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Investor releaseQuarter not tagged2026-02-16Aethlon Medical Inc (AEMD) Q3 2026 Earnings Call Highlights: Progress in Oncology Trials and ...
GuruFocus.com
Aethlon Medical Inc (AEMD) Q3 2026 Earnings Call Highlights: Progress in Oncology Trials and ...
This article first appeared on GuruFocus. Release Date: February 12, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Aethlon Medical Inc (NASDAQ:AEMD) reported progress in their Australian oncology trial, with successful completion of the first cohort and ongoing treatments in the second cohort. The company is expanding its extracellular vesicle (EV) research platform, supporting the hemopurifier as a potential multi-indication therapeutic. Aethlon Medical Inc (NASDAQ:AEMD) is advancing work on hemopurifier compatibility with a simplified blood treatment system, which could expand clinical and commercial flexibility. The company has achieved sustained operating expense reductions on a year-to-date basis compared to the prior year. Aethlon Medical Inc (NASDAQ:AEMD) has a cash balance of approximately $7 million as of December 31, 2025, indicating a stable financial position. Consolidated operating expenses for the quarter increased by 13.6% compared to the same period last year, primarily due to higher payroll and related costs. The operating loss for the quarter increased to $2.06 million compared to $1.81 million in the prior year period. Interest income earned on cash balances was lower than the previous year, at $44,000 compared to $60,000. The company is still in the early stages of its oncology trial, with the third cohort yet to be initiated, indicating that significant progress is still needed. There are potential regulatory hurdles and compatibility tests required for the integration of the hemopurifier with the new SLAMB SAA system, which could delay future developments. Warning! GuruFocus has detected 2 Warning Sign with AEMD. Is AEMD fairly valued? Test your thesis with our free DCF calculator. Q: You've moved on in the trial to cohort 2. Can you confirm that participants are involved in the trial for the same length of time as cohort 1? A: Yes, the follow-up period is the same. The difference is that in cohort 2, participants receive two hemo purifier treatments instead of one, typically on a Monday and Friday. This allows us to observe the kinetics of EV numbers between treatments and assess if two treatments lead to more lasting effects on EVs and T cells. - Dr. Steven LaRosa, Chief Medical Officer Q: Can you explain the potential impact of connecting the hemo purifier to the SLAM system...
Investor releaseQuarter not tagged2026-02-13Aethlon Medical Announces Fiscal Q3 2026 Financial Results and Corporate Update
PR Newswire
Aethlon Medical Announces Fiscal Q3 2026 Financial Results and Corporate Update
Clinical and research programs continue to advance, supported by year-to-date cost efficiencies Conference Call Today at 4:30 p.m. ET SAN DIEGO, Feb. 12, 2026 /PRNewswire/ -- Aethlon Medical, Inc. (the Company or Aethlon) (Nasdaq: AEMD), a medical therapeutic company focused on developing products to treat cancer and life-threatening infectious diseases, today reported financial results for its fiscal third quarter ended December 31, 2025, and provided an update on recent developments. Key Highlights Maintained Nasdaq Listing: Continued compliance with Nasdaq listing requirements, with all prior compliance matters remaining resolved. Clinical Progress: Cohort 2 of the Australian oncology trial is actively progressing, reflecting continued clinical execution. Scientific Advancement: Continued advancement of the Company's preclinical extracellular vesicle (EV) research platform, including Long COVID data published on bioRxiv and submitted for peer review, supporting the Hemopurifier's potential as a multi-indication therapeutic approach and a "pipeline within a single device". Technology Development: Continued evaluation of Hemopurifierᆴ (HP) compatibility with a simplified blood treatment system to support broader potential clinical application over time. Operational Efficiency: Maintained disciplined cost controls, resulting in lower year-to-date operating expenses compared to prior year. Clinical and Corporate Update Clinical Progress in Cancer Trial Enrollment and treatment of participants in Cohort 2 of the Australian oncology trial is actively underway, building on Cohort 1, which demonstrated favorable directional improvements in extracellular vesicle and immune cell numbers, as well as safety and tolerability. This nine-to-18 patient study is designed to evaluate the safety and feasibility of the Hemopurifier treatments and determine the appropriate dosing in participants with solid tumors whose disease is stable or progressing while on a treatment that includes the anti-PD-1 agents, Keytrudaᆴ or Opdivoᆴ. Technology Development: Under a Material Transfer Agreement (MTA), Stavro is evaluating the compatibility of the Hemopurifier with their SLAMB system, a simplified blood treatment platform. We believe this research may support future Hemopurifier use in oncology units and infusion centers without requiring a large dialysis catheter, dialysis machines,...
Investor releaseQuarter not tagged2026-02-13Aethlon Medical, Inc. Q3 2026 Earnings Call Summary
Moby
Aethlon Medical, Inc. Q3 2026 Earnings Call Summary
Progress in the Australian oncology trial is driven by a new patient recruitment strategy utilizing online advertising and phone pre-screening to build a participant pool. The Hemopurifier is being positioned as a 'pipeline within a single device' by exploring its ability to remove extracellular vesicles (EVs) across oncology, Long COVID, and autoimmune indications. Management is evaluating compatibility with the SLAMB system to transition the Hemopurifier from invasive dialysis-based administration to simpler, less-invasive infusion center settings. Operational performance is characterized by significant year-to-date cost reductions of 27% achieved through disciplined payroll and professional fee management. The scientific rationale for the current oncology study was validated through peer-reviewed publication in BMJ Open, supporting the mechanism of EV removal to improve natural immune response. Management targets late March 2026 for a Data Safety Monitoring Board (DSMB) meeting to review safety data from the second cohort of the oncology trial. The transition to the third and final cohort, involving three treatments per week, is contingent on DSMB recommendation and is tentatively planned for April 2026. Future R&D will focus on examining platelet-derived EV and microRNA removal in disease-specific plasma to broaden the therapeutic application of the Hemopurifier. The company assumes that demonstrating compatibility with simplified pump systems will eventually remove the requirement for supervising nephrologists and specialized dialysis units. Cash balance of approximately $7 million as of December 31, 2025, supports ongoing clinical and research activities. Quarterly operating loss increased to $2.06 million due to higher payroll costs, though this was partially offset by lower clinical trial expenses. The company is intentionally limiting the use of outside labs for Long COVID and EV research to maintain strict cost control while advancing preclinical data. Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Management explained that increasing to two treatments per week allows them to observe the kinetics of EV numbers between sessions. The goal is to determine if more frequent treatments lead to more long-lasting effects on T cells compared to the sing...
TranscriptFY2026 Q32026-02-12FY2026 Q3 earnings call transcript
Earnings source - 43 paragraphs
FY2026 Q3 earnings call transcript
Good day, and welcome to the Aethlon Medical Third Quarter Fiscal 2026 Earnings and Corporate Update Conference Call. [Operator Instructions] Please note that this event is being recorded. I would now like to turn the conference over to CEO and CFO, Jim Frakes. Please go ahead.
Thank you, operator, and good afternoon, everyone. Welcome to Aethlon Medical's Fiscal Third Quarter 2026 Earnings Conference Call. My name is Jim Frakes, and I'm the Chief Executive Officer and Chief Financial Officer of Aethlon Medical. At 4:15 p.m. Eastern Time today, Aethlon Medical released financial results for its fiscal third quarter ended December 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, Dr. Steven LaRosa, our Chief Medical Officer, and I will provide an overview of Aethlon's 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 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 could cause results to differ materially from those anticipated in forward-looking statements can be found under the caption Risk Factors in the company's annual report on Form 10-K for the fiscal year ended March 31, 2025, the company's most recent quarterly report on Form 10-Q and in the company's other filings with the Securities and Exchange Commission. Except as may be required by law, the company does not intend nor does it undertake any duty to update this information to reflect future events or circumstances. Now I would like to begin by highlighting progress during the December quarter and early calendar 2026 as we continue to execute against our strategy of advancing the Hemopurifier platform while maintaining disciplined cost control. Key developments include continued enrollment and treatment progress in our Australian oncology trial; ongoing expansion of our extracellular vesicle, or EV, research platform, supporting the Hemopurifier as a potential multi-indication therapeutic; advancement of work evaluating Hemopurifier compatibility with a simplified blood treatment system that could expand future clinical and commercial flexibility; and sustained operating expense reductions on a year-to-date basis compared to the prior year. And now I will turn the call over to Dr. LaRosa, who will cover updates on the Australian oncology trial and on our R&D efforts. Steve?
