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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].
Aethlon Medical Announces Financial Results for the Fiscal Third Quarter Ended December 31, 2024 and Provides Corporate Update
Prnewswire· 2025-02-12 21:15
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]
Aethlon Medical to Release Fiscal Third Quarter Financial Results and Host Conference Call on February 12, 2025
Prnewswire· 2025-02-05 13:01
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]
Aethlon Medical Treats First Patient in Australian Hemopurifier® Cancer Trial
Prnewswire· 2025-01-29 13:01
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]
Aethlon Medical Provides Update on the Ability of Its Hemopurifier® to Capture H5N1 Bird Flu
Prnewswire· 2024-12-20 13:01
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 ...
Biotech and Medical Tech Stocks Report Significant Updates in the Race for Cancer Treatments as Cancer Rates Rise Globally
Newsfile· 2024-11-14 13:00
Biotech and Medical Tech Stocks Report Significant Updates in the Race for Cancer Treatments as Cancer Rates Rise GloballyNovember 14, 2024 8:00 AM EST | Source: Econ Corp Services DBA Investorideas.comVancouver, Kelowna, and Delta, British Columbia--(Newsfile Corp. - November 14, 2024) - Investorideas.com, a go-to investing platform covering biotech and medical technology stocks releases a snapshot looking at the advancement of treatments for solid tumors as global cancer incidence rates rise ...
Aethlon Medical(AEMD) - 2025 Q2 - Earnings Call Transcript
2024-11-14 00:58
Financial Data and Key Metrics Changes - As of September 30, 2024, Aethlon Medical held a cash balance of approximately $6.9 million [22] - For the fiscal quarter ended September 30, 2024, consolidated operating expenses were approximately $2.9 million, a decrease from $3.2 million in the same period of 2023, representing a 9% reduction [22][25] - The net loss decreased to approximately $2.8 million in the fiscal quarter ended September 30, 2024, from approximately $3 million in the same quarter of 2023 [25] Business Line Data and Key Metrics Changes - The company advanced its oncology trial efforts in Australia, enrolling the first two patients in a clinical trial [8][9] - Aethlon received ethics committee approval for a similar trial in India, which will also focus on safety and feasibility [13] Market Data and Key Metrics Changes - The company is exploring opportunities to expand the use of the Hemopurifier for life-threatening viral infections, showing effectiveness against various viruses [19] Company Strategy and Development Direction - Aethlon Medical is focused on the research and clinical development of its Hemopurifier, targeting oncology and viral infections [6][19] - The company aims to streamline operations and reduce expenses while advancing its oncology program [7] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the progress of the oncology program and the potential for shareholder rewards [7] - The company is optimistic about the upcoming milestones in its clinical trials and the expected benefits from the Australian tax credit program [37] Other Important Information - The Hemopurifier is designed to bind and remove harmful exosomes and viruses, with potential applications in oncology and organ transplantation [6] - The company is awaiting full ethics board approval from a third Australian hospital, which is expected to expedite patient enrollment [10] Q&A Session Summary Question: Are the first two patients enrolled in the study representative of different solid tumor types? - Yes, both patients have different tumor types as described in the inclusion criteria [28][29] Question: Is the company confident about receiving ethics committee approval for the third site in Australia? - Yes, there is high confidence due to prior ethics approval from another site and ongoing training for the staff [30][31] Question: Why are there two separate trials in India and Australia with the same safety endpoint? - The decision was made to keep the patient populations distinct due to genetic and comorbidity differences [40] Question: When can the company expect to conclude enrollment and data from the trial in Australia? - The first data on safety is expected in January, with further data on extracellular vesicles and T-cell activity to follow in the summer of next year [44][45]
Aethlon Medical(AEMD) - 2025 Q2 - Quarterly Report
2024-11-13 22:15
