Company: APM
Filing Date: 2025-04-30
Form Type: 20-F
Source: 0001213900-25-037669
Chunk: 19

Company: Aptorum Group Ltd
Filing Date: 2025-04-30
Form: 20-F
Item: Item 3
Chunk 19
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 other pharmaceutical companies developing products in the same disease/therapeutic area and specialty pharmaceutical
and biotechnology companies worldwide. Many of the companies against which we may be competing have significantly greater financial resources
and expertise in research and development, manufacturing, animal testing, conducting clinical trials, obtaining regulatory approvals and
marketing approval for drugs than we do. Physicians, patients and third-party payors may prefer other novel products to ours, which means
that we may not generate significant sales revenues for that product and that product may not become profitable. The degree of market
acceptance of our drug candidates, if approved for commercial sale, will depend on a number of factors, including 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;                                                                                                                
  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 t...  

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