Thank you, Jim. Ongoing progress has been made in our Australian oncology trial of the Hemopurifier in participants with solid tumors not responding to a treatment regimen that includes immunotherapy with the anti-PD-1 agent, pembrolizumab, known as Keytruda, or nivolumab, known as Opdivo. We have previously reported the successful completion of the first cohort where 3 participants received a single Hemopurifier treatment without any device-related serious adverse events or dose-limiting toxicities. Favorable directional improvement in EV numbers and immune cell numbers were observed in this cohort with the HP treatment. We have now completed 2 HP treatments in 2 participants in the second cohort of the trial. We have also recently enrolled a third patient who has passed screening and is due to receive the 2 Hemopurifier treatments by the end of March -- excuse me, by the end of February. Once the 3 patients have completed treatment in Cohort 2, safety data will be presented to an independent Data Safety Monitoring Board. We are targeting late March for this meeting. The DSMB will provide Aethlon Medical with a recommendation to either advance to the third and final cohort of the trial where patients will get 3 Hemopurifier treatments in a given week or they may require 3 additional patients in the current cohort. Aethlon has noted an uptick in the number of interested potential participants in the study since we contracted the groups Trialfacts and Dedicated. Trialfacts performs online advertising of the trial, while Dedicated performs phone prescreening of interested participants. Participants who pass this initial screening are then referred on to the 3 investigative sites for informed consent and more detailed screening. This process has already resulted in HP treatment treated patients in the study and has provided a pool of potential future participants for Cohort 3 of the study. As a reminder, this 9 to 18-patient safety feasibility and dose-finding trial is in patients with solid tumors with stable or progressive disease while on a treatment regimen that includes either Keytruda or Opdivo. Patients who meet all exclusion -- all inclusion and no exclusion criteria are enrolled in sequential cohorts to receive 1, 2 or 3 Hemopurifier treatments during a treatment week. In addition to monitoring safety, the study is designed to examine the number of Hemopurifier treatments needed to decrease the concentration of extracellular vesicles and if these changes in EV concentrations improves the body's own natural ability to attack tumor cells. The scientific rationale and full design of this study have recently been published in the peer-reviewed journal, BMJ Open, and the link to this article could be found on the Aethlon Medical website. I'll now change gears and talk about the R&D update. Under a Material Transfer Agreement, Stavro is studying the compatibility of the Hemopurifier with their SLAMB system. This system utilizes a single small lumen vascular catheter and a simplified blood pump, compared to the large double-lumen vascular catheter and more complicated dialysis machines typically used for the treatment. This research could lead to a simplified system for performing Hemopurifier treatments in oncology units and in infusion centers in the future without the requirement to use a large double-lumen dialysis catheter, a bed in a dialysis unit, a dialysis machine or a supervising nephrologist. The Aethlon Medical R&D team continues to attempt to build on our preclinical data in Long COVID. We have previously shown that the GNA affinity resin in the Hemopurifier binds EVs in Long COVID patient samples and decreases microRNAs known to cause immune dysregulation. This data has been published in the preprint server bioRxiv and has been submitted for consideration in a peer-reviewed journal. We are now exploring possibilities of investigating other cargo within the EVs, such as viral particles, with our technology. Extracellular vesicles, including platelet-derived EVs, have been implicated in the pathogenesis of a myriad of indications in addition to cancer, including, but not limited to, lupus, rheumatoid arthritis, systemic sclerosis, multiple sclerosis, cardiovascular diseases, sepsis and ALS. Aethlon previously published data on the removal of platelet-derived EVs from healthy plasma by the Hemopurifier in the preprint server bioRxiv. We plan to further this work by examining platelet-derived EV and microRNA removal by Hemopurifier -- by the Hemopurifier in patients with some of these indications, so disease plasma, to further this work. This approach is in line with our thinking that the Aethlon Hemopurifier may provide a pipeline within a single device. With that, I'll turn the call back over to Jim for the financial discussion.
Thanks, Steve, and good afternoon again, everyone. Turning briefly to the financials. As of December 31, 2025, we had a cash balance of approximately $7 million. Our consolidated operating expenses for the 3 months ended December 31, 2025 were approximately $2.06 million, up $250,000 or 13.6% compared to the same period last year. This increase was primarily due to higher payroll and related costs, partially offset by lower clinical trial expenses and reduced professional fees, mainly from Investor Relations activities. As a result, the operating loss for the quarter increased to $2.06 million, compared to $1.81 million in the prior year period. Other income, primarily interest income earned on cash balances, was $44,000, slightly lower than the $60,000 recorded in the same quarter last year. Looking at the 9-month period, our operating expenses decreased significantly to $5.36 million, down $1.98 million or 27% from $7.34 million last year. This improvement reflects lower payroll, general and administrative costs and professional fees, highlighting the impact of our ongoing cost management initiatives. You can find more detail on these expense changes in our 10-Q, which breaks down specific drivers by category. We included these earnings results and related commentary in our press release issued this afternoon. The release also included the balance sheet for December 31, 2025 and the statements of operations for the 3 and 9-month periods ended December 31, 2025 and 2024. We will file our quarterly report on Form 10-Q following this call. Our next earnings call for the fiscal fourth quarter ending March 31, 2026 will coincide with the filing of our annual report on Form 10-K in June 2026. And now we would be happy to answer any questions that you may have. Operator, please open the call for questions.
[Operator Instructions] The first question today comes from Marla Marin with Zacks.
So I just want to touch on some of the things that you mentioned in the prepared remarks. You've moved on in the trial to Cohort 2. And given that part of the trial's goal is to determine dosage or the number of Hemopurifier treatments and impact that they have on the trial participant, so now you will be administering the treatment twice instead of, with Cohort 1, the onetime treatment. But the participants are involved in the trial for the same length of time. Is that correct?
It's the same follow-up period. The difference, as you correctly stated, was, instead of getting 1 Hemopurifier treatment in Cohort 1 and Cohort 2, they get 2. So they get it typically on a Monday and Friday. So a number of days in between. And we'll be able to see the kinetics of how -- what the EV numbers do in between treatments. And then we'll also see if the 2 treatments lead to more long-lasting decreases in EVs and more long-lasting effects on T cells compared to what we saw in the first cohort.
Okay. Thank you for clarifying that. Okay. Did somebody -- okay. Then my next question is, if it turns out that the -- investigating the potential to connect the Hemopurifier to, I think you called it the SLAMB system, can you give us some indication of like what that would mean in terms of potentially opening new doors or facilitating your ability to get the Hemopurifier into different medical centers potentially down the road?
Yes, sure. Yes. So right now, Marla, you have to put in a dialysis catheter, which is a fairly -- we call it kind of in medicine circles, we call it a garden hose. It's a large-bore catheter with 2 lumens, one that you take blood out and then when you return the blood in. That's a pretty invasive device. The SLAMB system uses a much smaller single-lumen catheter that wouldn't have to be put in, in the neck. So in hospitals, there are these things called PICC lines that have pretty much become ubiquitous, that are these small, thin catheters that could be put in the crook of the arm. That's what I would envision. So that would be a big change in terms of the invasiveness of the catheter. Currently, for the Hemopurifier, we use a dialysis machine to run it. We're solely using really the blood pump mechanism of the machine. We're not using all the other bells and whistles that a dialysis machine has because we're not removing any fluids or electrolytes. So we're at the mercy of a dialysis machine securing a bed in a dialysis unit because that's the only place dialysis could be done in the hospital, and having a treating nephrologist because they're the ones who are skilled in using the dialysis machine. So with this SLAMB system, you'd have a single-lumen catheter with a simplified pump, which presumably would be much easier from an operator standpoint. So that opens the ability to do this potentially in an oncology unit where people get their chemotherapy infusions or even in infusion centers, which most hospitals have in their ambulatory centers. So it really opens the door to doing this in oncology units as well as in, say, if it was a patient with autoimmune disease that gets an infusion of whatever immunosuppressive, those kind of units. So it really kind of removes you from the dialysis space. Potentially.
So just to make sure I understand, it removes you from that dialysis space and makes it much simpler for the hospital staff to administer the treatment. But also from the patient's perspective, it makes it less invasive and probably less daunting to receive the treatment. Is that the right way to think about it?
Yes. Because as I say, these PICC lines, they're typically put in what we call the antecubital fossa. That's the space in between your forearm and your upper arm, right, in front of your elbow. Getting a thin catheter there is a lot less daunting to a patient than getting a large catheter placed up in their neck. And they're also easier to take care of as well. They tend to have less complications. So yes, I think that from a patient perspective, I'd much rather have one of these catheters than a dialysis catheter. And I'd much rather be able to stay in my therapeutic home, meaning I'm going to an oncology unit to get my immunotherapy, I'd like to get my EV removal treatment in the same place and not have to go to a dialysis unit to have that done, which is what has to happen now. So it just makes it more integrated into care.
Got it. Okay. Last question for me. Jim, I know that you are extremely cost conscious about just about everything that the company is doing, and trying to make sure you maximize your R&D spend and your operating costs, optimize the operating costs. So in the press release and in the prepared remarks, you did talk about building upon some of the preclinical research that you had done. Can you just talk a little bit about -- confirm that everything you're doing is consistent with that same very cost-effective approach you're taking generally, and how you're able to do some of what you're doing, like the Long COVID, in a cost-effective manner?
Right. Well, you're right, I can't escape my Scottish heritage, I guess, on the cost containment front. We're trying to keep costs down as much as we can, yet still advance. So we're trying to obtain samples just for shipping costs basically, to the extent we can. We're trying to do the work in-house with our in-house -- with our small scientific staff, trying to limit the work by outside labs. But yet still advance. So we're publishing articles. We are learning things. It's -- we have to make trade-offs, but we do feel like we're advancing it, Marla. While keeping the focus on the oncology trial. We're, again, delighted that we treated 2 out of the likely 3 patients in the second cohort after finishing the first cohort last quarter. So the progress is picking up on that front too.
