ENDRA Life Sciences Inc.

Good day and welcome to the Enduro Life Sciences second quarter 2023 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 then zero on your telephone keypad. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then one on your telephone keypad. To withdraw your question, please press star then 2. 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 second quarter 2023 business update and financial results conference call. Earlier today, NDRA issued a press release on this topic. and also issued a news release announcing the submission of a de novo request for its TAIS system to the U.S. FDA, both of which are available in the investor section of NDRA'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 include 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 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 2022 fiscal year 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 Michael Thornton, NDRA's Chief Technology Officer. Mr. Thornton will be followed by Irina Pestrikova, Senior Director of Finance, to review the second quarter financial results. With that said, I will now turn the call over to Francois Michelon. Francois?

Thank you, Yvonne, and good afternoon, everyone. And thanks for joining us today to discuss NDRA's second quarter 2023 financial results and business highlights. As we announced earlier today, I'm extremely pleased that NDRA submitted its de novo request to the US FDA for the Thermoacoustic Enhanced Ultrasound Liver System, known as TEAS. Our de novo submission is a pivotal milestone for Andra, highlighting our team's commitment alongside our clinical partners to offer a non-invasive and cost-effective solution for measuring liver fat, which is the root cause of a disease affecting over 1 billion people worldwide. We see the de novo process as a gateway to establish a new regulatory standard, highlighting TEIS's groundbreaking capabilities, and we look forward to collaborating with the FDA during the review process. Gathering and analyzing the scan data along with assembling the submission itself was an enormous task, especially for a company the size of Endra. The process has taken a bit longer than we originally expected, but we're delighted to have made what we consider to be a first-rate submission to the FDA. Mike Thornton will provide more detail on our clinical and regulatory progress shortly. But before turning over to Mike, I'd like to mention a few other highlights from the second quarter. We showcased the TEIS liver system at two major European clinical conferences. Endra participated in the German Diabetes Association's 57th DDG Annual Meeting in Berlin, which underscored the role of liver health in managing type 2 diabetes. the company shared study findings in a peer-reviewed clinical abstract titled Thermoacoustic Assessment of Fatty Liver Disease, an Early Clinical Feasibility Study, at the esteemed European Association for the Study of the Liver Congress in Vienna, commonly known as EASL. This presentation served to elevate TEIS's profile amongst potential clinical users to support commercial adoption. At both conferences, In light of approaching commercial drug therapies targeting liver disease, we heard a lot of discussions about the clinical need for a safe and cost-effective way to suitably identify and monitor patients for their drug response. And this is where Endron tends to lead. In the second quarter, we also expanded our intellectual property portfolio to 64 issued patents globally. During the second quarter, Endra secured four additional patents, including one in the US and three in China. These newly issued patents not only reinforce Endra's unique position in assessing liver fat, but also open the doors for other potential applications of our thermoacoustic technology. The company is actively exploring licensing opportunities in non-core indications to augment the value of our growing IP portfolio. Finally, in May of this year, we raised approximately $4.7 million through an underwritten public offering. Management believes that ENDRA has sufficient cash to fund operations through several important milestones expected in 2023, including supporting commercial activities in Europe. Okay, over to Mike Thorne for more detail on our clinical and regulatory progress. Mike?