Company: PTHS
Filing Date: 2025-05-09
Form Type: PREM14C
Source: 0001140361-25-018219
Chunk: 62

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-05-09
Form: PREM14C
Chunk 62
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 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 continual review and periodic inspections by the FDA and other regulatory authorities for compliance with current good manufacturing practices (“cGMPs”) requirements and adherence to commitments made in the NDA or foreign marketing application. If Channel, or a regulatory authority, discovers previously unknown problems with a product, such as adverse events of unanticipated severity or frequency, or problems with the facility where the product is manufactured or disagrees with the promotion, marketing or labeling of that product, a regulatory authority may impose restrictions relative to that product, the manufacturing facility or Channel, including requiring recall or withdrawal of the product from the market or suspension of manufacturing. If Channel fails to comply with applicable regulatory requirements following approval of CC8464, CT2000, CT3000 or any future compound, a regulatory authority may:

| • | issue a warning letter asserting that Channel is in violation of the law; |

| • | seek an injunction or impose administrative, civil or criminal penalties or monetary fines; |

| • | suspend or withdraw regulatory approval; |

| • | suspend any ongoing clinical trials; |

| • | refuse to approve a pending NDA or comparable foreign marketing application (or any supplements thereto) submitted by Channel or its strategic partners; |

| • | restrict the marketing or manufacturing of the product; |

| • | seize or detain the product or otherwise require the withdrawal of the product from the market; |

| • | refuse to permit the import or export of compounds; or |

| • | refuse to allow Channel to enter into supply contracts, including government contracts. |

Any government investigation of alleged violations of law could require Channel to expend significant time and resources in response and could generate negative publicity. The occurrence of any event or penalty described above may inhibit Channel’s ability to commercialize CC8464, CT2000 and CT3000 and adversely affect its business, financial condition, results of operations and prospects. The FDA’s policies, and those of equivalent foreign regulatory agencies, may change and additional government regulations may be enacted that could prevent, limit or delay regulatory approval of CC8464, CT2000 and CT3000. Channel cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative action, either in the United States or abroad. If Channel is slow or unable to adapt to changes in existing requirements or the adoption of new