Good day, ladies and gentlemen. And welcome to your ENDRA Life Sciences Second Quarter 2020 Earnings Call. All lines have been placed on a listen-only mode and the floor will be open for your questions and comments following the presentation. [Operator Instructions] At this time, it is my pleasure to turn the floor over to your host, David Wells, CFO. Sir, the floor is yours.

Thank you, Karen. Appreciate it. Good afternoon. And welcome to ENDRA’s second quarter 2020 business update and financial conference call. We issued a press release this morning. For those of you who don’t have a copy of the release, you can access it in the Investors section of our website at www.endrainc.com. Before we begin, please note that today’s presentation includes forward-looking statements. All statements other than statements of historical facts, including statements regarding our strategies, financial condition, operations, costs, plans and objectives, as well as anticipated results of our development and commercialization efforts and the timing for receipt of required regulatory clearances and product launches are forward-looking statements. Except as otherwise required by federal securities laws, the company disclaims any obligations or undertaking to update or revise any forward-looking statements. Please refer to our Form 10-K for the 2019 fiscal year and subsequent Forms 10-Q filed with the SEC to get a better understanding of the risks and uncertainties related to forward-looking statements. I will now turn the call over to our Chairman and Chief Executive Officer, Francois Michelon. Francois?

Thank you, David. Good afternoon, everyone. Thank you for joining us today to review ENDRA’s second quarter 2020 performance and 2020 business update. Along with David and me on today’s call are Renaud Maloberti, Chief Commercial Officer; and Michael Thornton, ENDRA’s Chief Technology Officer. Let me quickly go through our agenda. First, I’ll highlight our recent achievements and David will review financials. And then Renaud will provide details on commercial activities with a particular focus on Europe and we’ll finally open up the call for a short Q&A. Before we get to operational business updates, I want to take a moment to comment on the recent loss of our Director, Dr. Sanjiv Sam Gambhir. Dr. Gambhir served as Chair of Radiology at Stanford University School of Medicine. He was an extraordinary clinician and scientists at the forefront of molecular imaging and cancer detection, and had served on ENDRA’s Board since 20-- 2008. We were deeply saddened by Dr. Gambhir’s passing. Sam was a rare combination of scientific brilliance and intensity, wrapped in a modest and approachable demeanor. He was one of ENDRA’s founders, helped us progress to our current state and he stayed actively engaged as a Board member until the very end. I want to ask Sam why he stayed involved with ENDRA, while he led a massive organization at Stanford, and advise much larger and well known biotech companies. His answer was immediate, quote, Francois, it’s very simple. I stay involved because ENDRA has the potential to improve the health of millions of people and dramatically lower healthcare costs associated with later stage acute disease management. ENDRA’s technology could be a game changer in the clinical care cycle of liver disease, end quote. Our thoughts and prayers remain with Sam’s wife and all of the extended Gambhir family.…

Thank you, Francois. I will now provide a summary of our reported second quarter 2020 financial results. Our operating expenses increased to $2.9 million for the quarter ended June 30, 2020, up from $2.3 million for the same period in 2019. Our research and development spending increased year-over-year by $182,000, and our sales and marketing costs increased to $135,000 for the quarter as we continued our efforts in the commercialization of our TAEUS product. Our general and administrative costs increased by $337,000, due to employment related cost, which included non-cash expenses for stock compensation, additional spending on costs associated with being a publicly traded company, including Investor Relations and increase costs for insurance. Our net loss for the quarter ended June 30, 2020 was $2.9 million, as compared to a net loss of $2.3 million for the quarter ended June 30, 2019. Our net loss included non-cash charges which totaled $584,000, comprised primarily of expenses for equity-based compensation and amortization of debt discount. Our net loss per share for the quarter ended June 30, 2020 was $0.20 per basic and diluted share. Our cash balance at June 30, 2020 was $749,000. However, as of August 14, 2020, it totaled approximately $2.4 million. This due primarily to voluntary early warrant exercises from existing warrant holders, which were received in July. We received $2.2 million and retired 3.1 million warrants, as warrant holders approached the company offering to exercise warrants in cash at a discounted price. We’ve filed a consent solicitation statement proposing to allow us to accept additional early exercise offers and we currently have approximately 8.1 million additional unregistered warrants, which could be eligible for offers of reduced price conversions. As a reminder, ENDRA continues to benefit from an asset light operating model, which keeps to a minimum the investment in our balance sheet and allows us to flex our spending as product development cycle matures. This is especially relevant and advantageous in the current COVID-19 economic environment. Combined with previously announced cost saving initiatives, including a one-third cash salary conversion for management and three full quarters of non-employee directors annual retainers paid in the form of restricted stock units instead of cash. We are confident in the company’s ability to fund normal operations and generate revenue from the sale of TAEUS systems in 2020. We continue to actively pursue and evaluate additional opportunities to strengthen our balance sheet and position our company for the exciting commercial growth opportunities that lie ahead. This includes the exercise of outstanding and registered warrants, various market-based funding opportunities, strategic partnerships, as well as non-dilutive academic research grants. I will now turn the call over to Renaud Maloberti. Renaud?

