Company: AEMD
Filing Date: 2025-02-12
Form Type: 10-Q
Source: 0001683168-25-000960
Chunk: 43

Company: AETHLON MEDICAL INC
Filing Date: 2025-02-12
Form: 10-Q
Item: Item 8
Chunk 43
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December 31, 2024

1. NATURE OF BUSINESS AND BASIS OF PRESENTATION ORGANIZATION

Aethlon Medical, Inc. (“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 for use in organ transplantation.
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.

We believe 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 exosomes
and exosomal 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 have launched in Australia and in India safety,
feasibility and dose-finding clinical trials of the Hemopurifier in cancer patients with solid tumors who have stable or progressive disease
during anti-PD-1 monotherapy treatment, such as Keytruda® (pembrolizumab) or Opdivo® (nivolumab). The primary endpoint of the
approximately nine to 18-patient, safety, feasibility and dose-finding trial in each country is safety.

The following two hospitals in Australia have
received ethics committee approval, have gone through training on our device and are now open for patient enrollment: Royal Adelaide