Company: PTHS
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001753926-25-000503
Chunk: 240

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1A
Chunk 240
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31, 2024 and 2023 stated that certain factors, including that we have suffered recurring losses from operations and have
an accumulated deficit at December 31, 2024, raised substantial doubt as to our ability to continue as a going concern. Because
we are not yet producing sufficient revenue to sustain our operating costs, we are dependent upon raising capital to continue
our business. If we are unable to raise capital, we may be unable to continue as a going concern.

We
are a clinical stage biopharmaceutical company with a limited operating history.

The
operations of our company, contributed to us by Chromocell Holdings, to date have been limited to financing and staffing our Company,
developing and licensing compounds, conducting preclinical and clinical studies of CC8464 for EM and iSFN, CT2000 for eye pain,
CT3000 for post-surgical pain and other pain indications. We have not yet demonstrated the ability to successfully complete a
large-scale, pivotal clinical trial, obtain marketing approval, manufacture a commercial scale product, arrange for a third party
to do so on our behalf, or conduct sales and marketing activities necessary for successful product commercialization. Consequently,
predictions about our future success or viability may not be as accurate as they could be if we had a history of successfully
developing and commercializing pharmaceutical products.

29 

Accordingly,
you should consider our prospects in light of the costs, uncertainties, delays and difficulties frequently encountered by companies
in the early stages of development, especially early-stage clinical pharmaceutical companies such as ours. Potential investors
should carefully consider the risks and uncertainties that a company with a limited operating history will face. In particular,
potential investors should consider that we cannot assure you that we will be able to, among other things:

    ●
    successfully implement
    or execute our current business plan, and we cannot assure you that our business plan will lead to an approval or successful
    commercialization;

    ●
    successfully manufacture
    our compounds and establish commercial supply;

    ●
    successfully complete
    the clinical trials necessary to obtain regulatory approval for the marketing of CC8464, CT2000 and CT3000;

    ●
    secure market exclusivity
    and/or adequate intellectual property rights for our compounds in each jurisdiction in which we do or plan to commercialize
    our compounds or where our competitors are organized or may engage in competitive activity;

    ●
    attract and retain
    an experienced management and advisory team;

    ●