Company: APM
Filing Date: 2025-11-17
Form Type: F-1
Source: 0001213900-25-111548
Chunk: 200

Company: Aptorum Group Ltd
Filing Date: 2025-11-17
Form: F-1
Chunk 200
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. ‘Lead’ molecules can mean slightly different things to                 
 different researchers or companies, but in this document, we refer to Lead Discovery as the process of identifying one or more small 
 molecules with the desired activity against the identified targets. Leads can be identified through one or more approaches, which    
 can depend on the target and what, if any, previous knowledge exists.                                                                |

| ● | Lead Optimization: In this stage of the drug discovery process, the aim is to produce a                                           
 preclinical drug candidate by maintaining the desired and favorable properties in the lead compounds, while repairing or reducing 
 deficiencies in their structures. For example, to optimize the chemical structures to improve, among others, efficacy, reduce     
 toxicity, improve metabolism, absorption and pharmacokinetic properties.                                                          |

| ● | CTA-Enabling Studies: Includes all the essential studies such as GLP toxicology studies,                              
 pharmacology and efficacy, pharmacokinetics, in vitro metabolism, CMC studies, and the data of which are used for CTA 
 submission.                                                                                                           |

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| ● | IND-Enabling Studies: Includes all the essential studies such as GLP toxicology studies,                              
 pharmacology and efficacy, pharmacokinetics, in vitro metabolism, CMC studies, and the data of which are used for IND 
 submission.                                                                                                           |

| ● | In vitro validation: At this stage, the efficacy and safety of a drug candidate are assessed 
 at cellular levels.                                                                          |

| ● | In vivo validation: At this stage, the efficacy, safety and pharmacokinetic of a drug 
 candidate are assessed in animal models.                                              |

| ● | IND Preparation and Submission: Preparation of a package of documents for different sections                                 
 such as CMC, clinical, nonclinical, etc. and getting them reviewed, approved and final checked and followed by submission to 
 regulatory agencies.                                                                                                         |

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