Core Insights - Aethlon Medical, Inc. announced the publication of a pre-clinical ex vivo study demonstrating the effectiveness of its Hemopurifier in removing platelet-derived extracellular vesicles (PD-EVs) from plasma, which supports ongoing oncology clinical trials in Australia [1][4][6] Group 1: Study Findings - The study showed a 98.5% removal of PD-EVs from 200 milliliters of healthy human plasma, simulating a 4-hour treatment session with the Hemopurifier [3][4] - The results indicate the potential of the Hemopurifier to address various diseases where PD-EVs are implicated, including cancer and other serious conditions [5][6] Group 2: Clinical Implications - The findings are expected to enhance the ongoing oncology clinical trial in Australia, where the focus will be on PD-EV removal in enrolled subjects [4][5] - The Hemopurifier is recognized as a Breakthrough Device by the FDA, aimed at treating advanced or metastatic cancer and life-threatening viral infections [6] Group 3: Future Directions - The company plans to submit the study findings for peer review and further investigate PD-EV removal in plasma samples from various diseases [5] - There is potential for the Hemopurifier to serve multiple therapeutic indications beyond oncology, suggesting a "pipeline within a device" concept [5]

Core Insights - Aethlon Medical's Hemopurifier® shows expanded therapeutic potential beyond virology and oncology, particularly in organ transplantation [1][2] - A preclinical study published in Transplant Immunology demonstrates the Hemopurifier's ability to remove extracellular vesicles (EVs) and microRNAs from discarded donor kidneys, which may improve kidney function post-transplant [1][2] - The company is currently focused on oncology trials in Australia and India, but the new data suggests a broader application for the Hemopurifier in organ preservation [2][3] Company Overview - Aethlon Medical is a therapeutic company developing the Hemopurifier, designed to combat cancer, life-threatening viral infections, and for organ transplantation [3] - The Hemopurifier has received FDA Breakthrough Device designation for treating advanced or metastatic cancer and life-threatening viruses [3] Research Findings - The preclinical study indicates significant reductions in EVs and microRNAs associated with renal dysfunction when using the Hemopurifier on perfusion fluid from discarded kidneys [2] - The study supports the hypothesis that EVs and microRNAs contribute to complications in kidney transplantation, such as delayed function and organ rejection [2] Future Directions - Further evaluation of the Hemopurifier's integration into machine perfusion circuits for discarded kidneys is necessary, with plans for clinical trials to assess its efficacy [2][3] - The technology could potentially enhance existing organ preservation methods, indicating a "pipeline within a device" for future therapeutic applications [2]

Core Viewpoint - Aethlon Medical, Inc. is set to present at the Emerging Growth Conference, highlighting its focus on developing innovative medical therapies for cancer and life-threatening infectious diseases [1][4]. Company Overview - Aethlon Medical is a therapeutic company that has developed the Hemopurifier, an immunotherapeutic device aimed at treating cancer and viral infections, as well as applications in organ transplantation [6]. - The Hemopurifier has shown efficacy in removing life-threatening viruses and harmful exosomes in human and pre-clinical studies, utilizing proprietary lectin-based technology [6]. - The device has received FDA Breakthrough Device designation for treating advanced or metastatic cancer and life-threatening viral infections [6]. Conference Details - The presentation will take place on February 19, 2025, at 11:25 AM Eastern time, lasting for 30 minutes [3]. - Attendees will have the opportunity to interact with the CEO, James Frakes, during the event, with a Q&A session planned [2]. - An archived version of the presentation will be available for those unable to attend live [3]. Emerging Growth Conference - The conference serves as a platform for public companies to present new products and services to the investment community efficiently [4]. - It attracts a diverse audience, including individual and institutional investors, investment advisors, and analysts [5].

