Aethlon Medical reports second cohort results from cancer study

Aethlon Medical reports second cohort results from cancer study

Gold slides as U.S.-Iran conflict lifts oil, hawkish Fed bets grow SAN DIEGO - Aethlon Medical, Inc. (NASDAQ:AEMD) announced today that patients in the second cohort of its Australian oncology feasibility study showed biological changes consistent with those observed in the first cohort following treatment with the investigational Hemopurifier, according to a press release statement. The study is evaluating the safety, feasibility and dosing of the Hemopurifier in patients with advanced solid tumors whose cancers have progressed despite treatment with anti-PD-1 immunotherapies. The positive study results come as the company navigates challenging financial conditions.

With a market capitalization of just $1.68 million and the stock down 94% over the past year to $0.71, Aethlon faces significant headwinds. According to InvestingPro analysis, the company is quickly burning through cash, though it maintains more cash than debt on its balance sheet—a critical consideration for investors in early-stage biotechnology firms. The second cohort showed directional changes in several biomarkers, including reductions in tumor-derived extracellular vesicles, platelet-derived EVs and PD-L1-positive EVs.

The company reported reductions in two microRNAs associated with tumor growth and cancer invasion, as well as improvements in multiple immune-related laboratory ratios. The company also reported increases in total T cells, CD4 and CD8 T-cell populations, and tumor-specific CD137-positive T cells in all three participants in the second cohort. "We are encouraged to observe similar directional changes across multiple biomarkers in both the first and second patient cohorts," said James Frakes, Chief Executive Officer and Chief Financial Officer of Aethlon Medical.

Enrollment in the third cohort is underway, with the first participant having completed three four-hour Hemopurifier treatments during a one-week period. An independent statistician will analyze the combined data after all three cohorts are complete to determine whether the observations support a dose-response relationship. The company stated that the findings represent descriptive observations from raw data generated in an early-stage feasibility study.

Formal statistical analyses have not yet been performed and will be conducted only after completion of all three study cohorts. The study was not designed to demonstrate clinical efficacy. The company noted that larger clinical trials with clinical efficacy endpoints will be required to determine whether the biological changes observed translate into meaningful clinical benefit.

The Hemopurifier has received FDA Breakthrough Device Designation for the treatment of patients with advanced or metastatic cancer who are unresponsive or intolerant to standard-of-care therapy. Despite recent stock weakness, InvestingPro data suggests the company may be undervalued at current levels based on Fair Value analysis. For investors seeking deeper insights, InvestingPro offers comprehensive Pro Research Reports covering AEMD and 1,400+ other US equities, transforming complex data into actionable intelligence.

In other recent news, Aethlon Medical announced a follow-on offering priced at $0.71 per share, involving 5,633,009 shares of common stock and warrants. The warrants, which will become exercisable upon stockholder approval, are set to expire five years from the approval date. Additionally, Aethlon Medical published a peer-reviewed study linking their Hemopurifier device to Long COVID markers.

The study, conducted with the University of California, San Francisco, found elevated levels of mannosylated extracellular vesicles in Long COVID patients, which the device can capture. In financial updates, Aethlon Medical reported a narrowed net loss of $7.2 million for the fiscal year ending March 31, 2026, compared to a $13.4 million loss the previous year, with operating expenses declining by 21.9%. Despite these advancements, the company’s stock saw a decline in after-hours trading as investors considered its early-stage clinical progress and cash requirements.