AETHLON MEDICAL INC Emerging Growth Conference
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Welcome back, everyone. We have an update from Aethlon Medical, Inc., trades on the NASDAQ under the symbol AEMD. It is a medical therapeutic company focused on developing the Hemopurifier, a clinical stage immunotherapeutic device that is designed to combat cancer and life-threatening viral infections, and for use in organ transplantation. Happy to welcome back CEO, Jim Frakes. Welcome, Jim. Thank you, Anna.
Thanks again for having us on to provide this update.
Yeah. Let us start, for investors who might be new to Aethlon, give us a quick overview of the company.
Sure. Aethlon Medical is developing the Hemopurifier. It is an investigational medical device designed to remove selectively harmful substances from the blood, including extracellular vesicles, also called EVs, and certain viruses. Here is our device, the Hemopurifier. Again, it is a blood filtration cartridge. It can be used with a number of blood pumping machines, including dialysis machines, CRRT machines, that are in hospitals and clinics worldwide. The patient sits in a chair. Blood is pushed by the pumping machine through our device. There are about 20,000 little fibers within this plastic cylinder, and outside those fibers we have our secret sauce, a plant lectin called GNA bound to diatomaceous earth. The blood flows in through the device. The pressure pushes through little pores that are about 200 nanometers in size.
The plasma from the blood with items that are smaller than 200 nanometers, such as viruses and those EVs I mentioned. The cellular elements, the white blood cells and red blood cells, stay inside the little fibers. Then as the plasma transverses the cylinder, it is pushed back into the fibers and then back to the body, and that continues for 4 hours. Each pass, hopefully, the virions and EVs are removed. Just a quick overview of the device. Our lead clinical focus is oncology, where we are studying whether removing those EVs, which can contain factors associated with cancer progression and immune suppression, may help create a more favorable environment for immune system improvement. At the same time, we are also exploring the broader potential of the Hemopurifier platform in diseases where EVs may play an important role, including long COVID and other disease areas.
While oncology is our lead program, we believe that the underlying technology does have broader potential.
Wonderful. Now you are in the final cohort of the Australian Oncology Study, and the Cohort 2 observations appear to be more consistent and longer lasting than those seen in Coh 1. So what are you looking for from Cohort 3?
Right. We are very pleased with the way the clinical trial is progressing. The Cohort 3, which is 3 patients given the Hemopurifier treatment 3 times in a week, so a Monday, Wednesday, Friday. It is particularly important because it gives us another opportunity to see whether the signal that we have observed in Cohort 2 continues. In Cohort 1, which was just a single treatment in 3 patients, they received that one 4-hour treatment, and in Cohort 2 they received 2 treatments. In Cohort 2, we saw decreases in EVs and microRNAs associated with cancer progression, along with increases in certain lymphocyte subsets and other blood chemistry elements we are looking at.
Importantly, those directional changes appeared more consistently across participants and persisted longer than we saw in Cohort 1, which kind of supports our hypothesis that mechanically scrubbing those elements out of the blood a second time, it should have a longer duration of an impact, because the tumors are continuously emitting EVs, and by mechanically scrubbing them out more than once, we're kind of doing a bit of a reset. We now need to see whether Cohort 3 confirms that trend. The data remains preliminary, so we're being, we believe, appropriately cautious. But if we continue to see greater consistency, magnitude, and duration of the changes, that would be encouraging as we think about our next stage of clinical development.
Now, assuming the final cohort supports what you've seen so far, what would the next step be for Aethlon Medical?
Right. Our goal is to complete all of the treatments of the 2 remaining patients. Again, we've done 7 of the 9. Then the 8-week follow-up of those 2 patients. We'd like to complete those milestones by the end of 2026. From there, we would analyze the complete data set, complete the clinical study report, and then have pre-registration discussions with the regulatory authorities, the FDA in the U.S., the Therapeutic Goods Administration in Australia. If the data supports moving forward, the next logical step for us would be to design a more structured efficacy study. I don't want to get ahead of the data, but our current thinking is that the 3-treatment approach being evaluated in Cohort 3 could potentially inform the design of that next study if we continue to see encouraging trends.
For investors, I believe the important milestones are the completion of the trial, the analysis of the full data set, and our subsequent regulatory discussion.
With that said, oncology is the lead program, but you've also been talking about long COVID and other diseases. How should investors think about the broader potential of the Hemopurifier platform?
We believe that the broader opportunity comes from the fact that EVs appear to play a role in a number of diseases. In long COVID, our research has shown that both small and large EVs from patient plasma can bind to that proprietary resin that I described inside the device. We've also observed decreases in certain microRNAs associated with immune dysregulation and inflammation. At the moment, we're continuing to do this work internally and at a relatively low cost, while also talking with academic institutions and regulatory agencies about what could be required to move these opportunities toward clinical development. Ultimately, advancing another indication into a clinical trial would require additional capital, partner, government grant funding, or some combination of those resources, in my opinion.
Finally, if you look ahead over the next 12 months or so, what are the key milestones you want retail investors to be watching?
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