Company: APM
Filing Date: 2025-10-14
Form Type: 424B5
Source: 0001213900-25-098635
Chunk: 36

Company: Aptorum Group Ltd
Filing Date: 2025-10-14
Form: 424B5
Chunk 36
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 structure-activity relationships, and                  
 the mechanism of action in humans. These studies also determine which investigational drugs are used as research tools to explore biological 
 phenomena or disease processes. The total number of subjects included in Phase 1 studies varies with the drug but is generally in            
 the range of twenty to eighty.                                                                                                               |

| ● | Phase 2. Phase 2 includes the early controlled                                                                                                
 clinical studies conducted to obtain some preliminary data on the effectiveness of the drug for a particular indication or indications        
 in patients with the disease or condition. This phase of testing also helps determine the common short-term side effects and risks associated 
 with the drug. Phase 2 studies are typically well-controlled, closely monitored, and conducted in a relatively small number of patients,      
 usually involving several hundred people.                                                                                                     |

| ● | Phase 3. Phase 3 studies are expanded controlled                                                                                         
 and uncontrolled trials. They are performed after preliminary evidence suggesting effectiveness of the drug has been obtained in Phase 2 
 and are intended to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk 
 relationship of the drug. Phase 3 studies are designed to provide an adequate basis for extrapolating the results to the general         
 population and transmitting that information in the physician labeling. Phase 3 studies usually include several hundred to several       
 thousand people.                                                                                                                         |

Progress reports detailing the results of the clinical trials must be submitted at least annually to the FDA and safety reports must be submitted to the FDA and clinical investigators within 15 calendar days for serious and unexpected suspected adverse events, any clinically important increase in the rate of a serious suspected adverse reaction over that listed in the protocol or investigator’s brochure, or any findings from other studies or animal or in vitro testing that suggest a significant risk in humans exposed to the drug candidate. Additionally, a sponsor must notify the FDA of any unexpected fatal or life-threatening suspected adverse reaction no later than 7 calendar days after the sponsor’s receipt of the information. There is no assurance that Phase 1, Phase 2, and Phase 3 testing can be completed successfully within any specified period, or at all. The FDA or the sponsor may suspend or terminate 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 product has been associated