Financial Data and Key Metrics Changes - As of December 31, 2024, Aethlon Medical had a cash balance of approximately $4.8 million [26] - Consolidated operating expenses for the fiscal quarter ended December 31, 2024, decreased by approximately $1.8 million or approximately 50% to $1.8 million compared to $3.6 million for the same quarter in 2023 [26] - Net loss decreased to approximately $1.8 million in the fiscal quarter ended December 31, 2024, from approximately $3.5 million in the same period of 2023 [29] Business Line Data and Key Metrics Changes - The company is focusing on oncology trials, specifically the Hemopurifier in patients with solid tumors, with three patients enrolled to date [10] - The trial has seen protocol amendments to improve enrollment speed and reduce screen failures, which are expected to enhance operational efficiency [14][15] Market Data and Key Metrics Changes - Aethlon is pursuing clinical trials in both Australia and India, with regulatory approvals obtained for the amended protocol in Australia and ongoing efforts in India [16][17] - The company is closely monitoring developments related to bird flu, Marburg virus, and Ebola virus, indicating potential market opportunities for the Hemopurifier [21] Company Strategy and Development Direction - The company has implemented strategic cost-cutting measures to optimize resources and maintain focus on high-impact oncology trials [24] - Aethlon aims to enhance resource allocation and reduce operational expenses while advancing clinical programs [24] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the progress of oncology trials and the potential for shareholder rewards from these efforts [8] - The company anticipates that operational expenses will increase as clinical trials progress, particularly in Australia and India [75] Other Important Information - The primary endpoint of the ongoing trial is safety, with a focus on monitoring adverse events and changes in laboratory measurements [18] - The Hemopurifier is designed to bind and remove extracellular vesicles from the bloodstream, which may improve therapeutic response rates to anti-PD-1 antibodies [20] Q&A Session Summary Question: Can you provide more details on the first three patients enrolled in the study? - The nine to 18 range refers to Hemopurifier treated patients, and the two patients who did not proceed still provide valuable data [35][36] Question: Will the new protocol inform the trial design in India? - Yes, the same amendment will be submitted to the ethics committee in India [44] Question: What is the expected timeline for reaching the 9 to 18 patient population? - There are no specific estimations, but the hope is to see a few patients over the next couple of months [61] Question: Is the Hemopurifier a potential first-line treatment for bird flu? - Currently, the Hemopurifier would not be a first-line treatment, but it could be considered if existing treatments fail [72] Question: Should the $1.8 million operating expense be considered the new run rate? - Operating expenses are expected to increase as clinical trials progress, but efforts will be made to hold the line on professional fees and payroll [75]

Financial Performance - Consolidated operating expenses for the three months ended December 31, 2024, decreased by $1,752,341 or 49.1% to $1,814,747 compared to $3,567,088 for the same period in 2023[100]. - Comprehensive loss decreased to $1,767,840 in the three months ended December 31, 2024, from $3,458,170 in the same period in 2023[105]. - For the nine months ended December 31, 2024, consolidated operating expenses decreased by $2,813,192 or 27.7% to $7,337,402 compared to $10,150,594 for the same period in 2023[106]. - Basic and diluted loss attributable to common stockholders was ($0.13) for the three months ended December 31, 2024, compared to ($1.37) for the same period in 2023[105]. - As of December 31, 2024, the company reported an accumulated deficit of $161,699,924 and limited working capital, raising substantial doubt about its ability to continue as a going concern[117]. - The company expects to incur increasing negative cash flows and net losses for the foreseeable future, necessitating additional capital through debt and/or equity financing[116][134]. Cash Flow and Financing - As of December 31, 2024, the company had a cash balance of $4,825,387 and working capital of $3,194,737, compared to a cash balance of $5,441,978 and working capital of $4,395,889 at March 31, 2024[112]. - Cash used in operating activities for the nine months ended December 31, 2024, was approximately $5,973,000, a decrease from $7,564,000 in the same period of 2023[127]. - The company raised approximately $5,368,000 from financing activities during the nine months ended December 31, 2024, compared to $1,245,000 in the same period of 2023[129][130]. - In June 2024, holders of Class A and Class B warrants exercised 300,000 and 2,880,000 shares, respectively, generating additional proceeds of $1,844,400[125]. - The company plans to access equity markets for additional capital, but there is no assurance of favorable terms or availability[135]. - Future capital requirements will depend on various factors, including progress in clinical trials and regulatory approvals, with expectations of continued cash flow challenges[116][134]. Clinical Trials and Product Development - The Hemopurifier has been safely utilized in 164 sessions with 38 patients, demonstrating potential to remove life-threatening viruses[84]. - The company has launched clinical trials of the Hemopurifier in Australia and India for cancer patients, focusing on safety and feasibility[85]. - The FDA has designated the Hemopurifier as a "Breakthrough Device" for two independent indications related to cancer and life-threatening viral infections[84]. - The company is investigating the Hemopurifier's potential applications in organ transplantation, particularly for kidneys from deceased donors[95]. - The company anticipates increased clinical trial expenses for oncology trials in Australia and India, including costs for manufacturing additional Hemopurifiers[131]. Market and Economic Conditions - The company is closely monitoring the impact of global events such as inflation and military conflicts on its business and financial condition[97]. - The company closed a public offering on May 17, 2024, selling 2,450,000 shares of common stock and pre-funded warrants for 5,650,000 shares, raising approximately $4.7 million in gross proceeds and $3.5 million in net proceeds after expenses[113][123].

