Aethlon Medical, Inc. Aktie

Good day, and welcome to the Aethlon Medical Fiscal Year-end March 31, 2026, Financial Results and Corporate Update Conference Call. [Operator Instructions]

Please note this event is being recorded. I would now like to turn the conference over to Jim Frakes, CEO and CFO of Aethlon Medical. Please go ahead.

Thank you, operator, and good afternoon, everyone. Welcome to Aethlon Medical's Fiscal Year-end March 31, 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 year ended March 31, 2026. 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, 2026, 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 fiscal year ended March 31 going on through the first part of June as we continue to execute against our strategy of advancing the Hemopurifier platform while maintaining disciplined cost control. During the period, we achieved important clinical research and intellectual property milestones. We continue to advance our oncology program while also expanding our evaluation of Hemopurifier applications into additional disease areas through preclinical research. These efforts reflect our broader objective of establishing the Hemopurifier as a platform technology with potential applications across multiple serious and life-threatening conditions.

Taken together, these achievements demonstrate continued execution against our key priorities of clinical development, platform expansion, intellectual property growth and disciplined resource management.

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. Enrollment and treatment of participants in Cohort 2 of our Australian oncology trial have been completed. As a reminder, 3 participants in Cohort 2 received two 4-hour Hemopurifier treatments during a 1-week treatment period. An independent data safety monitoring board reviewed the data, identified no safety concerns and recommended advancing to the third and final cohort of the study with no protocol modifications.

Screening is actively underway at all 3 investigative sites for this final cohort where 3 to 6 participants will be treated with 3 Hemopurifier sessions during a 1-week period. The first participant in Cohort 3 of the study has been enrolled and received 3 Hemopurifier treatments without any device deficiencies or immediate complications and is now in the safety follow-up period.

Serial extracellular vesicle and T cell measurements on participants in Cohort 2 have been measured by the central lab at the University of Sydney. Formal statistical analyses comparing the effects of the 3 different Hemopurifier dosing regimens on these parameters will be performed by our CRO at the completion of the trial. As a reminder, this is a 9- to 18-patient study designed to evaluate the safety and the feasibility of the Hemopurifier treatments and determine an appropriate dosing interval in participants with solid tumors whose disease is stable or progressing while on a treatment that includes anti-PD-1 agents, KEYTRUDA or Opdivo.

Segueing now to our preclinical activities. We are advancing our preclinical extracellular vesicle research activities, including studies evaluating removal of EVs and plasma samples from patients with rheumatoid arthritis and chronic kidney disease. Platelet-derived extracellular vesicles and their cargo have been noted to play a pathogenic role in rheumatoid arthritis. EVs in patients with chronic kidney disease have been demonstrated to contribute to congestive heart failure in this population. These efforts support the concept of a pipeline within a single device with EV removal as the primary mechanism of action.

Separately, we continued our evaluation of the Hemopurifier's compatibility with a simplified blood pump system developed by Stavro Medical. Initial testing assessed flow rates and transfer of dye fluid to the Hemopurifier. These assessments have been completed and were successful. Future studies being considered right now, including the use of blood or plasma and removal of surrogate markers for extracellular vesicles by the Hemopurifier using this blood pump system.

We believe that freeing the Hemopurifier up from a dialysis machine, dialysis unit and a large double lumen dialysis catheter would improve the number of physicians able to perform the Hemopurifier treatment and increase the number of places where such a treatment could be performed. For the patient, this could translate into having a less invasive vascular catheter placed and being able to receive their treatment in their therapeutic home.

Aethlon Medical is closely monitoring the evolving outbreak of the Bundibugyo species of Ebola in the Democratic Republic of the Congo and Uganda. The company has previously published in vitro removal data on the Marburg and Zaire species of Ebola from both cell culture fluid and plasma by a miniature version of the Hemopurifier. During the 2014 Zaire outbreak, a single 6.5-hour Hemopurifier treatment of a critically ill Ebola patient with multi-organ failure was associated with a 2-log reduction in viral load and clinical recovery.

