Aethlon Medical, Inc. (AEMD) Q3 2022 Earnings Report, Transcript and Summary

Good afternoon, and welcome to the Aethlon Medical Third Quarter Fiscal 2022 Earnings and Corporate Update Conference Call. All participants will be in a listen-only mode. [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 third quarter 2022 earnings conference call. My name is Jim Frakes, and I’m Aethlon’s Chief Financial Officer. At 4:15 P.M. Eastern Time today, Aethlon Medical released financial results for its third quarter ended December 31, 2021. 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 statements, 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, 2021, 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 in order to 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 Medical’s Chief Financial Officer – Chief Executive Officer, excuse me.

Thank you, Jim, and thanks all of you for dialing in. This is Chuck Fisher. I’m have the privilege of serving as Chief Executive Officer. It has been a busy three months since our last investor conference call on November 9, 2021. I’d like to – at this time, hand the call over to Dr. Steven LaRosa, Aethlon’s Chief Medical Officer, who will provide an update on our clinical trials in infectious diseases and I will then make some remarks on our clinical trial efforts in the cancer space. Steve?

Hi, everyone, and thanks for listening into our presentation. I am Dr. Steven LaRosa and I am 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, COVID-19 infection. This trial is being conducted under the open Investigational Device Exemption, IDE, for the Hemopurifier in life-threatening viral infections. The trial is designed to allow for up to 40 patients to be treated under an early feasibility study protocol and up to 20 clinical sites in the U.S. As you may recall, during the last quarter, we entered into 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 continue to make progress in our severe COVID trial during the quarter under our open Investigational Device Exemption for the Hemopurifier for life-threatening viral infections. We now have three hospitals, Hoag Newport Beach, Hoag Irvine, and Loma Linda Medical Center that are fully activated for patient enrollment and who are actively screening patients for the trial. An additional five centers, including UC Davis, LSU Shreveport, Thomas Jefferson Medical Center, University of Miami and Valley Baptist Medical Center, are expected to be open for enrollment in the near future. Also on the COVID front, during our last 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 COVID 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 in hepatitis C patients. Our goal with the Indian trial is to help patients there and also to generate supporting patient data that we expect will be submitted to the FDA along with our U.S. clinical data. This site in India is now open for enrollment and is actively screening COVID-19 patients. Now let me turn things back over to Chuck Fisher.

Thanks, Steve. As we have previously discussed, the Aethlon Hemopurifier has demonstrated binding of SARS-CoV-2 spike protein as reported in a peer review publication, the binding and removal from circulation of SARS-CoV-2 virus from a human patient. In this publication, we also reported on the removal of the – by the Hemopurifier of exosomes and exosomal microRNAs associated with the coagulopathy and acute lung injury. I’d also like to give you an update on our head and neck cancer trial. The team at the University of Pittsburgh Medical Center has continued to screen for additional patients for that trial, but largely due to the impact of COVID, has not found additional patients to meet the agreed inclusion and exclusion criteria for enrollment. As we consider cancer, to be a very meaningful market for the Hemopurifier. We are now looking to expand this trial to one or more additional sites to acceleration recruitment, and we are also considering starting additional trials both domestically and abroad and other forms of cancer. We continue our research and clinical development of our Hemopurifier to bind and remove COVID-19 bioparticles including many variant COVID-19 particles of interest and related exosomes. We are very pleased to once again be working with Dr. Kher, Medanta Medicity, who has previously done four clinical trials with Aethlon. With that, I’ll turn it back over to Jim for the financial discussion and open up floor to questions.

