Company: PTHS
Filing Date: 2025-05-27
Form Type: DEFM14C
Source: 0001140361-25-020509
Chunk: 54

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-05-27
Form: DEFM14C
Chunk 54
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 adverse determination related to litigation could adversely affect its results of operations, harm its reputation or otherwise negatively impact its business. In addition, depending on the nature and timing of any such dispute, a resolution of a legal matter could materially affect its future operating results, its cash flows or both. Risks Related to Development, Clinical Testing, and Regulatory Approval Channel is early in its efforts to develop CC8464, which is the only compound that it has advanced into clinical development. If it is unable to advance CC8464 through clinical trials, obtains regulatory approval and ultimately commercializes CC8464, or if it experiences significant delays in doing so, its business will be materially harmed. Channel is early in its development of CC8464. The development and commercialization of CC8464 (or any other compound that it may advance towards clinical development in the future) is subject to many uncertainties, including the following:

| • | successful enrollment and completion of the two studies Channel is planning to conduct in the next phase of its clinical trials (Phase 2); |

| • | positive results from its current and planned future clinical trials; |

| • | receipt of regulatory approvals from applicable regulatory authorities; |

| • | successful development of its internal manufacturing processes on an ongoing basis and maintenance of its potential future arrangements with third-party manufacturers for clinical supply; |

| • | commercial launch of CC8464, if and when approved, whether alone or in collaboration with others; and |

| • | acceptance of CC8464, if and when approved, by patients, the medical community and third-party payors. |

If Channel fails in one or more of these factors, it could experience significant delays or an inability to successfully commercialize CC8464, which would materially harm our business. If Channel does not receive regulatory approvals for CC8464, its business, financial condition, results of operations and prospects could be materially and adversely affected. Advancing a different compound than CC8464 towards clinical development would take substantial time and resources and be subject to the same risks as described here for CC8464.

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Channel is early in its efforts to develop CT2000 and have not moved into clinical trials. If it is unable to advance CT2000 through clinical trials, obtains regulatory approval and ultimately commercializes CT2000, or if it experiences significant delays in doing so, its business will be materially harmed. Channel is early in its development of CT2000. The development and commercialization of CT2000 (or any other compound that it