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Aethlon Medical, Inc. (AEMD)

Q4 2025 Earnings Call· Thu, Jun 26, 2025

$2.19

+0.92%

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Transcript

Operator

Operator

Good afternoon, and welcome to the Aethlon Medical Fourth Quarter Fiscal 2025 Earnings and Corporate Update Conference Call. [Operator Instructions] Please note this event is being recorded. I would now like to turn the conference over to Jim Frakes, Chief Executive Officer and Chief Financial Officer. Please go ahead.

James B. Frakes

Analyst

Thank you, operator, and good afternoon, everyone. Welcome to Aethlon Medical's Fiscal Fourth Quarter 2025 Earnings Conference Call. My name is Jim Frakes, and I am the Chief Executive Officer and Chief Financial Officer of Aethlon Medical. Now I have some bad news and some good news to report on this call. The bad news is since Dr. Steven LaRosa, our Chief Medical Officer, is out on a family vacation, you'll have to listen to my soliloquy throughout this call. But the good news is that we made more progress advancing in the clinic with our product this period than in any quarter since I've been with Aethlon. At 4:15 p.m. Eastern Time today, Aethlon Medical released financial results for its fiscal fourth quarter ended March 31, 2025. If you have not seen or received Aethlon Medical's earnings release, please visit the Investors page at www.aethlonmedical.com to view it. Following this introduction and the reading of the company's forward-looking statement disclaimer, I will provide an overview of our strategy and recent developments. I will then make some brief remarks on Aethlon's financials. We will then open up the call for the Q&A session. Before we start the business portion of the call, please note that this news release -- the news release today and this call contain forward-looking statements within the meaning of the Securities Act of 1933 as amended and the Securities Exchange Act of 1934 as amended. The company cautions you that any statement that is not a statement of historical fact is a forward-looking statement. These statements are based on expectations and assumptions as of the date of this conference call. Such forward-looking statements are subject to significant risks and uncertainties, and actual results may differ materially from the results anticipated in the forward-looking statements. Factors that…

Operator

Operator

[Operator Instructions] Our first question is from Marla Marin with Zacks.

Marla Marin

Analyst

So there's a lot going on. Given that the company is involved now in conducting ongoing clinical study in Australia upcoming in India, the long COVID initiative, is it still right to think that the focus areas remain oncology, number one, followed by infectious disease or/long COVID and then potentially organ transplantation?

James B. Frakes

Analyst

Marla, this is Jim. Our focus remains almost entirely on oncology. The upcoming trial in India is virtually parallel to the Australian trial. So we already have Hemopurifier stationed at the hospital, the PI is an expert using the Hemopurifier. So that remains our primary focus. We took advantage of the relationship with UC San Francisco's Long COVID unit to obtain some precious but free samples that we analyzed once we were set up for the oncology trial. So that's a cost-effective area that's potentially very valuable, but it's early. We're going to present at that conference in August. And if there's a possible grant situation, we'll pursue that. But our main focus remains oncology.

Marla Marin

Analyst

Okay. And when you say it's cost efficient, so there wasn't significant, if any, capital outlay in order to conduct the collaboration, and there is some potential for incoming nondilutive funds. Is that the right way to think about that?

James B. Frakes

Analyst

If we can land such a nondilutive grant or contract with the government, it's still very early, Marla. We're presenting some early data, it looks interesting, but we would have a lot of work to do. So I don't want to overplay that. We were -- our history is in viruses. If there's another situation where we can help, we'll be poised to do that. But I don't want to understate how much we're focused on oncology. It remains our primary.

Marla Marin

Analyst

Right. Okay. And then one follow-up on that and then one other last question. So with the first 3 patients having been treated in Australia, could you please remind us again of -- and you might have already said this in your prepared remarks, if you did, I apologize, but could you remind us what the expected time line is before you deliver some more robust data?

James B. Frakes

Analyst

Well, once -- there's an electronic data equivalent of the clipboard that used to be on patients' beds in the old days. Once that is finalized and the PIs have signed off on it, they'll be presented to the Data Safety Monitoring Committee. There's a tentative meeting set up in July. If they like everything, they're going to give us a green light to proceed to the next cohort, which will be 2 treatments per week. And at the same time, the blood samples that we've taken during the treatments and then afterwards have been sent by those hospitals to our lab at University of Sydney, and they'll measure the changes in EVs and T cells. And we expect to receive that data later on in the summer. As I mentioned in my remarks, I can't wait. I don't know what they'll be. Hopefully, good, but we've been waiting to see that kind of information for a long time as our shareholders.

