Earnings Labs

Aethlon Medical, Inc. (AEMD)

Q3 2020 Earnings Call· Mon, Feb 10, 2020

$2.19

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Transcript

Operator

Operator

Good day. And welcome to the Aethlon Medical Third Quarter Fiscal 2020 Earnings and Corporate Update. All participants will be in listen-only mode. [Operator Instructions] After today’s presentation, there will be an opportunity to ask questions. [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.

Jim Frakes

Analyst

Thank you, operator and good afternoon, everyone. Welcome to Aethlon Medical’s third quarter 2020 earnings conference call. My name is Jim Frakes, and I am 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, 2019. 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. Tim Rodell, and our Chairman, Dr. Chuck Fisher, 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. Rodell, please note that the news release today and this call contain forward-looking statements within the meaning of the Federal Securities Act of 1933 and the Securities Exchange Act of 1934. The Company cautions you that any statement that is not a statement of historical facts 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, 2019 and in the Company's other filings with the Securities and Exchange Commission. Except as may be required 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. Tim Rodell, Aethlon Medical's CEO.

Tim Rodell

Analyst

Thank you, Jim. And thank you all for dialing into our earnings call. I'd like to first to briefly address the suspension trading the company shares by the Securities and Exchange Commission on Friday. We will then update on the progress of our programs in oncology and we’ll then discuss our view of the evolving corona virus outbreak and the potential relevance of the Hemopurifier in this, in the future viral epidemics. As you know, on February 7, 2020, the Securities and Exchange Commission issued an order of suspension of trading, temporarily spending trading in Aethlon Medical Incorporated’s stock for a period of 10 days. The SEC order stated that the suspension was due to concerns regarding the accuracy and adequacy of information in the marketplace that appeared to be disseminated by third-party promoters and recent and unusual market activity since at least January 22, 2020. Aethlon is aware that certain third-party promoters may have made claims about the potential accuracy of its products with respect to the corona virus. The company neither solicited an advanced knowledge of, nor played any role in the preparation of such reports. Now I wanted to get that out of the way first, so that we can concentrate on what we and our shareholders really care about, which is a discussion of our R&D programs. So let we move to that. We are continuing the advancement of the Hemopurifier for advanced cancers under our recently approved IEE and breakthrough designation. As we previously disclosed, the initial clinical trial in cancer, known as an early feasibility study which is the device equivalent of a Phase 1 trial, will be a small single center, open label trial in 10 to 12 patients with advanced and/or metastatic squamous cell carcinoma of the head and neck or head…

Chuck Fisher

Analyst

Thank you, Jim and thanks, everybody for joining the call today. I think Tim did a nice job of summarizing the key events. The issue for us to deploy Hemopurifier at this point would be demonstrated with buying the 2019 in COV version of the virus, the ones in China and is spreading throughout the world. And two, based on what we're seeing, the intensity and severity of that is quite much larger in China than it is anywhere else. And as Tim pointed out, we would then need to work through the Chinese regulatory authorities should we have the data to present to them. And that's I think the key element here. We've been on top of this since day one. But what we really need to do is get to a point where we have the data that would support making a submission for some form of emergency use in China should they be open to granting that capability. So I think that's a key point on the corona virus on the larger issues of what the company is doing. We're tracking very well and I'm very pleased with the overall performance of the team and of all of our programs. Now, back to you, Tim.

Tim Rodell

Analyst

Thank you, Chuck. So we'll take questions at the end. But what I'd like to do now is turn the call back over to Jim Frakes, our Chief Financial Officer, to report on the financial part of the quarter. Jim?

Jim Frakes

Analyst

Thanks, Tim and good afternoon again, everyone. Our net loss was approximately $820,000 or $0.28 per share for the third quarter ended December 31, 2019 compared to a net loss of approximately $2 million or $1.67 per share for the quarter ended December 31, 2018. We recorded government contract revenue of approximately $413,000 in the three months ended December 31, 2019. This revenue resulted from work performed under our Phase 2 melanoma cancer contract with the NCI. We do not record any government contract revenue in the three months into December 31, 2018. Our consolidated operating expenses for the three months ended December 31, 2019 were approximately $1.29 million in comparison with $1.96 million for the three months ended December 31, 2018. This was a decrease of approximately $670,000 or 34% in 2019, and the decrease was due to a decrease in payroll and related expenses of approximately $755,000, which was partially offset by increases in professional fees of approximately $23,000 and in general and administrative expenses of approximately $58,000. The $755,000 decrease in payroll and related expenses was due to the combination of $513,000 reduction in our cash based compensation expense and $242,000 decrease in stock-based compensation. The reduction in cash based compensation expense was due to recording a $506,000 accrual in the December 2018 period related to contractually agreed severance payments or former CEO and former presidents with no comparable expense into December 2019 period. The $23,000 increase in our professional fees in 2019 was primarily due to $101,000 increase in our legal fees and $27,000 increase in our accounting fees, which were partially offset by $104,000 decrease in scientific consultant expenses. The increase in legal and accounting fees related to increased activity in our registration statement filings and in intellectual property actions among other matters. The $58,000…

Operator

Operator

[Operator Instructions] Our first question comes from Brian Marckx with Zacks Investment Research.

