Company: PTHS
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001753926-25-000503
Chunk: 49

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 49
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 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;

    ●
    We may be subject
    to litigation for a variety of claims, which could adversely affect our results of operations, harm our reputation or otherwise
    negatively impact our business;

    ●
    We are early in
    our efforts to develop CC8464, which is the only compound that we have advanced into clinical development. If we are unable
    to advance CC8464 through clinical trials, obtain regulatory approval and ultimately commercialize CC8464, or if we experience
    significant delays in doing so, our business will be materially harmed;

    ●
    We are early in
    our efforts to develop both of CT2000 and CT3000 and have not moved into pre-clinical or clinical trials. If we are unable
    to advance CT2000 and CT3000 through pre-clinical and clinical trials, obtain regulatory approval and ultimately commercialize
    CT2000 and CT3000, or if we experience significant delays in doing so, our business will be materially harmed;

    ●
    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 or future studies and clinical trials. CC8464 is our
    only compound in clinical development and advancing a different compound would require substantial time and resources as well
    as being subject to the same risks and uncertainties as described here for CC8464;

    ●
    Even if we obtain
    and maintain approval for CC8464, CT2000 and CT3000 from the FDA, we may never obtain approval for them outside of the United
    States, which would limit our market opportunities and adversely affect our business;

    ●
    While we plan to
    apply for orphan drug designation for CC8464 in the future, it may not effectively protect us from competition, and we may
    be unable to obtain similar designations for our future compounds. For instance, if our competitors are able to obtain orphan
    drug exclusivity for products that constitute the same drug and treat the same indications as our lead compounds before us,
    we may not be able to have competing products approved by the applicable regulatory authority for a significant