Biotech and Medical Tech Stocks to Watch - Big Moves Following Clinical Trial News October 8, 2025 - (Investorideas.com Newswire), a go-to investing platform covering biotech and medtech stocks releases an industry snapshot looking at recent clinical trial updates, featuring Aethlon Medical, Inc. (Nasdaq: AEMD), a medical therapeutic company focused on developing products to treat cancer and life-threatening infectious diseases. Recent clinical trial update news from Aethlon Medical, Inc. (Nasdaq: AE ...

, /PRNewswire/ -- Aethlon Medical, Inc. ("Aethlon" or the "Company") (Nasdaq: AEMD) today provided observations on the preliminary changes in extracellular vesicle (EV), microRNA and lymphocyte counts in the first patient cohort in its ongoing oncology clinical trial in Australia. The study is a safety, feasibility, and dose- finding trial evaluating the company's Hemopurifier (HP) in patients with cancer not responding to anti-PD-1 therapy. "As we promised during our last earnings call, we are sharing ear ...

SAN DIEGO, Sept. 4, 2025 /PRNewswire/ -- Aethlon Medical, Inc. ("Aethlon" or the "Company") (Nasdaq: AEMD), a medical therapeutic company focused on developing products to treat cancer and life-threatening infectious diseases, today announced the pricing of a public offering of an aggregate of 5,000,000 shares of its common stock (or pre-funded warrants in lieu thereof) and warrants to purchase up to 5,000,000 shares of common stock at a combined public offering price of $0.90 per share (or pre-funded warra ...

Financial Data and Key Metrics Changes - As of June 30, 2025, the company had a cash balance of approximately $3.8 million [20] - For the three months ended June 30, 2025, consolidated operating expenses were approximately $1.8 million, down roughly $800,000 or 32% from $2.6 million a year ago [20][21] - The operating loss decreased to $1.8 million compared to $2.6 million from the previous year, reflecting progress in aligning resources with strategic priorities [21] Business Line Data and Key Metrics Changes - The company advanced its lead oncology indication clinical program and delivered preclinical results supporting broader applications, including long COVID, while significantly reducing operating expenses [7] - The first cohort of the Australian oncology trial completed Hemopurifier treatments without any device deficiencies or immediate complications [10] - An independent data safety monitoring board recommended advancing to the second treatment cohort after reviewing safety data from the first cohort [11] Market Data and Key Metrics Changes - The Australian oncology trial is designed to include patients on either monotherapy or combination therapy, increasing the potential pool of patients for the study [12] - The global economic burden of long COVID is approximately $1 trillion per year, indicating a large unmet medical need [15] Company Strategy and Development Direction - The company decided not to proceed with the India study to focus resources on the Australian trial, which is seen as the fastest track toward regulatory approval [7][8] - The focus remains on moving the Hemopurifier towards regulatory approval and expanding its use across multiple diseases [7] Management Comments on Operating Environment and Future Outlook - Management acknowledged the need to continue raising funds for clinical research, ideally through strategic partnerships rather than financial investors [31] - The decision to halt the Indian trial was primarily strategic, aimed at avoiding potential delays in moving forward to the PMA phase [31][34] Other Important Information - The company presented preclinical data on long COVID at a symposium, indicating the potential for the Hemopurifier to remove extracellular vesicles associated with long COVID [15][16] - The company is actively recruiting additional sites in Australia to speed up patient enrollment for the clinical trial [42] Q&A Session Summary Question: Is the primary endpoint of the Australian study safety, and is the company on track to meet it? - Management confirmed that the first cohort has been treated without adverse events, indicating progress towards meeting the primary endpoint [25][26] Question: How does the preclinical data translate to actual patient treatment? - Management acknowledged that lab results may not directly reflect patient outcomes, emphasizing the importance of data from actual patients [27][28] Question: What are the implications of not moving forward with the Indian trial? - Management stated that the decision was strategic to avoid delays in regulatory approval, although cost savings were also a factor [30][31][34] Question: Will the company be able to speed up enrollment in the Australian trial? - Management confirmed efforts to speed up enrollment, including recruiting additional sites and using clinical trial liaisons and social media campaigns [41][42]

Core Insights - Aethlon Medical has made significant progress in its Australian oncology trial, completing the first treatment cohort and amending the protocol to broaden patient eligibility [1][2][5] - The company reported a 31.6% reduction in operating expenses for the fiscal first quarter, enhancing operational efficiency [10][16] - Promising preclinical data supports the potential of the Hemopurifier in treating various conditions, including Long COVID [10][12][14] Clinical Progress - The first treatment cohort in the Australian trial involved patients with solid tumors unresponsive to PD-1 inhibitors, with no serious adverse events reported [3][4] - The independent Data Safety Monitoring Board recommended advancing to the second treatment cohort, which will involve two Hemopurifier treatments within a week [4] - The trial aims to assess safety and the potential to improve the body's natural ability to attack tumor cells by reducing extracellular vesicle concentrations [7][8] Financial Performance - As of June 30, 2025, Aethlon had a cash balance of approximately $3.8 million [15] - Consolidated operating expenses for the quarter were approximately $1.8 million, down from $2.6 million in the same period last year [16][20] - The operating loss for the quarter decreased to $1.8 million compared to $2.6 million for the same period in 2024 [20] Preclinical and Research Developments - Aethlon's preclinical study demonstrated a 98.5% removal of platelet-derived extracellular vesicles from healthy human plasma during a simulated 4-hour treatment [10][11] - The company is collaborating with UCSF to explore the Hemopurifier's potential applications in Long COVID, with initial findings presented at a recent symposium [12][13][14] Strategic Decisions - Aethlon decided not to proceed with a planned oncology trial in India due to extended timelines and costs, allowing the company to focus on its ongoing trial in Australia [9] - The amended protocol for the Australian trial reflects current standards of care, expanding eligibility to patients receiving various treatment regimens that include anti-PD-1 agents [5]

