Aethlon Medical Q1 2026 Earnings Call Transcript

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August 13, 2025

Key Takeaways

  • Positive Sentiment: Completed the first cohort of the Australian oncology trial with three patients undergoing single four-hour Hemopurifier treatments, reporting no device-related serious adverse events and receiving DSMB approval to advance to the second cohort.
  • Positive Sentiment: Decided to discontinue the planned Indian oncology trial to conserve an estimated $500K–$1M and avoid regulatory delays, keeping focus on the faster Australian pathway toward a PMA application.
  • Positive Sentiment: Presented preclinical results showing 98.5% removal of platelet-derived extracellular vesicles in ex vivo studies and demonstrated binding/removal of EVs from long COVID patient samples, highlighting potential new indications.
  • Negative Sentiment: Held a cash balance of $3.8M as of June 30, 2025, and reduced operating expenses by 32% to $1.8M for the quarter, but acknowledged the need for additional funding to continue clinical development.
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Earnings Conference Call
Aethlon Medical Q1 2026
00:00 / 00:00

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Operator

Good afternoon, and welcome to the Athlon Medical First Quarter Fiscal twenty twenty six Earnings and Corporate Update. Participants will be in listen only mode. By pressing star then zero on your telephone keypad. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then one on your telephone keypad.

Operator

To withdraw your question, Please note this event is being recorded. I would now like to turn the conference over to Jim Fritz, Chief Executive Officer and Chief Financial Officer. Please go ahead, sir.

James Frakes
James Frakes
CEO, CFO & Director at Aethlon Medical

Thank you, operator, and good afternoon, everyone. Welcome to Aethlon Medical's fiscal first quarter twenty twenty six earnings conference call.

James Frakes
James Frakes
CEO, CFO & Director at Aethlon Medical

My name is Jim Frakes, and I'm the chief executive officer and chief financial officer of Aethlon Medical. At 04:15PM eastern time today, Aethlon Medical released financial results for its fiscal first quarter ended 06/30/2025. 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, Doctor. Steven LaRosa, our Chief Medical Officer, and I will provide an overview of Aethlon's strategy and recent developments.

James Frakes
James Frakes
CEO, CFO & Director at Aethlon Medical

I will then make some brief remarks on Aethlon's financials. We will then open up the call for the Q and 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.

James Frakes
James Frakes
CEO, CFO & Director at Aethlon Medical

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 ks for the fiscal year ended 03/31/2025, 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 six weeks apart.

James Frakes
James Frakes
CEO, CFO & Director at Aethlon Medical

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. Doctor. 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.

James Frakes
James Frakes
CEO, CFO & Director at Aethlon Medical

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 CDFCO to initiate a similar oncology trial at Madanta Meda City Hospital in New Delhi, India, Discussions with our India based CRO showed first patient treatment would likely flip to early twenty twenty six. 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.

James Frakes
James Frakes
CEO, CFO & Director at Aethlon Medical

So we expect to conserve $500,000 to $1,000,000 by this decision. Based on our current progress in Australia, we could complete treatment by late twenty twenty five or early twenty twenty six, 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 track toward our next milestone. And now I will turn the call over to Doctor.

James Frakes
James Frakes
CEO, CFO & Director at Aethlon Medical

La Rosa, who will cover updates on the Australian oncology trial and on our R and D efforts, particularly in long COVID and our recent preclinical data regarding the removal of platelet derived extracellular vesicles or EEDs. Steve?

Steven Larosa
Steven Larosa
Chief Medical Officer at Aethlon Medical

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, presented preclinical data in long COVID.

Steven Larosa
Steven Larosa
Chief Medical Officer at Aethlon Medical

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 one therapy agents. We can have completed Hemopurifier treatments in the three patients in our first cohort. The first patient completed a Hemopurifier treatment at our site at Royal Adelaide Hospital in January, and patients two and three were treated at Royal North Shore Hospital in Sydney on June 2 and June 16. All three participants completed the entire four hour Hemopurifier treatment without any device deficiencies and no immediate complications.

