I'd like to welcome back James B. Frakes, CEO and CFO, and Steven LaRosa, Chief Medical Officer of Aethlon Medical. Aethlon is a medical therapeutic company focused on developing products to treat cancer and life-threatening infectious diseases. For new investors to Aethlon, can you explain what makes the Hemopurifier unique, what its primary indications are, and how you are prioritizing those indications while considering potential use across multiple indications? Sure, I'm happy to, Anna. Thanks again for having us on your conference. Here is the Aethlon Hemopurifier. It's a medical device designed to remove infectious viruses and cancerous particles called exosomes or extracellular vesicles flung from the bloodstream. It can hook up to dialysis machines, plasmapheresis machines, CRRT machines, or other blood-pumping devices that are in hospitals and clinics worldwide. Again, extracorporeal outside the body, hooked up to a device that pumps the blood from a patient, and it's typically a 4-hour treatment. Originally, the Hemopurifier. And- Just to loop back to your question, Anna. Originally, the Hemopurifier was designed to remove viruses from the bloodstream, and we realized that it had applications in oncology as well, in cancer. That's been our main focus the last few years. We're a small company, limited resources, so we have to focus, and our primary focus is oncology, while not ignoring our virology background. If you can summarize, you mentioned it briefly, the historical clinical use of the Hemopurifier, including the number of patients treated, safety profile, and some key learnings that inform your current trials. Yeah. Historically, Anna, the device, as Jim said, was targeting enveloped viruses, which have a sugar on their surface that the device binds and removes. Our early trials were in HIV and Hepatitis C. Fortunately now there are really effective therapies for those. The company also did some work in acute COVID and Ebola. Those are kind of occurrences or pandemics as they happen, and we pivoted towards oncology, targeting extracellular vesicles, which are released from cells, including tumor cells, that lead to the spread of cancers and cause resistance to current agents. Where our lead indication right now is in oncology, particularly solid tumors, where the patients aren't responding to anti-PD-1 therapy, such as Keytruda or Opdivo. The number of patients, treated? We've treated all total, totaled 44 patients, 173 unique Hemopurifier sessions. The device has been remarkably well-tolerated with relatively minor side effects, things like headache, cough, backache, things that are quite common. Early on, we learned that we had to adjust the flow rate to prevent hemolysis, or breakage of red blood cells. We've done that, and that's not been an issue. We've also had a good strategy with real-time measures of coagulation and anticoagulation algorithm to prevent clotting within the device. We've made some tweaks along the way to ensure that these sessions can proceed to completion easily. Given this is a safety, feasibility, and dose-finding study, talk about the specific outcomes or metrics, you could indicate a successful trial and maybe some milestones that investors should be watching out for. Yeah, sure. As you said, this is a predominantly a safety and feasibility study of the Hemopurifier in patients with solid tumors who are not responding to anti-PD-1 agents. It's a 3-cohort study, sequential. In the first cohort, which has been completed, 3 patients received a single Hemopurifier treatment. No dose-limiting toxicities or device-related side effects, serious adverse events were encountered, and our independent Data Safety Monitoring Board recommended to proceed to the second cohort. We've just recently completed treatments of 3 patients, 2 treatments and 3 patients in the second cohort. They get 2 treatments within a given week. Those patients are now in the safety follow-up phase, and we anticipate a second independent Data Safety Monitoring Board meeting in March towards the end of March. They will give us a recommendation of whether we can move on to the third cohort, where patients will get three Hemopurifier treatments within a 1-week time period. In terms of metrics to look for, it would be the Data Safety Monitoring Board meeting occurring in March that gives us the directive to move forward. That will be followed within 2 months' time of data from our central lab that specifically looks at how good the device is at removing extracellular vesicles and improving anti-tumor T cells. That would be the next readout that people should pay attention to. Following that, of course, completion of the third and final cohort would signify the successful completion of the trial. We'll have a data readout and then be prepared to discuss the data in total. Can you talk about Australia? Why are you conducting your trials in Australia, and how does that position you for US regulatory engagement? veral pretty solid reasons to conduct the trial in Australia. Great medicine. Steve has run clinical trials in Australia before. Knew some principal investigators there. We are taking advantage of a very nice tax rebate program they have in Australia. They're trying to spur their life science industry. At the moment, it's a 43% rebate. For every dollar we spend in Australia on our clinical trial, we get 43 cents back, and this is cash. This isn't a tax. They call it a tax rebate, but it's cash. We got a check for several hundred thousand dollars a couple of months ago for the prior year's expenditures in Australia. That helps bring down the cost pretty significantly The data we've had data generated from clinical trials in other countries before, notably