Company: PTHS
Filing Date: 2025-05-27
Form Type: DEFM14C
Source: 0001140361-25-020509
Chunk: 55

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-05-27
Form: DEFM14C
Chunk 55
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 may advance towards clinical development in the future) is subject to many uncertainties, including the following:

| • | successful final completion of the formula for eye drops; |

| • | positive results from its planned future pre-clinical and 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 CT2000, if and when approved, whether alone or in collaboration with others; and |

| • | acceptance of CT2000, 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 CT2000, which would materially harm our business. If Channel does not receive regulatory approvals for CT2000, its business, financial condition, results of operations and prospects could be materially and adversely affected. Advancing a different compound than CT2000 towards clinical development would take substantial time and resources and be subject to the same risks as described here for CT2000. Channel is early in its efforts to develop CT3000 and have not moved into clinical trials. If it is unable to advance CT3000 through clinical trials, obtains regulatory approval and ultimately commercializes CT3000, or if it experiences significant delays in doing so, its business will be materially harmed. Channel is early in its development of CT3000. The development and commercialization of CT3000 (or any other compound that it may advance towards clinical development in the future) is subject to many uncertainties, including the following:

| • | successful final completion of the formula for the nerve block; |

| • | positive results from its planned future pre-clinical and 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 CT3000, if and when approved, whether alone or in collaboration with others; and |

| • | acceptance of CT3000, 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 CT3000, which would materially harm its business. If