Good afternoon, and welcome to the Aethlon Medical Fourth Quarter Fiscal 2022 Earnings and Corporate Update Conference Call. All participants will be in listen-only mode. After today’s presentation, there will be an opportunity to ask questions. Please note this event is being recorded. I would now like to turn the conference over to Jim Frakes, Chief Financial Officer. Please go ahead.

Thank you, operator, and good afternoon, everyone. Welcome to Aethlon Medical’s fiscal year-end earnings conference call. My name is Jim Frakes, and I’m Aethlon’s Chief Financial Officer. At 4:15 pm Eastern Time today, we released financial results for our fiscal year ended March 31, 2022. If you have not seen or received Aethlon Medical’s earnings release, please visit the Investors page at www.aethlonmedical.com. Following this introduction and the reading of our forward-looking statement, Aethlon’s CEO, Dr. Chuck Fisher; and our Chief Medical Officer, Dr. Steven LaRosa, 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 I hand the call over to Dr. Fisher, 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, 2022, our most recent 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, I will now turn the call over to Dr. Chuck Fisher, Aethlon’s Chief Executive Officer.

Thanks, Jim, and thanks all of you for dialing in today. This is Chuck Fisher. And I’ll make a few opening comments. It has been a busy four months since our last investor conference call on February 14, 2022. Before I hand the call over to Dr. Steven LaRosa, our Chief Medical Officer, who will provide an update of our clinical trials in infectious diseases, I would like to make some brief remarks about the current monkeypox outbreak as we receive numerous inquiries about that outbreak from investors and reporters. We previously commissioned Battelle Memorial Institute in 2008 to run a monkeypox virus, also known as MPV, in vitro study using a miniature version of our Hemopurifier. This study demonstrated that high concentrations of monkeypox virus, approximately 35,000 GPUs per milliliter were rapidly depleted from cell culture fluids when circulated through the Hemopurifier. The study indicated that the Hemopurifier removed 44% of infectious monkeypox virus in the first hour of testing, 82% after six hours, and 98% after 20 hours. The studies were conducted in triplicate, and data verification was provided by real-time PCR. Given the recent outbreak of the monkeypox virus, we continue to monitor the caseload and disease severity. We’ve had recent communications with the FDA to discuss what process we should follow should we receive a request from a hospital for single patient emergency use of our Hemopurifier. Monkeypox has not yet been declared an emergency by the Department of Health and Human Services Secretary. As such, there is not an emergency use authorization process in place. However, the World Health Organization has described the outbreak as 'unusual' and has indicated that the virus’s continuing spread is worrying enough to convene its expert committee on Thursday, June 23, 2022, to determine whether the disease should be declared a Public Health Emergency of International Concern. The International Health Regulations Emergency Committee met on June 23 regarding the multi-country monkeypox outbreak to advise the WHO Director General on whether it should be designated a Public Health Emergency of International Concern or PHEIC. The committee advised the WHO Director General that the outbreak should not constitute a Public Health International Emergency Concern event at this present time. However, the committee acknowledged the emergency nature of the event and indicated that controlling the future spread of this outbreak requires intense response efforts. They advised that the event should be closely monitored and reviewed after a few weeks, where additional information about the current unknowns, such as the incubation period as well as potential sexual transmission aspects, could become available to determine if significant changes have occurred that may warrant a reconsideration of their advice. Additionally, it is worth noting that NPR reported concerns regarding inadequate testing for the monkeypox virus on June 25, 2022, along with Nature Medicine's observation that far more mutations than expected are present in this particular outbreak, with double-stranded DNA mutation rates being significantly elevated. Now, let me turn the call over to Steven LaRosa, our Chief Medical Officer.