In December 2014, the FDA approved a compassionate use protocol as a supplement to our open IDE for life-threatening viral infections for which there is no treatment. This compassionate use protocol allows for the treatment of up to 20 subjects at up to 10 institutions in the U.S. Recent interactions with the FDA have confirmed that this protocol remains open for enrollment. Aethlon has shared the above information with both the World Health Organization's R&D Blueprint Expert Panel as well as the National Emerging Special Pathogens Training and Education Center, known as NETEC, who works closely with the 13 U.S. regional special pathogen treatment centers that would treat a patient with Ebola in the U.S. should it happen.

With that, I'll turn the call back over to Jim for the financial discussion and questions.

Thanks, Steve, and good afternoon again, everyone. Turning briefly to the financials. As of March 31, 2026, we had approximately $5 million in cash and cash equivalents which provide resources to support ongoing clinical and research activities. Subsequent to fiscal year-end, we further strengthened our balance sheet by raising approximately $1.85 million in net proceeds through our at-the-market program.

Turning to some high-level expense analysis. Our consolidated operating expenses declined 21.9% year-over-year to approximately $7.3 million, reflecting continued expense discipline and operational efficiency while advancing our clinical and research priorities. That compares to a $9.3 million of operating expenses in the fiscal year ended March 31, 2025. The decrease was primarily due to a $1.1 million reduction in payroll and related expenses, a $500,000 reduction in general and administrative expenses and a $400,000 reduction in professional fees.

Consistent with the reduction in operating expenses, the operating loss for the fiscal year decreased to approximately $7.3 million for fiscal 2026 from $9.3 million in the prior fiscal year. You can find more detail on these expense changes in our 10-K, which breaks down specific drivers by category. Our other income was approximately $142,000 for the fiscal year ended March 31, 2026, primarily reflecting interest income earned on cash balances. That compares to other expense of approximately $4 million in the prior fiscal year. The prior year amount included approximately $4.7 million of noncash financing-related charges.

So overall, our net loss attributable to our common stockholders was $7.2 million for the fiscal year ended March 31, 2026, compared to a net loss of $13.4 million for the fiscal year ended March 31, 2025. We included these earnings results and related commentary in our press release issued this afternoon. The release also included the balance sheet for March 31, 2026 and 2025, and the consolidated statements of operations for the fiscal years ended March 31, 2026 and 2025. We will file our annual report on Form 10-K following this call.

Our next earnings call for the fiscal first quarter ending June 30, 2026, will coincide with the filing of our quarterly report on Form 10-Q in August 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 comes from Marla Marin with Zacks.

So a lot going on. So just a couple of housekeeping questions. I want to get back to something that I think you said, Jim, the compassionate use protocol, which is still open. Can you refresh us in terms of your -- it would seem to me based on my recollection of -- I know you treated some seriously ill COVID patients, but it would seem to me that you're well below that threshold that you cited of the number of potential patients to be treated and the number of medical centers.

I believe the Ebola protocol is relevant only to Ebola. So it would be up to 20 patients -- Ebola patients at 10 centers.

Got it.

No, that compassionate use protocol is specific to Ebola and it's 20 patients at up to 10 centers.

Okay. Got it. So it had -- it's completely separate from the patients that you had treated in the past under emergency.

Yes.

Okay. Got it.

That is correct. That is correct.

Okay. Good. Can you give us a little more color on how you're planning to approach the preclinical activities around rheumatoid arthritis? I'm guessing that this is something that will be done in a very cost-efficient manner because that's what you've been doing in terms of expanding or extending your research activities outside the current ongoing trial. But can you give us some color and also some sense of what the time line there is?

You want to take that or?