No, that is very -- no, that's very apparent that things seem to really be moving forward at the pace that you are finally happy with or that is good to see rather.
Yes. That is true.
The next question comes from Jeremy Pearlman with Maxim Group.
Now first question, related to the oncology trial. You said that the -- more around the time line. Again, this is your best estimate. You said the third patient should be treated by the end of February and then you'll present the safety data by late March. How long do you think the board will respond back whether you can move on to the third cohort or you have to now, let's say, add additional patients into the second cohort? What do you think the time frame for that would be?
Great question. So yes, I had misspoke this, so I'm glad you caught my correction. That third patient will be treated at the end of this month, February. And then the Data Safety Monitoring Board will occur likely in late March. Last -- I can only go historically. Last time, following the open session, at the day of the meeting, they had a closed session. And they returned a signed document to me within a couple of hours after. So I would anticipate a decision same day or next business day.
Okay. Great. And then let's say, just assuming they move you on to the third and final cohort, how -- and you said also on your prepared remarks that you had a pool of applicants, you saw an uptick of interest of potential participants. How quick do you think you could turn those around to do the 3 Hemopurifier treatments and then -- and get to finalize the last cohort data and then push that through?
Yes. So that's a great question. So this is what's really exciting. So thanks to our Controller, Michele Bombardiere. She got this Trialfacts and Dedicated, these groups that Aethlon contracted with. They have been able to supply the site referrals. And so we have a number of these folks lined up. Once we get the -- with the current protocol, you can't enroll or sign a consent for a new patient until you advance to that next cohort. But once we do, those patients can then be approached. They're in the queue, so to speak. They can be approached for consent. There's then a screening period where they get some additional lab test and review. And then we have to line up the HP treatment around their next Hemopurifier treatment. But the really exciting thing is, and again, we can't count our chickens, but there's a queue of potential participants waiting, which is really exciting for me.
And they can roll into the third cohort.
They can roll into the third cohort, yes, without any -- yes. They'll sign consent and they'll just move on. And so as opposed to saying, "Now we got to go look," we at least have a pool to draw on.
No, that's great. It's really good to have that pool to draw on. And then maybe just -- this is just a theoretical question related to how do you decide on the time gap between the first treatment? Like, you said earlier, a Monday, and then you did the second treatment on a Friday. Is there a specific reason why you chose the 5 days? Or is it -- and is there a possibility where maybe extending the gap between the treatments would be more beneficial to the patient? Is this like the optimal time? I'm just curious.
Well, extracellular vesicles are produced by tumors -- people with active tumors continuously. So the turnover is quite rapid. So going in -- again, this is a safety feasibility and our first time in oncology, we said we have to start with a single treatment and see how they do. But we knew it's unlikely that that's going to keep EV numbers down long term, right? So we said, let's try 2 in a week and let's also try 3 in a week, meaning Monday, Wednesday, Friday. We thought anything more than that a patient won't tolerate because, for instance, in dialysis, it's very hard for people to do more than 3 times a week. So we thought that that was the most that somebody would be able to get during a week. And then the other part of the story, which I think you're getting at, is when we look, we'll say, how often do you have to repeat that whatever treatment regimen is? Do you have to do that every week? Do you have to do that every 2 weeks? Do you have to do that once a month? And the way we have our sampling of labs, we'll be able to ascertain that. Is it once a week and then x number of time in between? Is it twice a week with x number of time in, or is it 3 times a week? This was done with a little bit of background information from the plasma exchange trial at Mayo, where they ultimately thought that you needed at least 2 to 3x in a given week to keep EV numbers down. So it was -- the design was informed by what was in the literature in the plasma exchange space.
Got it. Understood. And then just last question, related also to this potential incorporating it into the SLAMB system. Is that -- is there going to be any -- would there be any regulatory hurdles from your end? Or since that device is, I'm assuming, is already approved, if it just is compatible, if you could get the Hemopurifier compatible with it, it's ready to go? Or is there some type of you would have to do some sort of a safety test or something related to that before you could use it into that system?
Yes. Well, they're submitting their -- they're working on their submission to the FDA. It's not already approved. So they'll have to do that. And then we would have to roll it in. I'm sure we would be expected to do a certain number of treatments with the 2 in place. So it's not -- that's the plan.
The next question comes from RK with H.C. Wainwright.
A couple of quick questions. With the Cohort 2, 2 out of 3 patients in, and if I understood it correctly, you are basically using the same patients who had -- who were in Cohort 1 into the Cohort 2? If that is true?
No. These are entirely new. These aren't the same patients that were in Cohort 1. These are entirely new patients.
Okay. So they're entirely new. Okay. Fine. So what -- you said the third patient is starting at the end of this month. So do you think in a couple of months down the line, we should be done with this Cohort 2? And the real question is, is there a real need to do Cohort 3? Or do you think with Cohort 2, you would be able to judge if 2 treatments with Hemopurifier is enough to get the benefit that they could get? Or you still think you would need to do Cohort 3?
Okay. So a bunch of questions there. One is, yes, you're right, the third patient is going to get their 2 HP treatments at the end of this month. Following that, the independent Data Safety Monitoring Board will decide if that's sufficient or whether -- because it's a 3 plus 3 safety study, they'll decide whether it's sufficient or whether we need to add 3 additional patients. So I can't know, wouldn't be appropriate for me to speak for them. But in the best possible scenario, by the time they meet at the end of March, we would have a directive to go ahead and begin in April with Cohort 3. To get to your next question about the need for Cohort 3, well, again, this is based on the Mayo Clinic data, which suggested that you needed 2 or 3. I think we would be really hamstringing ourselves to stop at 2 and not investigate 3 because I have every reason to believe 3 could potentially be superior to 2 in terms of EV removal or T cells. So I think we would be selling ourselves short to stop at 2. And I haven't seen any of the data from 2 to actually even prognosticate yet. So it's way premature to call on the efficacy of 2 right now.
It was a good question, but no, it's -- without knowing the data -- right.
Okay. So then I have a couple of questions on the SLAMB device, so -- integration. As you were stating, when you go from the dialysis machine to this machine, the tubing itself, the catheters itself are smaller in size, which makes the patient feel not so cumbersome. But on the other hand, the flow dynamics of the blood changes quite a bit between the larger tubing and the smaller tubing. So do you see that you might have to go through this rigmarole one more time with that machine because the flow dynamics have changed? The amount of capture of the EVs could be different because of the dynamics? What do you think?
Yes. Again, a lot of forward-looking questions there, but yes, so the first thing is -- the simple -- the first set of experiments is simply: is their pump compatible with the device, meaning does our device function without triggering alarms and clotting off, et cetera? They'll be using -- they'll be doing this, not on patients, but they'll be doing it in the lab with colored fluid and look at the pressures, et cetera. Then you're right, there probably would have to be some ex vivo experiments looking to see -- make sure the EV capture is similar, yes. So this is just the first step, is seeing the compatibility of the device -- of their pump with our device.
Okay. So basically, that's not going to really help us move this trial any faster at this point. So it's something in the future basically, correct?
Not the current trial and probably not even the next trial. I don't think it'd be done in time.
Okay. And then the last question from me is, at one point you were talking about India and then you kind of walked away from that idea. Do you still see a possibility of having the Indian hospital get back into doing a clinical trial so you can kind of speed up the progress here? Or is it first Australia and then we'll see what happens?
Yes. I think we're pretty highly focused on Australia, RK. We'd be -- while the PI is great there and the hospital is great, we're advancing at a very good pace right now in Australia. And we just want to finish executing and get this trial done and get the data out. I think there'll be some expense and some distraction. So the answer is no, we're not going to go back there.
It'd be hard to advance to a PMA trial if you had another safety feasibility trial going on somewhere else in the world.
Right. If there's an emergency, if there's a pandemic breaking out in India, we know them, the PI is very comfortable with our device, we certainly could do an emergency use situation there. I wouldn't hesitate to consider that. But in terms of going back and doing a safety trial, no.
This concludes our question-and-answer session. I would like to turn the conference back over to Mr. Frakes for any closing remarks.
In closing, we remain focused on advancing the Hemopurifier platform through disciplined clinical execution and careful capital management. We appreciate your continued interest and support. Have a good day. Goodbye.
The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.
