Aethlon Medical, Inc.
Q4 2018 Earnings Call Transcript

Published: 8 Jun 2018

[Operator:]

Good afternoon, everyone. And welcome to the Aethlon Medical Fourth Quarter Fiscal Year End 2018 Earnings and Corporate Update Conference Call. All participants will be in a listen-only mode [Operator Instructions]. After today’s presentation, there’ll be an opportunity to ask questions [Operator Instructions]. Please also note today’s event is being recorded. At this time, I’d like to turn the conference call over to Mr. Jim Frakes, Chief Financial Officer. Sir, please go ahead.

[Jim Frakes:]

Thank you, Jamie and good afternoon everyone. Welcome to Aethlon Medical's fiscal year end 2018 conference call. My name is Jim Frakes, and I am Aethlon’s Chief Financial Officer. At 4

[Jim Joyce:]

Thank you, Jim, and good afternoon, everyone. We appreciate your participation. As Jim Frakes will disclose during the financial report, we improved our balance sheet significantly during fiscal year 2018. We also advanced the contract with the National Cancer Institute related to our Exosome therapeutic endeavors. We expanded our intellectual property portfolio with multiple patent issuances. We added new members to our Board with relevant industry experience. And we just closed the launch of a follow-on clinical study by our Exosome Sciences subsidiary related to a candidate biomarker with diagnosed and monitored neurological tauopathy, including Chronic Traumatic Encephalopathy. Perhaps the greatest significance, we progressed the advancement of our Hemopurifier with the FDA. For those not familiar with our Hemopurifier, it’s a proprietary affinity hemofiltration device that we developed to eliminate life threatening viruses in the circulatory system of infected individuals. As most life threatening viruses are not addressed with approved therapies, we believe our device holds potential to fill significant void in global health. During fiscal year, we submitted preliminary and final reports to the FDA that’s formally concluded, and IDETs feasibility study of our Hemopurifier has demonstrated safety and health compromised dialysis patients infected with a viral pathogen. The study protocol was designed to be a surrogate model to advance our Hemopurifier as a broad-spectrum treatment countermeasure against life threatening viruses. In September, the FDA designated Hemopurifier to its Expedited Access Pathway program as a mean to accelerate the clinical advancement of our device. Subsequent to this designation, our Hemopurifier received Breakthrough Device designation by FDA, which is a new pathway established under the 21st Century Cures Act. A goal of FDA’s Breakthrough Device program is to provide patients with life-threatening diseases earlier access to candidate therapies. Under the Breakthrough Device program, the FDA permitted the proposed Indication for Use of our device to include; The Hemopurifier is a single-use device indicated for the treatment of life-threatening glycosylated viruses that are not addressed with an approved therapy. As we point out that most life threatening viruses for which there are no approved therapies are glycosylated. At present, we are in active, confidential discussions with FDA to determine the pathway to advance the indication of use under our Breakthrough Device designation. While we don't control this process, we expect to have clarity from FDA that we should be able to share in the near future. With that said, I will now turn the mic back over to our CFO, Jim Frakes, who will discuss our fiscal year 2018 financial results.

[Jim Frakes:]