Sure. So Marla, rheumatoid arthritis is just one of the many diseases where platelet-derived EVs, a sizable percentage of the EV population in our blood is implicated in the disease. What we did is the first instance is test healthy plasma to look for platelet removal of EVs -- platelet-derived EVs. And we did that in a single large volume healthy plasma sample. We subsequently purchased in a cost-effective way, a couple of additional healthy plasma samples.

And now we are purchasing large volume rheumatoid arthritis samples. And those are all being run at our lab with the focus on the platelet-derived EVs and the microRNA. So that work is currently underway. And then with the chronic kidney -- just finish -- also I mentioned chronic kidney disease. There's been recent publications that these patients have EVs that cause congestive heart failure, which is a huge source of morbidity and mortality in this population. So we have purchased small samples of chronic kidney disease plasma, and we're testing them for binding to the resin in our device. And again, that work is being done in-house as well.

And how should we think about next steps there? Because in the past, I know you've contributed to working on peer-reviewed papers. You've presented at different medical presentations. So how should we think about next steps depending upon the outcome of the testing that you're doing now?

Yes, sure. So we published a preprint in one of the preprint servers on removal of platelet-derived EVs from a single healthy plasma specimen. The feedback we received is we needed to run more samples and that we needed to also go into a relevant disease sample.

So with that in mind, we got the additional healthy plasma samples, and we got the rheumatoid arthritis samples. And we think that this will be the data needed to satisfy the reviewers and turn -- not turn, but have in addition to a preprint and actually peer-reviewed publication on the subject with respect to our device. Same thing with the CKD, chronic kidney disease samples, we'll look at binding to our resin, and we would then plan on turning that into an abstract at a medical meeting and a peer-reviewed publication. Again, filling -- trying to fill the preclinical pipeline.

Right. Got it. Got it. And building your database in the most cost-effective way that you can. Is that the right way to think about it?

Yes. Yes, I think that's a good way to say it.

Okay. And then last question from me. So you've treated the first participant in Cohort 3. And I think at your last conference call, you said you had -- you were very pleased with the interest that you had seen in participating in the trial. Is that still something that's operating in terms of moving on to treating the next participant?

Yes. No, we've seen good engagement and commitment from our 3 sites in terms of screening activity. So that remains a positive, bodes well. We did have a few patients that became screen failures for not meeting an inclusion or exclusion criteria. That happens in every study, unavoidable. So -- but the most important thing for me is that the engagement is there and the activity is there.

The next question comes from Anthony Vendetti with Maxim Group.

So just in terms of the efficacy, any endpoints you're looking for or readouts on an efficacy standpoint because I know obviously, the first studies are safety. But what are you looking for in terms of efficacy? And are you able to report on those other than internally know about it, are you able to publish that data?

Yes. So remember, the primary endpoint for this study is safety. Secondary endpoint is surrogate markers looking at the Hemopurifier activity, and those would be EV removal, extracellular vesicle removal and effects on T cells, including antitumor T cells. We previously reported on some qualitative observations from the first cohort, and those are in a prior press release where we saw some changes in EVs and T cells in the right direction.

As I just said, we've just received measurements from Cohort 2. But the big thing that will occur is at the end of the study, there'll be a formal statistical analysis looking at those dosing regimens between the 3 different dosing regimens. And that will look magnitude of EV decreases and duration of EV decreases as comparing the 3 strategies and again, magnitude and duration of positive effects on T cells. Those will be the major readouts. The study is not randomized and is small such that clinical outcomes are not a primary outcome or secondary outcome of the study. It's just way too small for such a -- for clinical efficacy.

Right, right. No, of course, at this stage. Yes. Certainly for statistical significance in terms of clinical efficacy. But nonetheless, if they're doing well and you're able to show that, even though that's not the primary endpoint, that's always encouraging.

What about any signals suggesting that the Hemopurifier may enhance the therapies like KEYTRUDA or Opdivo.

