Company: APM
Filing Date: 2025-07-15
Form Type: DRS
Source: 0001213900-25-063899
Chunk: 56

Company: Aptorum Group Ltd
Filing Date: 2025-07-15
Form: DRS
Chunk 56
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 be able to obtain adequate funding to complete the necessary steps for approval
for our drug candidates or any future drug candidates.

Preclinical studies in animals
and clinical trials in humans to demonstrate the safety and efficacy of our 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 our 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; |

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| ● | 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;                              |
| ● | 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 regulatory requirements or our clinical protocols; |

| ● | clinical sites and investigators deviating from trial protocol, failing to conduct the trial in accordance with regulatory requirements, withdrawing from or dropping out of a trial, or becoming ineligible to participate in a trial; |
| ● | failure of our clinical trial managers to satisfy their contractual duties or meet expected deadlines;                                                                                                                                  |
| ● | manufacturing issues, including