Company: PTHS
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001753926-25-000503
Chunk: 255

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1A
Chunk 255
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 review, in addition to other potentially applicable federal and state laws.

In
addition, product manufacturers and their facilities are subject to payment of user fees and continual review and periodic inspections
by the FDA and other regulatory authorities for compliance with cGMP requirements and adherence to commitments made in the NDA
or foreign marketing application. If we, or a regulatory authority, discover previously unknown problems with a product, such
as adverse events of unanticipated severity or frequency, or problems with the facility where the product is manufactured or disagrees
with the promotion, marketing or labeling of that product, a regulatory authority may impose restrictions relative to that product,
the manufacturing facility or us, including requiring recall or withdrawal of the product from the market or suspension of manufacturing.

If
we fail to comply with applicable regulatory requirements following approval of CC8464, CT2000, CT3000 or any future compound,
a regulatory authority may:

    ●
    issue a warning
    letter asserting that we are in violation of the law;

    ●
    seek an injunction
    or impose administrative, civil or criminal penalties or monetary fines;

    ●
    suspend or withdraw
    regulatory approval;

    ●
    suspend any ongoing
    clinical trials;

    ●
    refuse to approve
    a pending NDA or comparable foreign marketing application (or any supplements thereto) submitted by us or our strategic partners;

    ●
    restrict the marketing
    or manufacturing of the product;

    ●
    seize or detain
    the product or otherwise require the withdrawal of the product from the market;

    ●
    refuse to permit
    the import or export of compounds; or

    ●
    refuse to allow
    us to enter into supply contracts, including government contracts.

Any
government investigation of alleged violations of law could require us to expend significant time and resources in response and
could generate negative publicity. The occurrence of any event or penalty described above may inhibit our ability to commercialize
CC8464, CT2000 and CT3000 and adversely affect our business, financial condition, results of operations and prospects.

The
FDA’s policies, and those of equivalent foreign regulatory agencies, may change and additional government regulations may
be enacted that could prevent, limit or delay regulatory approval of CC8464, CT2000 and CT3000. We cannot predict the likelihood,
nature or extent of government regulation that may arise from future legislation or administrative action, either in the United
States or abroad. If we are slow or unable