Aethlon Medical (NASDAQ:AEMD) executives James B. Frakes, who serves as CEO and CFO, and Chief Medical Officer Steven LaRosa provided an update on the company’s Hemopurifier program and ongoing oncology-focused clinical trial during a recent conference presentation. Management described the Hemopurifier as an extracorporeal (outside-the-body) medical device designed to remove infectious viruses and cancer-associated particles, including exosomes—also referred to as extracellular vesicles (EVs)—from a patient’s bloodstream.
Hemopurifier technology and indication focus
Frakes explained that the Hemopurifier can be connected to existing blood-pumping infrastructure commonly found in hospitals and clinics worldwide, including dialysis machines, plasmapheresis machines, and CRRT systems. Treatment sessions are typically about four hours, with blood pumped from the patient through the device.
Prior clinical experience and safety learnings
LaRosa reviewed the Hemopurifier’s earlier clinical work, which targeted enveloped viruses. He said the company’s early trials were in HIV and hepatitis C, adding that effective therapies now exist for those infections. He also referenced work in acute COVID-19 and Ebola, describing those efforts as responsive to outbreaks and pandemics as they occur.
Across all historical uses, LaRosa said Aethlon has treated 44 patients in total, representing 173 unique Hemopurifier sessions. He characterized the device as “remarkably well-tolerated,” with relatively minor side effects such as headache, cough, and backache. He also outlined operational adjustments made over time, including modifying flow rates to prevent hemolysis (breakage of red blood cells) and implementing real-time coagulation monitoring and anticoagulation algorithms to reduce clotting risk within the device.
Oncology trial design, milestones, and upcoming readouts
Management said the company’s current lead oncology indication involves solid-tumor patients who are not responding to anti-PD-1 therapies such as Keytruda or Opdivo. LaRosa said EVs released by tumor cells are implicated in cancer spread and resistance to immunotherapy, and the company’s hypothesis is that removing EVs from the bloodstream could improve response to therapy. Frakes noted that anti-PD-1 therapies work “about a third of the time,” and Aethlon is aiming at the two-thirds of patients who do not respond.
The current study was described as a sequential, three-cohort safety, feasibility, and dose-finding trial:
- Cohort 1 (completed): Three patients received a single Hemopurifier treatment. LaRosa said no dose-limiting toxicities or serious device-related adverse events were observed, and an independent Data Safety Monitoring Board (DSMB) recommended advancing to the next cohort.
- Cohort 2 (treatments completed): Three patients received two Hemopurifier treatments within one week. Those patients are in the safety follow-up phase, and LaRosa said the company anticipates a second independent DSMB meeting toward the end of March.
- Cohort 3 (pending DSMB clearance): Patients would receive three Hemopurifier treatments within a one-week period.
In terms of near-term metrics, LaRosa highlighted the March DSMB meeting as the key gating event for moving into the third cohort. He added that within roughly two months after the DSMB decision, the company expects central lab data evaluating how well the device removes EVs and whether it improves anti-tumor T cells. Completion of the third cohort would mark completion of the trial, followed by a broader data readout.
Why Australia, and plans for regulatory engagement
Frakes said Aethlon is conducting the trial in Australia for several reasons, including clinical capabilities, LaRosa’s prior trial experience in the country, and relationships with principal investigators. He also pointed to Australia’s life science incentive program, stating that the company currently receives a 43% rebate on eligible clinical trial spending in Australia, paid as cash. Frakes said Aethlon received a check for “several hundred thousand dollars” for the prior year’s expenditures.
On regulatory considerations, Frakes said the company has previously generated clinical data in other countries—he cited India—and that the FDA accepted that data for U.S. regulatory engagement. He also said Aethlon has received FDA Breakthrough Device Designations in viruses and oncology. Looking ahead, management said it plans to take the Australian trial data back to U.S. regulators and also engage Australia’s Therapeutic Goods Administration (TGA) regarding future trials. Frakes said the company expects it will need another trial but does not yet know the size until discussions with regulators occur.
Operational execution, SLAM platform concept, and financial runway
LaRosa outlined how a potential “SLAM” system could simplify how treatments are delivered. He said the current approach requires a large dialysis catheter and use of a dialysis machine primarily for its blood pumping function, which typically means treatment in a dialysis unit with nephrology support. A SLAM-compatible setup, if feasible, could use a thinner single-lumen catheter and a simplified blood pump, potentially enabling treatment in oncology units or infusion centers rather than dialysis beds. Management emphasized these efforts are at an early, preliminary stage to assess compatibility.
On trial execution, Frakes credited the use of two groups—Trialfacts and Dedicated—for online marketing and screening directly to patients, with pre-screened candidates then referred to investigative sites. He said the approach has already helped enroll patients and has created a pipeline for the third cohort, with candidates effectively waiting for DSMB clearance.
Financially, Frakes said the company reported roughly $7 million in cash as of the quarter ended December 31, with a burn rate of about $500,000 per month, or $1.5 million per quarter. He added that Aethlon also has access to an at-the-market offering for approximately $1.8 million. Frakes said this should carry the company through the current trial, while noting that, like other small life science companies, Aethlon expects it will eventually need a strategic partnership or additional financing before reaching an approved product.
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.
