Earnings Labs

Aethlon Medical, Inc. (AEMD)

Q4 2017 Earnings Call· Wed, Jun 28, 2017

$2.19

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Transcript

Operator

Operator

Good afternoon and welcome to the Aethlon Medical Earnings Conference Call for the year ended March 31, 2017. All participants will be in listen-only mode. [Operator Instructions] After today’s presentation, there will be an opportunity to ask questions. [Operator Instructions] Participants of this call are advised that the audio of this conference call is being broadcast live over the internet and is also being recorded for playback purposes. A replay of the call will be available approximately one hour after the end of the call through July 5, 2017. I would now like to turn the conference over to Scott Gordon, President of CoreIR, the Company’s Investor Relations firm. Please go ahead, sir.

Scott Gordon

Analyst

Thank you, Nicole. And thank you for joining today’s conference call to discuss Aethlon Medical's corporate development and financial results for the year ended March 31, 2017. With us today are Jim Joyce, the Company’s CEO and Jim Frakes, CFO. At 4:15 PM Eastern time today, Aethlon Medical released financial results for the year ended March 31, 2017. If you have not received Aethlon Medical's earnings release please visit the investor’s page at www.aethlonmedical.com. During the course of this conference call the company will be making forward-looking statements within the meaning of Section 27-A of the Securities Act of 1933 and Section 21-E of the Securities Exchange Act of 1934 that involve risks and uncertainties. Statements containing words such as may, believe, anticipate, expect, intend, plan, project, will, projections, estimate, or other similar expressions constitute forward-looking statements. 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 may contribute to such differences include without limitation the company’s ability to maintain its listing on the NASDAQ capital market or any other national securities exchange that the company or its subsidiary will not be able to commercialize its products that the FDA will not approve the initiation or continuation of the company’s clinical programs or provide market clearance of the company’s products. The Company’s ability to raise capital when needed, the company’s ability to complete the development of its planned products, the company’s ability to manufacture its products either internally or through outside companies, the impact of government regulations, patent protection on the company’s proprietary technology, the ability of the company to meet the milestones contemplated in its contract with DARPA, product liability exposure, uncertainty of market acceptance, competition, technological change and other risk factors. The foregoing list of risks and uncertainties is illustrative, but not exhausted. Additional factors that could cause results to differ materially from those anticipated in the forward-looking statements can be found under the caption “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended March 31, 2016 and the 10-K to be filed for the year ended March 31, 2017 and in the company’s other filings with the Securities and Exchange Commission, except as made by required by law, the company does not intend nor does it undertake any duty to update this information to reflect future events. I will now turn the call over to Jim Joyce, Aethlon Medical's CEO.

James Joyce

Analyst

Thank you Scott for that very frightening disclaimer language. I appreciate everyone’s participation today as many of you should know our primary focus is to address unmet needs in global health and biodefense, our global opportunity is the treatment of life threatening viruses that are not addressed with antiviral drugs and this is a significant unmet need in global health especially as there is approximately 300 viruses that are infectious to man and only nine of those are addressed with an antiviral drug agent. There is three or four new human viruses discovered each year and we have this perfect storm of global warming, urban crowding and transcontinental travel that are fueling an increased emergence of pandemic viral outbreaks. And then finally there is one other factor I want you to think of, and that is that there is no antiviral strategy to address emerging unknown threats including viruses that could be engineered by man as agents of bioterrorism and two months ago Bill Gates pointed out at the Munich Security Conference that the one threat that could kill more than 10 million people and one of that beyond nuclear war was a genetically engineered viral pathogen. So our solution is the first in class therapy that’s being advanced through FDA approved studies, that is known as the Hemopurifier. It’s a broad spectrum viral treatment candidate and it’s designed for the single use for mobile of viral pathogens from blood. For those that have been following the company you know that we’ve taken this from a theoretical concept to a clinical reality. We’ve worked with leading government and non-government researches to validate the capture of more than 16 high threat viruses. We’ve conducted four investigational studies outside of the U.S. and this included in patients infected with Hepatitis C virus,…