Brian Marckx

Analyst

If we could just start with the cancer feasibility study program. Is there anything else that you can talk about relative to where you are or what you need, I guess before you can go ahead to the next steps, which I guess is to start the study? So any other details that you can -- can you give us. And anything in terms of when you think that the timeline might be for starting that study?

Tim Rodell

Analyst

Thanks, Brian, this is Tim Rodell and thanks for the question. As you know in any clinical trial, you need approval once the FDA has authorized the trial you need approval from at least one local review group, which is an institution review board. But in major academic cancer centers, there frequently is a multi step review process. We are in that process. Fortunately, I've seen actually some major academic centers where you have to go through sequential committee authorizations for up to five or six committees and that's not the case here. I can't give you an exact time frame. But we are hoping that will be open, we will have full approval of the appropriate groups including the IRB and be ready to start the trial. I would say shortly I think sometime around the end of the first quarter, maybe a reasonable prediction, but that could change.

Brian Marckx

Analyst

And is it fair to assume that if you can start on the timeline that you just mentioned, that you believe it would be finished by the end of the current calendar year, so by the end of 2020?

Tim Rodell

Analyst

Well, I would love to give you a firm answer to that. But as you know, that would probably be pretty dangerous for me to do. Until we actually open the trial and start to see the enrollment rates, it's very hard to predict exactly how fast they're going to go. This is a small trial 10 to 12 patients so we don't need that many. And this is a very busy center that we're going to be working and with a very large head and neck patient population. So I'm hopeful that the timeframe you talk about is realistic, but I'm really not going to be in a position to say anything much more than that until we see. Even if you already know exactly what the number of patients that are being taken care of in the center is, you still don't know what percentage of those patients are going to get consented for a trial like this. So I'm hopeful but that's a reasonable estimate. But that will be more comfortable giving you something a little bit more precise once we get open and see a couple months at the moment.

Brian Marckx

Analyst

Relative to the corona virus, I know it's early. Nobody has a whole lot of answers. So I certainly don't expect that you guys will have any details either. But if you can just talk about what your thoughts are or what you've seen relative to what's known about it today. If there's anything that gives you concern that the Hemopurifier may not be able to clear the corona virus?

Tim Rodell

Analyst

Well, it's really basically the issues that the Chuck and I talked about. I think that given the data that we have with a lot of other viruses, including as I said, one additional corona virus, the MWRS virus, it appears that the Hemopurifier has very broad activity against all glycosylated viruses that affect humans. But it would be unethical for us to enter into any kind of treatment without knowing specifically that this virus is bound to the Hemopurifier. So that's a data point that we need. I think the bigger question is our experience in treating viruses and we, as you know, we do have extremely expensive human clinical experience is with viruses were the primary mode of pathology, if you will, involves circulation. Hepatitis C virus circulates and if you decrease the amount of circulating Hepatitis C, patients do better we know that. We're not in the business of treating Hepatitis C anymore, simply because it's a drug -- it's a disease that can be treated with drugs now, rather than an invasive treatment like the Hemopurifier. But probably a much more relevant example is a single patient we treated with Ebola. And we do know, with Ebola virus and probably with all of the other hemorrhagic fever viruses, like barber agent like hantavirus here in the United States, these viruses circulate in very, very high titers. And the amount of circulating virus appears to be directly related to the outcome of the disease, how the patients do. So in a situation like the Ebola patient that we treated, we were able to see that we cleared huge quantities of the virus captured them in the Hemopurifier and the patient did better. The situation here is a bit different from that and I'm not saying that to predict what the outcome would be one way or another. But the coronavirus we know is transmitted through the ones that is, it's inhaled or it's picked up from mucous membranes. So it doesn't enter through the bloodstream and its primary target is the lung, patients get pneumonia and ultimately they're presumably dying of respiratory failure. Now some of those patients are probably in shock as well, we just don't have enough data on the fatal cases at this point to be able to say. So it's not a slam dunk that clearing circulating virus would have an impact on what's really hurting these patients, which is the damage in their lungs. So that's similar to basically what I've already said. We don't know enough yet at this point. If the answer to both of those questions is yes, we could bind the virus and patients have a lot of circulating virus that may have an impact on the outcome of their lung disease that I would say it could potentially have a role there.

