Company: AEMD
Filing Date: 2025-11-12
Form Type: 10-Q
Source: 0001683168-25-008271
Chunk: 40

Company: AETHLON MEDICAL INC
Filing Date: 2025-11-12
Form: 10-Q
Item: Item 8
Chunk 40
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September 30, 2025

1. NATURE OF BUSINESS AND BASIS OF PRESENTATION ORGANIZATION

Aethlon Medical, Inc., or Aethlon, the Company,
we or us, is a medical therapeutic company focused on developing the Hemopurifier® (HP), a clinical-stage immunotherapeutic device
intended for applications in cancer, life-threatening viral infections, and organ transplantation and other areas of significant unmet
needs. In human studies (167 sessions with 41 patients), the Hemopurifier was used safely and demonstrated the potential to remove enveloped
viruses. In pre-clinical studies, the Hemopurifier has exhibited the capacity to remove harmful extracellular vesicles (EVs) and enveloped
viruses from biological fluids, utilizing its proprietary lectin-based mechanism. These extracellular vesicles have been implicated in
disease processes such as immune suppression and metastasis in cancer as well as in the progression of severe life-threatening infectious
diseases. The U.S. Food and Drug Administration (“FDA”) has designated the Hemopurifier as a “Breakthrough Device”
for two independent indications:

    ·
    the treatment of individuals with advanced or metastatic cancer who are unresponsive to or intolerant of standard of care therapy, and with cancer types in which extracellular vesicles have been shown to participate in the development or severity of the disease; and

    ·
    the treatment of life-threatening viruses for which no approved therapies currently exist.

We are also evaluating
the Hemopurifier’s potential in additional clinical contexts based on its mechanism of action and preclinical findings.

Three clinical sites in Australia—Royal
Adelaide Hospital in Adelaide, Pindara Private Hospital in the Gold Coast, and GenesisCare North Shore Hospital in Sydney—are currently
open for enrollment in our phase 1 oncology trial. As of November 3, 2025, we have treated three participants in the first of three planned
treatment cohorts. The Data Safety Monitoring Board (DSMB), comprising independent medical experts in nephrology and oncology, has reviewed
the data from the initial cohort. Each of the three participants received a single 4-hour Hemopurifier treatment. Based on their evaluation,
the DSMB found no safety concerns and confirmed that the Hemopurifier continues to demonstrate a favorable safety and tolerability profile.
To date, no serious adverse events (SAEs) or Dose-Limiting Toxicities (DLTs) related