Company: PTHS
Filing Date: 2025-08-28
Form Type: S-3
Source: 0001753926-25-001403
Chunk: 23

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-08-28
Form: S-3
Chunk 23
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, including the approval of ZELSUVMI, is limited to those specific diseases and indications for which a product is deemed to be safe and effective by FDA. While physicians in the United States may choose, and are generally permitted, to prescribe drugs for uses that are not described in the product’s labeling and for uses that differ from those tested in clinical trials and approved by the regulatory authorities, our ability to promote ZELSUVMI or any future products will be narrowly limited to those indications that are specifically approved by the FDA. ZELSUVMI has been approved by the FDA for the treatment of molluscum contagiosum in adults and pediatric patients one year of age and older, and we are not permitted to promote ZELSUVMI for other uses.

If we are found to have promoted such off-label uses, we may become subject to significant liability. The U.S. federal government has levied large civil and criminal fines against companies for alleged improper promotion of off-label use and has enjoined several companies from engaging in off-label promotion. The FDA has also required that companies enter into consent decrees or permanent injunctions under which specified promotional conduct is changed or curtailed. If we cannot successfully manage the promotion of ZELSUVMI or any future product candidates, if approved, we could become subject to significant liability, which would materially adversely affect our business and financial condition.

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

We face an inherent risk of product liability exposure related to the commercial sales of ZELSUVMI, as well as the testing of our potential future product candidates in human clinical trials. If we cannot successfully defend ourselves against claims that ZELSUVMI or such product candidates caused injuries, we will incur substantial liabilities. Regardless of merit or eventual outcome, liability claims may result in:

| ● | decreased                                                           
 demand for ZELSUVMI and any product candidates that we may develop; |

| ● | injury                                                      
 to our reputation and significant negative media attention; |

| ● | loss        
 of revenue; |

| ● | withdrawal                      
 of clinical trial participants; |

| ● | significant                             
 costs to defend the related litigation; |

| ● | substantial                                             
 monetary awards paid to trial participants or patients; |

| ● | reduced                                                      
 resources of management to pursue our business strategy; and |

| ● | the                                                          
 inability to commercialize any products that we may develop. |

We currently hold product liability insurance that covers damages up to a $15 million annual