Welcome to the Life Sciences Investor Forum. On behalf of OTC Markets and our co-host, Zacks Small Cap Research, we are very pleased you've joined us. The next presentation of the day is from Aethlon Medical. Their session will be moderated by M Marin, Senior Analyst with Zacks Small Cap Research. Please note you may submit questions for the presenter. You can also view a company's availability for one-on-one meetings by clicking Book a Meeting. At this point, I am very pleased to welcome Jim Frakes, Chief Executive Officer and Chief Financial Officer of Aethlon Medical, which trades on Nasdaq under the symbol AEMD. Welcome, Jim and M Marin.
Thank you, Lily.
Thank you. Jim, we're talking about Aethlon Medical at a very exciting point in the company's development. Can you talk to us a little bit about your lead asset, about the Hemopurifier and what makes it unique?
Sure. I'm happy to. Thanks everybody for taking time out of your day to learn more about Aethlon Medical. If you can see on the camera, I'm holding one of our products. We make a device, a medical device called a Hemopurifier. It's designed to remove harmful viruses and cancerous particles called exosomes or extracellular vesicles from the bloodstream. This device is hooked to a blood pumping mechanism, usually a dialysis machine or a CRRT machine. There are a number of blood pumping devices in hospitals and clinics worldwide, and it plugs in. We only need the blood pump aspect of those machines. We don't need the other, pumping issues that a dialysis machine would have.
We have Breakthrough Device designation from the FDA for life-threatening viruses with no prescribed therapy or life-threatening oncologic situations. We also, t he origin of the device was in virology that we did a lot of work in hepatitis C to prove the concept and help some patients. However, I focus the company on oncology, on cancer, and we're doing a clinical trial, a safety trial in Australia at the moment. We're about two-thirds of the way through. It's going well. We're also looking at some areas of viruses that involve these EVs, extracellular vesicles.
There are platelet-derived EVs that are relevant to autoimmune diseases like lupus, and there have been recent articles on EVs in chronic kidney disease patients, CKD, that leads to heart problems. We're taking a look at that as well. The emphasis. We're a small company, we have to marshal our resources carefully, so our primary focus is oncology. I just want to make that clear. That's a very general background on our products.
Thank you. Just to recap what you said to make sure that, you know, we understand and for those people who are listening to the presentation who may not be, you know, specifically focused on this space but are more generalist investors, the Hemopurifier is designed to remove harmful particles that have been identified as being associated with a multiple of conditions and diseases, including in the oncology space and certainly many other spaces. Is that the right way to think of it?
That's correct. Most harmful viruses and these EVs, extracellular vesicles, are coated with a glycosylation, a sugary surface. When the blood goes into our device, the plasma is filtered out through these. There are about 20,000 little fibers inside the device, and outside the fibers, we have our secret sauce. It's diatomaceous earth bound to a plant lectin. That lectin grabs on to the sugary surface of the viruses and the EVs. The plasma, less whatever's been taken out, goes back into the fibers and back in the body. It's a circuit. Typically, patients are treated four hours.
Each pass-through, the objective is to take out more and more of the EVs and the viral particles and give the body's immune system a better chance to fight those maladies.
Okay. Great. Thank you. Now, you mentioned before that because you're a relatively small company, you need to be focused because you don't have unlimited access to resources. You said oncology, w hat is the primary clinical indications you're focused on today, and how are you prioritizing that while still preserving your flexibility across multiple potential uses of the device?
Right. Well, as I mentioned earlier, EVs, I'll call them EVs from now on, instead of saying extracellular vesicles every time, that they're nanoparticles. They're released by all cell types. They participate in cell-to-cell communication. In cancer, EVs have been noted to participate in the spread of cancer, also known as metastasis, growth of new blood vessels to the tumors, known as angiogenesis, cell death, known as apoptosis, and the inhibition of the body's T-cells that kill tumor cells. They also provide resistance to chemotherapy drugs and immunotherapy agents. Our hypothesis is if we remove some number of these EVs from the bloodstream of cancer patients, that will help reduce their metastasis. I think we all know people and regrettably that have fallen victim to cancer, and it spreads from one part of the body to the other. That is metastasis.
