Company: APM
Filing Date: 2025-11-17
Form Type: F-1
Source: 0001213900-25-111548
Chunk: 71

Company: Aptorum Group Ltd
Filing Date: 2025-11-17
Form: F-1
Chunk 71
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 but not limited to:

| ● | clinical indications for which our drug candidates are approved; |

| ● | physicians, hospitals, and patients considering our drug candidates 
 as a safe and effective treatment;                                  |

| ● | the potential and perceived advantages of our drug candidates 
 over alternative treatments;                                  |

| ● | the prevalence and severity of any side effects; |

| ● | product labeling or product insert requirements of the FDA,          
 NMPA, EMA, Health Canada or other comparable regulatory authorities; |

| ● | limitations or warnings contained in the labeling approved by                 
 the FDA, NMPA, EMA, Health Canada or other comparable regulatory authorities; |

| ● | the timing of market introduction of our drug candidates as 
 well as competitive drugs;                                  |

38

| ● | the cost of treatment in relation to alternative treatments 
 and their relative benefits;                                |

| ● | the availability of adequate coverage, reimbursement and pricing 
 by third-party payors and government authorities;                |

| ● | lack of experience and financial and other limitations on our                                                                   
 ability to create and sustain effective sales and marketing efforts or ineffectiveness of our sales and marketing partners; and |

| ● | changes in legislative and regulatory requirements that could                                                                        
 prevent or delay regulatory approval of our drug candidates, restrict or regulate post-approval activities and affect our ability to 
 profitably sell any drug candidates for which we obtain regulatory approval.                                                         |

We depend substantially on the success of the drug candidates being researched as our current Lead Projects. If we are unable to license or sublicense, sell or otherwise commercialize our drug candidates, or experience significant delays in doing so, our business will be materially harmed. Our business and the ability to generate revenue related to product sales, if ever achieved, will depend on the successful development, regulatory approval and licensing or sublicensing or other commercialization of our drug candidates or any other drug candidates we may develop. We have invested a significant amount of financial resources in the development of our drug candidates and we may invest in other drug candidates. The success of our drug candidates and any other potential drug candidates will depend on many factors, including but not limited to:

| ● | successful enrollment in, and completion of, studies in animals 
 and clinical trials;                                            |

| ● | other parties’ ability in conducting our clinical trials  
 safely, efficiently and according to the agreed protocol; |

| ● | receipt of regulatory approvals from the FDA, NMPA, EMA, Health             
 Canada and other comparable regulatory authorities for