Thanks, Jim, and good afternoon again everyone. At March 31, 2018, we had a cash balance of approximately $7 million. Our consolidated operating costs and expenses were approximately $5 million for the fiscal year ended March 31, 2018 compared to $6.5 million in the fiscal year ended March 31, 2017, a decrease of $1.5 million. The $1.5 million decrease was due to reductions in payroll and related expenses of approximately $844,000, and professional fees of approximately $608,000, and in general and administrative or G&A expense of approximately $57,000. The $844,000 decrease in payroll and related expenses was principally driven by $926,000 decrease in our non-cash stock-based compensation, which was partially offset by an $81,000 increase in cash, payroll and related expenses, and the headcount additions in our scientific staff. The $608,000 decrease in our professional fees was due to reductions in our non-DARPA related professional fees of $546,000, and our DARPA related professional fees of $39,000, and in Exosome Sciences’; professional fees of $24,000. The primary factors in $546,000 decrease in our non-DARPA related professional fees were; $224,000 reduction in legal fees due to a reduction in registration statement advance enacting activity in fiscal year '18 compared to fiscal year '17; a $146,000 reduction in clinical trial expense due to the conclusion of our clinical trial; and $114,000 reduction in business development expense. The $57,000 decrease in G&A expenses primarily arose from reductions in the G&A expenses and our DARPA related activities of $102,000; and in the G&A expenses at Exosome Sciences; of $30,000, which were partially offset by increases in our non-DARPA related activities of $75,000. We had other expense of approximately $869,000 for fiscal 2018 compared to other expense of approximately $1.2 million in fiscal 2017. During fiscal 2018, we recorded $149,625 in revenues under our contract with the National Cancer Institute, while during fiscal 2017 year recorded $392,000 in revenue from our government contract with DARPA. Overall, the net loss was approximately $5.7 million or $0.46 per share for fiscal 2018 compared to a net loss of approximately $7.3 million, or $0.94 a share for fiscal 2017. We put out these earnings and related commentary in a press release earlier this afternoon. That release included the balance sheet for March 31, 2018 and the statements of operations for the fiscal years ended March 31, 2018 and 2017. We will file our Form 10-K annual report following this call. And now, Jim Grossman, will be happy to take any questions that you may have. Operator, please open the call for questions.

[Operator:]

Ladies and gentlemen, we’ll begin the question-and-answer session [Operator Instructions]. Our first question comes from Brian Marckx from Zacks Investment Research. Please go ahead with your question.

[Brian Marckx:]

Jim, I wanted to start with the FDA and your discussions with them regarding a viable pathway for Hemopurifier. And I gather that you can't really talk too much in detail. But is there anything else that you can they can give us in terms of maybe expectations in terms of timelines, or at least whose court the ball is in as it is today? Is there deliverables that you need to put together to come to FDA to get to the next steps? Or is it more of a FDA has to do whatever it might be before and then get back to you? I am just trying to get a little bit more context around where it stands, I guess?

[Jim Joyce:]

Thanks for anticipating in the call today, good to catch up with you here. In terms of whose balls the court is, I think that’s a good question. Under the Expedited Access Pathway program, one of the primary factors of the program is the ability have more accurate communication with FDA. In this program involve the innovation pathway, which we participated in under a couple different DARPA’s DoD contracts. And we learned through those programs, the benefit of those programs is really active dialogue. And so we have very active dialogue under these programs. And then as I mentioned, we have the benefit of an EAP designation and then the additional benefit of the transition to a Breakthrough Device designation. So we have very active dialogue. The indication for use that was permitted under these programs is somewhat broad, but that is consistent with our historic objectives with FDA is to advance our product as a broad-spectrum countermeasure against life threatening virus, viruses that generally are not approved or not addressed with an approved therapy. I think at this point, the determination that needs to be made as to the most efficient way to collect data for viruses that fall under that indication, and that's the primary focal point of the discussion with FDA. And I will point out that our interpretation of the breakthrough device designation as compared to the Expedited Access Pathway designation is a slight nuance where it’s related to an analysis of efficient ways to collect data. And that analysis discusses whether or not it could be more efficient to collect data in a post market environment as compared to a pre-market environment. And those are the types of discussions that we're having right now. But we talk regularly with FDA and they’ve been very collaborative. I will share this Breakthrough Device designation program got initiated, I think, a lot faster than anyone anticipated. It came about as part of the 21st Century Cures Act, which we wrote an article once when that act got signed in the law that was potential benefit for our endeavor. But the program actually got enacted I think faster than anyone expected. And I think there was some time to digest what this meant, not just for us but from FDA’s standpoint as well. So we’ve enjoyed our dialogue with them and we hope to be able to provide more clarity in the near future.

