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Aethlon Medical signals expanded Australian oncology enrollment strategy while operating loss narrows to $1.5M (NASDAQ:AEMD)
Seeking Alpha· 2025-11-12 23:32
Group 1 - The article does not provide any specific information or data regarding companies or industries [1]
Aethlon Medical(AEMD) - 2026 Q2 - Earnings Call Transcript
2025-11-12 22:30
Financial Data and Key Metrics Changes - As of September 30, 2025, the company had a cash balance of approximately $5.8 million [14] - Consolidated operating expenses for the three months ended September 30, 2025, were approximately $1.5 million, down by approximately $1.4 million, or 48%, from $2.9 million in the same period of 2024 [14][15] - Operating loss for the quarter decreased to $1.5 million compared to $2.8 million in the prior year period [16] Business Line Data and Key Metrics Changes - The company is conducting an Australian oncology trial of the chemopurifier, with three participants in cohort one completing treatments without complications [5] - The trial aims to monitor safety and feasibility, focusing on the incidence of adverse events and changes in blood tests following treatments [6][8] Market Data and Key Metrics Changes - The company is exploring the implications of extracellular vesicles (EVs) in various diseases, including Long COVID, which affects approximately 400 million individuals worldwide [11][12] Company Strategy and Development Direction - Aethlon Medical is focusing on the chemopurifier's application in oncology and Long COVID, with plans to submit preclinical data for publication [12][24] - The company is working to accelerate patient enrollment in clinical trials through various strategies, including digital marketing and additional investigative sites [6][35] Management's Comments on Operating Environment and Future Outlook - Management acknowledged the challenges in recruiting patients for the oncology trial, citing the complexity of the treatment and the need for thorough explanations to potential participants [34] - The company is optimistic about the potential for EV reductions to be relevant in multiple indications, while also emphasizing the need to focus resources effectively [24][26] Other Important Information - The next earnings call for the fiscal third quarter ending December 31, 2025, will coincide with the filing of the quarterly report in February 2026 [17] Q&A Session Summary Question: Understanding recruitment for cohort two - Management discussed the importance of explaining the trial's observations to investigators to aid in patient recruitment [19] Question: Follow-up on cohort one participants - Management clarified that while they are following cohort one participants clinically, there is no additional EV or T cell data expected beyond the initial eight-week follow-up [20] Question: Timeline for completion of cohort two - Management indicated a target of one patient per month for cohort two, acknowledging potential slowdowns due to holidays [35] Question: Data implications for patient outcomes - Management expressed caution regarding the small sample size but noted directional changes in EV decreases and T cell improvements [36] Question: Stability of EV levels post-treatment - Management confirmed that EV levels decrease during treatment but may rebound after a few weeks, emphasizing the need for more treatments to achieve sustained reductions [40]
Aethlon Medical(AEMD) - 2026 Q2 - Quarterly Report
2025-11-12 22:10
Financial Performance - Consolidated operating expenses for Q3 2025 were approximately $1,510,000, a decrease of $1,392,000 or 48% compared to $2,902,000 in Q3 2024[101] - Net loss for Q3 2025 decreased to $1,487,100 from $2,806,973 in Q3 2024, with basic and diluted loss per share improving from ($16.11) to ($3.74)[106] - For the six months ended September 30, 2025, operating expenses were approximately $3,302,000, down $2,220,000 or 40% from $5,522,000 in the same period of 2024[107] - Comprehensive loss for the six months ended September 30, 2025, was $3,258,202, compared to $5,375,443 for the same period in 2024[111] - Net cash used in operating activities was approximately $3,374,000 for the six months ended September 30, 2025, a decrease from approximately $3,962,000 for the same period in 2024[116] - Net cash provided by financing activities decreased by approximately $1,640,000 for the six months ended September 30, 2025, raising $3,744,000 compared to $5,384,000 in the same period of 