Marla Marin

Analyst

Right. And then finally, my last question is, you talked about in the press release about some nonrecurring costs that were incurred in connection with the former -- some former executives. So should we be thinking that the nonrecurring expenses are for the time being are finished. We won't be seeing additional one-off costs?

James B. Frakes

Analyst

So we terminated 3 senior executives over like a year. And the former CEO, that ended -- there was a 1-year payout for each of those. His ended in November of 2024. The second one ended -- will end on Monday, June 30, and the third will end in September. And I'm not anticipating -- I'm not expecting any more. I think it would probably be me, our Chief Science Officer, we're the only ones left with contracts like that. And I certainly hope that's not the case and don't expect it will be the case. So yes, long-winded answer to your question, I'm not expecting more of that.

Operator

Operator

The next question is from Swayampakula Ramakanth with H.C. Wainwright.

Swayampakula Ramakanth

Analyst

In terms -- first of all, congratulations on getting the third patient through the trial. So based on what I heard so far, it looks like as soon as you get the okay from the DSMB review, you potentially could be starting the second cohort sometime in August or something like that. So -- and does the amended protocol comes into effect for the second cohort, is it? So should we expect the enrollment, the next 3 patients -- the enrollment of the next 3 patients go much faster than the 6-plus months that took for the first 3? How should we think about that? And then after that cohort, is there another DSMB look for safety before you start the third cohort where I think it's 3 Hemopurifiers per week.

James B. Frakes

Analyst

So the first cohort that we believe we finished is 1 treatment per week, just 1 treatment only in 1 week. The second cohort will be 2 treatments in 1 week. And the third cohort will be 3 treatments in 1 week, Monday, Wednesday, Friday or Tuesday, Thursday, Saturday. The DSMB will need to meet between each -- so the one next month about going to Cohort #2. And then again, they'll need to meet before going to Cohort #3 to answer that question. In terms of recruitments, we now have 3 hospitals recruiting. The hospital that took the longest to get running because of it's larger and more bureaucratic is Genesis Healthcare in Sydney. And the population is just so much bigger in Sydney than Adelaide or Gold Coast. I think it's over 3 million people versus 1.2 million or 3 million in Adelaide. So many more potential patients, and we see weekly updates on recruiting and there's ongoing recruiting. So we're -- we have a running start. We're not just waiting until the DSMB -- we're not going to treat anybody until they approved it, but we're trying to line up patients to quickly move into that. So there's a reason to think it should move much faster than the first cohort.

Swayampakula Ramakanth

Analyst

Okay. And is there any potential for a third hospital to be joining in Australia? Or is it just these 2 hospitals are going to run the entire program?

James B. Frakes

Analyst

Well, we have a third hospital in Gold Coast, which is north of Sydney, but they have not treated any patients yet. They could -- I mean they're still recruiting. I think it's a smaller hospital in a smaller population area. And we're looking at potential other hospitals. But again, we potentially only need 6 more patients, best case, 3 in each of the remaining 2 cohorts. So we have a running start. We're moving their screening. So there's reason to think it should go faster.

Swayampakula Ramakanth

Analyst

Okay. And then switching geographies and going into India. So this is -- my understanding is it's just one hospital, Medanta. So what is the protocol there? Is the protocol there with a monotherapy or combination therapy because now that you know you have some safety in the first cohort, so could you just go straight into combination therapies there? Or what -- how is the protocol approved there?

James B. Frakes

Analyst

That's a good question. Right now, it's the original protocol as a monotherapy, and it was just approved. So that's something to think about. But the population -- that hospital is in Delhi. I don't know what the population is, but many millions of people. So -- and it's a very high-end private hospital. So I think their clientele should be able to afford these expensive drugs. I mean we don't pay for them, but it's not a small public hospital out in the countryside. It's a big hospital in a big city.

Swayampakula Ramakanth

Analyst

Yes, I'm aware of it but...

James B. Frakes

Analyst

And the doctor that's in charge of the renal treatment side of the equation is very familiar with our technology. She's done many, many Hemopurifier treatments, albeit in hep C patients, not oncology patients. So they are comfortable with the device and the therapy.

Swayampakula Ramakanth

Analyst

Okay. But it's going to be the same, right? So it will be 3 patients per cohort and...

James B. Frakes

Analyst

Yes, same. Exactly the same...

Swayampakula Ramakanth

Analyst

Okay. Okay. All right. And then the same thing includes there, too, like there's a DSMB look after every cohort similar to what you're doing in Australia. Is that -- or that's not true.

James B. Frakes

Analyst

Yes -- I believe that's true.

