Aethlon Medical (NASDAQ:AEMD) said it has enrolled and treated the first participant in the third and final cohort of its Australian oncology clinical trial for the investigational Hemopurifier device, while reporting lower operating expenses for the fiscal first quarter ended June 30, 2026.
CEO and CFO James Frakes said the company is pursuing a strategy centered on advancing the Hemopurifier platform, expanding preclinical research into additional disease areas, growing its intellectual property portfolio, and maintaining cost discipline. The Hemopurifier is designed to bind and remove extracellular vesicles, or EVs, from blood, but remains an investigational device.
Final Oncology Cohort Underway
The company needs to treat two additional participants to complete the trial, provided future participants do not experience those safety events. Three investigative sites are continuing to pre-screen potential participants.
Aethlon’s stated goal is to complete Hemopurifier treatments and the eight-week follow-up central laboratory measurement period by the end of 2026. In closing remarks, Frakes said the company expects to complete treatment and related follow-up by the end of 2026 or early 2027. The next steps are expected to include data analysis, completion of a clinical study report and pre-registration discussions with regulatory authorities.
LaRosa cautioned that the company’s biomarker findings are preliminary, are based on a limited number of participants, and should not be interpreted as evidence of safety, effectiveness or clinical benefit.
Preliminary Biomarker Observations
Central laboratory measurements from the second trial cohort, in which patients received two four-hour treatments over one week, have been completed by the University of Sydney. The company said it observed decreases in total EV counts, including tumor-derived EVs, and in microRNAs associated with cancer progression following treatment.
LaRosa also cited increases in lymphocyte subsets and positive directional changes in laboratory parameter ratios that have been associated with responses to immunotherapy. He said the observed changes appeared more consistent among the three cohort-two participants and persisted longer than those seen in cohort one, whose participants received a single four-hour treatment.
During the question-and-answer session, LaRosa said the observations were based on raw data rather than formal analyses of changes from baseline or percentage changes from baseline. In cohort one, changes were generally observed in two of three participants, while cohort two showed more consistent observations across participants and, in some cases, changes extending through the eight-week follow-up period.
Independent formal statistical analyses, including a dose-response analysis, are planned after the full trial is completed. LaRosa said the company does not yet have EV, T-cell or microRNA results for the first cohort-three participant.
Management said three four-hour treatments in one week would likely represent the practical upper limit for a treatment schedule, citing patient tolerability and the logistical burden of setup, treatment and disconnection. If the third cohort produces observations similar to the second cohort, LaRosa said the company would consider taking a three-treatment-in-one-week regimen into a future efficacy trial, though he emphasized that such planning is premature until data are available.
Long COVID and Other Research Areas
Aethlon also discussed preclinical work evaluating potential uses of the Hemopurifier beyond oncology. LaRosa said research involving long COVID was published June 25, 2026, in the International Journal of Molecular Sciences.
According to LaRosa, the publication presented data showing that both small and large EVs from long COVID patient plasma samples bound to the company’s proprietary GNA affinity resin. After patient plasma was exposed to the resin, researchers observed decreases in microRNAs associated with immune dysregulation and inflammation.
LaRosa said those findings, combined with outside research describing COVID spike protein and proteins linked to inflammation and abnormal clotting within EVs of long COVID patients, raise the possibility of EV removal as an experimental therapeutic approach. The company plans to discuss potential clinical development paths and potential additional preclinical work with academic institutions and regulatory agencies.
The company is also conducting laboratory experiments assessing whether Hemopurifier technology can bind and remove EVs implicated in lupus and heart disease among patients with chronic kidney disease.
Frakes said Aethlon can continue conducting lower-cost exploratory work using its in-house scientists and equipment, as well as acquired or donated samples. Moving into clinical trials in additional disease areas, however, would likely require additional capital, a partner, or government grants, he said.
Financial Position and Spending
At June 30, Aethlon had approximately $4.9 million in cash and cash equivalents. Subsequent to quarter-end, the company raised about $4 million in gross proceeds through a public offering of common stock.
Frakes said management believes existing cash resources are sufficient to fund operations for at least the next 12 months under current plans.
Consolidated operating expenses declined 11.9% year over year to approximately $1.6 million in the fiscal first quarter, from $1.8 million in the prior-year quarter. Frakes attributed the reduction to lower professional fees, general and administrative expenses, and preclinical research costs. He said the company’s operating loss declined accordingly.
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.