2024[117] - Future capital requirements will depend on various factors, with expectations of continued negative cash flows and net losses for the foreseeable future[119] Cash and Inventory - Cash balance as of September 30, 2025, was $5,853,493, an increase from $5,501,261 at March 31, 2025[112] - The company has sufficient inventory of Hemopurifiers to support ongoing trials in Australia[95] Clinical Trials and Product Development - The Hemopurifier has been used safely in 167 sessions with 41 patients, demonstrating potential to remove enveloped viruses[86] - Enrollment for Cohort 2 of the oncology trial is open, aiming to enroll approximately 9 to 18 patients[88] - The company is exploring new applications for the Hemopurifier, with a study showing >98% removal of platelet-derived extracellular vesicles[92] - Clinical trial expenses for the planned oncology trial in Australia are expected to increase for the foreseeable future, including costs for manufacturing additional Hemopurifiers[118] Economic and Market Conditions - The company is monitoring the impact of inflation and geopolitical events on its business and future access to capital[97] - The ability to raise additional funds may be adversely impacted by worsening global economic conditions and market volatility[121] - The company plans to access equity markets for additional capital, but there is no assurance of favorable terms[120] Accounting Policies - Critical accounting estimates include long-lived assets, stock-based compensation, and clinical trial accruals, which are essential for portraying financial condition[123] - There have been no changes to critical accounting policies and estimates since the Annual Report for the year ended March 31, 2025[124]
Aethlon Medical(AEMD) - 2026 Q2 - Quarterly Results
2025-11-12 21:16
Financial Performance - Aethlon Medical reported a cash balance of approximately $5.8 million as of September 30, 2025[16]. - Consolidated operating expenses for the fiscal second quarter decreased by approximately $1.4 million or 48%, from $2.9 million in the same period in 2024 to approximately $1.5 million[17]. - The operating loss for the quarter decreased to $1.5 million compared to $2.8 million in the prior-year period[18]. - Net loss for the three months ended September 30, 2025, was $1,487,100 compared to a net loss of $2,806,973 for the same period in 2024, indicating a 47% improvement[33]. - Total operating expenses for the six months ended September 30, 2025, were $3,302,220, down from $5,521,856 in the prior year, a decrease of approximately 40%[33]. - Basic and diluted loss per share for the three months ended September 30, 2025, was $3.74, significantly lower than $16.11 for the same period in 2024[33]. - Professional fees for the three months ended September 30, 2025, were $393,796, down from $570,845 in the same period last year, a decrease of about 30.9%[33]. - Payroll and related expenses decreased to $594,611 from $1,372,899 year-over-year, a reduction of approximately 56.7%[33]. - Other comprehensive loss for the three months ended September 30, 2025, was $(4,000) compared to a gain of $3,804 in the same period last year[33]. Assets and Liabilities - Total current assets increased to $6,253,879 from $5,949,800, representing a growth of approximately 5.1%[31]. - Total liabilities decreased to $1,577,113 from $2,236,004, a reduction of about 29.5%[31]. - Total stockholders' equity rose to $5,745,977 from $5,123,530, an increase of approximately 12.2%[31]. - Cash and cash equivalents increased to $5,853,493 from $5,501,261, reflecting a growth of about 6.4%[31]. Research and Development - Recruitment for the second cohort of the Australian oncology trial of the Hemopurifier® is underway, evaluating safety and feasibility in patients with solid tumors[5]. - The study's primary endpoint is safety, enrolling approximately 9 to 18 participants with escalating doses of Hemopurifier treatment[12]. - Improvements in laboratory ratios associated with responses to immunotherapy were observed in at least two participants after a single 4-hour Hemopurifier treatment[9]. - Aethlon initiated an evaluation of Hemopurifier compatibility with a simplified blood treatment system, potentially leading to easier treatments in oncology units[14]. - The company is collaborating with UCSF on Long COVID research, with a manuscript in preparation for a peer-reviewed journal[7]. Compliance and Governance - Aethlon remains in good standing with Nasdaq, resolving compliance matters[7].
