ENDRA Life Sciences Inc. (NDRA) Q3 2022 Earnings Report, Transcript and Summary

Good day, and welcome to the ENDRA Life Sciences Third Quarter 2022 Financial Results Conference Call. All participants will be in a 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 Ms. Yvonne Briggs. Please go ahead.

Thank you, operator. This is Yvonne Briggs with LHA. Good afternoon, and welcome to ENDRA's third quarter 2022 business update and financial results conference call. Earlier today, ENDRA issued a press release on this topic, which is available in the Investors section of ENDRA's website. Before we begin, please note that today's discussion will include forward-looking statements. All statements by management other than statements of historical facts, including statements regarding the company's strategies, financial condition, operations, costs, plans, and objectives, as well as anticipated results of development and commercialization efforts, the timing of clinical studies, potential partnership opportunities, and expectations regarding regulatory processes, receipt of required regulatory clearances, and product launches are forward-looking statements. Except as otherwise required by federal securities laws, the company disclaims any obligation to update or revise any forward-looking statements. Please refer to the company's Form 10-K for the 2021 fiscal year and subsequent Form 10-Q for more information about risks and uncertainties related to forward-looking statements. In terms of the structure of today's call, Francois Michelon, Chairman and Chief Executive Officer will begin the prepared remarks; followed by Michael Thornton, ENDRA's Chief Technology Officer. Mr. Thornton will be followed by Renaud Maloberti, ENDRA's Chief Commercial Officer; and then Irina Pestrikova, Senior Director of Finance will review the third quarter financial results. With that said, I will now turn the call over to Francois Michelon. Francois?

Thank you Yvonne. Good afternoon everyone. Thanks for joining us today to discuss ENDRA’s third quarter financial results and business highlights. Today, we'll review the progress we're making on many fronts to advance our Thermo Acoustic Enhanced UltraSound known as TAEUS. I'd like to start by underscoring that the collection of high-quality clinical data that validate the TAEUS system is the top priority for ENDRA. These data will enable a compelling US regulatory submission and will also support global commercialization. In the meantime, we're continuing to build awareness of our TAEUS system with a steady cadence of marketing activities in Europe and US. And importantly, our balance sheet remains strong to enable the achievement of several significant milestones. As way of background, TAEUS is a proprietary technology platform with an initial application focused on accurately measuring liver fat for the early assessment of non-alcoholic fatty liver disease known as NAFLD, which affects over 1 billion people globally. TAEUS allows for the noninvasive visualization of tissues in ways similar to an MRI, but at the point of patient care and at about 150th the cost. TAEUS is approved for sale in countries that recognize the CE Mark, including those in the European Union, and in the US, we're diligently working towards submitting a de novo request to the FDA. Admittedly, it's taken longer than we expected to achieve our clinical milestones, partly because COVID restricted or even halted work at our partner clinical sites for the better part of two years and also, because ENDRA’s developing a completely new and game changing technology, which naturally comes with some challenges. But as you'll hear from Mike Thornton in a minute, we're making strong progress on the clinical data front, and as you'll hear from Renaud Maloberti, we're maintaining an excellent cadence of marketing activities to build awareness of our TAEUS fatty liver technology among prospective customers in Europe and the US. We also continue to enhance our intellectual property portfolio to protect our technology for multiple applications. In the third quarter, we had eight patents issued and now we have a total of 56 patents issued globally. Several recent ENDRA patents focus on novel cloud-enabled connectivity of medical devices, including ENDRA’s TAEUS system. And we're pursuing potential licensing opportunities for this technology to help other companies collect data from their equipment such as laboratory equipment, which may not have a direct Internet connection. On a separate point, we recently announced a special shareholder meeting to approve a reverse split of our stock. And I want to make it very clear, the reverse split is proposed to maintain compliance with NASDAQ listing requirements and there is no capital raise connected with ENDRA’s reverse split. Okay. Now, over to Mike Thornton. Mike?

Thank you, Francois. Let me summarize what we've accomplished clinically, where we are currently, and what we can expect in the near term. In 2019, we conducted a first-in-human feasibility study for a Thermo Acoustic liver application. At that time, there had previously been some academic research and preclinical work in the field of Thermo Acoustic but very little clinical work in humans have been performed beyond the breast cancer research by Dr. Robert Kruger and colleagues in the late 1990s and none for fatty liver applications. ENDRA's feasibility study with 19 human subjects provided an insight into the potential performance of a Thermo Acoustic application for fatty liver assessment. So far this year, using our clinically targeted platform, our clinical study sites have obtained 95 study participant exams that nearly double the number that we shared in our Q2 update. We know that the TAEUS system has low measurement variation based on instrument repeatability and reproducibility studies. This means that the TAEUS instrument provides consistent measurements day-to-day and across individually manufactured devices. Those studies show variation is less than 3% for the eschar [ph]. Now we see that some of our clinical study users are also able to obtain clinical TAEUS measurements repeatedly and with good reproducibility. However, we've identified some user variability and recognize that additional interactive guidance tools will enable consistent user performance across clinical sites. Specifically, we have updated the instructions for use and added interactive graphical user feedback that will guide users in positioning the TAEUS probe, enabling users to obtain measurements more reliably and with higher repeatability. We expect that subsequent iterations of the user guidance tool will leverage machine learning and other AI approaches to further improve the Intra and Inter-operator performance with our TAEUS system. A look ahead. In addition to deploying the user guidance tools, we will work with our current clinical study sites to complete the data collection for our US regulatory submission. We'll then begin activating additional study sites to build the clinical evidence in support of our commercialization efforts. As Francois mentioned, while it's taken longer than we expected to achieve our clinical milestones, we believe the additional effort to ensure repeatability and reproducibility across clinical sites is essential for our successful FDA submission. And longer term, it will also provide Renaud's commercial team with the clinical data to support commercialization. I'll now turn the call over to Renaud Maloberti. Renaud?