Steven Larosa
Steven Larosa
Chief Medical Officer at Aethlon Medical

At the pre specified seven day safety follow-up period, none of the three 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 one week follow-up worth of data. An independent data safety monitoring board, known as the DSMB, convened on 07/11/2025 to review the safety data on these first three patients in the first cohort. Following a closed session deliberation, the DSMB provided Aflon Medical senior leadership with a recommendation to advance to our second treatment cohort where patients will receive two Hemopurifier treatments during a one week period. All three of our sites in Australia are actively screening patients for this second cohort.

Steven Larosa
Steven Larosa
Chief Medical Officer at Aethlon Medical

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 does increases the potential pool of patients for the study. The laboratory of professor George Brown at the University of Sydney continues to work on the central lab tests 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 nine to 18 patient safety, feasibility and dose finding study is safety.

Steven Larosa
Steven Larosa
Chief Medical Officer at Aethlon Medical

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-one therapy. The patients, as mentioned, is designed in three cohorts. The first we've completed, the second cohort where patients get three treatments in one week period, and the third cohort where the patients get three Hemopurifier treatments in a one week period. As mentioned, in addition to monitoring safety, we're examining the number of Hemopurifier treatments needed to decrease the concentration of extracellular vesicle. And if these decreases in EV numbers improve the body's own natural ability to attack tumor cells.

Steven Larosa
Steven Larosa
Chief Medical Officer at Aethlon Medical

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 thirty to forty percent of patients who receive febrolizumab on 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-one therapies. The Athlon Hemopurifier has been designed to bind and remove BVDs from the bloodstream, which may improve the therapeutic response rates to the NTPD-one drugs. In preclinical studies, the Hemopurifier has been able to decrease the number of EVs in cancer patient samples.

Steven Larosa
Steven Larosa
Chief Medical Officer at Aethlon Medical

Now I'd like to segue to our r and d preclinical activities. Last evening, 08/12/2025, Aethlon presented a poster at the key Keystone Symposium on long COVID and other post acute infectious syndromes being held in Santa Fe, New Mexico. Long standing symptoms following acute COVID nineteen infection known as long COVID has been determined to affect approximately four hundred million individuals worldwide with a global economic burden of approximately $1,000,000,000,000 per year. This data could be found in a Nature Medicine 2024 publication. The presentations at this conference review 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.

Steven Larosa
Steven Larosa
Chief Medical Officer at Aethlon Medical

Exercise of 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 nineteen 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 bound to the GNA lectin and lectin affinity resin respectively in our device.

Steven Larosa
Steven Larosa
Chief Medical Officer at Aethlon Medical

We had active discussions with a number of participants, and we will take this feedback back to Akhwan to discuss potential next steps and other collaborations. We've since this data has now been presented publicly, we will share this poster on our Aflon Medical site in very near future. On 05/12/2025, the results of our preclinical ex vivo study entitled ex vivo removal of CD 40 one positive platelet microparticles from plasma by a medical device containing Galantis Nivalis Agglutinin resin was published in the preprint vehicle BioRx IV 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.

Steven Larosa
Steven Larosa
Chief Medical Officer at Aethlon Medical

The cargo contained within the platelet derived EVs have been noted to take part in damage to blood vessels, activation of immune cells, and spread of tumor cells. Excess ive levels of PDEVs have been implicated in a myriad of disease, 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 packed COVID study indicated that platelets activated platelets are a source of viral persistence within long COVID. We hypothesized in our publication and our study that the Athlon Hemopurifier, which contains the proprietary GNA affinity resin, might be able to buy these platelets derived EVs from plasma. In this experiment, we took 200 milliliters of healthy donated human plasma and circulated it over our Dethlon Hemopurifier to simulate a clinical Hemopurifier session.

Steven Larosa
Steven Larosa
Chief Medical Officer at Aethlon Medical

The data revealed that we removed ninety eight point five percent of platelet derived EVs at a time point equivalent to a four 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?

James Frakes
James Frakes
CEO, CFO & Director at Aethlon Medical

Thanks, Steve, and good afternoon again, everyone.

James Frakes
James Frakes
CEO, CFO & Director at Aethlon Medical

Let's touch briefly on the financials now. As of 06/30/2025, we had a cash balance of approximately $3,800,000. For the three months ended 06/30/2025, our consolidated operating expenses were approximately $1,800,000. That's down roughly $800,000 or 32% from $2,600,000 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.

