ENDRA Life Sciences Inc.

Good afternoon, ladies and gentlemen, and welcome to the Endra Life Sciences First Quarter 2021 Financial Results Conference Call. At this time, all participants have been placed on a listen-only mode, and we will open the floor for your questions and comments after the presentation. It is now my pleasure to turn the floor over to your host, Yvonne Briggs. Ma'am, the floor is yours.

Thank you, Operator. This is Yvonne Briggs with LHA, Endra Life Sciences Investor Relations Firm. Good afternoon and welcome to Endra's first quarter 2021 business update and financial results conference call. Earlier today, Endra issued a press release on this topic. And for those of you who don't have a copy, you can access it in the investor section of Endra's website. Before we begin, please note that today's discussion will include four looking statements. All statements 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 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 2020 fiscal year filed with the SEC 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 Renaud Meloberti, NDRA's Chief Commercial Officer, and then David Wells, Chief Financial Officer. With that said, I'll now turn the call over to Francois Michelon. Francois?

Thank you, Yvonne. Good afternoon, everyone. Thank you for joining us today to review Endra's first quarter 2021 financial results and business update. I'm delighted that our business progress and investor outreach has attracted growing attention within the investment community and has positioned Endra solidly as we enter the second quarter with a record high level of cash. I'm also pleased that Endra has accomplished several key milestones thus far in 2021, which we'll review on today's call. We continue to advance our thermoacoustic enhanced ultrasound technology, known as TEAS, on multiple fronts. As you know, TEAS is a simple-to-use proprietary technology platform with a first application focused on measuring liver fat for the early assessment of non-alcoholic fatty liver disease, known as NAFLD, and its inflammatory stage, known as non-alcoholic steatohepatitis, or NASH. we believe there's a significant opportunity for TEIS in this first indication as NAFLD and NASH affect more than a billion people globally. By enhancing existing ultrasound systems, which today cannot alone accurately measure liver fat for clinical staging of NAFLD NASH, TEIS allows clinicians to visualize tissues in ways similar to an MRI, but at the point of patient care and at 50 times lower cost. Last year, We received a CE mark for the NAFLD-NASH application for TEIS, and we also submitted a 510K application with the US FDA. As I mentioned on our last conference call, the TEIS 510K submission continues to be in the normal process with the FDA. We've been supporting the process by responding to the FDA's questions as they arise. And these questions relate to information, for example, requesting additional information on how the TEIS technology functions or how it relates on a number of levels to our chosen predicate. We consider this back and forth with the agency to be a standard part of the process for a new technology like TAIS. And naturally, this Q&A with the FDA can extend historical review timeframes, and the FDA doesn't provide guidance in terms of timing, but I want to assure investors we're in compliance with the process and we remain optimistic about securing FDA clearance in 2021. In the meantime, continue to advance on several other fronts. We're growing our clinical evaluation partnerships to generate independent clinical data to support commercial sales. As a reminder, these clinical evaluations are not related to our FDA submission. We added a new partnership this year in Salisbethel University Hospital in Bern, Switzerland, bringing our total to six evaluation sites, three in the US and three in Europe. Our partner, Rocky Vista in Utah, is scanning patients And we look forward to leveraging all these sites clinically and commercially as markets reopen and as hospital procedure backlogs return to normal levels. We're maintaining a cadence of other activities to drive awareness for TEIS. In April, our Chief Technology Officer, Michael Thornton, was invited to present at the American Institute of Ultrasound and Medicine's annual Integrative Ultrasound Meeting, which is considered by many to be the most important U.S. ultrasound-focused conference of the year. This presentation focused on Arteus technology and its initial clinical application for the measurement of liver fat. Ultrasound is one of the world's fastest growing imaging modalities, and at the AIUM conference, we noted four key growth areas for ultrasound. The first is the evolution of ultrasound beyond acute applications, not just looking for things like foreign masses that could be cancer, but now also using ultrasound to track biomarkers, that is, tracking things that correlate to clinical outcomes