AETHLON MEDICAL INC

Aethlon Medical, Inc. is a medical therapeutic company focused on developing the Hemopurifier, 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 contribute to disease progression. The Hemopurifier utilizes a proprietary lectin-based technology to bind and remove enveloped viruses and EVs from biological fluids. The U.S. Food and Drug Administration 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.

The company faces intense competition in the medical device industry from numerous U.S. and foreign companies, many of which have greater financial, personnel, operational and research and development resources. Competitors include blood filters produced by ExThera Medical Corporation. The company believes that because the field of exosome research is burgeoning, multiple competitors are or will be developing competing technologies to address exosomes in cancer. Progress is constant in the treatment and prevention of viral diseases, so the opportunities for the Hemopurifier may be reduced there as well.

The company generates no revenue from product sales and did not generate any revenue during the fiscal years ended March 31, 2026 and March 31, 2025. The company's business model calls for the partial or full outsourcing of clinical and other development, sales and marketing of its product candidates. The Hemopurifier can be used with approved dialysis machines serving as a blood pump, and could also potentially be developed as part of a proprietary closed system with its own pump and tubing set.

The Hemopurifier has been evaluated in human studies involving 173 ¹ treatment sessions in 44 ² patients with either viral infections or cancer. The device has been well tolerated with an adverse event profile consistent with extracorporeal therapy. The company is currently conducting a safety, feasibility and dose-finding clinical trial in Australia evaluating the Hemopurifier in patients with solid tumors who have stable or progressive disease during anti-PD-1 monotherapy treatment, designed to enroll approximately 9 to 18 ³ participants. Three clinical sites in Australia are currently open for patient enrollment: Royal Adelaide Hospital in Adelaide, Pindara Private Hospital on the Gold Coast, and GenesisCare North Shore Hospital in Sydney. During fiscal year 2026, the company completed enrollment and treatment of the first cohort of three participants, each of whom received a single 4-hour Hemopurifier treatment. Following DSMB review, enrollment commenced in the second cohort, in which participants received two Hemopurifier treatments during a one-week treatment period. In March 2026, the company completed the second cohort and the DSMB subsequently approved advancement to the third cohort of the study. To date, no serious adverse events or dose-limiting toxicities related to the Hemopurifier have been reported.

The company previously pursued approval of a similar oncology clinical trial in India and received formal approval from the Central Drugs Standard Control Organization on July 7, 2025, but elected not to proceed in order to conserve resources and focus efforts on the Australian oncology clinical trial. In small-scale or early feasibility human studies, the Hemopurifier has been used to treat individuals infected with Ebola, HIV, hepatitis-C and SARS-CoV-2. In vitro studies have demonstrated the ability of the Hemopurifier to capture multiple enveloped viruses including Ebola, Marburg virus, Zika, Lassa, MERS-CoV, Cytomegalovirus, Epstein-Barr, Herpes simplex, Chikungunya, Dengue, West Nile, H1N1 swine flu, H5N1 bird flu, and the reconstructed 1918 Spanish flu virus. The company terminated its U.S. and India-based COVID-19 studies due to low ICU patient volume and shifting priorities. The company continues to maintain an open IDE for viral indications. On May 12, 2025, results of a pre-clinical ex vivo study demonstrated approximately 98.5% ⁴ removal of platelet-derived EVs at a timepoint equivalent to a four-hour HP treatment. In November 2025, the company publicly released a separate pre-clinical preprint examining extracellular vesicle characteristics in plasma samples from individuals with Long COVID.

The company did not generate any revenue during the fiscal years ended March 31, 2026 and March 31, 2025. Consolidated operating expenses were $7,293,632 ⁵ for the fiscal year ended March 31, 2026, compared to $9,341,365 ⁶ for the fiscal year ended March 31, 2025, a decrease of $2,047,733 ⁷. The operating loss decreased to $7,293,632 ⁸ for fiscal year 2026 from $9,341,365 ⁹ for fiscal year 2025. As of March 31, 2026, the company had a cash balance of $5,026,458 ¹⁰ and working capital of $4,122,702 ¹¹, compared to a cash balance of $5,501,261 ¹² and working capital of $4,050,514 ¹³ at March 31, 2025. Research and development costs amounted to approximately $1,912,000 ¹⁴ and $2,212,000 ¹⁵ in the fiscal years ended March 31, 2026 and 2025, respectively.

The company is advancing clinical development activities for the Hemopurifier in oncology through its ongoing safety, feasibility and dose-finding clinical trial in Australia evaluating the Hemopurifier in patients with solid tumors who have stable or progressive disease during anti-PD-1 monotherapy treatment. The trial is designed to enroll approximately 9 to 18 ¹⁶ participants. Three clinical sites in Australia are currently open for patient enrollment. During fiscal year 2026, the company completed enrollment and treatment of the first cohort of three participants, each of whom received a single 4-hour Hemopurifier treatment. Following DSMB review, enrollment commenced in the second cohort, in which participants received two Hemopurifier treatments during a one-week treatment period. In March 2026, the company completed the second cohort and the DSMB subsequently approved advancement to the third cohort of the study. To date, no serious adverse events or dose-limiting toxicities related to the Hemopurifier have been reported. The company previously pursued approval of a similar oncology clinical trial in India and received formal approval from the CDSCO on July 7, 2025, but elected not to proceed in order to conserve resources and focus efforts on the Australian oncology clinical trial.

