Company: AEMD
Filing Date: 2025-06-26
Form Type: 10-K
Source: 0001683168-25-004780
Chunk: 187

Company: AETHLON MEDICAL INC
Filing Date: 2025-06-26
Form: 10-K
Item: Item 1A
Chunk 187
---
 products that are either more effective than those that we may
develop, alone or with our collaborators, or that are marketed before any products we develop are marketed. Our competitors include fully
integrated pharmaceutical companies and biotechnology companies as well as universities and public and private research institutions.
Many of the organizations competing with us have substantially greater capital resources, larger research and development staffs and facilities,
greater experience in product development and in obtaining regulatory approvals, and greater marketing capabilities than we do. If our
competitors develop more effective pharmaceutical treatments for infectious disease or cancer, or bring those treatments to market before
we can commercialize the Hemopurifier for such uses, we may be unable to obtain any market traction for our products, or the diseases
we seek to treat may be substantially addressed by competing treatments. If we are unable to successfully compete against larger companies
in the pharmaceutical industry, we may never generate significant revenue or be profitable.

We have limited experience in identifying
and working with large-scale contracts with medical device manufacturers; manufacture of our devices must comply with good manufacturing
practices in the United States.

To achieve the levels of production
necessary to commercialize our Hemopurifier and any other future products, we will need to secure large-scale manufacturing agreements
with contract manufacturers which comply with good manufacturing practice standards and other standards prescribed by various federal,
state and local regulatory agencies in the United States and any other country of use. We have limited experience coordinating and overseeing
the manufacture of medical device products on a large-scale. It is possible that manufacturing and control problems will arise as we attempt
to commercialize our products and that manufacturing may not be completed in a timely manner or at a commercially reasonable cost. In
addition, we may not be able to adequately finance the manufacture and distribution of our products on terms acceptable to us, if at all.
If we cannot successfully oversee and finance the manufacture of our products if they obtain regulatory clearances, we may never generate
revenue from product sales and we may never be profitable.

 19 

We have in the
past experienced a material weakness in our internal controls over financial reporting. If we fail to maintain effective internal controls
and fail to remediate any future or present control deficiencies, our ability to produce accurate and timely financial statements could
be impaired, which could harm our operating results, our ability to operate our business and our reputation with investors, ultimately
leading to a decline in the price of our Common Stock.

As
a public company, we are subject to