We've chosen to work indirectly with two main chemotherapy oncology drugs known as Keytruda or Opdivo. They're the biggest selling drugs in the world, and they're great, and they work about a third of the time. That's wonderful for the third where it's working. The two-thirds where it doesn't work, that's not helpful. Our objective is to try to help some of those two-thirds that participate in our trials, and hopefully when we receive approval to market down the road, we can help more people. The objective is to move up that percentage. We're in the first stage, a safety trial. It's designed for about nine patients. It's in three cohorts. The first cohort is three patients treated one time.
Second cohort is two, a lso three patients treated twice in a week. The last cohort, an additional three patients treated three times in a week. Let's call it a Monday, Wednesday, Friday. It's designed to be done before a patient's next Opdivo or Keytruda treatment. That's kind of a high-level picture of our design of our trial.
Okay. Thank you. Is it right to think that currently those two standard of care therapies, Keytruda and Opdivo, you said they currently work, you know, on about a third of the patients that are treated, let's call it, you know, 33%-ish. But even moving with the Hemopurifier in conjunction with those treatments, moving from 33% up to 34%-35%, we're still talking given the unfortunate prevalence of, you know, cancerous diseases, we're still talking huge numbers of patients that potentially could benefit.
Oh, yes. These are extremely large markets, both in terms of numbers of patients and for those large biotech companies, their sales of those products. The last number I believe I saw for Keytruda was $25 billion. I mean, it's a huge product. They've been approved for, I believe, more than 12 tumor types. This trial is designed for, it's a basket trial. It could be for most solid tumors that have been approved for Keytruda or Opdivo.
Okay. What are the key milestones that you think investors should be watching for as your current clinical trial progresses?
Sure. Well, we finished the first cohort in the December quarter. The independent Data Safety Monitoring Board met, gave us approval to proceed to the second cohort. We have now treated all three patients in the second cohort, the Data Safety Monitoring Board will meet later on this month to determine whether or not we should proceed to the third cohort in terms of safety. If they decide, I don't know why they wouldn't approve it, but if they don't, we'll have to do three additional patients. Assuming they do approve it, then we move on to the third cohort. In terms of milestones, the decision of the Data Safety Monitoring Board later on this month is the first milestone. We will have data down the road from the second cohort.
We released some data from the first cohort in the December quarter. We can talk about that a bit later if you'd like. Then, the beginning of the third cohort, completion of the third cohort, and then overall data from the whole trial. That data is being generated by the University of Sydney in Australia. They have a center there. They're a group of experts in EVs. We have a number of milestones coming up over the next six months or so.
Okay, great. Now staying with this discussion around progressing from the second cohort to the third cohort, potentially, do you currently have qualified candidates that you've already identified for the third cohort?
Yes. We actually have three patients in the queue right now. Assuming the safety monitoring board gives us the green light to move to the third cohort. We'll give revised paperwork to those three interested patients, and assuming they don't change their mind, I think we could move quite quickly through the third cohort. Again, I wanted to point out, we do our treatments immediately before their next Keytruda or Opdivo treatment. We know when their, these potential patients' next treatments are, so we would schedule those three, the Monday, Wednesday, Friday example, the week before their Opdivo or Keytruda treatment. There's some mechanical slotting in logistics, but it's excellent that we possibly have all three patients lined up, if nobody drops out.
Okay. Oh, great. Now, stepping back, just pivoting a little bit, there have been other indications that, you know, have been associated, or rather the Hemopurifier has been associated with having benefits for other indications. Can you talk a little bit about some of those and how you're maintaining your focus on cost containments, which I know is a big, you know, company focus, how you're maintaining that focus while still maintaining those avenues open as, you know, options down the road?
Sure. Well, we don't wanna ignore our virology background and there are some really interesting applications for the Hemopurifier in virology. But we have limited resources. We have to look at every investment. We were able to get a number of long COVID samples from a specialist group at the University of California, San Francisco, and we got those for free except for shipping. Our scientists internally did a lot of analysis. We ran that data by that group at UC San Francisco, participated in a major conference, and we're working on a peer-reviewed article with that UC San Francisco group in long COVID. But it's still early. All these things I'm gonna talk about now are early. We're not yet in the clinical trial phase.
