Aethlon Medical (NASDAQ:AEMD) Chief Executive Officer and Chief Financial Officer Jim Frakes outlined the company’s clinical priorities and near-term milestones during a presentation at the Life Sciences Investor Forum, moderated by Zacks Small Cap Research Senior Analyst M Marin. Frakes focused on the company’s Hemopurifier device, its current oncology-oriented clinical program, and the company’s capital position as it advances through a safety trial in Australia.
Hemopurifier device and how it works
Frakes described the Hemopurifier as an extracorporeal (outside-the-body) blood filtration device designed to remove “harmful viruses and cancerous particles” known as exosomes or extracellular vesicles (EVs) from the bloodstream. The device connects to existing blood-pumping systems commonly found in hospitals and clinics, such as dialysis machines or continuous renal replacement therapy (CRRT) machines, using only the pumping function.
Frakes explained the device’s mechanism of action by noting that many viruses and EVs have a glycosylated (“sugary”) surface. In the Hemopurifier, plasma is filtered and exposed to a binding material that captures those particles. He described the device as containing “about 20,000 little fibers,” with what he called the company’s “secret sauce” located outside the fibers: diatomaceous earth bound to a plant lectin, which binds to the glycosylated surfaces. Filtered plasma then returns to the patient in a circuit. Treatments are typically four hours, with the goal of removing more particles over repeated passes to give the immune system a better chance to respond, he said.
Oncology focus: trial design and hypothesis
Frakes said EVs are nanoparticles released by cells that participate in cell-to-cell communication, and in cancer they have been associated with processes such as metastasis, angiogenesis, apoptosis, suppression of tumor-killing T-cells, and resistance to chemotherapy and immunotherapy agents. The company’s hypothesis is that removing some number of EVs from the bloodstream could help reduce metastasis and improve outcomes.
He said Aethlon’s clinical work is being positioned alongside two checkpoint inhibitor therapies, Keytruda and Opdivo, which he characterized as major oncology drugs that work “about a third of the time.” The company’s stated objective is to improve outcomes for some of the patients who do not respond to those therapies.
Frakes detailed the structure of the ongoing safety study in Australia, describing it as a roughly nine-patient trial in three cohorts:
- Cohort 1: Three patients treated one time
- Cohort 2: Three patients treated twice in a week
- Cohort 3: Three patients treated three times in a week (e.g., Monday/Wednesday/Friday)
He said the treatments are intended to be performed immediately before a patient’s next Keytruda or Opdivo dose, and he described the trial as a “basket trial” that could include many solid tumors for which those drugs have been approved.
Milestones: DSMB decision and cohort progression
Frakes said the first cohort was completed in the December quarter and that an independent Data Safety Monitoring Board (DSMB) approved moving forward to the second cohort. He stated that all three patients in the second cohort have now been treated and that the DSMB was expected to meet “later on this month” to decide whether the study should proceed to the third cohort based on safety.
He identified a series of upcoming milestones over the next several months, including the DSMB’s decision, data from the second cohort, initiation and completion of the third cohort, and overall trial data. He said the data is being generated by the University of Sydney, which he described as having expertise in EVs.
Frakes also said the company already has three potential patients “in the queue” for the third cohort, and that enrollment could move quickly if the DSMB provides approval, subject to logistics and patient follow-through.
Why Australia and regulatory path
Frakes cited several reasons for conducting the safety trial in Australia: the quality of medical practice, the clinical trial experience of the company’s chief medical officer in Australia, and a reimbursement program in which the company receives $0.43 in cash for every $1 spent on trial activities in the country. He described the reimbursement as reducing the trial’s cost.
On regulatory considerations, Frakes said he did not expect international data to be a barrier to FDA interactions, referencing prior experience with the FDA accepting data from trials conducted in India. He said the plan after completing the current trial is to apply to Australia’s regulator, the Therapeutic Goods Administration (TGA), for the next step, and that the company would consider parallel work in both Australia and the U.S. depending on financial position and staffing.
Frakes also noted that, unlike drugs, medical devices typically require two trials: the current safety trial and a larger efficacy trial. He said the efficacy trial would involve more patients and would be shaped by discussions with regulators, but would not require thousands of patients like many drug trials.
Financial position, manufacturing, and partnership strategy
On the balance sheet, Frakes said the company ended December with “just under $7 million” in cash and no debt. He put the burn rate at roughly $1.5 million per quarter (about $500,000 per month), with some variability depending on the number of treated patients due to hospital payment structures. He also said the company has approximately $1.85 million available under an at-the-market facility that it has not used.
Frakes said Aethlon has conducted 173 Hemopurifier treatments in 44 patients to date, and that the treatment history has been “very safe,” with no serious adverse events related to the device. He added that early throughput adjustments had been made and that there have been no significant issues since. He also said the company has a manufacturing facility in San Diego and believes production could be scaled, noting it is currently manufacturing several times a year and has enough devices for the current trial.
Looking ahead to funding and execution of a larger efficacy trial, Frakes said the company expects it will need a partner for the next stage. He said Aethlon has engaged Maxim, an investment bank, to run a more formal process for strategic and financing partners, and that a partner with industry knowledge would be the “best case,” though a financially oriented partner could also be beneficial.
Frakes briefly discussed earlier-stage efforts to explore additional applications—such as long COVID, autoimmune conditions involving platelet-derived EVs, and chronic kidney disease-related EVs—while stressing these efforts are early and not yet in clinical trials. He said the company is evaluating potential grant opportunities in these areas but reiterated that oncology remains the primary focus due to limited resources.
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.
