By M. Marin
NASDAQ: AEMD
READ THE FULL AEMD RESEARCH REPORT
Company’s current strategic focus is assessing the Hemopurifier in oncology…
We participated in a chat with Aethlon Medical (NASDAQ: AEMD) CEO and CFO Jim Frakes last week and present our key takeaways in this report. The company’s lead asset, the Aethlon Hemopurifier, is an investigational extracorporeal device designed to bind and remove harmful extracellular vesicles (EVs) from the blood. It has FDA Breakthrough Device designation for the treatment of people with advanced or metastatic cancer who are either unresponsive to or cannot tolerate standard of care therapy, and with cancer types in which exosomes are indicated in the development or severity of the disease, and also for life-threatening viruses that are not addressed with approved therapies. The company believes the Hemopurifier is the only device currently being evaluated to remove EVs.
…while also developing a pipeline of indications for the device via highly cost-efficient initiatives
AEMD’s hypothesis that the Hemopurifier can be beneficial in treating multiple diseases and indications is supported by extensive pre-clinical activity. In ex vivo study, Hemopurifier removed 98.5% of platelet -derived EVs. EVs are seen to contribute to metastasis and to suppressing the immune system. Excessive levels of PD-EVs (platelet-derived EVs) have been implicated in many diseases, including cancer, lupus, systemic sclerosis, multiple sclerosis, Alzheimer's disease, sepsis, acute, and Long COVID.
In order to optimize R&D budget, the company’s current primary clinical focus is in the oncology space, but the company believes the Hemopurifier could have broad applications in multiple EV-associated diseases. AEMD is developing a pipeline of indications for the device in a highly cost-efficient manner. For example, AEMD has submitted research papers to peer-reviewed journals, presented a poster at a recent medical conference, and increased its attendance at medical meetings when appropriate, among other measures to raise awareness of the device and its potential benefits in the scientific community.
AEMD is conducting a basket oncology trial to study the impact of the Hemopurifier as a potential treatment in patients with various solid tumors who have stable or progressive disease during anti-PD-1 monotherapy treatment. Unfortunately, only about 30% of cancer patients who receive pembrolizumab (Keytruda®) or nivolumab (Opdivo®) treatment for solid tumors have lasting clinical responses. The company’s hypothesis is that using the Hemopurifier in conjunction with these and with combination therapy can increase the percentage of patients who can benefit.
Early data from an ongoing oncology trial looks promising
Early data looks promising. The device has shown reduction in EVs and other harmful particles, and no serious adverse events (SAEs) or Dose-Limiting Toxicities (DLTs) related to the Hemopurifier have been reported to date. To date, 173 Hemopurifier treatments have been administered in 44 patients with no SAEs. To accelerate enrollment in its ongoing trial, AEMD is working with clinical trial facilitator Trialfacts and has a queue of oncology patients interested in participating.
The study is designed to examine whether an increased number of Hemopurifier treatments can help extend positive patient responses, as the company seeks to build its database supporting development of the Hemopurifier as an oncology treatment. The company expects to report early data from Cohort 2 and independent Safety Board determination about progressing to Cohort 3 (or potentially treating additional Cohort 2 patients) by late March / early April.
AEMD is conducting the trial in Australia, which offers an R&D tax incentives rebate program that enables companies to receive a cash tax rebate of up to 43.5% on clinical trial-related R&D costs. AEMD expects to realize the benefits of this program and thereby reduce costs, maximize its R&D dollars, and lower risk. The company is confident that data generated in Australia will be accepted by the FDA and other regulatory boards if/when it submits applications for approval.
Down the road, if the company’s current evaluation of using the Hemopurifier with a simplified blood treatment system (currently, Hemopurifier treatment requires a dialysis or CRT machine), it could support broader potential clinical application of the device through less invasive means.
Cash, equivalents, & ATM expected to support efforts to advance clinical activities for 4+ quarters
Cash and equivalents at the end of December 2025 were just under $7.0 million. Reflecting its current average quarterly cash burn rate, management believes this balance, along with potentially accessing its ATM facility, is sufficient to support its efforts and continue to advance its clinical and research programs for more than four quarters. Management targets obtaining non-dilutive funding, possibly through licensing and/or partnership opportunities, if/when it advances to the next step in developing the Hemopurifier, with the efficacy trial depending on the data from Cohort 3.
Upcoming expected milestones include:
- Announce Cohort 2 data
- Board decision regarding progressing to Cohort 3
- Commence Cohort 3
- Complete Cohort 3
- Announce overall trial data
- Potentially advance to efficacy trial
SUBSCRIBE TO ZACKS SMALL CAP RESEARCH to receive our articles and reports emailed directly to you each morning. Please visit our website for additional information on Zacks SCR.
DISCLOSURE: Zacks SCR has received compensation from the issuer directly, from an investment manager, or from an investor relations consulting firm, engaged by the issuer, for providing research coverage for a period of no less than one year. Research articles, as seen here, are part of the service Zacks SCR provides and Zacks SCR receives payments totaling a maximum fee of up to $50,000 annually for these services provided to or regarding the issuer. Full Disclaimer HERE.