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 nm, 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 four 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 Cohort 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 three patients given the Hemopurifier treatment three 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 three patients, they received that one four-hour treatment, and in Cohort 2 they received two 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 two remaining patients. Again, we've done seven of the nine. Then the eight-week follow-up of those two 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 three-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?
I would highlight three things. First, completing the final cohort of our Australian Oncology Study and obtaining the full data set. That's a key first milestone. Second, analyzing that data and moving into the next round of regulatory discussions to determine the appropriate path for further clinical development. Third, continuing to build the broader Hemopurifier platform, including our work in long COVID and other diseases where EVs may be relevant. Reflecting my CFO background, I think it's important to note that we're doing all of this with a focus on disciplined capital management. We ended the June 30 quarter with approximately $4.9 million in cash and subsequently raised approximately $4 million in gross proceeds. Based on our current plans, we believe our cash resources are sufficient to fund our operations for at least the next 12 months. That's a comfortable space and runway to have.
That's wonderful. Are you seeing a relationship between the number of Hemopurifier treatments and the magnitude or duration of EV reduction?
Yes, to both. As I mentioned, the tumors are emitting EVs. After just the one treatment, they came back X weeks later. After two treatments, the duration lasted longer. It was exactly what we expected and hoped for. Not only did they come back later, but they came back at a lower level than the initial level of EVs.
You've reported no Hemopurifier-related serious adverse events or dose-limiting toxicities to date. How much of the device's clinical risk do you believe has now been removed?
Well, I think our safety database is persuasive. The regulators are the ones that have to agree with that conclusion. We have, I don't know, 150 odd treatments, with no device-related serious adverse events. It's a pretty strong safety database on that.
Perfect. Well, do you have any closing remarks for our viewers today, Jim?
No, I'd just like to thank the existing investors that are tuning in for staying with us and watching us. For the people that are new to our name and our business, please keep us on your radar screen. We do expect some important milestones later on this year, as I mentioned. Again, thanks everybody for your time.
Perfect. Well, thank you for this update, and we'll see you again real soon, Jim.
Great. Thanks, Anna. Goodbye.
All right, everyone, we'll be right back.