Company: APM
Filing Date: 2025-11-17
Form Type: F-1
Source: 0001213900-25-111548
Chunk: 64

Company: Aptorum Group Ltd
Filing Date: 2025-11-17
Form: F-1
Chunk 64
---
 will likely enable us to complete the preclinical development of at least one of our current Lead Projects, the full clinical development, manufacturing and launch of that drug candidate, will take significant additional time and likely require funding beyond the existing cash. In addition, if regulatory authorities require additional time or studies to assess the safety or efficacy of Aptorum’s drug candidates, we may not have or be able to obtain adequate funding to complete the necessary steps for approval for Aptorum’s drug candidates or any future drug candidates. Preclinical studies in animals and clinical trials in humans to demonstrate the safety and efficacy of Aptorum’s drug candidates are time-consuming, expensive and take several years or more to complete. Delays in preclinical or clinical trials, regulatory approvals or rejections of applications for regulatory approval in the U.S., Europe, the PRC or other markets may result from many factors, including but not limited to:

| ● | our inability to obtain sufficient funds required to conduct                                        
 or continue a trial, including lack of funding due to unforeseen costs or other business decisions; |

| ● | regulatory reports for additional analysts, reports, data, preclinical 
 studies and clinical trials;                                           |

| ● | failure to reach agreement with, or inability to comply with                                                                      
 conditions imposed by the FDA, NMPA, EMA, Health Canada or other regulators regarding the scope or design of our clinical trials; |

| ● | regulatory questions regarding interpretations of data and results                          
 and the emergence of new information regarding Aptorum’s drug candidates or other products; |

| ● | delay or failure in obtaining authorization to commence a clinical                                                                
 trial or inability to comply with conditions imposed by a regulatory authority regarding the scope or design of a clinical trial; |

| ● | withdrawal of clinical trial sites from our clinical trials                                                     
 as a result of changing standards of care or the ineligibility of a site to participate in our clinical trials; |

| ● | unfavorable or inconclusive results of clinical trials and supportive                                                  
 non-clinical studies, including unfavorable results regarding effectiveness of drug candidates during clinical trials; |

| ● | difficulty in maintaining contact with patients during or after 
 treatment, resulting in incomplete data;                        |

34

| ● | our inability to obtain approval from IRBs or ethics committees 
 to conduct clinical trials at their respective sites;           |

| ● | our inability to enroll and retain a sufficient number of patients 
 who meet the inclusion and exclusion criteria in a clinical trial; |

| ● | our inability to conduct a clinical trial in accordance with