Thank you, David. Through the second quarter, we accelerated our efforts in seeding the market and building our brand to start the commercialization of ENDRA’s TAEUS technology in Europe after we received the CE Mark and we continue to building awareness in the U.S. as we submitted for 510 for FDA clearance. With that in mind today, I’d like to update investors on our Europe commercialization strategy and key progress. As Francois mentioned in his opening remarks, our commercial strategy centers on three key elements. The first commercial element is to establish evaluation site in key markets. As widely reported, COVID-19 has impacted existing and new clinical trials for countless companies. However, as we mentioned on our call in May, we continue to be encouraged by the gradual return to normal operations we are seeing at healthcare facilities, though some facilities are facing a short-term backlog of delayed procedures and radiology exam, but all signs are this -- that this will smooth out quickly. With that in mind, I’m happy to report that we have a verbal approval and are waiting counter signature for our first European evaluation site in Germany. We are also in advanced stages of discussion with additional European site in key markets and we will formally announce these when we start scanning patient at each site in the coming month and contingent on European business operations returning continuing to open. Another good example of this progress is our June announcement of a new clinical partnership with the Medical College of Wisconsin or MCW. This would present the third clinical research partnership for ENDRA in the United States and is a natural progression from the feasibility study conducted by the Robarts Research Institute, which used healthy volunteers to establish the safety and efficacy of the TAEUS technology.…

Thanks very much, Renaud. I’ll wrap up the call by emphasizing that we remain laser focused on two key milestones, ramping up commercialization activities in Europe and supporting the FDA review of our 510(k) submission in the U.S. We look forward to providing investors with updates in the coming weeks and months, as we make specific progress on both fronts. With that, I’d like to open the call to questions, please. Karen?

Thank you. [Operator Instructions] We’ll take our first question from Brooks O'Neil with Lake Street Capital. Please go ahead.

Good afternoon, guys, and congratulations on all the progress. I guess…

Hi, Brooks.

…just a couple questions. First, I’m curious, Francoise, in your experience you mentioned the five months timetable to between submission and FDA approval. Number one, do you anticipate needing to do anything further or we just in a kind of clock ticking environment right now?

So great question. Yeah. Our experience says, so far, as I mentioned, has been very collaborative and open. So, yeah, it’s not as you throw it over the fence and wait to hear on the contrary, it’s very engaged by the FDA, which I’m very happy, as I mentioned, is seems to be interested and asking normal technical questions and wanting to understand the technology. As I also said, it’s a big document. So it’s natural that questions come up, clarifications. So it’s a back and forth process. The five months is really the best information we have in terms of averages. As an average, it could be shorter than that or longer than that. But we’ll continue to keep our investors informed of any material developments, and obviously, remain very engaged to support the process.

Sure. All that’s great. And then, maybe, could you just give us a sense for kind of how you feel about capital availability recognized. There’s still some warrants outstanding and money you have to pursue, but I always bite my fingernails down to the quick thinking about banks running short of money?

Sure. Yeah. I’ll let David kind of articulate that a little bit, if you would, David.