Swayampakula Ramakanth

Analyst

Okay. So now that at least you know you have both the geographies opened up, what are you thinking in terms of timing for this whole entire 9 or 18 patients that you want to test for this study to get done?

James B. Frakes

Analyst

Well, -- if we assume 1 patient a month for the remaining 6 in Australia that would take us out near calendar year-end. There would be data collection after that, writing up of reports, so another quarter or 2. But in terms of Australia, I think we're looking at about 9 to 12 months to be completely done, including writing up the report. India, we'll just have to see how fast it goes. We're just getting going there.

Swayampakula Ramakanth

Analyst

Okay. So we should have a decent picture in a year from now, at least from the Australian side...

James B. Frakes

Analyst

I would think so. I would think so.

Swayampakula Ramakanth

Analyst

Okay. All right. And then -- so with your current cash and with your current run rate, I mean the expense run rate, so what is the total run rate we could expect from this?

James B. Frakes

Analyst

Well, like all small life science companies that doesn't have revenues, we will need to keep raising money until we can take government grants or partner with a larger company. So eventually, we will need to do more equity financing, which is why your firm and other investment banks would make a good business in the life science sector.

Swayampakula Ramakanth

Analyst

So in terms of getting a partner to the table, what sort of data do you think will help you get there?

James B. Frakes

Analyst

Well, hopefully, the data from this safety study will be sufficient to partner but only time will tell. I don't think we have enough -- we don't have any yet really. So it's all our hypothesis with a lot of safety data.

Operator

Operator

The next question is from Anthony Vendetti with Maxim Group.

Anthony V. Vendetti

Analyst

Most of my questions have been answered. But maybe just following up because it was very recent that you received, I guess, June 19, the approval in India. Obviously, a large population there. I know you said about 1 a month in Australia. Do you think once that gets up and running, the opportunity to do more than 1 per month there exists? Or are you like, look, these are specialized patients shouldn't expect more than 1 per month.

James B. Frakes

Analyst

It's very possible. We've observed the actual HP treatments in both Adelaide and Sydney and they're basically held -- done in the dialysis suites without dialysis cartridges, our cartridge attached to a blood pumping machine. But the nurses seem comfortable with it from what we've seen we assume. So I don't think their ability to logistically treat the patients is a constraint. It's more of the patient recruitment. And if the oncologists begin to feel more comfortable, I would like to think more than one a month is possible. I can't. I mean I'll be happy if we can do 1 a month, but there's no reason why it couldn't be more.

Anthony V. Vendetti

Analyst

Yes. Because I think -- I mean I think just comparing the populations, I think 10x the population in India versus Australia. So larger patient pool is what I was thinking and...

James B. Frakes

Analyst

Right. Right.

Anthony V. Vendetti

Analyst

Right. And then you mentioned one of the ways, obviously, equity financing, but grant money too. And I think you -- Aethlon has had grants before. I was wondering if you could just talk about the landscape for grant approval these days with all the changes going on at the government. Is getting grants approved, a, taking longer? Or b, is there just less grant money available and therefore, more difficult to get grant money at this point?

James B. Frakes

Analyst

Well, we haven't had any experience with the HHS on the grant side of things since the regime change. I still get e-mails, ticklers from people in that business. So I know it is continuing. I mean I basically ran our DARPA. It was like a $6 million 5-year contract. So I'm -- and we've had 3 or 4 smaller ones with HHS in the oncology area studying exosomes. They were small $300,000 grants. So we are familiar with them. If we can find one that aligns with our goals, I'm 100% for it. But if it doesn't align with our goals, they're not really all that profitable. And I would think the -- with the current regime, the overhead rates that could be charged might be lower than -- based on what's happened with the universities' research overheads being cut. Not that that's really profit, but it's slimmer now than it was in those days. So we'll look. If we can find one that aligns, I think, would be fantastic.

Anthony V. Vendetti

Analyst

Okay. And then just last question on the expense side. I know you've cut expenses a couple of times here. It seems like you're pretty much at -- I'm not going to say it bare bones, but my guess is there's not much more to cut. What you have in terms of a staff is sort of what's necessary to continue to keep operating the company, correct?

James B. Frakes

Analyst

I think that's a good insight. That is where we are. In fact, as activity ramps up with these oncology trials, expenses in the G&A area might go up a bit. But that's why I cut them back because I knew with success that would ramp up a bit.

Operator

Operator

This concludes our question-and-answer session. I would like to turn the conference back over to Jim Frakes for any closing remarks.

James B. Frakes

Analyst

I'd like to thank you all again for joining us today to discuss our fiscal fourth quarter results, and we look forward to keeping you up to date on future calls. Thank you again. Goodbye.

Operator

Operator

The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.