Hello everyone, and thanks for listening to our presentation. I’m Dr. Steven LaRosa, the Chief Medical Officer at Aethlon. First, I would like to give you an update on our U.S. clinical trial investigating the Hemopurifier for the treatment of patients with severe SARS-CoV-2, also known as COVID-19 infection. This trial is being conducted under the open Investigational Device Exemption or IDE for the Hemopurifier in life-threatening infections. The trial is designed to allow for up to 40 patients to be treated under an early feasibility study protocol and at up to 20 clinical sites in the United States. As you may recall, we entered into an agreement with PPD, a leading global contract research organization, to oversee our U.S. clinical studies investigating the Hemopurifier for critically ill COVID-19 patients. We have made progress in our severe COVID trial during the March 2022 quarter under our open Investigational Device Exemption for the Hemopurifier for life-threatening viral infections. We currently have nine hospitals activated for patient enrollment, and they are actively screening patients for the trial. These hospitals include LSU Shreveport, Valley Baptist Medical Center in Texas, Loma Linda Medical Center, Hoag Irvine, and Newport Beach in Southern California, University of California Davis, University of Miami Medical Center, Cooper Medical, and Thomas Jefferson Medical Center. We are in the site activation process with additional U.S. medical centers as well. In June 2022, LSU Shreveport enrolled the first patient in the clinical trial. That patient completed the Hemopurifier treatment phase of the study and is now in the 28-day follow-up period. The patient tolerated all the Hemopurifier treatments without any adverse events. Additionally, on the COVID-19 front, I noted during our recent earnings call that we had obtained ethics review board approval and entered into a clinical trial agreement with Medanta Medicity Hospital, a multispecialty hospital in Delhi, India, for a COVID-19 clinical trial at that location. We have previously conducted multiple clinical trials with the principal investigator as well as a previous clinical trial with Medanta Medicity Hospital in hepatitis C patients. Our goal with this trial in India is to assist COVID-19 patients there while also generating supporting patient data that we expect will be submitted to the FDA along with our U.S. clinical trial data. This site in India is now open for enrollment and has treated one patient while actively screening for additional COVID-19 patients. We are in the process of selecting additional clinical sites for this study. Now, let me turn the call back over to Chuck Fisher.

Thanks, Steve. I’d also like to give an update on our head and neck cancer trial. We’ve enrolled two patients in the trial to date. The team at the University of Pittsburgh Medical Center has continued to actively screen for additional patients for this trial. We are currently creating a protocol supplement to potentially increase the pool of subjects for the study. We are also in discussions with additional sites and designing a basket trial to examine the effect of our Hemopurifier on exosomal removal in multiple tumor types. We have an active preclinical research program where we are conducting experiments on additional targets for our Hemopurifier, as well as the ones to further define exosome bindings. With that, I’ll turn it back over to Jim for the financial discussion, and then we will open up for questions.

Thanks, Chuck, and good afternoon again, everyone. On March 31, 2022, we had a cash balance of approximately $17.1 million. Our current cash position sets us up very well for conducting our planned clinical trials, as Steve LaRosa just noted, and for the manufacturing of our Hemopurifier for those trials. During the fiscal year ended March 31, 2022, we raised approximately $17.5 million in net proceeds from the issuance of common stock through a combination of a registered direct financing and ATM sales. We recorded approximately $294,000 of revenue related to our government contracts with the NIH in the fiscal year ended March 31, 2022 compared to approximately $659,000 in the fiscal year ended March 31, 2021. On March 31, 2022, we had approximately $345,000 of deferred revenue related to those contracts, as a result of not achieving certain milestones on those contracts. Our consolidated operating expenses for the fiscal year ended March 31, 2022 were approximately $10.72 million, compared to approximately $8.55 million for the fiscal year ended March 31, 2021, an increase of approximately $2.17 million in the fiscal year ended March 31, 2022. The $2.17 million increase in the 2022 period was due to increases in payroll and related expenses of approximately $1.17 million and in general and administrative expenses of approximately $1 million, which were partially offset by a decrease of approximately $4,000 in our professional fees. The $1.17 million increase in the fiscal year ended March 31, 2022 in payroll and related expenses was due to an increase in cash-based compensation of approximately $1.2 million, which was partially offset by a decrease in stock-based compensation of approximately $29,000. The $1.2 million increase in cash-based compensation was primarily due to increases of approximately $826,000 and $721,000 in G&A payroll and in R&D payroll, respectively, due to headcount increases and approximately $203,000 in relocation-related compensation to senior executives who relocated to San Diego, California, as a condition of their employment. These increases were partially offset by the combination of a $452,000 accrual in the 2021 period related to the separation agreement with our former CEO, which had no comparable expense in the 2022 period, and a net decrease of approximately $135,000 in cash bonuses. The $1 million increase in the fiscal year ended March 31, 2022 in G&A expenses primarily arose from increases of $453,000 in clinical trial expenses, $209,000 in rent expense, and $195,000 in insurance expenses. As a result of the changes in revenues and expenses I just described, our net loss before non-controlling interests increased to approximately $10.4 million for the fiscal year ended March 31, 2022 from approximately $7.9 million for the fiscal year ended March 31, 2021. We included these earnings results and related commentary in a press release issued earlier this afternoon. That release included the balance sheet for March 31, 2022, and the statements of operations for the fiscal years ended March 31, 2022, and 2021. 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, 2022 will coincide with the filing of our quarterly report on Form 10-Q in early August. And now Chuck, Steve, and I would be happy to take any questions that you may have. Operator, please open the call for questions.

