Company: APM
Filing Date: 2025-07-15
Form Type: DRS
Source: 0001213900-25-063899
Chunk: 50

Company: Aptorum Group Ltd
Filing Date: 2025-07-15
Form: DRS
Chunk 50
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 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 results of later-stage clinical trials. Drug
candidates in later stages of clinical trials may fail to show the desired safety and efficacy traits despite having progressed through
studies in animals and initial clinical trials. In some instances, there can be significant variability in safety and/or efficacy results
between different trials of the same drug candidate due to numerous factors, including changes in trial procedures set forth in protocols,
differences in the size and type of the patient populations (including genetic differences), patient adherence to the dosing regimen and
the patient dropout rate. Results in later trials may also differ from earlier trials due to a larger number of clinical trial sites and
additional countries and languages involved in such trials. In addition, the design of a clinical trial can determine whether its results
will support approval of a drug candidate, and flaws in the design of a clinical trial may not become apparent until the clinical trial
is well advanced and significant expense has been incurred.

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A number of companies in the
pharmaceutical and biotechnology industries have suffered significant setbacks in advanced clinical trials due to lack of demonstrated
efficacy or adverse safety profiles, notwithstanding promising results in earlier trials. Clinical trials of potential products often
reveal that it is not practical or feasible to continue development efforts. Furthermore, if the trials we conduct fail to meet their
primary statistical and clinical endpoints, they will not support the approval from the FDA, NMPA, EMA, Health Canada or other comparable
regulatory authorities for our drug candidates. If this occurs, we