Investor releaseQuarter not tagged2026-02-04Aethlon Medical to Release Fiscal Third Quarter Financial Results and Host Conference Call on February 12, 2026
PR Newswire
Aethlon Medical to Release Fiscal Third Quarter Financial Results and Host Conference Call on February 12, 2026
SAN DIEGO, Feb. 4, 2026 /PRNewswire/ -- Aethlon Medical, Inc. (Nasdaq: AEMD), a medical therapeutic company focused on developing products to treat cancer and life threatening infectious diseases, today announced that it will issue financial results for its fiscal third quarter ended December 31, 2025, at 4:15 p.m. ET on Thursday, February 12, 2026. Management will host a conference call on Thursday, February 12, 2026, at 4:30 p.m. ET to review financial results and recent corporate developments. Following management's formal remarks, there will be a question and answer session. Interested parties can register for the conference call by navigating to https://dpregister.com/sreg/10206585/1034a255186. Please note that registered participants will receive their dial-in number upon registration. Interested parties without internet access or unable to pre-register may dial in by calling: PARTICIPANT DIAL IN (TOLL FREE): 1-844-836-8741 PARTICIPANT INTERNATIONAL DIAL IN: 1-412-317-5442 All callers should ask for the Aethlon Medical, Inc. conference call. A replay of the call will be available approximately one hour after the end of the call through March 12, 2026. The replay can be accessed via Aethlon Medical's website or by dialing 1-855-669-9658 (USA or Canada) or 1-412-317-0088 (international) or Canada toll free at 1-855-669-9658. The replay conference ID number is 3024961. About Aethlon and the Hemopurifierᆴ Aethlon Medical is a medical therapeutic company focused on developing the Hemopurifier, a clinical stage immunotherapeutic device which is designed to combat cancer and life-threatening viral infections and for use in organ transplantation. In human studies, the Hemopurifier has demonstrated the removal of life-threatening viruses and in pre-clinical studies, the Hemopurifier has demonstrated the removal of harmful exosomes from biological fluids, utilizing its proprietary lectin-based technology. This action has potential applications in cancer, where exosomes may promote immune suppression and metastasis, and in life-threatening infectious diseases. The Hemopurifier is a U.S. Food and Drug Administration (FDA) designated Breakthrough Device indicated for the treatment of individuals with advanced or metastatic cancer who are either unresponsive to or intolerant of standard of care therapy, and with cancer types in which exosomes have been shown to part...
Investor releaseQuarter not tagged2025-11-13Aethlon Medical Announces Fiscal Q2 2025 Financial Results and Corporate Update
PR Newswire
Aethlon Medical Announces Fiscal Q2 2025 Financial Results and Corporate Update
Clinical and research progress continues alongside substantial cost reductions. Conference Call Today at 4:30 p.m. ET SAN DIEGO, Nov. 12, 2025 /PRNewswire/ -- Aethlon Medical, Inc. (the Company or Aethlon) (Nasdaq: AEMD), a medical therapeutic company focused on developing products to treat cancer and life-threatening infectious diseases, today reported financial results for its fiscal second quarter ended September 30, 2025, and provided an update on recent developments. Key Highlights Maintained Nasdaq Listing: Compliance matters resolved, Aethlon remains in good standing with Nasdaq. Clinical Progress: Recruitment underway for Cohort 2 of the Australian oncology trial under amended protocol. Scientific Advancement: Ongoing collaboration with UCSF on Long COVID research, with a manuscript in preparation for peer-reviewed journal. Technology Development: Initiated evaluation of Hemopurifier compatibility with a simplified blood treatment system Operational Efficiency: Operating expenses reduced by 48%, reflecting disciplined cost management. Clinical and Corporate Update Clinical Progress in Cancer Trial Aethlon continues to advance its clinical, scientific, and operational initiatives in support of its mission to develop therapeutic devices for cancer and infectious diseases. Nasdaq compliance matters have been resolved, and the company remains listed on the Capital Market. Recruitment has begun for the second cohort of the Australian oncology trial of the Hemopurifier® is underway under the amended protocol that allows patients receiving combination therapies with Pembrolizumab (Keytruda®) or Nivolumab (Opdivo®). The study is designed to evaluate safety, feasibility, and dose-finding in patients with solid tumors who have not responded to PD-1 therapy. Additional cohorts will examine whether sequential Hemopurifier treatments decrease extracellular vesicle (EV) concentrations and enhance the body's immune response against tumor cells. As previously reported, the laboratory of Professor Georges Grau at the University of Sydney analyzed EVs and lymphocyte counts in samples from patients in the first cohort before and after Hemopurifier treatment. EVs are nanoparticles that are involved in cell-to-cell communication and are implicated in the spread of cancer (metastasis), growth of new blood vessels to the tumor, (angiogenesis), cell death (apoptosis), and i...
TranscriptFY2026 Q22025-11-12FY2026 Q2 earnings call transcript
Earnings source - 35 paragraphs
FY2026 Q2 earnings call transcript
Good day, and welcome to the Aethlon Medical Second Quarter Fiscal 2026 Earnings and Corporate Update Conference Call. [Operator Instructions] Please note today's event is being recorded. I would now like to turn the conference over to Jim Frakes, CEO and CFO. Please go ahead.
Thank you, operator, and good afternoon, everyone. Welcome to Aethlon Medical's Fiscal Second Quarter 2026 Earnings Conference Call. My name is Jim Frakes, and I'm the Chief Executive Officer and Chief Financial Officer of Aethlon Medical. At 4:15 p.m. Eastern Time today, Aethlon Medical released financial results for its fiscal second quarter ended September 30, 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, Dr. Steven LaRosa, our Chief Medical Officer, and I will provide an overview of Aethlon's 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 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 could cause results to differ materially from those anticipated in forward-looking statements can be found under the caption Risk Factors in the company's annual report on Form 10-K for the fiscal year ended March 31, 2025, the company's most recent quarterly report on Form 10-Q and in the company's other filings with the Securities and Exchange Commission. Except as may be required by law, the company does not intend nor does it undertake any duty to update this information to reflect future events or circumstances. And now I will turn the call over to Dr. LaRosa, who will cover updates on the Australian oncology trial and on our R&D efforts. Steve?
Thank you, Jim. I'll start off with the clinical update. Ongoing progress has been made in our Australian oncology trial of the Hemopurifier in participants with solid tumors not responding to a regimen that includes immunotherapy with an anti-PD-1 agent. We've completed Hemopurifier treatments in the three participants in Cohort 1. All three participants completed a single 4-hour Hemopurifier treatment without any device deficiencies or immediate complications. At the prespecified 7-day safety follow-up, none of the three participants experienced a dose-limiting toxicity, or a device-related serious adverse event, an independent data safety monitoring board that was convened on July 11, 2025, recommended advancing to the second cohort where participants will receive two Hemopurifier treatments during a 1-week treatment period. All three investigative sites in Australia have been busy prescreening potential participants for the second cohort. Potential participants have been identified by these screening efforts and these participants are currently reviewing the informed consent document. In an attempt to accelerate enrollment, Aethlon has embarked on a 3-pronged strategy. First, we held a virtual investigator meeting with the three Australian principal investigators and sites to share best practices for identifying potential participants and describing the trial to those participants; two, we are working with our Australian CRO, ResQ, to identify one to two additional new sites; and three, we've engaged the company Trialfacts to perform clinical trial advertising, online prescreenings and referral of potential participants to the investigative sites. As a reminder, the primary endpoint of the approximate 9 to 18 patients safety, feasibility and dose-finding trial is safety. Safety is determined by monitoring for the incidence of adverse events and clinically significant changes in blood tests following the Hemopurifier treatments. The trial involves patients who are not responding to a treatment regimen that includes an anti-PD-1 agent and the participants will receive either 1, 2 or 3 Hemopurifier treatments during a 1-week treatment period. In addition to monitoring safety, the study is designed to examine the number of Hemopurifier treatments needed to decrease the concentrations of extracellular vesicle or EVs. And if changes in these EV concentrations improve the body's own natural ability to attack tumor cells. These exploratory central laboratory analyses will inform the design of later efficacy and safety trials, including a premarket approval study known as a PMA study, required by the FDA and other regulatory agencies. As described in our press release from October 7, 2025, the laboratory of Professor Georges Grau at University of Sydney has performed analysis of extracellular vesicle, EV number and lymphocyte counts on samples before and after the HP treatment in the three patients in the first cohort. EVs are nanoparticles that participate in cell-to-cell communication and are implicated in the spread of cancer known as metastasis, the growth of new blood vessels to the tumor, known as -- called angiogenesis, and also inhibit the body's T cells, which are important for killing tumor cells. Two of the three participants in the trial showed decreases in large EVs, known as microvesicles, following the Hemopurifier treatment. When examining the subsets of EVs, decreases were also noted in large and small platelet-derived EVs, in two of the three patients. We observed decreases in the subset of large EVs carrying the ligand PD-L1 in all three participants during the Hemopurifier treatment. Persistently elevated counts of EVs with PD-L1 have been associated with a lack of response to anti-PD-1 agents. Following a single 4-hour Hemopurifier treatment decreases were also observed in 7 out of 10 microRNAs examined in two of the three participants. MicroRNAs are about one component of the cargo of extracellular vesicles, and have been previously been reported to promote cancer growth and metastasis. After a single 4-hour treatment improvements in laboratory ratios associated with responses to immunotherapy were noted in two of the three participants. These ratios included the neutrophil to lymphocyte ratio, monocyte to lymphocyte, lymphocyte to albumin and the systemic immune-inflammation Index. Increase were noted in total T cells, CD8 and CD4 T cell subsets, and tumor-specific CD137 positive T cells in participants following the Hemopurifier treatment. Heterogeneity was noted in the time to these changes in the three participants and the magnitude of the changes observed. Additional data from the subsequent two cohorts will help to determine whether these observations are reproducible, and whether there is a dose response with additional Hemopurifier treatments in terms of the magnitude and the duration of these changes. I'll now switch to an update on the preclinical R&D activities. Aethlon Medical presented preclinical data on August 12, 2025, at the Keystone Symposium on Long COVID and other post-acute infection syndromes. Long-standing symptoms following acute COVID-19 infection, known as Long COVID, have been demonstrated to effect approximately 400 million individuals worldwide with a global economic burden of $1 trillion per year. No treatment has been approved by a regulatory agency for the treatment of long COVID. Extracellular vesicle have been implicated in the pathogenesis of Long COVID. The data we presented demonstrated that large and small extracellular vesicles from Long COVID patients bound to the GNA lectin and the lectin affinity resin that's present in the Aethlon Hemopurifier. Following this presentation, Aethlon's R&D lab has focused on studying the cargo of the extracellular vesicles removed from the Long COVID patient samples. We are currently preparing a manuscript for submission with these results with plans on submitting to a preprint server and a peer-reviewed journal, in a publication that's being done with our collaborators at UCSF Medical Center. Recently, Aethlon Medical signed a material transfer agreement, an MTA, to study the compatibility of the Aethlon Hemopurifier with a system that utilizes a single small-lumen vascular catheter and a simplified blood pump. Currently, operation of the Hemopurifier requires a large double-lumen dialysis catheter, a more complicated dialysis machine as well as supervising nephrologists, dialysis nurses and the requirement for a dialysis unit bed. The research done under this MTA could lead to a simplified system for performing Hemopurifier treatments in oncology units in the future. With that, I'll turn the call over to Jim for the financial discussion and questions.
