Company: PTHS
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001753926-25-000503
Chunk: 52

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 52
---
, 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;

    ●
    secure acceptance
    of our compounds in the medical community and with third-party payors and consumers;

    ●
    raise sufficient
    funds in the capital markets or otherwise to effectuate our business plan; and

    ●
    utilize the funds
    that we do have and/or raise in the future to efficiently execute our business strategy.

If
we cannot successfully execute any one of the foregoing, our business may fail, and your investment will be adversely affected.

We
have incurred net losses since inception. We expect to incur losses for the foreseeable future and may never achieve or maintain
profitability.

There
are numerous risks and uncertainties associated with pharmaceutical product and biological development, and we are unable to accurately
predict the timing or amount of increased expenses or when, or if, we will be able to achieve profitability.

We
have had net losses since inception, and we had an accumulated deficit of approximately $21.5 million and $13.5 million as of
December 31, 2024 and December 31, 2023, respectively, which includes a net loss of approximately $8.0 million for year ended
December 31, 2024, and approximately $7.4 million the year ended December 31, 2023, respectively. Overall, these conditions have
raised substantial doubt regarding our ability to continue as a going concern beyond one year of the filing of our consolidated
financial statements. Our ability to continue as a going concern is dependent upon the ability to complete clinical studies and
implement our business plan, raise capital, generate sufficient revenues and to control operating expenses.

We
have primarily financed our operations through a combination of a series of cash advances, equity raises, bridge and promissory
note issuances