Company: APM
Filing Date: 2025-12-05
Form Type: 424B5
Source: 0001213900-25-118752
Chunk: 237

Company: Aptorum Group Ltd
Filing Date: 2025-12-05
Form: 424B5
Chunk 237
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 Phase 1 studies also evaluate drug metabolism, structure-activity           
 relationships, and the mechanism of action in humans. These studies also determine which investigational drugs are used as research 
 tools to explore biological phenomena or disease processes. The total number of subjects included in Phase 1 studies varies         
 with the drug, but is generally in the range of twenty to eighty.                                                                   |

| ● | Phase 2. Phase 2 includes the early controlled clinical studies conducted to obtain                                               
 some preliminary data on the effectiveness of the drug for a particular indication or indications in patients with the disease or 
 condition. This phase of testing also helps determine the common short-term side effects and risks associated with the drug.      
 Phase 2 studies are typically well-controlled, closely monitored, and conducted in a relatively small number of patients,         
 usually involving several hundred people.                                                                                         |

| ● | Phase 3. Phase 3 studies are expanded controlled and uncontrolled trials. They are                                                   
 performed after preliminary evidence suggesting effectiveness of the drug has been obtained in Phase 2, and are intended to          
 gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of 
 the drug. Phase 3 studies are designed to provide an adequate basis for extrapolating the results to the general population and      
 transmitting that information in the physician labeling. Phase 3 studies usually include several hundred to several thousand         
 people.                                                                                                                              |

Progress reports detailing
the results of the clinical trials must be submitted at least annually to the FDA and safety reports must be submitted to the FDA and
clinical investigators within 15 calendar days for serious and unexpected suspected adverse events, any clinically important increase
in the rate of a serious suspected adverse reaction over that listed in the protocol or investigator’s brochure, or any findings
from other studies or animal or in vitro testing that suggest a significant risk in humans exposed to the drug candidate. Additionally,
a sponsor must notify the FDA of any unexpected fatal or life-threatening suspected adverse reaction no later than 7 calendar days
after the sponsor’s receipt of the information. There is no assurance that Phase 1, Phase 2 and Phase 3 testing can
be completed successfully within any specified period, or at all. The FDA or the sponsor may suspend or terminate a clinical trial at
any time on various grounds, including a finding that the research subjects or patients are being exposed to an unacceptable health risk.
Similarly, an IRB can suspend or terminate approval of a clinical trial at its institution if the clinical trial is not being