Company: PTHS
Filing Date: 2025-09-16
Form Type: 8-K/A
Source: 0001753926-25-001500
Chunk: 39

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-09-16
Form: 8-K/A
Chunk 39
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| ● | our                                                           
 ability to offer our products for sale at competitive prices; |

| ● | the                                                                        
 convenience and ease of administration compared to alternative treatments; |

| ● | the                                                                                                                 
 willingness of the target patient population to try new treatments and of physicians to prescribe these treatments; |

| ● | our                                                            
 ability to hire and retain a sales force in the United States; |

| ● | the                                             
 strength of marketing and distribution support; |

| ● | the                                                                                                                             
 availability of third-party coverage and adequate reimbursement for ZELSUVMI and any product candidates that receive regulatory 
 approval;                                                                                                                       |

| ● | the                                              
 prevalence and severity of any side effects; and |

| ● | any                                                                      
 restrictions on the use of our products together with other medications. |

The failure of healthcare professionals or patients to perceive the benefits of using ZELSUVMI for the treatment of molluscum contagiosum instead of other alternative therapies, such as curettage, cantharidin application or cryotherapy, would adversely affect the commercial success of ZELSUVMI.

If we are unable to establish effective sales, marketing and distribution capabilities for ZELSUVMI or any product candidate that may receive regulatory approval, we may not be successful in commercializing ZELSUVMI or our other product candidates if and when they are approved.

We have only recently commercially launched ZELSUVMI and to achieve commercial success for it and any other product candidate for which we may obtain regulatory approval, we will need to establish an effective sales and marketing organization. We have built a focused sales and marketing organization to launch ZELSUVMI in the United States, but it may not be large enough to support the market acceptance and revenue growth of ZELSUVMI that we expect and may need to expand if we receive approval of other product candidates. There are inherent risks to establishing and maintaining a standalone commercial organization, which is also time-consuming and requires significant financial resources.

Factors that create risk and may inhibit our efforts to commercialize our products on our own include:

| ● | our                                                                                                 
 inability to recruit, train and retain adequate numbers of effective sales and marketing personnel; |

| ● | the                                                                                                                                  
 inability of sales personnel to obtain access to physicians or educate adequate numbers of physicians on the benefits of prescribing 
 ZELSUVMI or any potential future products;                                                                                           |

| ● | inability                                                       
 to obtain favorable insurance coverage of any approved product; |

| ● | the                                                                                                                         
 lack of complementary products to be