Platelet-derived EVs, that's very interesting. Again, autoimmune diseases like lupus, rheumatoid arthritis, they're all potential targets. More recently, we've learned EVs are very relevant in CKD or chronic kidney disease, where they travel from the damaged kidney to cause heart problems. All of those, any or all of those could be possible grant opportunities to move it forward. In the meantime, we're investing some amounts to bring in necessary items into our lab to do that research work. Again, the main focus is on oncology and we have to stay focused.
Yes. Now, I also wanted to mention, I do see questions are coming in from the audience. If, as a reminder, you do wanna ask a question, please type it into the Q&A bar that you'll see on your screen. We talked a little bit about the current trial. Can you tell us a little bit about the reasons that you decided to conduct this trial in Australia?
Sure. First of all, they practice great medicine there. The doctors are world-class. Dr. Steven LaRosa, our Chief Medical Officer, has run clinical trials in Australia in the past and is knowledgeable about the hospitals and key decision-makers there. They also have a very advantageous, they call it a tax credit, where we, for every $1 that we spend in Australia on our trial, we get reimbursed $0.43. It's not a tax credit, it's actually cash. That brings down the cost of the trial nicely. The objective of this tax credit in Australia is to spur their indigenous life science industry. That's very helpful in terms of bringing down the cost of the trial. Those three factors.
How will conducting the trial in Australia in any way impact or it won't impact your applications to the FDA and other regulators outside of Australia?
I don't think it- My only previous experience with giving data that originated internationally to the FDA was in clinical trials we did in India, and they accepted that. I don't know why they wouldn't accept data from Australia. We will apply. The plan is to apply when we finish this trial and write everything up to apply to their equivalent of the FDA, it's called the TGA, to do the next step there. If we're in position financially and with sufficient personnel to do it in both countries, we would do that.
Okay. This might be a good time, I know you touched upon it earlier, but could you please repeat what you see as key milestones that people, that investors should be looking for over the next 12-18 months?
Sure. Well, again, we have a number coming up over the next few months. The decision of the Data Safety Monitoring Board, vis-à-vis moving on to cohort three. The data from cohort two, the two treatments in a week cohort. Starting and finishing cohort three, and then the overall data from the project. That all could be the next few quarters. Our move forward into the efficacy trial. I should have prefaced, unlike drugs, devices only need two trials. The safety trial that we're in right now, then the larger efficacy trial which would have more patients. It would be based on a discussion with the regulator as to how many, but it wouldn't be thousands like a drug would be.
We have a number of milestones that we're looking forward to telling the world about over the next 12 months.
Okay. Great. As you look forward towards, you know, hitting some of those milestones, can you give us a little bit of color on what your capital position is now and your cash runway to get to those events?
Sure. We published our December quarterly report just a few weeks ago. We ended December with just under $7 million of cash. No debt of any sort. Our current burn rate is roughly $1.5 million a quarter or $500,000 a month. That's dependent somewhat on how many patients are treated because we do pay the hospitals. Part of the payments to them are based on those number of treatments. Potentially $7 million divided by $1.5 is more than four quarters. We also have a I think $1.85 million available on a at-the-market facility that we could use, but haven't yet to generate additional cash. We have some cash. We've kept our burn rate low for what we're trying to accomplish. I feel reasonably good about our position.
Great. Now you've talked in the past about, you know, you're currently leveraging dialysis equipment for the Hemopurifier use, but you've talked about how that's not, you know, necessarily the best route. Can you talk about what you're doing with a potential usage of a more simplified system?
Right. We know a company here that is trying to develop a much more simplified blood pumping system. It would work just in the catheters that we've all, I'm sure all of us have had in our arms when we've been to the doctor or the hospital. Much simpler. You don't need a nephrologist, kidney doctor, you don't need a specialist dialysis nurse. Just virtually every healthcare professional could operate it. Right now the Hemopurifier is typically in a dual lumen catheter that's placed in the clavicle, which all dialysis patients have. My feeling is if you have cancer and it's not responding to the primary drugs that you wouldn't object to having the catheter there for one to two weeks.
