Company: PTHS
Filing Date: 2025-05-09
Form Type: PREM14C
Source: 0001140361-25-018219
Chunk: 23

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-05-09
Form: PREM14C
Chunk 23
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 has incurred net losses since inception. Channel expects to incur losses for the foreseeable future and may never achieve or maintain profitability. |

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TABLE OF CONTENTS

Risks Related to LNHC’s Business

| • | LNHC has incurred significant losses since its inception. LNHC expects to incur losses until revenue from ZELSUVMI is sufficient to fund LNHC’s operations, if ever, and may never achieve or maintain profitability. If LNHC does not achieve or maintain profitability, it may need additional funding to continue its business operations; |

| • | LNHC has a limited operating history and no prior history of commercializing products, which may make it difficult for you to evaluate the success of its business to date and to assess its future viability; |

| • | LNHC depends heavily on the commercial success of ZELSUVMI, which was approved by the FDA in January 2024 and has not yet launched in the United States. There is no assurance that LNHC’s commercialization efforts in the United States with respect to ZELSUVMI will be successful or that LNHC will be able to generate profit at the levels or within the timing it expects; |

| • | LNHC’s products may become subject to unfavorable third-party coverage or reimbursement policies, which would harm its business; |

| • | Delays or disruptions in LNHC’s supply chain and manufacturing of LNHC’s products, including ZELSUVMI, and potential product candidates could adversely affect LNHC’s sales and marketing efforts and LNHC’s development and commercialization timelines and could result in increased costs or in LNHC breaching its obligations to others; |

| • | LNHC has never produced at a commercial scale any products that utilize the NITRICIL technology, and any delay or disruptions in the on-going qualification of manufacturing facilities and process or in the manufacture of LNHC’s (i) API, including berdazimer sodium, the API of LNHC’s ZELSUVMI product, or (ii) potential future clinical trial materials or commercial supplies of any other potentially approved product candidates utilizing the NITRICIL technology, could adversely affect LNHC’s development and commercialization timelines and results or result in increased costs or in LNHC breaching its obligations to others; and |

| • | LNHC relies on in-licenses from third parties. If LNHC loses these rights, its business may be materially and adversely affected, its ability to develop improvements to its technology platform may be negatively and substantially impacted, and if disputes arise, LNHC may