Company: AEMD
Filing Date: 2025-06-26
Form Type: 10-K
Source: 0001683168-25-004780
Chunk: 606

Company: AETHLON MEDICAL INC
Filing Date: 2025-06-26
Form: 10-K
Item: Item 2
Chunk 606
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 (“Aethlon,”
the “Company,” “we” or “us”) is a medical therapeutic company focused on developing the Hemopurifier,
a clinical-stage immunotherapeutic device designed to combat cancer and life-threatening viral infections and with additional potential
applications e in organ transplantation and other areas of significant unmet needs. In human studies, 164 sessions with 38 patients, the
Hemopurifier was safely utilized and demonstrated the potential to remove life-threatening viruses. In pre-clinical studies, the Hemopurifier
has demonstrated the potential to remove harmful exosomes and exosomal particles from biological fluids, utilizing its proprietary lectin-based
technology. This action has potential applications in cancer, where exosomes and exosomal particles may promote immune suppression and
metastasis, and in 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 either unresponsive to or intolerant of standard of care therapy, and with cancer types in which exosomes or exosomal particles have been shown to participate in the development or severity of the disease; and

    ·
    the treatment of life-threatening viruses that are not addressed with approved therapies.

Oncology

We believe that the Hemopurifier
may be a substantial advancement in the treatment of patients with advanced and metastatic cancer through its design to bind to and remove
harmful remove harmful extracellular vesicles particles that promote the growth and spread of tumors. In October 2022, we formed a wholly-owned
subsidiary in Australia to initially conduct oncology-related clinical research, then seek regulatory approval and commercialize our Hemopurifier
in Australia.

We completed an in vitro
binding study of extracellular vesicles from cancer patient samples, to provide pre-clinical evidence to support our trial design and
translational endpoints. Our study indicated positive results from this study, providing evidence that our Hemopurifier removes extracellular
vesicles, or EVs, from plasma. This translational study provides pre-clinical evidence to support our phase 1 safety, feasibility and
dose-finding clinical trials of our Hemopurifier in patients with solid tumors who have stable or progressive disease during anti-PD-1
monotherapy treatment, such as Keytruda® or Opdivo®.

We have