Financial Performance - Total current assets increased to $7,138,083 as of September 30, 2024, up from $6,225,788 as of March 31, 2024, representing a growth of 14.6%[9] - Total liabilities rose to $2,828,222 as of September 30, 2024, compared to $2,479,650 as of March 31, 2024, indicating an increase of 14.1%[10] - The net loss for the three months ended September 30, 2024, was $2,806,973, a decrease from the net loss of $3,034,456 for the same period in 2023, reflecting an improvement of 7.5%[13] - Basic and diluted loss per share for the three months ended September 30, 2024, was $(0.20), compared to $(1.22) for the same period in 2023, showing a significant reduction in loss per share[13] - For the six months ended September 30, 2024, the net loss was $5,378,414, compared to a net loss of $6,316,635 for the same period in 2023, representing a 14.8% improvement in losses year-over-year[17] Cash and Assets - Cash and cash equivalents increased to $6,859,075 as of September 30, 2024, compared to $5,441,978 as of March 31, 2024, marking a rise of 26.0%[9] - The cash and restricted cash at the end of the period on September 30, 2024, was $6,946,581, compared to $10,263,426 at the end of the same period in 2023, reflecting a decrease in available cash[17] - The total stockholders' equity as of September 30, 2024, was $6,019,108, up from $5,766,332 as of March 31, 2024, reflecting an increase of 4.4%[11] - The accumulated deficit as of September 30, 2024, was $(159,945,141), compared to $(154,566,728) as of March 31, 2024, indicating an increase in the deficit[11] Operating Expenses - Total operating expenses for the six months ended September 30, 2024, were $5,521,856, down from $6,583,506 for the same period in 2023, a decrease of 16.2%[13] - Professional fees for the three months ended September 30, 2024, were $570,845, down from $1,133,111 for the same period in 2023, a decrease of 49.6%[13] - Payroll and related expenses for the three months ended September 30, 2024, increased to $1,372,899 from $1,191,426 in 2023, an increase of 15.2%[13] - The company reported total operating expenses of $2,902,119 for the three months ended September 30, 2024, down from $3,175,346 in the same period of 2023, a decrease of 8.61%[13] Research and Development - The company incurred research and development expenses of $261,486 for the three months ended September 30, 2024, compared to $628,447 for the same period in 2023, representing a decrease of approximately 58.4%[47] - For the six months ended September 30, 2024, research and development expenses totaled $702,115, down from $1,687,010 in the same period of 2023, indicating a reduction of about 58.3%[47] Clinical Trials and Product Development - The Hemopurifier has been designated as a "Breakthrough Device" by the FDA for treating advanced or metastatic cancer and life-threatening viral infections, highlighting its potential in critical medical applications[18] - Clinical trials for the Hemopurifier have commenced in Australia and India, focusing on safety, feasibility, and dose-finding in cancer patients, with trials involving approximately 9 to 18 patients in each country[20][22] - The company has established a wholly-owned subsidiary in Australia to conduct oncology-related clinical research and seek regulatory approval for the Hemopurifier[19] - The Hemopurifier has shown potential in removing harmful exosomes and exosomal particles, which may contribute to cancer progression and immune suppression[18] - The company has successfully enrolled the first two patients in its Australian clinical trial for the Hemopurifier, marking a significant milestone in its clinical program[85] Financing Activities - The company raised $5,384,307 from the issuance of common stock during the six months ended September 30, 2024, compared to $1,086,119 in the same period of 2023, indicating a significant increase in financing activities[17] - The company completed a public offering on May 17, 2024, raising gross proceeds of approximately $4.7 million, with net proceeds of about $3.5 million after deducting fees and expenses[55] Management and Governance - The company appointed James B. Frakes as the permanent CEO effective October 3, 2024, while also retaining his role as CFO[84] - In April 2024, the company granted 32,894 RSUs to each of the four eligible non-employee directors, with each RSU priced at $1.52 per share[59] - For the three months ended September 30, 2024, the company accrued $68,250 for board fees and paid out $68,250, compared to $57,000 paid in the same period in 2023[60] Legal and Regulatory Matters - The company is currently not involved in any litigation or pending legal proceedings, reflecting a stable legal environment[82] - The company has received ethics review board approval for its COVID-19 clinical trial at Medanta Medicity Hospital and Maulana Azad Medical College in India[29] Future Outlook - The company expects that existing cash as of September 30, 2024, will not be sufficient to fund operations for at least twelve months from the issuance date of its financial statements[43] - The company is closely monitoring the impact of global events such as inflation and military conflicts on its business operations and financial condition[33]
Aethlon Medical(AEMD) - 2025 Q2 - Quarterly Results
2024-11-13 21:15
Exhibit 99.1 Aethlon Medical Announces Financial Results for the Fiscal Second Quarter Ended September 30, 2024 and Provides Corporate Update Achieves Key Milestone with Enrollment of First Two Patients in the Safety, Feasibility, and Dose Finding Study of Aethlon's Hemopurifier® in Patients with Solid Tumors Not Responding to Anti-PD-1 Antibodies Two Australian Sites Open For Patient Enrollment in Hemopurifier® Cancer Trial Conference Call to be Held Today at 4:30 p.m. ET SAN DIEGO, November 13, 2024 -- Ae ...