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Immunotherapy Clinical Trials - A New Approach to Treating Cancer
Newsfile· 2024-09-19 14:00
Vancouver, Kelowna, and Delta, British Columbia--(Newsfile Corp. - September 19, 2024) - Investorideas.com, a go-to investing platform, releases the second of a two-part series looking at news and developments for the treatment of cancer and solid tumors focusing on immunotherapy, featuring Aethlon Medical, Inc. (NASDAQ: AEMD), a medical therapeutic company focused on developing products to treat cancer and life-threatening viral infections. Aethlon's Hemopurifier® is a clinical stage immunotherapeutic dev ...
Aethlon Receives Ethics Committee Approval for Hemopurifier® Cancer Trial in India
Prnewswire· 2024-09-19 12:01
Aethlon Medical Granted Full Ethics Approval from the Medanta Institutional Ethics Committee for a Safety, Feasibility, and Dose Finding Study of its Hemopurifier® in Cancer Patients with Solid Tumors Not Responding to Anti-PD-1 AntibodiesSAN DIEGO, Sept. 19, 2024 /PRNewswire/ -- Aethlon Medical, Inc. (Nasdaq: AEMD), a medical therapeutic company focused on developing products to treat cancer and life threatening infectious diseases, today announced that, on September 9, 2024, the Medanta Institutional Ethi ...
Aethlon Medical to Present at Virtual Investor Conferences in September
Prnewswire· 2024-09-17 12:01
SAN DIEGO, Sept. 17, 2024 /PRNewswire/ -- Aethlon Medical, Inc. (Nasdaq: AEMD), a medical therapeutic company focused on developing products to treat cancer and life-threatening infectious diseases, today announced that management will present at the following virtual investor conferences in September:September 19-20: Life Sciences Investor Forum: James Frakes, Interim Chief Executive Officer and Chief Financial Officer and Steven LaRosa, MD, Chief Medical Officer, will present a company overview at this co ...
Innovation Driving Cancer's Solid Tumors Market
Newsfile· 2024-09-17 11:30
Vancouver, Kelowna, and Delta, British Columbia--(Newsfile Corp. - September 17, 2024) - Investorideas.com, a go-to investing platform, releases the first of a two-part series looking at news and developments for the treatment of cancer and solid tumors featuring Aethlon Medical, Inc. (NASDAQ: AEMD), a medical therapeutic company focused on developing products to treat cancer and life-threatening viral infections.Read the full article at Investorideas.comhttps://www.investorideas.com/News/2024/biotech/0917 ...
Aethlon Medical Announces Activation of Royal Adelaide Hospital to Begin Patient Screening and Enrollment in Hemopurifier® Cancer Trial
Prnewswire· 2024-09-16 12:01
Core Points - Aethlon Medical, Inc. has initiated a clinical trial for the Hemopurifier® targeting patients with solid tumors who are not responding to anti-PD-1 therapies [1][2] - The trial aims to assess the safety, feasibility, and optimal dosing of the Hemopurifier in patients with stable or progressive disease during anti-PD-1 monotherapy [3] Company Overview - Aethlon Medical focuses on developing the Hemopurifier, an immunotherapeutic device designed to treat cancer and life-threatening viral infections [4] - The Hemopurifier has received FDA Breakthrough Device designation for treating advanced or metastatic cancer and life-threatening viruses [4] Clinical Trial Details - The trial will enroll approximately 18 patients and will monitor adverse events and changes in safety lab tests after a two-month run-in period of anti-PD-1 therapy [3] - Patients will receive 1, 2, or 3 Hemopurifier treatments over one week, with the study also examining the impact on extracellular vesicle (EV) concentrations [3] Research and Development - The Hemopurifier is designed to remove extracellular vesicles implicated in cancer spread and resistance to therapies, potentially improving response rates to anti-PD-1 antibodies [2][3] - Preclinical studies have shown the Hemopurifier's effectiveness in reducing exosome levels in cancer patient plasma [2]
Aethlon Medical to Present at the Life Sciences Investor Forum September 19th
GlobeNewswire News Room· 2024-09-13 12:35
SAN DIEGO, Sept. 13, 2024 (GLOBE NEWSWIRE) -- Aethlon Medical, Inc. (Nasdaq: AEMD), a medical therapeutic company focused on developing products to treat cancer and life-threatening infectious diseases, is pleased to announce that Jim Frakes, interim CEO and CFO and Steve LaRosa, Chief Medical Officer, will present live at the Life Sciences Investor Forum, hosted by VirtualInvestorConferences.com, on September 19th 2024. DATE: September 19th TIME: 1:30 PM ETLINK: https://bit.ly/3XjDJkLAvailable for 1x1 meet ...
