On June 26, 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 fourth quarter ended March 31, 2025, and provided an update on recent developments (Press release, Aethlon Medical, JUN 26, 2025, View Source [SID1234654144]).
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Key Fiscal 2025 Highlights
First three patients treated in Hemopurifier cancer trial at Australian sites
Indian regulatory approval received to initiate a similar oncology study
Study protocol expanded to reflect evolving immunotherapy standard of care
Preclinical data demonstrate 98.5% removal of platelet-derived EVs in simulated Hemopurifier treatment
Collaboration with UCSF to investigate Long COVID with findings to be presented at the Keystone Symposium
Operating expenses reduced significantly through streamlined operations
Clinical Progress in Cancer Trial
Aethlon completed Hemopurifier treatments in the first three participants enrolled in its safety, feasibility, and dose-finding study of patients with solid tumors unresponsive to anti-PD-1 agents. Participant #1 was treated at Royal Adelaide Hospital in January 2025, while Participants #2 and #3 received treatment at Royal North Shore Hospital in Sydney in June 2025. All participants completed a single 4-hour Hemopurifier treatment without device deficiencies or immediate complications and have now completed the pre-specified 7-day safety follow-up.
This milestone triggers the first meeting of an independent Data Safety Monitoring Board (DSMB), to review safety data and recommend advancement to the second treatment cohort. In the next cohort, participants will receive two Hemopurifier treatments during a one-week period.
Preliminary data from the first cohort, including effects on extracellular vesicle (EV) removal and anti-tumor T-cell activity, are expected in approximately three months.
In parallel, the trial protocol was amended to broaden eligibility to include patients receiving combination therapies with Pembrolizumab (Keytruda) or Nivolumab (Opdivo), in line with current treatment practices.
Currently, only about 30% of patients receiving pembrolizumab or nivolumab experience lasting clinical responses. EVs released by tumors have been implicated in cancer progression and resistance to anti-PD-1 therapies. The Hemopurifier is designed to bind and remove these EVs from the bloodstream, potentially improving the therapeutic response rates to anti-PD-1 antibodies. In preclinical studies, the Hemopurifier has been shown to reduce the number of EVs in cancer patient plasma samples.
As a reminder, the primary endpoint for the approximate 9 to 18-patient study is safety. The trials will monitor any adverse events and clinically significant changes in lab tests of Hemopurifier treated patients with solid tumors with stable or progressive disease at different treatment intervals. Patients who do not respond to the PD-1 antibody therapy will be eligible to enter the Hemopurifier period of the study where sequential cohorts will receive 1, 2, or 3 Hemopurifier treatments during a one-week period.
In addition to safety, the study includes exploratory analyses evaluating how many Hemopurifier treatments are needed to decrease the concentration of EVs, and if these changes in EV concentrations improve the body’s own natural ability to attack tumor cells. These findings are intended to guide the design of future safety and efficacy trials, including a potential Premarket Approval (PMA) study required by the FDA and other global regulatory agencies.
Regulatory Approval India
On June 19, 2025, the Company received formal approval from India’s Central Drugs Standard Control Organization (CDSCO) to initiate a similar trial at Medanta Medicity Hospital. The approval followed a meeting with the Subject Expert Committee and prior Ethics Committee clearance. The trial will begin following a Site Initiation Visit (SIV) conducted by Aethlon’s India-based CRO, Qualtran.
Preclinical Study Supports Broader Applications
On May 12, 2025, the results from Aethlon’s preclinical ex vivo study were published in bioRxiv, and the manuscript has been submitted to a peer-reviewed journal for publication. Those results showed that the Hemopurifier, using proprietary Galanthus nivalis agglutin (GNA) affinity resin, removed 98.5% of platelet -derived extracellular vesicles (PD-EVs) from human plasma during a timepoint equivalent to a 4-hour HP treatment. Excessive levels of PD-EVs have been implicated in a myriad of diseases, including cancer, lupus, systemic sclerosis, multiple sclerosis, Alzheimer’s disease, sepsis, acute and Long COVID. The results of this study support the ongoing oncology trial in Australia and suggest potential applications of the Hemopurifier in other EV-associated diseases.
The manuscript describing this study has been submitted to a peer-reviewed journal for publication.
