Company: PTHS
Filing Date: 2025-08-28
Form Type: S-3
Source: 0001753926-25-001403
Chunk: 18

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-08-28
Form: S-3
Chunk 18
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, operating results and prospects.

As is the case with biopharmaceuticals
generally, it is likely that there may be side effects and adverse events (“AEs”) associated with use of
ZELSUVMI or our product candidates. Results of our preclinical testing and clinical trials could reveal a high and unacceptable
severity and prevalence of side effects or unexpected characteristics. Undesirable side effects caused by our product candidates
could cause us or regulatory authorities to interrupt, delay or halt clinical trials and could result in a more restrictive label
or the delay or denial of regulatory approval of our product candidates by the FDA. The drug-related side effects could affect
patient recruitment or the ability of enrolled patients to complete the trial or result in potential product liability claims.
Any of these occurrences may harm our business, financial condition and prospects significantly.

Additionally, with respect to ZELSUVMI or any of our product candidates that receive marketing approval, if we or the FDA later identify undesirable side effects caused by ZELSUVMI or such product candidates or other products with the same or related active ingredients, a number of potentially significant negative 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