Aethlon Medical Announces Fiscal Q2 2025 Financial Results and Corporate Update
Prnewswire· 2025-11-12 21:15
Core Insights - Aethlon Medical, Inc. reported financial results for its fiscal second quarter ended September 30, 2025, highlighting clinical progress and cost reductions [1][12][13]. Clinical and Corporate Update - The company is advancing its clinical initiatives, particularly in cancer treatment, and has resolved Nasdaq compliance matters, maintaining its listing [2][16]. - Recruitment for the second cohort of the Australian oncology trial of the Hemopurifier® has begun, allowing patients to receive combination therapies with Pembrolizumab or Nivolumab [3][9]. - The primary endpoint of the study is safety, with plans to enroll approximately 9 to 18 participants [9]. Scientific Developments - Analysis of extracellular vesicles (EVs) from patients in the first cohort showed decreases in large EVs after Hemopurifier treatment, which are implicated in cancer progression [4]. - Improvements in laboratory ratios associated with immunotherapy responses were observed in at least two participants following treatment [6]. - Ongoing collaboration with UCSF focuses on Long COVID research, with a manuscript in preparation for peer-reviewed publication [10]. Financial Performance - Operating expenses decreased by 48% to approximately $1.5 million for the quarter, down from $2.9 million in the same period in 2024 [12][14]. - The operating loss for the quarter decreased to $1.5 million compared to $2.8 million in the prior-year period [15]. - As of September 30, 2025, Aethlon had a cash balance of approximately $5.8 million [13]. Operational Achievements - The company has initiated an evaluation of the Hemopurifier's compatibility with a simplified blood treatment system, which could enhance treatment delivery in oncology units [11]. - Significant cost management efforts have led to reductions in payroll, general and administrative expenses, and professional fees [17].
Aethlon Medical to Release Fiscal Second Quarter Financial Results and Host Conference Call on November 12, 2025
Prnewswire· 2025-11-07 13:01
Core Insights - Aethlon Medical, Inc. will release its financial results for the fiscal second quarter ended September 30, 2025, on November 12, 2025, at 4:15 p.m. ET [1] - A conference call will be held on the same day at 4:30 p.m. ET to discuss the financial results and recent corporate developments [2] - The Hemopurifier is an investigational medical device designed to remove enveloped viruses and tumor-derived extracellular vesicles from circulation [4] Company Overview - Aethlon Medical, Inc. is a clinical-stage medical device company based in San Diego, California, focusing on oncology and infectious diseases [6] - The Hemopurifier has received U.S. Food and Drug Breakthrough Device Designation for treating advanced or metastatic cancer and life-threatening viruses [5] Conference Call Details - Interested parties can register for the conference call online, and those without internet access can dial in using provided toll-free numbers [2][3] - A replay of the call will be available approximately one hour after the call ends, accessible through the company's website or via specific phone numbers [4]
Biotech and Medical Tech Stocks to Watch - Big Moves Following Clinical Trial News
Investorideas.com· 2025-10-08 13:41
Core Insights - The article highlights significant advancements in clinical trials for biotech and medical tech companies, particularly focusing on Aethlon Medical, Envoy Medical, Soligenix, and MBX Biosciences, showcasing their recent progress and milestones in the sector [3][4]. Aethlon Medical, Inc. - Aethlon Medical is conducting an ongoing oncology clinical trial in Australia, evaluating the Hemopurifier in cancer patients unresponsive to anti-PD-1 therapy, with preliminary observations showing encouraging changes in extracellular vesicles (EVs), microRNAs, and lymphocyte counts after treatment [5][7]. - In the initial cohort of three patients, decreases in seven out of ten examined microRNAs were noted, indicating potential effects on cancer growth and metastasis [6][8]. - The study's small sample size limits the ability to draw definitive conclusions about clinical efficacy or dose response, with further data needed from subsequent cohorts [11][12]. Envoy Medical, Inc. - Envoy Medical received FDA approval to expand its pivotal clinical trial for the Acclaim® cochlear implant, based on promising data from the first ten patients, allowing for a shortened timeline to commercialization by three to six months [13][14]. - The initial trial phase showed no serious adverse events, and the data indicated that the Acclaim® cochlear implant can achieve effectiveness for its intended use [16]. Soligenix, Inc. - Soligenix's confirmatory Phase 3 study for HyBryte™ in treating cutaneous T-cell lymphoma (CTCL) has concluded its first Data Monitoring Committee meeting, confirming no safety concerns and an acceptable safety profile consistent with prior studies [17][18]. - The company anticipates providing updates on enrollment progress and response rates before year-end, with topline results expected in the second half of 2026 [19]. MBX Biosciences, Inc. - MBX Biosciences announced that its once-weekly canvuparatide achieved the primary endpoint with statistical significance in its Phase 2 Avail™ trial for chronic hypoparathyroidism, with 63% of treated patients meeting the primary composite endpoint [21][22]. - The company plans to initiate a Phase 3 clinical trial in 2026, building on the positive results from the Phase 2 trial, which demonstrated the potential for canvuparatide to become a best-in-class treatment for hypoparathyroidism [23][24].