India, and the FDA did accept that for our U.S. regulatory engagements. I should note, we have Breakthrough Device designations from the FDA in viruses and oncology. So we do plan to take that data back to the U.S., as well as engage with the regulators in Australia about future trials. We're very pleased with the our partners in Australia, the doctors, the We have three hospitals we work with there. It's the University of Sydney's lab that's doing our data analysis is world-class. We're very pleased with our venture in Australia. Let's talk about the SLAM platform opportunity. Would SLAM expand the total addressable market beyond current indications, and how does it represent a potential evolution of the Hemopurifier, and talk about the potential benefits? Yeah, sure. When the device was first, the program, the development was first started, we utilized essentially a dialysis infrastructure, right? You have to have a dialysis catheter put in. In the clinical world, we kind of somehow call this a garden hose. I mean, it's a large catheter with two limbs, and it's quite daunting having both for the person putting it in, which I've done many times, and for the patient seeing this coming at them. We have to use this catheter, and we have to use a dialysis machine purely for its blood pumping mechanism. We don't use all the bells and whistles that a dialysis machine uses in terms of removing salts, fluid, et cetera. We're simply using the blood pump. What that means is, we have to have the patient in a dialysis unit, with a dialysis machine and a guiding nephrologist. What the SLAM system would, if it, if it's compatible, would potentially do is you'd use a much thinner single-lumen catheter, so it'd be much more comfortable for the patient, much easier to place, and a simplified blood pump that would not require a dialysis machine. Therefore, the patient would not have to be in a dialysis bed, and you wouldn't need a treating nephrologist. It could be performed in the oncology units or infusion centers, where people with autoimmune diseases or other things live. If the patient wouldn't have to travel from their therapeutic home, if you will, where they get their other treatment, to a dialysis unit. We're currently doing very early preliminary studies to see if our device is compatible with this SLAM system, and if it is, what it means is, the patients will be treated where they live, if you will. Great. With all this recent progress that's appears to be accelerating, what operational or strategic changes have enabled this increased momentum? Yeah, no, I... One of our colleagues had the brilliant idea of engaging these groups called Trialfacts and Dedicated. What they are is, they're groups that do online marketing directly to patients, essentially telling them about the trial, what we're doing, and then the patients actually can elicit their interest. They can submit something on the portal, and then the other group, Dedicated, actually does online screening with the patient in their. They can do it from their computer at home. If they pass the initial screening, those patients are then referred on to the investigative sites. This has been quite successful. We've already enrolled a couple patients as a result of this process, and in fact, we have a number of patients lined up for the subsequent third cohort through this process. The sites love it, of course, because they're being hand-delivered pre-screened patients. This has been really something that's accelerated this trial. This third cohort enrollment, you currently have a pipeline of qualified candidates? Talk about that and how confident you are in maintaining this timeline. Yeah, no. As I said, we have this Data Safety Monitoring Board meeting coming up at the end of March. Once we get the go ahead, those patients are essentially in a holding pattern. The sites are maintaining engagement with them, explaining to them exactly where we are in the process and to hold tight. These are people who are still getting their immunotherapy, and this would be a dish added on, so they're coming in for follow-ups. Those patients are sitting there, essentially waiting for the directive that they can sign the consent and be involved in the study. You have a queue, which is always good to have in a clinical trial. Talk about larger strategic or pharmaceutical partners. Do you have any of those in the pipeline? Well, we do talk with the people in our industry from time to time. The, I'd qualify it as very early stage discussions. They wanna see the data, before anything significant could happen. I realize we did, we didn't mention exactly what our hypothesis is on oncology, Steve. Well. No, I. We shouldn't skip that. Yeah. if we may, Anna, I'd like to loop back to that. No, as I mentioned early on, extracellular vesicles are released by tumor cells, and they're implicated in the spread of cancers and the resistance to immunotherapy, and the theory is removing those would improve response to therapy. That's probably the simplest way to explain it. Right. The trial is designed to work with patients that are on Keytruda or Opdivo, which are mainline, state-of-the-art drugs to treat cancer and many solid tumor cancers. They're great for the patients. When it works, it's fantastic, it only works about a third of the time. Our target market, if you wanna call it that, are the two-thirds that do not respond to their Keytruda and/or Opdivo. Our hope and dream is maybe we can improve it from a third to a higher percentage, so that's the goal. These EVs, extracellular vesicles, are implicated, as Steve said, in metastasis. If we can help slow down the metastasis, the transportation of the cancer from one to organ to another, That's our