Company: APM
Filing Date: 2025-04-30
Form Type: 20-F
Source: 0001213900-25-037669
Chunk: 6

Company: Aptorum Group Ltd
Filing Date: 2025-04-30
Form: 20-F
Item: Item 3
Chunk 6
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ly, there can be
no assurance that we will ever be able to develop suitable potential drug candidates through internal research programs. This could materially
adversely affect our future growth and prospects.

If we encounter difficulties enrolling patients
in our clinical trials, our clinical development activities could be delayed or otherwise adversely affected.

Although we obtained CTA/FDA
approval to initiate clinical trials for our Lead Projects, there can be no assurance, timely completion of clinical trials in accordance
with their protocols depends, among other things, on our ability to enroll a sufficient number of patients who meet the trial criteria
and remain in the trial until its conclusion. We may experience difficulties enrolling and retaining appropriate patients in our clinical
trials for a variety of reasons, including but not limited to:

  the size and nature of the patient population;                  
  patient eligibility criteria defined in the clinical protocol;  

  the size of study population required for statistical analysis of the trial’s primary endpoints;                                                                                                      
  the proximity of patients to trial sites;                                                                                                                                                             
  the design of the trial and changes to the design of the trial;                                                                                                                                       
  our ability to recruit clinical trial investigators with the appropriate competencies and experience;                                                                                                 
  competing clinical trials for similar therapies or other new therapeutics exist and will reduce the number and types of patients available to us;                                                     
  clinicians’ and patients’ perceptions as to the potential advantages and side effects of the drug candidate being studied in relation to other available therapies, including any new drugs or tr...  

  our ability to obtain and maintain patient consents;                             
  patients enrolled in clinical trials may not complete a clinical trial; and      
  the availability of approved therapies that are similar to our drug candidates.  

Even if we are able to enroll
a sufficient number of patients in our clinical trials, delays in patient enrollment may result in increased costs or may affect the timing
or outcome of the planned clinical trials, which could prevent completion of these trials and adversely affect our ability to advance
the development of our drug candidates.

Clinical drug development involves a lengthy
and expensive process and could fail at any stage of the process. We have limited experience in conducting clinical trials and results
of earlier studies and trials may not be reproduced in future clinical trials.

For our drug candidates, clinical
testing is expensive and can take many years to complete, while failure can occur at any time during the clinical trial process. The results
of studies in animals and early clinical trials of our drug candidates may not predict the