Company: PTHS
Filing Date: 2025-05-27
Form Type: DEFM14C
Source: 0001140361-25-020509
Chunk: 107

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-05-27
Form: DEFM14C
Chunk 107
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| • | establishes a sales, commercial and distribution infrastructure and manufacturing and logistics capabilities to commercialize approved products and may in the future obtain regulatory approvals; |

| • | seeks to in-license or acquire additional product candidates; |

| • | develops its regulatory compliance efforts to address requirements applicable to marketed products; |

| • | maintains, expands and protects its intellectual property portfolio; |

| • | hires and retains sales, marketing, manufacturing, commercial and scientific personnel; and |

| • | incurs additional legal, accounting and other expenses in operating as a public company. |

To become and remain profitable, LNHC must succeed in commercializing ZELSUVMI and/or developing and potentially commercializing future product candidates that generate significant revenue. This will require it to be successful in a range of challenging activities, including commercialization of ZELSUVMI, completing preclinical testing and clinical trials of any of LNHC’s potential future product candidates, obtaining regulatory approval, and manufacturing, marketing and selling any future product candidates for which it may obtain regulatory approval, as well as discovering and developing additional product candidates. LNHC may never succeed in these activities and, even if it does, may never generate revenue that is significant enough to achieve profitability. LNHC’s revenue will be dependent, in part, upon the size of the markets in the territories for which LNHC has gained or may gain regulatory approval, the accepted price for the product, the ability to obtain coverage and

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**reimbursement and whether LNHC owns the commercial rights for that territory. If the number of LNHC’s addressable patients is not as significant as LNHC estimates, if any indication approved by regulatory authorities is narrower than LNHC expects, or any targeted treatment population is narrowed by competition, physician choice or treatment guidelines, LNHC may not generate significant revenue from sales of such products.

Because of the numerous risks and uncertainties associated with commercialization and product development, LNHC may not achieve profitability in the time frame it currently expects, or at all. If LNHC is required by regulatory authorities to perform studies in addition to those expected, or if there are any delays in the initiation and completion of any clinical trials that LNHC may decide to conduct or the development of any of LNHC’s future product candidates, LNHC’s expenses could increase.

Even if LNHC achieves profitability, LNHC may not be able to sustain or increase profitability on a quarterly or annual basis. LNHC’s failure to become and remain profitable would depress the value of LN