Company: PTHS
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001753926-25-000503
Chunk: 51

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 51
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 or our directors, officers, employees or agents;

    ●
    The other factors
    set forth under “Risk Factors.”

These
and other risks are more fully described in the section entitled “Risk Factors” in this Report. If any of these risks
actually occurs, our business, financial condition, results of operations, cash flows, and prospects could be materially and adversely
affected. As a result, you could lose all or part of your investment in our securities.

Risks
Related to Our Business

The
report of the independent registered public accounting firm on our 2024 and 2023 financial statements contains a going concern
qualification.

The
report of the independent registered public accounting firm covering our consolidated financial statements for the years ended
December 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