James Frakes
James Frakes
CEO, CFO & Director at Aethlon Medical

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 the 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 $1,800,000 compared to $2,600,000 from last year's June, 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 the related commentary in our press release issued this afternoon.

James Frakes
James Frakes
CEO, CFO & Director at Aethlon Medical

The release also included the balance sheet for 06/30/2025, and the statements of operations for the three months periods ended 06/30/2025 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 09/30/2025, 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

Session. To ask a question, you may press star then 1 on your telephone keypad. If you are using a speakerphone, please pick up your handset before pressing the keys. If at any time your question has been addressed and you would like to withdraw your question, please press star then 2. Again, it is star then 1 to ask a question.

Operator

At this time, we will pause momentarily to assemble our roster. The first question comes from Marla Marin with Zacks. Please go ahead.

Marla Marin
Senior Analyst at Zacks Investment Research

Thank you. So, there's a lot going on. And just remind us, I think you said in the press release that the primary the endpoint of the study in Australia is 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?

James Frakes
James Frakes
CEO, CFO & Director at Aethlon Medical

Steve, do you wanna take that one?

Steven Larosa
Steven Larosa
Chief Medical Officer at Aethlon Medical

Yeah. No. Yeah. So we we passed the first, you know, the three cohort study. We passed the first cohort, an independent data safety monitoring board made up of experts in hematology, oncology and nephrology, reviewed the safety data and said move forward to the second cohort for where patients get two treatments.

Steven Larosa
Steven Larosa
Chief Medical Officer at Aethlon Medical

So we think it's a a a a big hurdle to have that.

Marla Marin
Senior Analyst at Zacks Investment Research

Okay. So now I trying to put in perspective, you know, on preclinical data, an extremely high metric, 98 and a half percent of extracellular vesicles were removed in simulated treatment. But now we're looking at actual treatment, you know, in in a clinical study. Mhmm. Those the kind of data that we should expect to see, I mean, I don't know.

Marla Marin
Senior Analyst at Zacks Investment Research

It would seem to me that that number was, you know, in a laboratory setting is not really what we should expect to see out of this study with actual, you know, with actual participants, patients who are ill. Is that not the way you're thinking about it?

Steven Larosa
Steven Larosa
Chief Medical Officer at Aethlon Medical

Yeah. No. I think you're tracking perfectly, Marla. What's in the lab is not what what the proof is in the pudding is in what happens in actual patients. So, hopefully, soon, we'll have our data data from the first cohort from the Growlab and what matters ultimately is the reduction in actual from from patients who have been treated.

Marla Marin
Senior Analyst at Zacks Investment Research

Mhmm. Okay. Great. Thanks. And switching now, Jim, I have a a question for you on, you know, you you have really, really done, I think, as much as you can do to try to cut expenses here.

Marla Marin
Senior Analyst at Zacks Investment Research

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, you know, possibly some element of cost containment, but but more so strategic. Have you thought in terms of, you know, what that implies for for you right now in terms of, you know, 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?

Steven Larosa
Steven Larosa
Chief Medical Officer at Aethlon Medical

Well, like every development phase, 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 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.

Marla Marin
Senior Analyst at Zacks Investment Research

Mhmm. Okay. And again

Steven Larosa
Steven Larosa
Chief Medical Officer at Aethlon Medical

And and and I 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.

Steven Larosa
Steven Larosa
Chief Medical Officer at Aethlon Medical

They they have many new regulations. They're much more like the FDA in terms of bureaucracy and it is just far slower bureaucratically than the Australian trial. And it it just didn't make sense to potentially hand spring the company for one to two years waiting for that trial to conclude. That would be over the edge with the decision.

Marla Marin
Senior Analyst at Zacks Investment Research

Alright. I get it. That makes sense to me. And also you've talked in the past about, you know, 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, you know, relative to conducting research here in The US, you know, cost would have been lower in India.

Marla Marin
Senior Analyst at Zacks Investment Research

But there wasn't anything comparable in terms of a rebate. Okay.

