On November 12, 2025 Aethlon Medical, Inc. (the Company or Aethlon) (Nasdaq: AEMD), a medical therapeutic company focused on developing products to treat cancer and life-threatening infectious diseases, reported financial results for its fiscal second quarter ended September 30, 2025, and provided an update on recent developments.
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Key Highlights
Maintained Nasdaq Listing: Compliance matters resolved, Aethlon remains in good standing with Nasdaq.
Clinical Progress: Recruitment underway for Cohort 2 of the Australian oncology trial under amended protocol.
Scientific Advancement: Ongoing collaboration with UCSF on Long COVID research, with a manuscript in preparation for peer-reviewed journal.
Technology Development: Initiated evaluation of Hemopurifier compatibility with a simplified blood treatment system
Operational Efficiency: Operating expenses reduced by 48%, reflecting disciplined cost management.
Clinical and Corporate Update
Clinical Progress in Cancer Trial
Aethlon continues to advance its clinical, scientific, and operational initiatives in support of its mission to develop therapeutic devices for cancer and infectious diseases. Nasdaq compliance matters have been resolved, and the company remains listed on the Capital Market.
Recruitment has begun for the second cohort of the Australian oncology trial of the Hemopurifier is underway under the amended protocol that allows patients receiving combination therapies with Pembrolizumab (Keytruda) or Nivolumab (Opdivo). The study is designed to evaluate safety, feasibility, and dose-finding in patients with solid tumors who have not responded to PD-1 therapy. Additional cohorts will examine whether sequential Hemopurifier treatments decrease extracellular vesicle (EV) concentrations and enhance the body’s immune response against tumor cells.
As previously reported, the laboratory of Professor Georges Grau at the University of Sydney analyzed EVs and lymphocyte counts in samples from patients in the first cohort before and after Hemopurifier treatment. EVs are nanoparticles that are involved in cell-to-cell communication and are implicated in the spread of cancer (metastasis), growth of new blood vessels to the tumor, (angiogenesis), cell death (apoptosis), and inhibition of the body’s T cells, which are important for killing tumor cells. Two of the three participants in the trial showed decreases in large EVs, also known as microvesicles, following the Hemopurifier treatment. Decreases were observed in large and small platelet-derived EVs in two of the three patients. We observed decreases in the subset of large EVs carrying PD-L1 in all three participants during the Hemopurifier treatment. Persistently elevated counts of EVs with PD-L1 have been associated with lack of response to anti-PD-1 agents.
Decreases were observed in seven out of ten microRNAs examined in two of the three participants following a single 4-hour Hemopurifier treatment. MicroRNAs are one component of the cargo of extracellular vesicles, previously reported to promote cancer growth and metastasis.
Improvements in laboratory ratios associated with responses to immunotherapy including Neutrophil, Lymphocyte, Monocyte, Albumin and Systemic Immune-Inflammation were observed in at least two participants after a single 4-hour treatment. Increases were noted in total T cell numbers, CD8 and CD4 T cell subsets, and tumor specific T cells (CD137 +ve) in participants following Hemopurifier treatment without a consistent pattern in terms of timing of improvement.
Additional data from the subsequent two cohorts will help determine whether these observations are reproducible, and whether there is a dose response with additional Hemopurifier treatments in terms of the magnitude and duration of the changes.
We believe the unmet need remains significant: currently, only approximately 30-40% of patients who receive pembrolizumab or nivolumab will have lasting clinical responses to these agents. EVs produced by tumors are believed to contribute to both cancer progression and resistance to anti-PD-1 therapies.
The study’s primary endpoint is safety. The study will enroll approximately 9 to 18 participants. Eligible patients with solid tumors with stable or progressive disease receive escalating doses of Hemopurifier treatment across sequential cohorts – one, two, and three Hemopurifier treatments administered over the course of a single week. In addition to evaluating safety, the study is designed to assess whether reducing the concentration of EVs may improve the body’s own natural ability to attack tumor cells. These exploratory findings are expected to inform the design of future efficacy and safety trials, including a Premarket Approval (PMA) study.
Scientific Collaboration in Long COVID Research and Technology Development
Analysis of EV cargo from Long COVID patient samples continues in collaboration with the University of California, San Francisco (UCSF). These studies build on prior findings showing that the Hemopurifier can bind and remove large and small EVs from Long COVID patients. A manuscript detailing these results is being prepared for submission to a peer-reviewed journal.
We also initiated an evaluation to study the compatibility of the Hemopurifier with an alternative blood treatment system that uses a single small-lumen catheter and simplified blood pump compared to traditional hemodialysis setups. This research could lead to simplified system for performing Hemopurifier treatments in Oncology units in the future.
Operational Achievements
Operating expenses decreased by 48% during the quarter, reflecting the Company’s ongoing efforts to reduce costs while advancing its clinical and research programs.
"We remain focused on executing our clinical and research strategy while maintaining operational discipline," said James Frakes, CEO and CFO of Aethlon Medical. "Our ongoing trial progress, research collaborations, and technology initiatives continue to support our long-term goal of developing therapeutic solutions for cancer and life-threatening infectious diseases."
Financial Results for the Fiscal Second Quarter Ended September 30, 2025
As of September 30, 2025, Aethlon had a cash balance of approximately $5.8 million.
Consolidated operating expenses for the three months ended September 30, 2025 were approximately $1.5 million, down by approximately $1.4 million or 48%, from $2.9 million in the same period in 2024. The decreases were reflected across payroll, general and administrative and professional fees.
Payroll and related expenses decreased by approximately $778,000, reflecting lower headcount, reduced bonus accruals, and absence of prior-year severance charges.
General and Administrative expenses declined by approximately $437,000 driven by lower clinical trial costs, in part due to a $218,000 R&D tax incentive, as well as reductions in supplies, insurance, and other operational costs.
Professional fees decreased by approximately $177,000, mainly from reduced investor relations and contract labor expenses, partially offset by higher legal, tax, audit and financial services costs.
As a result of these factors, operating loss for the quarter decreased to $1.5 million compared to $2.8 million in the prior-year period.
Other income totaled $22,730 for the three months ended September 30, 2025, compared to $95,146 in the prior-year period. In both quarters, other income was primarily interest income earned on cash balances.
The consolidated balance sheets for September 30, 2025 and March 31, 2025, along with the consolidated statements of operations for the three and six months ended September 30, 2025 and 2024, are included at the end of this release.
Conference Call
Management will host a conference call today, Wednesday, November 12, 2025, at 4:30 p.m. ET to review the Company’s financial results and recent corporate developments. Following management’s formal remarks, there will be a question and answer session.
Interested parties can register for the conference call by navigating to View Source Please note that registered participants will receive their dial-in number upon registration.
(Press release, Aethlon Medical, NOV 12, 2025, View Source [SID1234659847])