James Frakes

Analyst

Thanks, Jim. At March 31, 2017 the Company had a cash balance of approximately $1.6 million. That cash position will continue to be used to fund our future clinical studies and operations. The Company recorded revenues of $392,000 from its government contracts in fiscal 2017 compared to $887,000 in [Indiscernible] 2016. Those revenues were from work performed under the government contract with the DARPA, and the related subcontract with Battelle Memorial Institute, both of those contracts were completed during the past fiscal year. Our consolidated operating expenses were $6.5 million in fiscal 2017 compared to $5.3 million in fiscal 2016, an increase of approximately $1.2 million. That increase was due to an increase in payroll and related expenses of approximately $1.4 million. However, the increase in payroll and related expenses was caused by a $2.0 million increase in our noncash stock-based compensation due to the vesting of restricted stock units granted during the fiscal year. Excluding that non-cash increase, our overall cash operating expenses actually decreased by approximately $800,000 from reductions in our cash payroll expenses, professional fees and general and administrative expenses, specifically our cash-based payroll decline by approximately $587,000, our professional fees decreased by approximately $97,000 and our general and administrative expenses declined by approximately $80,000. The Company had other expense of $1.2 million in fiscal 2017 compared to $573,000 in fiscal 2016, an increase of $627,000. That increase was largely due to a $358,000 charge for a loss on debt extinguishment and a $346,000 charge for warrant repricing expense in fiscal 2017 with no comparable expense in 2016, both of those were non-cash expenses. And our actual interest and debt expenses were $304,000 in fiscal 2017 compared to $574,000 in fiscal 2016. Overall, the net loss for fiscal 2017 was $7.3 million, or $0.94 per share compared to a net loss for fiscal 2016 of $4.9 million, or $0.66 per share. We will file our Form 10-K annual report later on this afternoon. In the statements of cash flows in that annual report you will see that we reduced our cash used in operating activities by approximately $823,000 as a result continued focus on keeping our cash burn rates while we go through our clinical progression. That number is consistent with the $800,000 decrease in our cash-based operating expenses that I previously noted. And I’d also like to mention that there will be some 10-K related filings over the next week or so as we update our S-1 related registration statements with the information from the 10-K. And now Jim Joyce and I would be happy to take any questions that you may have. Nicole, please open the call for questions.

Operator

Operator

Thank you. [Operator Instructions] And our first question comes from Brian Marckx of Zacks Investment Research. Please go ahead.

Brian Marckx

Analyst

Hi, Jim and Jim. And we can talk a little about the EAP pathway, and I guess in the context of what your goals are in terms of an indicated use there. And I guess initially in terms of the feasibility study and that data it has -- is that data -- is all of that data going to be part of the initial EAP submission?

James Joyce

Analyst

Brian, this is Jim Joyce. No. All of that data is not part of the EAP submission. The EAP submission is abbreviated submission. I will include much of the high level data that was already included back to FDA in our preliminary report in our feasibility study. But it will be more inclusive of the bigger picture of our historic operations or validations against different viral pathogens as well as previous clinical studies and abbreviation of those different studies, and more or less the submission outlines, the rationale of what the EAP pathway is and how you meet those objectives. And we think as a medical device we clearly meet the objective. There is no assurance that we’ll get that designation, but if we do we look forward to it because it puts you in a position to actively communicate with FDA and it could be -- we have the reviewers that have their own ideas on clinical design for mainstream viral pathogens. And if you can engage directly in the design of protocols for a variety of different pathogens threats I think that could be a very effective means to push the technology forward into the marketplace.

Brian Marckx

Analyst

Jim, what are your thoughts today in terms of, I guess an indicated use under the EAP pathway. We’ve talked recently and you said that the initial submission doesn't need to have indicated use I believe, but what are your thoughts in terms of how that proceeds if you get the EAP and breakthrough device designation what's kind of the next steps in terms of developing a clinical study? Is something like an HCV ESRD a larger study? Is that potentially in the game plan or kind of how should we think about what is essentially a PMA pathway and expedite PMA pathway. How would that -- what are your thoughts I guess in terms of what the next steps would be?

James Joyce

Analyst

No, I appreciate the question because every time we move forward FDA establishes a new president because we’re the first device of its kind to move forward through FDA studies. So, we really have to distinguish the pathogen threats that we address that are virulent threats where you can’t run controlled human studies. And these are the threats where we believe we can continue to advance those in discussions with government agencies based on the broad-spectrum countermeasures focus of the U.S. government as dictated through the 2016 PHEMCE initiative. And again there is many countermeasures in the strategic national stockpile that are not FDA approved, they are because they’ve been demonstrated to be safe and offer the possibility of being effective in humans to protect them against bioterror and pandemic threats. So that's one pathway. On the EAP pathway the continued progression through FDA where we have the opportunity to obtain label indications specific to a virus, I first want to point out that the program that we just ran the feasibility study was originally a protocol designed by FDA. We have previously run the protocol in India with success and again we feel we replicated that here in the U.S., but that protocol was designed to advance our product as a broad-spectrum countermeasure against viral pathogens in the United States, it was a protocol designed by FDA. So, it’s a feasibility study that’s modular, now allows us to branch out in the pivotal studies. And the pivotal studies, we have a number of different opportunities. You referenced ESRD patients potentially infected with Hepatitis C as continued studies. We have an interest in amongst more in hepatitis space, amongst more than just hepatitis C. We think there are opportunities in Hep B, Hep A. One of the things that we…

