Company: PTHS
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001753926-25-000503
Chunk: 258

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1A
Chunk 258
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though we may obtain orphan drug exclusivity for CC8464, that exclusivity may not effectively protect the compound from competition
because different drugs can be approved for the same condition. In the United States, even after an orphan drug is approved, the
FDA may subsequently approve another drug for the same condition if the FDA concludes that the latter drug is not the same drug
or is clinically superior in that it is shown to be safer, more effective or makes a major contribution to patient care. In the
European Union, marketing authorization may be granted to a similar medicinal product for the same orphan indication if:

    ●
    the second applicant
    can establish in its application that its medicinal product, although like the orphan medicinal product already authorized,
    is safer, more effective or otherwise clinically superior;

    ●
    the holder of the
    marketing authorization for the original orphan medicinal product consents to a second orphan medicinal product application;
    or

    ●
    the holder of the
    marketing authorization for the original orphan medicinal product cannot supply enough quantities of orphan medicinal product.

If
we are not able to secure an orphan drug designation, or if the exclusivity associated with such designation does not effectively
protect us from competition, our business, financial condition, results of operations and prospects will be adversely affected.

FDA
designations to expedite drug development and review, including “orphan drug” designation, Breakthrough Therapy designation,
and/or Fast Track designation, even if granted for any of our compounds, may not lead to a faster development, regulatory review
or approval process and do not increase the likelihood that any of our compounds will receive marketing approval in the United
States.

As
with any future application for “orphan drug” designation for CC8464 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