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

Company: Aptorum Group Ltd
Filing Date: 2025-10-14
Form: 424B5
Chunk 10
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 consists of preclinical and clinical phases. The preclinical phase can further sub-divided into the following stages:

| ● | Target Identification & Selection: The target                                                                                               
 is the naturally existing cellular or modular structure that appears to have an important role in a particular disease pathway and will     
 be targeted by the drug that will subsequently be developed. Target validation techniques for different disease areas can be very different 
 but typically include from in vitro and in silico methods through to the use of whole animal models.                                        |

| ● | Lead Discovery: Following “Target Identification &                                                                                            
 Selection,” compound screening assays are developed as part of the Lead Discovery. ‘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.                                                                                                         |

| ● | 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.                                                                                         |

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