Company: PTHS
Filing Date: 2025-05-09
Form Type: PREM14C
Source: 0001140361-25-018219
Chunk: 58

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-05-09
Form: PREM14C
Chunk 58
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 obtain approval for indications or patient populations that are not as broad as intended or desired; |

| • | obtain approval with labeling that includes significant use or distribution restrictions or safety warnings; |

| • | be subject to additional post-marketing testing requirements; |

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| • | be required to perform additional clinical trials to support approval or be subject to additional post-marketing testing requirements; |

| • | have regulatory authorities withdraw, or suspend, their approval of the drug or impose restrictions on its distribution; |

| • | be subject to the addition of labeling statements, such as warnings or contraindications; |

| • | be sued; or |

| • | experience damage to its reputation. |

As CC8464 is Channel’s only compound in clinical development, any setback may have a significant negative effect on its business. Channel’s drug development costs will increase if it experiences delays in testing or obtaining marketing approvals. Channel does not know whether any of our preclinical studies or clinical trials will begin as planned, need to be restructured or be completed on schedule, if at all. Channel, the FDA or an Institutional Review Board may suspend Channel’s clinical trials at any time if it appears that Channel or its collaborators are failing to conduct a trial in accordance with regulatory requirements, including the FDA’s current GCP, regulations, that Channel is exposing participants to unacceptable health risks, or if the FDA finds deficiencies in Channel’s IND applications or the conduct of these trials. Therefore, Channel cannot predict with any certainty the schedule for commencement and completion of future clinical trials. If Channel experiences delays in the commencement or completion of its clinical trials, or if Channel terminates a clinical trial prior to completion, the commercial prospects of its drug candidates could be negatively impacted, and its ability to generate revenues from its drug candidates may be delayed. As CC8464 is Channel’s only compound in clinical development, any setback may have a significant negative effect on its business. Even if Channel completes the necessary clinical trials, it cannot predict when, or if, it will obtain regulatory approval to commercialize CC8464, CT2000 and CT3000 and the approval may be for a narrower indication than it seek. Channel cannot commercialize a compound until the appropriate regulatory authorities have reviewed and approved the compound. Even if CC8464, CT2000 and CT3000 meet their respective safety and efficacy endpoints in clinical trials, the regulatory authorities may not complete their review processes in a timely manner, or Channel may not be able to obtain regulatory approval. Additional