Aethlon Medical(AEMD)

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Aethlon Medical to Release Fiscal Fourth Quarter Financial Results and Host Conference Call on June 26, 2025
Prnewswire· 2025-06-20 12:01
Core Viewpoint - Aethlon Medical, Inc. is set to release its financial results for the fiscal fourth quarter ended March 31, 2025, on June 26, 2025, at 4:15 p.m. ET [1] Financial Results Announcement - The financial results will be followed by a conference call hosted by management on June 26, 2025, at 4:30 p.m. ET to discuss the results and recent corporate developments [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 participant dial-in number is available at 1-844-836-8741, with an international dial-in option at 1-412-317-5442 [3] - A replay of the call will be accessible approximately one hour after the call ends and will be available until July 26, 2025 [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]
Aethlon Medical Treats Second Patient in Australian Hemopurifier® Cancer Trial
Prnewswire· 2025-06-18 12:01
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]
Aethlon Medical (AEMD) Conference Transcript
2025-06-17 20:40
Aethlon Medical (AEMD) Conference Summary Company Overview - Aethlon Medical Inc. is a medical therapeutic company focused on developing products to treat cancer and life-threatening infectious diseases [1][2]. Key Points and Arguments Long COVID Research - Aethlon Medical is collaborating with the University of California in San Francisco to explore the potential utility of their Hemopurifiers in treating long COVID [3]. - Preliminary research indicates that the Hemopurifiers can bind extracellular vesicles and the spike protein associated with long COVID [3][4]. - The CDC estimates that 6-7% of the U.S. population, approximately 44-48 million people, suffer from long COVID, highlighting a significant market opportunity [6]. - The U.S. government has invested $1 billion in long COVID research without finding effective therapies, indicating a gap in the market that Aethlon aims to address [7]. Oncology Trials - Aethlon's primary focus remains on oncology, with ongoing trials in India and Australia [4][12]. - Regulatory changes in India have delayed the start of trials, but the company is optimistic about beginning soon [12][13]. - In Australia, three hospitals are involved in the clinical trial, with the first patient treated in January [14][16]. - The trial is a safety study for patients with solid tumors undergoing anti-PD-1 monotherapy, with a structured cohort design to assess treatment safety and efficacy [17][18]. Product Development - The Hemopurifier is an extracorporeal device that can be integrated with blood pumping machines, targeting extracellular vesicles emitted by tumors and other diseases [9][10]. - Aethlon is applying for patent protection related to their work on extracellular vesicles, which connects to their oncology research [11]. Additional Important Information - Aethlon Medical has been accepted to present preliminary findings at the Keystone Conference in August, which may provide further validation of their research [5]. - The company is hopeful about potential government grant opportunities related to their long COVID research [7]. - The upcoming milestones in the oncology trials are critical for the company's future, with expectations for significant developments soon [20]. This summary encapsulates the key aspects of Aethlon Medical's recent conference, focusing on their research initiatives, product development, and ongoing clinical trials.
Aethlon Medical to Present New Pre-Clinical Data at the Keystone Symposium on Long COVID and Other Post-Acute Infection Syndromes
Prnewswire· 2025-06-09 12:01
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]
Aethlon Medical Announces Publication of Preclinical Data Showing Ability of the Hemopurifier® to Remove Platelet-Derived Extracellular Vesicles from Plasma
Prnewswire· 2025-05-14 12:01
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]
Aethlon Medical Publishes Preclinical Data on the Hemopurifier® in Transplant Immunology Journal
Prnewswire· 2025-03-10 12:01
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]
Aethlon Medical to Present at the Emerging Growth Conference on February 19, 2025
Prnewswire· 2025-02-13 13:01
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].
Aethlon Medical(AEMD) - 2025 Q3 - Earnings Call Transcript
2025-02-13 01:11
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]
Aethlon Medical(AEMD) - 2025 Q3 - Quarterly Report
2025-02-12 22:15
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].
Aethlon Medical(AEMD) - 2025 Q3 - Quarterly Results
2025-02-12 21:15
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].