Aethlon Medical, Inc. (AEMD) Earnings Call Transcript & Summary

Good afternoon, and welcome to the Aethlon Medical Fourth Quarter Fiscal 2022 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 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 p.m. 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 Financial Officer -- Executive Officer.

Thanks, Jim, and thank all of you for dialing in today. This is Chuck Fisher, and I'll make a few opening comments. It has been a busy 4 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 [indiscernible] about that outbreak from investors and reporters. We previously commissioned [indiscernible] Memorial Institute in 2008 to run a monkeypox virus MPV in vitro study using [indiscernible] of our Hemopurifier. This study demonstrated that high concentrations of monkeypox virus, approximately 35,000 cpu/ml 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 6 hours, and 98% after 20 hours. The studies were conducted in triplicate and data verification was provided by real-time PCR. Given the recent outbreaks of monkeypox virus, we continue to monitor caseload and disease severity. We've had recent communications with the FDA to discuss what process would be, should we be reached out to by a hospital requesting single-patient emergency use for our Hemopurifier. Monkeypox has not yet been declared an emergency by the Department of Health and Human Services Secretary. And as such, it is not an emergency use authorization process in place. However, the World Health Organization has described the outbreak as "unusual" and said that the virus' continuing spread was worrying enough to convene its expert committee on Thursday, June 23, 2022 to decide whether the disease should be declared a public health emergency of international concern. The International Health Regulations Emergency Committee met on 23 June of this year. Regarding the multi-country monkeypox outbreak to advise the WHO director general on whether it should be constituted a public health emergency of international concern [indiscernible]. The committee advised the WHO Director General, that the outbreak should not constitute a public health international emergency concern at this present time. However, the committee acknowledged that emergency nature of the event and then controlling the future spread of this outbreak requires intense response efforts. [indiscernible] should be closely monitored and reviewed after a few weeks when additional information about the current unknowns, for instance, incubation period, [indiscernible] transmission, et cetera, become available to determine if significant changes have occurred that may warrant a reconsideration of their advice. It is worth noting that the NPR brought a piece expressing concern regarding the inadequate testing on 25 June 2022, inadequate testing for monkeypox virus. Additionally, Nature Medicine made the observation that there are far more mutations than would be expected 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 am 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, known as COVID-19 infection. This trial is conducted under the open Investigational Device Exemption, or IDE, for the Hemopurifier and life-threatening infections. The trial is designed to allow for up to 40 patients to be treated under an early feasibility study protocol 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, or CRO, to oversee our U.S. clinical studies investigating the Hemopurifier for critically COVID-19 patients. We continue to make 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 now have 9 hospitals activated for patient enrollment and they are actively screening patients for the trial. These hospitals include LSU Shreveport, Sally 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. The 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 adverse events. Also on the COVID-19 front, during our recent earnings call, I noted that we had recently obtained ethics review board approval and entered into a clinical trial agreement with Medanta Medicity Hospital, a multi-specialty hospital in Delhi, India for a COVID trial -- 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, Medanta Medicity Hospital in hepatitis C patients. Our goal with this trial in India is to help COVID-19 patients there and also generate 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 1 patient and is actively screening for additional COVID-19 patients. We are also 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 have enrolled 2 patients in the trial to date. The team at the University of Pittsburgh Medical Center has continued to actively screening for additional patients for this trial. We are in the process of creating a protocol supplement to potentially increase the pool of subjects for the study. We are also in discussions with additional sites and are designing basket trial to examine the effect of our Hemopurifier on exosomal removal in multiple tumor types. We have an active preclinical research programs where we are conducting experiments on additional targets for our Hemopurifier, as well as the ones to further define exosome binding. With that, I'll turn it back over to Jim for the financial discussion and then 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 Steven 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 and 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 in 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 2 senior executives that relocated to San Diego, California as a condition of their employment. Those 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, with 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 noncontrolling 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, Steven and I would be happy to take any questions that you may have. Operator, please open the call for questions.

[Operator Instructions] 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 [indiscernible] to some of your conversations or interactions with the regulators as you try to move forward?

Right, Marla. This is Steven Larosa. Thank you for your question. So we are -- we have a breakthrough designation in COVID-19 and viral infections with the FDA and are in close contact with them in terms of -- in our current clinical trials, we noted we enrolled our first patient. So that data will be forthcoming. We don't have that currently. But we've had conversations with them about potential ways to adjust the study to -- so that we can continue the trial and enroll more patients. I don't know if that answers your question.

No, I was thinking about some of the data that you're getting outside of the trial [indiscernible].

Yes. The data we have, Marla, outside the trial is data that are from patients we've treated, a single-patient emergency use criteria -- these were published in a peer-reviewed journal in Frontiers in Medicine. The data is very interesting in that in one patient who was not viremic, we were able to show the removal of exosomes and exosomal microRNAs that are implicated in coagulopathy and acute lung injury. And those exosomal microRNAs decreased with Hemopurifier treatment at the same time the patient's oxygenation and coagulopathy were improving. In a second patient who was in fact, 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 6 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?

