Company: PTHS
Filing Date: 2025-08-28
Form Type: S-3
Source: 0001753926-25-001403
Chunk: 8

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-08-28
Form: S-3
Chunk 8
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 drug product or problems with the    
 execution of or quality systems supporting the analytical testing work, whether conducted 
 internally or by third-party service providers, could adversely affect our development    
 and commercialization timelines and result in increased costs of potential development    
 programs initiated by us.                                                                 |

| ● | Our                                                                                           
 business involves the use of hazardous materials and we and our third-party suppliers         
 and manufacturers must comply with environmental laws and regulations, which can be expensive 
 and restrict how we do business.                                                              |

| ● | We                                                                      
 may be adversely affected by the effects of inflation or trade tariffs. |

Risks Related to Our Dependence on Third Parties

| ● | We                                                                                          
 will rely on third parties to conduct any preclinical studies and clinical trials. If       
 these third parties do not successfully carry out their contractual duties or meet expected 
 deadlines, we may be unable to obtain regulatory approval for or commercialize any of       
 our future product candidates.                                                              |

| ● | Our                                                                                    
 employees, independent contractors, principal investigators, CMOs, CROs, consultants,  
 commercial partners and vendors may engage in misconduct or other improper activities, 
 including noncompliance with regulatory standards and requirements, which could expose 
 us to liability and hurt our reputation.                                               |

Risks Related to Intellectual Property

| ● | We                                      
 rely on in-licenses from third parties. |

| ● | Third                                                                                   
 party intellectual property may prevent us from developing our potential products; our  
 intellectual property may not prevent competition; and any intellectual property issues 
 may be expensive and time consuming to resolve.                                         |

| ● | If                                                                                               
 we are unable to obtain and maintain sufficient intellectual property protection for             
 our products and technology, or if the scope of the intellectual property protection             
 obtained is not sufficiently broad, our competitors could develop and commercialize technologies 
 similar to ours, and our ability to successfully sell our products and services may be           
 impaired.                                                                                        |

| ● | Issued                                                                                           
 patents directed to the NITRICIL platform and technology could be found invalid or unenforceable 
 if challenged in court or before administrative bodies in the United States or abroad.           |

| ● | Changes                                                                                
 in patent law in the United States and other jurisdictions could diminish the value of 
 patents in general, thereby impairing Ligand’s ability to protect our products,        
 platform and technology on which we rely.                                              |

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| ● | We                                      
 rely on in-licenses from third parties. |