Company: PTHS
Filing Date: 2025-05-27
Form Type: DEFM14C
Source: 0001140361-25-020509
Chunk: 130

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-05-27
Form: DEFM14C
Chunk 130
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 future decisions, conclusions, views, activities or otherwise regarding a particular product candidate or LNHC’s business. LNHC may expend its limited resources to pursue a particular product candidate or indication and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success. Because LNHC has limited financial and management resources. As such, LNHC is currently primarily focused on the commercialization of ZELSUVMI for the treatment of molluscum contagiosum, and LNHC may forgo pursuit of opportunities, including the development of other potential product candidates. LNHC’s resource allocation decisions may cause it to fail to capitalize on viable commercial products or profitable market opportunities. LNHC’s spending on current and future development programs and product candidates for specific indications, if any, may not yield any commercially viable products. If LNHC does not accurately evaluate the commercial potential or target market for a particular product candidate, LNHC may relinquish valuable rights to that product candidate through collaboration, licensing or other royalty arrangements in cases in which it would have been more advantageous for it to retain sole development and commercialization rights to such product candidate.

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The regulatory approval processes of the FDA and comparable foreign authorities are lengthy, time consuming and inherently unpredictable. If LNHC is not able to obtain required regulatory approval for any product candidates, its business will be substantially harmed. The time required to obtain approval or other marketing authorizations by the FDA and comparable foreign authorities is unpredictable but typically takes many years following the commencement of clinical trials and depends upon numerous factors, including the substantial discretion of the regulatory authorities. In addition, approval policies, regulations, or the type and amount of clinical data necessary to gain approval may change during the course of a product candidate’s clinical development and may vary among jurisdictions. With the exception of ZELSUVMI, LNHC has not obtained regulatory approval for any product candidates, and it is possible that no other product candidates that LNHC may seek to develop in the future will ever obtain regulatory approval. Neither LNHC nor any future collaborator is permitted to market any future drug product candidates in the United States until LNHC receives regulatory approval of an NDA or sNDA as applicable, from the FDA. Prior to obtaining approval to commercialize any other potential drug product candidate in the United States or abroad, LNHC must demonstrate with substantial evidence from well-controlled clinical trials, and to the satisfaction of the FDA or foreign regulatory agencies, that such product candidates are safe and effective for their intended uses.