Steven Larosa
Steven Larosa
Chief Medical Officer at Aethlon Medical

You are you are correct. We have that nice tax rebate in Australia. I think it's still 43% or thereabouts. I I don't believe it's changed. And and there's no rebate like that in India.

Steven Larosa
Steven Larosa
Chief Medical Officer at Aethlon Medical

So while the cost would have been lower by the hospital, it's I I'm not sure. Might even cancel lower in Australia after factoring in rebate.

Marla Marin
Senior Analyst at Zacks Investment Research

Mhmm. Okay. Okay. Thank you.

Steven Larosa
Steven Larosa
Chief Medical Officer at Aethlon Medical

Thank you, Marla.

Operator

The next question comes from RK with H. C. Wainwright. Please go ahead.

Ramakanth Swayampakula
MD & Senior Healthcare Analyst at H.C. Wainwright & Co., LLC

Thank you. Good afternoon. I have a couple of questions. The first question regarding the the Indian trial itself. I'm just trying to understand, you know, what was the reason to having set up in the first place, setting up an an parallel Indian trial as that was going on in Australia.

Ramakanth Swayampakula
MD & Senior Healthcare Analyst at H.C. Wainwright & Co., LLC

And the second question is, does do you think I know the first quarter is done and, you know, one of the physician scientists is actually doing analysis, you know, with regards to I'm I'm assuming the extra reticular, you know, the the the efficacy itself is what he is he or she is looking for. But have you or do you think you can speed up the enrollment in those three centers. Are are you trying to get additional centers in Australia so that you can add more patients if if you wanted a larger dataset to make the make the decision for the next development stage?

James Frakes
James Frakes
CEO, CFO & Director at Aethlon Medical

Steve, do want to reply?

Steven Larosa
Steven Larosa
Chief Medical Officer at Aethlon Medical

Sure. So first on the on the EV and t cell data, we've actually accelerated the time lines to try to get data back from the Growlab quicker, and they have been very responsive. Like I said, I'm 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.

Steven Larosa
Steven Larosa
Chief Medical Officer at Aethlon Medical

One is we're following prescreening logs from all three active sites. We're keeping in close contact for our CRO with our activity. We are actively recruiting plans for two additional sites, again, to augment enrollment. And three, we are looking at a couple different types of initiatives to help enrollment. One is the use of what's called clinical trial liaisons.

Steven Larosa
Steven Larosa
Chief Medical Officer at Aethlon Medical

The other is with social media campaigns. So, yeah, we are actively turning over every rock to to look for ways to speed up enrollment and think that those will pay dividends.

Ramakanth Swayampakula
MD & Senior Healthcare Analyst at H.C. Wainwright & Co., LLC

Okay. Thank you for that. So do you think when the when the when the girl lab gets done with the with the with the analysis, will will you be able to put out some sort of a press release or talk about it? Or do you need to wait for the all the three cohorts to be done before you start talking about some of the deficiency data?

Steven Larosa
Steven Larosa
Chief Medical Officer at Aethlon Medical

Well, I I so my feeling is we 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 one, two, or three. So the the the trial the jury really won't be out on the dosing until we're done with all three cohorts. So, again, we'll be able to make some observations, but I I wanted I I truly want to see what the dose response is, what the treatment effects are from each individual cohort.

Ramakanth Swayampakula
MD & Senior Healthcare Analyst at H.C. Wainwright & Co., LLC

Okay. Thank you.

James Frakes
James Frakes
CEO, CFO & Director at Aethlon Medical

But 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.

Ramakanth Swayampakula
MD & Senior Healthcare Analyst at H.C. Wainwright & Co., LLC

Okay. No. That's great. Thank you.

Operator

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

James Frakes
James Frakes
CEO, CFO & Director at Aethlon Medical

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.

Operator

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

Executives
    • James Frakes
      James Frakes
      CEO, CFO & Director
    • Steven Larosa
      Steven Larosa
      Chief Medical Officer
Analysts
    • Marla Marin
      Senior Analyst at Zacks Investment Research
    • Ramakanth Swayampakula
      MD & Senior Healthcare Analyst at H.C. Wainwright & Co., LLC
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