Brian Marckx

Analyst

Okay. And so in terms of the countermeasure pathway, potential pathway related to PHEMCE. I think as you mentioned on a prior call that you’d expected to meet with the BARDA regarding that. Has that meeting taken place?

James Joyce

Analyst

That meeting -- we previously met with BARDA a number of years ago when the focus was -- the focus was driven towards disease specific drugs not broad-spectrum drugs and the definition of countermeasure was much more limited. And we're actually a finalist for an award but funds got re-appropriated. The fact today is we've resubmitted for meetings with BARDA and not just the typical what they call a TechWatch [ph] meeting. It kind of a one-on-one meeting with new leadership, BARDA’s leadership has shifted and this is not just leadership as BARDA that shifted. As you probably know we have new leadership at FDA that’s expected to be very progressive in treating advancing therapies against disease conditions where there is no approved treatment, but we expect to meet with BARDA in the near future. But we’re already navigating forward with some established companies in the space. They have done a very good job in navigating themselves through biodefense initiatives and have products in the counter -- in the strategic national stockpile as well as relationships with individuals we work with originally that were instrumental in the creation of project BioShield that have been involved in stockpile procurements for other companies. So, we’re building a team that kind of take the new PHEMCE initiatives and leverage those to advance our product with the U.S. government and U.S. government is also kind of established the template. There’s been upwards of $100 billion spent on biodefense initiatives since 2001 and so money has been spent, time has gone by, it’s kind of really understand how it is you can potentially combat these threats, in this template that the US is really kind of develop is something that we believe other nations are going to pursue as well as I said previously these threats they are not just an issue for the United States and how to protect this, it’s an issue for every nation.

Brian Marckx

Analyst

Okay. Thanks Jim. Appreciate it. That’s all I had.

James Joyce

Analyst

Okay Brian. Thank you.

Operator

Operator

Our next question comes from Yi Chen of H.C. Wainwright. Please go ahead.

Yi Chen

Analyst

Hi. Thank you for taking my questions, and congratulations on successfully completing the feasibility study. So my first question is assuming that you successfully get the Expedited Access Pathway designation from the FDA, what is the timeframe we should expect from -- for you to run further studies and the -- so and what's the potential cost of that?

James Frakes

Analyst

Yes. So, what I can tell you is upon submission our expectation is we should have a response whether our application is accepted or not in about 30 days related to the EAP breakthrough device designation. In terms of cost of follow-on studies, but one thing that that we don't have an understanding of yet will be the size of the patient population we know it’s a medical device's who oversight and governed by CDRH, the Center for Devices and Radiological Health at FDA. We’re not a biologic. We know that traditional studies go through CDRH. They're not studies where you’re treating patients, thousands of patients as you would expect in a phase 1, phase 2, phase 3 drug study. For us it's a feasibility study which we just completed and that a pivotal study. In historically all I can say is that CDRH studies with extra extracorporeal devices. Typically we’ve seen pivotal studies range between 48 to a little more than 300 subjects of which usually 50% of those subjects are control subjects. So, the cost going forward and running the studies is really going to be driven by size of the requested patient population. This is where it becomes very important to leverage our allusion assay that quantifies virus capture in the cartridge and no longer circulating in the patient as if more absolute data point. So it eliminates some data analysis and determining whether or not you’re hitting you label indication which in our case a single-use removal viral pathogens from blood. But we can’t make a projection on cost at this time until we concluded with FDA what specific indication we would first pursue. We’re not limited to pursuing any single indication through a pivotal study. This could be one or more multiple indications and we think there's a number of promising indications beyond the bioterror and pandemics threat that you could pursue in pivotal studies but we just – we’re not to the point where we could project the cost of those studies.

Yi Chen

Analyst

Got it. So if I understand it correctly, it seems like in the near future you may run three studies in parallel. One is a study targeting specific infectious disease and go through the probably FDA PNA passway but expedite it. Another study is pandemic treatment study working with the U.S. government and such study could be the CTE studying NFL players is that is at the right concept?

