Company: APM
Filing Date: 2025-12-05
Form Type: 424B5
Source: 0001213900-25-118752
Chunk: 226

Company: Aptorum Group Ltd
Filing Date: 2025-12-05
Form: 424B5
Chunk 226
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 intend to use this standard for any regulatory submission. The US FDA or other regulatory agencies may not necessarily employ
the same statistical standard to assess the efficacy in clinical trials, the results of which would be submitted for regulatory approval.
Although a p-value of 0.05 has become the standard, the US FDA or other regulatory agencies may also individualize their efficacy standard
for different clinical programs based on the indications, the purpose of a clinical trial, among others.

FDA Application Status

As of the date hereof, we received
CTA and IND approvals for ALS-4 and SACT-1 from Health Canada and US FDA to initiate human clinical trial. We have not submitted other
applications for IND to the FDA or other regulatory agencies.

Competition

Our industry is highly competitive
and subject to rapid and significant change. While we believe that our development and commercialization experience, scientific knowledge
and industry relationships provide us with competitive advantages, we face competition from pharmaceutical and biotechnology companies,
including specialty pharmaceutical companies, and generic drug companies, academic institutions, government agencies and research institutions.

There are a number of large
pharmaceutical and biotechnology companies that currently market and sell drugs or are pursuing the development of drugs for the diagnosis
and treatment of diseases for which we are developing products or technology. Moreover, a number of additional drugs are currently in
clinical trials and may become competitors if and when they receive regulatory approval.

Many of our competitors have
longer operating histories, better name recognition, stronger management capabilities, better supplier relationships, a larger technical
staff and sales force and greater financial, technical or marketing resources than we do. Mergers and acquisitions in the pharmaceutical
and biotechnology industries

may result in even more resources being concentrated
among a smaller number of our competitors. Our commercial opportunity could be reduced or eliminated if our competitors develop or market
products or other novel therapies that are more effective, safer or less costly than our current drug candidates, or any future drug candidates
we may develop, or obtain regulatory approval for their products more rapidly than we may obtain approval for our current drug candidates
or any such future drug candidates. Our success will be based in part on our ability to identify, develop and manage a portfolio of drug
candidates that are safer and more effective than competing products.

| 3 | https://www.ke.hku.hk/story/innovation/the-magic-of-chinese-yam-for-treatment-of-menopausal-syndrome; 
 see also, Scientific Reports, 5-