ENDRA Life Sciences Inc.

Good day and welcome to the NDRA Life Sciences fourth quarter 2021 financial results conference call. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star, then one on your touch-tone keypad. To withdraw your question, please press star, then two. Please note this event is being recorded. I would now like to turn the conference over to Yvonne Briggs. Please go ahead.

Thank you, Operator. This is Yvonne Briggs with LHA. Good afternoon and welcome to NDRA's fourth quarter 2021 Business Update and Financial Results conference call. Earlier today, NDRA issued a press release on this topic, which is available in the Investors section of NDRA's websites. 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 2021 Form 10-K filed later today and subsequent SEC filings 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 Malaberti, NDRA's Chief Commercial Officer, and Irina Pestrikova, Senior Director of Finance. With that said, I will now turn the call over to Francois Michelon. Francois?

Thank you, Yvonne. Good afternoon, everyone, and thanks for joining us today for a discussion of Endra's 2021 fourth quarter and full year financial results and an update on our business. The last few months have been a productive time for Endra with several noteworthy accomplishments, including first, clarifying the U.S. regulatory strategy for Artea system to a de novo pathway, a strategy that is supported by the FDA. Second, securing new clinical research partners in China and the U.K. which will expand the sources of data supporting our global commercialization efforts. Third, signing a second pharmaceutical partnership to expand the adoption of TEIS beyond the clinical end-user market. Fourth, ramping up our commercial efforts in Europe as pandemic restrictions are lifted in key geographies. Fifth, strengthening our intellectual property portfolio to protect our technology and enhance our out-licensing opportunities. And sixth, maintaining a capital-efficient business model with a solid balance sheet in order to support our operating plan in 2022. I'll start with an update on our U.S. regulatory strategy. Last month, we announced that after extensive and productive dialogue with the FDA, ENDRA is now pursuing a de novo request for our TEAS liver system. The de novo process builds on our completed 510 submission and provides us with the opportunity for an entirely new product classification, which can yield important and sustainable commercial advantages for the TEIS platform once approved. We'll be able to leverage a substantial portion of our 510 submission, which encompasses many of the same elements needed for the de novo request, including safety and efficacy data. We believe we're aligned with the FDA on the scope of the clinical data they require, and we intend to include data from a subset of our global clinical partnerships. We're committed to generating this additional data as quickly as possible and to submitting the de novo in the coming months. Finally, since the FDA is familiar with key elements of our 510 submission, we're optimistic that the de novo process will be efficient. As a reminder, we previously secured CE mark approval, which serves as an important precedent for additional regulatory approvals throughout the world, and more importantly, means we can actively market the TEA system in Europe, which is our current commercial focus. I'm happy to announce that earlier today we received the ISO 13485-2016 recertification from the British Standards Institution, which validates the foundation and sustainability of our quality management system upon which we obtain our CE marking. In addition, I want to note that the FDA has proposed adoption of these ISO standards in an effort to harmonize its quality system regulation with the international standard. So, NDRA is ahead of the game here. In terms of commercial activity, the COVID-19 recovery is on a positive trend globally from a mortality perspective. However, the pandemic continues to impact individual countries at different levels. As such, Endra's sales team is driving awareness for our TAIS system in person and virtually as allowed in each geography. For example, in Germany, which still restricts in-person sales visits to hospitals, we're conducting virtual sales calls. In France and the UK, I'm encouraged that we're now conducting a growing number of in-person sales calls and demonstrating our technology in person at clinical conferences in hepatology and increasingly endocrinology. Renaud will go in-depth into our commercial activities in a moment. Let's turn to our clinical research activity. We've grown our clinical research partnerships to eight globally, three in the U.S., four in Europe, and one in Asia. In December, we added the prestigious King's College Hospital in London, a teaching hospital that's world-renowned for its pioneering research in liver disease. Last month, we expanded into China with our new clinical research partner, Shanghai General Hospital, which has the highest ranking in China's classification system of A++ by China's National Health Commission. This rating is awarded to only 12 of China's approximate 35,000 healthcare facilities. We believe this is one of the strongest partners possible to provide an entry point strategically into the Chinese healthcare market to help address an estimated 350 million people in China affected by NAFLD and NASH. Collecting TAIS clinical data from our eight global partners is the primary focus for ENDRA in 2022. This local data from sites in France, the UK, Germany, Switzerland, will be key to driving commercial adoption of TAIS in each market. providing independent local evidence of how TEAS performs compared to the gold standard of MRI. We've had a good start to the year with data collection underway at two clinical sites in the U.S. and expect a third site to initiate recruitment of study participants in the next few weeks. Each of these sites will be comparing liver fat assessments in patients scanned with a TEAS system with the same patients scanned with MRIs. with both scans performed with a couple of weeks of one another to ensure comparability of results. As we noted on previous calls, many of the world's clinical research activities were paused for last year or two due to COVID, so our progress has been slowed a bit. While we continue to see some backlog of MRI systems at hospitals where postponed elective procedures have returned in high volume, overall healthcare access and operations are looking stronger in 2022, which is an encouraging recent development. Internationally, we remain committed to getting our European research sites in the UK, France, Germany, and Switzerland up and running in the coming months. And all told, we anticipate scanning 200 to 300 patients globally by the end of 2022. I'll point out that TAIS clinical studies don't need to be completed and published to support our sales team. The research sites just need to be active so our sales team can connect potential buyers to speak with the study investigators and discuss how TAIS is performing relative to MRI. Turning now to Andrew's commercial opportunities beyond frontline clinicians in hepatology, radiology, and endocrinology, we believe our technology holds considerable potential value to pharmaceutical companies and contract research organizations that are conducting clinical studies and need an efficient and practical way to measure liver fat as a metabolic biomarker. By our count, There are over 50 companies working in this area, and each company has up to several hundred research sites associated with their drug trials. In November, we signed a collaboration agreement with VGI Health Technologies to pilot TEIS as an add-on technology to support their patient screening and biomarker measurement during their upcoming Phase II NAFL-NASH study. This follows our first pharmaceutical collaborative agreement with Hepion Pharmaceuticals to incorporate our TEIS technology into their phase 2B study for the treatment of NASH. We believe TEIS can help drive time and cost savings for companies developing liver and metabolic disease drugs, starting with a clinical trial enrollment process, which currently rejects in the industry on average over 50% of potential recruits after incurring the high cost and inconvenience of an MRI or biopsy. Ender's technology may have an important role upfront in screening patients to determine if they meet the study's criteria before they're sent to an MRI or biopsy. This belief is substantiated by the two existing pharma partnerships we've secured, as well as other active discussions underway. Turning now to our intellectual property, continue to grow our portfolio to protect our technology globally from multiple indications, as well as positioning Endra for out-licensing opportunities. In the fourth quarter of 2021, Four domestic patents were issued for a total of 24 patents in the U.S. To date, in 2022, one patent has been issued in the U.S., two patents have been issued in Europe, and two were issued in China. Our current global IP portfolio stands at 89 assets, which we define as patents in preparation, filed, or issued. With that update, I'd like to turn the call over to Renaud Malaberti to provide more detail on our commercial activities. Renaud?