Aethlon Medical advances to next cohort in cancer device trial

SAN DIEGO - Aethlon Medical, Inc. (NASDAQ:AEMD) announced Tuesday that the independent Data Safety Monitoring Board (DSMB) has recommended advancing to the next patient cohort in its ongoing clinical trial of the Hemopurifier device without modifications. The company, currently valued at $2.3 million, faces significant financial challenges according to InvestingPro analysis, with a rapid cash burn rate despite maintaining more cash than debt on its balance sheet.

The trial is evaluating the company’s investigational Hemopurifier in patients with solid tumors who have stable or progressive disease while receiving treatment that includes pembrolizumab (Keytruda) or nivolumab (Opdivo).

According to the company, the DSMB found no safety concerns after reviewing data from the initial cohort of three participants, each of whom received a single 4-hour Hemopurifier treatment. No serious adverse events or dose-limiting toxicities related to the device have been reported.

"The DSMB’s positive recommendation is encouraging and underscores the favorable safety profile observed to date in patients with cancer," said Steven LaRosa, Chief Medical Officer of Aethlon Medical.

The second cohort will now begin enrollment at three active clinical sites in Australia. Participants in this phase will receive two Hemopurifier treatments over a one-week period.

The Hemopurifier is an extracorporeal device designed to remove tumor-derived extracellular vesicles and enveloped viruses from circulation. It holds FDA Breakthrough Device designation for treatment of advanced or metastatic cancer unresponsive to standard therapy, and for life-threatening viruses not addressed with approved therapies.

The primary endpoint of the trial is the incidence of adverse events and clinically significant changes in safety laboratory tests. The study also aims to examine the number of treatments needed to decrease the concentration of extracellular vesicles.

This information is based on a press release statement from Aethlon Medical. The stock currently trades near its 52-week low of $1.10, with a current ratio of 3.13 indicating strong short-term liquidity. For deeper insights into AEMD’s valuation and 14 additional ProTips, including detailed financial analysis, visit InvestingPro, where you’ll find comprehensive research reports covering 1,400+ US stocks.

In other recent news, Aethlon Medical has reported significant developments in its operations and research initiatives. The company announced a 26% reduction in annual operating expenses, bringing them down to $9.3 million, while maintaining a cash balance of $5.5 million as of March 31, 2025. During its first-quarter 2025 earnings call, Aethlon Medical shared its strategic focus on oncology and ongoing clinical trials, which have contributed to a positive market reaction, despite the absence of specific earnings and revenue forecasts. The company is currently conducting clinical trials for its Hemopurifier in Australia and India, with regulatory approval recently obtained in India to initiate a similar oncology study.

Aethlon Medical has also expanded its trial protocol to include patients receiving combination therapies, aligning with current treatment practices. The company is actively collaborating with the University of California, San Francisco on long COVID research, with findings to be presented at an upcoming symposium. Furthermore, Aethlon Medical is seeking partnerships and grant opportunities to support its research initiatives, as emphasized by CEO Jim Frakes. The company raised $2.3 million through a warrant inducement offer and recognized $324,000 in employee retention tax credits. These recent developments underscore Aethlon Medical’s commitment to advancing its clinical research and operational efficiencies.

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