Company: APM
Filing Date: 2025-04-30
Form Type: 20-F
Source: 0001213900-25-037669
Chunk: 7

Company: Aptorum Group Ltd
Filing Date: 2025-04-30
Form: 20-F
Item: Item 3
Chunk 7
---
 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.

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 would need to replace the failed study with new trials, which would
require significant additional expense, cause substantial delays in commercialization and materially adversely affect our business, financial
condition, cash flows and results of operations.

If clinical trials of our drug candidates
fail to demonstrate safety and efficacy to the satisfaction of the FDA, NMPA, EMA, Health Canada or other comparable regulatory authorities,
or do not otherwise produce positive results, we may incur additional costs or experience delays in completing, or ultimately be unable
to complete, the development and commercialization of our drug candidates.

Before applying for and obtaining
regulatory approval for the sale of any of our drug candidates, we must conduct extensive clinical trials to demonstrate the safety and
efficacy of our drug candidates in humans. Clinical testing is expensive, difficult to design and implement, can take many years to complete
and may fail. A failure of one or more of our clinical trials can occur at any stage of testing and successful interim results of a clinical
trial