Company: PTHS
Filing Date: 2025-05-27
Form Type: DEFM14C
Source: 0001140361-25-020509
Chunk: 122

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-05-27
Form: DEFM14C
Chunk 122
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 product candidates it may progress in the**

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TABLE OF CONTENTS

future will depend heavily on the successful development, regulatory approval and commercialization of these assets. The success of ZELSUVMI and any product candidates that LNHC develops or otherwise may acquire which receives regulatory approval will depend on several factors, including:

| • | timely and successful completion of preclinical studies and clinical trials; |

| • | successful development of, or making arrangements with and management of third-party manufacturers for, the commercial manufacturing processes for ZELSUVMI and any product candidates that receive regulatory approval; |

| • | receipt of timely regulatory approvals from applicable regulatory authorities; |

| • | commercial sales of ZELSUVMI and, if approved, any of LNHC’s future product candidates; |

| • | acceptance of ZELSUVMI and, if approved, any of LNHC’s future product candidates by patients, the medical community and third-party payors for their approved indications; |

| • | LNHC’s success in educating physicians and patients about the benefits, administration and use of ZELSUVMI and, if approved, any of LNHC’s future product candidates; |

| • | the prevalence and severity of adverse events experienced with ZELSUVMI and any of LNHC’s future product candidates; |

| • | the availability, perceived advantages, cost, safety and efficacy of alternative treatments for the indications addressed by ZELSUVMI and any future product candidates; |

| • | LNHC’s ability to produce ZELSUVMI and, if approved, any of LNHC’s future product candidates on a commercial scale; |

| • | obtaining and maintaining patent, trademark and trade secret protection and regulatory exclusivity for ZELSUVMI and any future product candidates and otherwise protecting LNHC’s rights in its intellectual property portfolio; |

| • | maintaining compliance with regulatory requirements, including cGMPs; |

| • | competing effectively with other products and procedures; and |

| • | maintaining a continued acceptable safety, tolerability and efficacy profile of ZELSUVMI and any future products following approval. |

Whether regulatory approval will be granted is unpredictable and depends upon numerous factors, including the substantial discretion of the regulatory authorities. The success of any of LNHC’s potential product candidates in clinical trials is not guaranteed, and even if clinical trials are successful, such results do not guarantee regulatory approval. The FDA or other comparable foreign regulatory authorities may require that LNHC conduct additional studies or clinical trials, provide additional data,