Company: PTHS
Filing Date: 2025-09-29
Form Type: 424B3
Source: 0001753926-25-001561
Chunk: 50

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-09-29
Form: 424B3
Chunk 50
---
 medical supplies to report payments and other transfers of value to physicians for which payment is available under    
 Medicare, Medicaid or the Children’s Health Insurance Program (with certain exceptions) to report annually to CMS information        
 related to physicians (defined to include doctors, dentists, optometrists, podiatrists, and chiropractors), certain non-physician    
 practitioners (physician assistants, nurse practitioners, clinical nurse specialists, certified nurse anesthetists, anesthesiology   
 assistants and certified nurse-midwives) and teaching hospitals, as well as ownership and investment interests held by physicians    
 and their immediate family members. Manufacturers must submit reports on or before the 90th day of each calendar year disclosing     
 reportable payments made in the previous calendar year;                                                                              |

<div align='center'>28</div>

| ● | analogous                                                                                                                               
 state laws and regulations, such as state anti-kickback and false claims laws, which may apply to items or services reimbursed          
 under Medicaid and other state programs or, in several states, regardless of the payer, including private insurers. Some state          
 laws require pharmaceutical companies to report expenses relating to the marketing and promotion of pharmaceutical products and         
 to report gifts and payments to individual health care providers in those states. Some of these states also prohibit certain marketing- 
 related activities including the provision of gifts, meals, or other items to certain health care providers. Some states restrict       
 the ability of manufacturers to offer co-pay support to patients for certain prescription drugs. Some states require the posting        
 of information relating to clinical studies and their outcomes. Other states and cities require identification or licensing of          
 sales representatives. In addition, several states require pharmaceutical companies to implement compliance programs or marketing       
 codes of conduct; and                                                                                                                   |

| ● | analogous                                                                                                                                
 foreign laws and regulations, including restrictions imposed on the promotion and marketing of medicinal products in the EU member       
 states and other countries, restrictions on interactions with healthcare professionals and requirements for public disclosure            
 of payments made to physicians. Laws (including those governing promotion, marketing and anti-kickback provisions), industry regulations 
 and professional codes of conduct often are strictly enforced. Even in those countries where we may decide not to directly promote       
 or market our products, inappropriate activity by our international distribution partners could have implications for us.                |

Ensuring that our business arrangements and interactions with healthcare professionals, third-party payors, patients and others comply with applicable healthcare laws and regulations will require substantial resources. Various state, federal and foreign regulatory and enforcement agencies continue actively to investigate violations