Aethlon Medical(AEMD) - 2025 Q1 - Earnings Call Transcript
2024-08-14 22:45
Financial Data and Key Metrics Changes - As of June 30, 2024, Aethlon Medical had a cash balance of approximately $9.1 million [16] - Consolidated operating expenses for the fiscal quarter ended June 30, 2024, were approximately $2.6 million, a decrease of approximately $800,000 or 24% compared to $3.4 million for the same quarter in 2023 [16][18] - Net loss decreased by approximately $700,000 to approximately $2.6 million in the fiscal quarter ended June 30, 2024, from approximately $3.3 million in the same quarter of 2023 [18] Business Line Data and Key Metrics Changes - The decrease in operating expenses was attributed to a $600,000 reduction in general and administrative expenses and a $300,000 decrease in professional fees, partially offset by a $100,000 increase in payroll and related expenses [16][17] - The decrease in G&A expenses was primarily due to a $447,000 reduction in supplies related to the Hemopurifier manufacturing [17] Market Data and Key Metrics Changes - The company is advancing its Hemopurifier technology, which has potential applications in oncology and infectious diseases, indicating a focus on addressing significant market needs [7][15] Company Strategy and Development Direction - Aethlon Medical is focused on the research and clinical development of its Hemopurifier, aiming to achieve measurable progress in oncology indications while reducing expenses [7][8] - The company is preparing for clinical trials in Australia, with expectations for increased activity and potential value-creating milestones in the near future [11][12] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about achieving the company's objectives and noted that the clinical trial activities are expected to ramp up, which may lead to higher R&D expenses [22] - The company is actively evaluating its COVID-19 trial in India and is monitoring patient admissions, indicating a responsive approach to current health crises [15] Other Important Information - The Bellberry Human Research Ethics Committee granted full ethics approval for a clinical trial of the Hemopurifier in patients with solid tumors, valid until August 6, 2025 [9] - The primary endpoint of the clinical studies is safety, with a focus on monitoring adverse events and changes in lab tests for Hemopurifier-treated patients [12] Q&A Session Summary Question: Is the normalized operating expense a good run rate going forward? - Management indicated that while there are expected reductions in professional fees, increased clinical trial activities will likely offset some of these savings [22] Question: What is the training process for the clinical trial sites? - Management confirmed that site initiation visits are scheduled, and there will be ongoing support and training for the sites to ensure proper implementation of the Hemopurifier [24][25] Question: Has all necessary paperwork been completed for the clinical trials? - Management confirmed that all required paperwork for ethics committees has been submitted and is awaiting governance review [27]
Aethlon Medical(AEMD) - 2025 Q1 - Quarterly Report
2024-08-14 21:10
Financial Performance - Consolidated operating expenses for Q2 2024 were $2,620,858, a decrease of $787,302 or 23.1% compared to $3,408,716 in Q2 2023[107]. - Net loss for Q2 2024 decreased to $2,571,440 from $3,282,179 in Q2 2023, with basic and diluted loss per share improving to ($0.34) from ($1.35)[111]. - A significant decrease in general and administrative expenses of $556,309 was attributed to reduced supply costs and other operational efficiencies[107]. - For the three months ended June 30, 2024, expenses decreased by approximately $787,000 compared to the same period in 2023, with cash used in operating and investing activities decreasing by approximately $964,000[114]. - Net cash used in operating activities was approximately $1,748,000 for the three months ended June 30, 2024, a decrease of $734,000 from $2,482,000 in the same period in 2023[129]. - The company anticipates continuing to incur increasing negative cash flows and net losses for the foreseeable future, necessitating additional capital raises[132]. Liquidity and Capital Raising - Cash balance as of June 30, 2024, was $9,072,379, up from $5,441,978 at March 31, 2024, indicating improved liquidity[112]. - The company closed a public offering on May 17, 2024, raising approximately $4.7 million in gross proceeds, with net proceeds around $3.5 million after expenses[113]. - As of June 30, 2024, the company raised $5,379,229 net through equity offerings and warrant exercises, alleviating substantial doubt about its ability to continue as a going concern[114]. - The company raised approximately $5,384,000 from financing activities during the three months ended June 30, 2024, primarily from the sale and issuance of common stock and warrants[130]. - The gross proceeds from the May 2024 public offering were approximately $4.7 million, with net proceeds of approximately $3.5 million after deducting fees and expenses[125]. - As of June 30, 2024, $5,302,617 of 2022 ATM Shares remained available for sale under the 2022 ATM Agreement[118]. - The Class A and Class B warrants from the May 2024 offering have an exercise price of $0.58 per share and are immediately exercisable[123]. Clinical Development - The Hemopurifier has received FDA designation as a "Breakthrough Device" for treating advanced cancer and life-threatening viral infections[90]. - Clinical trials for the Hemopurifier are planned in Australia and India, with ethics approvals obtained for trials involving solid tumors[93][101]. - The company is investigating the use of the Hemopurifier in organ transplant settings to reduce complications from viral infections[103]. - The company is working with NAMSA to manage clinical trials for the Hemopurifier in oncology indications in the U.S. and Australia[92]. - The Hemopurifier has shown potential in capturing various viruses in vitro, including HIV, Ebola, and Zika virus, indicating broad therapeutic applications[96]. - The company expects clinical trial expenses for planned oncology trials in Australia and India to increase for the foreseeable future[131]. Legal and Compliance Risks - The company has identified a material weakness in internal control over financial reporting and is actively implementing measures to remediate it[140]. - The company is not currently involved in any pending or threatened legal proceedings[143]. - Claims made against the company in the ordinary course of business may lead to litigation[143]. - Unfavorable outcomes from litigation could result in monetary damages, fines, or penalties[143]. - The occurrence of adverse outcomes could materially affect the company's operational results[143]. - The company acknowledges the inherent uncertainties associated with litigation[143]. - Potential injunctions could prohibit the company from selling certain products or engaging in specific activities[143]. - The impact of legal proceedings may affect future periods' results of operations[143]. - The company is monitoring claims and litigation risks as part of its business strategy[143]. - Legal proceedings are considered a normal risk in the company's business operations[143]. - The company remains vigilant in managing potential legal challenges[143].
