Company: APM
Filing Date: 2025-11-17
Form Type: F-1
Source: 0001213900-25-111548
Chunk: 60

Company: Aptorum Group Ltd
Filing Date: 2025-11-17
Form: F-1
Chunk 60
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 to comply with applicable cGCP, the clinical data generated in our clinical trials may be deemed unreliable and the FDA, NMPA, EMA, Health Canada or comparable regulatory authorities may require us to perform additional clinical trials before approving our marketing applications. 31 We may experience numerous unexpected events during, or as a result of, clinical trials that could delay or prevent our ability to receive regulatory approval or commercialize our drug candidates, including but not limited to:

| ● | regulators, institutional review boards (“IRBs”)                                                                                         
 or ethics committees may not authorize us or our investigators to commence a clinical trial or conduct a clinical trial at a prospective 
 trial site;                                                                                                                              |

| ● | clinical trials of our drug candidates may produce negative                                                                                 
 or inconclusive results, and we may decide, or regulators may require us, to conduct additional clinical trials or abandon drug development 
 programs;                                                                                                                                   |

| ● | the number of patients required for clinical trials of our drug                                                                      
 candidates may be larger than we anticipate, enrollment may be insufficient or slower than we anticipate or patients may drop out at 
 a higher rate than we anticipate;                                                                                                    |

| ● | our contractors and investigators may fail to comply with regulatory                    
 requirements or meet their contractual obligations to us in a timely manner, or at all; |

| ● | we might have to suspend or terminate clinical trials of our                                                                         
 drug candidates for various reasons, including a lack of clinical response or a determination that participants are being exposed to 
 unacceptable health risks;                                                                                                           |

| ● | regulators, IRBs or ethics committees may require that we or                                                                         
 our investigators suspend or terminate clinical research for various reasons, including non-compliance with regulatory requirements; |

| ● | the cost of clinical trials of our drug candidates may be greater 
 than we anticipate;                                               |

| ● | the supply or quality of our drug candidates or other materials                                    
 necessary to conduct clinical trials of our drug candidates may be insufficient or inadequate; and |

| ● | our drug candidates may cause adverse events, have undesirable                                                                     
 side effects or other unexpected characteristics, causing us, our investigators, or regulators to suspend or terminate the trials. |

If we are required to conduct additional clinical trials or other testing of our drug candidates beyond those that we currently contemplate, if we are unable to successfully complete clinical trials of our drug candidates or other testing, if the results of these trials or tests are not positive or are only modestly positive or if they raise safety concerns, we may:

| ● | be delayed in obtaining