Financial Performance - Aethlon Medical reported a cash balance of approximately $4.8 million as of December 31, 2024[15]. - Consolidated operating expenses decreased by approximately $1.8 million, or 50%, to $1.8 million compared to $3.6 million for the same quarter in 2023[16]. - The net loss for the fiscal quarter ended December 31, 2024, decreased to approximately $1.8 million from approximately $3.5 million in the same quarter of 2023[20]. - Net loss for the three months ended December 31, 2024, was $1,754,783, compared to a net loss of $3,466,121 for the same period in 2023, showing a reduction of approximately 49.3%[31]. - Basic and diluted loss per share improved from $(1.37) to $(0.13) for the three months ended December 31, 2024, indicating a significant reduction in loss per share[31]. - Interest income for the three months ended December 31, 2024, was $59,964, compared to $100,967 in the same period of 2023, a decrease of approximately 40.5%[31]. - Accumulated deficit increased from $(161,699,924) to $(154,566,728), indicating a reduction in the deficit by about 4.4%[29]. Clinical Trials and Research - The company has enrolled three patients in its Hemopurifier cancer trial, with one patient successfully treated[3]. - Aethlon has implemented strategic cost-cutting measures to enhance operational efficiency, focusing on high-impact oncology trials in Australia and India[9]. - The company received ethics committee approval for protocol amendments at all three clinical sites in Australia, facilitating improved patient enrollment[6]. - The protocol amendment allows for enrolling patients only after confirming non-responsiveness to anti-PD-1 therapy, streamlining the trial process[5]. - Approximately 30% of patients receiving pembrolizumab or nivolumab have lasting clinical responses, highlighting the need for improved treatment options[12]. - The Hemopurifier is designed to remove extracellular vesicles (EVs) from the bloodstream, potentially improving therapeutic responses to anti-PD-1 antibodies[12]. - Aethlon is pursuing approval for a similar clinical trial in India, with HREC approval obtained at Medanta Medicity Hospital[7]. Financial Position - Total current assets increased from $4,968,407 to $6,225,788, representing a growth of approximately 25.3%[29]. - Total liabilities rose from $2,191,193 to $2,479,650, an increase of about 13.1%[29]. - Total stockholders' equity increased from $4,334,166 to $5,766,332, representing an increase of about 32.9%[29]. - Total assets grew from $6,525,359 to $8,245,982, an increase of approximately 26.3%[29]. - Total operating expenses decreased from $3,567,088 to $1,814,747, a decline of about 49.1% year-over-year for the three-month period[31]. - Cash and cash equivalents increased from $4,825,387 to $5,441,978, reflecting a growth of approximately 12.8%[29].

