As filed with the Securities and Exchange Commission on January 7, 2026. Registration Statement No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT Under THE SECURITIES ACT OF 1933 AETHLON MEDICAL, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Nevada 3826 13-3632859 (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identification Number) 11555 Sorr ...

SAN DIEGO, Dec. 5, 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 that it has entered into a securities purchase agreement with a single institutional investor to purchase 595,897 shares of common stock (or pre-funded warrants in-lieu thereof), together with warrants to purchase up to an aggregate 1,042,820 shares of common stock, in ...

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Core Insights - Aethlon Medical, Inc. announced a pre-clinical study indicating the potential of the Hemopurifier device in treating Long COVID by targeting extracellular vesicles (EVs) [1][6][4] Company Overview - Aethlon Medical is focused on developing the Hemopurifier, a clinical-stage immunotherapeutic device aimed at treating cancer and life-threatening viral infections [7][8] - The Hemopurifier has received FDA Breakthrough Device designation for treating advanced or metastatic cancer and life-threatening viruses [8] Long COVID Context - Long COVID affects an estimated 44 to 48 million people in the U.S., with a projected economic burden of $2 billion for those experiencing symptoms for a year [2] - Symptoms include fatigue, shortness of breath, and cognitive difficulties, persisting for weeks or months after initial COVID-19 infection [2] Research Findings - The study published on November 20, 2025, demonstrated that the Hemopurifier can remove harmful EVs from the blood, which are implicated in Long COVID [1][5] - Elevated levels of both large and small EVs were found in the plasma of Long COVID patients compared to recovered controls, indicating a potential therapeutic target [5][6] - The GNA affinity resin in the Hemopurifier was shown to deplete specific microRNAs associated with inflammatory pathways, suggesting a mechanism for reducing inflammation in Long COVID [5][6] Future Directions - Aethlon Medical plans to further investigate whether the removal of EVs can decrease SARS-CoV-2 viral particles, which may contribute to Long COVID pathogenesis [6]

Group 1 - The article does not provide any specific information or data regarding companies or industries [1]

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]

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]

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].

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].

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]