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NATURE OF BUSINESS AND BASIS OF PRESENTATION
3 Months Ended
Jun. 30, 2026
Accounting Policies [Abstract]  
NATURE OF BUSINESS AND BASIS OF PRESENTATION

1. NATURE OF BUSINESS AND BASIS OF PRESENTATION

 

Aethlon Medical, Inc., or Aethlon, the Company, we or us, is a medical therapeutic company focused on developing the Hemopurifier® (HP), a clinical-stage investigational immunotherapeutic device designed to address unmet needs in oncology, life-threatening infectious diseases, organ transplantation and other disease states in which extracellular vesicles (EVs) contribute to disease progression. The Hemopurifier utilizes a proprietary lectin-based technology to bind and remove enveloped viruses and EVs from biological fluids. EVs have been associated with immune suppression, metastasis, and resistance to therapy in cancer, as well as progression of severe infectious diseases.

 

In pre-clinical studies, the Hemopurifier has also demonstrated the ability to bind disease-associated extracellular vesicles (“EVs”) and a panel of enveloped viruses. The Hemopurifier has been evaluated in human studies, involving 176 treatment sessions in 45 patients with either viral infections or cancer. The device has been well tolerated with an adverse event profile that is consistent with extracorporeal therapy. In certain human studies designed to evaluate viral clearance from biological fluids, findings demonstrated the removal of enveloped viruses. The U.S. Food and Drug Administration (“FDA”) has granted the Hemopurifier “Breakthrough Device” designation for two independent indications:

 

  · the treatment of individuals with advanced or metastatic cancer unresponsive to or intolerant of standard-of-care therapy; and
     
  · the treatment of life-threatening viruses not addressed with approved therapies.

 

Three clinical sites in Australia—Royal Adelaide Hospital in Adelaide, Pindara Private Hospital in the Gold Coast, and GenesisCare North Shore Hospital in Sydney—are currently enrolling patients in our safety, feasibility and dose-finding oncology trial in patients with solid tumors not responding to treatment, including either Keytruda® or Opdivo®. The trial is designed to enroll approximately 9 to 18 patients across three sequential dosing cohorts evaluating the safety and feasibility of the Hemopurifier. During the first fiscal quarter of 2027, we initiated Cohort 3 and treated the first participant in this cohort. Enrollment in the trial remains ongoing.

 

The Company previously pursued approval of a similar clinical trial in India. After reviewing extended timelines associated with site activation and trial execution, we decided to discontinue the India program to conserve resources and focus our efforts on the Australian oncology trial.

 

The Hemopurifier is designed to address life-threatening viral infections, particularly those involving highly glycosylated viruses for which there are no approved therapies. It has previously been used under FDA and international regulatory frameworks to treat individuals infected with HIV, hepatitis C, Ebola and SARS-CoV-2. While our COVID-19 clinical trials in the U.S. and India have been terminated due to low ICU enrollment, these programs provided real-world evidence of Hemopurifier use in critically ill patients. We maintain an open Investigational Device Exemption (“IDE”) for viral indications, preserving the ability to respond to future outbreaks or emerging pathogens.

 

In addition to our ongoing clinical development programs, we continue to explore potential new applications for the Hemopurifier through internal pre-clinical research and academic collaborations. During the first fiscal quarter of 2027, our manuscript entitled Increased Mannosylation of Extracellular Vesicles in Long COVID Plasma Provides a Potential Therapeutic Target for Galanthus nivalis Agglutinin (GNA) Affinity Resin was accepted for publication in the International Journal of Molecular Sciences. The manuscript describes exploratory ex vivo laboratory research conducted in collaboration with the University of California, San Francisco Long COVID Clinic examining extracellular vesicle characteristics in plasma samples from individuals with Long COVID. We also continue to investigate the Hemopurifier’s ability to remove disease-relevant extracellular vesicles through pre-clinical studies, including platelet-derived extracellular vesicles implicated in cancer, autoimmune disease and neurological disorders. These research activities are intended to inform potential future clinical indications and expand the potential utility of the Hemopurifier platform.

 

Successful outcomes of human trials will also be required by the regulatory agencies of certain foreign countries where we plan to market and sell the Hemopurifier. Some of our patents may expire before FDA approval or approval in a foreign country, if any, is obtained. However, we believe that certain patent applications and/or other patents issued to us more recently will help protect the proprietary nature of our Hemopurifier treatment technology.

 

Summary of Significant Accounting Policies

 

During the three months ended June 30, 2026, there were no changes to our significant accounting policies as described in our Annual Report on Form 10-K for the fiscal year ended March 31, 2026.

 

Reverse Stock Split

 

On July 31, 2026, the Company effected a 5-for-1 reverse stock split of its issued and outstanding shares of common stock. The Company’s common stock began trading on a split-adjusted basis on the Nasdaq Capital Market on August 4, 2026. All share and per share amounts presented in the accompanying unaudited condensed consolidated financial statements and the accompanying notes have been retroactively adjusted to reflect the reverse stock split for all periods presented.

 

Basis of Presentation

 

Our accompanying unaudited condensed consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles, or GAAP, for interim financial information and with the instructions to Form 10-Q and Article 8 of the Securities and Exchange Commission, or SEC, Regulation S-X. Accordingly, they should be read in conjunction with the audited financial statements and notes thereto for the fiscal year ended March 31, 2026, included in our Annual Report on Form 10-K filed with the SEC on June 10, 2026.

 

The accompanying unaudited condensed consolidated financial statements include the accounts of Aethlon Medical, Inc. and its wholly owned subsidiary, Aethlon Medical Australia Pty Ltd. All significant inter-company transactions and balances have been eliminated in consolidation.

 

In the opinion of management, the accompanying unaudited condensed consolidated financial statements, taken as a whole, contain all adjustments, consisting only of normal recurring adjustments, considered necessary to fairly present the Company’s financial position as of and for the period ended June 30, 2026, its results of operations and comprehensive loss for the three months ended June 30, 2026, and its cash flows for the three months ended June 30, 2026. The condensed consolidated balance sheet at March 31, 2026 has been derived from the audited consolidated balance sheet at March 31, 2026, contained in the above referenced 10-K and has been retrospectively adjusted to reflect the reverse stock split described above, including the related adjustments to Common Stock and Additional Paid-in Capital. The results of operations for the three months ended June 30, 2026 are not necessarily indicative of the results to be expected for the full year or any future interim periods.

 

Use of Estimates

 

The preparation of condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the condensed consolidated financial statements and accompanying notes. Significant estimates include, but are not limited to, stock-based compensation, accrued clinical trial costs, research and development expenses, the useful lives of long-lived assets, and other accrued liabilities. Actual results could differ materially from those estimates.

 

Liquidity and Going Concern

 

Management believes that the Company’s cash and cash equivalents as of June 30, 2026, together with the proceeds received from its financing completed in July 2026, will be sufficient to fund its planned operations for at least twelve months from the date these condensed consolidated financial statements are issued.

 

Although we believe our current cash resources, together with proceeds received subsequent to June 30, 2026, are sufficient to fund our planned operations for at least the next twelve months, we will likely require additional capital in the future to continue advancing the clinical development of the Hemopurifier beyond that period. The timing and amount of future capital requirements will depend on numerous factors, including the progress of our clinical and preclinical development programs, regulatory activities, manufacturing requirements, and other operating expenditures. 

 

Restricted Cash

 

As of June 30, 2026, we maintained a restricted cash balance of $99,150 in an interest-bearing money market deposit account with JPMorgan Chase, which supports our lease obligations. This balance includes a $5,000 buffer above the required security amount.