Company: PTHS
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001753926-25-000503
Chunk: 71

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 71
---
 we
    develop may nevertheless be covered by third parties’ patents or other exclusive rights;

    ●
    a new compound may,
    on further study, be shown to have harmful side effects or other characteristics that indicate it is unlikely to be effective
    or otherwise does not meet applicable regulatory criteria;

    ●
    a new compound may
    not be capable of being produced in commercial quantities at an acceptable cost, or at all; and

    ●
    a new compound may
    not be accepted as safe and effective by patients, the medical community or third-party payors.

If
we are unsuccessful in identifying and developing additional new compounds, our potential for growth may be impaired.

We
face significant competition in an environment of rapid technological change and the possibility that our competitors may achieve
regulatory approval before us or develop therapies that are more advanced or effective than ours, which may adversely affect our
financial condition and our ability to successfully market or commercialize CC8464, CT2000 and CT3000.

Many
of our potential competitors, alone or with their strategic partners, have substantially greater financial, technical and other
resources, such as larger research and development, clinical, marketing and manufacturing organizations. Mergers and acquisitions
in the biotechnology and pharmaceutical industries may result in even more resources being concentrated among a smaller number
of competitors. Our commercial opportunity could be reduced or eliminated if competitors develop and commercialize products that
are safer, more effective, have fewer or less severe side effects, are more convenient or are less expensive than any compound
that we may develop. Competitors also may obtain FDA or other regulatory approval for their products more rapidly or earlier than
we may obtain approval for ours, which could result in our competitors establishing a strong market position before we are able
to enter the market. Additionally, technologies developed by our competitors may render CC8464, CT2000 and CT3000 uneconomical
or obsolete, and we may not be successful in marketing CC8464, CT2000 and CT3000 against competitors.

In
addition, as a result of the expiration or successful challenge of our patent rights, we could face more litigation with respect
to the validity and/or scope of patents relating to our competitors’ products. The availability of our competitors’
products could limit the demand, and the price we are able to charge, for any compound that we may develop and commercialize.

On
December 23, 2023, we entered into the Benuvia License