The Aethlon R&D laboratory continues to explore potential new indications for the Hemopurifier. The company has published in the peer-reviewed journal Transplant Immunology the ability of the device to remove extracellular vesicles and their microRNA cargo from acellular perfusates of discarded kidneys that had undergone normothermic machine perfusion. On May 12, 2025, results of a pre-clinical ex vivo study demonstrated approximately 98.5% ¹⁷ removal of platelet-derived EVs at a timepoint equivalent to a four-hour HP treatment. In November 2025, the company publicly released a separate pre-clinical preprint describing 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. The company believes the results support the ongoing Australian oncology clinical trial and may support investigation of the Hemopurifier in additional disease indications.

The filing does not contain specific margin or cost outlook targets beyond the historical expense trends described.

The company has sufficient inventory of Hemopurifiers to support its ongoing oncology trial in Australia as well as any near-term expansion of that study. While the company has received FDA approval to begin manufacturing at its San Diego facility under its IDE supplement, it is still awaiting FDA approval of a separate supplement to qualify an additional supplier of a key Hemopurifier component as a second source. The company continues to work with the FDA on this process. As of June 8, 2026, the company had 9 ¹⁸ full-time employees and no part-time employees, all located in the United States.

Research and development costs amounted to approximately $1,912,000 ¹⁹ and $2,212,000 ²⁰ in the fiscal years ended March 31, 2026 and 2025, respectively. Subsequent to March 31, 2026, the company sold an aggregate of 800,111 ²¹ shares of common stock under its ATM facility, resulting in gross proceeds of approximately $1,904,000 ²². Net proceeds, after sales commissions of approximately $48,000 ²³ and SEC, settlement and delivery fees of approximately $6,000 ²⁴, were approximately $1,851,000 ²⁵. Following the filing of Amendment No. 1 to its prospectus supplement on June 4, 2026, the company may offer and sell shares of its common stock having an aggregate offering price of up to approximately $542,716 ²⁶ pursuant to its ATM facility. The company has not paid any dividends on its common stock to date and does not anticipate paying any cash dividends in the foreseeable future.

The company has incurred significant losses and expects to continue to incur losses for the foreseeable future. The company has never been profitable and did not generate any revenue during the fiscal years ended March 31, 2026 and March 31, 2025. Although the company had cash and cash equivalents of approximately $5.5 million ²⁷ as of March 31, 2026, patient recruitment may occur more rapidly than expected along with the concomitant increases in expenses; therefore there is substantial doubt that the company's cash on hand will carry the company for 12 months beyond the filing date of the financial statements. The company expects to seek additional capital through equity financings and other potential sources of funding; however, there can be no assurance that such financing will be available on acceptable terms, in sufficient amounts, or at all. The company's ability to raise additional funds may be adversely impacted by its ability to remain listed on Nasdaq, potential worsening global economic conditions and disruptions to and volatility in the credit and financial markets.

The company continues to monitor the impact of inflation, global economic conditions, geopolitical conflicts, capital market volatility and other macroeconomic factors on its business, operations, clinical development programs and future access to capital. The extent to which these factors may affect the company's business, financial condition and results of operations remains uncertain and will depend on future developments beyond the company's control. The company's ability to raise additional funds may be adversely impacted by its ability to remain listed on Nasdaq, the potential worsening global economic conditions and disruptions to and volatility in the credit and financial markets in the United States, including due to bank failures, actual or perceived changes in interest rates and economic inflation, and worldwide resulting from macroeconomic factors.

The company has incurred significant losses and expects to continue to incur losses for the foreseeable future, having never been profitable and generating no revenue during the fiscal years ended March 31, 2026 and March 31, 2025. Although the company had cash and cash equivalents of approximately $5.5 million ²⁸ as of March 31, 2026, there is substantial doubt that cash on hand will carry the company for 12 months beyond the filing date, and the company will require additional financing to sustain operations, which may dilute existing stockholders. The Hemopurifier has not received required regulatory approval from the FDA or any foreign regulatory agencies to be commercially marketed and sold, and the PMA process is costly, time-consuming and uncertain. The company faces intense competition from entities with greater financial resources, and its Hemopurifier technology may become obsolete if competitors develop more effective treatments. The company is dependent on single-source suppliers for three critical Hemopurifier components, and delays in qualifying new suppliers or interruptions in production have and may continue to prevent or delay manufacturing. The company's ability to maintain compliance with Nasdaq listing requirements is uncertain, and delisting could materially adversely affect financial condition and the ability to sell shares.

Management's message emphasizes that the company is a medical therapeutic company focused on developing the Hemopurifier, a clinical-stage immunotherapeutic device designed to address unmet needs in oncology, life-threatening infectious diseases, organ transplantation and other disease states. Key themes include the advancement of the Australian oncology clinical trial, with the company having completed enrollment and treatment of the first cohort of three participants, each of whom received a single 4-hour Hemopurifier treatment, and the DSMB subsequently approving advancement to the third cohort of the study. Management also highlights the pre-clinical ex vivo study demonstrating approximately 98.5% ²⁹ removal of platelet-derived EVs, and the publication of a pre-clinical preprint examining extracellular vesicle characteristics in Long COVID plasma. Strategic priorities emphasized include conserving resources by electing not to proceed with the India oncology trial, continuing to work with the FDA on qualifying an additional supplier of a key Hemopurifier component, and evaluating potential expense reduction opportunities while seeking additional financing through equity offerings, debt financings and/or strategic transactions.