Company: AEMD
Filing Date: 2025-06-26
Form Type: 10-K
Source: 0001683168-25-004780
Chunk: 41

Company: AETHLON MEDICAL INC
Filing Date: 2025-06-26
Form: 10-K
Item: Item 1
Chunk 41
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facilities. If any of these occur, the development and commercialization of our Hemopurifier product candidate could be delayed, curtailed
or terminated, because we may not have sufficient financial resources or capabilities to continue such development and commercialization
on our own.

If we or our contractors or service providers
fail to comply with regulatory laws and regulations, we or they could be subject to regulatory actions, which could affect our ability
to develop, market and sell our Hemopurifier product candidate and any other future product candidates that we may develop, if any, and
may harm our reputation.

If we or our manufacturers
or other third-party contractors fail to comply with applicable federal, state or foreign laws or regulations, we could be subject to
regulatory actions, which could affect our ability to successfully develop, market and sell our Hemopurifier product candidate or any
future product candidates, if any, and could harm our reputation and lead to reduced or non-acceptance of our proposed product candidates
by the market. Even technical recommendations or evidence by the FDA through letters, site visits, and overall recommendations to academia
or biotechnology companies may make the manufacturing of a clinical product extremely labor intensive or expensive, making the product
candidate no longer viable to manufacture in a cost-efficient manner. The mode of administration may make the product candidate not commercially
viable. The required testing of the product candidate may make that candidate no longer commercially viable. The conduct of clinical trials
may be critiqued by the FDA, or a clinical trial site’s IRB or Institutional Biosafety Committee, which may delay or make impossible
clinical testing of a product candidate. The IRB for a clinical trial may stop a trial or deem a product candidate unsafe to continue
testing. This would have a material adverse effect on the value of the product candidate and our business prospects.

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We will need to outsource and rely on third
parties for the clinical development, sales and marketing of our Hemopurifier or any future product candidates that we may develop, and
our future success will be dependent on the timeliness and effectiveness of the efforts of these third parties.

We do not have the required
financial and human resources to carry out on our own all the pre-clinical and clinical development for our Hemopurifier product candidate
or any other or future product candidates that we may develop, and do not have the capability and resources to market or sell our Hemopurifier
product candidate or