Financial Data and Key Metrics Changes - As of March 31, 2025, the company had a cash balance of approximately $5.5 million [16] - Operating expenses for the year were approximately $9.3 million, a reduction of about $3.3 million or 26% compared to the prior year [17] - A noncash charge of $4.6 million was recognized related to a warrant inducement offer made in March 2025 [17][18] Business Line Data and Key Metrics Changes - The company treated the first three patients in its oncology trial using the Hemopurifier at clinical sites in Australia [6] - Regulatory approval was received in India to initiate a similar oncology study [12] - The trial protocol was expanded to align with evolving standards of care in immunotherapy [6] Market Data and Key Metrics Changes - The collaboration with UCSF on long COVID research is ongoing, with findings to be presented at the upcoming Keystone Symposium [14] - The economic burden of long COVID is estimated to impact 44 to 48 million people in the US [15] Company Strategy and Development Direction - The primary focus remains on oncology, with ongoing trials in Australia and India [22][24] - The company aims to streamline operations and reduce costs while focusing resources on areas with the greatest clinical and regulatory impact [15][16] - Future exploration of the Hemopurifier's applications beyond oncology is being considered, particularly in conditions like lupus and Alzheimer's disease [14] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the progress made in clinical trials and the potential for future partnerships based on safety data [62] - The company anticipates needing to raise additional funds until it can secure government grants or partnerships with larger companies [61] - Management does not expect further nonrecurring expenses related to terminated executives [32][33] Other Important Information - The company has published results of a preclinical study showing a 98.5% removal of platelet-derived extracellular vesicles during Hemopurifier treatments [13] - The next earnings call is scheduled for August 2025, coinciding with the filing of the quarterly report [19] Q&A Session Summary Question: What are the focus areas for the company? - The primary focus remains on oncology, with the upcoming trial in India being parallel to the Australian trial [22][24] Question: What is the expected timeline for more robust data from the Australian trial? - Preliminary data from the first cohort is expected in about three months, with a data safety monitoring board meeting set for July [28][29] Question: Are nonrecurring expenses finished? - Management does not anticipate further nonrecurring expenses following the termination of three senior executives [32][33] Question: Will patient recruitment in India be faster than in Australia? - There is potential for faster recruitment in India due to the larger population and the hospital's capabilities [70][72] Question: What is the landscape for grant approvals currently? - The company is familiar with the grant process and is open to pursuing grants that align with its goals, though the current environment may present challenges [78][80]

Financial Data and Key Metrics Changes - As of March 31, 2025, the company had a cash balance of approximately $5.5 million [16] - Operating expenses for the year were approximately $9.3 million, a reduction of about $3.3 million or 26% compared to the prior year [17] - A noncash charge of $4.6 million was recognized related to a warrant inducement offer made in March 2025 [17] - The company recorded approximately $324,000 in other income related to the employee retention tax credit under the CARES Act [18] Business Line Data and Key Metrics Changes - The company treated the first three patients in its oncology trial using the Hemopurifier at clinical sites in Australia [6] - Regulatory approval was received in India to initiate a similar oncology study [12] - The trial protocol was expanded to align with evolving standards of care in immunotherapy [6] Market Data and Key Metrics Changes - The collaboration with UCSF on long COVID research is ongoing, with findings to be presented at the upcoming Keystone Symposium [14] - The economic burden of long COVID is estimated to impact 44 to 48 million people in the US [15] Company Strategy and Development Direction - The primary focus remains on oncology, with ongoing trials in Australia and India [22] - The company aims to streamline operations and reduce costs while focusing resources on areas with the greatest clinical and regulatory impact [15] - Future exploration of the Hemopurifier in addressing long COVID is being considered, but oncology remains the main priority [24] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the progress made in clinical and laboratory settings, noting it as the most significant advancement since joining the company [16] - The company is preparing for potential partnerships and government grants to support ongoing research and development [57] Other Important Information - The company plans to file its annual report on Form 10-K following the call and will hold its next earnings call in August 2025 [19] Q&A Session Summary Question: What are the focus areas for the company? - The focus remains primarily on oncology, with the upcoming trial in India being parallel to the Australian trial [22][24] Question: What is the expected timeline for delivering more robust data from the Australian trial? - Preliminary data from the first cohort is expected in about three months, with a data safety monitoring board meeting set for July [28][29] Question: Are there any nonrecurring costs expected in the future? - Management does not anticipate additional nonrecurring expenses following the termination of senior executives [32][33] Question: How quickly can patient recruitment be expected in India? - Recruitment in India may proceed faster than one patient per month, depending on oncologists' comfort levels [66][68] Question: What is the landscape for grant approvals currently? - The company is familiar with the grant process and is open to pursuing grants that align with its goals, though the current environment may present challenges [72][74] Question: What is the current expense run rate? - The company is operating at a level that is necessary to continue operations, with potential increases in expenses as clinical activities ramp up [76][78]

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]