Core Insights - Aethlon Medical has achieved a key milestone by treating the first patient in the Hemopurifier® safety, feasibility, and dose-finding study for solid tumors not responding to anti-PD-1 antibodies [1] - The company has opened patient enrollment at two clinical sites in Australia for the Hemopurifier cancer trial [1] - Significant reductions in operating expenses have been reported, enhancing operational efficiency [1] Clinical Trials - The Australian oncology trial of the Hemopurifier has seen steady progress, with three patients enrolled so far [2] - One patient successfully underwent a 4-hour Hemopurifier treatment without complications, while two patients were withdrawn due to pre-specified stopping criteria [2][9] - Protocol modifications have been made to improve enrollment speed and reduce screen failures, including changes to patient eligibility criteria [3][4] Regulatory Approvals - The amended protocol for the trial has received approval from Human Research Ethics Committees (HREC) at all three clinical sites [5] - Aethlon is pursuing a similar clinical trial in India, with HREC approval obtained at Medanta Medicity Hospital, awaiting further regulatory approval [6] Operational Efficiency - Strategic cost-cutting measures have been implemented to optimize resources and reduce operational expenses [7] - The company reported a 50% decrease in consolidated operating expenses for the fiscal quarter ended December 31, 2024, amounting to approximately $1.8 million [14] Financial Results - As of December 31, 2024, Aethlon had a cash balance of approximately $4.8 million [13] - The net loss for the fiscal quarter decreased to approximately $1.8 million from approximately $3.5 million in the same quarter of the previous year [18] - Operating expenses decreased significantly due to reductions in payroll, professional fees, and general administrative expenses [14][15][17] Future Outlook - The primary endpoint of the ongoing trials is safety, with a focus on monitoring adverse events and changes in lab tests for Hemopurifier-treated patients [9][10] - The Hemopurifier aims to improve therapeutic response rates to anti-PD-1 antibodies by removing extracellular vesicles (EVs) from the bloodstream [11]

Core Viewpoint - Aethlon Medical, Inc. is set to release its financial results for the fiscal third quarter ending December 31, 2024, on February 12, 2025, at 4:15 p.m. ET [1] Financial Results Announcement - The financial results will be discussed in a conference call on February 12, 2025, at 4:30 p.m. ET, which will include a question and answer session [2] - Interested parties can register for the conference call online, and registered participants will receive their dial-in number upon registration [2] Conference Call Details - For those without internet access, a toll-free number is available for participation: 1-844-836-8741 (domestic) and 1-412-317-5442 (international) [3] - A replay of the call will be available approximately one hour after the call ends and can be accessed through Aethlon Medical's website or by dialing specific numbers for domestic and international callers [4] Company Overview - Aethlon Medical focuses on developing the Hemopurifier, an immunotherapeutic device aimed at treating cancer and life-threatening viral infections [5] - The Hemopurifier has shown promise in human studies for removing life-threatening viruses and harmful exosomes, which may contribute to immune suppression and cancer metastasis [5] - The device has received FDA Breakthrough Device designation for treating advanced or metastatic cancer and life-threatening viruses not addressed by approved therapies [5]

Core Insights - Aethlon Medical has achieved a significant milestone by treating the first patient with the Hemopurifier in a clinical trial targeting solid tumors that do not respond to anti-PD-1 therapies [1][3] - The trial aims to assess the safety, feasibility, and dosing of the Hemopurifier in patients with stable or progressive disease after anti-PD-1 monotherapy [5] Company Overview - Aethlon Medical, Inc. is a publicly traded medical device company based in San Diego, California, focused on developing therapeutic devices to treat cancer and life-threatening infectious diseases [7] - The Hemopurifier is designed to remove enveloped viruses and tumor-derived extracellular vesicles from circulation, potentially improving responses to existing cancer therapies [6][7] Clinical Trial Details - The clinical trial involves approximately 18 patients and will monitor the incidence of adverse events and changes in safety lab tests after treatment with the Hemopurifier [5] - The study will also evaluate the number of Hemopurifier treatments required to decrease extracellular vesicle concentrations and whether this enhances the body's ability to attack tumor cells [5] Treatment Context - Only 30-40% of patients receiving pembrolizumab or nivolumab show lasting clinical responses, highlighting the need for alternative treatment strategies [4] - The Hemopurifier has shown promise in preclinical studies by reducing the number of exosomes in cancer patient plasma, which may help overcome resistance to anti-PD-1 therapies [4][6]

SAN DIEGO, Dec. 20, 2024 /PRNewswire/ -- Aethlon Medical, Inc. (Nasdaq: AEMD), a medical therapeutic company focused on developing products to treat cancer and life-threatening infectious diseases, today provided a statement of its investigational medical device with respect to H5N1 avian influenza "Bird Flu."Aethlon has recently received a number of inquiries regarding the potential utility of its Hemopurifier device in the treatment of Bird Flu. These inquiries come on the heels of the reporting of isolat ...