Company: PTHS
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001753926-25-000503
Chunk: 55

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 55
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 arose from inadequate segregation
of duties, ineffective information technology controls and lack of certain financial reporting and transaction processing controls.
If we are unable to remedy our material weaknesses, or if we generally fail to establish and maintain effective internal controls
appropriate for a public company, we may be unable to produce timely and accurate consolidated financial statements, and we may
conclude that our internal control over financial reporting is not effective, which could adversely impact our investors’
confidence and our stock price.

We
will need to raise additional funding to receive approval for CC8464, CT2000, CT3000 or any other future compound. Such funding
may not be available on acceptable terms, or at all. Failure to obtain this necessary capital when needed may force us to delay,
limit, sell or terminate certain of our product development efforts or other operations.

To
complete the process of obtaining regulatory approval for CC8464, CT2000 and CT3000 and to build the sales, marketing, licensing
and distribution infrastructure that we believe will be necessary to commercialize CC8464, CT2000 and CT3000, if approved, we
will require substantial additional funding. In addition, if we obtain marketing approval for CC8464, CT2000 and CT3000, we expect
to incur significant expenses related to product sales, medical affairs, marketing, manufacturing and distribution.

Our
future capital requirements will depend on many factors, including:

    ●
    the progress, timing,
    results and costs of our dose escalation and phase 2 clinical trial for CC8464;

    ● 
    the
progress, timing, results and costs of our human POC trials for CT2000; 

    ●
    the
        progress, timing, results and costs of our GMP manufacturing and human POC for CT3000;

    ●
    the progress, timing
    and costs of manufacturing clinical trial for our planned pivotal clinical trials;

    ●
    the potential development
    and the filing on an IND application for other future compounds;

    ●
    the initiation,
    scope, progress, timing, costs and results of drug discovery, laboratory testing, manufacturing, preclinical studies and clinical
    trials for any other future compounds that we may pursue in the future, if any;

    ●
    the outcome, timing
    and costs of seeking regulatory approvals;

    ●
    the costs associated
    with the manufacturing process development and evaluation of third-party manufacturers;

    ●
    the costs of future