Company: PTHS
Filing Date: 2025-05-27
Form Type: DEFM14C
Source: 0001140361-25-020509
Chunk: 127

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-05-27
Form: DEFM14C
Chunk 127
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 side effects may inhibit market acceptance due to tolerability concerns as compared to other available therapies. Any of these developments could materially harm LNHC’s business, financial condition and prospects.

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Additionally, with respect to ZELSUVMI and any future product candidates for which it may obtain approval, if LNHC or others later identify undesirable side effects caused by such product, a number of potentially significant negative consequences could result. For example, the FDA could require LNHC to adopt a Risk Evaluation and Mitigation Strategy (“REMS”), to ensure that the benefits of treatment with such product outweigh the risks for each potential patient, which may include, among other things, a communication plan to health care practitioners, patient education, extensive patient monitoring or distribution systems and processes that are highly controlled, restrictive and more costly than what is typical for the industry. LNHC may also be required to engage in similar safety-related actions, such as patient education, certification of health care professionals or specific monitoring. Other potentially significant negative consequences associated with adverse events include:

| • | LNHC may be required to suspend marketing of a product, or it may decide to remove such product from the marketplace; |

| • | regulatory authorities may withdraw or change their approvals of a product; |

| • | regulatory authorities may require additional warnings on the label or limit access of a product to selective specialized centers with additional safety reporting and with requirements that patients be geographically close to these centers for all or part of their treatment; |

| • | LNHC may be required to create a medication guide outlining the risks of a product for patients, or to conduct post-marketing studies; |

| • | LNHC may be required to change the way a product is administered; |

| • | LNHC could be subject to fines, injunctions, or the imposition of criminal or civil penalties, or be sued and held liable for harm caused to subjects or patients; and |

| • | a product may become less competitive, and LNHC’s reputation may suffer. |

Any of these events could diminish the usage or otherwise limit the commercial success of ZELSUVMI or any of its future product candidates and prevent LNHC from achieving or maintaining market acceptance ZELSUVMI or for any other approved products. If LNHC experiences delays or difficulties in the enrollment and/or maintenance of patients in any clinical trials it may initiate, its receipt of necessary regulatory approvals could be delayed or prevented. If LNHC initiates clinical trials, it may find it difficult to adequately enroll patients. If LNHC