Brian Marckx

Analyst

Tim, just for a little clarity on kind of where you are in terms of sort of the next steps I guess. Is it to talk the Chinese authorities, maybe you've already done that, I don't know? But do you have sort of a specific game plan, sequential steps that you need to go through that you think will answer the questions that you have relative to whether Hemopurifier have applicability against corona virus?

Tim Rodell

Analyst

I think two things that we would need as I said, the two things we need to know are can we bind it and that's an experiment that we're not in a position to do now but we're going to keep our eyes open for when we could do that. As you know, this is a dangerous virus and has to be evaluated in high level bio-security facilities, the kind of facilities that are used to handle all life threatening viruses, so we would need to identify, we will need to identify a place where that can happen and we will need access to the virus. Beyond that, I think that we're going to need to understand more about what levels the virus circulates at and begin to put together a story that we could take to the Chinese regulatory authorities and say that we actually think that this could work here. So it's a bit of a sequential story. I can't give you an exact timeframe for how that could happen, but that's the process. What I will say is that the dissemination of information about this virus, about this outbreak, is stunningly current. The New England Journal opened up essentially an ongoing edition where they're turning around publications, case reports and case series, literally on a daily basis. All of the other major medical journals are publishing very quickly. So we are learning a lot about how these patients get infected, how the virus is transmitted and ultimately how the patients who do succumb die. So you know, I think we're going to have a much better idea of what the actual course of the disease is over the course of the next few weeks. The other thing we're going to have an idea is what the course is likely to be for this particular outbreak. That is, is it slowly becoming contained, the rate at which it is expanding outside China is encouragingly slow and limited at this point, but whether China has peaked or not, I don't think we know. We'll understand that better over the course of the next few weeks. Chuck, do you want to add anything to that?

Chuck Fisher

Analyst

I think you captured the key points. The issues is to recognize rebind what circulating. And if you into from this from other diseases, whether it's Ebola or Marburg, or the flu, of ‘19, ‘18, et cetera, many of them had a respiratory component, but they keep in each one of them, they had a high levels of circulating titers, as Tim just mentioned. We're able to demonstrate that we in fact bind the virus, which is not an unreasonable assumption since we have bound other corona viruses, it's possible. And two, if there's an association between circulating viral titers in the blood with the severity of the pulmonary disease, then I think that's the case that makes it more attractive to present to the regulatory authorities as we believe there's a real hypothesis where we can really make a difference, that we're way shorter that right now, as Tim mention, because we need access to specimens and we need transparency on embellishment of the titers. And to put a point to that, I think we all have to recognize how challenging this is to the Chinese medical care system and particularly their physicians and nurses that are managing these patients. They’re in essentially a 24x7 365 program now and we're seeing some of their physicians and the health care providers die. That tells me that in a concentrated environment, if the various much worse, if we capture people and get them isolated perhaps they're able to clear, we don't know if this something in that juxtaposition that raises the mortality in that setting. Those are all questions I think all of us who study these kind of fields are very much looking at. And whether you look at the WHO or any of the surveillance or organizations, they're all same, fundamentally the same thing.

Brian Marckx

Analyst

Just one last one relative to the Chinese and getting access to the virus. Have you -- do you have a communication with the Chinese directly? And the other part of that is do you have a kind of a game plan or some sort of insight into when or if you'd be able to get access, samples, access to samples?

Tim Rodell

Analyst

First of all, the viruses, once they're identified tend to become available to researchers reasonably quickly and we were actually able to evaluate the MERS virus fairly early in that epidemic. So I would say we would expect that it will become available to researchers in the reasonably near future. I don’t want to say in terms of days or weeks. I won't comment on any contact with Chinese regulatory authorities, I don't think that would be appropriate. What I would say is that it is our understanding that the Chinese are doing the same thing that all regulators are doing, which is making sure that potentially helpful things can get deployed and introduced as quickly as possible. But I'm not going to comment on any contact we may or may not have had with the Chinese regulators. What I will say is that for us to have a meaningful conversation with any regulatory authority would require a certain understanding of the two major issues that we've been talking about.

Operator

Operator

This will conclude our question-and-answer session. I would like to turn the conference back over to Dr. Rodell for any closing remarks.

Tim Rodell

Analyst

I just again like to thank everybody for calling in and for your continuing interest. We intend to be as forthcoming as we possibly can with respect to all of the issues that we've discussed. So when we have something meaningful and material to say, we plan to get it out as quickly as possible. Thanks again and have a good afternoon.

Operator

Operator

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