Aethlon Medical (NASDAQ:AEMD) CEO and CFO Jim Frakes said the company is focused on advancing its Hemopurifier device as a platform technology designed to remove disease-promoting particles from the bloodstream, with oncology as its primary clinical focus.
Speaking in a company update interview, Frakes described Aethlon’s mission as improving outcomes for patients with life-threatening diseases by helping existing therapies work better, rather than replacing them. He said many cancer patients either do not respond to current treatments or stop responding, and Aethlon believes tumor-released particles in the bloodstream may interfere with the body’s immune response.
Hemopurifier Positioned as a Complementary Device
Frakes described the Hemopurifier as a specialized blood filtration system that connects to blood-pumping equipment such as dialysis or continuous renal replacement therapy machines used in hospitals and clinics. During a typical treatment, which he said runs about four hours, blood circulates through the device, where targeted particles are captured before the blood is returned to the patient.
Because the device is designed to remove harmful particles rather than add another drug, Frakes said Aethlon’s approach could potentially complement multiple therapies across different diseases. He contrasted the company’s strategy with many oncology companies that are developing drugs to target cancer cells directly.
“Rather than targeting the cancer cells directly with a drug, we’re working to improve the environment surrounding the cancer by removing those harmful circulating particles,” Frakes said.
Australian Oncology Trial Nears Completion
Aethlon is conducting a small safety trial in Australia involving cancer patients who are failing Merck’s KEYTRUDA or Bristol Myers Squibb’s OPDIVO therapies. Frakes said the trial is expected to enroll about nine patients, though it could expand by up to three additional patients if device-related serious adverse events occur. He said seven of the nine patients have been treated and that no such device-related serious adverse events have occurred so far.
Frakes said the company has observed reductions in extracellular vesicles, or EVs, and changes in immune system biomarkers that are consistent with Aethlon’s scientific hypothesis. He said the company believes EVs released by tumors may play a role in metastasis and immune system interference.
He cautioned that it remains early and that Aethlon still needs to complete the study and conduct statistical analysis before drawing conclusions. However, he said the biological signals observed so far give the company “increasing confidence that the device is doing what it was designed to do.”
Frakes said the next steps are to complete the trial, analyze the full data set and meet with regulators, including the U.S. Food and Drug Administration and Australia’s Therapeutic Goods Administration, to discuss the design of the next clinical trial.
Long COVID and Infectious Disease Work Remain Part of Platform
While oncology is Aethlon’s lead clinical focus, Frakes said the company continues to see potential applications beyond cancer. He pointed to Aethlon’s collaboration with the University of California, San Francisco, on long COVID, saying that work has helped the company better understand how persistent viral proteins and inflammatory particles may contribute to symptoms in some patients.
Frakes said he receives weekly inquiries through the company’s website from long COVID patients and noted that there is no approved therapy. He described long COVID as a potentially significant market but reiterated that oncology remains the company’s primary focus.
The Hemopurifier was originally developed to remove viruses from the bloodstream. Frakes said many harmful viruses have glycosylated, or sugary carbohydrate, surfaces that are similar to EV surfaces, allowing both to bind within the device.
He also discussed the device’s prior use during the 2014 Ebola outbreak, when a critically ill physician was treated in Germany with a single six-plus-hour Hemopurifier treatment. Frakes said the patient’s viral load was reduced and the patient ultimately went home, though he emphasized it involved one patient and was not a clinical trial. He said the FDA later approved a protocol to treat Ebola patients, and that the protocol remains in place, though no direly ill Ebola patients have been brought back to the U.S. during the current outbreak of a different Ebola strain in Africa.
Financing and Strategic Alternatives
Frakes said Aethlon recently raised about $4 million in gross proceeds after raising $1.9 million through at-the-market sales in the June quarter. He said he chose to raise capital because the company had close to one year of cash, enough to complete the current trial but not enough to move into regulatory meetings and a larger follow-on clinical trial.
“We’re pretty well-financed at the moment,” Frakes said, adding that the company has no debt and that he has cut the burn rate in half since becoming CEO in addition to his longtime role as CFO.
Frakes acknowledged the financing had a short-term negative impact on Aethlon’s stock value but said the company is now better capitalized and should be able to reach milestones without needing to raise more capital “anytime soon.”
On strategic alternatives, Frakes said the board regularly evaluates opportunities, including partnerships, licensing arrangements, strategic collaborations and other business opportunities. He said larger companies want to see data from the current study before further conversations, and that Aethlon believes its strongest negotiating position will come from generating good clinical data.
Focus on Oncology First
Frakes said Aethlon is currently focused on solid tumors for which KEYTRUDA and OPDIVO are approved, including head and neck cancer, lung cancer and skin cancers. He said blood cancers may also be of interest because the device filters blood, but the company has not yet focused on that area.
Looking ahead, Frakes said he hopes investors will see the company complete clinical milestones, generate compelling data, advance regulatory discussions and maintain financial and operational discipline.
“Success in biotechnology must be earned through data,” Frakes said. “Every study that we complete helps us to better understand the potential of the Hemopurifier.”
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.
