Company: AEMD
Filing Date: 2025-02-12
Form Type: 10-Q
Source: 0001683168-25-000960
Chunk: 74

Company: AETHLON MEDICAL INC
Filing Date: 2025-02-12
Form: 10-Q
Item: Item 8
Chunk 74
---
 Form 10-K for the fiscal year ended March 31, 2024, filed with the SEC on June 27, 2024, and should be carefully
considered, together with other information in this Quarterly Report on Form 10-Q and our other filings with the SEC before making investment
decisions regarding our securities.

    ·
    We have incurred significant losses and expect to continue to incur losses for the foreseeable future.

    ·
    We will require additional financing to sustain our operations, achieve our business objectives and satisfy our cash obligations, which may dilute the ownership of our existing stockholders.

    ·
    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.

    ·
    Delays, interruptions or the cessation of production by our third-party suppliers of important materials or delays in qualifying new materials, has and may continue to prevent or delay our ability to manufacture our Hemopurifier.

    ·
    We face intense competition in the medical device industry.

    ·
    Our Hemopurifier technology may become obsolete.

    ·
    If we fail to comply with extensive regulations of U.S. and foreign regulatory agencies, the commercialization of our products could be delayed or prevented entirely.

    ·
    If we are unable to regain compliance with the listing requirements of the Nasdaq Capital Market, our common stock may be delisted from the Nasdaq Capital Market, which could have a material adverse effect on our financial condition and could make it more difficult for you to sell your shares.

 29 

    ·
    
    As a public company with limited financial
resources undertaking the launch of new medical technologies, we may have difficulty attracting and retaining executive management and
directors.

    ·
    
    We plan to expand our operations, which may
strain our resources; our inability to manage our growth could delay or derail implementation of our business objectives.

    ·
    
    Our success is dependent in part on our executive
officers.

    ·
    
    We have not received, and may never receive,
approval from the FDA to market a medical device in the United States. Even though we have received breakthrough device designation for
the Hemopurifier for two independent indications, this designation may not expedite the development or review of the Hemopurifier and
does not provide assurance ultimately of PMA submission or approval by the FDA.

    ·
    Delays in successfully