Yes. I would just call your attention to that prior press release that shows that the EVs, including tumor-derived EVs went down in the first cohort and that there were improvements in T cells and antitumor T cells in the first cohort.

Okay. And then any biomarkers or exosome-related findings that have emerged as well? I guess the EVs is what you're talking about?

Yes. In the first cohort of particular interest to us was that EVs carrying PD-L1 on the surface went down during the treatment. These particular population of EVs have been implicated as a cause of resistance to anti-PD-1 therapy. So the fact that they went down with treatment, again, at least in the first cohort was a positive signal that will have to be corroborated, confirmed in the subsequent cohorts and the magnitude and duration will have to be examined. But that was of particular interest to me at least.

Okay. So, so far, to sum it up, if I could do so, everything is moving in the direction you would want it to be moving in terms of what you're seeing so far with the patients that have been treated.

Correct.

The next question comes from Jeremy Pearlman with Maxim Group.

I think that was -- I didn't dial in. I think the [indiscernible] to that. I'm sorry. Anthony already asked the question.

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

Thank you. 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 and look forward to speaking with you in August. Thank you very much. Goodbye.

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

Greetings. Welcome to Aethlon Medical, Inc. Annual Meeting of Stockholders Call.

[Operator Instructions] Please note this conference is being recorded.

I will now turn the conference over to your host, James Frakes, Chief Executive Officer and Chief Financial Officer. Jim, please go ahead.

Thank you. Good morning. My name is Jim Frakes, and I'm the Chief Executive Officer and Chief Financial Officer of Aethlon Medical, Inc. I am pleased to welcome you to the Aethlon Medical Annual Meeting of Stockholders. The meeting will now officially come to order. The time is now approximately 8:00 a.m. Pacific Time on February 19, 2026, and the polls are now open for voting on all matters to be presented. As you know, we have adopted a virtual format for our annual meeting this year in order to provide a consistent and convenient experience to all shareholders regardless of location.

Before we proceed with the formal business of the meeting, I'd like to introduce to you the members of the Board and the business team who are with us today. The other members of the Board with us virtually today are Edward G. Broenniman, Dr. Chetan Shah, Angela Rossetti and Nicolas Gikakis. The other officer of the company with us virtually today is Michele Bombardiere, VP Controller. I would also like to introduce Jennifer Trowbridge of Procopio, Cory, Hargreaves & Savitch LLP, the company's outside legal counsel, who is also in attendance virtually and available to respond to appropriate questions as needed. Ms. Trowbridge will be serving as Inspector of Election and Secretary of the Annual Meeting.

We will now proceed with the formal business of the meeting in the order set forth in the notice of annual meeting and proxy statement. We will first present the proposals submitted for stockholder approval by our Board. We will take questions related to the proposals. And after all of the proposals have been presented, after which we will announce the preliminary results of the voting.

As I mentioned earlier, the polls are open for voting on all matters to be presented. Each share of common stock issued and outstanding as of the close of business on January 14, 2026, the record date for the annual meeting, is entitled to 1 vote on each matter to be presented.

After I describe each item to be voted on, we will close the polls. We will not accept ballots, proxies, revocations or changes after the closing of the polls. If you have already submitted your vote by proxy and do not wish to change your vote, you do not need to vote now, and your shares will be voted as previously instructed. If you intend to vote and have not already done so or you desire to change your vote, you must submit your vote online now. If you have not voted, I encourage you to vote online now to ensure your vote is counted.

If you hold shares through a bank, broker or other nominee, you must follow the directions you receive from them in order to vote or to change your previously submitted vote. Stockholders of record and registered beneficial owners may submit questions or comments for the Q&A portion of this meeting. Questions can be submitted by e-mail to me, Jim Frakes, CEO and CFO of Aethlon at [email protected]. We will try to answer the questions submitted that are germane to the proposals and/or this meeting as and if we have time. I will screen incoming questions. And during the Q&A portion of the meeting, we will read germane questions out loud before someone from our team responds. Please submit your questions now to make sure that they are received in a timely fashion for our review and response.

