Announcement • Mar 25
Aethlon Medical, Inc. Advances to Final Cohort in Oncology Clinical Trial Aethlon Medical, Inc. announced that the independent Data Safety Monitoring Board (DSMB) overseeing its ongoing clinical trial AEMD-2022-06 has completed its scheduled safety review of the second cohort participant data and recommended advancing to the third and final cohort. The trial, titled "Safety, Feasibility, and Dose-Finding Study of Aethlon Hemopurifier in Patients with Solid Tumors Who Have Stable or Progressive Disease While on a Treatment That Includes Pembrolizumab or Nivolumab", is being conducted to assess the Hemopurifier's safety, feasibility, and optimal dosing. The DSMB, comprised of independent medical experts in nephrology and oncology, reviewed data from participants enrolled in the second cohort, in which patients received two Hemopurifier treatments over a one-week period. Based on their evaluation, the DSMB found no safety concerns and confirmed that the Hemopurifier continues to demonstrate a favorable safety and tolerability profile. To date, no serious adverse events (SAEs) or Dose-Limiting Toxicities (DLTs) related to the Hemopurifier device or treatment have been reported. Enrollment for Cohort 3 is now open. In this final cohort, participants will receive three Hemopurifier treatments over a one-week period further evaluating safety, feasibility and dosing parameters at the study's three active clinical sites in Australia. This trial is designed to enroll approximately 9 to 18 patients with solid tumors who have stable or progressive disease, while receiving treatment that includes Pembrolizumab (Keytruda®) or Nivolumab (Opdivo®). The primary endpoint of this trial is the incidence of adverse events and clinically significant changes in safety laboratory tests of Hemopurifier-treated patients. In addition to safety monitoring, the study is designed to examine the number of Hemopurifier treatments needed to decrease the concentration of extracellular vesicles (EVs) and if these changes in EV concentrations improve the body's own natural ability to attack tumor cells. These findings are expected to inform the design of a future efficacy and safety, Premarket Approval (PMA), study required by regulatory authorities. The Aethlon Hemopurifier is an investigational medical device designed to remove enveloped viruses and tumor-derived EVs from circulation. It is used extracorporeally with a blood pump and combines plasma separation, size exclusion, and affinity binding using a plant lectin resin that targets mannose-rich surfaces found on EVs and viruses. EVs released by solid tumors are believed to play a role in metastasis and the resistance to immunotherapies and chemotherapy. Removal of enveloped viruses and extracellular vesicles has been demonstrated in both vitro studies and human subjects. The Hemopurifier holds a U.S. Food and Drug Breakthrough Device for the treatment of individuals with advanced or metastatic cancer unresponsive to or intolerant of standard-of-care therapy; and the treatment of life-threatening viruses not addressed with approved therapies. The Hemopurifier is being developed under an open Investigational Device Exemption (IDE) for both indications. New Risk • Feb 15
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$7.1m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$7.1m free cash flow). Earnings are forecast to decline by an average of 13% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (439% increase in shares outstanding). Revenue is less than US$1m. Market cap is less than US$10m (US$1.91m market cap). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$20m net loss in 3 years). Share price has been volatile over the past 3 months (16% average weekly change). Announcement • Feb 04
Aethlon Medical, Inc. to Report Q3, 2026 Results on Feb 12, 2026 Aethlon Medical, Inc. announced that they will report Q3, 2026 results at 4:15 PM, US Eastern Standard Time on Feb 12, 2026 
