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 has made significant progress in its Australian oncology trial, completing the first treatment cohort and amending the protocol to broaden patient eligibility [1][2][5] - The company reported a 31.6% reduction in operating expenses for the fiscal first quarter, enhancing operational efficiency [10][16] - Promising preclinical data supports the potential of the Hemopurifier in treating various conditions, including Long COVID [10][12][14] Clinical Progress - The first treatment cohort in the Australian trial involved patients with solid tumors unresponsive to PD-1 inhibitors, with no serious adverse events reported [3][4] - The independent Data Safety Monitoring Board recommended advancing to the second treatment cohort, which will involve two Hemopurifier treatments within a week [4] - The trial aims to assess safety and the potential to improve the body's natural ability to attack tumor cells by reducing extracellular vesicle concentrations [7][8] Financial Performance - As of June 30, 2025, Aethlon had a cash balance of approximately $3.8 million [15] - Consolidated operating expenses for the quarter were approximately $1.8 million, down from $2.6 million in the same period last year [16][20] - The operating loss for the quarter decreased to $1.8 million compared to $2.6 million for the same period in 2024 [20] Preclinical and Research Developments - Aethlon's preclinical study demonstrated a 98.5% removal of platelet-derived extracellular vesicles from healthy human plasma during a simulated 4-hour treatment [10][11] - The company is collaborating with UCSF to explore the Hemopurifier's potential applications in Long COVID, with initial findings presented at a recent symposium [12][13][14] Strategic Decisions - Aethlon decided not to proceed with a planned oncology trial in India due to extended timelines and costs, allowing the company to focus on its ongoing trial in Australia [9] - The amended protocol for the Australian trial reflects current standards of care, expanding eligibility to patients receiving various treatment regimens that include anti-PD-1 agents [5]

Financial Data and Key Metrics Changes - As of March 31, 2025, the company had a cash balance of approximately $5.5 million [16] - Operating expenses for the year were approximately $9.3 million, a reduction of about $3.3 million or 26% compared to the prior year [17] - A noncash charge of $4.6 million was recognized related to a warrant inducement offer made in March 2025 [17][18] Business Line Data and Key Metrics Changes - The company treated the first three patients in its oncology trial using the Hemopurifier at clinical sites in Australia [6] - Regulatory approval was received in India to initiate a similar oncology study [12] - The trial protocol was expanded to align with evolving standards of care in immunotherapy [6] Market Data and Key Metrics Changes - The collaboration with UCSF on long COVID research is ongoing, with findings to be presented at the upcoming Keystone Symposium [14] - The economic burden of long COVID is estimated to impact 44 to 48 million people in the US [15] Company Strategy and Development Direction - The primary focus remains on oncology, with ongoing trials in Australia and India [22][24] - The company aims to streamline operations and reduce costs while focusing resources on areas with the greatest clinical and regulatory impact [15][16] - Future exploration of the Hemopurifier's applications beyond oncology is being considered, particularly in conditions like lupus and Alzheimer's disease [14] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the progress made in clinical trials and the potential for future partnerships based on safety data [62] - The company anticipates needing to raise additional funds until it can secure government grants or partnerships with larger companies [61] - Management does not expect further nonrecurring expenses related to terminated executives [32][33] Other Important Information - The company has published results of a preclinical study showing a 98.5% removal of platelet-derived extracellular vesicles during Hemopurifier treatments [13] - The next earnings call is scheduled for August 2025, coinciding with the filing of the quarterly report [19] Q&A Session Summary Question: What are the focus areas for the company? - The primary focus remains on oncology, with the upcoming trial in India being parallel to the Australian trial [22][24] Question: What is the expected timeline for more robust data from the Australian trial? - Preliminary data from the first cohort is expected in about three months, with a data safety monitoring board meeting set for July [28][29] Question: Are nonrecurring expenses finished? - Management does not anticipate further nonrecurring expenses following the termination of three senior executives [32][33] Question: Will patient recruitment in India be faster than in Australia? - There is potential for faster recruitment in India due to the larger population and the hospital's capabilities [70][72] Question: What is the landscape for grant approvals currently? - The company is familiar with the grant process and is open to pursuing grants that align with its goals, though the current environment may present challenges [78][80]

Core Insights - Aethlon Medical has achieved a significant milestone by treating the second patient with the Hemopurifier in its clinical trial for solid tumors not responding to anti-PD-1 antibodies [1][2] - The trial aims to assess the safety and feasibility of the Hemopurifier, with the first cohort consisting of approximately 18 patients [6] - The Hemopurifier is designed to remove tumor-derived extracellular vesicles (EVs) from the bloodstream, potentially improving responses to anti-PD-1 therapies [5][7] Group 1: Clinical Trial Progress - The second patient was treated on June 11, 2025, at the Royal North Shore Hospital/University of Sydney, following the first patient treated on January 29, 2025 [1][2] - Both patients completed the 4-hour Hemopurifier treatment without device deficiencies or immediate complications, and have finished the 7-day safety follow-up period [2][4] - The Data Safety Monitoring Board (DSMB) will review the safety data after the third patient is enrolled, which is expected to occur soon [3][4] Group 2: Device and Mechanism - The Hemopurifier is an investigational device that utilizes plasma separation and affinity binding to remove enveloped viruses and EVs from circulation [7][8] - Preclinical studies indicate that the Hemopurifier can reduce the number of exosomes in cancer patient plasma, which may enhance the effectiveness of anti-PD-1 therapies [5][6] - The device holds FDA Breakthrough Device designation for treating advanced or metastatic cancer patients who are unresponsive to standard therapies [8] Group 3: Future Directions - The primary endpoint of the trial is to monitor adverse events and significant changes in safety lab tests among treated patients [6] - The study will also explore the number of Hemopurifier treatments required to decrease EV concentrations and whether this improves the immune response against tumor cells [6] - Data on the effects of the Hemopurifier on anti-tumor T cell activity is anticipated approximately three months after the enrollment of the third patient [3]