Company: AEMD
Filing Date: 2025-11-12
Form Type: 10-Q
Source: 0001683168-25-008271
Chunk: 89

Company: AETHLON MEDICAL INC
Filing Date: 2025-11-12
Form: 10-Q
Item: Item 3
Chunk 89
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 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.

    ·
    Delays in successfully commencing or completing our planned clinical trials could jeopardize our ability to obtain regulatory approval and sustain our operations.

 24 

Other than disclosed herein, there have been no
material changes to the risk factors previously disclosed under the heading “Risk Factors” in our Annual Report. The risks
described in our Annual Report are not the only risks facing our company. Additional risks and uncertainties not currently known to us
or that we currently deem to be immaterial also may materially adversely affect our business, financial condition or future results.

Inadequate funding for the FDA, other government agencies or
comparable foreign regulatory authorities could hinder their ability to hire and retain key leadership and other personnel, prevent new
products and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal
business functions on which the operation of our business may rely, which could negatively impact our business.

Federal agencies in the United States are currently
operating under a government shutdown that began on October 1, 2025, following the expiration of the most recent continuing resolution.
Without appropriation of additional funding to federal agencies, our business operations related to our clinical development activities
for the U.S. market could be impacted. The ability of the FDA to review and approve new products can be affected by a variety of factors,
including government budget and funding levels, ability to hire and retain key personnel and accept the payment of user fees, and statutory,
regulatory, and policy changes. Average review times at the agency have fluctuated as a result In addition, government funding of other
government agencies or comparable foreign regulatory authorities on which our operations may rely, including those that fund research
and development activities, is subject to the political process, which is inherently fluid and unpredictable. The Trump Administration
has issued executive orders seeking to greatly reduce the size of the federal workforce, including through layoffs and severance packages
offered to employees of federal agencies within the executive branch and independent agencies, including the FDA. Any such reduction in
personnel may result in longer review times by the FDA and other agencies.

Disruptions and personnel turnover, as a result