Company: PTHS
Filing Date: 2025-05-27
Form Type: DEFM14C
Source: 0001140361-25-020509
Chunk: 108

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-05-27
Form: DEFM14C
Chunk 108
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HC and could impair its ability to raise capital, diversify LNHC’s offerings or continue LNHC’s 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’s operations to date have been largely focused on developing and commercializing ZELSUVMI, which was approved by the FDA for the treatment of molluscum contagiosum in adult and pediatric patients one year of age and older in January 2024. LNHC holds a license to commercialize ZELSUVMI, which has not commercially launched. LNHC has not demonstrated an ability to successfully complete clinical trials, obtain regulatory approval for a product, manufacture a product on a commercial scale, or arrange for a third party to do so on its behalf, or conduct sales and marketing activities necessary for successful commercial launch and commercialization over time. Consequently, any predictions you make about LNHC’s future success or viability may not be as accurate as they could be if LNHC had a longer operating history or a history of successfully commercializing products.

LNHC may encounter unforeseen expenses, difficulties, complications, delays and other known or unknown factors in achieving its business objectives.**

**Risks Related to the Commercialization of LNHC’s Product and any Future Product Candidates**

**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 business currently depends heavily on its ability to successfully commercialize ZELSUVMI in the United States for the treatment of molluscum contagiosum. LNHC may never be able to successfully commercialize ZELSUVMI or its expectations with respect to profit. There is no guarantee that the infrastructure, systems, processes, policies, personnel, relationships and materials LNHC built in preparation for the launch and commercialization of ZELSUVMI in the United States will be sufficient for it to achieve success at the levels LNHC expects. Additionally, healthcare providers may not accept a new treatment for the treatment of molluscum contagiosum. LNHC may also encounter challenges related to reimbursement of ZELSUVMI, even if it has positive early indications from pay