Company: PTHS
Filing Date: 2025-05-27
Form Type: DEFM14C
Source: 0001140361-25-020509
Chunk: 133

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-05-27
Form: DEFM14C
Chunk 133
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 approvals LNHC may receive, including the approval obtained for ZELSUVMI, will require the submission of periodic reports to regulatory authorities and ongoing surveillance to monitor the safety and efficacy of the product. Such approvals may also contain significant limitations related to use restrictions for specified age groups, warnings, precautions or contraindications, and may include burdensome post-approval study or risk management requirements. For example, the FDA may require a REMS as a condition of approval of LNHC’s future product candidates, which could include requirements for a medication guide, physician training and communication plans or additional elements to ensure safe use, such as restricted distribution methods, patient registries and other risk minimization tools. If LNHC or a regulatory agency discover previously unknown problems with a product, such as adverse events of unanticipated severity or frequency, or problems with the facilities where the product is manufactured, a regulatory agency may impose restrictions on that product, the manufacturing facility or LNHC, including requiring recall or withdrawal of the product from the market or suspension of manufacturing. In addition, failure to comply with FDA and other comparable foreign regulatory requirements may subject LNHC to administrative or judicially imposed sanctions, including:

| • | restrictions on the marketing or manufacturing of LNHC’s products, withdrawal of the product from the market or voluntary or mandatory product recalls; |

| • | restrictions on product distribution or use, or requirements to conduct post-marketing studies or clinical trials; |

| • | fines, restitutions, disgorgement of profits or revenues, warning letters, untitled letters or holds on clinical trials; |

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| • | refusal by the FDA to approve pending applications or supplements to approved applications submitted, or suspension or revocation of approvals; |

| • | product seizures or detentions, or refusal to permit the import or export of LNHC’s products; and |

| • | injunctions or the imposition of civil or criminal penalties. |

The occurrence of any event or penalty described above may inhibit LNHC’s ability to commercialize its product candidates and generate revenue and could require LNHC to expend significant time and resources in response and could generate negative publicity. The FDA’s and other regulatory authorities’ policies may change and additional government regulations may be promulgated that could prevent, limit or delay marketing authorization of any future product candidates LNHC may develop. LNHC also 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 LNHC is