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Aethlon Medical(AEMD) - 2025 Q4 - Annual Report
2025-06-26 21:10
Financial Performance - The consolidated operating expenses for the fiscal year ended March 31, 2025, were $9,341,364, a decrease of $3,295,203 from $12,636,568 in the prior year[300]. - Payroll and related expenses decreased by $1,332,359, driven by a reduction in salaries and related expenses and stock-based compensation[301]. - Professional fees decreased by $1,302,834, primarily due to a reduction in legal fees and the termination of services with a contract manufacturing organization[302]. - General and administrative expenses decreased by $660,010, with significant reductions in raw material purchases and laboratory supplies[303]. - The operating loss decreased to $9,341,364 for the fiscal year ended March 31, 2025, from $12,636,568 in the prior year[304]. - Other expense included a non-cash charge of $4,612,862 related to a warrant inducement offer[305]. - The company recognized $324,450 in other income related to the Employee Retention Tax Credit during the fiscal year ended March 31, 2025[306]. Cash and Capital Management - As of March 31, 2025, the company had a cash balance of $5,501,261 and working capital of $4,050,514, compared to $5,441,978 and $4,395,889, respectively, at March 31, 2024[307]. - The company raised capital through a warrant inducement offer and a public offering during the fiscal year ended March 31, 2025[309]. - The company raised aggregate net proceeds of $7,746,311 during the fiscal year ended March 31, 2025, after deducting $405,002 in commissions and legal expenses[310]. - The company raised approximately $3,540,000 from the issuance of common stock and approximately $2,316,000 from the exercise of warrants under induced terms in the fiscal year ended March 31, 2025[335]. - Net cash used in operating activities was approximately $7,646,000 in fiscal 2025, a decrease of approximately $2,484,000 compared to $10,130,000 in fiscal 2024[332]. - The company intends to use the net proceeds from the warrant exercise for working capital and general corporate purposes[312]. - The company generated approximately $7,727,000 from financing activities in the fiscal year ended March 31, 2025, compared to $1,288,000 in the previous fiscal year[334]. - The company may face challenges in accessing additional capital due to potential worsening global economic conditions and market volatility[330]. Clinical Trials and Product Development - The Hemopurifier has demonstrated a 98.5% removal of platelet-derived extracellular vesicles in a pre-clinical study, supporting its ongoing clinical trials[293]. - The company expects clinical trial expenses for planned oncology trials to increase for the foreseeable future, along with rent payments for headquarters and manufacturing facilities[325]. - The company anticipates continuing to incur increasing negative cash flows and net losses for the foreseeable future, necessitating additional capital raises[326]. - A second patient was treated with the Hemopurifier at GenesisCare North Shore Hospital in Sydney, Australia, with the procedure lasting 4 hours[346]. Stock and Compensation - The Company granted 4,112 RSUs to each of the four non-employee directors in April 2024, with each RSU priced at $12.16 per share[343]. - In April 2025, the Company granted 17,858 RSUs to each of the four non-employee directors, with each RSU priced at $2.80 per share[347]. - A reverse stock split of 1-for-8 was approved, effective June 6, 2023, combining every 8 shares of common stock into one share[345]. - The Company's authorized common stock remained at 60,000,000 shares following the reverse stock split[345]. - As of March 31, 2025, there were no vested RSUs outstanding[344]. - The RSUs granted in April 2024 are subject to vesting in four equal installments, with 25% vesting on June 30, September 30, December 31, 2024, and March 31, 2025[343]. - The RSUs granted in April 2025 are also subject to vesting in four equal installments, with 25% vesting on June 30, September 30, December 31, 2025, and March 31, 2026[347]. - The Director Compensation Policy provides for a grant of stock options or $50,000 worth of RSUs for current non-employee directors at the beginning of each fiscal year[343]. - Newly elected non-employee directors receive stock options or $75,000 worth of RSUs upon election[343].
Aethlon Medical Announces Financial Results for the Fiscal Fourth Quarter Ended March 31, 2025, and Provides Corporate Update
Prnewswire· 2025-06-26 20:15
Core Insights - Aethlon Medical, Inc. has made significant progress in its Hemopurifier® cancer trial, having treated three patients and received regulatory approval in India for a similar study [1][9][11] - The company has successfully reduced operating expenses by approximately 26% year-over-year, positioning itself for sustained focus on clinical and regulatory goals [14][16] - Preliminary data from the ongoing trials is expected to provide insights into the efficacy of the Hemopurifier in treating solid tumors and potentially Long COVID [4][10][13] Clinical Progress in Cancer Trial - The first three participants in the Hemopurifier trial completed treatment without complications, and safety follow-ups have been conducted [3][4] - An independent Data Safety Monitoring Board (DSMB) will review safety data and recommend advancement to the next treatment cohort [4] - The trial protocol has been amended to include patients receiving combination therapies with Pembrolizumab or Nivolumab, reflecting current treatment practices [5][6] Regulatory Approval India - Aethlon received approval from India's CDSCO to initiate a similar trial at Medanta Medicity Hospital, following necessary ethical clearances [9] Preclinical Study Supports Broader Applications - A preclinical study demonstrated that the Hemopurifier can remove 98.5% of platelet-derived extracellular vesicles (PD-EVs) from human plasma, indicating potential applications in various diseases [10][11] Scientific Collaboration in Long COVID Research - Aethlon is collaborating with UCSF to investigate the Hemopurifier's potential in treating Long COVID, with findings to be presented at an upcoming symposium [13] Operational Achievements - The company streamlined operations, resulting in a significant reduction in operating expenses, which decreased from approximately $12.6 million in fiscal 2024 to $9.3 million in fiscal 2025 [16][20] Financial Results for the Fiscal Fourth Quarter Ended March 31, 2025 - As of March 31, 2025, Aethlon had a cash balance of approximately $5.5 million [15] - The operating loss for the fiscal year ended March 31, 2025, was $9.3 million, down from $12.6 million the previous year [20][32]
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]