Thanks, Steve, and good afternoon again, everyone. Let's touch briefly on the financials. As of September 30, 2025, we had a cash balance of approximately $5.8 million. Our consolidated operating expenses for the 3 months ended September 30, 2025, were approximately $1.5 million, down by approximately $1.4 million or 48%, from $2.9 million in the same period of 2024. The decreases were reflected across our expense categories of payroll, general and administrative expenses and professional fees. Our payroll and related expenses decreased by approximately $778,000, reflecting lower headcount, reduced bonus accruals, and absence of prior year severance charges. Our general and administrative expenses declined by approximately $437,000 driven by lower clinical trial costs and in part due to a $218,000 R&D tax incentive credit from the Australian government as well as reductions in supplies, insurance and other operational costs. And our professional fees decreased by approximately $177,000, mainly from reduced investor relations and contract labor expenses, partially offset by higher legal tax audit and financial services costs. As a result of these factors, our operating loss for the quarter decreased to $1.5 million, again, compared to $2.8 million in the prior year period, reflecting solid progress in aligning our resources with our strategic priorities. You can find more detail on these expense changes in our Form 10-Q, which breaks down specific drivers by category. We included these earnings results and related commentary in our press release issued this afternoon. The release also included the balance sheet for September 30, 2025, and the statements of operations for the 3- and 6-month periods ended September 30, 2025 and 2024. We will file our quarterly report on Form 10-Q following this call. Our next earnings call for the fiscal third quarter ending December 31, 2025, will coincide with the filing of our quarterly report on Form 10-Q in February 2026. And now we would be happy to answer any questions that you may have. Operator, please open the call for questions.
[Operator Instructions] Today's first question comes from Marla Marin with Zacks.
So I just want to understand one thing in terms of the recruitment for Cohort 2, to what extent will potential participants understand that you are moving forward and that there were some positive responses in Cohort 1? Or that doesn't come into play at all?
Steve?
Marla. Yes, so it's a good question. So when we had our virtual investigator meeting, we went over again with the investigators, what we saw in terms of observations with the EVs and the T cells in the first cohort, so that they would understand those and be able to explain them. And then we also had a very, I think, good discussion about how to describe this trial to the patients. So there was a lot of good input from all three PIs. So I think the investigator meeting had a lot of value from that perspective.
Okay. And then also so you had -- as you have been explaining for a while, there was a follow-up with the Cohort 1 participants, a 7-day follow-up. Is there any sense in terms of subsequently whether there's -- that group of those three people are still performing in the way that you would expect or that wouldn't be in any way statistically meaningful data to have?
Well, we have -- the observations were based on the labs that went out to 8 weeks. So we have all that data for those patients. So there's no subsequent EV or T cell data that we expect from that group of patients. And then although we are following them clinically, that is not an endpoint. This is an early safety and feasibility trial. So we can't make any comments about the clinical response.
Okay. Right. That makes sense. And with Cohort 2, can you just remind us in terms of you're looking for, this as a dosage finding study as well as safety study. So what should we be thinking about once you down the road when you release top line data, what you'll be looking for?
Yes. So great question. So in Cohort 2, during a 1-week period, the patient will get -- the participant will get to HP treatment. So Monday, Friday would be the schedule as opposed to a single treatment. So what we would like to see not only most importantly, can someone tolerate two treatments in a week. That's the main objective. But what we'd like to see is that the EV decreases that we observed in the first cohort would be more profound because they're getting two treatments instead of one. And that the T cell changes would also increase over time. So a dose response, even though it's a device, not a drug, a dose response. And then, of course, reproducing what we saw in the first three patients. So I think the next tranche of data will give us more information than we have right now.
Yes. Okay. Yes, that makes sense. And your -- as I think you've said in the past, you're not walking away from some of the other indications where you think the Hemopurifier can be effective. But given the realities of budgets and time constraints and all, you're not investing a lot of time or money in some of these other indications. So the paper that you wrote and then the presentation at the medical forum, are those the kind of things that we should think about for you going forward in the near term to try to keep people apprised of what's going on with the Hemopurifier?
Yes. No. As we've talked about before, I think EV reductions are relevant in a large number of indications. We've got to focus our efforts because of our staff and amount of funding. I would expect in the near term that we will have a preprint on our Long COVID data. So that's something to look forward to. And that data will also simultaneously get submitted to a peer-reviewed journal, which, of course, gets -- as I said, peer review. So that would be the next. So the Long COVID data. And then we -- as we can, we will look at EVs and other diseases. But again, we have -- as you said, we have to be focused based on our resources.
So we are monitoring other indications, but we're trying to stay focused.
Right. No, no, I get it. And then, Jim, a question for you in terms of you're always looking for ways to stretch or optimize your spending. I'm guessing that at this point, you really -- there's not a lot that you can do because you've pretty much optimized your spending. In terms of -- in the past, like quite a long time ago, there were some -- you had access to some sort of government funding that was not dilutive. Have you thought about that again? Or is that really not applicable now as you're moving through clinical trials?
Well, if the -- a government contract was aligned close to perfectly with our goals we would be interested. But if it was an excursion into a different field, it's just -- especially with the current administration cutting overhead on these contracts, they weren't all that profitable before. And now with the overhead reductions, I think that it's probably breakeven or close to breakeven at best. So it would have to dovetail really well with our goals -- to help us get to those goals more efficiently. So we're not averse to doing it, but it has to be the right contract or grant.
And our next question today comes from Jeremy Pearlman of Maxim Group.
Okay. So you had approval for -- to move on to the second cohort, roughly 4 months ago. Maybe if you could explain or why -- or hypothesize why you think it's taking so long to recruit patients?
Steve?
Yes. It's -- as we've kind of said before, this is not an easy sell to patients. Cancer patients don't usually get a large catheter put in and get their blood filtered over a machine. And so that takes some explaining. So I think -- and there's a lot of time points where patients have to get samples done. So -- and then explaining to a patient what the -- in a safety and feasibility trial, what the value would be to them, we had a lot of discussions at the investigator meeting. So it's an EV removal in cancer is a novel concept. And extracorporeal therapies for cancer patients are -- is a novel concept, and that just requires some explaining to them. And -- so the slow enrollment to me is not all that unexpected.
Okay. Understood. And you -- based on that -- based on these new initiatives you're instituting to try and accelerate enrollment, do you still think by a time line for completion of the second cohort by the end of, let's say, mid-2026. Is that reasonable? Or how should we look at the -- based on these time lines?
Yes. I mean, we've tried to say that we would anticipate one patient per month. One of the things one must bear in mind is that it is now summer in Australia. So people are going on vacation and it's the holiday. So a slowdown during the holidays, I would not be unexpected. But one patient a month is what we're targeting. We do hope that the -- we're not standing pat. As I've said, -- we've engaged this company called Trialfacts. So they're actually doing digital marketing. They're doing an online screening form and then they're referring potentially eligible patients to the sites. I think that will help. And we're actually looking for an additional one to two sites. So we're trying to exhaust every avenue to try to ramp things up.
Okay. That's great. And then just the last question related to some of the data that you talked about earlier on the call and that was in the press release today. Is that -- does that fit in with your hypothesis that this could help extend the patient life or help improve patients who have -- who are going under immunotherapy as well? Or is it not enough of a decrease yet in the T cells and the EVs?
Yes. So I'm always cautious because it's three patients. That's probably the most important thing. So the more patients, the more confidence one would have. But directionally, EV decreases is what we want to see, and we're seeing that overall and in some subsets and some improvement in different lymphocyte populations that are involved in tumor killing, they're going directionally in the right way. So if we see that this is reproducible in the next cohort and that the magnitude of the changes is increased, that would give one more confidence. So yes, things -- at least what we're seeing now, we're seeing directionally -- directional changes that we wanted to see.