Will the Secretary of the meeting please report at this time with respect to the mailing of the notice of the meeting and the stockholders' list.

Yes. This is Jennifer here. I have at this meeting a complete list of the holders of record of the company's common stock on January 14, 2026, the record date for this meeting. A list of stockholders of record is available for inspection by the stockholders of record during this meeting for any reason germane to this meeting. I also have an affidavit certifying that on or about January 16, 2026, a notice of Annual Meeting of Stockholders of the company was deposited in the United States mail to all stockholders of record at the close of business on January 14, 2026.

Thank you. At this time, I am appointing Ms. Trowbridge to act as Inspector of Election at this meeting. Ms. Trowbridge has taken and subscribed the customary oath of office to execute her duties with strict impartiality. We will file this oath with the records of the meeting. Her function is to decide upon the qualifications of voters, accept their votes and when balloting on all matters is completed, to tally the final votes.

Will the Secretary please report at this time with respect to the existence of a quorum?

Yes. Proxies have been received for 445,731 of the 973,213 shares of common stock outstanding on the record date, which represents approximately 45.8% of the total outstanding shares. This constitutes a quorum for the meeting today, and we may carry out the business of the meeting.

Thank you. We will now proceed with the formal business of this meeting. After all of the proposals have been described, we will answer any questions related to the proposals submitted online. As a reminder, we ask that any questions or comments during this portion of the meeting pertain only to these proposals. Please submit any questions as soon as possible for our review.

There are 7 proposals to be considered by the stockholders at this meeting. The first item of business is the election of 5 directors to serve until the Annual Meeting of Stockholders in 2026 and until their successors are elected. The nominees for directors are: Edward G. Broenniman, James B. Frakes, Nicolas Gikakis, Angela Rossetti and Chetan Shah M.D.

The second item of business today is the ratification of the appointment of Haskell & White LLP as our independent registered public accounting firm for the fiscal year ending March 31, 2026.

The third item of business is the approval of an amendment to our 2020 equity incentive plan, as amended, to increase the number of shares of our common stock authorized for issuance thereunder by 100,000 shares.

The fourth item of business is the approval of an amendment to our Articles of Incorporation to increase the total authorized shares of our common stock from 6 million to 100 million.

The fifth item of business is the approval for the purposes of complying with Nasdaq Listing Rule 5635(d) of the issuance of up to an aggregate 1,662,553 shares of common stock issuable upon the exercise of common warrants, placement agent warrants and prefunded warrants issued in connection with the securities purchase agreement dated as of December 5, 2025, in connection with the company's private placement financing.

The sixth item of business is the approval for the purposes of complying with Nasdaq Listing Rule 5635(d) of the issuance of up to 368,471 shares of the company's common stock issuable upon the exercise of new unregistered common stock purchase warrants issued pursuant to that certain warrant inducement agreement dated December 5, 2025.

The seventh and final item of business is the approval of an adjournment of the annual meeting to another place or a later date or dates, if necessary or appropriate, to solicit additional proxies in the event we have not received sufficient votes in favor of any of the foregoing proposals.

That was the final proposal for today's meeting. I will now take a moment to review any questions submitted during the proposals before we close the polls. As a reminder, we will only review and answer questions at this time that pertain to the proposals.

We have not received any questions related to the proposals. Therefore, we will proceed. The time is now 8:10 a.m. Pacific Time, and the polls are now closed for voting.

Let's now move on to the announcement of results of voting. May we have the results of the voting, please?

Yes. All right. The report of the Inspector of Election covering the proposals presented is as follows: the proposal to elect each of Edward G. Broenniman, James B. Frakes, Nicolas Gikakis, Angela Rossetti and Chetan S. Shah as directors of the company is carried. The selection of Haskell & White LLP as the company's independent registered public accounting firm for the fiscal year ending March 31, 2026, is approved. The proposal to approve an amendment to the company's 2020 equity incentive plan as amended, to increase the number of shares of the company's common stock authorized for issuance thereunder by 100,000 shares is approved.