hope, and that's what, that's our hypothesis, that we can help that. Long-winded answer. All right. to a straightforward question. Well, let's talk about your cash position. What is it? Maybe talk about your monthly burn, and projected runway. Sure. We just published our December 31st quarterly numbers, two weeks ago. We closed December with roughly $7 million of cash. Our burn rate currently is about $500,000 a month or $1.5 million a quarter. That includes the, as we have treatments, there are. We're assuming continued treatments of patients, for obvious reasons. Even though we get 43 cents on the dollar back, we're assuming continued treatments of patients, for obvious reasons. And we have access to an at-the-market offering to raise an additional $1.8 million or so as well. This should carry us through this trial, and, you know, until we have an approved product, we will, like all life science, small life science companies, need to either have a strategic partnership or additional financial rounds. We're good for a while, and that's. A lot of small companies would like to be in our position, I think. I know this is a hard question to answer, can you talk about a potential expected regulatory pathway in the U.S.? Well, we need to complete our data from all three cohorts, assimilate it, write it up. Depending on where we are with strategic partners, we may go first to the FDA, or we may go first to the Australian equivalent of the FDA, which is called the TGA. That perhaps is slightly more straightforward in Australia. We're open-minded about that. We will have to do another trial. We just don't know how big it will have to be, how many patients yet, until we engage with the regulators. The market size, what is the estimated addressable market for your lead indication? That's a very difficult question. The oncology market's huge, unfortunately, because it's such a dire malady. The last number I saw for Keytruda was $25 billion a year. Obviously, we're not even in that neighborhood, but it's a large addressable market. There are many, many companies trying to participate in this market. We think we're the only one that is focused on removing these extracellular vesicles or EVs, so we have a unique potential niche, but it would be a, you know, small percentage of that huge number. Let's talk about the top three value-creating catalysts investors should focus on over the next year. Sure. Well, as Steve mentioned, the Data Safety Monitoring Board is going to meet next month to review the safety aspects of the 2nd cohort. If all goes well, they'll give us a green light for the 3rd cohort. That's something that's pretty near term. It's gonna be in a few weeks. As Steve mentioned, we expect to have some disclosure of, like we did after the 1st cohort, of the data. We will have data forthcoming after The University of Sydney finishes their analysis. That could be... It'll be in the June quarter. I couldn't tell you if that's April, mid-April, late April, May, but somewhere in that quarter. That's an important... milestone, then the completion of the third cohort, and then the final data package. We have a number of, for our little company, very important milestones. Can you speak? I mean, over the next few months. Any strategy? Okay, any strategies in place to accelerate recruitment, and how this might affect your overall commercialization timeline? Well, we've. Steve mentioned the steps we've taken, and it really has stepped up recruitment. If those patients that are in the queue roll into the third cohort, that's potentially all we need. We've taken those steps. I'm very pleased with the and I know Steve is, too, in the recruitment pace. And the 3 hospitals we're working with, their staffs have done a great job running the treatments, so we're happy with our partners there. How do you believe Gapadent and Hemopurifier technologies differentiate from competitive platforms like monoclonals, antivirals, vaccines, and other devices in terms of efficacy, safety, and scalability? Well, that's quite a range of treatments. What do you think, Steve? vaccines. Yeah. is a totally different approach. Vaccines, and, you know, as you're probably aware, and a lot of people are working on, quote, "cancer vaccines," you know, I'm sure that work will continue. In terms of the current regimens, you know, when you're talking about small molecules or monoclonals, these are drugs that are given that have a certain safety profile. They have associated side effects. Even in immunotherapy, there's a number of people who get autoimmune sequelae of those drugs, so they're not, the safety profile is not particularly clean. You know, our strategy kind of goes back to one of the oldest victims in medicine, which is remove the evil humors, right? What we're doing is removing extracellular vesicles. We're not taking anything else out. All things considered, the safety profile, and we have to complete the trial, the safety profile should be cleaner than an exogenously given drug. All right. Well, congratulations on a lot of this progress. Do you have any closing remarks for our viewers today? Well, we just want to thank the viewers for taking time out of their schedules to follow our company. We really hope that they keep us on the radar screen. We do have, for us, very significant disclosures coming over the next few months, and we want people to have us on the radar screen to track us. That's our hope, and we'd like to thank you for giving us an opportunity to chat on your platform and for your questions on it. Perfect. Well, thank you, gentlemen. Thank you for your time today, and we look forward to continuing on this conversation next time. Super. Thank you. All right, everyone, we'll be right back.