Company: PTHS
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001753926-25-000503
Chunk: 70

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 70
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 from the FDA, there is no assurance that any
of our other compounds that we may develop in the future will receive a similar designation from the FDA or that we will receive
Breakthrough Therapy or Fast Track designations for our compounds. Further, even if we do receive favorable designations from
the FDA, the receipt of any of these designations may not result in a faster development process, review or approval compared
to products considered for approval under conventional FDA procedures and does not assure ultimate approval by the FDA.

We
may expend our limited resources to pursue a compound or indication and fail to capitalize on our compounds or indications that
may be more profitable or for which there is a greater likelihood of success.

We
have limited financial and managerial resources. As a result, we may forego or delay pursuit of opportunities with other of our
compounds or for other indications that later prove to have greater commercial potential. Our resource allocation decisions may
cause us to fail to timely capitalize on viable commercial products or profitable market opportunities. Our spending on current
and future research and development programs and our lead compounds for specific indications may not yield any commercially viable
products. If we do not accurately evaluate the commercial potential or target market for a particular compound, we may relinquish
valuable rights to that compound through collaboration, licensing or other royalty arrangements in cases in which it would have
been more advantageous for us to retain sole development and commercialization rights to such compound.

If
we are not successful in discovering, developing and commercializing additional compounds, our ability to expand our business
and achieve our strategic objectives would be impaired.

Although
a substantial amount of our effort initially focuses on developing CC8464, CT2000 and CT3000 towards approval in the U.S. and
other countries, an additional component of our strategy is to discover, develop and potentially commercialize a portfolio of
compounds to treat orphan diseases and potentially, non-orphan diseases. Identifying new compounds requires substantial technical,
financial and human resources, whether any other compounds are ultimately identified. We may not be able to identify new molecules
with the potential for clinical development and ultimate approval. Even if we identify new compounds that initially show promise,
we may fail to successfully develop and commercialize such new compounds for many reasons, including the following:

    ●
    the research methodology
    used may not be successful in identifying potential new compounds;

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    ●
    competitors may
    develop alternatives that render our compounds obsolete;

    ●
    new compounds