The proposal to approve an amendment to our Articles of Incorporation to increase the total authorized shares of our common stock from 6 million to 100 million is approved. The issuance of shares of common stock issuable upon the exercise of common warrants, placement agent warrants and prefunded warrants issued in connection with a December 2025 private placement is approved. The issuance of the company's common stock issuable upon the exercise of new unregistered common stock purchase warrants pursuant to a warrant inducement agreement also dated December 5, 2025, is approved. The proposal to approve an adjournment of the annual meeting to another place or a later date or dates, if necessary or appropriate, to solicit additional proxies in the event we have not received sufficient votes in favor of the foregoing proposals is also approved.

Because each of the proposals presented for approval at today's meeting have been approved by our stockholders, we will not be adjourning the meeting to another place or time, and we'll close out all matters of business at today's meeting.

We expect to report our preliminary voting results or if available to us on a timely basis, our final voting results on a current report on Form 8-K to be filed with the SEC within 4 business days after the end of this meeting. If not reported earlier, we expect to report our final voting results in an amendment to our Form 8-K within 4 business days after the final results are known to us.

This concludes the formal portion of today's meeting, and the annual meeting is now adjourned. We will now entertain any appropriate questions from stockholders.

We did not receive any such questions. Therefore, we will move on to closing remarks. I'd like to thank all the stockholders for attending today's meeting and your continued support of Aethlon. Operator, please close the call.

Thank you. This concludes today's conference, and you may disconnect at this time. Thank you for your participation.

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.

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.

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.

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

Thank you, operator, and good afternoon, everyone. Welcome to Aethlon Medical's Fiscal Fourth Quarter 2025 Earnings Conference Call. My name is Jim Frakes, and I am the Chief Executive Officer and Chief Financial Officer of Aethlon Medical.

Now I have some bad news and some good news to report on this call. The bad news is since Dr. Steven LaRosa, our Chief Medical Officer, is out on a family vacation, you'll have to listen to my soliloquy throughout this call. But the good news is that we made more progress advancing in the clinic with our product this period than in any quarter since I've been with Aethlon.

At 4:15 p.m. Eastern Time today, Aethlon Medical released financial results for its fiscal fourth quarter ended March 31, 2025. If you have not seen or received Aethlon Medical's earnings release, please visit the Investors page at www.aethlonmedical.com to view it. Following this introduction and the reading of the company's forward-looking statement disclaimer, I will provide an overview of our strategy and recent developments. I will then make some brief remarks on Aethlon's financials. We will then open up the call for the Q&A session.

Before we start the business portion of the call, please note that this news release -- the news release today and this call contain forward-looking statements within the meaning of the Securities Act of 1933 as amended and the Securities Exchange Act of 1934 as amended. The company cautions you that any statement that is not a statement of historical fact is a forward-looking statement. These statements are based on expectations and assumptions as of the date of this conference call.

Such forward-looking statements are subject to significant risks and uncertainties, and actual results may differ materially from the results anticipated in the forward-looking statements. Factors that 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 portion update of this call. Let me start by highlighting some key developments from fiscal year-end 2025 through today. We treated the first 3 patients in our oncology trial using the Hemopurifier at clinical sites in Australia.

We received regulatory approval in India to initiate a similar oncology study. We expanded our trial protocol to align with evolving standard of care in immunotherapy. Our preclinical data demonstrate 98.5% removal of platelet-derived extracellular vesicles or EVs in simulated Hemopurifier treatments. We're collaborating with University of California, San Francisco or UCSF on long COVID research with findings to be presented at the upcoming Keystone Symposium. And importantly, we significantly reduced our operating expenses through streamlined operations.

