Aethlon Medical(AEMD) - 2025 Q4 - Annual Results

Key Fiscal 2025 Highlights Aethlon Medical achieved significant milestones in FY2025, including advancing its Hemopurifier® cancer trials and reducing operating expenses - Treated the first three patients in the Hemopurifier® cancer trial at Australian sites[7] - Received Indian regulatory approval for a similar oncology study[7] - Expanded the study protocol to align with current immunotherapy standards[7] - Demonstrated 98.5% removal of platelet-derived EVs in a preclinical simulated treatment[7] - Collaborated with UCSF on Long COVID research, with findings to be presented at the Keystone Symposium[7] - Significantly reduced operating expenses through streamlined operations[7] Clinical and R&D Updates Aethlon advanced its Hemopurifier® clinical trials in Australia and India, with preclinical data supporting broader applications including Long COVID Clinical Progress in Cancer Trial - The first three participants in the safety, feasibility, and dose-finding study for solid tumors have been treated with the Hemopurifier® in Australia, completing the 4-hour treatment without immediate complications[5] - This milestone triggers a Data Safety Monitoring Board (DSMB) review to assess safety and recommend advancing to the second cohort, where patients will receive two Hemopurifier treatments in one week[6] - The primary endpoint of the 9-18 patient study is safety, with exploratory analyses evaluating the impact on EV concentrations and the body's anti-tumor response to guide future trials[10][11] - The trial protocol was amended to include patients receiving combination therapies with Pembrolizumab (Keytruda®) or Nivolumab (Opdivo®), reflecting current standards of care[8] Regulatory Approval in India - On June 19, 2025, Aethlon received formal approval from India's Central Drugs Standard Control Organization (CDSCO) to initiate a similar oncology trial[12] - The trial will be conducted at Medanta Medicity Hospital and will commence after a Site Initiation Visit (SIV)[12] Preclinical Study and Broader Applications - A preclinical ex vivo study demonstrated that the Hemopurifier® removed 98.5% of platelet-derived extracellular vesicles (PD-EVs) from human plasma[13] - These results suggest potential applications for the Hemopurifier® in other EV-associated diseases, including cancer, lupus, multiple sclerosis, Alzheimer's, sepsis, and Long COVID[13] 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 (August 10-13, 2025)[15] - The study analyzed the binding of extracellular vesicles from Long COVID patients to the Hemopurifier's resin, supporting further investigation into this unmet medical need affecting millions in the U.S[15] Financial Performance Aethlon significantly reduced operating expenses by 26% to $9.3 million in FY2025, ending with $5.5 million cash, despite an increased net loss of $13.4 million due to a non-cash charge Fiscal 2025 Financial Summary | Metric | FY 2025 | FY 2024 | Change | | :--- | :--- | :--- | :--- | | Cash and cash equivalents | $5.5 million | $5.4 million | +$0.1M | | Consolidated operating expenses | $9.3 million | $12.6 million | -$3.3M (-26%) | | Operating loss | ($9.3 million) | ($12.6 million) | +$3.3M | | Net loss | ($13.4 million) | ($12.2 million) | -$1.2M | Detailed Operating Expense Analysis - Total operating expenses decreased by approximately $3.3 million (26%) year-over-year, from $12.6 million to $9.3 million[18] - Payroll and related expenses declined by $1.3 million due to executive terminations and workforce reductions[19] - Professional fees decreased by $1.3 million, driven by savings in legal, contract manufacturing, and consulting costs[20] - General and administrative expenses fell by $660,000 due to lower raw material, lab supply, and insurance costs, partially offset by a $467,000 increase in clinical trial expenses for the Australian study[21] Other Income and Expense - A non-cash charge of approximately $4.6 million was recorded related to a warrant inducement offer in March 2025, which did not impact operating cash flows[23] - The company recognized approximately $324,450 in other income from the Employee Retention Tax Credit (ERTC) under the CARES Act[24] Financial Statements Aethlon's FY2025 financial statements show total assets of $7.4 million, total liabilities of $2.2 million, and a net loss of $13.4 million or ($8.58) per share Condensed Consolidated Balance Sheets | (in thousands) | March 31, 2025 | March 31, 2024 | | :--- | :--- | :--- | | ASSETS | | | | Cash and cash equivalents | $5,501 | $5,442 | | TOTAL CURRENT ASSETS | $5,950 | $6,226 | | TOTAL ASSETS | $7,360 | $8,246 | | LIABILITIES & EQUITY | | | | TOTAL CURRENT LIABILITIES | $1,899 | $1,830 | | TOTAL LIABILITIES | $2,236 | $2,480 | | TOTAL STOCKHOLDERS' EQUITY | $5,124 | $5,766 | | TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | $7,360 | $8,246 | Consolidated Statements of Operations | (in thousands) | Fiscal Year Ended 3/31/25 | Fiscal Year Ended 3/31/24 | | :--- | :--- | :--- | | Total operating expenses | $9,341 | $12,637 | | OPERATING LOSS | ($9,341) | ($12,637) | | Total other expense (income) | $4,047 | ($428) | | NET LOSS | ($13,388) | ($12,208) | | Basic and diluted net loss per share | ($8.58) | ($38.87) | | Weighted average shares outstanding | 1,561 | 314 | Corporate Information and Forward-Looking Statements Aethlon Medical, developer of the FDA Breakthrough Device Hemopurifier®, provided corporate updates and cautioned on forward-looking statements subject to inherent risks About Aethlon and the Hemopurifier® - Aethlon Medical is focused on developing the Hemopurifier®, a clinical-stage immunotherapeutic device designed to combat cancer, life-threatening viral infections, and be used in organ transplantation[29] - The Hemopurifier® holds two FDA Breakthrough Device designations: one for advanced or metastatic cancer and another for life-threatening viruses not addressed by approved therapies[29] Conference Call Information - Management hosted a conference call on June 26, 2025, at 4:30 p.m. ET to review financial results and corporate developments[26] - A replay of the call is available through July 26, 2025, with replay ID number 4903201[28] Forward-Looking Statements - This press release contains forward-looking statements that involve risks and uncertainties, where actual results may differ materially from expectations[31] - Key risks include the ability to raise capital, successfully complete clinical trials, obtain regulatory approvals, and manage manufacturing and research collaborations[31]