Company: PTHS
Filing Date: 2025-05-27
Form Type: DEFM14C
Source: 0001140361-25-020509
Chunk: 61

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-05-27
Form: DEFM14C
Chunk 61
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 event Channel is able to execute on our objectives. These regulatory review committees and advisory groups and the new guidelines they promulgate may lengthen the regulatory review process, require Channel to perform additional studies, increase its development costs, lead to changes in regulatory positions and interpretations, delay or prevent approval and commercialization of CC8464, CT2000 and CT3000 or future compounds or lead to significant post-approval limitations or restrictions. As Channel advances CC8464, CT2000 and CT3000, it will be required to consult with these regulatory and advisory groups and comply with applicable guidelines. If Channel fails to do so, it may be required to delay or discontinue development of CC8464, CT2000 and CT3000. These additional processes may result in a review and approval process that is longer than Channel otherwise would have expected. Delay or failure to obtain, or unexpected costs in obtaining, the regulatory approval necessary to bring a potential product to market could decrease Channel’s ability to generate sufficient product revenue, and our business, financial condition, results of operations and prospects would be materially and adversely affected. Even if Channel obtains regulatory approval for CC8464, CT2000 and CT3000, its compounds will remain subject to regulatory oversight. Even if Channel obtains any regulatory approval for CC8464, CT2000 and CT3000, its lead compounds, they will be subject to ongoing regulatory requirements for manufacturing, labeling, packaging, storage, advertising, promotion, sampling, record-keeping and submission of safety and other post-market information. Any regulatory approvals that Channel receives for CC8464, CT2000 and CT3000 may also be subject to a post-approval safety

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monitoring program, limitations on the approved indicated uses for which the product may be marketed or to the conditions of approval, or contain requirements for potentially costly post-marketing testing, including Phase 4 clinical trials, and surveillance to monitor the quality, safety and efficacy of the product. For example, the holder of an approved NDA is obligated to monitor and report adverse events and any failure of a product to meet the specifications in the NDA. The holder of an approved NDA also must submit new or supplemental applications and obtain FDA approval for certain changes to the approved product, product labeling or manufacturing process. Advertising and promotional materials must comply with FDA rules and are subject to FDA 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