Thanks, Mike. Last week, as part of ENDRA's ongoing marketing activities, Francois and I attended ENDRA 11th Clinical Meeting of the Year, the American Association for the Study of Liver Disease, known as AASLD in Washington, D.C. AASLD is the most important liver disease conference in the US, attracting well over 8,000 clinicians and industry participants. This was the first time in three years that the conference was held in-person. So the meeting was packed and high energy, and we were able to demonstrate our TAEUS system to a good number of potential customers. ENDRA also sponsored a well-attended presentation by two leading hepatologists Dr. Raza Malik and Dr. Kris Kowdley on the State of Diagnostics and Therapeutics in liver disease. This presentation are available on ENDRA’s website. At AASLD, we also met with Hepion Pharmaceuticals, and the partnership remains strong, with both companies looking forward to deploying our TAEUS system as a screening tool as Hepion ramps up their Phase 2b clinical site. The three things we took away from the AASLD meeting, which reflect broader market trends were: first, with well over 1 billion people affected by NAFLD Nash, growing at a 12% to 15% annually. There is a growing unmet clinical need for accessible high-quality noninvasive diagnostics to identify patients early when the disease is reversible. MRI is too costly and liver biopsy is invasive and increasingly suspected of sampling and interpreter errors. We did notice a number of new diagnostic entrants in the AASLD, but most added nothing, new to existing ultrasound technologies such as acceleration [ph], so we feel very good about the continued differentiation of ENDRA technology versus competitive alternatives. Second, we heard a lot of discussion about how liver biopsy may be a bottleneck of pharma therapy development in the liver space. In other words, if you're using an endpoint measurement tool that is prone to sampling and interpreter error like biopsy, you may not be making optimal decisions about which drugs to advance or to stop. Despite this, it was encouraging to see positive clinical results from NAFLD Nash therapeutic companies, such as Altimmune, Alnylam and Akero, all of which could assist in expanding the market for TAEUS. Currently, there are no FDA-approved drugs for NAFLD Nash. And third, NAFLD Nash is increasingly viewed as a multidisciplinary disease at the intersection of radiology, hepatology, endocrinology general practice, bariatric surgery and even psychology for lifestyle and weight loss. That's great for ENDRA because it broadens the market opportunity to deploy our technology outside radiology, and hepatology into endocrinology and primary care settings where checking liver fat should be as routine as checking blood pressure and cholesterol. So if you distill these three points, you see that ENDRA’s goals of providing a high-quality non-invasive diagnostic tool is increasingly relevant for patients across a growing range of clinical care setting and also for pharmaceutical developers and CROs in the medium term. As Mike and the clinical team build the body of clinical evidence that will be essential to our TAEUS sales activity. On the ground in Europe, ENDRA is remaining flexible in our sales efforts by offering rental and lease options in addition to direct capital purchases if -- for the TAEUS system. We believe this range of purchase options, combined with the clinical data and the continued market need for a better diagnostic tool for NAFLD across a range of high-value clinical segment will ultimately lead to our first sales and revenues. Now I'd like to turn the call over to Irina to review the financial results for the third quarter of 2022. Irina?

Thank you, Renaud. Our financial results for the third quarter of 2022 are as follows: For the quarter ended September 30, 2022, our operating expenses increased to $3.4 million from $2.7 million for the same period in 2021. The increase was primarily due to higher spending for commercialization of TAEUS and ongoing product development. Our research and development expense increased year-over-year by approximately $660,000 due to ongoing product development work. Our sales and marketing expenses increased by approximately $140,000 for the quarter as we began to expand our sales and marketing efforts, as Renaud described, including attending a growing number of medical conferences. General and administrative expenses decreased by approximately $35,000 due to lower payroll expenses. Our net loss per share for the 2022 third quarter was $0.05, and compared with a net loss of $0.06 per share a year ago. We continue to maintain our asset-light operating model with further hires in our operations team in anticipation of future growth. As we execute our regulatory and commercial strategy for TAEUS, we plan to adjust the expense structure accordingly and support of these activities. As of September 30, 2022, we had cash and cash equivalents of $8 million. With our current balance sheet, we deliver well capitalized with cash runway to support the submission of our De Novo request for the FDA and continued sequential activities in Europe. And now I'll turn the call back to Francois.

