By M. Marin
NASDAQ: AEMD
READ THE FULL AEMD RESEARCH REPORT
Moving to final dosing cohort brings AEMD closer to generating, reporting data to move toward potential regulatory approval
Aethlon Medical (NASDAQ: AEMD), a clinical-stage medical therapeutic company advancing its lead asset, the Hemopurifier, to treat cancer and life-threatening viral infections, reported 4Q FY 2026 financial results yesterday and provided a business update. Importantly, the company’s Australian oncology study has advanced to the Cohort 3 final dosing. Enrollment activities for Cohort 3 continue at all three participating sites. AEMD recently treated the first participant in Cohort 3 at Australia’s Royal North Shore Hospital, where the participant completed three Hemopurifier treatments over a one-week period with no device deficiencies. The first Cohort 3 participant is now in the follow-up period. Moving the final dosing cohort ahead brings AEMD closer to generating and reporting data to inform future development and dosing strategy to move toward potential regulatory approval.
In Cohort 1, participants received one Hemopurifier treatment during a one-week period. Cohort 2 participants received two treatments. Once enrollment and treatment of participants in Cohort 2 was completed, the independent Data Safety Monitoring Board (DSMB) overseeing the clinical trial completed its safety review of the data from the participants in Cohort 2. The DSMB recommended that the trial progress to the final third cohort, indicating that "no safety concerns were noted with Hemopurifier device/procedure." Specifically, no serious adverse events (SAEs) or Dose-Limiting Toxicities (DLTs) related to the Hemopurifier treatment have been reported to date.
Recent and upcoming expected milestones
- Announce Cohort 2 safety ✓
- Board decision regarding progressing to Cohort 3 ✓
- Initiate Cohort 3 ✓
- Complete Cohort 3
- Announce overall trial data
- Potentially advance to efficacy trial
The Hemopurifier is an investigational extracorporeal device designed to bind and remove harmful extracellular vesicles (EVs) from the blood. It has FDA Breakthrough Device designation for the treatment of people with advanced or metastatic cancer who are either unresponsive to or cannot tolerate standard of care therapy, and with cancer types in which exosomes are indicated in the development or severity of the disease, and also for life-threatening viruses that are not addressed with approved therapies. The company believes the Hemopurifier is the only device currently being evaluated to remove EVs.
Studying whether Hemopurifier + standard of care therapies can increase percentage of patients who benefit
The trial is a safety and dose-finding study. The trial will monitor any adverse events and clinically significant changes in treated patients who have solid tumors with stable or progressive disease following treatment with Keytruda®, Opdivo®, or combined therapy. Despite the strong success of these standard of care therapies, only about 30% of cancer patients who receive pembrolizumab (Keytruda®) or nivolumab (Opdivo®) treatment for solid tumors have lasting clinical responses. The company’s hypothesis is that using the Hemopurifier in conjunction with these and with combination therapy can increase the percentage of patients who benefit.
In addition to monitoring safety, the study is designed to examine the number of Hemopurifier treatments needed to decrease the concentration of EVs and if these changes in EV concentrations improve the body's own natural ability to attack tumor cells.
Device has shown reduction in EVs, which are seen to contribute to metastasis & a range of diseases
The device has shown reduction in EVs and other harmful particles. Moreover, to date, over time, 173 Hemopurifier treatments have been administered in 44 patients with no SAEs. Once Cohort 3 treatment is completed, AEMD plans to report data from the overall study and, depending on Cohort 3 data, potentially form a partnership to assist with funding a subsequent efficacy trial.
EVs are seen to contribute to metastasis and to suppressing the immune system. Down the road, if the company’s current evaluation of the Hemopurifier in oncology proves beneficial, AEMD believes the device could support broader potential clinical application in a range of diseases. Excessive levels of PD-EVs (platelet-derived EVs) have been implicated in many diseases, including cancer, lupus, systemic sclerosis, multiple sclerosis, Alzheimer's disease, sepsis, acute and Long COVID, rheumatoid arthritis, and chronic kidney disease.
AEMD advanced preclinical research evaluating Hemopurifier applications in additional indications, including rheumatoid arthritis and chronic kidney disease. These activities are expected to support the expansion of the device's potential addressable market beyond oncology and infectious disease and could potentially create future opportunities to expand the platform into large markets characterized by significant unmet medical need. The company’s activities are being conducted in a cost-efficient manner consistent with AEMD’s continued focus on managing operating expenses.
As the company continues to build a database supporting the application of the Hemopurifier, an interview was published in IEEE Spectrum subsequent to FY-end featuring Aethlon's Chief Medical Officer and a physician involved in the treatment of an Ebola virus patient with the Hemopurifier during the 2014 outbreak, highlighting AEMD's experience with Ebola treatments. In addition, the company also confirmed the continued availability of its FDA-authorized expanded access (compassionate use) protocol and shared the protocol as well as past in vitro and in vivo data with organizations involved in global and U.S. emerging pathogen preparedness efforts, including the World Health Organization's R&D Blueprint expert panel and the National Emerging Special Pathogen Training and Education Center. Presumably, this could potentially lead to treatment of an Ebola patient if appropriate.
Potential for Hemopurifier compatibility with simplified blood treatment system could boost ease of using device; expanding IP portfolio
Separately, the company continues to assess the Hemopurifier’s compatibility with a simplified blood treatment system being developed by Stavro Medical. Initial testing assessing flow rates and transfer of fluid through the Hemopurifier has been completed, and future studies evaluating removal of surrogate markers for EVs by the Hemopurifier using the system are under consideration. If successful, the company believes a transition to a simplified system could expand potential treatment settings and improve the scalability and accessibility of Hemopurifier treatment.
In FY 2026, the company also strengthened its intellectual property (IP) portfolio through the issuance of patents in both the U.S. and Europe covering two potential applications of the Hemopurifier for coronavirus-related conditions: excessive clotting known as coagulopathy during acute COVID-19 infection and symptoms of Long COVID. These patents extend protection for certain applications into the 2040s.
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