Scientific Collaboration in Long COVID Research
Aethlon’s collaborative research with the UCSF Long COVID Clinic was accepted for a poster presentation at the Keystone Symposium on Long COVID and Other Post-Acute Infection Syndromes (August 10-13, 2025). The study analyzed blood samples from participants with Long COVID as well as controls that had recovered from COVID-19 infection to evaluate the binding of larger and smaller extracellular vesicles to the Hemopurifier’s lectin affinity resin, respectively. These findings build on prior clinical evidence and support further investigation of the Hemopurifier in Long COVID, an unmet medical need affecting approximately 44 and 48 million people in the United States alone, with an estimated economic burden of 2 billion dollars in those with symptoms lasting a year.
Operational Achievements
In fiscal 2025, Aethlon streamlined operations and significantly reduced its operating expenses, positioning the company for sustained focus on its clinical and regulatory goals.
Financial Results for the Fiscal Fourth Quarter Ended March 31, 2025
As of March 31, 2025, Aethlon had a cash balance of approximately $5.5 million.
Consolidated operating expenses for the fiscal year ended March 31, 2025, were approximately $9.3 million, representing a decrease of $3.3 million or approximately 26%, compared to $12.6 million for the fiscal year ended March 31, 2024. This reduction was primarily driven by lower payroll and related expenses, professional fees, and general and administrative costs.
Payroll and related expenses declined by an approximate $1.3 million, reflecting an approximate $900,000 reduction in salaries and related expenses and an approximate $800,000 decrease in stock-based compensation. These reductions were primarily attributable to the termination of three executives—one in the fiscal year 2024, one in July and October 2024—and a workforce reduction of non-executive staff in August 2024. The decrease in stock-based compensation was primarily due to the absence of accelerated vesting charges recognized in the prior year related to the termination of our former Chief Executive Officer, as well as reduced expenses following the departure of executives and staff. These decreases were partially offset by an increase of approximately $400,000 in severance expenses associated with the termination of two former executives.
Professional fees also declined by approximately $1.3 million. This decrease includes $600,000 in legal costs savings resulting from a transition to a new legal firm, and an approximate $500,000 related to the termination of services with a contract manufacturing organization and the completion of a project that involved using an outside lab to process samples. Consulting fees related to scientific projects and regulatory projects declined by approximately $300,000. These reductions were partially offset by an approximate $85,000 increase in accounting fees associated with obtaining audit firm consents for various securities filings.
General and administrative expenses decreased by approximately $660,000. The reduction was driven primarily by a $534,000 reduction in costs related to fewer raw material purchases, no cleanroom certification expenses, and reduced reliance on outside services for maintenance of the manufacturing facility. Laboratory supplies and testing costs also declined by $337,000 following the completion of oncology and transplant-related projects. Insurance expenses decreased by $141,000, reflecting lower medical and workers’ compensation premiums due to reduced headcount, as well as an overall decrease in business insurance costs. Additional reductions included $44,000 in travel and entertainment expenses, $24,000 decrease in office supplies, and $19,000 in depreciation expense related to the disposal of certain equipment. These decreases were partially offset by a $467,000 increase in clinical trial expenses associated with our ongoing oncology study in Australia.
As a result of the above factors, our operating loss decreased to $9.3 million for the fiscal year ended March 31, 2025, from $12.6 million for the fiscal year ended March 31, 2024.
Other Income (Expense)
Other expenses for the year ended March 31, 2025, included a non-cash charge of approximately $4.6 million related to a warrant inducement offer. In March 2025, we offered certain warrant holders the opportunity to exercise existing warrants at a temporarily reduced exercise price in exchange for the issuance of new warrants. The inducement expense recognized represents the combined fair value of the new warrants issued and the incremental fair value resulting from the modification of the exercise price of the existing warrants. This transaction did not impact cash flows from operating activities.
During the fiscal year ended March 31, 2025, we recognized approximately $324,450 in other income related to the Employee Retention Tax Credit (ERTC) under the CARES Act and subsequent legislation. We recorded the ERTC as other income in the periods in which the payments were received. In addition, we recognized $36,339 in interest income related to the ERTC during fiscal 2025. As of March 31, 2025, the remaining expected credit was recorded as a receivable within other current assets on our consolidated balance sheet. No amounts were recorded in the prior fiscal year.
The consolidated balance sheets for March 31, 2025 and March 31, 2024, and the consolidated statements of operations for the fiscal years ended March 31, 2025 and 2024 follow at the end of this release.
Conference Call
Management will host a conference call today, Thursday, June 26, 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.