over time, like stiffness of breast tissue or liver fat. The second noteworthy area at the AIUM conference was obviously the growing role of artificial intelligence to improve ultrasound settings, image quality, and diagnoses. The third big trend focused on using alternative energy sources to generate an ultrasound wave with or without placing a probe directly on the patient for use with burn victims, for example. And finally, the fourth growth area was about using ultrasound therapeutically to treat tissue, for example, ablating disease tissue or opening up the blood-brain barrier to help treat Alzheimer's. What's noteworthy for investors is that Endra is well-positioned to capitalize on all four of these ultrasound trends. We're actively leading in two of the main areas, biomarkers and combining ultrasound with other energy sources, and we're developing AI enhancements for our TAIS liver application. We also have intellectual property that enables applications in the fourth area, therapeutics, with our TAIS tissue temperature mapping algorithm. Endra will continue to participate in these worthwhile clinical conferences, as many clinicians and pharmaceutical companies attend them to learn about new research and technologies, as well as to pursue collaborations. In fact, most of our clinical collaboration sites in the U.S. and Europe originated with people we met at these conferences. Given Endra's active participation in six or more global clinical conferences each year since 2018, we've built broad awareness for TEIS, and developed a substantial global network of clinical contacts which we're leveraging as sales leads. We look forward to attending the European Association for the Study of Liver Disease conference next month and several others in Europe and the US throughout the balance of the year. By the way, we've added an events page on our website that lists the conferences we plan to attend. We continue to build our commercial team to bring TEAS to market and recently added two more sales representatives in Europe, one in France and one in a pan-European responsibility, bringing our European team to four. As we gain traction in the market, we're looking to have an endosales representative in each target European country, working collaboratively with our partner GE Healthcare's representatives to call on radiologists and calling independently on other segments such as gastrohepatology and endocrinology. Upon 510K clearance, we plan to mirror that same sales strategy in the U.S., targeting major regions around our current and future U.S. clinical evaluation sites. Another significant milestone in the first quarter was the signing of our collaboration with Hepion Pharmaceuticals to incorporate Archaea's technology in their upcoming Phase 2B study of CRV431 for the treatment of NASH. This is our first pharmaceutical partnership with TAIS and will be used as an add-on technology to support patient screening and biomarker measurement of liver fat. We believe it's an important collaboration and the first of several as pharmaceutical companies and contract research organizations explore ways to drive efficiencies in drug development. We also believe that pharmaceutical partnerships will provide an additional commercial growth opportunity for NDRA beyond a clinical end-user market as we enable researchers in the metabolic disease space to measure liver fat as a biomarker for their studies the way they do today with blood glucose or cholesterol in a cost-effective and easy manner. Ender's technology, I remind you, can benefit pharmaceutical companies and CROs in three ways. Enders technology will enable pharmaceutical companies to more efficiently screen in or screen out patients during the trial enrollment phase before patients incur the time, cost, and inconvenience of a biopsy or an MRI. And I remind our listeners that currently many pharmaceutical companies and CROs suffer screening failure rates over 50%. Second, during the trial, Endres technology can provide easier liver fat measurements between MRI and biopsy measurements, adding potentially to the trial's data set and identifying liver trends more quickly. Finally, once drugs are commercially approved, TEIS can serve as an easy-to-use assessment tool to identify patients who are suitable for therapy and to help monitor their treatment. Turning now to our intellectual property, continue to strengthen our portfolio to protect our technology globally for both current and future applications. Earlier this month, we announced the issuance of two additional US patents, which increased our total issued patents to four since the start of the year. I'm very proud that our current IP portfolio has grown to 85 assets, which we define as filed, issued, licensed, or pending patent applications. With that update, I'd like to turn the call over to Renaud, our Chief Commercial Officer, to provide more details on our commercialization activities. Renaud?