James Joyce

Analyst

Yes. But the point I would make in the pandemic threats, based on viruses that we validated the capture of insight and we’ve since demonstrated the safety of our device, we’re not sure to what extent additional studies need to be conducted specific to FDA. We know that FDA products approved products are not the basis of countermeasures being put into the strategic national stockpile. But one of the things that will be seeking is a designation from FDA, the kind of answers to questions in terms of an FDA approval, this is not related to stockpiling alert technology, but to request a designation as to what if any other studies need to be conducted and counter against bioterror or pandemics threats where we validated capture the virus, we’ve demonstrated safety through our feasibility study and there is no ability to conduct control, controlled studies in humans. So that something that we’re going need to get a kind of ruling on again kind of new president ruling. But one thing that we've already addressed previously that in these bioterror and pandemic threats as a medical device we don't fall under the rule provision for a drug or vaccine which requires that if you can't address demonstrate efficacy in humans because it’s not possible to run studies for obvious humanitarian standpoint you can affect individuals with virulent pathogens to run studies that there is a what’s was called the animal rule that you need to demonstrate effectiveness into animal models, different animal models, for many of these pathogen there is no animal model that exists. In our cases, the device we don’t fall under that rule. So we believe that as it relates to FDA demonstration of safety and capture the actual form of the virus infectious to man is a pathway for the disease indication.

Yi Chen

Analyst

Got it. So is it reasonable to expect that the bioterrorism and pandemic treatment study without human beings involved could be the first pathway to generate could be the initial pathway to generate first revenue from product sales potentially?

James Joyce

Analyst

No. I think that’s fair to say and I think there's also an alarming amount of the interest right now inside of the beltway [ph] related to submitting a strategy in place that could potentially address newly emerging pandemic threats or genetically engineered viral pathogens. There is no strategy to address those at this point in time. And our mechanism of capturing viruses by the glycan shield that they coat themselves with as a means to -- immune surveillance and this is also an impediment to vaccine and drug development. That mechanisms which provides us broad spectrum capability and unfortunately the strategy to-date has been – there’s an outbreak of a new pathogen or pathogen, many cases where we’ve known about it for decades, but there’s just no treatment countermeasures. There’s an outbreak of a sudden, there’s a fire drill to develop an antiviral drug or a vaccine. There’s discussion of promising vaccines, but all these things take years to develop. And there’s really not enough participants to develop these countermeasures. Normally as you know you’d expect the large – you need a large candidate pool of treatment countermeasures to a specific disease to expect one to be approved and demonstrated to be effective. So in essence what I’m saying is, there’s a very little likelihood that any of these threats can be addressed on a timely basis when there’s an outbreak. You can’t start your research programs when an outbreak occurs. You can’t start your research programs when there’s a newly emerged pathogen, you can’t start it when there is a new genetically engineered pathogen threat that’s been released. So the problem historically has been, there’s no net [ph], it’s either people are going to die, people are going to die until there is a traditional drug or vaccine [ph] counter measure and we think in this area we represent the net that we are the backdrop to be able to address this multitude of threat related to viral pathogen of which most viral pathogens are not addressed with a drug or vaccine. So we think we are re-thinking the feel of how to address these different threat and we believe that the work we’ve been finding a way on for more than a decade, the shift in regulatory landscape in FDA and major shift in the landscape for the federal government on what they are thinking to put in a strategic national stockpile we think these are all favourable trends for us.

Yi Chen

Analyst

So during the rest of 2017 can we expect more clarity regarding what additional work needs to be done by Aethlon Medical to satisfy the government’s needs to be a kind of measure for both threat and pandemic?

James Joyce

Analyst

I believe that’s fair to say and that’s driven by we are going to get feedback whether or not our application on our expited access breakthrough technology application whether or not that’s accepted and that will be a trigger for a next absolute FDA if it’s accepted, that will expedite the pathway of communicating what we are going to be doing beyond outside of the bioterror and pandemic threat indications moving forward in the pivotal studies.

Yi Chen

Analyst

Okay. Thank you very much.

James Joyce

Analyst

Thank you, Yi.

Operator

Operator

We have now reached our allotted time for questions. This concludes our question and answer session. I would like to turn the conference back over to Jim Joyce for closing remarks.

James Joyce

Analyst

Okay, thank you operator. I wish to thank everyone again for your time today. We will ofcourse continue to update you on our upcoming developments in our participation both in industry and investor conference and other events in the near future. Thank you again for your time and continued support.

Operator

Operator

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