[Brian Marckx:]

Jim, in terms of not necessarily directly related to the 21st Century Cures Act, but I guess more on maybe a broader view with how FDA has evolved, I guess, I'll say. Maybe that’s not the best word. But in terms of how they’ve changed maybe under the new Trump administration and with the new -- with Scott Gottlieb at the head of the FDA, and the changes that they've made in terms of pathways and maybe being a little bit more progressive, maybe that's not a best word to start. But in terms of thinking out of the box, I guess. How do you think that that may play in your favor, I guess, with this specific endeavor, if at all, I guess?

[Jim Joyce:]

Well, I think the appointment of the new commissioner, Scott Gottlieb, I think has been very impact. I think he’s demonstrated significant leadership. He’s been very clear about his objectives to get patients earlier access to candidate therapy, especially life threatening disease conditions. And I think his leadership is resonating throughout FDA at different divisions, whether it’s related to drugs or CDRH, which is our jurisdiction at FDA. I think the other thing that people might not recognize is that many of the candidate targets that we’re looking at would be considered high threat bio-terror, a pandemic threats and one of the questions is also, how you respond to an emerging threat that was previously unknown. And so the one thing I also want to provide some color on that we’re very appreciative of is we really see with HHS seems to be coordinating well with its other interagency partners, including FDA. And this is something we did know he historically see that HHS, their mandate to government healthcare agencies comes through the Public Health Emergency Medical Countermeasure Enterprise, as acronym is known as PHEMCE. And PHEMCE now has an objective to advance broad-spectrum countermeasures against high threat pathogen, but also a priority on countermeasures that also may have commercial applications, which we feel we very much fit into from a data standpoint. We believe we have collected probably more data as a candidate broad-spectrum countermeasure than other candidates that exist. But previously, the PHEMCE initiatives and FDA and other healthcare agencies have been somewhat disjointed. What I now see is much greater coordination between the agencies, or I should say, actual coordination between the agencies, which we hope will be beneficial to us. But for many years, there’s -- a primary focus put on trying to align a single countermeasure with each and every threat, which is not feasible. And I think at this point in time, the focus shifting towards broad-spectrum objectives at HHS is also resonating with FDA. And we now know those departments interact with each other on these programs. So we think it's not just a bigger focus on providing patient access to these therapies, we also believe that the government is coordinating the efforts in a much more efficient manner.

[Brian Marckx:]

I wanted to talk a little bit about the ESI business, and the TauSome biomarker and the CTE study. I wasn't exactly 100% clear, I didn't -- I don't know if I just didn’t interpret, the press release correctly, but it was in March, I think, the 22nd somewhere around there, talked about the TGEN study. And it's not clear how ESI fits into that study. It’s not exactly clear what the design of the study is. It wasn't even clear what the IDE specifically related to. So is there any more insight you can provide in terms of what your role is versus TGEN's role? Is this a CTE study? Is it a TBI study? Is it both? And anything more that, I guess, you can provide around that would be helpful.

[Jim Joyce:]