Thanks, Chuck, and good afternoon, again, everyone. At December 31, 2021, we had a cash balance of approximately $20.4 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 nine months ended December 31, 2021, we raised approximately $17.5 million in net proceeds from the issuance of common stock in a combination of a registered direct financing and ATM sales. Our consolidated operating expenses for the three months ended December 31, 2021, were approximately $2.55 million compared to approximately $3.07 million for the three months ended December 31, 2020. This decrease of approximately $520,000 or 17% in the 2021 period was due to decreases in payroll and related expenses of approximately $520,000 and in professional fees of approximately $190,000, which were partially offset by an increase in general and administrative expenses of approximately $190,000. The $520,000 decrease in payroll and related expenses was primarily due to the combination of a $440,000 accrual in the December 2020 period, related to the separation agreement with our former CEO and $250,000 in bonuses paid in the December 2020 period, with no comparable expenses in the December 2021 period. Additionally, stock-based compensation expense decreased by $180,000 in the December 2021 period, again, largely due to the separation agreement with our former CEO. Partially offsetting those decreases were $180,000 in relocation-related compensation to two senior executives that relocated to San Diego, California as a condition of their employments and to increases in cash-based compensation of approximately $90,000 and $89,000 in our G&A payroll and in our R&D payroll, respectively, due to headcount increases. The $190,000 decrease in our professional fees was primarily due to an $80,000 decrease in our scientific consulting expenses, a $51,000 decrease in our legal fees, a $37,000 decrease in recruiting fees and $19,000 decrease in website services and a $17,000 decrease in our directors’ compensation, which were partially offset by a $17,000 increase in our accounting fees. And the $190,000 increase in G&A expenses during the quarter ended December 31, 2021, was primarily due to an $183,000 increase in our clinical trial expenses. We recorded approximately $17,000 of revenue related to our cost reimbursable sub-award arrangement with the University of Pittsburgh in connection with an NIH contract entitled "Depleting Exosomes to Improve Responses to Immune Therapy in Head and Neck Cancer.” We recorded an $115,000 invoice submitted under our Phase 2 Melanoma Cancer Contract as deferred revenue since certain of the milestones for the period were not achieved. As a result, we recorded total government contract revenue of approximately $17,000 in the three months ended December 31, 2021. As a result of the changes in revenues and expenses that I just reviewed, our net loss before noncontrolling interests increased to approximately $2.5 million for the three months ended December 31, 2021, from approximately $2.4 million for the three months ended December 31, 2020. We included these earnings results and related commentary in a press release issued earlier this afternoon. That release included the balance sheet for December 31, 2021, and the statements of operations for the three- and nine-month periods ended December 31, 2021 and 2020. 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, 2022, will coincide with the filing of our annual report on Form 10-K in June. And now Chuck, Steve and I would be happy to take any questions that you might have. Operator, please open the call for questions.

[Operator Instructions] The first question is from Marla Marin with Zacks. Please go ahead.

Thank you. So first, I just have one housekeeping question for Jim. Is it fair to say that at this point, we’ve anniversaried the noise around separation agreement with the former CEO and for future quarterly comps will be a little bit more apples to apple?

Yes, that’s correct, Marla.

Okay. Great. Thanks. Okay. So switching topics a little bit. Obviously, there’s a lot of talk in the news right now about the variants, the COVID variants. Are you anticipating any kind of challenges in terms of recruiting as a result of that? And also, does – do you foresee any kind of small tweaks that you have to make to the studies in order to continue studying Hemopurifier with these different variants?

Marla, this is Chuck. Thanks for a great question. What we are learning so far is not complete yet. It is in the variants that we test and we test for their spike protein. We finally binding that and therefore, should be able to reduce infectivity on that basis. We’ve not had a chance to do that on all the proteins of the virus is just yet. Steve?

Yes. To answer your two questions on the recruiting front, the difference with the current variant is it’s affecting a lot of the healthcare workers. So that’s a challenge in terms of staffing at the hospitals. We don’t anticipate any changes needed for the study itself because of the – due to the variants as all COVID would be covered with glycoproteins, which are filter should – our Hemopurifier cartridge should bind. So, we don’t think that any study modifications would be necessary.

Okay. Thank you. And then one last question, which is, can you give us any color on how India is right now vis-à-vis COVID. I mean I think months ago, what we were reading was that their situation was probably more advanced or worse than ours. And can you tell us now exactly, how you see that market in terms of your study that you’re about to launch?

Right. So, we’re in close communication with Medanta Medicity’s investigators, and they are actually have been screening. And so they tell us there are, in fact COVID patients within the hospital and within the ICU. I can’t give you exact numbers, but there are patients that are available for screening right now.

Okay, Thank you very much.

[Operator Instructions] The next question is from Anthony Vendetti with Maxim Group. Please go ahead.

