Company: AEMD
Filing Date: 2025-11-12
Form Type: 10-Q
Source: 0001683168-25-008271
Chunk: 41

Company: AETHLON MEDICAL INC
Filing Date: 2025-11-12
Form: 10-Q
Item: Item 8
Chunk 41
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 to the Hemopurifier have been reported.

Enrollment for Cohort 2 is now open. In this phase,
participants will receive two Hemopurifier treatments over a one-week period at the study's three active clinical sites in Australia.
This trial, which aims to enroll approximately 9 to 18 patients, is designed to evaluate the safety and feasibility of administering the
Hemopurifier at varying dosing intervals in patients with solid tumors who have stable or progressive disease, while receiving treatment
that includes Pembrolizumab (Keytruda®) or Nivolumab (Opdivo®).

The Company previously pursued approval of a similar
clinical trial in India. We received formal approval from the Indian regulatory agency, the Central Drugs Standard Control Organization
(CDSCO), to conduct this trial in India on July 7, 2025. We were working with our India CRO, Qualtran, toward site initiation at Medanta
Medicity Hospital. However, after reviewing extended timelines associated with site activation and trial execution, we made the decision
to cancel the Indian trial to conserve resources and to concentrate efforts on the Australian oncology trial.

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 first fiscal quarter
of 2026, 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