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Executive readout · one minute
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Good afternoon, and welcome to the Aethlon Medical Fourth Quarter Fiscal 2025 Earnings and Corporate Update Conference Call. 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.
Thank you, operator, and good afternoon, everyone. Welcome to Aethlon Medical's Fiscal Fourth Quarter 2025 Earnings Conference Call. My name is Jim Frakes, and I am the Chief Executive Officer and Chief Financial Officer of Aethlon Medical. I have both bad news and good news to share. The bad news is that since Dr. Steven LaRosa, our Chief Medical Officer, is on family vacation, you'll have to listen to me for this call. However, the good news is that we've made significant progress in the clinic with our product during this period, more than in any previous quarter since I joined Aethlon. At 4:15 p.m. Eastern Time today, Aethlon Medical released its financial results for the fiscal fourth quarter that ended March 31, 2025. If you haven't seen the earnings release yet, please visit the Investors page at www.aethlonmedical.com. After this introduction and the reading of the company's forward-looking statement disclaimer, I will give an overview of our strategy and recent developments, followed by some brief remarks on Aethlon's financials. We'll then open up the call for the Q&A session. Before starting the main part of the call, please note that today’s news release and this call contain forward-looking statements as defined in the Securities Act of 1933 and the Securities Exchange Act of 1934. The company warns you that any statement not based on historical fact is a forward-looking statement. These statements are based on our expectations and assumptions as of today. Such forward-looking statements come with significant risks and uncertainties, and actual results may vary materially from those anticipated. Factors that might cause actual results to differ can be found in the Risk Factors section in the company's annual report on Form 10-K for the fiscal year ending March 31, 2025, the latest quarterly report on Form 10-Q, and in the company’s other filings with the Securities and Exchange Commission. Unless required by law, the company does not intend or undertake any obligation to update this information to reflect future events or circumstances. Now, let's discuss the business updates. I want to highlight some key developments from the fiscal year-end 2025 to today. We treated the first three patients in our oncology trial using the Hemopurifier at clinical sites in Australia, and we've received regulatory approval in India to start a similar oncology study. We also expanded our trial protocol to align with evolving standards of care in immunotherapy. Our preclinical data shows a 98.5% removal of platelet-derived extracellular vesicles during simulated Hemopurifier treatments. Additionally, we are collaborating with the University of California, San Francisco on long COVID research, with findings to be presented at the upcoming Keystone Symposium. Importantly, we significantly cut our operating expenses through streamlined operations. Let me provide more details on some of these points, beginning with the progress in our cancer trial in Australia. We have completed Hemopurifier treatments for the first three participants in our safety, feasibility, and dose-finding study involving patients with solid tumors unresponsive to anti-PD-1 agents. The first participant was treated at Royal Adelaide Hospital in January 2025, while the second and third participants received treatment at Royal North Shore Hospital in Sydney in June 2025. Each participant underwent a single 4-hour Hemopurifier treatment without device deficiencies or immediate complications and has completed the scheduled 7-day safety follow-up. This milestone triggers the initial meeting of an independent Data Safety Monitoring Board, which will review safety data and decide whether we can proceed to the next treatment cohort. If approved, the next group of patients will undergo two Hemopurifier treatments over one week. We expect to receive preliminary data from this first group in about three months, which will provide insights into the effects of the Hemopurifier on EV levels and antitumor T cell activity. Like everyone else, I am eager to see the impact of our product on EV removal and antitumor T cell activity among these cancer patients treated with our Hemopurifier. We also revised the trial protocol to allow patients receiving combination therapies with either pembrolizumab, known as KEYTRUDA, or nivolumab, marketed as OPDIVO. This change aligns with current treatment practices and should help us reach a wider patient pool since only about 30% of patients respond long-term to these therapies. Tumor-derived EVs are believed to contribute to resistance against these treatments, and the Hemopurifier is engineered to bind and eliminate these EVs from the bloodstream, potentially enhancing therapeutic response rates to anti-PD-1 antibodies. In our preclinical studies, we've demonstrated that the Hemopurifier can