Sure. And Brooks listen, if your fingernails are down to the stubs, mine -- I am all the way down to the bone, because in this market with the uncertainties that are out there and I don’t need to enumerate them, because I think we all know what they are. Certainly, it’s something to be concerned of. However, we are working with and supported by a very loyal base of shareholders who -- and investors who continue to cast their votes with their purchases of our stock. The warrants exchange, which we’re in the middle of, is voluntary and we just love to see that. Of course, we’re looking very closely at additional market based opportunities that are going to be the most advantageous to both the investor and the company and the existing investors. I would love to give you a very specific answer of exactly how it plays out. But today we haven’t given forward looking statements. So our -- we have given guidance. So as a result, I am kind of limited by that. But also it’s a very tumultuous ground that we’re working -- walking on. But as long as we keep performing, as long as we keep the loyal shareholder base who’ve been with us for a long time, as long as we keep making the smart decisions, I think, we are, I think, we are going to be fine.

Great.

That’s great. And then maybe -- and it’s possible that I didn’t fully understand all the comments, but as you think about the path to sort of U.S. commercialization, would you expect that to kind of follow the same path and the same cadence you generally following in the EU or do you see the market here developing differently? Thanks…

Yeah. Hey…

… for taking my questions.

Yeah. Thank you, Brooks. Great question. Yeah. So I think the commercial strategy is global. The implementation is local. But it mimics what we’re doing in Europe. It’s targeting specific regions, putting an evaluation site and ENDRA salesperson in that region. So in the U.S. we could imagine. Now that we’ve already got three evaluation sites spread out throughout the U.S. at -- in the Mid-Atlantic with UPMC, University of Pittsburgh Medical Center, Medical College of Wisconsin in the Midwest and Rocky Vista University in the Southwest in Utah. We will carve up the U.S. as we believe the regional market opportunities align with that and very likely put around five people throughout the U.S. in a similar manner. But as we said earlier in our prepared comments, we don’t want to hire people too early. I think it comes back to your question of funding, we have not increased our overhead dramatically and hired people to then just see them sitting on the bench, unable to actually go out there and sell. So we’re trying to be very smart about this. But I think in the U.S., because of the three sites and the data that we will start collecting in the second half here, will be a little bit ahead of the game when we get the 510(k) clearance. So I hope that that answers the question. The answer is the same model. We very much want to control our destiny while being partnered with good partners like GE, but GE is a big company with a lot of fish to fry and we want to make sure that we’re not just depending on GE. We will also want to call on customers that we’ve developed relationships outside of the core radiology focus of GE, specifically, in areas that we’ve developed in hepatology, endocrinology and elsewhere. We think of hybrid approach of a small sales team combined with strategic partner sales channels is the best way to achieve that. Hope that’s helpful. Thanks for your question.

Yeah. That makes a lot of sense. Thank you very much.

Thank you.

We’ll take our next question from Vernon Bernardino with H.C. Wainwright. Please go ahead.

Hi, Vernon.

Hi. Good afternoon and congrats on the submission and kudos to the e-marketing. I am very want to and very excited to take a look and visit the virtual booth when it’s up and ready.

Yeah. I -- an extra comment on that Vernon. I think pre-COVID having a virtual booth was probably considered second rate to being there in person. But I would say that, nowadays everyone is exactly in the same boat and that includes GE and very large companies. So we have to maximize the visibility through a virtual booth, which will allow us to a little more interactively in three dimensions, interact with the product, interact with some of our materials. But it also comes after building for two years and attending 13 of these global conferences in person. I was in the booth, Renaud, David, Michael, we were all in the booth and that’s a big reason why we collected that -- built those relationships and started collecting those 3,500 names. We’re not just starting the process now. So we’re going to try and make as great a little booth as we can, along with every other virtual participant and we will certainly be trying to capture more leads and develop relationships, but it’s thankfully coming on the heels of a lot of physical groundwork that we’ve done in the years past.

No. Suddenly…

Yeah.

…your innovation in these days is going to get to a lot of interest and I look forward to seeing it for myself.

Thank you, Vernon.

So regarding the evaluation sites, as learners could further unpack the activities described what’s involved in establishing these evaluation sites? And also what is the timeframe that it usually takes to establish and evaluate?