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

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

Chuck, Jim and Steven. I was wondering, we still have over 100,000, at least a 7-day average of cases COVID recorded daily. But a lot of them are not severe cases anymore. Just wondering what are the key challenges you think [indiscernible] what have you identified are the key challenges for enrolling patients in the study and perhaps a little differently, what have your clinical sites or activated hospitals, I think maybe the challenges or ways that they could perhaps enroll patients more quickly?

So as you -- I think you've picked up on -- there are still a number -- fairly large number of COVID-19 cases, but what we've noted, as others have noted, is the vaccines have been quite good at preventing severe infection. So what we're seeing is, although the cases are up, the number of the sites are telling us the number of hospitalizations and ICU admissions is still relatively low, although it has increased recently as the feedback we've received from hospitals. So we still feel that the story is not over with COVID and that there will likely still be cases that are eligible. The other interesting -- the challenge is to get into our current trial, you have to be on renal replacement therapy, and that has decreased, the need for renal replacement due to COVID has decreased during the pandemic. So we're also trying to work with the regulators to see if we can increase the potential pool of patients that would be eligible for the study.

Now pardon me, if I don't remember this, but as far as the patients are concerned, how -- what is the length of treatment and as far as the design of the study is concerned, the original number of patients that you're targeting for a complete study?

So 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. So the design is that a patient will receive a 4- to 6-hour Hemopurifier session once daily for four consecutive days, during which time there would be blood drawn for both COVID viral load measurements in the blood to see if the Hemopurifier decreases viral load as well as biomarkers of inflammation and coagulation. Throughout the whole 28-day study period, we'd also be monitoring to see if a patients' organ failures improve and what their clinical outcome is at the end of that time period. So our design has stayed the same throughout the trial. We're not going to -- we don't plan on making changes to that 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 as to the number of patients that you've planned to enroll [indiscernible]? And are they open to a lower number of patients such that this study could be completed in a time in which perhaps the Hemopurifier could be considered sooner rather than later as a treatment option for severe COVID patients?

So to answer your questions, they gave us approval to treat up to 40 patients as part of this approval, a typical safety and feasibility study, however, typically is in the order of 10 to 15 patients. So we would have the ability where this is an open-label study to review our data as it comes in, both safety and efficacy and then revisit the time point -- revisit that data with the FDA, especially given the breakthrough designations at any time. So it's not a situation where we have to enroll 40 patients. There is the latitude to examine the data as it comes in and then discuss with the FDA.

And last question for me, and sorry to keep on and on and on. Do you test -- are the patients tested for, for example, like PCR, the type of variant that they have? For example, if [indiscernible] 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 and have the ability then to determine exactly which variable it is. Yes.

Perfect. Looking forward to more data.

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

No, exactly. And that's why I asked the question, and looking forward to more of that kind of data.

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

So just following up on the Keytruda trial. So you have 2 patients so far. If I remember from the last call, Chuck, you mentioned about increasing the number of sites to try to increase that enrollment to get up to 10 to 12. Have you been successful in recruiting physicians and patients at these other sites and it's just taking longer to sign up? Or what can you give us an update on the additional sites?

Sure. Good question. Thanks for calling. The -- obviously, the first patient went very smoothly, but that was at a time when the hospital was not hit by COVID. They subsequently hit by COVID pretty badly, including running over to the cancer hospital and that embargoed use of patients or having patients would come in that could get the -- our treatment for COVID. Subsequently, where we are now is the -- as the same has tapered off a bit, they're not as severe, which Steven mentioned earlier and less in the ICU -- sorry, the head and neck patients are hard to come by at present, and there's been a lot of screening. So what we're working with the University of Pittsburgh as well is thinking more broadly than them to be adding other hospital sites with other physicians who specialize in head and neck to increase numbers in those trials.

Yes. I would just comment that one of the challenges in head and neck is having patients who have enough reserves, enough strength to tolerate the Hemopurifier. So there may be people who are eligible by their disease, but because of their functional status, that's been a challenge as well as with COVID. But we've had some recent discussions with the PI about some attempts that we can make any protocol supplement to broaden the inclusion criteria. And we're going to pursue those. Additionally, as Chuck said, we're also currently drafting a protocol for an additional trial, which is more of a basket trial where you're looking at the effect of the Hemopurifier upfront before Keytruda in a number of different tumor types that where Keytruda is indicated. So we're rapidly pursuing getting that protocol draft written so that we could get that trial going?

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

Well, there's a whole host -- in a basket trial, we would include a number of different tumor types and what we would particularly be interested in looking at is, can we restore responsiveness to Keytruda in people who've had a run-in period and are showing signs that they're failing because that is actually 70% of the people who get Keytruda ultimately go on to fail. So if we can actually restore their responsiveness in a number of tumor types, that would be the next strategy.

Okay. That makes sense. Just to Chuck's point that some patients are not strong enough to withstand the Hemopurifier. How do you measure that? How do you determine if is it a number of factors or is there a specific determinant?

Yes. There's a number of grading and scoring scales that describe someone's functional status and you include those in your inclusion criteria to make sure that you have somebody who is not severely debilitated from the cancer. So there are standards to grade that.

Okay. That was helpful.

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

We'd like to thank everybody for joining us on this call today to discuss our fourth quarter results. We look forward to keeping you up-to-date on future calls. And thank you very much for joining, and have a good day. Goodbye.

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