And our next question today comes from Sean Lee of H.C. Wainwright.
This is Sean here for RK. I just have two quick ones. First, on the Australian study. Regarding the lower EV levels that you saw, was that directly following treatment or after a period of time? And were you -- was that stable following levels? Did the EV levels rebound after a while?
Yes. So what we did is we got a sample before they went on the machine -- before they went on the device, one at 2 hours into their treatment and one at 4 hours. So at the end of the treatment, and then subsequent weeks 1, 2, 3, 4 and 8 following treatment. And so we saw, again, particularly in the larger EV populations, decreases during the treatment, so at the 2-hour and 4-hour time point. And as -- because EVs are being produced continuously, you do see a rebound usually over the course of a couple of weeks. And so yes, they do start going back up. So what you'd like to now examine because this is a dose-finding study as well is that with more treatments in a given week, the EVs will both go down further and stay down longer. But we've only got the single treatment so far. So yes, they go down during the treatment, and then they do start rising after a couple of weeks after the treatment.
Which was expected.
And that's totally expected, yes.
I think you mentioned that the follow-up for 8 weeks doing Cohort 1. For Cohort 2, are you expecting to follow them any longer? Or are we still looking at the 8 weeks data in maximum?
Yes. No, the EV and T cell data only goes out to post-treatment week 8. We don't go any further than that.
And that concludes our question-and-answer session. I'd like to turn the conference back over to Jim Frakes for any closing remarks.
I'd like to thank you again for joining us today in our discussion of our fiscal second quarter results, and we look forward to keeping you up-to-date on future calls. Thanks again. Goodbye.
Thank you. That concludes today's conference call. We thank you all for attending today's presentation. You may now disconnect your lines, and have a wonderful day.
Investor releaseQuarter not tagged2025-11-07Aethlon Medical to Release Fiscal Second Quarter Financial Results and Host Conference Call on November 12, 2025
PR Newswire
Aethlon Medical to Release Fiscal Second Quarter Financial Results and Host Conference Call on November 12, 2025
SAN DIEGO, Nov. 7, 2025 /PRNewswire/ -- Aethlon Medical, Inc. (Nasdaq: AEMD), a medical therapeutic company focused on developing products to treat cancer and life threatening infectious diseases, today announced that it will issue financial results for its fiscal second quarter ended September 30, 2025, at 4:15 p.m. ET on Wednesday, November 12, 2025. Management will host a conference call on Wednesday, November 12, 2025, at 4:30 p.m. ET to review financial results and recent corporate developments. Following management's formal remarks, there will be a question and answer session. Interested parties can register for the conference call by navigating to https://dpregister.com/sreg/10204579/1005d2109f4. Please note that registered participants will receive their dial-in number upon registration. Interested parties without internet access or unable to pre-register may dial in by calling: PARTICIPANT DIAL IN (TOLL FREE): 1-844-836-8741 PARTICIPANT INTERNATIONAL DIAL IN: 1-412-317-5442 All callers should ask for the Aethlon Medical, Inc. conference call. A replay of the call will be available approximately one hour after the end of the call through December 12, 2025. The replay can be accessed via Aethlon Medical's website or by dialing 1-855-669-9658 (domestic) or 1-412-317-0088 (international) or Canada toll free at 1-855-669-9658. The replay conference ID number is 1454680. About the Hemopurifier® The Aethlon Hemopurifier is an investigational medical device designed to remove enveloped viruses and tumor-derived extracellular vesicles (EVs) from circulation. It is used extracorporeally with a blood pump and combines plasma separation, size exclusion, and affinity binding using a plant lectin resin that targets mannose-rich surfaces found on EVs and viruses. EVs released by solid tumors are believed to play a role in metastasis and the resistance to immunotherapies and chemotherapy. Removal of enveloped viruses and extracellular vesicles has been demonstrated in both vitro studies and human subjects. The Hemopurifier holds a U.S. Food and Drug Breakthrough Device Designation for: The treatment of individuals with advanced or metastatic cancer unresponsive to or intolerant of standard-of-care therapy; and the treatment of life-threatening viruses not addressed with approved therapies. About Aethlon Medical, Inc. Aethlon Medical, Inc. (Nasdaq: AEMD) is a clinic...
Investor releaseQuarter not tagged2025-08-16Aethlon Medical Inc (AEMD) Q1 2026 Earnings Call Highlights: Strategic Focus on Australian ...
GuruFocus.com
Aethlon Medical Inc (AEMD) Q1 2026 Earnings Call Highlights: Strategic Focus on Australian ...
Release Date: August 13, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Aethlon Medical Inc (NASDAQ:AEMD) has made significant progress in its Australian oncology trial, with the first cohort of patients completing treatment without any device deficiencies or serious adverse events. The company has received formal approval from India's CDSCO to initiate an oncology trial, although they have decided to focus resources on the Australian trial for strategic reasons. Aethlon Medical Inc (NASDAQ:AEMD) has significantly reduced operating expenses by approximately 32%, primarily through payroll savings and reduced legal and consulting fees. The company is actively exploring the use of its hemo purifier for broader applications, including long COVID, and has presented promising pre-clinical data at a symposium. Aethlon Medical Inc (NASDAQ:AEMD) benefits from a 43% cash tax rebate in Australia, which helps offset research costs and makes conducting trials there financially advantageous. The decision to not proceed with the Indian trial may delay potential strategic partnerships or regulatory approvals, as the company focuses solely on the Australian trial. Despite cost reductions, Aethlon Medical Inc (NASDAQ:AEMD) will still need to raise additional funds to continue its clinical research, as it does not yet have approved products for sale. The company faces challenges in accelerating patient enrollment in its Australian trial, although efforts are being made to address this through additional sites and recruitment strategies. The efficacy of the hemo purifier in actual clinical settings remains to be proven, as pre-clinical results may not directly translate to patient outcomes. Aethlon Medical Inc (NASDAQ:AEMD) is still in the early stages of its clinical trials, and it may take time to gather sufficient data to inform dosing and treatment effects. Warning! GuruFocus has detected 2 Warning Sign with AEMD. Q: Can you confirm if the primary endpoint of the Australian study is safety, and if the first cohort has shown no adverse events related to the hemo purifier treatment? A: Yes, the primary endpoint is safety. We have successfully passed the first cohort with no adverse events, and an independent data safety monitoring board has recommended moving forward to the second cohort. (Dr. Steven La Rosa, Chief Me...
Investor releaseQuarter not tagged2025-08-14Aethlon Medical Announces Financial Results for the Fiscal First Quarter Ended June 30, 2025, and Provides Corporate Update
PR Newswire
Aethlon Medical Announces Financial Results for the Fiscal First Quarter Ended June 30, 2025, and Provides Corporate Update
Australian Cancer Trial Advances with First Cohort Complete, Amended Protocol, and Promising Preclinical Data Published; Operating Expenses Cut by 32% Conference Call to be Held Today at 4:30 p.m. ET SAN DIEGO, Aug. 13, 2025 /PRNewswire/ -- Aethlon Medical, Inc. (the Company or Aethlon) (Nasdaq: AEMD), a medical therapeutic company focused on developing products to treat cancer and life-threatening infectious diseases, today reported financial results for its fiscal first quarter ended June 30, 2025, and provided an update on recent developments. Key First Quarter Highlights First Cohort Complete in Australian Hemopurifier® cancer trial — all patients treated without device-related serious adverse events and no dose-limiting toxicities observed Amended Protocol broadens patient eligibility to allow all treatment regimens that include an anti-PD-1 agent Preclinical Data: 98.5% removal of platelet-derived extracellular vesicles (EVs) in simulated 4-hour treatment Long COVID Pre-Clinical Research collaboration with UCSF advances, with findings presented at the prestigious Keystone Symposium Operating Expenses Reduced by 31.6%, enhancing operational efficiency Clinical Progress in Cancer Trial Ongoing progress continues in the Australian Oncology trial evaluating the Hemopurifier in participants with solid tumors that have not responded to anti-PD-1 immunotherapy. Aethlon successfully completed the first treatment cohort in its safety, feasibility, and dose-finding study. This initial cohort involved single Hemopurifier treatments for participants with tumors unresponsive to PD-1 inhibitors such as pembrolizumab (Keytruda®) or nivolumab (Opdivo®). Treatments were completed at Royal Adelaide Hospital and Royal North Shore Hospital between late January and June 2025. All participants tolerated the 4-hour Hemopurifier treatment without device-related deficiencies or immediate complications, and no dose-limiting toxicities or device-related serious adverse events were observed at the pre-specified 7-day safety follow-up. One participant subsequently died from disease progression, unrelated to the Hemopurifier treatment, and was only able to complete one week of follow-up. On July 11, 2025, the independent Data Safety Monitoring Board (DSMB) convened to review the safety data from the three participants in this first cohort. Following closed-session deliberations, th...
TranscriptFY2026 Q12025-08-13FY2026 Q1 earnings call transcript
Earnings source - 24 paragraphs
FY2026 Q1 earnings call transcript
Good afternoon, and welcome to the Aethlon Medical First Quarter Fiscal 2026 Earnings and Corporate Update. 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, sir.
