Company: PTHS
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001753926-25-000503
Chunk: 242

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1A
Chunk 242
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 those currently expected, or if there are any delays in completing our clinical trials or the development of CC8464,
CT2000, CT3000 and/or other future compounds, our expenses could increase and revenue could be further delayed. We anticipate
that our expenses will increase substantially if, and as, we:

    ●
    continue our research
    and the clinical development of CC8464, CT2000 and CT3000;

    ●
        
    launch
human proof of concept of CT2000 for the treatment of eye pain;

    ●
    conduct
CMC and develop GMP formulations and human proof of concept of CT3000 for the treatment of post-surgical pain;

    ●
    initiate additional
    clinical trials and preclinical studies for any additional compounds that we may pursue in the future;

    ●
    prepare an NDA for
    filing with the FDA, a marketing authorization application, and approvals in certain other countries;

    ●
    oversee the manufacturing
    of material for clinical trials or potential commercial sales;

    ●
    develop a portfolio
    of compounds;

    ●
    establish a business
    development operation to in- our out-license certain assets;

    ●
    establish a sales,
    marketing and distribution infrastructure to commercialize any compound for which we may obtain marketing approval;

    ●
    develop, maintain,
    expand, protect and enforce our intellectual property rights portfolio; and/or

    ●
    acquire or in-license
    other compounds and technologies.

To
become and remain profitable, we must develop and eventually commercialize one or more compounds with significant market potential.
This will require us to be successful in a range of challenging activities, including completing the clinical trials, developing
and validating commercial scale manufacturing processes, obtaining marketing approval for our compounds, manufacturing, and marketing.
Licensing and selling any future compounds for which we may obtain marketing approval and satisfying any post-marketing requirements.
If we were required to discontinue development of CC8464, CT2000 or CT3000, if CC8464, CT2000 or CT3000 does not receive regulatory
approval, if we do not obtain our targeted indication(s) for CC8464, CT2000 or CT3000, or if CC8464, CT2000 pr CT3000 fails to
achieve sufficient market acceptance for any indication, we could be delayed by many years in our ability to achieve profitability.
Our failure to become and remain profitable would decrease the value of