Company: PTHS
Filing Date: 2025-09-29
Form Type: 424B3
Source: 0001753926-25-001561
Chunk: 11

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-09-29
Form: 424B3
Chunk 11
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 to incur losses until revenue from ZELSUVMI is sufficient to fund our operations, if ever, and may never achieve or maintain profitability. If we do not achieve or maintain profitability, we may need additional funding to continue our business operations.

Since the Merger, we have devoted substantially all of our financial resources and efforts to the development and commercialization of ZELSUVMI, our product for the topical treatment of molluscum contagiosum. ZELSUVMI was approved by the FDA for the treatment of molluscum contagiosum in adults and pediatric patients one year of age and older in January 2024.

We have had net losses since inception,
and we had an accumulated deficit of approximately $26.9 million and $17.9 million as of June 30, 2025 and June 30, 2024, respectively,
which includes a net loss of approximately $3.2 million for the three months ended June 30, 2025, and approximately $1.8 million
the three months ended June 30, 2024, respectively. Overall, these conditions have raised substantial doubt regarding our ability
to continue as a going concern beyond one year of the filing of our consolidated financial statements. Our ability to continue
as a going concern is dependent upon the ability to complete clinical studies and implement our business plan, raise capital, generate
sufficient revenues and to control operating expenses.

We expect to continue to incur significant expenses and operating losses until revenue from ZELSUVMI is sufficient to fund our operations, if ever. Our net losses may fluctuate significantly from quarter to quarter and year to year. Our expenses may increase substantially, as we:

| ● | commercialize 
 ZELSUVMI;     |

| ● | operate                                                                                                   
 our manufacturing facility, at which we create the active pharmaceutical ingredient (“API”) for ZELSUVMI; |

| ● | work                                                                              
 with third-party contract manufacturers to produce the ZELSUVMI finished product; |

| ● | maintain                                                                                                                              
 or expand a sales, commercial and distribution infrastructure and manufacturing and logistics capabilities to commercialize currently 
 approved products as well as any future products that receive regulatory approval;                                                    |

| ● | seek                                                      
 to in-license or acquire additional products or programs; |

| ● | develop                                                                                    
 our regulatory compliance efforts to address requirements applicable to marketed products; |

| ● | maintain,                                               
 expand and protect our intellectual property portfolio; |

| ● | hire                                                                             
 and retain sales, marketing, manufacturing,