Company: PTHS
Filing Date: 2025-08-28
Form Type: S-3
Source: 0001753926-25-001403
Chunk: 9

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-08-28
Form: S-3
Chunk 9
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| ● | We                                                                                          
 may be subject to claims challenging the inventorship of the patents and other intellectual 
 property on which we rely.                                                                  |

| ● | If                                                                                      
 we are unable to protect the confidentiality of our information and our trade secrets,  
 the value of our technology could be materially and adversely affected and our business 
 could be harmed.                                                                        |

| ● | If                                                                                       
 our trademarks and trade names are not adequately protected, we may not be able to build 
 name recognition in our markets of interest and our competitive position may be harmed.  |

Risks Related to Legal and Regulatory Compliance Matters

| ● | Current                                                                                 
 and future healthcare reform legislation or regulation may increase the difficulty and  
 cost for us to commercialize ZELSUVMI and may adversely affect the prices we may obtain 
 and may have a negative impact on our business and results of operations.               |

| ● | If                                                                                       
 we fail to comply with our reporting and payment obligations under the Medicaid Drug     
 Rebate Program or other governmental pricing programs in which we participate, we could  
 be subject to additional reimbursement requirements, penalties, sanctions and fines,     
 which could have a material adverse effect on our business, financial condition, results 
 of operations and growth prospects.                                                      |

| ● | We                                                                                   
 are subject to federal, state and foreign healthcare laws and regulations, including 
 fraud and abuse laws.                                                                |

| ● | Changes                                                                               
 in and actual or perceived failures to comply with applicable data privacy, security  
 and protection laws, regulations, standards and contractual obligations may adversely 
 affect our business, operations and financial performance.                            |

| ● | If                                                                                         
 plaintiffs bring product liability lawsuits against us or our partners, we or our partners 
 may incur substantial liabilities and may be required to limit commercialization of our    
 approved products and product candidates.                                                  |

| ● | We                                                                                    
 face risks related to handling of hazardous materials and other regulations governing 
 environmental safety.                                                                 |

| ● | We                                                                                          
 may also be subject to other laws and regulations not specifically targeting the healthcare 
 industry.                                                                                   |

Other Risks and Uncertainties Affecting Our Business

| ● | The                                                                                       
 occurrence of a catastrophic disaster could disrupt our business, damage our facilities   
 beyond insurance limits, increase our costs and expenses, or we could lose key data which 
 could cause us to curtail or cease operations.                                            |

| ● | Impairment                                                                                  
 charges pertaining to goodwill, identifiable intangible assets or other long-lived assets   
 from our mergers