Aethlon Medical Q3 Earnings Call Highlights

by · The Markets Daily

Aethlon Medical (NASDAQ:AEMD) provided an update on its Hemopurifier program and reported fiscal third-quarter results for the period ended Dec. 31, 2025, highlighting continued progress in its Australian oncology trial, expanded research efforts around extracellular vesicles (EVs), and a year-to-date reduction in operating expenses versus the prior year.

Australian oncology trial advances to second cohort

Chief Medical Officer Dr. Steven LaRosa said the company has continued to enroll and treat patients in its Australian safety, feasibility, and dose-finding study of the Hemopurifier in participants with solid tumors that are not responding to regimens that include anti-PD-1 immunotherapies pembrolizumab (Keytruda) or nivolumab (Opdivo).

LaRosa reiterated that the first cohort was completed previously, with three participants receiving a single Hemopurifier treatment. The company reported that cohort one saw no device-related serious adverse events or dose-limiting toxicities, and Aethlon observed “favorable directional improvement” in EV numbers and immune cell numbers following treatment.

For the second cohort, LaRosa said Aethlon has completed two Hemopurifier treatments in two participants. A third patient has been enrolled, has passed screening, and is expected to receive two treatments by the end of February. After the three cohort-two participants complete treatment and safety follow-up, the company plans to present the data to an independent data safety monitoring board (DSMB), targeting a meeting in late March.

Management said the DSMB will recommend either moving to the third and final cohort—where participants would receive three Hemopurifier treatments in a single week—or requiring enrollment of three additional patients in the current cohort.

During the question-and-answer session, LaRosa clarified that patients in cohort two are entirely new participants and not drawn from cohort one. He also described the cohort-two schedule as typically treatments on a Monday and a Friday, with the same follow-up period as cohort one. The spacing is intended to help the team evaluate the “kinetics” of EV levels between treatments and whether two treatments generate more durable reductions in EVs and more sustained effects on T-cells than what was seen after a single treatment.

LaRosa added that the decision to explore two or three treatments per week was informed in part by prior work in the plasma exchange setting, including data from the Mayo Clinic suggesting two to three treatments in a week may be needed to keep EV numbers down.

Participant outreach efforts build a potential “queue” for enrollment

Aethlon said it has seen an uptick in interested potential participants since contracting with TrialFax and Dedicated. TrialFax provides online advertising for the trial, while Dedicated conducts phone prescreening before referring prospective participants to the three investigative sites for informed consent and more detailed screening.

In Q&A, LaRosa said these efforts have already helped generate treated patients and created a pool of potential participants. He noted that under the current protocol the sites cannot enroll or consent new patients for the next cohort until the trial officially advances, but he described having a “queue” of candidates who could be approached once cohort three opens, subject to screening and scheduling around treatment timing.

R&D: evaluating compatibility with a simplified blood treatment system

LaRosa discussed research under a material transfer agreement with Stavro to study the Hemopurifier’s compatibility with the SLAMB system. He described SLAMB as using a single small-lumen vascular catheter and a simplified blood pump, compared with the large double-lumen dialysis catheter and dialysis machines typically used for Hemopurifier treatments.

LaRosa said a simplified system could potentially enable future Hemopurifier use in oncology units or infusion centers without requiring a dialysis machine, a dialysis bed, or a supervising nephrologist. In Q&A, he contrasted the current approach—relying on dialysis equipment primarily for the blood pump function—with a smaller, less invasive catheter that could resemble commonly used PICC lines, which are typically placed in the arm rather than the neck.

He also noted SLAMB is not already FDA-approved, and that Stavro is working on its submission. LaRosa said he expects Aethlon would likely need to perform a certain number of treatments with the combined setup. Responding to another question, he said the initial experiments are focused on basic pump-device compatibility in the lab (such as pressures and alarms), with additional work potentially needed to confirm EV capture performance.

Expanding EV research, including Long COVID and other indications

Aethlon also highlighted ongoing expansion of its EV research platform. LaRosa said the company previously showed that the GNA affinity resin in the Hemopurifier binds EVs in Long COVID patient samples and reduces microRNAs associated with immune dysregulation. He said those findings were posted on bioRxiv and have been submitted to a peer-reviewed journal.

LaRosa said the company is exploring investigations into other EV cargo, including potential viral particles, and noted that EVs—such as platelet-derived EVs—have been implicated in a range of diseases beyond cancer. He listed examples including lupus, rheumatoid arthritis, systemic sclerosis, multiple sclerosis, cardiovascular diseases, sepsis, and ALS.

Aethlon previously published bioRxiv data on removal of platelet-derived EVs from healthy plasma, and LaRosa said the company plans to further this work by examining platelet-derived EV and microRNA removal in patients with some of these indications. He described the approach as consistent with Aethlon’s view that the Hemopurifier could support “a pipeline within a single device.”

CEO and CFO Jim Frakes also emphasized continued cost control while advancing R&D. In response to an analyst question, Frakes said the company is attempting to obtain samples largely for shipping costs, perform more work in-house with a small scientific staff, and limit reliance on outside labs, while continuing to publish and learn from the work.

Financial results: cash balance near $7 million; expenses down year-to-date

Frakes reported that as of Dec. 31, 2025, Aethlon had a cash balance of approximately $7 million.

For the fiscal third quarter, consolidated operating expenses were approximately $2.06 million, an increase of $250,000, or 13.6%, compared with the same period last year. Frakes attributed the rise primarily to higher payroll and related costs, partially offset by lower clinical trial expenses and reduced professional fees, mainly tied to investor relations activities. Operating loss for the quarter was $2.06 million, compared with $1.81 million in the prior-year quarter.

Other income, primarily interest earned on cash balances, was $44,000, compared with $60,000 in the same quarter last year.

On a nine-month basis, operating expenses decreased to $5.36 million, down $1.98 million, or 27%, from $7.34 million in the prior-year period. Frakes said the improvement reflected lower payroll, general and administrative costs, and professional fees, and he pointed investors to the company’s Form 10-Q for additional category-level detail. He said the company planned to file its quarterly report following the call.

Looking ahead, Frakes said the company expects its next earnings call, covering the fiscal fourth quarter ended March 31, 2026, to coincide with the filing of its annual report on Form 10-K in June 2026.

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.

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