lower EV levels in plasma samples from cancer patients. I want to emphasize that the primary goal of this study remains safety. We are monitoring for any adverse events and significant changes in lab tests following the treatments. The study is designed to include between 9 to 18 participants, who will receive 1 to 3 Hemopurifier treatments depending on their cohort. We are also conducting exploratory analyses to understand how the number of Hemopurifier treatments affects EV levels and whether reducing EVs might enhance the body's natural ability to combat tumor cells, which could influence the design of future clinical trials, including potential premarket approval studies. Regarding activities in India, on June 19, we received official approval from India's Central Drugs Standard Control Organization to initiate a similar oncology study at Medanta Medicity Hospital. This approval followed a successful meeting with a Subject Expert Committee and prior Ethics Committee clearance. The trial will begin after a site initiation visit conducted by our India-based CRO, Qualtran. I also want to provide a quick update from our research lab. On May 12, we published results from a preclinical ex vivo study and submitted a manuscript for publication in a peer-reviewed journal. In that study, we demonstrated that the Hemopurifier, utilizing our proprietary GNA affinity resin, can remove 98.5% of platelet-derived extracellular vesicles from human plasma during a time point equivalent to a 4-hour treatment. Elevated levels of PD-EVs have been linked to various serious conditions beyond cancer, including lupus, systemic sclerosis, multiple sclerosis, Alzheimer's disease, sepsis, and both acute and long COVID. These results reinforce the rationale for our current oncology efforts and suggest potential future therapeutic applications. Moving on to our scientific collaboration in long COVID research, our collaboration with the UCSF Long COVID clinic has been accepted for a poster presentation at the Keystone Symposium on Long COVID scheduled for August 10-13. This study analyzed blood samples from long COVID patients versus recovered individuals to evaluate the interaction of larger and smaller EVs with our lectin affinity resin. These findings contribute to the growing evidence supporting further exploration of the Hemopurifier to address the significant unmet medical need affecting approximately 44 million to 48 million people in the U.S., with a considerable economic burden for those experiencing symptoms for at least a year. Finally, I want to emphasize the work we've done this past year to streamline operations and significantly lower operating costs. This initiative focused our resources on areas with the greatest clinical and regulatory impact. In summary, I have been with Aethlon Medical for a long time, and I have never witnessed this level of progress in the clinic and lab since I joined. I am very pleased with our advancements. Now, let’s briefly touch on the financials. As of March 31, 2025, we had approximately $5.5 million in cash. Our operating expenses for the year were around $9.3 million, reflecting a decrease of about $3.3 million or 26% compared to the previous year. This reduction was primarily due to lower payroll, related expenses, professional fees, and general administrative costs. We did incur a non-cash charge affecting the income statement, including a $4.6 million non-cash charge related to a warrant inducement offer made in March 2025, which raised approximately $2.3 million in cash by temporarily lowering the exercise price of existing warrants and issuing new ones. Because this is a non-cash charge, it didn't impact our balance sheet's net worth. For those interested in diving deeper into the financial details, please refer to the earnings release we just issued or the upcoming 10-K annual report. We also recorded about $324,000 in other income related to the employee retention tax credit under the CARES Act, and an additional $36,000 in interest income related to that credit from the IRS, with the remaining expected credit logged as a receivable on our balance sheet. No such amounts were recorded in the previous fiscal year. We included these earnings results and related commentary in our earlier press release. The release also contains the balance sheet for March 31, 2025, along with the statements of operations for the fiscal years ending March 31, 2025, and 2024. As mentioned earlier, we will file our annual report on Form 10-K after this call. Our next earnings call for the fiscal first quarter ending June 30, 2025, will coincide with the filing of our quarterly report on Form 10-Q in August 2025. Now, I would be happy to answer any questions you may have. Operator, please open the call for questions.
Our first question is from Marla Marin with Zacks.
So there's a lot going on. Given that the company is involved now in conducting ongoing clinical study in Australia upcoming in India, the long COVID initiative, is it still right to think that the focus areas remain oncology, number one, followed by infectious disease or/long COVID and then potentially organ transplantation?
