ENDRA Life Sciences Inc.

Hello, everyone, and welcome to this Andra Life Sciences first quarter 2020 earnings conference call. During today's prepared remarks, all phone participants shall remain in a listen-only mode, but later you will have the opportunity to ask questions. As a reminder, today's conference is being recorded, and to get us started with opening remarks and introductions, I am pleased to turn the floor to CFO Mr. David Wells. Good afternoon, Mr. Wells.

Thank you, Jim. Good afternoon and welcome to NDRA's first quarter 2020 business update and financial conference call. We issued a press release this afternoon. 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 approvals and product launches are forward-looking statements. except as otherwise required by federal securities laws, the company disclaims any obligations are undertaking to update or revise any forward-looking statements. Please refer to our form 10-K for the 2019 fiscal year 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, and thank you for joining us today to review NDRA's first 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, NDRA's Chief Technology Officer. Let me quickly go through today's agenda. First, I'll highlight our recent achievements and David will review financials. Then I'll provide an update on our key milestones and expectations for 2020, followed by Renaud, who will provide additional commentary on commercial activities with a focus on Europe. And finally, we'll open the call for Q&A. Before I begin, I want to acknowledge all the people who are dealing with COVID-19 as a patient, parent, family member, or friend. Our thoughts and well wishes are with all of you, and our particular appreciation goes out to the frontline caregivers providing help to those in need. On a corporate level, David will detail proactive actions we've taken to align the company's structure with this environment, while also ensuring our ability to bring the TEA system to market in 2020. Right now, I'd like to discuss the company's progress during the quarter on our stated 2020 objectives and commercial milestones. For those who may not be aware of Endra's story, we're the pioneer of thermoacoustic enhanced ultrasound, known as TEAS. TEAS allows clinicians to visualize tissue in ways similar to an MRI, but at 50 times lower cost at the point of patient care. Endra's goal is to develop 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 possibly cancer. During the first quarter, we achieved a major milestone paving the way for commercialization of TEIS. When we receive the CE mark approval for our TEIS fatty liver imaging probe, also known as FLIP, we receive this ahead of schedule in March. The CE mark indicates that the TEIS FLIP system complies with all applicable European directives and regulations in the European Union and other CE mark geographies, which include 27 EU member states. In spite of the global slowdowns brought on by the COVID-19 pandemic, we've continued to move aggressively to capitalize on our CE mark approval and our first mover advantage. More specifically, we've launched new clinical education tools and are advancing a network of potential TAIS evaluation sites in Europe where we see the greatest opportunity to achieve near-term commercial success. We remain on target to install TEAS at our first evaluation sites in Europe this summer. This will be followed by training our partners, recruiting and scanning patients as soon as hospital operations return to normal. And we see this cycle gaining momentum over the summer and are encouraged by our partners' enthusiasm to start using the TEAS system. Renaud will provide more details in a few minutes regarding the important activities underway to support the commercial ramp in Europe. Turning now to the progress we're making in our second key market, the U.S., with our CE mark in hand, we focused our regulatory resources on completing our 510 application to the FDA during the current quarter. I'm happy to report we remain on track to make the final submission to the FDA during the current quarter, finalizing verification testing, labeling requirements, and assuring compliance with FCC regulation. which will position Andra to receive approval and begin initial commercial activities of the TEA slip system in the U.S. in the second half of this year. I cannot overstate the significance of this upcoming milestone as the FDA approval will position Andra to simultaneously ramp commercially in two major markets in 2020, the U.S. and Europe, each with an acute need for a practical and cost-effective liver diagnostic solution. In anticipation of the FDA milestone, we continue to advance our pre-commercial activities in the U.S. This includes renewing our collaboration agreement with GE Healthcare during the first quarter, extending the agreement's term to January of 2021. As a reminder, under the terms of the agreement, GE Healthcare will continue to support Endra's commercialization activities for its TEAS technology for use in the fatty liver application by facilitating introductions to GE Healthcare ultrasound customers. will afford GE certain rights of first offer with respect to manufacturing and licensing for the TEAS liver application. As widely reported, COVID-19 has impacted existing and new clinical trials for countless companies. However, we're encouraged by the fact that healthcare facilities appear to be gradually returning to normal. What's more, the recent Centers for Medicare guidance about healthcare facilities restarting elective procedures aligns with the feedback we are getting from our clinical partners. On that front, we continue to strengthen our relationship with our U.S. clinical partners, Rocky Vista University and the University of Pittsburgh Medical Center, finalizing experimental design and patient recruitment, even as COVID-19 has affected hospital operations. As soon as these sites are ready to resume normal operations, Endra will be ready, and we see that happening in June and July. Jonathan Behr, Scott Sober, Alexander Tokman, Richard Jacroux, Ziad Rouag, also known as the IRB, which allows research institutions to use technology that's deemed to be a low risk ahead of the 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 approval later this year. Following 510 approval, we can look forward to leveraging Rocky Vista and UPMC as great reference sites for our U.S. commercial teams. Organizationally, I'd like to highlight the recent additions to the NDRA team. During Q1, we expanded our scientific advisory board with the addition of Dr. Raza Malik, Director of Hepatology and Associate Chief, Division of Gastroenterology at Tufts Medical Center in Boston. More recently, we added Lou Bassanese, Founder of Disruptive Tech Research to NDRA's Board of Directors. While Dr. Malik bolsters our already strong team of clinical professionals advocating on behalf of Endra to the worldwide liver health community, we look forward to leveraging Lou's expertise in identifying disruptive, patent-protected technologies, as well as corporate communications to help us broaden awareness with institutional and retail investors as we begin our commercialization phase. Bottom line. could not be more pleased with the progress we've made during these challenging times to keep the company on track to receive critical regulatory approvals and advanced commercialization activities on schedule in Europe and the United States. I'd like to turn the call over to David Wells to review the financial results for the first quarter ending March 31st, 2020.