Company: PTHS
Filing Date: 2025-09-29
Form Type: 424B3
Source: 0001753926-25-001561
Chunk: 18

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-09-29
Form: 424B3
Chunk 18
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 establishing clinical trial sites and patient registration for clinical trials, as well as in acquiring technologies complementary to, or that may be necessary for, our programs.

The commercial success of our products and product candidates will depend upon the degree of market acceptance by physicians, patients, third-party payers and others in the medical community.

The commercial success of our products, including ZELSUVMI and any other products for which we may obtain regulatory approval, will depend in part on the medical community, patients and third-party payers accepting our products and product candidates as effective and safe. If these products do not achieve an adequate level of acceptance, we may not generate significant product revenue and may not become profitable. The degree of market acceptance of our products will depend on a number of factors, including:

| ● | the                                                                              
 safety and efficacy of the products, and advantages over alternative treatments; |

| ● | the                               
 labeling of any approved product; |

| ● | the                                                                                                                            
 prevalence and severity of any side effects, including any limitations or warnings contained in a product’s approved labeling; |

| ● | the                                                                       
 prevalence of the disease or condition for which the product is approved; |

| ● | the                                                                    
 emergence, and timing of market introduction, of competitive products; |

| ● | the                                                                      
 effectiveness of our and our collaboration partners’ marketing strategy; |

| ● | obtaining                                               
 and maintaining adequate pricing and reimbursement; and |

| ● | sufficient                                                                                                                        
 third-party insurance coverage or governmental reimbursement, which may depend on our ability to provide compelling evidence that 
 a product meaningfully improves health outcomes to support such insurance coverage or reimbursement.                              |

Even if a product candidate displays a favorable efficacy and safety profile in preclinical studies and clinical trials, market acceptance of the product will not be known until after it is launched. Any failure to achieve market acceptance of our products will harm our business, results and financial condition.

Furthermore, government agencies, as well as private organizations involved in healthcare, from time to time publish guidelines or recommendations to healthcare providers and patients. Such guidelines or recommendations can be very influential and may adversely affect product usage directly (for example, by recommending a decreased dosage of a product in conjunction with a concomitant therapy) or indirectly (for example, by recommending a competitive product over a product of ours). Consequently, we do not know if physicians or patients will adopt or use our products for their approved indications.

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Our products may become subject to unfavorable third-party coverage or reimbursement policies,