Company: PTHS
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001753926-25-000503
Chunk: 277

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1A
Chunk 277
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 business strategy; and

    ●
    the inability to
    commercialize any products that we may develop.

In
addition, we currently do not have product liability insurance, but plan to obtain such insurance at appropriate levels prior
to initiating studies in humans or clinical trials and prior to marketing and selling any drug or device products. Any insurance
we obtain may not provide sufficient coverage against potential liabilities. These liabilities could prevent or interfere with
our product development and commercialization efforts. Furthermore, if we were unable or otherwise failed to obtain and maintain
sufficient insurance at a reasonable cost to protect it against any such liabilities, that inability could have a material adverse
effect on its business.

51 

Risks
Related to Our Intellectual Property

If
we are unable to obtain and maintain adequate U.S. and foreign patent protection for our compounds, including CC8464, CT2000 and
CT3000, or if the scope of the patent protection obtained is not sufficiently broad, our competitors could develop and commercialize
products and technologies similar or identical to ours, and our ability to successfully commercialize CC8464, CT2000, CT3000 and
any of our other current or future compounds may be adversely affected.

Our
success depends, in large part, on our ability to obtain and maintain patent protection in the United States and other countries
with respect to CC8464, CT2000 and CT3000, additional new compounds in our product pipeline, and our institutional knowledge.
The patent prosecution process is expensive, time- consuming and complex. In particular, we may not be able to file, prosecute,
maintain, and/or enforce all necessary or desirable patent applications and issued patents at a reasonable cost or in a timely
manner.

We
have secured U.S. Patent No. 9,458,118 (the “CC8464 Patent”), covering the chemical composition and use of our clinical-stage
NaV1.7 blocker. Apart from the CC8464 Patent, we have filed multiple patent applications in foreign jurisdictions, including Canada,
France, India and Japan. It is possible that some of our pending patent applications in foreign jurisdictions will not result
in issued patents in a timely fashion or at all, and even if we are granted the patents we are currently pursuing in foreign jurisdictions,
the patents may not be issued in a form that will provide us with the full scope of protection that we desire, they may not prevent
competitors or other third parties from competing with us, and/or