Core Insights - Aethlon Medical, Inc. has provided updates on its ongoing oncology clinical trial in Australia, focusing on the Hemopurifier's effects on cancer patients not responding to anti-PD-1 therapy [3][4][11] Clinical Trial Observations - The initial cohort of three patients showed promising changes in extracellular vesicles (EVs), microRNAs, and lymphocyte counts after a single treatment with the Hemopurifier [4][5] - Changes in EV and microRNA levels typically returned to baseline within 1 to 3 weeks post-treatment [6] - Two of the three participants exhibited decreases in large EVs, which are implicated in cancer metastasis and immune response inhibition [10] Hemopurifier Mechanism - The Hemopurifier is designed to remove enveloped viruses and tumor-derived EVs from circulation, potentially aiding in cancer treatment by targeting mannose-rich surfaces on EVs and viral proteins [9][11] - The device has received U.S. Food and Drug Administration Breakthrough Device Designation for treating advanced or metastatic cancer and life-threatening viruses [11] Patient Response and Data Limitations - Increases in total T cell numbers and specific T cell subsets were noted in participants following treatment, although the data is limited due to the small sample size [10] - The study's preliminary nature means that no definitive conclusions can be drawn regarding the clinical efficacy of the Hemopurifier [8][10]

Core Insights - Aethlon Medical, Inc. is conducting an ongoing oncology clinical trial in Australia to evaluate the safety, feasibility, and dose-finding of its Hemopurifier device in cancer patients unresponsive to anti-PD-1 therapy [1][2] Summary by Categories Clinical Trial Observations - Preliminary results from the first patient cohort indicate encouraging changes in extracellular vesicles (EVs), microRNAs, and lymphocyte counts after a single Hemopurifier treatment [2][3] - In the initial three patients, two showed decreases in large EVs, which are implicated in cancer metastasis and immune evasion [7] - All three participants exhibited decreases in large EVs carrying PD-L1, which is associated with resistance to anti-PD-1 therapies [7] - Seven out of ten microRNAs examined showed decreases in two of the three participants following treatment, indicating potential effects on cancer growth and metastasis [7] - Improvements in laboratory ratios related to immunotherapy responses were observed in at least two participants after treatment [7] Device Information - The Aethlon Hemopurifier® is designed to remove enveloped viruses and tumor-derived EVs from circulation, potentially aiding in cancer treatment [9] - The device operates extracorporeally and utilizes a combination of plasma separation, size exclusion, and affinity binding [9] - It holds a U.S. Food and Drug Breakthrough Device Designation for treating advanced or metastatic cancer and life-threatening viruses [10] Limitations and Future Directions - The small sample size limits the ability to draw definitive conclusions about the efficacy and dose response of the Hemopurifier [3][8] - Further data from subsequent cohorts will be necessary to determine the reproducibility of the observed changes and the potential for dose-dependent effects [3] - The current observations are part of an early feasibility study and should not be interpreted as evidence of clinical benefit or safety beyond the study parameters [8]

Financial Data and Key Metrics Changes - As of June 30, 2025, the company had a cash balance of approximately $3.8 million [20] - For the three months ended June 30, 2025, consolidated operating expenses were approximately $1.8 million, down roughly $800,000 or 32% from $2.6 million a year ago [20][21] - The operating loss decreased to $1.8 million compared to $2.6 million from the previous year, reflecting progress in aligning resources with strategic priorities [21] Business Line Data and Key Metrics Changes - The company advanced its lead oncology indication clinical program and delivered preclinical results supporting broader applications, including long COVID, while significantly reducing operating expenses [7] - The first cohort of the Australian oncology trial completed Hemopurifier treatments without any device deficiencies or immediate complications [10] - An independent data safety monitoring board recommended advancing to the second treatment cohort after reviewing safety data from the first cohort [11] Market Data and Key Metrics Changes - The Australian oncology trial is designed to include patients on either monotherapy or combination therapy, increasing the potential pool of patients for the study [12] - The global economic burden of long COVID is approximately $1 trillion per year, indicating a large unmet medical need [15] Company Strategy and Development Direction - The company decided not to proceed with the India study to focus resources on the Australian trial, which is seen as the fastest track toward regulatory approval [7][8] - The focus remains on moving the Hemopurifier towards regulatory approval and expanding its use across multiple diseases [7] Management Comments on Operating Environment and Future Outlook - Management acknowledged the need to continue raising funds for clinical research, ideally through strategic partnerships rather than financial investors [31] - The decision to halt the Indian trial was primarily strategic, aimed at avoiding potential delays in moving forward to the PMA phase [31][34] Other Important Information - The company presented preclinical data on long COVID at a symposium, indicating the potential for the Hemopurifier to remove extracellular vesicles associated with long COVID [15][16] - The company is actively recruiting additional sites in Australia to speed up patient enrollment for the clinical trial [42] Q&A Session Summary Question: Is the primary endpoint of the Australian study safety, and is the company on track to meet it? - Management confirmed that the first cohort has been treated without adverse events, indicating progress towards meeting the primary endpoint [25][26] Question: How does the preclinical data translate to actual patient treatment? - Management acknowledged that lab results may not directly reflect patient outcomes, emphasizing the importance of data from actual patients [27][28] Question: What are the implications of not moving forward with the Indian trial? - Management stated that the decision was strategic to avoid delays in regulatory approval, although cost savings were also a factor [30][31][34] Question: Will the company be able to speed up enrollment in the Australian trial? - Management confirmed efforts to speed up enrollment, including recruiting additional sites and using clinical trial liaisons and social media campaigns [41][42]

Core Insights - Aethlon Medical, Inc. is presenting research on the Hemopurifier® device's ability to bind extracellular vesicles (EVs) in Long COVID samples at an upcoming symposium [1][6] - Long COVID affects an estimated 44 to 48 million people in the U.S., with a significant economic burden projected at $2 billion for those experiencing symptoms for a year [2] - The Hemopurifier is designed to remove harmful EVs from the blood, which are implicated in the pathogenesis of Long COVID [4][8] Company Overview - Aethlon Medical focuses on developing the Hemopurifier, an investigational device aimed at treating cancer and life-threatening infectious diseases [8] - The Hemopurifier has shown efficacy in removing life-threatening viruses and harmful EVs in pre-clinical studies [8] - The device has received FDA Breakthrough Device designation for treating advanced or metastatic cancer and life-threatening viruses [10] Research Details - The research presented will evaluate the binding of EVs from Long COVID patients to the Hemopurifier's affinity resin, which targets the sugar mannose [5][6] - The study involves collaboration with the University of California San Francisco Medical Center Long COVID clinic [5] - The poster presentation is scheduled for August 12, 2025, and will be available on Aethlon's corporate website afterward [6][7]