ENDRA Life Sciences Inc.

Good day, ladies and gentlemen, and welcome to your Indra 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. If you should require assistance throughout the conference, please press star zero to reach a live operator. 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 NDRA'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 investor section of our website at www.ndrainc.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 obligation 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 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?

Francois Michelon 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 Malaberti, 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. Sanjeev Sam Gambir. Dr. Gambir served as chair of radiology at Stanford University School of Medicine. He was an extraordinary clinician and scientist at the forefront of molecular imaging and cancer detection and had served on Andra's board since 2008. We were deeply saddened by Dr. Gambir'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 once asked Sam why he stayed involved with Endra while he led a massive organization at Stanford and advised 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 Gambier family. As we shared in July, no changes are anticipated to Endra's day-to-day business activities as a result of Sam's passing, and we'll continue to leverage the clinical expertise of our advisors, Dr. Rubin, Dr. Gao, and Dr. Malik. I can tell you that the team and company are more committed now than ever to making Sam's vision for a practical liver disease diagnostic solution a reality. For those who may be new to the Endra story, were the pioneer of thermoacoustic enhanced ultrasound, known as TEAS. TEAS is a platform which allows clinicians to visualize tissue in ways similar to an MRI, but at 50 times lower cost, and very importantly, at the patient bedside. Our goal is to develop multiple clinical applications for the TEAS technology in areas of high unmet clinical need, and our initial focus is on helping the more than 1 billion people globally affected by non-alcoholic fatty liver disease, known as NAFLD, and non-alcoholic steatohepatitis, known as NASH, where there's an acute need for a practical tool to assess and monitor liver fat before the conditions progress to fibrosis, cirrhosis, and cancer. That brings us to discussing the company's progress during the quarter on our stated 2020 objectives. During the second quarter, we achieved another major milestone on the path to commercializing TEIS with our 510 pre-market notification submission to the US Food and Drug Administration. The submission represents the culmination of years of scientific research, quality system implementation, safety and performance data collection, and I'm very proud of the Ender team, particularly for working tirelessly through an unprecedented global pandemic to ensure the submission was made on the aggressive schedule we set before COVID was a consideration. For any investors that are unaware, the 510 submission is not a simple application. It's an extremely detailed piece of work and represents a significant undertaking in terms of time and company resources. To illustrate the enormity of the task and accomplishment for on-time completion, Our final package submitted to the FDA in June came in at approximately 1,700 pages to meet all of the information requirements. I'm happy to report from our experiences so far that it does not seem that the FDA is noticeably impacted by COVID-related delays. In fact, since our submission, the FDA has been very engaging and collaborative, asking technical questions as part of the customary review process. The 510 process typically takes five months on average from submission to clearance. And based on that, while we can't control the process, we remain optimistic about the potential to secure FDA clearance for TEAS in the U.S. before the end of the year. As we said last quarter, it's also worth emphasizing that clinical data from our three U.S. evaluation sites is not currently required for FDA clearance. The agreements were signed using the Institutional Review Board process. also known as IRB, which allows research institutions to use technology that is deemed to be a low risk ahead of FDA regulatory clearance. So we'll be ahead of the game collecting clinical data that can support our US commercial launch even before we anticipate receiving the 510 clearance. Following 510 , we can look forward to these sites as great reference sites for our US commercial teams. will continue to provide relevant updates to investors regarding the process as they materialize. While the FDA conducts its regulatory review, the Andra team is actively executing the key components of our European commercialization plan. You'll recall we received CE mark approval for our Tejas fatty liver imaging probe, also known as FLIP, towards the end of the first quarter of this year. The CE marking indicates that the TEAS flip system complies with all applicable European directives and regulations in the European Union and other CE mark geographies, including the 27 EU member states. In spite of the global slowdowns brought on by the COVID-19 pandemic, we've continued to execute our business plan to capitalize on our CE mark approval and first mover advantage. Our global commercial plan consists of three key elements. The first element is to establish clinical evaluation sites in each target country to build Endra's base of clinical evidence and cultivate reference sites for commercial teams. We've secured three sites in the U.S. and are expecting imminent signature on our first European site with several more in the pipeline. Second, build a small hybrid commercial Endra team. One person in each target European country and after we receive FDA clearance in key U.S. regions. These salespeople will support the clinical evaluation sites, work with GE sales teams to drive TAIS sales in radiology, and independently pursue market development opportunities in hepatology and other clinical segments. The third element of our commercial plan is to build out our global e-marketing presence and clinical education tools. for its own merits, but also as necessitated in the new COVID world. I'm going to let Renaud go into a lot more detail about these areas in a moment. Turning now to our collaboration agreement with GE Healthcare, which was renewed in the first quarter through January of 2021, the partnership remains strong, and we have regular commercial calls to update our progress, coordinate plans, allocate resources, and share market feedback. GE has been helpful in providing ultrasound equipment for NDRA's needs, and GE continues to view liver diagnostics as a key market opportunity. Under the terms of the agreement, GE Healthcare will facilitate introductions for NDRA to GE ultrasound customers in key markets. Finally, we've made strong progress in building our intellectual property portfolio to defend our technology in current and future clinical applications. Our IP portfolio currently stands at 72 assets, defined as filed, issued, and licensed patents and pending patent applications. And we've got a full-time patent agent on staff to help us grow this portfolio. Bottom line, I'm really pleased with the progress we've made during these challenging times to keep the company on track, advancing our regulatory position and commercialization activities in Europe and the United States. I'd like to turn the call over to David to review the financial results for the second quarter ending June 30, 2020. David? Thank you, Francois.