Company: PTHS
Filing Date: 2025-09-16
Form Type: 8-K/A
Source: 0001753926-25-001500
Chunk: 37

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-09-16
Form: 8-K/A
Chunk 37
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 and principal stockholder, Ligand, will have the ability to control or significantly influence all matters submitted to our stockholders for approval.

Since the Merger,
our executive officers, directors and principal stockholder, Ligand, in the aggregate, beneficially own a substantial portion of
our outstanding shares of capital stock, on a fully diluted basis, subject to certain assumptions. As a result, if these stockholders
were to choose to act together, they would be able to control or significantly influence all matters submitted to the combined
company’s stockholders for approval, as well as our management and affairs. For example, these persons, if they choose to
act together, would control or significantly influence the election of directors and approval of any merger, consolidation or sale
of all or substantially all of the combined company’s assets. This concentration of voting power could delay or prevent an
acquisition of the combined company on terms that other stockholders may desire.

We have a limited operating history and history of commercializing products, which may make it difficult for you to evaluate the success of our business to date and to assess our future viability.

Since the Merger, our 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. We hold a worldwide license to commercialize
ZELSUVMI, subject to an out license for Japan, and recently launched the product, but our commercialization efforts are in early
stages. We have limited experience in demonstrating the 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 our behalf, or conduct sales
and marketing activities necessary for successful commercial launch and commercialization over time. Consequently, any predictions
you make about our future success or viability may not be as accurate as they could be if we had a longer operating history or
a history of successfully commercializing products.

We may encounter unforeseen expenses, difficulties, complications, delays and other known or unknown factors in achieving our business objectives.

Risks Related to the Commercialization of Our Product and any Future Product Candidates

We depend heavily on the commercial success of ZELSUVMI, which was approved by the FDA in January 2024, which we have only recently launched in the United States. There is no assurance that our commercialization