We will now begin the question-and-answer session. The first question is from Marla Marin with Zacks. Please go ahead.

You’ve done a lot of work outside of the ongoing clinical trials that you’re conducting now, a lot of work on researching the impact of the Hemopurifier. Can you give us any color on how that enters into some of your conversations or interactions with the regulators as you try to move forward?

Marla, this is Steven LaRosa. Thank you for your question. We have a breakthrough designation in COVID-19 and viral infections with the FDA, and we are in close contact with them regarding our current clinical trials. We noted that we enrolled our first patient, so that data will be forthcoming; we don’t have it currently. However, we’ve had conversations with them about potential ways to adjust the study so that we can continue the trial and enroll more patients. I hope that answers your question.

Well, I was thinking about some of the data that you’re getting outside of the trial…

Yes. The data we have, Marla, outside the trial is data from patients we’ve treated under single patient emergency use criteria. These were published in a peer-reviewed journal in Frontiers in Medicine. The data is very interesting. In one patient who was not viremic, we were able to show the removal of exosomes and exosomal micro RNAs that are implicated in coagulopathy and acute lung injury. These exosomes and micro RNAs decreased with Hemopurifier treatment at the same time the patient’s oxygenation and coagulopathy improved. In a second patient who was viremic with COVID-19, we were able to show for the first time in vivo that the Hemopurifier decreased the COVID viral load by 58% during the first six hours of Hemopurifier treatment.

And when you speak to or interact with the FDA, does any of that come into play, given that it’s not actually the outcome of an ongoing clinical trial?

They are aware of this data, but they want to see obviously safety and efficacy data and a larger number of patients enrolled in the clinical trial.

Okay. Thank you.

The next question is from Vernon Bernardino with H.C. Wainwright. Please go ahead.

I was wondering, we still have over 100,000, at least a seven-day average cases of COVID recorded daily, but a lot of them are not severe cases anymore. Just wondering, what are the key challenges you've identified for enrolling patients in the study? Perhaps a little differently, what do your clinical sites, or activated hospitals think may be the challenges, or ways that they could perhaps enroll patients more quickly? Thank you.

As I think you’ve picked up on, there are still a number of fairly large number of COVID-19 cases. However, what we’ve noted, as others have observed, is that vaccines have been effective at preventing severe infection. Therefore, although the cases are up, the number of hospitalizations and ICU admissions remains relatively low, although it has recently increased as per feedback from hospitals. We still feel that the narrative isn't over with COVID, and there will likely still be cases that are eligible. Another challenge is that to enter our current trial, a patient must be undergoing renal replacement therapy, which has decreased. The need for renal replacement due to COVID has decreased during the pandemic. We’re also trying to engage with the regulators to see if we can widen the potential pool of patients eligible for the study.

Now, pardon me if I don’t remember this. But as far as the patients are concerned, what is the length of treatment, and as far as the design of the study is concerned, what was the original number of patients that you were targeting for a complete study?

We were granted approval to conduct a trial of up to 40 patients in a safety and feasibility type trial. So that is still the plan. Could you repeat the second part of your question?

Just wondering if the length of the treatment is still the same as originally designed?

Right, the design is that a patient will receive a four- to six-hour Hemopurifier session once daily for four consecutive days, during which time there will be blood drawn for both COVID viral load measurements and biomarkers of inflammation and coagulation. Over the entire 28-day study period, we’d also monitor to see if a patient’s organ functions improve and what their clinical outcome is at the end of that period. Our design has remained consistent throughout the trial, and we don’t plan on making changes to the follow-up period or treatment period going forward.