Thank you, operator, and good afternoon, everyone. Welcome to Aethlon Medical's Fiscal First Quarter 2026 Earnings Conference Call. My name is Jim Frakes, and I'm the Chief Executive Officer and Chief Financial Officer of Aethlon Medical. At 4:15 p.m. Eastern Time today, Aethlon Medical released financial results for its fiscal first quarter ended June 30, 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, Dr. Steven LaRosa, our Chief Medical Officer, and I will provide an overview of Aethlon's 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 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 could cause results to differ materially from those anticipated in forward-looking statements can be found under the caption Risk Factors in the company's annual report on Form 10-K for the fiscal year ended March 31, 2025, the company's most recent quarterly report on Form 10-Q and in the company's other filings with the Securities and Exchange Commission. Except as may be required by law, the company does not intend nor does it undertake any duty to update this information to reflect future events or circumstances. With that, we will now cover the business update portion of this call. First, I'd like to note that because of our March 31 fiscal year, we report our fourth quarter and then the ensuing first quarter quite close in time, basically 6 weeks apart. As a result, in this earnings call, we will also touch on some of the late-breaking news from our previous earnings call in late June. Overall, we are pleased with the progress in our Australian oncology trial. Dr. LaRosa will cover the specifics on that trial shortly, but I wanted to give some high- level thoughts first. Keep in mind that several of these points are forward-looking statements, as I just noted. In the first quarter, we advanced our lead oncology indication clinical program, delivered preclinical results supporting broader applications including long COVID, all while significantly reducing operating expenses. Our focus remains on moving the Hemopurifier towards regulatory approval and expanding use across multiple diseases. While we received formal approval from India's Central Drug Standard Control Organization, or CDSCO to initiate a similar oncology trial at Medanta Medicity Hospital in New Delhi, India. Discussions with our India-based CRO showed first patient treatment would likely slip to early 2026. Given this extended time line and our broader strategic priorities, we decided not to proceed with the India study. This choice is about focus, not just savings, though we expect to conserve $500,000 to $1 million by this decision. Based on our current progress in Australia, we could complete treatments by late 2025 or early 2026, analyze data and be in a position to apply for a PMA or efficacy trial in Australia and engage strategic partners. If we were still early in the Indian trial at that point, regulators or potential strategic partners could require us to finish it first, delaying our path forward. Avoiding that risk is why we are focusing our resources in Australia, which keeps us on the fastest toward our next milestone. And now I will turn the call over to Dr. LaRosa, who will cover updates on the Australian oncology trial and on our R&D efforts, particularly in long COVID and our recent preclinical data regarding the removal of platelet-derived extracellular vesicles or EVs. Steve?
Thank you, Jim. Hello, everyone. I'm joining you live from the Keystone Symposium Conference on Long COVID in Santa Fe, New Mexico, where last evening, I presented preclinical data in long COVID, more about that in a little bit. First, I'd like to give you our progress in our lead indication in oncology, our Australian clinical trial of patients with solid tumors not responding to immunotherapy with anti-PD-1 agents. We have completed Hemopurifier treatments in the 3 patients in our first cohort. The first patient completed a Hemopurifier treatment at our site at Royal Adelaide Hospital in January, and patients 2 and 3 were treated at Royal North Shore Hospital in Sydney on June 2 and June 16 of this year. All 3 participants completed the entire 4-hour Hemopurifier treatment without any device deficiencies and no immediate complications. At the prespecified 7-day safety follow-up period, none of these 3 participants experienced a dose-limiting toxicity or a device-related serious adverse event. The second patient enrolled, unfortunately, went on to die from progression of his cancer and can only provide a 1-week follow-up worth of data. An independent Data Safety Monitoring Board known as the DSMB convened on July 11, 2025, to review the safety data on these first 3 patients in the first cohort. Following a closed session deliberation, the DSMB provided Aethlon Medical's senior leadership with a recommendation to advance to our second treatment cohort where patients will receive 2 Hemopurifier treatments during a 1- week period. All 3 of our sites in Australia are actively screening patients for this second cohort. These sites are screening under an amended protocol that allows patients on either monotherapy or combination therapy that includes pembrolizumab or nivolumab. This protocol amendment was performed to reflect changes in standard of care, leaning now more towards combo therapy and it thus increases the potential pool of patients for the study. The laboratory of Professor Georges Grau at the University of Sydney continues to work on the central lab test on the first patient cohort samples to look for the effects of the Hemopurifier on extracellular vesicle numbers and antitumor T cell function. We would expect to be able to make some observations of this data sometime in September 2025. As a reminder, the primary endpoint of this approximate 9 to 18-patient safety, feasibility and dose-finding study is safety. The trial will monitor for any adverse events and clinically significant changes in lab tests of Hemopurifier-treated patients with solid tumors who have stable or progressive disease while on a regimen that includes either KEYTRUDA or OPDIVO anti-PD-1 therapy. The patients, as mentioned, it's designed in 3 cohorts. The first we've completed, the second cohort where patients get 2 treatments in a 1-week period and the third cohort where the patients get 3 Hemopurifier treatments in a 1-week period. As mentioned, in addition to monitoring safety, we're examining the number of Hemopurifier treatments needed to decrease the concentration of extracellular vesicles, and if these decreases in EV numbers improve the body's own natural ability to attack tumor cells. These exploratory central laboratory analyses are expected to inform the dosing of a later efficacy and safety trial, including a PMA or premarket approval study that is required by the FDA and other regulatory agencies. Currently, only approximately 30% to 40% of patients who receive pembrolizumab or nivolumab will have a lasting clinical response to these agents. Extracellular vesicles produced by tumors have been implicated in the spread of cancers as well as the resistance to anti-PD-1 therapies. The Aethlon Hemopurifier has been designed to bind and remove these EVs from the bloodstream, which may improve the therapeutic response rates to the anti-PD-1 drugs. In preclinical studies, the Hemopurifier has been able to decrease the number of EVs in cancer patient samples. Now I'd like to segue to our R&D preclinical activities. Last evening, August 12, 2025, Aethlon presented a poster at the Keystone Symposium on long COVID and other post-acute infectious syndromes being held in Santa Fe, New Mexico. Long-standing symptoms following acute COVID-19 infection known as long covid has been determined to affect approximately 400 million individuals worldwide with a global economic burden of approximately $1 trillion per year. This data can be found in a Nature Medicine 2024 publication. The presentations at this conference reviewed the clinical trials that have been conducted to date and show that there is currently no agent that is approved for the treatment of long COVID, indicating a large unmet medical need. Extracellular vesicles have been implicated in the pathogenesis of long COVID. Since we had previously demonstrated removal of extracellular vesicles by the Hemopurifier in emergency use patients with severe acute COVID-19 infection, we hypothesized that the patients with long COVID would have extracellular vesicles with the mannose sugar on their surface that would be amenable to removal by our device. With this in mind, we partnered with investigators at the University of California San Francisco Medical Center, Long COVID link cohort, and they provided us samples from -- blood samples from patients with long COVID as well as people who had COVID but had fully recovered. The data we presented last evening demonstrated that both large and small extracellular vesicles from long COVID patients found to the GNA lectin and lectin affinity resin, respectively, in our device. We had active discussions with a number of participants, and we will take this feedback back to Aethlon to discuss potential next steps and other collaborations. Since this data has now been presented publicly, we will share this poster on our Aethlon medical site in the very near future. On May 12, 2025, the results of our preclinical ex vivo study entitled ex vivo removal of CD41-positive platelet microparticles from plasma by a medical device containing Galanthus nivalis agglutinin resin was published in the preprint vehicle bioRxiv and is publicly available. This manuscript has also been submitted to a peer-reviewed publication for review. Platelet-derived extracellular vesicles are the most numerous EV population in the body and are released by platelets in response to a variety of stimuli. The cargo contained within these platelet-derived EVs have been noted to take part in damage to blood vessels, activation of immune cells and spread of tumor cells. Excessive levels of PD-EVs have been implicated in a myriad of diseases, not only cancer, but also lupus, systemic sclerosis, multiple sclerosis, Alzheimer's disease, sepsis and acute and long COVID. As a matter of fact, this morning, a presentation from the Paxlovid study indicated that platelets, activated platelets are a source of viral persistence within long COVID. We hypothesized in our publication analysis and our study that the Aethlon hemopurifier, which contains the proprietary GNA affinity resin might be able to bind these platelet-derived EVs from plasma. In this experiment, we took 200 milliliters of healthy donated human plasma and circulated it over our Aethlon Hemopurifier to simulate a clinical Hemopurifier session. The data revealed that we removed 98.5% of platelet-derived EVs at a time point equivalent to a 4-hour treatment in a patient. The results of this study support our current Australian clinical trial in oncology as well as open the investigation of the hemopurifier in the diseases I just mentioned. With that, I'll turn the call back over to Jim for the financial discussion, and then we will take questions. Jim?
