    additional clinical trials to support approval or be subject to additional post-marketing testing requirements;

    ●
    have regulatory