Company: PTHS
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001753926-25-000503
Chunk: 56

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 56
---

    activities, including product sales, medical affairs, marketing, manufacturing and distribution, in the event we receive marketing
    approval for CC8464, CT2000, CT3000 or any other future compounds we may develop;

    ●
    the extent to which
    the costs of future compounds, if approved, will be paid by health maintenance, managed care, pharmacy benefit and similar
    healthcare management organizations, or will be reimbursed by government authorities, private health coverage insurers and
    other third-party payors;

32 

    ●
    the costs of commercialization
    activities for CC8464, CT2000, CT3000 and other future compounds if we receive marketing approval for CC8464, CT2000, CT3000
    or any other future compounds we may develop, including the costs and timing of establishing product sales, medical affairs,
    marketing, distribution and manufacturing capabilities;

    ●
    subject to receipt
    of marketing approval, if any, revenue received from commercial sale of CC8464, CT2000, CT3000 or any of our other future
    compounds;

    ●
    the terms and timing
    of any future collaborations, licensing, consulting or other arrangements that we may establish;

    ●
    the amount and timing
    of any payments we may be required or decide to make, or that we may receive, in connection with the licensing, filing, prosecution,
    maintenance, and enforcement of any patents or other intellectual property rights and defense against third party intellectual
    property infringement claims, including milestone and royalty payments and patent prosecution fees that we are obligated to
    pay pursuant to our license agreements, if any;

    ●
    the development
    of alternative treatments for EM or iSFN or other pain indications;

    ●
    our ability to establish
    and maintain collaborations and licenses on favorable terms, if at all; and

    ●
    the extent to which
    we acquire or in-license other compounds and technologies.

Identifying
potential compounds and conducting preclinical testing and clinical trials is a time-consuming, expensive and uncertain process
that takes years to complete, and we may never generate the necessary data or results required to obtain marketing approval and
achieve product sales. Our lead compounds, if approved, may not achieve commercial success. Our future compound’s revenues,
if any, will be derived from or based on sales of compounds that may not be commercially available for many years, if at all.
Accordingly