Company: PTHS
Filing Date: 2025-08-28
Form Type: S-3
Source: 0001753926-25-001403
Chunk: 16

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-08-28
Form: S-3
Chunk 16
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 with respect to ZELSUVMI, or that we will generate significant profit from ZELSUVMI or any product candidate or become profitable.

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ZELSUVMI and any of our product candidates that receive regulatory approval, may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial success.

ZELSUVMI and any of our product candidates that receive regulatory approval may fail to gain sufficient market acceptance by physicians, patients, third-party payors and others in the medical community. If ZELSUVMI or our potential product candidates, if approved, do not achieve an adequate level of acceptance, we may not generate sufficient revenue, and we may not become profitable. The degree of market acceptance of ZELSUVMI and our product candidates, if approved for commercial sale, will depend on a number of factors, including:

| ● | the                                                                           
 efficacy, safety and potential advantages compared to alternative treatments; |

| ● | 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