Company: PTHS
Filing Date: 2025-08-28
Form Type: S-3
Source: 0001753926-25-001403
Chunk: 7

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-08-28
Form: S-3
Chunk 7
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 community necessary for commercial success.                              |

| ● | 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.                                                                           |

| ● | ZELSUVMI                                                                                 
 or our product candidates may cause undesirable side effects or have other properties    
 that could limit their commercial profile, expose us to product liability claims, delay  
 or prevent regulatory approval of our product candidates or additional indications, or   
 result in significant negative consequences following any additional marketing approval, 
 any of which may adversely impact our business, financial condition, operating results   
 and prospects.                                                                           |

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| ● | We                                                                                    
 face substantial competition, which may result in a smaller than expected commercial  
 opportunity and/or other firms may discover, develop or commercialize products before 
 or more successfully than we do.                                                      |

| ● | 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.                                                                                 |

| ● | Our                                                                                        
 products may become subject to unfavorable third-party coverage or reimbursement policies, 
 which would harm our business.                                                             |

| ● | The                                                                                     
 market for ZELSUVMI and our future product candidates may not be as large as we expect. |

| ● | The                                                                                     
 FDA and other regulatory agencies actively enforce the laws and regulations prohibiting 
 the promotion of off-label uses.                                                        |

| ● | Product                                                                                        
 liability lawsuits could cause us to incur substantial liabilities and limit commercialization 
 of any products that we may develop.                                                           |

Risks Related to Our Operations and Manufacturing

| ● | Delays                                                                                    
 or disruptions in our supply chain and manufacturing of our products, including ZELSUVMI, 
 and potential product candidates could adversely affect our sales and marketing efforts   
 and our development and commercialization timelines and could result in increased costs   
 or in our breaching our obligations to others.                                            |

| ● | We                                                                                       
 have limited experience in producing commercial scale products that utilize the NITRICIL 
 technology, which was assigned to Ligand in March 2024, including the API, berdazimer    
 sodium, used in the ZELSUVMI product.                                                    |

| ● | Unexpected                                                                                
 results in the analysis of raw materials, the API or