Company: PTHS
Filing Date: 2025-05-27
Form Type: DEFM14C
Source: 0001140361-25-020509
Chunk: 56

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-05-27
Form: DEFM14C
Chunk 56
---
 Channel does not receive regulatory approvals for CT3000, its business, financial condition, results of operations and prospects could be materially and adversely affected. Advancing a different compound than CT3000 towards clinical development would take substantial time and resources and be subject to the same risks as described here for CT3000. CC8464 is in early-stage development, and there is no guarantee that the results from prior clinical and preclinical studies will be indicative of Channel’s ability to complete or the results to be obtained in the current or future studies and clinical trials. CC8464 is Channel’s only compound in clinical development and advancing a different compound would require substantial time and resources as well as being subject to the same risks and uncertainties as described here for CC8464. There is no guarantee that results of Channel’s potential future clinical trials will be positive or that it will be able to complete this or any potential future clinical trials on the anticipated timelines or at all. Furthermore, research and discoveries by Channel or others may identify serious adverse events, undesirable side effects or other unexpected properties of its current and future compounds, including CC8464, that could delay, prevent or cause the withdrawal of regulatory approval, limit the commercial potential, or result in significant negative consequences following marketing approval.

30

TABLE OF CONTENTS

The regulatory authorities may not complete their review processes in a timely manner, or Channel may not be able to obtain regulatory approval. Additional delays may result if an FDA Advisory Committee or other regulatory authority recommends non-approval or restrictions on approval. In addition, Channel may experience delays or rejections based upon additional government regulation from future legislation or administrative action, or changes in regulatory authority policy during the period of product development, clinical trials and the review process. Regulatory authorities also may approve a future compound for more limited indications than requested or they may impose significant limitations in the form of narrow indications, warnings or post-approval safety monitoring program. These regulatory authorities may require precautions or contra-indications with respect to conditions of use or they may grant approval subject to the performance of costly post-marketing clinical trials. In addition, regulatory authorities may not approve the labeling claims that are necessary or desirable for the successful commercialization of CC8464. Any of the foregoing scenarios could materially harm the commercial prospects for CC8464 and materially and adversely affect our business, financial condition, results of operations and prospects. Channel may encounter substantial delays in its pre-clinical and clinical trials, or it may fail to demonstrate safety and efficacy to the satisfaction of applicable regulatory authorities. Before obtaining marketing