Okay. And sorry to jump back to the first question. With the 40 patients, can you either describe or provide some kind of insight as to what the FDA thinks of the number of patients that you plan to enroll? Are they open to a lower number of patients so that this study could be completed sooner, allowing the Hemopurifier to be considered as a treatment option for severe COVID patients?

To answer your question, they granted us approval to treat up to 40 patients as part of this approval. A typical safety and feasibility study typically includes around 10 to 15 patients. We can examine our data as it comes in, including both safety and efficacy, and then discuss this with the FDA, particularly since we have breakthrough designation, at any point. This means we don’t have to strictly enroll all 40 patients; we have the flexibility to assess data as it’s collected and make discussions with the FDA.

Thank you for that. And last question from me, and sorry to keep going. Do you test the patients for, for example, the type of variant they have, for instance, if B45 is now comprising 50% of the patients? Is that some kind of data that you’d be able to collect?

Yes, we will have multiple viral measurements in the blood from every patient, which allows us to determine exactly which variant is present.

Terrific. Thank you for taking my questions, and looking forward to more data.

And Vernon, I think it’s worth noting that to date, we have also demonstrated binding of most known variants, and we anticipate that will continue.

No, exactly. And that’s why I asked the question. I look forward to more of that kind of data. Thank you.

Sure.

The next question is from Anthony Vendetti with Maxim Group. Please go ahead.

So, just following up on the KEYTRUDA trial. You have two patients so far. If I remember from the last call, Chuck, you mentioned about increasing the number of sites to try to boost enrollment to get up to 10 to 12. Have you been successful in recruiting physicians and patients at these other sites? Is it just taking longer to sign up, or what can you give us as an update on the additional sites?

Sure. Good question. Thanks for asking. Obviously, the first patient went smoothly, but that was at a time when the hospital was not harshly affected by COVID. Subsequently, we experienced a significant surge, particularly hitting the cancer hospital, which limited our ability to have patients available for treatment. Now, the situation has eased somewhat, as Steve mentioned, and the number of ICU patients has also decreased. However, head and neck cancer patients are difficult to come by at present. We are conducting screening, and we’re working with the University of Pittsburgh and exploring options to engage additional hospital sites with physicians who specialize in head and neck cancer to increase numbers in those trials.

Yes. I would add that one of the challenges with head and neck patients is ensuring they have enough reserve and strength to tolerate the Hemopurifier treatment. There may be eligible individuals based on their disease, but their functional status can be a limitation. Additionally, we’ve had recent discussions with the principal investigator about potential adjustments we could make in protocol supplements to broaden inclusion criteria, and we’re going to pursue those. We are also currently drafting a protocol for an additional trial, which will investigate the effect of the Hemopurifier before KEYTRUDA in different tumor types that are indicated for KEYTRUDA. We are working quickly to get that protocol drafted so we can initiate that trial.

Right, because KEYTRUDA is used for a number of different cancers. What do you think would be the logical next cancer to explore after head and neck with KEYTRUDA?

There are numerous candidates that could be included in a basket trial. Our focus will be on determining whether we can restore responsiveness to KEYTRUDA in individuals who have experienced a decline in their effectiveness. Notably, this issue affects about 70% of patients receiving KEYTRUDA who eventually stop responding. Demonstrating restoration of responsiveness across various tumor types would be a promising strategy going forward.

Okay. That makes sense. Just to Chuck’s point that some patients are not strong enough to endure the Hemopurifier treatment. How do you assess that? Is it numerous factors or is there a specific determinant?

Yes. There are several grading and scoring scales that help define a person’s functional status, which we include in our inclusion criteria to ensure that the candidate is not severely debilitated due to their cancer, thus making it necessary to evaluate this metric.

Okay. Thank you very much. I appreciate your insights. That was helpful.

Thanks, Anthony.

This concludes our question-and-answer session. I would like to turn the conference back over to Chuck Fisher for any closing remarks.

We’d like to thank everyone for joining us on this call today to discuss our fourth quarter results. We look forward to keeping you updated on future calls. Thank you very much for joining, and have a good day. Goodbye.

The conference is now concluded. Thank you for attending today’s presentation. You may now disconnect.