Good day, and welcome to the Aethlon Medical Second Quarter Fiscal 2026 Earnings and Corporate Update Conference Call. 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; second, we are working with our Australian CRO, ResQ, to identify one to two additional new sites; and third, 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 one, two or three 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 the 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 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 seven out of ten microRNAs examined in two of the three participants. MicroRNAs are about one component of the cargo of extracellular vesicles and have been previously 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. Increases 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 affect 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 three 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. 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 three- and six-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.

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. So as you've been explaining for a while, there was a follow-up with the Cohort 1 participants, a 7-day follow-up. Is there any insight into whether that group of three people is still performing as expected, or would that not yield any statistically meaningful data?

The observations were based on the labs that were conducted over 8 weeks, and we have all that data for those patients. There won't be any subsequent EV or T cell data expected from this patient group. While we are continuing to monitor them clinically, that is not considered an endpoint. This is an early safety and feasibility trial, so we cannot comment on 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?

In Cohort 2, over a one-week period, participants will receive two HP treatments. The schedule will be on Monday and Friday rather than just a single treatment. Our main objective is to determine whether participants can tolerate two treatments in a week. Additionally, we hope to see a more significant decrease in EV compared to what we observed in the first cohort, as well as an increase in T cell changes over time. This reflects a dose response, even though it's a device rather than a drug. Furthermore, we aim to replicate the results we saw in the initial three patients. I believe the next set of data will provide us with more insights than we currently possess.

Yes, that makes sense. As you mentioned before, you are not abandoning some of the other indications where the Hemopurifier may be useful. However, due to budget and time constraints, you are not heavily investing in those additional indications. Should we expect that the paper you wrote and your presentation at the medical forum will be the types of updates you'll provide in the near term to keep people informed about the progress of the Hemopurifier?

Yes, I believe EV reductions are significant in many indications. We need to concentrate our efforts due to our staffing and funding constraints. I anticipate that we will soon have a preprint available for our Long COVID data, which is something to look forward to. This data will also be submitted to a peer-reviewed journal for review. That's our next step with the Long COVID data. We will also consider EVs in other diseases as we can, but we must remain focused given our limited resources.

So we are monitoring other indications, but we're trying to stay focused.

Right. I understand. Jim, I have a question for you regarding your ongoing efforts to stretch or optimize spending. At this point, it seems like there's not much left you can do since you've mostly optimized your expenditures. In the past, you had access to some non-dilutive government funding. Have you considered that again, or is it no longer relevant as you progress through clinical trials?

We would consider a government contract if it closely aligns with our goals. However, if it ventures into a different area, it's less appealing, especially with the current administration reducing overhead on these contracts. They were not very profitable before, and with these cuts, they are likely only breakeven or close to it at best. Therefore, it would need to fit well with our objectives to enhance efficiency. We're open to it, but it requires the right contract or grant.

And our next question today comes from Jeremy Pearlman of Maxim Group.

Okay. You received approval to proceed with the second cohort about four months ago. Could you explain or speculate on why you think it's taking so long to recruit patients?

Steve?

Yes. As we've mentioned before, this is not an easy sell to patients. Cancer patients typically do not have a large catheter inserted to have their blood filtered through a machine, which requires some explanation. There are also many time points where patients need to provide samples. Additionally, when discussing with patients the value of participating in a safety and feasibility trial, we had numerous conversations at the investigator meeting. The concept of EV removal in cancer is new, as are extracorporeal therapies for cancer patients, which requires further explanation. Therefore, I do not find the slow enrollment surprising.

Okay. Understood. Based on the new initiatives you're implementing to accelerate enrollment, do you still anticipate completing the second cohort by mid-2026? Is that a reasonable expectation, or how should we interpret the timelines?

Yes. We anticipate one patient per month. It's currently summer in Australia, so many people are on vacation, which could lead to a slowdown during the holidays. However, our target remains one patient a month. We are not being passive; we have engaged a company called Trialfacts to assist with digital marketing. They are implementing an online screening form and referring potentially eligible patients to our sites. I believe this will be beneficial. We are also looking to add one or two more sites to explore every option available to increase enrollment.

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. Does that fit in with your hypothesis that this could help extend the patient life or improve patients who are undergoing immunotherapy as well? Or is it not enough of a decrease yet in the T cells and the EVs?

Yes. I'm always cautious since this involves only three patients, which is a crucial factor. Generally, having more patients would increase confidence. However, we're observing the decrease in EVs, which is a positive direction. Additionally, there's some improvement in various lymphocyte populations that are crucial for tumor elimination, trending positively as well. If this is consistent in the next group of patients and the changes are more significant, it would enhance our confidence. Currently, we are noticing the directional changes we anticipated.

And our next question today comes from Sean Lee of H.C. Wainwright.

This is Sean here for RK. I just have two quick questions. First, regarding the Australian study, were the lower EV levels observed directly after treatment or after some time? Additionally, were those levels stable, or did the EV levels rebound later?

We obtained samples before the treatment began, at the 2-hour mark, and at the 4-hour mark. We collected additional samples at the end of the treatment and then again at weeks 1, 2, 3, 4, and 8 post-treatment. We observed decreases in the larger EV populations during treatment, specifically at the 2-hour and 4-hour points. Since EVs are produced continuously, we typically see a rebound in their levels over the following weeks. Therefore, after a couple of weeks, EV levels do start to rise again. Our next objective is to investigate whether administering more treatments in a week would lead to a more significant reduction in EV levels and a longer duration of reduced levels. However, so far, we have only conducted a single treatment. Thus, while levels decrease during the treatment, they do begin to rise again a few weeks later.

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.