Marla, this is Jim. Our focus remains almost entirely on oncology. The upcoming trial in India is virtually parallel to the Australian trial. So we already have Hemopurifier stationed at the hospital, the PI is an expert using the Hemopurifier. So that remains our primary focus. We took advantage of the relationship with UC San Francisco's Long COVID unit to obtain some precious but free samples that we analyzed once we were set up for the oncology trial. So that's a cost-effective area that's potentially very valuable, but it's early. We're going to present at that conference in August. And if there's a possible grant situation, we'll pursue that. But our main focus remains oncology.
Okay. And when you say it's cost efficient, so there wasn't significant, if any, capital outlay in order to conduct the collaboration, and there is some potential for incoming nondilutive funds. Is that the right way to think about that?
If we can land such a nondilutive grant or contract with the government, it's still very early, Marla. We're presenting some early data, it looks interesting, but we would have a lot of work to do. So I don't want to overplay that. Our history is in viruses. If there's another situation where we can help, we'll be poised to do that. But I don't want to understate how much we're focused on oncology. It remains our primary.
Sure. Regarding the first three patients treated in Australia, can you remind us about the expected timeline for when we can expect to see more detailed data?
Well, once there's an electronic data equivalent of the clipboard that used to be on patients' beds in the old days. Once that is finalized and the PIs have signed off on it, they'll be presented to the Data Safety Monitoring Committee. There's a tentative meeting set up in July. If they like everything, they're going to give us a green light to proceed to the next cohort, which will be 2 treatments per week. And at the same time, the blood samples that we've taken during the treatments and then afterwards have been sent by those hospitals to our lab at University of Sydney, and they'll measure the changes in EVs and T cells. And we expect to receive that data later on in the summer. As I mentioned in my remarks, I can't wait. I don't know what they'll be. Hopefully, good, but we've been waiting to see that kind of information for a long time as our shareholders.
Right. And then finally, my last question is, you talked about in the press release some nonrecurring costs that were incurred in connection with some former executives. So should we be thinking that the nonrecurring expenses are for the time being are finished. We won't be seeing additional one-off costs?
We terminated three senior executives over the past year. The former CEO had a one-year payout that ends in November 2024. The second one will end on June 30, and the third will conclude in September. I do not anticipate any more terminations like that. It will likely just be me and our Chief Science Officer who have contracts of this nature. I sincerely hope that isn’t the case, and I don’t expect it will be. So, in summary, I do not expect any more of those expenses.
The next question is from Swayampakula Ramakanth with H.C. Wainwright.
First of all, congratulations on getting the third patient through the trial. Based on what I've heard, it seems that once you receive the approval from the DSMB review, you could potentially start the second cohort in August. Will the amended protocol take effect for the second cohort? Should we expect the enrollment of the next three patients to proceed significantly faster than the six-plus months it took for the first three? How should we approach that? Additionally, after this cohort, will there be another DSMB review for safety before you begin the third cohort, where I believe you plan to use three Hemopurifiers per week?
The first cohort involves one treatment per week, and the second cohort will be two treatments in one week. The third cohort will consist of three treatments in one week, scheduled for either Monday, Wednesday, Friday or Tuesday, Thursday, Saturday. The DSMB will meet between each cohort, with a meeting next month to discuss moving to Cohort #2 and another meeting before advancing to Cohort #3. We currently have three hospitals recruiting, with Genesis Healthcare in Sydney taking the longest to begin operations due to its size and bureaucracy. The population in Sydney is significantly larger than in Adelaide or Gold Coast, with over 3 million people compared to 1.2 million. This provides many more potential patients, and we receive weekly updates on recruitment, which is ongoing. We have a head start and are not waiting for the DSMB's approval to start treating patients; instead, we are preparing to quickly move forward once we have the green light. Thus, we expect this process to progress much faster than the first cohort.
Okay. And is there any potential for a third hospital to be joining in Australia? Or is it just these 2 hospitals are going to run the entire program?