This would open things up immensely. I have to caution this is very preliminary. They don't have FDA approval yet. We have sent them some Hemopurifiers and they've tested it, you know, running colored water and things like that through it and seems to work with these very early-stage tests. It's just, it could open things up quite a bit for us and for other extracorporeal devices as well in the future. I don't wanna overstress it because it is so preliminary.
Right. I know you've gotten questions in the past about strategic partnerships, and then there was a brief announcement that you made earlier today. Can you give us any kind of color on what you're thinking is there?
Sure. I think I've been pretty clear over the last couple of years. We think we've got the resources both monetary and personnel to complete this safety trial. To go on to the larger efficacy trial we need a partner and we've talked to people from time to time. We decided that we needed more of a process. We needed to reach out to strategic and other financing partners. We engaged an investment bank called Maxim, and we put out a press release on that this morning. The best case would be a company that's in our industry that really knows the markets that we're in. If it's more of a financially oriented stronger partner, that would be great too.
We decided we needed a process and to just to start moving forward because we feel like we're pretty well along in this safety trial. We feel. Like we've really accomplished something.
That said, how many Hemopurifiers are you currently, you know, do you currently have, and how many, you know, people have you treated, and how scalable do you think this platform could be?
Well, right now, we've had 173 Hemopurifier treatments in 44 patients. That number is growing pretty nicely. Quite largely it's been very safe. There have been no serious adverse events device related. We needed to tune the throughput of the plasma through the device. That was achieved early on. Since then there have been no significant issues. We do have a manufacturing facility here in San Diego. We could ramp up the number of Hemopurifiers quite a bit that we make. At the moment, we have enough for the trial. We're manufacturing three or four times a year, but it is scalable.
Okay. Great. You touched upon this before about the target addressable market. You know, we all know without knowing the actual statistics that it's large. Do you have, you know, anything you wanna share about the size of the market opportunity for you?
Well, I don't. I mean, those oncology drugs, successful oncology drugs are just huge, and I don't want to imply that we're going to grab a significant percentage of that. That would not be the correct way to approach this. It's quite a big market. If we can improve that 1/3 percentage that I mentioned earlier, even 1%, it would be significant. You know, we're a high-risk investment. I always tell people that, but the return could be very nice as well. It's a high-risk, high-return kind of hitting for the fences type of investment opportunity here, with a lot of risk, no doubt. But b ig market, we're trying to do something that could be very important for people.
When you talk to clinicians, it may be too early to actually, you know, ask this question, but are you hearing, are you getting any kind of feedback that supports your confidence that the Hemopurifier could really be beneficial here?
I think it's too early to answer that in any specific way. The data from the first cohort did show the targets that we were looking at largely went the direction we wanted them to go, and you know, with the T-cells and EVs, but it was only three patients. We need to go through these. We need to get through the safety trial and perhaps even get into the efficacy trial to generate more data to have a better answer to that question. There was nothing in the data that was going in the wrong direction. I was actually pretty excited about it.
Okay. I have two more questions before I wanna, you know, ask about your conclusions or, you know, wrap up. First, what do you think the market might be overlooking? What stands out as your key, you know, the key thing you are thinking the market could be overlooking? What do you think the Hemopurifier solves that current treatment are not solving?
Well, it's hard to say what the market's overlooking. The company's been around a long time. It spent a lot of years in virology. Perhaps we had a good opportunity with COVID, but the vaccinations really did a good job and removed that opportunity. I wouldn't say we were a restart, but the refocus on oncology I think is relatively recent, and I would like to think people could focus on that and see something here. Your second question was what?
Well, what you just said, you did have some positive data during the pandemic when you did emergency use cases, correct?
Yes. We removed EVs. We helped one patient that was direly ill with COVID. It helped her survive. If we can improve patient outcomes in cancer even a few%, that's just moving the needle quite a bit. I'm, I like to think we can make a difference.
Do you have a few, you know? We are almost out of time.
I see that. Darn it. We are the only product that removes EVs. That's a differentiating factor with us versus everybody else as far as I know. We are out of time. There were some good questions asked. I'm sorry we couldn't respond to them, but you could shoot emails to me, or to Susan Noonan, our investor relations expert, and we'll try to answer them if we can. I'd like to thank everybody for taking time out of their busy day to learn more about our company.
Thank you. This concludes the presentation.