Aethlon reports first-quarter fiscal 2027 results and third-cohort dosing

Aethlon Medical, Inc. reported results for the fiscal first quarter ended June 30, 2026, and gave a corporate update in a press release filed as Exhibit 99.1 to a Form 8-K dated August 13, 2026. The company said it dosed the first participant in the third and final cohort of its Phase 1 oncology study in Australia. James Frakes, the company's CEO and CFO, said: "We advanced our clinical and research programs during the quarter."

The clinical update

Early observations from the first two cohorts showed consistent decreases in tumor-derived extracellular vesicles and in microRNAs linked to cancer progression, along with improvements in immune function associated with potential response to immunotherapy. The company says these observations are preliminary and will be evaluated fully after the study is complete. The release gives no numbers, no statistics and no comparison group. The primary endpoint is safety, so these biomarker changes are exploratory and do not show that patients benefited.

A manuscript describing extracellular vesicle characteristics in patients with Long COVID was accepted for publication in the International Journal of Molecular Sciences. The manuscript reports that vesicles isolated from the plasma of people with Long COVID bind to the proprietary affinity resin in the Hemopurifier, a laboratory finding and not a result in treated patients.

Finances

Cash and cash equivalents were approximately $4.9 million as of June 30, 2026. After quarter-end, Aethlon raised approximately $4.0 million in gross proceeds through a public offering of common stock. Based on current plans, the company believes its cash resources are sufficient to fund operations for at least the next 12 months. The 10-K shows a net loss of $7.2 million and cash used in operations of $7.0 million for the year ended March 31, 2026. The $4.0 million came from selling new common stock, which dilutes existing holders.

Consolidated operating expenses for the quarter decreased 11.9% to approximately $1.6 million, from $1.8 million in the prior-year quarter. The company attributed the decline to lower professional fees and reduced general and administrative and preclinical research costs, and said the operating loss declined accordingly.

For the fiscal year ended March 31, 2026, the company's 10-K filed June 10, 2026 reported research and development expense of $1.9 million, against $2.2 million a year earlier. The net loss was $7.2 million, against $13.4 million, and cash from operations was negative $7.0 million, against negative $7.6 million.

The oncology trial

The Australian study is a safety, feasibility and dose-finding trial in patients with solid tumors who have stable or progressive disease during anti-PD-1 monotherapy, such as Keytruda or Opdivo. It is designed to enroll approximately 9 to 18 participants, and the primary endpoint is safety. Exploratory analyses will look at how many Hemopurifier treatments are needed to produce sustained reductions of extracellular vesicles and to improve anti-tumor T cell activity.

According to the 10-K, the first cohort of three participants each received a single 4-hour treatment. An independent Data Safety Monitoring Board reported no safety concerns and recommended moving to the second cohort, whose participants received two treatments during a one-week period. The company completed the second cohort in March 2026, and the board then approved advancement to the third cohort. The annual report says no serious adverse events or dose-limiting toxicities related to the Hemopurifier had been reported. Three sites in Australia are open for enrollment.

The company had also won approval for a similar trial in India but later chose not to proceed there, in order to conserve resources.

The device

The Hemopurifier is an investigational extracorporeal device that removes enveloped viruses and tumor-derived extracellular vesicles from circulation. It holds an FDA Breakthrough Device designation for the treatment of individuals with advanced or metastatic cancer who are unresponsive to or intolerant of standard-of-care therapy, and for life-threatening viruses not addressed with approved therapies. The 10-K says the device has been evaluated in human studies involving 173 treatment sessions in 44 patients with viral infections or cancer.

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