So, great, great question. I think one comment is, first of all, now that we’ve got several existing evaluation sites, we’re naturally finding the process to be a little bit easier in terms of approaching a subsequent site, certainly, in the U.S., because they see that others are participating. They know people there speak highly and so it’s kind of snowballing in a nice way. But we don’t want to go too fast. So I think three sites in the U.S. is a very good start. In Europe, frankly, those relationships that I mentioned that we started cultivating and trade shows are -- were seeded very often in meetings and clinical conferences. And looking back at UPMC, we were approached in the booth by UPMC, saying, hey, this is interesting, tell me more about it and it led a year later to an agreement. So that’s the same process, Renaud, because of his deep relationships in Europe. His European background language skills, has been advancing those discussions. And as I said, we’re really on the cusp in Germany, we’re waiting for counter signature and that will happen. People are a little bit on vacation, as many of you know, in August. But those have advanced and we’re really confident that the signing, as well as deployment of our staff to support those evaluation sites will coincide with a good opening in Europe we believe based on what we know today. So it takes time. Certainly, it’s taken several months to get to these levels, but we feel good about it. Does that answer your question, Vernon?

Yes. Perfectly. And if I may follow up, how might an outbreak, for example, affect these sites?

Oh! I’m sorry. I didn’t quite catch your question.

How might an outbreak affect these sites, obviously, it is…

Sure.

…fair too cases within your control [ph]?

Yeah. Yeah. Yeah. Yeah. I can’t foresee that. I will say that, we’ve -- all regions are different, but based on our discussions with the sites that we’re discussing, their operations are returning gradually to normal. They get -- some of them are working through some backlogs of procedures including procedures in radiology and we think that will normalize and flatten out. So we believe to answer the other question that you asked, which I, frankly forgot to answer, we view these as typically six months to nine months evaluations doing something like 75 patients per site, comparing our technology to an MRI, as we did at the Robarts Canadian feasibility study. And so starting them here in the second half, we think we will have visibility to the data in the first half of 2021. But along the way, it’s much more than data. It’s about building a relationship with this site, being a key opinion leader in France, Germany, being able to reference these sites and show the Dr. Smith, Dr. Jones in your country is using it, being able to demonstrate it on patients for other commercial customers. It’s this multifaceted benefit. It’s not just about the data. I hope that’s helpful.

Very helpful. And you mentioned expecting initial sales in fourth quarter in Europe, might we perhaps the pricing, what pricing looks like in the fourth quarter?

Yeah. So we have historically indicated that we’re targeting a price point of around US$50,000. That was derived from a host of factors. Our market research, focus groups from clinicians, the relative price points of other technologies in this space, the price point of the ultrasounds that we hope to enhance which typically are $100,000 or above. And, therefore, we’re targeting that, as you know, and I think, what’s inferred in your question is, you don’t really know what the price elasticity is going to be until you get in the ground and you ask someone to make a purchase. We believe that based on that analysis, based on the hundreds of discussions we’ve had over the years about the potential value of this product and also how it aligns with other benchmarks that there’s a real appetite for this. And we believe that even before a reimbursement code that the economic payback and value proposition since it is associated our technology with a reimburse procedure of ultrasound, that there’s an attractive increased utilization of the capital that’s already in the clinicians office. So we’re enhancing that ultrasound. We are driving appropriately increased procedures there and we believe that the payback is can be as short as six months for clinicians. So there’s a host of factors that we’re looking at, but very encouraged with that. Hope that’s helpful.

Great. Very helpful. Thanks for all the insights and congrats again. It was very aggressive schedule and you guys did it. Congratulations.

Thank you so much, Vernon.

[Operator Instructions] We’ll take our next question from Ed Woo with Ascendiant Capital. Please go ahead.

Yeah. Also congratulations on the quarter. I was going to say I’m going to love your virtual tradeshow and booth, but how am I going to get my free pens and free phone chargers off from now on?

We’re going to miss that, as well as shaking everyone’s hand and coming home with a cold every single tradeshow. Yeah, we’ll definitely miss that.

Sounds good. And then, going back to your comment about six months to nine months in getting about 75 patients, is that from when you expect to sign the contract or is still going to be some lead time to get a site up especially in Europe.

Yeah.

Where you haven’t had a site…

Great question.