Thanks, Steve, and good afternoon again, everyone. Let's touch briefly on the financials now. As of June 30, 2025, we had a cash balance of approximately $3.8 million. For the 3 months ended June 30, 2025, our consolidated operating expenses were approximately $1.8 million. That's down roughly $800,000 or 32% from $2.6 million a year ago. Most of the improvement came from payroll-related savings, including the absence of executive severance recorded last year, lower headcount and a related drop in stock- based compensation. We also saw a meaningful reduction in legal fees after transitioning to a new firm and lower scientific consulting costs with the wrap- up of a project. Our general and administrative expenses were modestly lower as well, helped by reduced insurance costs, but we did see an uptick in clinical trial spending as our trial advances. All in, these efficiencies brought our operating loss down to $1.8 million compared to $2.6 million in last year's June quarter, reflecting solid progress in aligning our resources with our strategic priorities. You can find more detail on these expense changes in our 10-Q, which breaks down specific drivers by category. We included these earnings results and related commentary in our press release issued this afternoon. The release also included the balance sheet for June 30, 2025, and the statements of operations for the 3-month periods ended June 30, 2025, and 2024. We will file our quarterly report on Form 10-Q following this call. Our next earnings call for the fiscal second quarter ending September 30, 2025, will coincide with the filing of our quarterly report on Form 10-Q in November 2025. And now I'd be happy to answer any questions that you may have. Operator, please open the call for questions.
[Operator Instructions] The first question comes from Marla Marin with Zacks.
So there's a lot going on. And -- just remind us, I think you said in the press release that the primary endpoint of the study in Australia is safety. And so far, with the first cohort having been treated, it looks like there's no adverse events related to treatment with the Hemopurifier. So it looks like you're on track to meet the primary endpoint. Is that the right way to think about it?
Steve, do you want to take that one?
Yes. So we've passed the first -- it's a 3-cohort study. We've passed the first cohort, an independent Data Safety Monitoring Board made up of experts in oncology and nephrology, reviewed the safety data and said, move forward to the second cohort where patients get to treatment. So we think it's a big hurdle to have passed.
Okay. So now trying to put in perspective on preclinical data, an extremely high metric, 98.5% of extracellular vesicles were removed in simulated treatment. But now we're looking at actual treatment in a clinical study. Those -- The kind of data that we should expect to see, I mean, I don't know, it would seem to me that, that number in a laboratory setting is not really what we should expect to see out of this study with actual participants, patients who are ill. Is that not the way you're thinking about it?
Yes. No, I think you're tracking perfectly, Marla. What's in the lab is not -- what the proof is in the pudding is in what happens in actual patients. So hopefully, soon, we'll have our data from the first cohort from the Grau lab? And what matters ultimately is the reduction in actual -- from patients who have been treated.
Okay. Great. And switching now, Jim, I have a question for you on -- you've really, really done, I think, as much as you can do to try to cut expenses here. It doesn't seem that there's any more that you can do. The decision to not move forward with the trial in India, strategic as well as possibly some element of cost containment, but more so strategic. Have you thought in terms of what that implies for you right now in terms of -- obviously, you will need cash again at some point to continue funding clinical research. But have you thought about what that means for you in terms of timing?
Well, like every development stage life science company that doesn't have its products approved for sale yet, we will need to continue to raise money, but hopefully, eventually with strategic partners rather than financial investors. But we'll see what the appetite is going forward. As you say, the India decision was far more about the potential delay in getting approval to move forward into the PMA phase than the savings, even though the savings are nice.That was not the main factor. And I must say, Marla, I was the driving force behind doing the Indian trial. The nephrologist has done a great job for us in the past, and they're great. But one advantage of India was that all of the previous viral trials we did. We got off the ground very quickly. They did a good job. That's not the case anymore. They have many new regulations. They're much more like the FDA in terms of bureaucracy, and it was just far slower bureaucratically than the Australian trial. And it just didn't make sense to potentially hamstring the company for 1 to 2 years waiting for that trial to conclude. It just -- that put me over the edge with the decision.
I get it. That makes sense to me. And also, you've talked in the past about one of the attractive factors about conducting clinical research in Australia is the cash tax rebate. I don't think there was any similar -- I mean, I think expenses are relative to conducting research here in the U.S., costs would have been lower in India, but there wasn't anything comparable in terms of a rebate.
You are correct. We have that nice tax rebate in Australia. I think it's still 43% or thereabouts. I don't believe it's changed. And there's no rebate like that in India. So while the cost would have been lower by the hospital, I'm not sure, it might have even pencil lower in Australia after factoring in the rebate.
The next question comes from RK with H.C. Wainwright.
I have a couple of questions. The first question regarding the Indian trial itself. I'm just trying to understand what was the reason to having set up -- in the first place, setting up a parallel Indian trial as that was going on in Australia. And the second question is, does -- do you think -- I know the first cohort is done and one of the physician scientists is actually doing analysis with regards to -- I'm assuming the extra vesicular -- the efficacy itself is what he or she is looking for. But have you -- or do you think you can speed up the enrollment in those 3 centers? Or are you trying to get additional centers in Australia so that you can add more patients if you wanted a larger data set to make the decision for the next development stage.
Steve, do you want to reply?
Sure. So first, on the EV and T cell data, we've actually accelerated the time lines to try to get data back from the Grau lab quicker, and they have been very responsive. So like I said, I'm hopeful that there'll be some early data in September. To your second question, we're doing multiple efforts to try to speed things up. One is we're following prescreening logs from all 3 active sites. We're keeping in close contact through our CRO with our activity. We are actively recruiting plans for 2 additional sites, again, to augment enrollment. And three, we are looking at a couple of different types of initiatives. To help enrollment. one is the use of what's called clinical trial liaisons. The other is with social media campaigns. So yes, we are actively turning over every rock to look for ways to speed up enrollment and think that those will pay dividends.
Okay. So do you think when the Grau lab gets done with the analysis, will you be able to put out some sort of press release or talk about it? Or do you need to wait for the -- all the 3 cohorts to be done before you start talking about some of that efficacy data.
Well, so my feeling is we will have -- we'll be able to make some observations from this first cohort. But remember, it's only a single HP treatment. And we do not know -- that's why the dose-finding component is part of it. We don't know if you need 1, 2 or 3. So the trial, the jury really won't be out on the dosing until we're done with all 3 cohorts. So again, we'll be able to make some observations, but I want to -- I truly want to see what the dose response is, what the treatment effects are from each individual cohort.
As Steve noted in his remarks, RK, our current expectation is that we'll be able to present those remarks or observations rather in September.
This concludes our question-and-answer session. I would like to turn the conference back over to Jim Frakes for any closing remarks.
I'd like to thank you again for joining us today to discuss our fiscal first quarter results. We look forward to keeping you up to date on future calls. Thanks again. Goodbye.
The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.
Investor releaseQuarter not tagged2025-08-05Aethlon Medical to Release Fiscal First Quarter Financial Results and Host Conference Call on August 13, 2025
PR Newswire
Aethlon Medical to Release Fiscal First Quarter Financial Results and Host Conference Call on August 13, 2025
SAN DIEGO, Aug. 5, 2025 /PRNewswire/ -- Aethlon Medical, Inc. (Nasdaq: AEMD), a medical therapeutic company focused on developing products to treat cancer and life threatening infectious diseases, today announced that it will issue financial results for its fiscal first quarter ended June 30, 2025, at 4:15 p.m. ET on Wednesday, August 13, 2025. Management will host a conference call on Wednesday, August 13, 2025, at 4:30 p.m. ET to review financial results and recent corporate developments. Following management's formal remarks, there will be a question and answer session. Interested parties can register for the conference call by navigating to https://dpregister.com/sreg/10201884/ffac7acee8. Please note that registered participants will receive their dial-in number upon registration. Interested parties without internet access or unable to pre-register may dial in by calling: PARTICIPANT DIAL IN (TOLL FREE): 1-844-836-8741 PARTICIPANT INTERNATIONAL DIAL IN: 1-412-317-5442 All callers should ask for the Aethlon Medical, Inc. conference call. A replay of the call will be available approximately one hour after the end of the call through September 13, 2025. The replay can be accessed via Aethlon Medical's website or by dialing 1-877-344-7529 (domestic) or 1-412-317-0088 (international) or Canada toll free at 1-855-669-9658. The replay conference ID number is 1454680. About the Hemopurifier® The Aethlon Hemopurifier is an investigational medical device designed to remove enveloped viruses and tumor-derived extracellular vesicles (EVs) from circulation. It is used extracorporeally with a blood pump and combines plasma separation, size exclusion, and affinity binding using a plant lectin resin that targets mannose-rich surfaces found on EVs and viruses. EVs released by solid tumors are believed to play a role in metastasis and the resistance to immunotherapies and chemotherapy. Removal of enveloped viruses and extracellular vesicles has been demonstrated in both vitro studies and human subjects. The Hemopurifier holds a U.S. Food and Drug Breakthrough Device Designation for: The treatment of individuals with advanced or metastatic cancer unresponsive to or intolerant of standard-of-care therapy; and the treatment of life-threatening viruses not addressed with approved therapies. About Aethlon Medical, Inc. Aethlon Medical, Inc. (Nasdaq: AEMD) is a clinical-stage m...