Aethlon Medical(AEMD) - 2025 Q1 - Quarterly Results
2024-08-14 20:15
Financial Performance - Aethlon Medical reported a cash balance of approximately $9.1 million as of June 30, 2024[8]. - Consolidated operating expenses for the fiscal first quarter were approximately $2.6 million, a decrease of approximately $800,000 or 24% compared to $3.4 million in the same period of 2023[8]. - The decrease in operating expenses was primarily due to a $600,000 reduction in general and administrative expenses and a $300,000 reduction in professional fees[8]. - The net loss for the fiscal quarter ended June 30, 2024, decreased to approximately $2.6 million from approximately $3.3 million in the same quarter of 2023[10]. - Net loss for the fiscal year ended June 30, 2024, was $2,571,440, a reduction from a net loss of $3,282,179 for the same period in 2023, reflecting a 22% improvement[20]. - Total operating expenses decreased to $2,620,858 for the fiscal year ended June 30, 2024, down from $3,408,160 in 2023, marking a 23% reduction[20]. - Basic and diluted net loss per share improved to $(0.34) for the fiscal year ended June 30, 2024, compared to $(1.35) in 2023, showing a significant improvement[20]. - Professional fees decreased to $614,082 for the fiscal year ended June 30, 2024, down from $976,638 in 2023, a reduction of 37%[20]. - General and administrative expenses decreased to $751,974 for the fiscal year ended June 30, 2024, down from $1,308,283 in 2023, indicating a 43% decrease[20]. Assets and Liabilities - Total current assets increased to $9,550,437 as of June 30, 2024, up from $6,225,788 on March 31, 2024, representing a 53% increase[18]. - Total liabilities rose to $2,702,801 as of June 30, 2024, compared to $2,479,650 on March 31, 2024, indicating an increase of approximately 9%[18]. - Cash and cash equivalents increased to $9,072,379 as of June 30, 2024, up from $5,441,978 on March 31, 2024, representing a 67% increase[18]. - Total stockholders' equity rose to $8,712,616 as of June 30, 2024, compared to $5,766,332 on March 31, 2024, reflecting a 51% increase[18]. - The weighted average number of common shares outstanding increased to 7,457,888 for the fiscal year ended June 30, 2024, compared to 2,431,476 in 2023, indicating a significant increase in shares[20]. Clinical Trials and Research - Aethlon Medical received two ethics committee approvals for a clinical trial of the Hemopurifier® in patients with solid tumors, with patient enrollment expected to open in October 2024[1][6]. - The primary endpoint of the upcoming trial is safety, monitoring adverse events and lab test changes in treated patients[6]. - The Hemopurifier has shown potential to improve therapeutic response rates to anti-PD-1 antibodies by binding and removing extracellular vesicles from the bloodstream[5]. - Aethlon Medical is exploring the Hemopurifier's use for treating life-threatening viral infections, with ongoing trials for COVID-19 in India[7]. - The company anticipates submitting applications to additional ethics committees in Australia and India, with potential approvals expected in late 2024[6]. - Aethlon Medical aims to conduct site initiation visits and begin patient enrollment at additional sites by the end of 2024[6].
Aethlon Medical Announces Financial Results for the Fiscal First Quarter Ended June 30, 2024 and Provides Corporate Update
Prnewswire· 2024-08-14 20:15
Received Two Australian Ethics Committee Approvals for a Safety, Feasibility, and Dose Finding Study of Aethlon's Hemopurifier® in Patients with Solid Tumors Not Responding to Anti-PD-1 Antibodies; Expects to Open Patient Enrollment in October of 2024 Achieved Significant 24% Reduction in Fiscal First Quarter Operating Expenses Compared to the Same Period in 2023Conference Call to be Held Today at 4:30 p.m. ETSAN DIEGO, Aug. 14, 2024 /PRNewswire/ -- Aethlon Medical, Inc. (Nasdaq: AEMD), a medical therapeuti ...