Company: PTHS
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001753926-25-000503
Chunk: 88

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 88
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 or
a limitation or other change in the indications for which they may be used. If we cannot successfully defend ourselves against
claims that our compounds or drugs caused injuries, we will incur substantial liabilities. Depending on their merit or eventual
outcome, liability claims may result in:

    ●
    decreased demand
    for any product candidates or drugs that we may develop;

    ●
    injury to our reputation
    and significant negative media attention;

    ●
    withdrawal of clinical
    trial participants;

    ●
    significant costs
    to defend the related litigation;

    ●
    substantial monetary
    awards paid to trial participants or patients.

    ●
    loss of revenue;

    ●
    reduced resources
    of our management to pursue our 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.