Aethlon Medical (NASDAQ:AEMD) said it is nearing completion of its Australian oncology study of the Hemopurifier, an investigational blood-filtration device designed to selectively remove extracellular vesicles, or EVs, and certain viruses from blood.
Chief Executive Officer Jim Frakes said the company has completed seven of nine planned patient treatments in the study and is working to finish treatments for the remaining two patients, followed by eight-week follow-up periods. The company aims to complete those steps by the end of 2026, he said.
Final Oncology Cohort Underway
The Australian study’s third and final cohort is evaluating three patients receiving the Hemopurifier three times in one week, on a Monday-Wednesday-Friday schedule. Earlier cohorts evaluated one treatment in three patients and two treatments in another three patients.
Frakes said the second cohort showed decreases in EVs and microRNAs associated with cancer progression, alongside increases in certain lymphocyte subsets and other blood-chemistry measures. He said those directional changes appeared more consistently across participants and lasted longer than observations from the single-treatment first cohort.
“We now need to see whether Cohort 3 confirms that trend,” Frakes said, stressing that the data remain preliminary.
He said the company is looking for greater consistency, magnitude and duration of changes in the final cohort. Frakes also said Aethlon observed that EV levels returned later after two treatments than after one treatment, and returned at a lower level than the initial EV measurements.
Potential Next Steps Include Regulatory Discussions
Once the final treatments and follow-up are completed, Aethlon plans to analyze the full dataset and prepare a clinical study report. The company then intends to hold pre-registration discussions with the U.S. Food and Drug Administration and Australia’s Therapeutic Goods Administration.
If the findings support further development, Frakes said the next step would likely be a more structured efficacy study. He added that the three-treatment regimen now being evaluated in the final cohort could inform the design of a future study if the results remain encouraging.
The company’s oncology program is its lead clinical focus, though Aethlon is also evaluating the broader potential of the Hemopurifier platform in long COVID and other conditions in which EVs may have a role.
Long COVID Work Continues Internally
Frakes said Aethlon’s research has found that both small and large EVs from long COVID patient plasma can bind to the proprietary resin within the Hemopurifier. The company has also observed reductions in certain microRNAs associated with immune dysregulation and inflammation, he said.
Aethlon is conducting the work internally at what Frakes characterized as a relatively low cost while speaking with academic institutions and regulators about requirements for advancing additional indications into clinical development. He said a clinical trial in another indication would require additional capital, a partner, government grant funding, or a combination of those sources.
On safety, Frakes said the company has recorded roughly 150 treatments without device-related serious adverse events or dose-limiting toxicities. He described the safety database as persuasive, while noting that regulators ultimately determine the significance of those findings.
Cash Position and Investor Milestones
Frakes said Aethlon ended the June 30 quarter with approximately $4.9 million in cash and subsequently raised about $4 million in gross proceeds. Based on current plans, he said the company believes its cash resources are sufficient to fund operations for at least the next 12 months.
For investors, Frakes identified three areas to watch: completion of the final oncology cohort and full dataset; analysis of the results and subsequent regulatory discussions; and continued development work for the Hemopurifier platform in long COVID and other diseases.
About Aethlon Medical (NASDAQ:AEMD)
Aethlon Medical, Inc (NASDAQ: AEMD) is a clinical?stage biotechnology company focused on developing novel immunotherapeutic medical devices to address life?threatening diseases. The company’s lead product candidate, the Hemopurifier®, is an extracorporeal affinity device designed to remove circulating viruses and immunosuppressive exosomes from the bloodstream. By targeting glycosylated pathogens and exosomes, Aethlon aims to restore immune function and improve patient outcomes in oncology and infectious disease settings.
The Hemopurifier platform leverages proprietary lectin affinity technology to selectively bind and eliminate harmful particles without depleting healthy blood components.