Thanks very much, Irina, Renaud and Mike. In closing, here are the three key messages I want listeners to take away from this call. First, ENDRA’s primary focus is the effective collection of clinical data to enable both a successful US regulatory submission in the short-term and strong global commercialization over the long-term. We're making excellent progress in this area, as you heard from Mike, with 95 scans year-to-date, nearly doubling our scans since Q2. Second, we're maintaining a steady cadence of marketing activities to build awareness of our TAEUS technology with a growing number of clinical specialties in Europe and the US. We've participated in 11 clinical conferences this year, versus eight conferences last year. And our customer database now includes over 5,000 clinician names that we continue to cultivate across the globe [ph]. Third, we have a strong balance sheet that we believe will enable us to achieve several important milestones, including ramping up commercial activities in Europe and submitting our de novo regulatory filing in the US. With that overview, I'd like to turn the call over to our listeners for questions. Operator?

We will now begin the question-and-answer session. [Operator Instructions] And the first question will come from Edward Woo with Ascendiant Capital. Please go ahead.

Yes. Congratulations on the progress. As you attended all these various conferences, have you noticed any change in people being concerned about the macro environment?

Well, thanks. Listen, I'm going to ask also my colleagues to weigh in since we've been sharing the burden in the market going out to these conferences. Yes, I think there's a growing optimism that wasn't there a year ago. I mean, while there's a little more reality setting in on the mania that perhaps was in place pre-COVID about therapies for NAFLD NASH. As we mentioned, there's a realization that the main measurement tool for endpoints biopsies may be so stringent or prone to error that it may be hampering some development. We're really excited about the progress of some companies like Aquiro [ph] and others are making. So, I think overall, there's realistic optimism that's building. As you heard also from Renaud, the macro epidemiology is daunting. I mean it's well over 1 billion people affected growing in double-digits. So, for us, centrally located, we don't really care what drugs succeed. We hope many do, but we're agnostic to that. That will precipitate even more the need to screen these patients, put them on therapies, and then monitor the results. And we hope that ENDRA can play a central role there. So, aside from other factors that we can't control, such as supply chain and interest rates, we think that in our space, the clinical need remains large and hungry. Clinicians are eager and in fact, more are weighing in on this metabolic disease. As Renaud mentioned, it's really becoming a multidisciplinary view of the disease. So, primary care endocrinology, bariatric surgery, and many others are increasingly aware and interested in treating this obesity and liver epidemic. And so we think that we continue to be very well placed in that despite the micro and macro trends. Mike Thornton, perhaps you have another perspective or you could add some more color to that on your time in the field?

Sure. Thanks, Francois. Yes, I think broadly, endocrinology, diabetology, obesity specialists, these clinicians continue to be excited about a point of care fatty liver assessment tool that's cost effective. You heard about the clinical need, it's clear. And we're excited about what our technology has the potential to uniquely do for liver and metabolic health.

I hope, Ed that touches on most of what you were asking?

Yes, it does. Understood. Thank you very much. My last quick question is, congratulations on the 95 TAEUS scan that you got year-to-date. Have you guys been able to really develop learnings and experience so that the next 95, would be significantly faster as they get more comfortable with the system.

Let me again turn that over to Mike, who's leading that effort, if you would, Mike.

Yeah. So as Francois mentioned, we continue to remain focused on our target of 200 scans. But clearly achieving that goal depends, not only on our users' comfort with the device, but also the availability of MRI time and study subject recruitment, which can vary from site-to-site. That's what we've seen. One thing I want to be clear about is, we are targeting 200 or more scans to support our commercialization efforts. But we don't believe, we'll need 200 scans to complete our de novo submission. We're supporting our clinical investigators and sites in every possible way to collect that necessary data effectively. I think -- some of what I talked about, the great feedback we get from our current sites is a new technology that's really critical. And these guidance tools are going to drive engagement and reliability and effectiveness. So we're excited.

Great. Well, thank you for …

Thanks Mike.

…taking my questions and I wish you guys good luck. Thank you.

Thank you.

Thank you, Ed. We've covered a lot of ground I don't see any other questions in queue operators. So I think we can wrap-up the call. And we respect everyone's time.

Well, this concludes our question-and-answer session. I would like to turn the conference back over to Mr. Francois Michelon, for any closing remarks.

Thanks, Chuck and again, just a quick thank you to everyone listening today. Thank you to all our listeners new and historical association. And also thank you to the ENDRA team, who are working in a very lean and focused way to bring game-changing technology to the marketplace. We look forward to speaking with all of you again on our next quarterly conference call. And we wish you a good evening. Thank you.

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