Company: PTHS
Filing Date: 2025-05-27
Form Type: DEFM14C
Source: 0001140361-25-020509
Chunk: 65

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-05-27
Form: DEFM14C
Chunk 65
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 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. |

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TABLE OF CONTENTS

If Channel is not able to secure an orphan drug designation, or if the exclusivity associated with such designation does not effectively protect Channel from competition, its 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 Channel’s compounds, may not lead to a faster development, regulatory review or approval process and do not increase the likelihood that any of its 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 Channel’s other compounds that it may develop in the future will receive a similar designation from the FDA or that Channel will receive Breakthrough Therapy or Fast Track designations for its compounds. Further, even if Channel does 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. Channel may expend its limited resources to pursue a compound or indication and fail to capitalize on its compounds or indications that may be more profitable or for which there is a greater likelihood of success. Channel has limited financial and managerial resources. As a result, it may forego or delay pursuit of opportunities with other of its compounds or for other indications that later prove to have greater commercial potential. Channel’s resource allocation decisions may cause it to fail to timely capitalize on viable commercial products or profitable market opportunities. Channel’s spending on current and future research and development programs and its lead compounds for specific indications may not yield any commercially viable products. If Channel does not accurately evaluate the commercial potential or target market for a particular compound, it may relinquish valuable rights to that compound through collaboration, licensing or