Company: APM
Filing Date: 2025-11-17
Form Type: F-1
Source: 0001213900-25-111548
Chunk: 201

Company: Aptorum Group Ltd
Filing Date: 2025-11-17
Form: F-1
Chunk 201
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 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 work for proof-of-concept. |

| ● | Product Optimization: The practice of making changes or adjustments to a product to make it 
 more desirable.                                                                             |

| ● | Clinical Validation: Confirming the performance of a technology using clinical/patient 
 samples.                                                                               |

| ● | Pre-commercialization preparation: The logistics that need to be accomplished before 
 commercialization.                                                                   |

| ● | Formulation: Preparation of a marketed dosage form from active ingredients and 
 excipients/additives.                                                          |

| ● | Commercialization: The process of introducing a new product or production method into 
 commerce — making it available on the market.                                         |

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