Company: PTHS
Filing Date: 2025-09-16
Form Type: 8-K/A
Source: 0001753926-25-001500
Chunk: 41

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-09-16
Form: 8-K/A
Chunk 41
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 consequences could result, including, among other things:

| ● | regulatory                                                                                                            
 authorities may withdraw, suspend, or vary approvals of such product, including the FDA, withdrawing approval for the 
 affected medicine;                                                                                                    |

| ● | regulatory                                                
 authorities may require additional warnings on the label; |

| ● | regulatory                                                                                            
 authorities may require a recall or we or our potential partners may voluntarily recall such product; |

| ● | we                                                                                                                                
 may be required to create a medication guide outlining the risks of such side effects for distribution to patients at significant 
 cost or instate a Risk Evaluation and Mitigation Strategies (“REMS”) or Risk Management Plan (“RMP”);                             |

| ● | regulatory                                                                                                                 
 authorities may require the addition of warnings, such as black box or other warnings, or contraindications in the product 
 labeling that could diminish the usage of the product or otherwise limit the commercial success of the affected product;   |

| ● | our                                                                                                                       
 ability to promote our approved medicines may be limited and we could be required to change administration of, or modify, 
 such product in some other way;                                                                                           |

| ● | regulatory                                                                                                                   
 authorities may require us to modify, suspend or terminate our clinical trials, conduct additional clinical trials or engage 
 in costly post-marketing testing and surveillance to monitor the safety or efficacy of such product;                         |

| ● | undesirable                                                                                                    
 side effects may limit physicians’ or patients’ willingness to initiate or continue therapy with such product; |

| ● | sales                       
 may decrease significantly; |

| ● | we                                                             
 could be sued and held liable for harm caused to patients; and |

| ● | our                                                                                    
 corporate brand and reputation or the reputation of our approved medicines may suffer. |

Such events could prevent us from achieving or maintaining market acceptance of ZELSUVMI or our product candidates, and could significantly harm our business, results of operations and prospects.

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 development and commercialization of new products is highly competitive. We face competition with respect to ZELSUVMI and will face competition with respect to any product candidates that we may seek to develop or commercialize in the future, from many different sources, including major pharmaceutical and specialty pharmaceutical companies, compounding facilities, academic institutions and governmental agencies and public and private research institutions.

ZELSUVMI may compete with other procedure-based treatment regimens