Absolutely. The study is a study that we initiated, first site location at the Translational Genomics Research Institute, which you mentioned as TGEN, in Phoenix, principal investigator there is Dr. Kendall Jensen. Our objective is to set up multiple site locations to accrue subjects that qualify for the program. The primary subjects that were enrolling are NFL players, both current and former, age 20 and above. And this is a follow-on study, because the study we performed as part of the first NIH funded study on CTE. In our study we keep referencing CTE, but this is we’re really looking at the TauSome biomarker as a biomarker to potentially diagnose but probably more quarterly monitor tauopathies, which is a series with 21 different neurological disorders that involve the abnormal plaquing of Tau protein in the brain, including Alzheimer's disease. In the first study, we saw a significant elevation in TauSome levels in formal NFL players that are at high risk or suffering CTE as compared to same age group controls. In fact, they were nine times higher. And we also have the opportunity to demonstrate TauSome levels and diagnosed Alzheimer’s patients, which were 10-times higher as compared to the same group -- age group controls. So we saw a correlation between those two tauopathies. Our study than we just kicked off with TGEN is we’re enrolling subjects, but we’re also not just looking for the TauSome biomarker in the blood as the candidate blood test. But based on our work in the field of exosome biology, we’re also looking into saliva and urine as candidate markers as well. On our first day of enrollment, we enrolled formal -- nine former NFL players in day-one. We had great participation and great support from the NFL Alumni Association in Phoenix, and we’re in discussions with other NFL Alumni Associations in different cities. And with next enrollment date -- in fact, in Arizona Republic two days ago to make sure everybody knew that the next enrollment date is Monday, of which we expect to enroll more former NFL players, as well as control subjects. So the study we take is going quite well. Our partner at that location TGEN, we take the samples, we split it with them and then they’re going to be studying for the cargo, looking into cargo of the exosomes that we’re isolating as a biomarker. They’re looking at the cargo to see what more they can learn about this disease condition. And then we anticipate in the near future to disclose future sites where we have different collaborators in areas where there’s high concentrations of former NFL players where we obtain the samples we need, but we bring in additional collaborator in that has another facet of research they would like to do related to this disease conditions. So we’re very happy with the way the study is going. We haven't been very vocal about that, because we’re very much focused on communicating the progress of our Hemopurifier with FDA that we’re excited about the potential of this study. And I think from a data collection standpoint and outcome so far in terms of the possibility of the biomarker that could potentially diagnose or more importantly monitor with disease condition in living individuals, which currently is impossible, we think we have the marker or biomarker with the -- collection and supporting data so far. So we think it’s very promising, and we’re happy with the progress of the new study.

[Operator:]

And our next question comes from Yi Chen from H.C. Wainwright. Please go ahead with your question.

[Yi Chen:]

Jim, would you say it is likely that in the third quarter that the FDA -- you and FDA, might reach a final pathway that it can release to the public?

[Jim Joyce:]

We would certainly hope so. I mean -- and we think that’s certainly feasible that -- and I think I’ve learned not to make any absolute commitments other than to say we’re very pushy on the active dialogue that we have with FDA very, very regular dialogue. This is the benefit of these programs are that unlike other pathways where you might have to submit and communicate with FDA occasionally every few months, I mean, we can actively -- dialog on a weekly basis. So I think we both have the goal of getting patients access through our therapy, we just need to design the methodology of how we do that.

[Yi Chen:]

And while we wait for the FDA's final decision. Are there any currently ongoing trials, including investigator sponsored trials that are using the Hemopurifier that could have some clinical -- additional clinical data reported during the remainder of 2018?

[Jim Joyce:]

Not at this point. We’re hesitant to initiate those types of studies while we’re waiting to get a clear readout from FDA on how to advance the product under the indication for use -- going to put the device program. We certainly have other potential applications in the markets that would lay outside of the indication for use that we’re interested in as well. But we really are focused on obtaining clarity from FDA, which we hope we’ll be able to communicate here in the near future.

[Yi Chen:]

And regarding the clinical study in CTE. When do you expect to have some clinical data readout, is it likely to advance in 2018 or 2019?

[Jim Joyce:]

I think that’s probably 2019. And considering the -- we're happy with the enrolment. But I think by the time we assimilate the data from subjects that are at high risk who are suffering from CTE, as well as the control data by the time that we assimilate that. I think previously we were very fortunate to get the data published in the Journal of Alzheimer's disease, which brought a lot of attention to our endeavors. And I am sure will want to work with our collaborators to again publish this data before we put it out into the public domain in any other fashion or thing.

[Yi Chen:]

Can you remind us how many subjects will be in the CTE study?

[Jim Joyce:]

Our objective is up to 200 subjects between former NFL players and control subjects, which we [think definitely] would be the largest study ever in the disease condition.

[Operator:]

And ladies and gentlemen, at this time, we reached the end of today's question-and-answer session. I’d like to turn the conference call back over to management for any closing remarks.

[Jim Joyce:]

This is Jim Joyce, CEO. We appreciate everyone’s participation this afternoon, and look forward to our future communications. Again, we appreciate your support and have a nice weekend.

[Operator:]

Ladies and gentlemen, the conference has now concluded. We thank you for attending today's presentation. You may now disconnect your lines.