…built yet?

Great. Great question. So I think six months to nine months is a genuine estimate based on from the start of scanning to patients and are -- citing, if you will, the system, training the staff, starting to scan and it could go faster than that. But I didn’t want people to hang their hat on something premature, because these clinicians, these primary investigators are not doing our research alone. They are practicing clinicians and have other things and we don’t know in what directions they can get pulled. So six months to nine months, we think is an appropriate full cycle from citing our product, training the staff, scanning patients at the site and then distilling, analyzing, and hopefully, publishing on the data and we think that that’s reasonable. Unfortunately, we can’t control it beyond making sure that the product is working well. So this is not something that, we are driving in a -- as a project per se, this is something that is quite objective and that has increased value, because it’s done independently by the clinicians who are leading the studies. I hope that’s helpful.

Great. And do you also plan to have income data to report?

Not likely, simply because, I think, harkening back to my closing statement there a second ago. These really are independent researchers. So if they feel like sharing something midstream, obviously, we’d welcome and support it. But I don’t want to set people up to think that they’re going to get data beforehand. Now, I also want to be clear, this process we have the initial study up in Canada. So there is some human data. As we’ve always said, we need more, but we don’t necessarily feel we need to wait in Europe. We have the CE Mark. Certain clinicians, including the ones that are poised to kick off the European studies have expressed interest and really are curious and they want to try it. So you can see the snowball effect of having those sites, having people in the country go and visit these reference sites, talk to the clinicians. And the commercial power of being able to see something like that in your country to help you make a decision even before data, for the early adopters, we believe is compelling.

Great. And then, just talking about the economics of these studies, how much do you have to invest in these studies or reference sites?

Yeah. We -- yeah. Good question. So suffice it to say, we’ve not disclosed what we invest there. But I want to be very clear, unlike a pharmaceutical study that could cost millions and millions of dollars and take two years to three years. These are well-scoped studies, which we’ve negotiated with partners, who are not in it to make money, they are in it to perform the best medicine and are on the leading edge of exploring new technologies to benefit healthcare. And so I think you’ll see that it’s -- I’m sorry to dodge the question Ed, but suffice it to say, these are been very cost effective and we’ll support it by providing our product initially and having a body in the country to support the studies along the way. And then at the reasonable time flip the switch and hopefully that customer or that investigator becomes a commercial customer. We find that to be very compelling.

Great. That sounds good. Then my last question is on your GE partnership, when does the term end?

January 2021. And that is…

Okay.

… by the way, the third time we’ve renewed it with GE since 2016. As you’ll recall, I, Renaud, Mike Thornton and several others are long-term friends and ex-employees of GE. We have good relationships with GE. And as Renaud mentioned, we think it’s a very interesting synergy. One, we get some exposure and introductions from GE market leader in ultrasound. And GE potentially gets a differentiating technology that it can add on to its installed base of ultrasounds. GE has approximately 30% to 35% of the global market share in ultrasound. It has a lot of ultrasounds in the field and those units are turnover typically every five years to seven years. So in the meantime, GE and all its competitors enjoy maintaining a relationship, adding value through accessories, new software, new features, including we believe ENDRA’s technology to their customers, and saying, hey, Dr. Smith, you’ve got a GE system. You can here’s an accessory that works well with it. We have an exclusivity with ENDRA and it could allow you to measure hepatic steatosis. You’re doing liver scans today. Here’s something you couldn’t do before measuring liver fat. So we think it’s very compelling for GE and certainly for us to be associated with them.

Great. Well thanks for answering my questions and good luck. Thank you.

Thank you so much. I think, Karen, based on what I see, I think, we’re out of questions. I want to respect everyone’s time and just jump in proactively here to thank everyone for joining our call today. We’re really excited with our progress, especially in this tumultuous world, but I think we’re making excellent progress on the regulatory front commercially, as Renaud mentioned, and on the capital front also we feel that we’re making great progress. Thanks to David and our investors. Look forward to updating everyone on the next quarterly call and wish everyone a very good evening.

Ladies and gentlemen, this does conclude today’s teleconference. We thank you for your participation. You may disconnect your lines at this time and have a great day.

Bye-bye.

Thank you