Company: AEMD
Filing Date: 2025-08-13
Form Type: 10-Q
Source: 0001683168-25-006049
Chunk: 22

Company: AETHLON MEDICAL INC
Filing Date: 2025-08-13
Form: 10-Q
Item: Item 1
Chunk 22
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 solid tumors who have stable or progressive disease, while receiving treatment
that includes Pembrolizumab (Keytruda®) or Nivolumab (Opdivo®).

The Company received formal approval from the India’s regulatory
agency, the Central Drugs Standard Control Organization (CDSCO), to initiate an oncology clinical trial in India on July 7, 2025. The
Company had been working with its India CRO, Qualtran LLC, toward site initiation at Medanta Medicity Hospital. While the Company had
initially anticipated a more expedited startup in India subsequent discussions with the CRO indicated longer-than-expected timelines.
After evaluating the project duration and cost of conducting the study, the Company made a strategic decision to discontinue efforts in
India and to concentrate its resources on the ongoing oncology trial in Australia, which remains the Company’s primary clinical
development priority.

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The
Hemopurifier is designed to address life-threatening viral infections, particularly those involving highly glycosylated viruses for which
there are no approved therapies. It has previously been used under FDA and international regulatory frameworks to treat individuals infected
with HIV, hepatitis C, Ebola, and SARS-CoV-2. While our COVID-19 clinical trials in the U.S. and India have been terminated due to low
ICU enrollment, these programs provided real-world evidence of Hemopurifier use in critically ill patients. We maintain an open IDE for
viral indications, preserving the ability to respond to future outbreaks or emerging pathogens.

In addition to our ongoing clinical trials, we continue
to explore potential new applications for the Hemopurifier through internal pre-clinical research. In the quarter ended June, 30 2025
results of our pre-clinical ex-vivo study entitled “Ex Vivo Removal of CD41 positive platelet microparticles from Plasma by a Medical
Device containing a Galanthus nivalis agglutinin (GNA) affinity resin” were published in the pre-print vehicle bioRxiv. This manuscript
has been submitted to a peer-reviewed publication for review. In the study we evaluated the Hemopurifier’s ability to remove disease-relevant
extracellular vesicles (EVs), including those derived from platelets, which are implicated in cancer, autoimmune disease, and neurological
disorders. The study demonstrated >98% removal of platelet-derived EVs from healthy human plasma in a simulated clinical session. We
are also collaborating with