Thanks. Appreciate it. Good afternoon everyone. Maybe, Chuck, on the three centers. So UPMC, so far, mostly due to COVID, haven’t enrolled new patients in the KEYTRUDA trial. These new centers that you’re working on, what’s your best estimate in terms of the ability for these new centers to have patients that meet the criteria necessary to be in that KEYTRUDA trial?

Anthony, I just want to make sure I’m answering your question appropriately. Are you referring to the COVID trial or the oncology trials?

The first – well, I’m going to ask about both, I was starting with the oncology trial.

Well, what I can tell you, the oncology trial is both domestically and internationally, we were in contact with other centers and discussing different tumor types and designs, and those discussions are happening currently.

We have very productive conversations with a lot of interest, Anthony. So, we’re pleased with that at this point. And to a certain extent, there are places where it has been the best seriously hit by COVID and have not had the bed offset the current – has happened in the United States.

Okay. And then – switching gears to the COVID trial, how many patients are currently enrolled in that? And then obviously, as rates drop precipitously here domestically, is there – do you foresee some difficulty in getting more patients enrolled in the COVID trial?

So Anthony, to answer your question, we have not enrolled any of the 40 patients to date. But there’s an interesting phenomena where at the peak of the wave, the healthcare systems and the staffing were somewhat overwhelmed. So, now we’re more in a sweet spot where the number of cases may have come down, but it doesn’t have the same repercussions on the staffing within the hospital so that would actually counterintuitively makes it more easy – it makes it easier for them to enroll because they’re not buried under the weight of the wave.

Okay.

Just to reiterate, so the staffing has improved and the cases have put less strain, but there is still a number of cases within a hospital. So it just makes it easier to enroll from a staffing perspective.

So it’s good that easier to enroll from a staffing perspective and that seems to be the case in terms of staffing as people start to return from the peak positivity rates and call outs from being impaired or for having COVID, right, but the AXEL [ph] trial itself – yes, go ahead.

Yes. So just to expand upon it, we’ve actually had TIs and whole study research teams that have been shut down because they’ve all had coded and they’re returning to work. So that’s just one example.

Sure. No, no, that makes sense. I’m sure that’s across the country for all types of studies, right? So, now that they’re returning though, obviously, it’s delayed things, but what’s your best estimate in terms of the expectation for the COVID trial in terms of ramping up and any type of timeline or – yes, any type of time line or estimate you could provide on that as you see that sort of playing out the rest of this year?

So there’s a few different cohorts, now where we’re happy that we have three hospitals that are actively screening in the U.S. And now we have at least five sites that are kind of in the final stages of activation. Often for that group, the final stage of device training is all of that remains. So, we’ve gotten through the laborious process of IRB approvals, contracts, budgets, that’s all passed and we’re in the final stages. So, I can’t give you an exact date of when they’ll be open, but it will be in the near future. So, we’ve kind of gone through the bulk of the process, the activation process for those sites.

Okay. And the last question is more sort of on the process and the strategy going forward. It’s good that you’ve expanded the reach, both for three hospitals actively screening for COVID and looking to expand beyond University of Pittsburgh Medical Center on the oncology side for the KEYTRUDA trial. In terms of recruiting patients in general to meet these criteria, is there – does it make sense? Or have you contemplated looking at CROs or is there anything that could expedite the process for you? Or it’s just – it’s going to be process no matter what, and the cost benefit doesn’t warrant using any – outsourcing any of this?

So for the COVID study, we’re employing the CRO PPD and what we’ve noticed is an acceleration actually of our activation – site activation process as a result of employing them. The same is true, we brought on Qualtran, which is an India CRO and they’ve been quite helpful in getting Medanta Medicity up and running. The oncology study is a single center study so that, it becomes easier to manage. But for future oncology studies that we would envision that we would also employ a CRO. Yes, we agree that it does actually accelerate the timeframe to get things done.

Okay, great. I’ll hop back in the queue. Thank you.

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.

I’d like you thank all of you once again for joining us today to discuss our Q3 results. We look forward to keeping you informed an up to date on our future calls. Thank you very much for joining us. Have a good day.

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