Company: PTHS
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001753926-25-000503
Chunk: 241

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1A
Chunk 241
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    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, licensing arrangements, government grants and the IPO (from which we raised net proceeds of approximately $5.7
million, after deducting underwriting discounts, commissions and other offering expenses). Our ability to achieve significant
profitability depends on our ability to successfully complete the development of, and obtain the regulatory approvals necessary
to commercialize, CC8464, CT2000, CT3000 and/or additional compounds. We expect that it will take several years, if ever, before
we have a commercialized compound. The net losses we incur may fluctuate significantly from quarter to quarter.

30 

If
we are required by the FDA, the EMA, or other international regulatory authorities to which we may be subject, to perform studies
in addition to