Now let me go into more detail on a few of these items, starting with the progress in our cancer trial in Australia. We've completed Hemopurifier treatments in the first 3 participants enrolled in our safety, feasibility and dose finding study of patients with solid tumors unresponsive to anti-PD-1 agents. Participant #1 was treated at Royal Adelaide Hospital in January 2025, while participants #2 and #3 received treatment at Royal North Shore Hospital in Sydney in June 2025.

Each participant received a single 4-hour Hemopurifier treatment without device deficiencies or immediate complications and have now completed the prespecified 7-day safety follow-up. This milestone triggers the first meeting of an independent Data Safety Monitoring Board, or DSMB, which will review safety data and determine whether we can advance to the next treatment cohort. If we get the go-ahead, the next group of patients will receive 2 Hemopurifier treatments over the course of a 1-week period.

We expect to receive preliminary data from the first cohort in about 3 months. This will include insights into how the Hemopurifier affected EV levels and antitumor T cell activity. I, like all of you, I'm anxious to learn what the effects of our product are on EV removal and antitumor T cell activity from these cancer patients that were treated with our Hemopurifier.

We also amended the trial protocol to allow enrollment of patients receiving combination therapies with either pembrolizumab better known as KEYTRUDA or nivolumab marketed as OPDIVO. That change reflects current treatment practices and should help us reach a broader patient pool. To put it in perspective, only about 30% of patients respond to these therapies long term. Tumor-derived EVs are thought to play a role in resistance to these treatments. The Hemopurifier is designed to bind and remove these EVs from the bloodstream, potentially improving the therapeutic response rates to anti-PD-1 antibodies.

In our preclinical studies, we've already seen the Hemopurifier reduce the number of EV levels in plasma samples from cancer patients. But just to reiterate, the primary endpoint of this study is safety. We're monitoring for any adverse events and clinically significant changes in lab tests following the Hemopurifier treatments. The study is designed to include between 9 to 18 participants and the patients will receive between 1 and 3 Hemopurifier treatments depending on the cohort.

We are also conducting exploratory analysis to understand how the number of Hemopurifier treatments impact EV levels and whether lowering EVs might help improve the body's own natural ability to attack tumor cells. Those insights may help us shape the design of future clinical trials, including a potential premarket approval study.

Turning to activities in India. On June 19, we received formal approval from India's Central Drugs Standard Control Organization, or CDSCO, India's regulatory authority to begin a similar oncology study at Medanta Medicity Hospital. That approval followed a successful meeting with a Subject Expert Committee and prior Ethics Committee clearance. The trial will begin following a site initiation visit conducted by our India-based CRO, Qualtran.

I'd also like to share a quick update from our research lab. On May 12, we published results of a preclinical ex vivo study in bioRxIV, and we have submitted a manuscript to a peer-reviewed journal for publication. In that study, we showed that the Hemopurifier using our proprietary GNA affinity resin removed 98.5% of platelet-derived extracellular vesicles or PD-EVs from human plasma during a time point equivalent to a 4-hour Hemopurifier treatment.

Excessive levels of PD-EVs have been implicated in many 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 behind our current oncology work and point to possible additional therapeutic applications in the future. Next, I'd like to make a few remarks about 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 this August, specifically August 10 through 13. The study analyzed blood samples from patients with long COVID and compared them to recovered individuals to evaluate the binding of larger and smaller EVs to our lectin affinity resin. These findings add to our growing body of evidence and support future exploration -- further exploration of the Hemopurifier in addressing the significant and still unmet medical need, impacting an estimated 44 million to 48 million people in the U.S., with an estimated economic burden in the billions in those with symptoms lasting for at least a year.

Finally, I want to highlight the work we did this past year to streamline our operations and significantly reduce our operating costs. This wasn't just about tightening the belt. It was about focusing our resources where they have the greatest clinical and regulatory impact.