We have a third hospital in Gold Coast, which is north of Sydney, but they haven't treated any patients yet as they are still in the recruiting phase. It’s a smaller hospital located in a less populated area. We're also exploring other potential hospitals. However, we might only need six more patients in total, ideally three from each of the two remaining cohorts. This gives us a good starting point, and we are progressing with their screening, which suggests that the process could be quicker.
Okay. Is there a DSMB review after every cohort, similar to what you're doing in Australia, or is that not the case?
Yes, I believe that's accurate.
Okay. So now that at least you know you have both the geographies opened up, what are you thinking in terms of timing for this whole entire 9 or 18 patients that you want to test for this study to get done?
Well, if we assume 1 patient a month for the remaining 6 in Australia that would take us out near calendar year-end. There would be data collection after that, writing up of reports, so another quarter or 2. But in terms of Australia, I think we're looking at about 9 to 12 months to be completely done, including writing up the report. India, we'll just have to see how fast it goes. We're just getting going there.
Okay. So we should have a decent picture in a year from now, at least from the Australian side...
I would think so. I would think so.
Okay. All right. Given your current cash and expense run rate, what total run rate can we expect?
Well, like all small life science companies that don't have revenues, we will need to keep raising money until we can take government grants or partner with a larger company. So eventually, we will need to do more equity financing, which is why your firm and other investment banks would make a good business in the life science sector.
So in terms of getting a partner to the table, what sort of data do you think will help you get there?
Hopefully, the data from this safety study will be enough to attract a partner, but only time will tell. Right now, we don’t have sufficient information; it's mostly based on our hypotheses supported by a lot of safety data.
The next question is from Anthony Vendetti with Maxim Group.
Most of my questions have been answered. But maybe just following up because it was very recent that you received, I guess, June 19, the approval in India. Obviously, a large population there. I know you said about 1 a month in Australia. Do you think once that gets up and running, the opportunity to do more than 1 per month there exists? Or are you like, look, these are specialized patients we shouldn't expect more than 1 per month?
It's very possible. We've observed the actual HP treatments in both Adelaide and Sydney, and they're conducted in the dialysis suites without dialysis cartridges, using our cartridge attached to a blood pumping machine. The nurses appear comfortable with it based on our observations. Therefore, I don't think their ability to logistically treat the patients is a constraint; it's more about patient recruitment. If the oncologists become more comfortable, I believe it's reasonable to expect that doing more than one a month is possible. I'll be satisfied with one a month, but there's no reason it couldn't be more.
Yes. Just comparing the populations, India has ten times the population of Australia. So I was thinking there is a larger patient pool.
Right. Right.
You mentioned equity financing as one option, but also grant money. Aethlon has received grants in the past, and I was curious about the current landscape for grant approvals given the changes happening in the government. Is the process for getting grants taking longer, or is there just less grant money available, making it more challenging to secure funding right now?
We haven't engaged with the HHS regarding grants since the change in administration. I still receive updates from people in that sector, so I know things are ongoing. I previously managed our DARPA contract, which was a $6 million deal over five years. We've also had a few smaller grants focused on oncology that were around $300,000 each. We're familiar with the process. If we can locate a grant that meets our objectives, I'm fully supportive of pursuing it. However, if it doesn't align with our goals, they tend not to be very profitable. I also believe that with the current administration, any overhead rates that can be charged may be lower due to reductions in university research overheads. While it's not purely profit, the margins are tighter now than they used to be. We will explore opportunities, and if we find a suitable grant, it would be excellent.
Okay. And for my last question regarding expenses, I see that you've made several cuts. It looks like you're operating near the minimum necessary level, suggesting there might not be much more to reduce. The current staff you have seems adequate for keeping the company running, right?
I think that's a good insight. That is where we are. In fact, as activity ramps up with these oncology trials, expenses in the G&A area might go up a bit. But that's why I cut them back because I knew with success that would ramp up a bit.
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 all again for joining us today to discuss our fiscal fourth quarter results, and we look forward to keeping you up to date on future calls. Thank you again. Goodbye.
The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.
SEC filing · Item 2.02
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