Medical Tech Stock Aethlon Medical's (NASDAQ: AEMD) Australian Oncology Clinical Trial Update and Progress
Investorideas.com· 2025-10-07 13:45
Core Insights - Aethlon Medical, Inc. has provided updates on its ongoing oncology clinical trial in Australia, focusing on the Hemopurifier's effects on cancer patients not responding to anti-PD-1 therapy [3][4][11] Clinical Trial Observations - The initial cohort of three patients showed promising changes in extracellular vesicles (EVs), microRNAs, and lymphocyte counts after a single treatment with the Hemopurifier [4][5] - Changes in EV and microRNA levels typically returned to baseline within 1 to 3 weeks post-treatment [6] - Two of the three participants exhibited decreases in large EVs, which are implicated in cancer metastasis and immune response inhibition [10] Hemopurifier Mechanism - The Hemopurifier is designed to remove enveloped viruses and tumor-derived EVs from circulation, potentially aiding in cancer treatment by targeting mannose-rich surfaces on EVs and viral proteins [9][11] - The device has received U.S. Food and Drug Administration Breakthrough Device Designation for treating advanced or metastatic cancer and life-threatening viruses [11] Patient Response and Data Limitations - Increases in total T cell numbers and specific T cell subsets were noted in participants following treatment, although the data is limited due to the small sample size [10] - The study's preliminary nature means that no definitive conclusions can be drawn regarding the clinical efficacy of the Hemopurifier [8][10]
Aethlon Medical's Hemopurifier® shows Changes in Extracellular Vesicles, Extracellular MicroRNAs, and T Cell Numbers in Australian Oncology Clinical Trial
Prnewswire· 2025-10-07 12:01
Core Insights - Aethlon Medical, Inc. is conducting an ongoing oncology clinical trial in Australia to evaluate the safety, feasibility, and dose-finding of its Hemopurifier device in cancer patients unresponsive to anti-PD-1 therapy [1][2] Summary by Categories Clinical Trial Observations - Preliminary results from the first patient cohort indicate encouraging changes in extracellular vesicles (EVs), microRNAs, and lymphocyte counts after a single Hemopurifier treatment [2][3] - In the initial three patients, two showed decreases in large EVs, which are implicated in cancer metastasis and immune evasion [7] - All three participants exhibited decreases in large EVs carrying PD-L1, which is associated with resistance to anti-PD-1 therapies [7] - Seven out of ten microRNAs examined showed decreases in two of the three participants following treatment, indicating potential effects on cancer growth and metastasis [7] - Improvements in laboratory ratios related to immunotherapy responses were observed in at least two participants after treatment [7] Device Information - The Aethlon Hemopurifier® is designed to remove enveloped viruses and tumor-derived EVs from circulation, potentially aiding in cancer treatment [9] - The device operates extracorporeally and utilizes a combination of plasma separation, size exclusion, and affinity binding [9] - It holds a U.S. Food and Drug Breakthrough Device Designation for treating advanced or metastatic cancer and life-threatening viruses [10] Limitations and Future Directions - The small sample size limits the ability to draw definitive conclusions about the efficacy and dose response of the Hemopurifier [3][8] - Further data from subsequent cohorts will be necessary to determine the reproducibility of the observed changes and the potential for dose-dependent effects [3] - The current observations are part of an early feasibility study and should not be interpreted as evidence of clinical benefit or safety beyond the study parameters [8]
Market Analysis: Top Losers in Recent Trading
Financial Modeling Prep· 2025-09-04 22:00
Company Performance - Neonode Inc. experienced a stock price drop of approximately 68.34%, closing at $6.81, down from a year high of $29.9, influenced by market reactions to company developments and industry trends [2][8] - Artelo Biosciences saw a 50.34% decrease in its stock price, closing at $4.35, amid ongoing clinical trials and a public offering priced at $3 million [3][8] - 707 Cayman Holdings Limited faced a 48.45% decline in its stock price to $0.39, potentially due to challenges in the retail sector and exploring a crypto treasury reserve with Precious Choice Global Limited [4][8] - Aethlon Medical's stock price fell by 45.76% to $0.73, possibly linked to recent performance updates and investor sentiment towards the healthcare sector, with a public offering valued at $4.5 million [5] - Purple Biotech's stock price decreased by 43.54%, closing at $0.80, which may be related to clinical trial results and market conditions affecting biotech firms [6] Market Trends - The significant price movements of these companies highlight the importance of monitoring market trends, company developments, and broader economic factors that can impact stock performance [7]