So in summary, I've worked at Aethlon Medical for a long time, and I've never seen this much forward progress in the clinic and in the lab since I joined the company. I'm very pleased with the progress. Now let's touch briefly on the financials.

As of March 31, 2025, we had a cash balance of approximately $5.5 million. Our operating expenses for the year came in at approximately $9.3 million. This was a reduction of approximately $3.3 million or 26% compared to the prior year. This decrease was largely due to lower payroll and related expenses as well as reductions in professional fees and general and administrative expenses. We did record a noncash charge that impacted the income statement.

Most notably, we recognized a $4.6 million noncash charge related to a warrant inducement offer that we made in March 2025. We raised approximately $2.3 million in cash through this warrant inducement offer. This involved temporarily lowering the exercise price of existing warrants and the issuance of new warrants. Because it was a noncash charge, it did not impact the net worth on our balance sheet.

For those that wanted to take a deeper dive into the numbers, please refer to the earnings release that we just issued or the full 10-K annual report that we will issue following this call. Also, we recognized approximately $324,000 in other income related to the employee retention tax credit under the CARES Act and an additional $36,000 in related interest income from the IRS.

The remaining expected credit was recorded as a receivable within current assets on our balance sheet. No such amounts were recorded in the prior fiscal year. We included these earnings results and related commentary in our press release issued this afternoon. The release also included the balance sheet for March 31, 2025, and the statements of operations for the fiscal years ended March 31, 2025 and 2024.

As I mentioned earlier, we will file our annual report on Form 10-K following 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. And now I'd be happy to answer any questions that you may have. Operator, please open the call for questions.

[Operator Instructions] 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. We were -- our history is in viruses. If there's another situation where we can help, we'll be poised to do that. But I don't want to understate how much we're focused on oncology. It remains our primary.

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

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 about some nonrecurring costs that were incurred in connection with the former -- some former executives. So should we be thinking that the nonrecurring expenses are for the time being are finished. We won't be seeing additional one-off costs?

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

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

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

So the first cohort that we believe we finished is 1 treatment per week, just 1 treatment only in 1 week. The second cohort will be 2 treatments in 1 week. And the third cohort will be 3 treatments in 1 week, Monday, Wednesday, Friday or Tuesday, Thursday, Saturday. The DSMB will need to meet between each -- so the one next month about going to Cohort #2. And then again, they'll need to meet before going to Cohort #3 to answer that question.

In terms of recruitments, we now have 3 hospitals recruiting. The hospital that took the longest to get running because of it's larger and more bureaucratic is Genesis Healthcare in Sydney. And the population is just so much bigger in Sydney than Adelaide or Gold Coast. I think it's over 3 million people versus 1.2 million or 3 million in Adelaide. So many more potential patients, and we see weekly updates on recruiting and there's ongoing recruiting. So we're -- we have a running start. We're not just waiting until the DSMB -- we're not going to treat anybody until they approved it, but we're trying to line up patients to quickly move into that. So there's a reason to think it should move much faster than the first cohort.

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?

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

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

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

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

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

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

Yes, same. Exactly the same...

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

Yes -- I believe that's true.

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

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

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

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

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

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

Right. Right.

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

Well, we haven't had any experience with the HHS on the grant side of things since the regime change. I still get e-mails, ticklers from people in that business. So I know it is continuing. I mean I basically ran our DARPA. It was like a $6 million 5-year contract. So I'm -- and we've had 3 or 4 smaller ones with HHS in the oncology area studying exosomes. They were small $300,000 grants.

So we are familiar with them. If we can find one that aligns with our goals, I'm 100% for it. But if it doesn't align with our goals, they're not really all that profitable. And I would think the -- with the current regime, the overhead rates that could be charged might be lower than -- based on what's happened with the universities' research overheads being cut. Not that that's really profit, but it's slimmer now than it was in those days. So we'll look. If we can find one that aligns, I think, would be fantastic.

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

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.