Company: APM
Filing Date: 2025-10-14
Form Type: 424B5
Source: 0001213900-25-098635
Chunk: 11

Company: Aptorum Group Ltd
Filing Date: 2025-10-14
Form: 424B5
Chunk 11
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Human clinical trials are typically conducted in three sequential phases that may overlap or be combined:

| ● | Phase 1. Phase 1 includes the initial introduction                                                                                           
 of an investigational new drug into humans. These studies are closely monitored and may be conducted in patients but are usually conducted   
 in healthy volunteer subjects. These studies are designed to determine the metabolic and pharmacologic actions of the drug in humans,        
 the side effects associated with increasing doses, and, if possible, to gain early evidence on effectiveness. During Phase 1, sufficient     
 information about the drug’s pharmacokinetics and pharmacological effects should be obtained to permit the design of well-controlled,        
 scientifically valid, Phase 2 studies. Phase 1 studies also evaluate drug metabolism, 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. Even if we conclude that the product is safe, the applicable regulator, such as the FDA, may not accept our data; final 
 safety and efficacy are determined by the FDA or an applicable foreign regulator as part of their approval process for the product.      |

Our non-therapeutics projects can be sub-divided into the following stages:

| ● | Development and Experimentation: Early development