Company: PTHS
Filing Date: 2025-09-16
Form Type: 8-K/A
Source: 0001753926-25-001500
Chunk: 21

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-09-16
Form: 8-K/A
Chunk 21
---
 each institution participating in the clinical trial must review and approve each protocol before a clinical trial commences at that institution and must also approve the information regarding the trial and the consent form that must be provided to each trial subject or his or her legal representative, monitor the study until completed and otherwise comply with IRB regulations. The FDA or the sponsor may suspend a clinical trial at any time on various grounds, including a finding that the research subjects or patients are being exposed to an unacceptable health risk. Similarly, an IRB can suspend or terminate approval of a clinical trial at its institution if the clinical trial is not being conducted in accordance with the IRB’s requirements or if the drug has been associated with unexpected serious harm to patients. In addition, some clinical trials are overseen by an independent group of qualified experts organized by the sponsor, known as a data safety monitoring board or committee. Depending on its charter, this group may determine whether a trial may move forward at designated check points based on access to certain data from the trial. There are also requirements governing the reporting of ongoing clinical studies and clinical study results to public registries, including clinicaltrials.gov.

Human clinical trials are typically conducted in three sequential phases that may overlap or be combined:

| • | Phase                                                                                                                            
 1: The product candidate is initially introduced into healthy human subjects, or in some cases, patients with the target disease 
 or condition, and tested for safety, dosage tolerance, absorption, metabolism, distribution and excretion and, if possible, to   
 gain an early indication of its effectiveness.                                                                                   |

| • | Phase                                                                                                                               
 2: The product candidate is administered to a limited patient population with a specified disease or condition to identify possible 
 adverse effects and safety risks, to preliminarily evaluate the efficacy of the product candidate for specific targeted diseases    
 and to determine dosage tolerance and appropriate dosage.                                                                           |

| • | Phase                                                                                                                           
 3: The product candidate is administered to an expanded patient population to further evaluate dosage, to provide substantial   
 evidence of efficacy and to further test for safety, generally at multiple geographically dispersed clinical trial sites. These 
 clinical trials are intended to establish the overall risk-benefit ratio of the product candidate and provide an adequate basis 
 for product labeling.                                                                                                           |

Post-approval trials, sometimes referred to as Phase 4 studies, may be conducted after initial marketing approval. These trials are used to gain additional experience from the treatment of patients in the intended therapeutic indication. In certain instances, the FDA may mandate the performance of